1331: Brood X

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Sat, 20 Mar 2021 02:59

U.S Deputy Secretary of State Antony Blinken (left) shakes hand with Chinese Vice President Li Yuanchao before a meeting at the Great Hall of the People on February 11, 2015 in Beijing, China. | Andy Wong/Getty Images

The first showdown is over, and each side came out throwing punches.

Now China and the United States will huddle with their partners in hopes of building international support to pressure the other on multiple fronts.

AdvertisementSenior officials from the two countries held three sessions in Anchorage, Alaska, on Thursday and Friday '-- the first high-level gathering of U.S. and Chinese officials since President Joe Biden took office. The gathering began with bitter exchanges, and ended with somber words.

''There are a number of areas where we are fundamentally at odds,'' U.S. Secretary of State Antony Blinken said as the last session drew to a close Friday, ''including China's actions in Xinjiang, with regard to Hong Kong, Tibet, increasingly Taiwan, as well as actions that it is taking in cyberspace. And it's no surprise that when we raised those issues clearly and directly we got a defensive response.''

Early next week, Russian Foreign Minister Sergey Lavrov will visit China, with the United States sure to be on the agenda. The Biden administration's relationship with both countries is on a downward slide. Biden recently agreed that Russian dictator Vladimir Putin is a ''killer,'' while Putin replied by ominously wishing Biden ''good health.''

While Lavrov is in China, Blinken will be heading to Brussels, where he will participate in a NATO gathering and discuss China with European allies. The Biden administration says it wants to rally a coalition of countries to stand up to Beijing on fronts ranging from cyber to human rights to trade practices.

AdvertisementThe Biden administration is looking at taking actions in the next few weeks to punish China over what U.S. officials say is a genocidal campaign against Uighur Muslims in its Xinjiang region, according to a China analyst in touch with Biden administration officials.

The actions will likely include new economic sanctions and could also involve some coordinated measures with countries in Europe which, too, are alarmed by the Xinjiang crisis.

''It's going to be a tense relationship probably for a generation,'' said Matt Kroenig, a former Pentagon official who now serves as deputy director of The Atlantic Council's Scowcroft Center for Strategy and Security. ''And maybe there will be areas for cooperation on issues like climate change or arms control. But overall, the relationship will get worse before it gets better.''

'Strength and action'In Washington, the Biden administration's tough line on China is being well received. Biden is eager to seek ways to work with Republicans on China-related matters, and shows of bipartisan harmony are likely to be more common in the coming months.

AdvertisementIn fact, after their sessions with Chinese officials Yang Jiechi and Wang Yi ended Friday, Blinken and National Security Adviser Jake Sullivan met with Alaska's senators, Dan Sullivan and Lisa Murkowski, both of whom are Republicans.

One package of legislation that could offer a shot at showing a united front is being pulled together by Senate Majority Leader Chuck Schumer. It is expected to include earlier legislative work Schumer did with GOP Sen. Todd Young of Indiana. The emerging package, which some observers hope could reach the floor as early as April, would focus heavily on investing in science and technology to outcompete the Chinese.

The U.S. and its partners may also take other moves that are more shrouded but highly consequential.

Earlier this week, for instance, the U.S. issued subpoenas on multiple Chinese companies that, according to the Commerce Department, ''provide information and communications technology and services in the United States.'' The move signaled a potential crackdown on Chinese companies that could pose what the administration sees as a national security risk to America.

One thing not likely to happen soon? A face-to-face meeting between Biden and Chinese leader Xi Jinping, under whom the Chinese government has taken an increasingly repressive and authoritarian turn.

Biden administration officials insist they want to find ways to work with China on issues of common interest, such as climate change and battling pandemics. So it's likely the two sides will continue to engage at various levels, even if it's through phone calls and on the sidelines of other forums.

''We'll continue to work with China going forward,'' Sullivan said as the meeting was wrapping up Friday.

A spokesperson for the State Department did not immediately answer questions about the potential future U.S. actions.

The politics of pressureThe Biden administration, like the Trump administration before it, describes China as America's top geopolitical rival. In Washington, that feeling is widely shared among members of both political parties.

AdvertisementOn Friday, a bipartisan group of lawmakers introduced a resolution blasting the Chinese government for its evisceration of democracy in Hong Kong. The resolution also calls on the Biden administration to use sanctions and other tools to punish Chinese officials for the crackdown.

Some U.S. lawmakers also weighed in with sharp barbs against Beijing as the meeting in Alaska was going on.

''I have many policy disagreements with the Biden administration, but every single American should unite against Beijing's tyrants,'' said Sen. Ben Sasse (R-Neb.), who praised Blinken and Sullivan for telling their Chinese counterparts not to bet against the United States.

The Chinese Communist Party is a weak and callous regime, asserted Rep. Mike McCaul (R-Texas), the top Republican on the House Foreign Affairs Committee. ''Strength and action are the only things the CCP understands,'' McCaul said in a statement.

Thursday's gathering in Anchorage began with a public portion featuring some pointed verbal jousting by both sides.

Blinken told Chinese officials that the U.S. would continue to speak out about Beijing's crackdowns in Hong Kong and on Uighur Muslims, along with other points of contentions. Despite China's insistence that these are internal matters, they threaten the rules-based international order, Blinken said, making them fair game for American comment and action.

Yang shot back that the United States is an international bully and that it has its own poor human rights record, including mistreating Black Americans. Wang said the Chinese people were ''outraged'' by the U.S. decision earlier this week to impose a series of sanctions on Chinese officials said to be involved in the crackdown on Hong Kong.

Usually these opening remarks take just a few minutes, but the U.S. side decided to respond to the Chinese allegations, and then the Chinese officials took a second opportunity to lay out their grievances, dragging out the public portion.

AdvertisementA senior Biden administration official afterward accused the Chinese side of ''grandstanding,'' while the Chinese Foreign Ministry said that upon reaching Anchorage, its diplomats' ''hearts were chilled by the biting cold as well as the reception by their American host.''

The actual, closed portion of the first session was ''substantive, serious, and direct,'' the senior administration official said. ''In fact, the discussion went well beyond the two hours we had allotted. We used the session, just as we had planned, to outline our interests and priorities, and we heard the same from our Chinese counterparts.''

It's difficult to say how much of the public back-and-forth was theatrics for each country's respective domestic audiences versus messaging to each other.

Chinese diplomats, however, have been more aggressive on the global front in recent years, often deploying harsh language that analysts say is largely about shoring up nationalist sentiment in China. These diplomats have been referred to as ''Wolf Warriors.''

Even if the Wolf Warriors' main goal is to boost Chinese nationalism, the harsh rhetoric has annoyed foreign officials.

China ''obviously feels it can afford to be more assertive, to the point of being combative,'' a former senior U.S. national security official said. ''It probably plays well in China but also helps cement a growing sentiment here that the Chinese Communist Party is Enemy No. 1.''

Chinese officials have tried to cast this week's discussions as the start of a series of talks '-- a so-called ''strategic dialogue.'' But the Biden administration has dismissed that, saying it was a ''one-off'' gathering.

The goal, they said, was to give both sides a chance to lay out their disagreements as well as talk about where they can work together.

Advertisement''Beijing has been talking about its desire to change the tone of the relationship, and of course, we're going to be looking at deeds, not words on that front,'' a senior administration official told reporters earlier this week.

''And we're of course coming to these discussions with a very clear-eyed view about [China's] pretty poor track record of keeping its promises.''

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Thu, 18 Mar 2021 21:34

The Chinese government maintained tight control of a World Health Organization investigation in Wuhan into the origins of the coronavirus, according to a report from The Wall Street Journal, which said that Beijing was granted veto power over which scientists were allowed to take part in the mission.

According to the Journal, the constraints placed on the WHO team rendered the scientists unable to conduct a thorough investigation into the virus' origins.

A team of more than a dozen scientists, including one American, visited Wuhan last month, where they met with Chinese authorities and scientists to figure out how the coronavirus first infected humans.

A report of the investigation is expected to be released next week, after Chinese authorities have had a chance to review it and make edits, according to the Journal.

Some members of the WHO team, including Peter Daszak, the lone American on the mission, have dismissed one prominent theory that the virus originated from an accident at the Wuhan Institute of Virology, which studies coronaviruses.

Most of the scientists have said that they believe that the virus jumped from an animal species in Western China to humans, possibly at one of Wuhan's outdoor food markets. (RELATED: 'Tailored To China's Terms': Fauci's Deputy Had To Sign Beijing-Approved Confidentiality Form Before WHO Trip To Wuhan)

Daszak has come under criticism from some within the scientific community who say he has a conflict of interest because his organization, EcoHealth Alliance, has worked closely with the Wuhan Institute. Daszak also organized a group of scientists in February 2020 to release a letter that called the lab leak hypothesis a ''conspiracy theory.''

Peter Daszak speaks to media upon arriving with other WHO members to the Wuhan Institute of Virology in Wuhan in China's central Hubei province on February 3, 2021. (HECTOR RETAMAL/AFP via Getty Images)

Officials in both the Trump and Biden administrations have criticized the Chinese government for withholding information from the WHO team.

''We have deep concerns about the way in which the early findings of the COVID-19 investigation were communicated and questions about the process used to reach them,'' National Security Adviser Jake Sullivan said in a statement on Feb. 12.

Chinese authorities also exercised control over a WHO mission early last year.

Emails obtained by the Daily Caller News Foundation show that Cliff Lane, the deputy to Anthony Fauci at the National Institutes of Allergy and Infectious Diseases, was required to sign a confidentiality agreement ''tailored to China's terms'' before taking part in the February 2020 mission.

WHO officials began organizing the Wuhan investigation in July 2020, according to the Journal.

That month, two officials from WHO agreed with Chinese authorities on a ''terms of references'' document which laid out the goals of the investigation. But according to the Journal, the document did not call for full inspections of labs in Wuhan. It also gave Chinese authorities veto power over which scientists could join the team.

A spokesman for WHO, Tarik Jasarevic, told the Journal that the Chinese government did not object to any of the scientists chosen for the mission.

The WHO scientists visited a hospital early in their trip where they attended an exhibition that commemorated Chinese authorities' ''decisive victory in the battle'' against the coronavirus. The exhibit also praised Chinese President Xi Jinping, according to the Journal.

Content created by The Daily Caller News Foundation is available without charge to any eligible news publisher that can provide a large audience. For licensing opportunities of our original content, please contact licensing@dailycallernewsfoundation.org.

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Source: ZeroHedge News

Fri, 19 Mar 2021 14:08

The global supply chain remains "stretched thin," with Ford Motor Company announcing Thursday evening that it will continue to build its top-selling F-150 trucks and Edge SUVs without certain parts, according to CNBC, quoting a Ford spokeswoman.

The spokeswoman said the automaker would continue building the F-150 and Edge models for "several weeks" without specific semiconductor components. When those chips are made available, the vehicles, expected to be "in the thousands," will have workers install the chips.

Production woes don't stop there. Ford canceled three production shifts through Friday at a Kentucky plant that produces Ford Escape and Lincoln Corsair crossovers. Next week, Ford expects to limit production of the Ford Fiesta car made in Germany.

By now, the world knows the massive chip shortage is worsening and could jeopardize the economic recovery.

Ford expects the chip shortage could lower its earnings by at least $1 billion $2.5 billion this year.

In response to the shortage that has severely hit some global automakers to the point of limiting production and furlough workers until supply bottlenecks are resolved, President Biden recently signed an executive order which seeks to address the global semiconductor chip shortage after a session with a bipartisan group of lawmakers to discuss the growing crisis. "Make no mistake, we're not simply planning to order up reports. We are planning to take actions to close gaps as we identify them," a White House official said.

To gauge just how serious the supply chain disruption is, one needs only to read what the respondents to the most recent mfg ISM said to get a sense of how bad it truly is:

"Things are now out of control. Everything is a mess, and we are seeing wide-scale shortages." (Electrical Equipment, Appliances & Components)While the massive semiconductor shortage affects automakers worldwide, other companies in different industries are starting to feel the pressure. Samsung is the latest to confirm that the current chip shortage is "very serious" and "poses a slight problem" for the electronics company heading into the second quarter.

Goldman Sachs' Jan Hatzius provided an outline to clients this week of recent media reports documenting the disruptions.

Hatzius believes supply-chain and logistical challenges will persist through 2021 and only be alleviated next year.

In the meantime, the chip shortage is getting more serious, affecting the production output of certain companies.

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Sun, 21 Mar 2021 11:55

Sign up for the Week in Patriarchy, a newsletter on feminism and sexism sent every Saturday.From curfews to criminalizing ejaculation: it's time to regulate menShould men be allowed out after 6pm? Probably not, a Green party peer has said. Introducing a curfew for men would ''make women a lot safer'', Baroness Jenny Jones argued in Britain's House of Lords on Wednesday, in the wake of the horrific suspected kidnapping and murder of Sarah Everard.

As you can imagine, large numbers of men (and a fair few women) promptly had a meltdown at this suggestion. Nigel Farage tweeted that it was an example of the left being ''deranged''. Meanwhile Mark Drakeford, the Welsh first minister, described the idea of a male curfew as ''a sad distraction when what's needed is a proper discussion about women's safety and why a woman is killed every three days by a man in the UK''.

Boys, calm down please; let's not get hysterical here. Nobody seriously really thinks a curfew for men is a good idea. Not least because, almost one in three women in the UK will experience domestic abuse in her lifetime and women are far more likely to be killed by a partner than a stranger '' so it's not like keeping men in the house after 6pm would make women safe. Jones was doing this little thing called pointing out double standards. As Jones later clarified (and it's pretty depressing that she had to clarify this), her remarks were not a serious policy proposal. Rather, they were a response to the fact that London police have advised women ''not to go out alone'' after Everard's disappearance, and no one seemed to ''bat an eyelid''.

We're used to women's freedoms and women's bodies being up for debate, you see. We're used to women being told to modify our behaviour as a reaction to male violence. Women may not be under a formal curfew but you only need to look at the disgusting victim-blaming that went on with Sarah Everard to see that we're under an informal one. Why was she out at 9.30 at night? Why did she walk home instead of taking a cab? What did she expect? Our freedom of movement after dark may not be restricted by the government, but we often don't have the freedom to fully relax. We regulate our behaviour automatically; we keep our keys in our hands, we stay on high alert, we pay extra to take a cab because we're worried about walking home. Street harassment is so common we brush it off as ''nothing''; after all, it's not like there's anything that we can do we about it anyway. As a recent letter to the Guardian pointed out, ''you can be fined for dropping litter in the UK, but not for harassing a woman or girl in public''.

Women's bodies are public property in a way that men's bodies aren't. Our rights are up for debate in a way that men's rights aren't. Just this week Arkansas banned nearly all abortions in the state, with no exceptions for rape or incest. One imagines many of the same sort of people who think that the government should be able to force a woman to carry her rapist's child in her body for nine months would balk at the idea of the government telling a man he couldn't go out at night.

The policing '' both formal and informal '' of female bodies is so normalized that, as Jones noted, we often don't ''bat an eyelid'' at it any more. Unless, of course, those same standards are applied to men. Jones isn't the first lawmaker to try to turn the tables to make a point; in 2018 a Georgia lawmaker responded to a restrictive new abortion law with a ''Testicular Bill of Rights'' proposing, among other things, that men get permission from their sexual partners before obtaining erectile dysfunction medication. In 2012 a group of six female lawmakers similarly proposed bills regulating men's access to reproductive health. One suggestion? ''Any action in which a man ejaculates or otherwise deposits semen anywhere but in a woman's vagina shall be interpreted and construed as an action against an unborn child.''

I don't think the idea of a male curfew is a ''distraction'' at all. Rather, I reckon the men who are so outraged by the concept ought to take a moment and think about how outrageous the policing of female bodies is. If you're up in arms about the idea of a male curfew, perhaps you should think critically about why you're not as angry about all the ways in which women are told to adapt their behaviour in response to male violence.

Tashnuva Anan Shishir becomes Bangladesh's first transgender news readerBangladesh is home to an estimated 1.5 million transgender people, who face widespread discrimination and violence. This was a small but incredibly important step forward.

Women hold roughly two-thirds of all student debt in the United StatesOne reason for this: the fact women earn less than men with the same level of education, making it harder for them to pay off their loans.

Why are male politicians in love with topless vaccine selfies?Priya Elan considers this hairy question.

Who run the (bronze age) world? Girls!A burial site found in Spain suggests women might have held political power in the El Argar society that controlled territories along the south-eastern Iberian peninsula from about 2200 to 1550BC. The remains of a woman who clearly liked jewels were found on the site: ''It's like everything she touched had silver on it,'' said one expert. A crownlike object found on the woman was almost identical to four others found on women at another El Argar site; there is speculation they may have been political leaders.

Scientists want to send sperm to the moonNoah's Ark is getting an extra-terrestrial upgrade: a paper presented during an aerospace conference this week suggests sending 3,335 million sperm and egg samples to the moon as a ''global insurance policy''.

Libya gets its first female foreign ministerNajla el-Mangoush will be joined by four other women in the cabinet.

The week in passwordarchyNetflix knows that you share your password with your nearest and dearest (along with some random people that your dad forwarded your Netflix info on to) and isn't happy about it. The streaming service has begun testing a feature that will crack down on password sharing. My parents have already written to me to express their dismay.

I worked in a power plant outside Tokyo for a couple of months back in 2017. It was January until March time frame so"flu" season. Everyday during the safety meeting they would mention how many people had the flu and reminded us to gargle and wash our hands. They had a dispenser of Japanese Listerine in the bathroom and a ton of little cups.

These were temporary offices/bathrooms for the power plant outage. Even so it was a full bathroom not port-a-johns. They even had the full Japanese electric toilets. They know how to do power plant outages in Japan.

Thanks,

Bill

https://www.nytimes.com/1971/11/04/archives/ftc-terms-false-the-claim-that-listerine-can-cure-colds.html

1971:

WASHINGTON, Nov. 3 —The Federal Trade Commission today accused the maker of Listerine mouthwash of falsely claiming that the product cured, prevented or lessened colds and sore throats.

In a complaint to be issued if a consent agreement is not reached, the commission charged that the Warner‐Lambert Company product had no real effect on colds or sore throats. The proposed order would ban all such claims and require that each advertisement for Listerine during the next year contain a statement that the commission had alleged that the, claims were misleading.

In a statement, the Commission said: “Warner‐Lambert has represented that the latest or most recent tests prove that children who gargle with Listerine twice a day have fewer and milder colds and miss fewer days of school because of colds than children‐who do not, when studies or tests conducted between 1967 and 1970 do not prove or support this representation.”

“The statement, Kills germs by ‘millions on contact,’ represents, contrary to the fact, that the ability of Listerine to kill germs is of medical significance in the prevention, cure or treatment of colds and sore throats.”

Then, in 1977

In its next $10 million worth of advertisements, the makers of Listerine mouthwash must tell consumers that the product "will not help prevent colds or sore throats or lessen their severity."

The ruling by a federal appeals court here yesterday upheld the right of the Federal Trade Commission to order such corrective advertising for a product whose ads in the past have made false claims. For decades, the makers of the 100-year-old mouthwash product had advertised that it was beneficial for colds, cold symptoms and sore throats.

Government attorneys said the 2-to-1 ruling by the U.S. Court of Appeals for D.C., which traced the history of past government orders concerning misleading advertisements ranging from clocks to baking powder, is a landmark decision in the field of consumer protection.

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Sun, 21 Mar 2021 11:45

Privacy

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Fri, 19 Mar 2021 15:07

Respondents said positive feelings during the pandemic year had been prompted by volunteering, exercise, caring for a pet or a feeling of general gratitude. Image: Ismo Pekkarinen / AOPFor the fourth year in a row Finland ranked as the happiest country in the world, according to this year's World Happiness Report.

Unlike in previous years, the happiness index included surveys on how countries have dealt with the coronavirus pandemic that has shaken the world for more than a year.

The report's authors said this year's survey examined the effects of the crisis on the structure and quality of people's lives as well as looked at how governments dealt with it.

Trailing behind Finland on the happiness index were Iceland, Denmark, Switzerland, and the Netherlands.

All of the Nordic countries were ranked within the list's top 10, while Estonia was 28th and Russia 60th most happy out of the index's total of 149 nations.

The southern African country of Zimbabwe was listed at the bottom of the happiness rankings. Meanwhile the 20 countries found at the bottom of the list were located in Africa, many of which were dealing with difficult situations, unrest or even civil war.

The annual, independent survey is organised by the United Nations Sustainable Development Solutions Network. Rankings were reached via several surveys but chiefly used data from the Gallup World Poll.

About 1,000 respondents in each country were asked to, for example, rate the quality of their lives on a scale of zero to 10.

Other questions included how many times respondents laughed or felt joy and satisfaction the previous day. Conversely, the survey also took into account negative emotions such as asking how often respondents had felt worry, sadness or anger the previous day.

Corona crisis effectThe happiness report is in its ninth year of publication, but this year it also looked at how countries and their inhabitants had dealt with the coronavirus pandemic.

The survey asked how people's lives and feelings may have changed during 2020 compared to the previous few years.

The causes of negative feelings included weakened economies, health worries of the respondent or a relative as well as job losses and difficulty finding employment.

Meanwhile, respondents said positive feelings during the pandemic year had been prompted by volunteering, exercise, caring for a pet or a feeling of general gratitude.

While organised by the UN, World Happiness Report was compiled "by a group of independent experts acting in their personal capacities. Any views expressed in [the] report do not necessarily reflect the views of any organization, agency or program of the United Nations," the report's website states.

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Fri, 19 Mar 2021 15:13

Evidence gathering exercise will inform the development of the UK's proposed Covid-19 vaccine passport scheme By Alex Scroxton, Security Editor Published: 16 Mar 2021 9:15

The government is launching a call for evidence as part of its review of proposed Covid-19 vaccine passports, seeking input from organisations and private individuals with relevant expertise, as well as interested members of the public.

As previously revealed by the prime minister in his Covid-19 exit roadmap, Westminster is examining whether or not some kind of technical vaccine passport could play a part in reopening the UK's economy, easing restrictions on social contact, and improving public safety in the coming months.

Such a certification '' which will likely almost inevitably be centred on a mobile application '' would likely use testing or vaccination data to confirm in various settings that people are less at risk of passing the virus on.

The review will take into account aspects around ethics, equality, privacy, legal and operational factors, and explore what limits will need be placed on organisations using certification.

Cabinet Office minister and chancellor of the Duchy of Lancaster, Michael Gove, who is leading the probe, said: ''This review into Covid-status certification is an important part of our plan to help reopen the country and return to normal.

''However, we recognise that there are complex issues of ethics, privacy and inclusion that need to be fully considered. That is why I want to get as many views as possible on Covid-status certification and its potential implications to help inform the review,'' said Gove.

Live tests of one proposed vaccine passport solution, developed by Mvine and iProov with backing from Innovate UK using funding initially announced during the pandemic's first wave, is currently ongoing with two trials set to report in the next fortnight. The technology uses an unspecified ''mathematical model'' of the user's face to associate them with a reference number linked to their Covid-19 test or vaccination.

It is claimed that this process makes it possible to prove your Covid-19 status and for doctors and nurses to check this is accurate by assuring said status is linked to you, and nobody else. This supposedly does not require the specific identification of individuals, and that no identity is captured or stored.

But many privacy campaigners are not so sure that such measures will be effective or used appropriately. Commenting on the review back in February, the Open Rights Group's Jim Killock said: ''Vaccine passports have the potential to be extremely discriminatory and invasive of personal privacy. They could be used as an excuse for ID cards through the back door. And the supposed benefits may be limited and temporary.''

The review is supposed to include ahead of the planned fourth step of the lockdown easing plan, which is currently set to happen no earlier than 21 June, and if it goes ahead as hoped, will effectively remove all legal restrictions on social contact and end lockdown measures.

Westminster has also published the terms of reference for its review, setting out its full objectives and scope, and a reporting timetable. This can be read here. The call for evidence, meanwhile, will remain open until Monday 29 March.

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Sat, 20 Mar 2021 14:59

On Thursday, America was graced with a gloating op-ed from Florida Gov. Ron DeSantis in The Wall Street Journal explaining how ''the elites'''--meaning, apparently, everyone who ever took a biology course in high school'--were so, so wrong when they tried to slow down the spread of COVID-19 and he was absolutely right to encourage parties on the beach. On the same day, Politico staffer Michael Kruse added a coat of finest boot polish with a second editorial insisting that DeSantis ''won the pandemic'' because ''Florida has fared no worse '... than other states.''

DeSantis is not just taking a victory lap over a course paved with 32,000 dead Floridians, he's doing so at a time when his state is still logging 5,000 new cases of COVID-19 a day (second highest in the nation). That's over twice the level Florida was reporting last fall right before it experienced the sharpest surge of the whole pandemic. So yes, lauding DeSantis is premature. Yes, it's hideously ugly and insensitive'--not just to the families of the dead, but to the hundreds of thousands of Floridians left with long-term damage from COVID-19.

But there is something that really should be earning DeSantis the admiration of Republicans everywhere. Becauseli while New York nursing home numbers may be getting national attention, the truth is we have not a #$%ing clue about what actually happened in Florida. That's because no one, in no other state, has done more to cover up the facts of the pandemic than Ron DeSantis.

Going into the pandemic, Florida had a system that mirrored that of many states. At the county level, medical examiners tallied both the numbers and the cause of death. This information was both made available to the public and sent to the state. By no coincidence at all, one of DeSantis' first moves during the pandemic was to stop county officials from making these numbers public. Starting in March 2020, county medical examiners were forbidden from revealing the numbers or cause of death, and instead told to report their information only to the state.

If this sounds like it wouldn't make much difference, in April there was a strange spike in ''pneumonia deaths'' in Florida'--a spike that existed nowhere else. The official Florida site blamed these deaths, when they were given any cause at all, on flu. This was happening at a point when flu numbers were already way down in other states, but COVID-19 deaths were on the rise. Right from the beginning, to believe DeSantis means that Florida was having an absolutely unique experience in which COVID-19 was less deadly than anywhere else in the nation, but they were plagued by a mysterious, unconnected rash of respiratory illness.

And then there was just how those Florida numbers on COVID-19 were getting to the public. Data scientist Dr. Rebekah Jones was hired to create a dashboard for the state where the official numbers could be displayed. But in May, Jones was fired from that position after she was told to ''manually change data to drum up support for the plan to reopen.'' At that time, when ''only'' 2,000 people had died in Florida, DeSantis was already taking a victory lap around the state, claiming to have defeated the coronavirus without making spring breakers set down a single Heineken.

By then, the state's medical examiners were up in arms over the differences between what they were seeing and what the state was reporting. They called the DeSantis numbers ''a sham'' and pointed out that the number of respiratory deaths the state was shoveling into the pneumonia category, with no mention of COVID-19, was the highest in at least five years. As the South Florida Sun Sentinel reported, the sharp increase in pneumonia deaths ''alters the fundamental narrative of the coronavirus outbreak in Florida: This pandemic started earlier and has been broader, deadlier and more rampant than previously known.'' When the Miami Herald managed to get their hands on data from medical examiners, they found it ''riddled with holes.''

It also became clear that not only was Florida not taking any responsibility for tourists who came there, shared coronavirus on the beach, and returned home to deliver their virus souvenir to family and friends, it wasn't counting the people who died in Florida if they were from out of state. That didn't just include those who dropped in for a few weeks, it included ''snowbirds'' who spend a good part of the year at Florida homes. People who lived in Florida, got sick in Florida, and died in Florida did not show up on Florida's dashboard unless they were also official residents of Florida'--and even then, the odds that they might have been left off seem high.

By June, Jones was tweeting out claims that that DeSantis' government was covering up increasing hospitalization rates and had manually deleted at least 1,200 cases of COVID-19 in order to artificially meet guidelines that allowed for more rapid reopening in advance of the July 4 holiday. Jones then created her own website to give Florida a better idea of what was actually happening, including showing available hospital beds and ICU beds'--information that DeSantis had stripped from the official site.

Almost immediately, Jones came under attack with claims that she had ''illegally accessed'' data'--data that should have been public in the first place. She was repeatedly harassed by state officials and her attempts to provide more accurate data were blocked by a tightening of security around data that DeSantis, unlike every previous administration, claimed to be private. This culminated in a Dec. 7 raid on Jones' home by Florida state police who carried off the computers used for her alternative data site. The action was egregious enough that, as the Tampa Bay Times reported, a lifelong Republican attorney who had been appointed to a judicial nominating commission by DeSantis resigned his position, saying that he want to call attention to how Florida was blocking ''public access to truthful data.''

The truth about Florida is '... we don't know the truth about Florida. We do know that DeSantis has behaved recklessly and irresponsibly, that he has defied medical advice, used authoritarian tactics to hide information, and sold vaccine access to the highest bidder while denying vaccine to communities of color.

But even if the information that is currently out there were perfectly accurate '... how is it a ''win?'' Yes, ''Florida has fared no worse'' than some other states '... if by that Politico means those states that were unfortunate enough to be caught in the blast of the initial surge at a time when there were neither available tests nor information about how to treat COVID-19. Florida is squarely in the middle of the list of states on both deaths by population and cases by population. If it's done better than about half the states, it's done worse than the others. That includes running a worse rate of both deaths and cases than California. Just looking up the Atlantic coast, the rate of deaths in Florida is 27% higher than in Virginia and 36% higher than in North Carolina. Hell, it's 180% higher than in Maine.

What exactly is supposed to represent a ''win'' here? Is DeSantis supposed to be given accolades because Florida didn't slip beneath the sea under the weight of all the dead bodies? Republicans aren't just ready to hand DeSantis a participation trophy, they're trying to turn it into a blue ribbon.

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Sun, 21 Mar 2021 11:52

Vaccine against COVID-19

Oxford''AstraZeneca COVID-19 vaccine Box containing 100 COVID-19 Vaccine AstraZeneca doses

Vaccine descriptionTargetSARS-CoV-2Vaccine typeViral vectorClinical dataTrade namesCOVID-19 Vaccine AstraZeneca,[1][2][3] AstraZeneca COVID-19 Vaccine,[4] Covishield[5]Other namesAZD1222,[6][7]ChAdOx1 nCoV-19,[8]ChAdOx1-S,[9]License dataPregnancycategoryRoutes ofadministrationIntramuscularATC codeLegal statusLegal statusAU: S4 (Prescription only) [9]CA: Schedule D; Authorized by interim order [4][10]UK: Conditional and temporary authorisation to supply [2][11]EU: Conditional marketing authorisation [12][13][14]KR, BR '' Approved[15][16]IND, INA,[17] BD, AG, SV, DOM, MEX, NE, SL, SRB[18]: Emergency Authorization only

IdentifiersCAS NumberDrugBankUNIIVial of the Oxford''AstraZeneca vaccine manufactured by the

Serum Institute of India (marketed as Covishield in India and in a few other countries)

[5]The Oxford''AstraZeneca COVID-19 vaccine, codenamed AZD1222,[7] is a COVID-19 vaccine developed by Oxford University and AstraZeneca given by intramuscular injection, using as a vector the modified chimpanzee adenovirus ChAdOx1.[19][20][21][22] One dosing regimen showed 90% efficacy when a half-dose was followed by a full-dose after at least one month, based on mixed trials with no participants over 55 years old.[6] Another dosing regimen showed 62% efficacy when given as two full doses separated by at least one month.[6]

The vaccine was developed by Oxford University's Jenner Institute and Oxford Vaccine Group with the collaboration of the Italian manufacturer Advent Srl located in Pomezia, which produced the first batch of the COVID-19 vaccine for clinical testing.[23] The team is led by Sarah Gilbert, Adrian Hill, Andrew Pollard, Teresa Lambe, Sandy Douglas and Catherine Green.[24][23]

The vaccine has a good safety profile with around 10% of recipients during clinical trials reporting mild adverse effects including injection site pain, headache and nausea.[25] More rarely, anaphylaxis may occur (the UK Medicines and Healthcare products Regulatory Agency (MHRA) has 234 reports out of approximately 11.7 million vaccinations as of 7 March 2021[update]).[25]

On 30 December 2020, the vaccine was first approved for use[11][26] in the UK's vaccination programme,[27] and the first vaccination outside of a trial was administered on 4 January 2021.[28] The vaccine has since been approved by several medicine agencies worldwide, such as the European Medicines Agency (EMA),[12][14] and the Australian Therapeutic Goods Administration (TGA),[9] and has been approved for an Emergency Use Listing (EUL) by the World Health Organization.[29]

In March 2021, a number of countries paused use of the vaccine out of fears it may be implicated in cases of blood clotting observed in vaccine recipients.[30] The European Medicines Agency (EMA),[31][32] the UK MHRA[33] and AstraZeneca[34] have stated that overall blood clotting rates were not higher than would be expected naturally. On 18 March 2021, the EMA announced that out of the around 20 million people that had received the vaccine in the EU and UK overall blood clotting rates were normal, but that it had identified 15 very rare cases of unusual blood clots accompanied by low levels of blood platelets that might be linked to the vaccine.[32] The EMA updated the vaccine information to inform patients about the remote possibility of such syndromes but confirmed that the vaccine's benefits still outweigh the risks.[32] Italy has resumed vaccinations with other countries expected to follow.[35]

Vaccine platform [ edit ] The Oxford''AstraZeneca COVID-19 vaccine is a replication-deficient simian adenovirus vector, containing the full'length codon'optimised coding sequence of SARS-CoV-2 spike protein along with a tissue plasminogen activator (tPA) leader sequence.[36][37]

The adenovirus is called replication-deficient because some of its essential genes were deleted and replaced by a gene coding for the spike. Following vaccination, the adenovirus vector enters the cells, releases its genes, those are transported to the cell nucleus, thereafter the cell's machinery does the transcription in mRNA and the translation in proteins.

The one of interest is the spike protein, an external protein that enables the SARS-type coronavirus to enter cells through the enzymatic domain of ACE2.[38] Producing it following vaccination will prompt the immune system to attack the coronavirus through antibodies and T-cells if it later infects the body.[6]

History [ edit ] 2020 development [ edit ] In February 2020, the Jenner Institute agreed a collaboration with the Italian company Advent Srl for the production of the first batch of a vaccine candidate for clinical trials.[39]

In March 2020,[40][41]after the Gates Foundation urged the University of Oxford to find a large company partner to get its COVID-19 vaccine to market, the university backed off from its earlier pledge to donate the rights to any drugmaker.[42]The U.K. government encouraged the University of Oxford to work with AstraZeneca instead of Merck & Co., a US based company. People at Oxford were reportedly concerned the vaccine would not be distributed worldwide. Government ministers also had concerns that a vaccine manufactured in the U.S. would not be available in the U.K., according to anonymous sources in Wall Street Journal. Financial considerations at Oxford and spin-out companies may have played a part.[43][44]

In June 2020, the US National Institute of Allergy and Infectious Diseases (NIAID) confirmed that the third phase of testing for potential vaccines developed by Oxford University and AstraZeneca would begin in July 2020.[45]

Clinical trials [ edit ] In July 2020, AstraZeneca partnered with IQVIA to speed up US clinical trials.[46]

On 31 August 2020, AstraZeneca announced that it had begun enrolling adults for a US-funded, 30,000-subject late-stage study.[47]

On 8 September 2020, AstraZeneca announced a global halt to the vaccine trial while a possible adverse reaction in a participant in the United Kingdom was investigated.[48][49][50] On 13 September, AstraZeneca and the University of Oxford resumed clinical trials in the United Kingdom after regulators concluded it was safe to do so.[51] AstraZeneca was criticised for vaccine safety after concerns from experts noting the company's refusal to provide details about serious neurological illnesses in two participants who received the experimental vaccine in Britain.[52] While the trial resumed in the UK, Brazil, South Africa, Japan[53] and India, it remained on pause in the US till 23 October 2020[54] while the Food and Drug Administration (FDA) investigated a patient illness that triggered the clinical hold, according to the United States Department of Health and Human Services (HHS) Secretary Alex Azar.[55]

On 15 October 2020, Dr Jo£o Pedro R. Feitosa, a 28-year-old doctor from Rio de Janeiro, Brazil, who received a placebo instead of the test vaccine in a clinical trial of AZD1222, died from COVID-19 complications.[56][57][58] The Brazilian health authority Anvisa announced that the trial would continue in Brazil.[59]

Results of Phase III trial [ edit ] On 23 November 2020, Oxford University and AstraZeneca announced interim results from the vaccine's ongoing Phase III trials.[6][60] There was some criticism of the methods used in the report, which combined results of 62% and 90% from different groups of test subjects given different dosages to arrive at a 70% figure.[61][62][63] AstraZeneca said it would carry out a further multi-country trial using the lower dose which had led to a 90% claim.[64]

The full publication of the interim results from four ongoing Phase III trials on 8 December 2020 clarified these reports.[65] In the group who received the first dose of active vaccine more than 21 days earlier, there were no hospitalisations or severe disease, unlike those receiving the placebo. Serious adverse events were balanced across the active and control arms in the studies, i.e. the active vaccine did not have safety concerns. A case of transverse myelitis was reported 14 days after booster vaccination as being possibly related to vaccination, with an independent neurological committee considering the most likely diagnosis to be of an idiopathic, short segment, spinal cord demyelination. The other two cases of transverse myelitis, one in the vaccine group and the other in the control group, were considered to be unrelated to vaccination.[65]

A subsequent analysis, published on 19 February, has shown an efficacy of 76% 22 days after the first dose and increase to 81.3% when the second dose is given 12 weeks or more after the first.[66]

2021 development [ edit ] In February 2021, Oxford''AstraZeneca indicated developments to adapt the vaccine to target new variants of the coronavirus,[67] with expectation of a modified vaccine being available "in a few months" as a "booster jab".[68] A key area of concern is whether the E484K mutation could impact the immune response and, possibly, current vaccine effectiveness.[69] The E484K mutation is present in the South African (B.1.351) and Brazilian (B.1.1.28) variants, with a small number of cases of the mutation also detected in infections by the original SARS-CoV-2 virus and the UK/Kent (B.1.1.7) variant.[69]

Scottish Study [ edit ] A study was carried out by universities across Scotland of the effectiveness of first dose of Pfizer''BioNTech and Oxford''AstraZeneca COVID-19 vaccines against hospital admissions in Scotland, based on a national prospective cohort study of 5.4 million people. Between 8 December 2020 to 15 February 2021, 1,137,775 patients were vaccinated in the study, 490,000 of which were with the Oxford''AstraZeneca vaccine. The first dose of the Oxford''AstraZeneca vaccine was associated with a vaccine effect of 94% for COVID-19 related hospitalisation at 28''34 days post-vaccination. Results for both vaccines combined showed a vaccine effect for prevention of COVID-19 related hospitalisation which was comparable when restricting the analysis to those aged '‰¥80 years (81%). The majority of the patients over the age of 65 were given the Oxford''AstraZeneca vaccine. As of 22 February 2021[update], the study had not been peer-reviewed.[70][71]

Approvals [ edit ] On 27 November 2020, the UK government asked the Medicines and Healthcare products Regulatory Agency to assess the AZD1222 vaccine for temporary supply,[125] and it was approved for use on 30 December 2020, as their second vaccine to enter the national rollout.[126]

On 4 January 2021, Brian Pinker, 82, became the first person to receive the Oxford''AstraZeneca COVID-19 vaccine outside of clinical trials.[28]

The European Medicines Agency (EMA) received an application for a conditional marketing authorisation (CMA) for the vaccine on 12 January 2021. A press release stated that a recommendation on this could be issued by the agency by 29 January, with the European Commission then making a decision on the CMA within days.[3] The Hungarian regulator unilaterally approved the vaccine instead of waiting for EMA approval.[127]

On 29 January 2021, the EMA recommended granting a conditional marketing authorisation for AZD1222 for people 18 years of age and older,[12][13] and the recommendation was accepted by the European Commission the same day.[14][128]

On 30 January 2021, the Vietnamese Ministry of Health approved the AstraZeneca vaccine for domestic inoculation, the first to be approved in Vietnam.[129]

The vaccine has also been approved by Argentina,[130] Bangladesh,[131] Brazil,[132] the Dominican Republic,[93] El Salvador,[133] India,[134][135] Malaysia,[136] Mexico,[137] Nepal,[138] Pakistan,[139] the Philippines,[140] Sri Lanka,[141] and Taiwan[142] regulatory authorities for emergency usage in their respective countries.

On 7 February 2021, the vaccine roll out in South Africa was suspended. Researchers from the University of the Witwatersrand said in a prior-to-peer analysis that the AstraZeneca vaccine provided minimal protection against mild or moderate disease infection among young people.[143][144] The BBC reported on 8 February 2021 that Katherine O'Brien, director of immunisation at the World Health Organization, indicated she felt it was "really plausible" the AstraZeneca vaccine could have a "meaningful impact" on the South African variant particularly in preventing serious illness and death.[145] The same report also indicated the Deputy Chief Medical Officer for England Jonathan Van-Tam said the (Witwatersrand) study did not change his opinion that the AstraZeneca vaccine was "rather likely" to have an effect on severe disease from the South African variant.[145]

On 10 February 2021, South Korea granted its first approval of a COVID-19 vaccine to AstraZeneca, allowing the two-shot regimen to be administered to all adults, including the elderly. The approval came with a warning, however, that consideration is needed when administering the vaccine to individuals over 65 years of age due to limited data from that demographic in clinical trials.[146][147]

On 10 February 2021, the World Health Organization (WHO) issued interim guidance and recommended the AstraZeneca vaccine for all adults, its Strategic Advisory Group of Experts also having considered use where variants were present and concluded there was no need not to recommend it.[148]

On 16 February 2021, the Australian Therapeutic Goods Administration (TGA) granted provisional approval for COVID-19 Vaccine AstraZeneca.[9][1]

On 26 February 2021, the vaccine was authorized with terms and conditions by Health Canada.[149]

Suspensions [ edit ] On 3 March 2021, Austria suspended the use of a batch of the vaccine after two persons suffered blood clot related complications after vaccination that resulted in one death.[150] In total four blood clot cases have been identified for the same batch of 1 million doses.[150] Although no causal link with vaccination had yet been established,[151] several other countries, including Denmark,[152] Norway,[152] Iceland,[152] Bulgaria,[153] Ireland,[154] Italy,[151] Spain,[155] Germany,[156] France, Netherlands[157] and Slovenia[158] also halted the vaccine rollout while awaiting the European Medicines Agency to finish a safety review. Indonesia is also halting their vaccine rollout awaiting more safety reviews from World Health Organization.[159]

On 11 March 2021, the European Medicines Agency stated that there was no indication that vaccination had caused blood clots, which are not listed as side effects with the vaccine.[150][31] According to the EMA, the number of thromboembolic events in vaccinated people is no higher than that seen in the general population.[31] As of 11 March 2021[update], 30 cases of thromboembolic events had been reported among the almost 5 million people vaccinated in the European Economic Area.[31] The Medicines and Healthcare products Regulatory Agency of the UK has also stated that after more than 11 million doses administered it had not been confirmed that the reports of blood clots were caused by the vaccine and that vaccinations would not be stopped.[33] On 12 March 2021 the World Health Organization stated that a causal relationship had not been shown and that vaccinations should continue.[160]

On 14 March 2021, AstraZeneca has confirmed that after over 17 million people have been vaccinated in the European Union and UK there has been no evidence of an increased risk of blood clots in any particular country.[34] The company reported that as of 8 March 2021[update], across the EU and UK, there have been 15 events of deep vein thrombosis and 22 events of pulmonary embolism reported among those given the vaccine, which is much lower than would be expected to occur naturally in a general population of that size.[34]

On 15 March 2021, the German Paul-Ehrlich Institute reported that out of 1.6 million vaccinations seven cases of cerebral vein thrombosis in conjunction with a deficiency of blood platelets had occurred.[161] According to the PEI, the number of cases of cerebral vein thrombosis after vaccination was statistically significantly higher than the number of cases that would occur in the general population during a similar time period.[161] These reports prompted the PEI to recommended a temporary suspension of vaccinations until the EMA has completed their review of the cases.[162]

On 17 March 2021, the World Health Organization issued a statement on AstraZeneca COVID-19 vaccine safety signals which said that it considered the benefits of this vaccine outweighed its risks and recommended that vaccinations continue.[163]

On 18 March 2021, the EMA announced that out of the around 20 million people that had received the vaccine general blood clotting rates were normal, but that it had identified 7 cases of disseminated intravascular coagulation, and 18 cases of cerebral venous sinus thrombosis.[32] A causal link with the vaccine had not been proven, but the EMA decided to conduct further analysis and to inform patients of the remote possibility of such rare syndromes.[32] The EMA confirmed that the vaccine's benefits still outweigh the risks.[32] As a result of this statement, Italy has announced it will resume vaccinations with other countries expected to follow.[35]

Safety profile [ edit ] As of 7 March 2021[update], the MHRA said that over 11.7 million Oxford''AstraZeneca vaccinations had been given.[25] Around 10% of recipients in the clincal trials experience adverse effects, mostly mild in nature, including "injection site tenderness, injection-site pain, headache, fatigue, myalgia, malaise, pyrexia (fever), chills, arthralgia, and nausea".[25] 234 cases of anaphylaxis had been reported. Across all COVID-19 vaccines types, incidences of Bell's palsy in vaccine recipients were no higher than would be expected naturally. 534 (237 Pfizer/BioNTech, 289 Oxford University/AstraZeneca, 8 other) people, mostly the elderly or infirm, had died shortly after vaccination, but this figure was consistent with an expected coincidental death rate, with no suggestion of a causal link.[25]

Production and supply [ edit ] The vaccine is stable at refrigerator temperatures and costs around US$3 to US$4 per dose.[164] On 17 December, a tweet by the Belgian Budget State Secretary revealed the European Union (EU) would pay '‚¬1.78 ( US$2.16 ) per dose.[165]

According to AstraZeneca's vice-president for operations and IT, Pam Cheng, the company would have around 200 million doses ready worldwide by the end of 2020, and capacity to produce 100 million to 200 million doses per month once production is ramped up.[61]

In June 2020, further to making 100 million doses available to the UK's NHS for their vaccination programme,[166] AstraZeneca and Emergent BioSolutions signed a US$87 million deal to manufacture doses of the vaccine specifically for the US market. The deal was part of the Trump administration's Operation Warp Speed initiative to develop and rapidly scale production of targeted vaccines before the end of 2020.[167] Catalent will be responsible for the finishing and packaging process.[168] The majority of manufacturing work will be done in the UK.[citation needed ]

On 4 June 2020, the World Health Organization's (WHO) COVAX (COVID-19 Vaccines Global Access) facility made initial purchases of 300 million doses from the company for low- to middle-income countries.[169] Also, AstraZeneca and Serum Institute of India reached a licensing agreement to supply 1 billion doses of the Oxford University vaccine to middle- and low-income countries, including India.[170][171]

On 29 September 2020, a grant from the Bill and Melinda Gates Foundation allowed COVAX to secure an additional 100 million COVID-19 vaccine doses either from AstraZeneca or from Novavax at US$3 per dose.[172]

On 13 June 2020, AstraZeneca signed a contract with the Inclusive Vaccines Alliance, a group formed by France, Germany, Italy, and the Netherlands, to supply up to 400 million doses to all European Union member states.[173][174][175] However, the European Commission took over negotiations on behalf of the whole EU, signing a deal at the end of August.[176][177][178]

In August 2020, AstraZeneca agreed to provide 300 million doses to the USA for US$1.2 billion , implying a cost of US$4 per dose. An AstraZeneca spokesman said the funding also covers development and clinical testing.[179] It also reached technology transfer agreement with Mexican and Argentinean governments and agreed to produce at least 400 million doses to be distributed throughout Latin America. The active ingredients would be produced in Argentina and sent to Mexico to be completed for distribution.[180]

In September 2020, AstraZeneca agreed to provide 20 million doses to Canada.[181][182]

In October 2020, Switzerland signed an agreement with AstraZeneca to pre-order up to 5.3 million doses.[183][184]

On 5 November 2020, a tripartite agreement was signed between the government of Bangladesh, Serum Institute of India and Beximco Pharma of Bangladesh. Under the agreement Bangladesh ordered 30 million doses of Oxford''AstraZeneca vaccine from Serum through Beximco for $4 per shot.[185]

In November 2020, Thailand ordered 26 million doses of vaccine from AstraZeneca.[186] It would cover 13 million people,[187] approximately 20% of the population, with the first lot expected to be delivered at the end of May.[188][189][190]The public health minister indicated the price paid was $5 per dose;[191] AstraZeneca (Thailand) explained in January 2021 after a controversy that the price each country paid depended on production cost and differences in supply chain, including manufacturing capacity, labour and raw material costs.[192]In January 2021, the Thai cabinet approved further talks on ordering another 35 million doses[193] and the Thai FDA approved the vaccine for emergency use for 1 year.[194][195]Siam Bioscience, a company owned by Vajiralongkorn, will received technological transfer,[196]and has the capacity to manufacture up to 200 million doses a year for export to ASEAN.[197]

Also in November, the Philippines agreed to buy 2.6 million doses,[198]reportedly worth around '‚±700 million (approximately $5.6/dose).[199]

In December 2020, South Korea signed a contract with AstraZeneca to secure 20 million doses of its vaccine, reportedly worth equivalently to those signed by Thailand and the Philippines,[200] with the first shipment expected as early as January 2021. As of January 2021[update], the vaccine remains under review by the South Korea Disease Control and Prevention Agency.[201][202] AstraZeneca signed a deal with South Korea's SK Bioscience to manufacture its vaccine products. The collaboration calls for the SK affiliate to manufacture AZD1222 for local and global markets.[203]

On 7 January 2021, the South African government announced that they had secured an initial 1 million doses from the Serum Institute of India, to be followed by another 500,000 doses in February.[204]

Myanmar signed a contract with Serum Institute of India to secure 30 million doses of its vaccine in December 2020. Myanmar will get doses for 15 million people from February 2021.[205]

On 22 January 2021, AstraZeneca announced that in the event the European Union approved the COVID-19 Vaccine AstraZeneca, initial supplies would be lower than expected due to production issues at Novasep in Belgium. Only 31 million of the previously predicted 80 million doses would be delivered to the European Union by March 2021.[206] In an interview with Italian newspaper La Repubblica, AstraZeneca's CEO Pascal Soriot said the delivery schedule for the doses in the European Union was two months behind schedule. He mentioned low yield from cell cultures in one large-scale European site.[207] Analysis published in The Guardian also identified an apparently low yield from bioreactors in the Belgium plant and noted the difficulties in setting up this form of process, with variable yields often occurring.[208] As a result, the European Union imposed export controls on vaccine doses; controversy erupted as to whether doses were being diverted to the UK, and whether or not deliveries to Northern Ireland would be disrupted.[209]

On 24 February 2021, a shipment of the vaccine to Accra, Ghana via COVAX made it the first country in Africa to receive vaccines via the initiative.[210]

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Thu, 18 Mar 2021 23:20

Published: December 31, 2020 (upd.)Share on: Twitter / Facebook

WHO-sponsored review of ivermectin trials indicates 83% reduction in covid mortality.

Dr Andrew Hill of the Department of Pharmacology at the University of Liverpool (UK) is currently performing a WHO-sponsored review and meta-analysis of randomized controlled trials of ivermectin against covid. In the following 12-minute video, Dr Hill is presenting his preliminary results, which indicate a highly significant 83% reduction in covid mortality (95% CI 65%-92%).

This result is based on in-hospital trials, so it does not yet take into account early ambulatory and prophylactic treatment. The authors of the review intend to include three more trials, due to be published sometime in January, before providing a final conclusion. At the end of his presentation, Dr Hill describes low-cost ivermectin as a potentially ''transformative treatment'' against covid.

Update January 20: The final analysis has been published as a preprint on Research Square. It found a 75% reduction in covid mortality and will be continually updated with future trial results.

Additional materialStudies overview: Overview of all covid-19 ivermectin studies (IVMMETA)Covid-19 treatment protocol: Front Line Covid-19 Critical Care Alliance (FLCCC)Mode of action: Ivermectin highly effective in inhibiting coronavirus replication (NCB)Where to buy IvermectinIf not available locally, Ivermectin can be bought from certified pharmaceutical exporters on Indiamart, but some countries may not allow its importation. Patients are asked to consult a doctor.

See alsoOn the treatment of Covid-19On post-acute (''long'') CovidFacts about Covid-19Share on: Twitter / Facebook

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Fri, 19 Mar 2021 13:28

ð'šð'šŠð'š— ð'š‘ ð'š›ð'šŠð'šŒð'šŽð'š-- : NEW - "Vaccination = Freedom," reads a controversial "light art" projection at the TV tower in D¼sseldorf, Germany'... https://t.co/dumTLgBJqP

Fri Mar 19 13:26:51 +0000 2021

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Sat, 20 Mar 2021 12:00

Injecting MEN with the female hormone progesterone could reduce the severity of their COVID-19, study claimsExperts recruited 40 male patients who had been hospitalised with COVID-19Half were treated with a five-day course of progesterone injections twice dailyThis group scored 1.5 points better on a 7-point clinical scale after seven daysWhile results were promising, the team said larger clinical trials will be neededBy Ian Randall For Mailonline

Published: 15:02 EDT, 19 March 2021 | Updated: 15:39 EDT, 19 March 2021

Injection with the female sex hormone progesterone could improve outcomes for men hospitalised with severe COVID-19 infections, a study has concluded.

The finding by researchers from California follows multiple reports that men are at a higher risk of severe illness and death from coronavirus than women.

Progesterone has certain anti-inflammatory properties and thus, the team said, may be able to dampen the often fatal immune responses called 'cytokine storms'.

Injection with the female hormone progesterone could improve outcomes for men hospitalised with severe COVID-19 infections, a study has concluded (stock image)

The research was undertaken by pulmonologist Sara Ghandehari of the Cedars-Sinai hospital in Los Angeles and her colleagues.

'As an ICU doctor, I was struck by the gender disparity among COVID-19 patients who were very sick, remained in the hospital and needed ventilators,' she said.

Progesterone is produced in both men and women's bodies, although the latter produce considerably more of the hormone during their reproductive years.

Experts have also noted that premenopausal women tend to experience less severe cases of COVID-19 than their postmenopausal counterparts.

Premenopausal women tend to have higher progesterone levels while such tends to decrease to lower levels post-menopause.

In their clinical trial, which was undertaken from April''August last year, the researchers recruited 40 male patients who had been hospitalised with moderate to severe COVID-19 and randomly divided them into two groups.

One group acted as a control sample, for comparison, and received only the standard medical care given at that time for the disease.

The experimental group, meanwhile, also received 100 milligram injections of progesterone twice daily for five days during the time they were hospitalised.

All the patients were assessed by the team daily for either 15 days or until they were discharged from hospital.

On the seventh day, each patient was ranked on a standard seven-point scale of clinical status, which ranged from 7 ('not hospitalized, no limitations on activities') though to 1 ('death').

Progesterone (depicted) has anti-inflammatory properties and thus, the team said, may be able to dampen the often fatal immune responses called 'cytokine storms' seen with COVID-19

The researchers found that, compared with the control group, patients who received the progesterone treatments scored a median of 1.5 points higher on the scale.

The experimental group also had fewer days of hospitalisation overall and a lower need for supplemental oxygen and mechanical ventilation, although the team said the differences between the groups in these areas was not statistically significant.

No serious adverse effects were observed as a result of the progesterone injections. Two patients did die during the 15-day study period '-- one from each of the two groups '-- but such were unrelated to the experiment treatments, the team said.

'While our findings are encouraging for the potential of using progesterone to treat men with COVID-19, our study had significant limitations,' cautioned Dr Ghandehari.

Firstly, she explained, the sample size was relatively small and was primarily made up of White, Hispanic and obese individuals with a moderate burden of other conditions, which serve to increase the risk of worse outcomes.

Furthermore, while the trial was randomised and featured a control group, it was also unblinded '-- meaning that the research team, physicians and patients all knew who had received the experimental treatment.

'Further research is necessary in larger, more heterogeneous populations, including postmenopausal women and at other treatment centres,' Dr Ghandehari added.

This, she continued, will allow the team 'to establish the degree of clinical efficacy and to assess any other potential safety concerns of this treatment approach.'

The full findings of the study were published in the journal Chest.

WHAT IS PROGESTERONE? Progesterone is a hormone that is secreted by the corpus luteum, a temporary endocrine gland that the female body produces after ovulation.

It prepares the body for the possibility of pregnancy after ovulation.

It causes a thickening of the uterus lining to allow for an egg to embed into the wall.

After a woman's cycle is completed and they are not pregnant the gland breaks down and the menstrual cycle begins.

If a woman does become pregnant the chemical continues to be produced to maintain the layer and provide oxygen to the developing fetus.

Said to be 'oestrogen's cousin' or the 'relaxing hormone', is thought to help to maintain pregnancy.

It is not typically prescribed on the NHS in the UK unless a woman has three or more miscarriages in a row.

If progesterone levels are too low with regard to estrogen levels, a woman will experience sleep disturbances, irritability, anxiety, weight gain, breast swelling, breast tenderness, and itching, bloating, sweating, loss of memory, and loss of libido.

Despite its widespread use in pregnancy the hormone has also been shown to promote nerve, blood vessel, and bone tissue repair.

This has therefore brought around applications in tissue regeneration.

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Sun, 21 Mar 2021 13:26

According to researchers at the Oslo University Hospital (Rikshospitalet), a strong immune response after the AstraZeneca vaccine led to three health workers getting blood clots. The information became known before EMA's publication of its report.

The news became known on Thursday morning, NTB reports. One of the health workers is dead.

''We have received findings that can explain our inpatients' clinical course,'' chief physician and professor P¥l Andre Holme at Rikshospitalet said at an urgent press conference on Thursday.

''We believe this is important to put out, we have found a sensible explanatory model,'' Holme said.

Strong immune responseHolme has led a group at the hospital that has worked hard to find out why three health workers under the age of 50 were admitted with a severe blood clot after taking the AstraZeneca vaccine.

The conclusion is now that a strong immune response after vaccination has led to blood clots.

According to Holme, the explanation is that the immune response has led to the formation of antibodies that have caused the platelets to act in a way that blood clots have formed.

At the same time, the antibodies have contributed to platelets being removed from the circulation so that the people have had a low number of platelets and thus also experienced bleeding.

''We believe this is the direct reason why we see this clinical picture,'' Holme said at the press conference on Thursday.

EMA report expected Later Thursday, the European Medicines Agency (EMA) is expected to present its vaccine assessment. A number of countries in Europe have suspended vaccination with AstraZeneca's corona vaccine, pending the EMA's conclusion.

The researchers have no answer as to why exactly the three health workers got a blood clot.

''We have theories, but we have nothing to suggest why some get it and others do not,'' said Holme.

According to Holme, so far, no explanation has been found as to why some get this reaction and others do not.

''We will now start looking at whether there are underlying factors or special predispositions. There is an enormous amount of work here,'' Holme said.

''This is serious''Health workers have been the primary recipients of the AstraZeneca vaccine in Norway so far.

''This is serious, and a partly expected conclusion, unfortunately, based on the described symptom picture. We are awaiting the EMA and the Norwegian Medicines Agency's assessments,'' Lill Sverresdatter Larsen, the Norwegian Nurses' Association leader, told newspaper VG.

Steinar Madsen, medical director at the Norwegian Medicines Agency, did not want to comment on the findings immediately.

''We have to look at the results first, so I do not want to comment on it here and now,'' Madsen told NTB.

''Now, this has to be discussed in the European Side Effects Committee.''

AstraZeneca also didn't want to comment on the information.

''We are awaiting the EMA's decision later today before we give comments,'' AstraZeneca's press manager Christina Malmberg H¤gerstrand told NTB.

Source: (C) NTB Scanpix / #Norway Today / #NorwayTodayNews

Do you have a news tip for Norway Today? We want to hear it. Get in touch at info@norwaytoday.no

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Fri, 19 Mar 2021 13:30

SummaryResearchers at the Sloan Kettering Institute have found that changes in an information-carrying molecule called messenger RNA can inactivate tumor-suppressing proteins and thereby promote cancer. The findings pinpoint previously unknown drivers of the disease. It's important to note that mRNAs are a normal component of all cells and the specific ones discussed here are not involved in mRNA-based vaccines, like the one developed against SARS-CoV-2.

Most people think of cancer as a disease of disorderly DNA. Changes, or mutations, in the sequence of DNA alter the function of the proteins made from that DNA, leading to uncontrolled cell division.

But between DNA and proteins is another layer of information, called messenger RNA (mRNA), which serves as a crucial link between the two. New research suggests that mRNA itself may carry cancer-causing changes. And, because genetic tests don't usually look at mRNA, those changes have so far gone undetected by cancer doctors.

''If you sequenced the DNA in cancer cells, you would not see these changes at all,'' says Christine Mayr, a molecular biologist at the Sloan Kettering Institute who is the senior author of a new paper on the topic published today in Nature. ''But these mRNA changes have the same ultimate effect as known cancer drivers in DNA, so we believe they may play a very important role.''

If you sequenced the DNA in cancer cells, you would not see these changes at all.

The findings turn some common assumptions about cancer on their head and point to the need to look past DNA for answers to questions about what causes the disease.

From DNA to mRNAIf DNA is the genetic blueprint for life, as is often said, then it's a fairly cumbersome set of instructions. The information in DNA is encoded in the particular sequence of some 3 billion nucleotide ''letters'' '-- varying combinations of A, T, G, and C. Blocks of these letters '-- genes '-- are used to make particular proteins, a cell's main workhorses. But DNA lives in the nucleus of a cell, while proteins are made in the surrounding cytoplasm. To bridge this gap, a cell must first make an RNA copy of a gene's DNA. This RNA copy, called messenger RNA, is then transported out of the nucleus. It is this mRNA copy that cells read and translate into a protein.

Usually, the mRNA copy is a bit shorter than its DNA precursor. That's because the useful pieces of information in DNA, called exons, are often separated by blocks of sequences that are not needed. These unnecessary parts, called introns, must be cut out to make a final product. After the introns are removed, the remaining exons are spliced together, not unlike splicing together pieces of film and leaving some on the cutting room floor.

These findings help explain a long-standing conundrum, which is that CLL cells have relatively few known DNA mutations.

If the mRNA copy doesn't include all of the exons in a gene or is cut short, then the protein made from that mRNA will also be truncated. It may no longer function properly. And if that protein is a tumor suppressor '-- one that protects against cancer '-- then that could spell problems.

What Dr. Mayr and her colleagues, including postdoctoral fellow Shih-Han (Peggy) Lee, graduate student Irtisha Singh, and SKI computational biologist Christina Leslie, found is that many of the mRNAs in cancer cells produce these truncated tumor-suppressor proteins. The changes occur not only in known tumor-suppressor genes but also in previously unrecognized ones.

''The changes to the mRNA make proteins that are very similar to the proteins that are made when you have a mutation in the DNA that causes a truncated protein to be made,'' she says. ''In the end, the outcome for the cell is very similar, but how it happened is very different.''

Found: Missing Cancer MutationsDr. Mayr's team looked specifically at chronic lymphocytic leukemia (CLL), a type of blood cancer. A colleague at MSK, Omar Abdel-Wahab, supplied them with blood samples from people with the condition. Using a method that Dr. Mayr's lab developed to detect these particular mRNA changes, they found that a substantially greater number of people with CLL had an inactivation of a tumor-suppressor gene at the mRNA level than those who had it at the DNA level.

These findings help explain a long-standing conundrum, which is that CLL cells have relatively few known DNA mutations. Some CLL cells lack even known mutations. In effect, the mRNA changes that Dr. Mayr's team discovered could account for the missing DNA mutations.

Because CLL is such a slow-growing cancer and people with CLL often live for many years, it's too early to say whether these mRNA changes are associated with a poorer prognosis.

There are some important differences between the mRNA changes and a bona fide DNA mutation. Most important, the inactivation of tumor suppressors through mRNA is usually only partial; only about half of the relevant protein molecules in the tumor cells are truncated. But in many cases this is enough to completely override the function of the normal versions that are present. And because this truncation could apply to 100 different genes at once, the changes can add up.

Lessons for Cancer DiagnosticsThough Dr. Mayr's team identified the mRNA changes in CLL, they're likely not limited to this blood cancer. The team found them in samples of T cell acute lymphocytic leukemia too, for example. Other researchers have found them in breast cancer. Dr. Mayr hopes that scientists will be inspired to explore the significance of mRNA changes in these and other types of cancers.

''Current cancer diagnostic efforts predominantly focus on the sequencing of DNA in order to identify mutations,'' Dr. Mayr says. ''But our research suggests that changes at the mRNA level might be as frequent.''

In other words, cancer diagnostics may need to change to include these previously unknown cancer drivers.

This work was funded by a National Cancer Institute grant (U01-CA164190), a Starr Cancer Consortium award, an Innovator Award of the Damon Runyon-Rachleff Cancer Foundation and the Island Outreach Foundation (DRR-24-13), a National Institutes of Health Director's Pioneer Award (DP1-GM123454), the Pershing Square Sohn Cancer Research Alliance, and an MSK Core grant (P30 CA008748).

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Fri, 19 Mar 2021 14:10

Mar. 19, 2021 | 12:10 PM

FILE - In this March 5, 2021, file photo, a nurse holds a vial of AstraZeneca COVID-19 vaccine provided through the global COVAX initiative, at Kenyatta National Hospital in Nairobi, Kenya. (AP Photo/Ben Curtis, File)

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Sat, 20 Mar 2021 12:45

E ver since the Food and Drug Administration granted emergency use authorization for two new vaccines, employers, schools, and other organizations are grappling with whether to require Covid-19 vaccination.

While organizations are certainly free to encourage their employees, students, and other members to be vaccinated, federal law provides that, at least until the vaccine is licensed, individuals must have the option to accept or decline to be vaccinated.

Knowing what an organization can or cannot do with respect to Covid-19 vaccines can help them keep their employees, students, and members safe and also save the them from costly and time-consuming litigation.

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Much remains unknown about the safety and efficacy of the vaccineEven though the FDA granted emergency use authorizations for the Pfizer/BioNTech and Moderna vaccines in December 2020, the clinical trials the FDA will rely upon to ultimately decide whether to license these vaccines are still underway and are designed to last for approximately two years to collect adequate data to establish if these vaccines are safe and effective enough for the FDA to license.

The abbreviated timelines for the emergency use applications and authorizations means there is much the FDA does not know about these products even as it authorizes them for emergency use, including their effectiveness against asymptomatic infection, death, and transmission of SARS-CoV-2, the virus that causes the disease.

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Given the uncertainty about the two vaccines, their EUAs are explicit that each is ''an investigational vaccine not licensed for any indication'' and require that all ''promotional material relating to the Covid-19 Vaccine clearly and conspicuously '... state that this product has not been approved or licensed by the FDA, but has been authorized for emergency use by FDA'' (emphasis added).

EUAs are clear: Getting these vaccines is voluntaryThe same section of the Federal Food, Drug, and Cosmetic Act that authorizes the FDA to grant emergency use authorization also requires the secretary of Health and Human Services to ''ensure that individuals to whom the product is administered are informed '... of the option to accept or refuse administration of the product.''

Likewise, the FDA's guidance on emergency use authorization of medical products requires the FDA to ''ensure that recipients are informed to the extent practicable given the applicable circumstances '... That they have the option to accept or refuse the EUA product '...''

In the same vein, when Dr. Amanda Cohn, the executive secretary of the CDC's Advisory Committee on Immunization Practices, was asked if Covid-19 vaccination can be required, she responded that under an EUA, ''vaccines are not allowed to be mandatory. So, early in this vaccination phase, individuals will have to be consented and they won't be able to be mandatory.'' Cohn later affirmed that this prohibition on requiring the vaccines applies to organizations, including hospitals.

The EUAs for both the Pfizer/BioNTech and Moderna vaccines require facts sheets to be given to vaccination providers and recipients. These fact sheets make clear that getting the vaccine is optional. For example, the one for recipients states that, ''It is your choice to receive or not receive the Covid-19 Vaccine,'' and if ''you decide to not receive it, it will not change your standard of medical care.''

What this means in practiceWhen the FDA grants emergency use authorization for a vaccine, many questions about the product cannot be answered. Given the open questions, when Congress granted the authority to issue EUAs, it chose to require that every individual should be allowed to decide for himself or herself whether or not to receive an EUA product. The FDA and CDC apparently consider this fundamental requirement of choice important enough that even during the height of the Covid-19 pandemic they reinforced that policy decision when issuing their guidance related to the Covid-19 vaccines.

This means that an organization will likely be at odds with federal law if it requires its employees, students or other members to get a Covid-19 vaccine that is being distributed under emergency use authorization.

State law often prohibits retaliating against an employee for refusing to participate in a violation of federal law. Organizations that require Covid-19 vaccination in violation of federal law may face lawsuits under these state laws not only to block the policy but also for damages and attorneys' fees. Such potentially costly lawsuits can be avoided by refraining from adopting policies that require vaccination or penalize members for choosing not to be vaccinated.

Organizations are free to encourage vaccinations through internal communications, through educational events, and through other measures to urge employees to be vaccinated. They can take these measures so long as: (1) they are not viewed as coercive, (2) the organization makes clear the decision regarding whether to receive the vaccine is voluntary, and (3) the measures comply with the requirements in the EUAs and the related regulations for these products.

People across the world have had their lives upended during the last year. The urgency to return to normalcy is felt deeply by many. As decision-makers at organizations decide on their Covid-19 vaccination policy, they should be careful to not let this passion lead the organization to run afoul of the law.

Aaron Siri is the managing partner at Siri & Glimstad LLP, a complex civil litigation firm with its principal office in New York City. This article is not intended to provide legal advice but to offer broad and general information about the law.

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Sun, 21 Mar 2021 11:24

IV. RESPONSIBILITIES FOR INFORMED CONSENT

A. The IRB1. Review of All Informed Consent Materialsa. Adequacy and Appropriateness of Wording b. Use of Standardized Language2. Review of the Consent Process 3. IRB Review Procedures 4. Identification of Revised Consent Forms

B. The Clinical Investigator1. Delegation of Consent Interview 2. Financial Relationships and Interests

C. The Sponsor1. Considerations for Multicenter Clinical Investigations

D. The FDA1. Investigational New Drugs and Biologics 2. Investigational Medical Devices

V. ADDITIONAL CONSIDERATIONS

A. Review of Patient Records B. Non-English Speaking Subjects C. Subjects with Low Literacy and Numeracy D. Physically Challenged Subjects E. Impaired Consent Capacity F. Children as Subjects G. Subject Participation in More Than One Clinical Investigation H. Suspension/Termination of a Study I. Data Retention upon the Withdrawal of Subjects K. Reporting Aggregate Results of the Clinical Investigation

FOOTNOTES

I. INTRODUCTIONThis guidance is intended to provide information to institutional review boards (IRBs), clinical investigators, and study sponsors about FDA's informed consent regulations. This guidance, when finalized, will supersede "A Guide to Informed Consent," issued in September 1998, by the Office of Health Affairs, FDA. To enhance human subject protection and reduce regulatory burden, the Department of Health and Human Services, Office for Human Research Protections and FDA have been actively working to harmonize the agencies' regulatory requirements and guidance for human subject research. This guidance document was developed as a part of these efforts.

The U.S. Department of Health and Human Services announced in 2011 that the federal government is contemplating various ways of enhancing the regulations overseeing research on human subjects. Before developing proposed changes to the regulations '' which have been in place since 1991 and are often referred to as the Common Rule '' the government issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking the public's input on an array of issues related to the ethics, safety, and oversight of human research. The changes under consideration can be found in in the July 26, 2011 Federal Register in an ANPRM titled "Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators." FDA issues this draft guidance while the agencies continue to explore potential changes to the Common Rule. To the extent that issues presented in this draft guidance intersect with the Common Rule FDA plans to coordinate with other relevant federal agencies to facilitate consistency across policies.

FDA's informed consent requirements are set forth in FDA's regulations on Protection of Human Subjects (21 CFR part 50). These regulations apply to clinical investigations regulated by FDA. 2 The informed consent requirements in 21 CFR part 50 are not intended to preempt any applicable Federal, State or local laws that require additional information to be disclosed for informed consent to be legally effective. (21 CFR 50.25(c).) If the clinical investigation is conducted or supported by the Department of Health and Human Services (HHS) and involves an FDA-regulated product, then the study is subject to both 45 CFR part 46 and 21 CFR part 50, meaning that both sets of regulations must be followed. Where the regulations differ, the regulations that offer the greater protection to human subjects should be followed.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. The use of the word must in Agency guidances means that something is required under the FDA regulations.

II. SUMMARY OF THE CONSENT PROCESSTo many, the term informed consent is mistakenly viewed as synonymous with obtaining a subject's signature on the consent form. FDA believes that obtaining a subject's oral or written informed consent is only part of the consent process. Informed consent involves providing a potential subject with adequate information to allow for an informed decision about participation in the clinical investigation, facilitating the potential subject's comprehension of the information, providing adequate opportunity for the potential subject to ask questions and to consider whether to participate, obtaining the potential subject's voluntary agreement to participate, and continuing to provide information as the clinical investigation progresses or as the subject or situation requires. To be effective, the process must provide sufficient opportunity for the subject to consider whether to participate. (21 CFR 50.20.) FDA considers this to include allowing sufficient time for subjects to consider the information and providing time and opportunity for the subjects to ask questions and have those questions answered. The investigator (or other study staff who are conducting the informed consent interview) and the subject should exchange information and discuss the contents of the informed consent document. This process must occur under circumstances that minimize the possibility of coercion or undue influence. (21 CFR 50.20.)

The consent process begins with subject recruitment, and it includes advertising used to recruit subjects into the clinical trial. 3 Once a potential subject is identified, a person knowledgeable about the clinical investigation and capable of answering questions raised by the potential subject should conduct a consent interview.

The consent form must contain information to allow the subject to make an informed decision about participation in a clinical investigation (see section III, FDA Informed Consent Requirements and Discussion). 4 (21 CFR 50.20 and 21 CFR 50.25.) The consent form serves several purposes, including helping to ensure that the subject receives the required information, providing a "take home" reminder of the elements of the clinical investigation, providing contact information in case additional questions or concerns arise, and documenting the subject's voluntary agreement to participate.

The informed consent process often continues after the consent form is signed. Depending on the clinical investigation, additional information may need to be given to the subject, and the subject may need additional opportunities to ask questions and receive answers throughout the clinical investigation. (See section III.C.5, Providing Significant New Findings to Subjects, for a discussion of when findings developed during the clinical investigation must be communicated to subjects.)

III. FDA INFORMED CONSENT REQUIREMENTS AND DISCUSSIONFor all FDA-regulated clinical investigations (except as provided in 21 CFR 50.23 and 50.24 5), legally effective informed consent must be obtained from the subject or the subject's legally authorized representative. Informed consent must meet the requirements of 21 CFR 50.20, and must include the basic information required by 21 CFR 50.25(a). If appropriate to the clinical investigation, one or more of the additionalelements of information at 21 CFR 50.25(b) must also be addressed. For "applicable clinical trials" initiated on or after March 7, 2012, an additional element of informed consent is required by 21 CFR 50.25(c). 6

Below, the sections of 21 CFR 50.20 and 21 CFR 50.25 are set out in italics followed by a discussion of each regulation.

A. General Requirements for Informed ConsentExcept as provided in §§ 50.23 and 50.24, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence. (21 CFR 50.20.)

1. Exceptions to Informed Consent

Informed consent is required for participation in FDA-regulated clinical investigations except under limited circumstances as described in 21 CFR 50.23 (involving certain life-threatening situations, military operations, or public health emergencies) and 21 CFR 50.24 (involving emergency research 7). See 21 CFR 50.20. Nothing in FDA's informed consent regulations is intended to limit the authority of a physician to provide emergency medical care to the extent the physician is permitted to do so under applicable Federal, State, or local law (21 CFR 50.25(d)).

2. Coercion and Undue Influence

The conditions under which informed consent is sought and the relationship between the subject and the person obtaining consent must be carefully considered to minimize the possibility of coercion or undue influence (21 CFR 50.20). According to the Belmont Report, "Coercion occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance. Undue influence, by contrast, occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance."

For example, when an employing party seeks to enroll employees in a clinical investigation sponsored or conducted by the employing party, the protocol should contain safeguards to ensure that participation is voluntary and that there is no undue influence by supervisors, peers, or others. Similarly, because of a potential conflict of interest and the nature of the physician-patient relationship, when the investigator is also the prospective subject's physician, the physician should be careful to ensure that the prospective subject understands that enrollment in the clinical investigation is voluntary and that a decision to forego enrollment will not adversely affect his/her medical care. The consent form should emphasize that an individual's participation is truly voluntary.

Note that coercion and undue influence may be situational. For example, in a clinical investigation involving the surgical insertion of an investigational device, waiting to obtain informed consent until the potential subject is in the preoperative area may fail to minimize the possibility of undue influence.

In addition, statements that claim investigational test articles are safe or effective for the purposes for which they are being investigated are prohibited. (21 CFR 312.7(a) and 21 CFR 812.7(d).) Likewise, statements that inappropriately overstate the possibility of benefit should be avoided because they may unduly influence potential subjects. Careful wording is needed in order to avoid overstating potential benefits that may contribute to a subject's therapeutic misconception. 8

Furthermore, statements such as "FDA has given permission for the clinical investigation to proceed" or "FDA has approved the clinical investigation" should be avoided, because such statements may contribute to the misimpression that the investigation has FDA's endorsement.

3. Language Understandable to the Subject or the Legally Authorized Representative 9

The information given to the subject, which could include information provided orally during the consent interview or written information in the consent form, must be in language understandable to the potential subject or legally authorized representative (21 CFR 50.20). "Understandable" means the information presented to potential subjects is in a language and at a level the subjects can comprehend (including an explanation of scientific and medical terms). In ensuring that information is understandable, it should be noted that more than one-third of U.S. adults, 77 million people, have basic or below basic health literacy. 10 Limited health literacy affects adults in all racial and ethnic groups. 11 In addition, more than one-half of U.S. adults have basic or below basic quantitative literacy 12 and are challenged by numerical presentations of health, risk, and benefit data.

4. Exculpatory Language

The consent process may not include exculpatory language through which a subject is made to waive or appear to waive any of his or her legal rights, or release or appear to release the investigator, the sponsor, the institution, or its agents from liability for negligence (21 CFR 50.20). FDA considers exculpatory language to be language that has the general effect of freeing or appearing to free an individual or an entity from malpractice, negligence, blame, fault, or guilt.

The following are examples of exculpatory language that would violate 21 CFR 50.20, and therefore cannot appear in consent forms: 13

I waive any possibility of compensation, including any right to sue, for injuries that I may receive as a result of participation in this research.If you suffer a research-related injury, neither the institution nor the investigator can assume financial responsibility or liability for the expenses of treatment for such injury.In the event that you suffer a research-related injury, your medical expenses will be your responsibility or that of your third party payer.An example of one potential way to explain that a subject's legal right to seek to collect compensation for research-related injuries in certain situations is not being waived is included below. Other language that similarly conveys this concept would also be acceptable (see section III.B.6, Compensation and Medical Treatment in Event of Injury, for additional examples):

In the event that you suffer a research-related injury, your medical expenses will be your responsibility or that of your third-party payer, although you are not precluded from seeking to collect compensation for injury related to malpractice, fault, or blame on the part of those involved in the research.B. Basic Elements of Informed Consent(a) Basic elements of informed consent. In seeking informed consent, the following information shall be provided to each subject: (21 CFR 50.25(a).)

1. Description of Clinical Investigation

A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental. (21 CFR 50.25(a)(1).)

A clear statement that the clinical investigation involves research is important so prospective subjects are aware that, although preliminary data (bench, animal, pilot studies, literature) may exist, the purpose of their participation is primarily to contribute to research (for example, to evaluate the safety and effectiveness of the test article, to evaluate a different dose or route of administration of an approved drug, etc.) rather than to their own medical treatment.

FDA recommends that potential subjects first be informed of the care a patient would likely receive if not part of the research and then be provided with information about the research. This sequence allows potential subjects to understand how the research differs from the care they might otherwise receive. The description should identify tests or procedures that would be part of usual care that will not be performed as well as those required by the protocol that would not be part of their care outside of the research, for example, drawing blood samples for a pharmacokinetic study. The information provided should also inform prospective subjects about the potential consequences of these differences in care. Note that all experimental procedures must be identified as such. (21 CFR 50.25(a)(1).) Procedures related solely to research (for example, protocol-driven versus individualized dosing, randomized assignment to treatment, blinding of subject and investigator, and receipt of placebo if the study is placebo-controlled) must be explained.

The description of the clinical investigation must describe the test article and the control. The description should include relevant information of what is known about both the test article and the control. For example, the description should indicate whether the test article is approved/cleared for marketing and describe that use. Clarification may be provided that a marketed product may be prescribed by a health care practitioner for the labeled indication as well as other conditions/diseases he/she determines are reasonable. The description should also provide relevant information about any control used in the study. For example, whether the control is a medically recognized standard of care 14 or is a placebo (including an explanation of what a placebo is). The information provided about the test article and control should include appropriate and reliable information about the benefits and risks of each, to the extent such information is available.

The consent process should outline what the subject's participation will involve in order to comply with the protocol, for example, the number of clinic visits, maintenance of diaries, and medical or dietary restrictions (including the need to avoid specific medications or activities, such as participation in other clinical investigations (see section v.g, Subject Participation in More Than One Clinical Investigation)). If describing every procedure would make the consent form too lengthy or detailed, FDA recommends providing the general procedures in the consent form with an addendum describing all study procedures. It may be helpful to provide a chart outlining what happens at each visit to simplify the consent form and assist the subject in understanding what participation in the clinical investigation will involve. FDA believes that removing procedural details from the consent form will reduce its length, enhance its readability, and allow its focus to be on more important content, such as the risks and anticipated benefits, if any.

The informed consent process must clearly describe the expected duration of the subject's participation in the clinical investigation (see 21 CFR 50.25(a)(1)), which includes their active participation as well as long-term follow-up, if appropriate. The subject must be informed of the procedures that will occur during such follow-up, which may be provided in a chart as described above. (21 CFR 50.25(a)(1).)

2. Risks and Discomforts

A description of any reasonably foreseeable risks or discomforts to the subject. (21 CFR 50.25(a)(2).)

The informed consent process must describe the reasonably foreseeable risks or discomforts to the subject. This includes risks or discomforts of tests, interventions and procedures required by the protocol (including standard medical procedures, exams and tests), especially those that carry significant risk of morbidity or mortality. Possible risks or discomforts due to changes to a subject's medical care (e.g., by changing the subject's stable medication regimen or by randomizing to placebo) should also be addressed. The explanation of potential risks of the test article and control, if any, and an assessment of the likelihood of these risks occurring should be based on information presented in the protocol, investigator's brochure, package labeling, and previous research reports.

Reasonably foreseeable discomforts to the subject must also be described. (21 CFR 50.25(a)(2).) For example, the consent form should disclose the severity and duration of pain from a surgical procedure or the discomfort of prolonged immobilization for MRI.

All possible risks do not need to be described in detail in the informed consent form, especially if it could be overwhelming for subjects to read. Information on risks that are more likely to occur and those that are serious should be included. The discussion may include information on whether a risk is reversible and the probability of the risk based on existing data. Information on what may be done to mitigate the most likely to occur and serious risks and discomforts should also be considered for inclusion.

The description should not understate the probability and magnitude of the reasonably foreseeable risks and discomforts. If applicable, the consent document should include a description of the reasonably foreseeable risks not only to the subject, but also to "others" (for example, radiation therapy where close proximity to subjects post procedure may be of some risk to others). When appropriate, a statement must be included that the clinical investigation may involve currently unforeseeable risks to the subject (or to the subject's embryo or fetus, if the subject is or may become pregnant). (21 CFR 50.25(b)(1).) (See section III.C.1, Unforeseeable Risks.)

3. Benefits

A description of any benefits to the subject or to others which may reasonably be expected from the research. (21 CFR 50.25(a)(3).)

The description of potential benefits should be clear, balanced, and based on reliable information to the extent such information is available. This element requires a description of the potential benefits not only to the subject (for example, "This product is intended to decrease XXX; however, we cannot guarantee that you will benefit"), but also to "others" (for example, "your participation in this research may not benefit you but may benefit future patients with your disease or condition"). Overly optimistic representations of the clinical investigation may be misleading and may violate FDA regulations that prohibit promotion of investigational drugs and devices (see 21 CFR 312.7 and 21 CFR 812.7). Because the purpose of the study is to determine the safety and/or effectiveness of the test article compared to the control, it is not yet known whether the test article may or may not provide a benefit.

FDA considers payment to subjects for participation in clinical investigations to be compensation for expenses and inconveniences, not a benefit of participation in research. If payments are provided, the consent process should not identify them as benefits. 15

4. Alternative Procedures or Treatments

A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. (21 CFR 50.25(a)(4).)

To enable an informed decision about taking part in a clinical investigation, consent forms must disclose appropriate alternatives to entering the clinical investigation, if any, that might be advantageous to the subject. (21 CFR 50.25(a)(4).) Prospective subjects must be informed of the care they would likely receive if they choose not to participate in the research. This includes alternatives such as approved therapies for the patient's condition, other forms of therapy (e.g., surgical), and when appropriate, supportive care with no disease-directed therapy. 16 This disclosure must include a description of the current medically recognized standard of care, 17 particularly in studies of serious illness. Standard of care may include uses or treatment regimens that are not included in a product's approved labeling (or, in the case of a medical device cleared under the 510(k) process, in the product's statement of intended uses). 18 FDA believes that treatment options lacking evidence of therapeutic value do not need to be discussed.

When disclosing appropriate alternative procedures or courses of treatment, FDA believes a description of any reasonably foreseeable risks or discomforts and potential benefits associated with these alternatives must be disclosed. Where such descriptions or disclosures can contain quantified comparative estimates of risks and benefits (e.g., from the clinical literature), they should do so. The agency does not believe that imposing such a strict requirement for every case would be realistic or appropriate. 19 Where such well-defined estimates are not possible, the agency believes that a description of the risks and benefits will be sufficient.

It may be appropriate to refer the subject to a healthcare professional who can more fully discuss the alternatives, for example, when alternatives include various combinations of treatments such as radiation, surgery and chemotherapy for some cancers. This referral should be completed prior to the subject signing and dating the consent form.

FDA recognizes that, while an individual subject may be eligible for more than one clinical investigation, that determination and the decision as to which trial would be most appropriate for a particular subject would need to be made on a case-by-case basis. FDA believes that the discussion of other trials for which the subject may be eligible is best left to the informed consent discussion rather than the informed consent document and may need to include the subject's primary care provider.

As applicable, the informed consent process should advise that participation in one clinical investigation may preclude an individual's eligibility to participate in other clinical investigations for the same or other indications. When there are multiple clinical investigations for evaluating the treatment of a particular disease, the sequence in which a subject may participate in the protocols may be important and should be discussed with the subject and the subject's primary care provider, if appropriate.

5. Confidentiality

A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the records. (21 CFR 50.25(a)(5).)

The consent process must describe the extent to which confidentiality of records identifying subjects will be maintained (21 CFR 50.25(a)(5)) and should identify all entities, for example, the study sponsor, who may gain access to the records relating to the clinical investigation. The consent process must also note the possibility that FDA may inspect records (21 CFR 50.25(a)(5)), and should not state or imply that FDA needs permission from the subject for access to the records. Please note that under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, FDA does not need permission to inspect records containing health information (45 CFR 164.512). FDA may inspect study records, for example, to assess investigator compliance with the study protocol and the validity of the data reported by the sponsor.

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA may inspect and copy all records relating to the clinical investigation. 21 U.S.C. § 374(a)(1). See also 21 CFR 312.58(a), 312.68, and 812.145(b). FDA generally will not copy records that include the subject's name unless there is reason to believe the records do not represent the actual cases studied or results obtained. When FDA requires subject names, FDA will generally treat such information as confidential, but on rare occasions, FDA may be required to disclose this information to third parties, for example, to a court of law. See 21 CFR 20.63(a) and 20.83(a)-(b). Therefore, the consent process should not promise or imply absolute confidentiality by FDA.

6. Compensation and Medical Treatment in Event of Injury

For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained. (21 CFR 50.25(a)(6).)

For clinical investigations involving more than minimal risk, the informed consent process must describe any compensation and medical treatments available to subjects if injury occurs. 20 (21 CFR 50.25(a)(6).) Because available compensation and medical treatments may vary depending on the medical circumstances of the individual subject or the policies of the institution, the consent process should include an explanation to subjects of where they may obtain further information. An example of an adequate statement is, "the sponsor has made plans to pay for medical costs related to research-related injuries" followed by an explanation of how to obtain further information. If no compensation is available, the consent process should include statements such as: 21

Because of hospital policy, the hospital is not able to offer financial compensation should you be injured as a result of participating in this research. However, you are not precluded from seeking to collect compensation for injury related to malpractice, fault, or blame on the part of those involved in the research, including the hospital.Because of hospital policy, the hospital makes no commitment to provide free medical care or payment for any unfavorable outcomes resulting from participation in this research. Medical services will be offered at the usual charge. However, you are not precluded from seeking to collect compensation for injury related to malpractice, fault, or blame on the part of those involved in the research, including the hospital.Also, see section III.A.4, Exculpatory Language.

7. Contacts

An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject. (21 CFR 50.25(a)(7).)

The consent process must provide information on how to contact an appropriate individual for pertinent questions about the clinical investigation and the subjects' rights, and whom to contact in the event that a research-related injury to the subject occurs. (21 CFR 50.25(a)(7).) This information should include contact names (or offices) and their telephone numbers. FDA recommends that the individual or office named for questions about subjects' rights not be part of the investigational team. Subjects may be hesitant to report specific concerns or identify possible problems to someone who is part of the investigational team. In addition, the consent process should include information on whom to contact and what to do in the event of an emergency, including 24-hour contact information, if appropriate.22

If contact information changes during the clinical investigation, then the new contact information must be provided to the subject. (21 CFR 50.25(a)(7).) This may be done through a variety of ways, for example, a card providing the relevant contact information for the clinical investigation.

8. Voluntary Participation

A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. (21 CFR 50.25(a)(8).)

This element requires that subjects be informed that they may decline to take part in the clinical investigation or may stop participation at any time without penalty or loss of benefits to which subjects are entitled. (21 CFR 50.25(a)(8).) Language that limits the subject's right to decline to participate or withdraw from the clinical investigation must not be used. If special procedures should be followed for the subject to withdraw from the clinical investigation, the consent process must outline and explain the procedures (21 CFR 50.25(b)(4), see section III.C.4, Consequences of Subject's Decision to Withdraw). Also note that subjects may not withdraw data that was collected about them prior to their withdrawal, as discussed in Section V.I, Data Retention upon the Withdrawal of Subjects.

C. Additional Elements of Informed ConsentThe regulations identify additional elements of informed consent to be included, when appropriate. (21 CFR 50.25(b).)

(b) Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:

The following elements are appropriate to provide to prospective subjects when the IRB determines the information is material to prospective subjects' decisions to participate:

1. Unforeseeable Risks

A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable. (21 CFR 50.25(b)(1).)

When appropriate, the consent process must contain a statement that the particular test article or procedure may involve risks to subjects (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable. (21 CFR 50.25(b)(1).) If long-term safety studies (such as bench and animal testing) are not completed, the informed consent process should explain that researchers have not completed studies that may identify potential risks, for example, carcinogenicity or teratogenicity.

2. Involuntary Termination of Subject's Participation

Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent. (21 CFR 50.25(b)(2).)

When appropriate, the consent process must inform the subject of anticipated circumstances under which the investigator may end the subject's participation without the subject's consent. (21 CFR 50.25(b)(2).) Such circumstances may arise if, for example, the subject is unable to comply with procedures required by the clinical investigation, if the subject no longer meets the eligibility criteria for continuing in the study, or if the site withdraws from the study. A simple statement that the investigator or sponsor may withdraw the subject from participation at any time is inadequate and does not inform the subject of anticipated circumstances that may trigger his/her withdrawal from the clinical investigation. For example, the consent process may inform the subject that the investigator may withdraw the subject's participation in the clinical investigation if the subject does not follow the instructions given to him/her by the investigator, such as repeatedly failing to return for protocol-required clinic visits or repeatedly failing to follow dosing or device instructions. If a subject is withdrawn from the study, the clinical investigator should explain to the subject the reasons for withdrawal, discuss other available treatment or research options, and, if appropriate, discuss plans to follow the subject after withdrawal for side effects.

3. Additional Costs to Subject

Any additional costs to the subject that may result from participation in the research. (21 CFR 50.25(b)(3).)

If subjects may incur additional expense because they are taking part in the clinical investigation, the consent process must explain the added costs. (21 CFR 50.25(b)(3).) FDA recommends that the cost of any tests, procedures and/or products that may be charged to the subject, the subject's insurance or other reimbursement mechanism be explained as part of the informed consent process. Subjects should be made aware that insurance or other reimbursement mechanisms might not fund the medical care they receive because they are participating in a clinical investigation even when the care is the standard care they would otherwise receive if not participating in a clinical investigation. 23

Additionally, insurance or other forms of reimbursement might not pay for care related to complications or injuries arising from participation in a clinical investigation. (See also section III.B.6, Compensation and Medical Treatments in Event of Injury.) If the subject's insurance is charged and there are deductibles or copayments, the subject should be informed of whether he/she will be responsible for these costs. If funds will be available to cover costs not covered by insurance or other forms of reimbursement, the consent form should describe how these funds will be made available to subjects or direct subjects on how to obtain further information. Because these issues may be complex, it may be appropriate to refer the subject to a knowledgeable financial counselor or reimbursement specialist to explain the costs and the insurance and reimbursement issues prior to signing the consent form.

Beyond the costs directly related to participation in the research, it may be appropriate to identify additional costs that the subject may incur, such as loss of income when the subject takes time off from work to participate in the clinical investigation and transportation costs.

In some cases the cost of an investigational product may be charged to the subject. In clinical investigations involving investigational devices, the sponsor is permitted to recover the costs of research, development, manufacture, and handling of investigational devices (see 21 CFR 812.7(b)). FDA may authorize sponsors in certain clinical investigations of drugs to recover the direct costs of making the investigational drug available, such as costs to manufacture, ship, and handle (e.g., store) the drug (see 21 CFR 312.8).24 When these costs are passed to the subject, the consent process must identify these costs.

4. Consequences of Subject's Decision to Withdraw

The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject. (21 CFR 50.25(b)(4).)

When appropriate, the consent process must describe the consequences of a subject's decision to withdraw from the clinical investigation and the procedures for orderly termination of participation by the subject. (21 CFR 50.25(b)(4).) For example, when withdrawal from a clinical investigation may adversely affect the subject, the informed consent process must explain the withdrawal procedures that are recommended in order to ensure the subject's safety, and should specifically state why they are important to the subject's welfare. For some clinical investigations, an intervention should be withdrawn gradually or the investigator may recommend follow-up to ensure the subject's safety when an investigational intervention is prematurely terminated due to a subject's withdrawal. In these cases, the consent process must explicitly inform the subject of the potential adverse effects of premature termination of the investigational intervention. If applicable, the consent process must explain whether a subject who withdraws early will receive future payments.

5. Providing Significant New Findings to Subjects

A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject. (21 CFR 50.25(b)(5).)

The consent process must, when appropriate, include a statement that significant new findings that may relate to the subject's willingness to continue participation, such as new risk information, will be provided to the subject. (21 CFR 50.25(b)(5).) Significant new findings may include an unexpected adverse event or an adverse event occurring at greater frequency or severity than previously stated in the consent process. FDA encourages the inclusion of this statement in the consent form for clinical investigations where knowledge of risk is limited, for example, clinical investigations of the first use in humans, novel therapies, and new molecular entities, or complex clinical investigations that involve significant risk.

6. Number of Subjects

The approximate number of subjects involved in the study. (21 CFR 50.25(b)(6).)

The informed consent process must state the approximate number of subjects who will be involved in the clinical investigation, when appropriate. (21 CFR 50.25(b)(6).) For example, a subject's decision may be influenced by knowledge that the clinical investigation is a small initial trial of the product (such as a phase 1 or 2 drug clinical investigation or a device feasibility clinical investigation where only a small number of subjects participate).

D. Element of Informed Consent for "Applicable Clinical Trials"25When seeking informed consent for applicable clinical trials, as defined in 42 U.S.C. 282(j)(1)(A), the following statement shall be provided to each clinical trial subject in informed consent documents and processes. This will notify the clinical trial subject that clinical trial information has been or will be submitted for inclusion in the clinical trial registry databank under paragraph (j) of section 402 of the Public Health Service Act. The statement is: "A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time."

All informed consent forms and processes for "applicable clinical trials" 26 initiated on or after March 7, 2012, must contain the above quoted statement. 27 While additional explanation may be provided, the statement may not be modified.

E. Documentation of Informed Consent1. Requirement for Written Documentation of Informed Consent

(a) Except as provided in § 56.109(c), informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject's legally authorized representative at the time of consent. A copy shall be given to the person signing the form. (21 CFR 50.27(a).)

When obtaining informed consent, informed consent must be documented by a signed and dated written consent form except under two specific circumstances, as described in FDA's regulations at 21 CFR 56.109(c). 28 (21 CFR 50.27.) When written informed consent is required, the use of electronic, including digital, signatures is permitted under FDA's regulations, provided it is in compliance with applicable regulations. 29

In the event that an IRB waives the requirement for written documentation of informed consent (under 21 CFR 56.109(c)(1)), FDA recommends that the elements of informed consent be reviewed verbally with the subject or the subject's legally authorized representative. Additionally, the IRB may require the investigator to provide subjects with a written statement regarding the clinical investigation. (21 CFR 56.109(d).) FDA recommends that when an IRB waives the documentation requirement for informed consent in circumstances where there is minimal risk of harm as allowable under 21 CFR 56.109(c)(1), the consent process and discussion be described and noted in the records relating to the clinical investigation. 30

2. Alternative Methods of Obtaining Informed Consent

Traditionally, informed consent has been obtained in a face-to-face interview using paper consent forms. New technologies are becoming available that may serve as an alternative to the paper consent form in the informed consent process. Parties interested in pursuing alternative methods of obtaining informed consent are encouraged to contact FDA. 31 Currently, FDA is considering alternative methods using these new technologies and would be interested in comments on these alternative methods.

Even in the context of paper consent forms, there may be certain circumstances when an alternative to a face-to-face consent interview may be appropriate. For example, such an alternative may be appropriate when the subject or the subject's legally authorized representative is unable to visit the investigational site to sign the consent form, or if the screening procedures for the clinical investigation require prior activity, such as fasting, that requires consent but does not require a visit to the investigational site. When written informed consent is required, informed consent cannot be obtained solely by telephone. For studies involving no more than minimal risk, and no procedures for which written consent is normally required outside the research context, oral consent from a subject or a subject's legally authorized representative is permissible under 21 CFR 56.109(c). When oral consent is used, FDA recommends that documentation of the process (information provided, name of individual obtaining consent, date consent obtained) be included in the study records (see 21 CFR 312.62(b) and 21 CFR 812.140(a)(3)).

Methods other than a face-to-face consent interview may be acceptable if those methods allow for an adequate exchange of information and documentation, and a method to ensure that the signer of the consent form is the person who plans to enroll as a subject in the clinical investigation or is the legally authorized representative of the subject. For example, the consent form may be sent to the subject or the subject's legally authorized representative by facsimile or e-mail, and the consent interview may then be conducted by telephone when the subject or subject's legally authorized representative can read the consent form during the discussion. After the consent discussion, the subject or the subject's legally authorized representative can sign and date the consent form and return the document to the clinical investigator by facsimile, scanning the consent form and returning it through a secure e-mail account, or by posting it to a secure internet address. Alternatively, the subject may bring the signed and dated consent form to his/her next visit to the clinical site or mail it to the clinical investigator. The signed document should be filed with the subject's case history. See 21 CFR 312.62(b) and 812.140(a)(3). In addition, the person signing the consent form must receive a copy of the consent form (21 CFR 50.27(a)). Although FDA regulations do not require the subject's copy to be a signed copy, FDA recommends that a copy of the signed consent form be provided.

3. Requirement for Dating Consent Form

In addition to signing the consent form, the subject or the subject's legally authorized representative must enter the date of signature on the form (21 CFR 50.27(a)) to allow confirmation that the subject or the subject's legally authorized representative provided consent prior to participation in the clinical investigation, as required by 21 CFR 50.20. In those cases where the subject provides consent on the same day 32 that he/she begins participation in the clinical investigation, the subject's case history must document that the subject provided consent prior to participation in the research (see 21 CFR 312.62(b) and 21 CFR 812.140(a)(3)). The person signing the consent form must receive a copy of the consent form (21 CFR 50.27(a)), and the subject's case history should contain the signed and dated consent form. Although FDA regulations do not require the subject's copy to be a signed copy, FDA recommends that a copy of the signed consent form be provided.

4. Forms for Documentation of Informed Consent

Under 21 CFR 50.27:

(b) Except as provided in § 56.109(c), the consent form may be either of the following:

(1) A written consent document that embodies the elements of informed consent required by § 50.25. This form may be read to the subject or the subject's legally authorized representative, but, in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed. (2) A short form written consent document stating that the elements of informed consent required by § 50.25 have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining the consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative in addition to a copy of the short form.

The regulations provide for obtaining written informed consent by two different methods: a long form that embodies all the elements of informed consent (see 21 CFR 50.25), or a short form that states that the elements of informed consent have been presented orally to the subject or the subject's legally authorized representative.

a. Long Form

The long form embodies all the elements of informed consent as required under 21 CFR 50.25. When the long form is used, a copy must be provided to the person signing the form, that is, the subject or the subject's legally authorized representative. (21 CFR 50.27(a).)

b. Short Form

An IRB may approve a short form to be used in appropriate situations where the elements of informed consent required by 21 CFR 50.25 are presented orally to the subject or the subject's legally authorized representative. (21 CFR 50.27(b)(2).) For example, IRBs may consider approving the use of a short form in situations where the subject or the subject's legally authorized representative is unable to read due to illiteracy or blindness (see section V.C, Subjects with Low Literacy and Numeracy, and section V.D, Physically Challenged Subjects).

When the short form is used, the IRB is required to approve a written summary of the information to be presented orally. (21 CFR 50.27(b)(2).) The information presented orally is to be the same quantity and quality of information as when a long form is used. 33 A copy of the short form and the written summary must be given to the person signing the form (that is, the subject or the subject's legally authorized representative). (21 CFR 50.27(b)(2).)

Use of the short form requires that a witness be present to the oral presentation of information to the subject or the subject's legally authorized representative. (21 CFR 50.27(b)(2).) FDA recommends that an impartial third party, not otherwise connected with the clinical investigation (for example, clinical staff not involved in the research or a patient advocate), serve as the witness. FDA recommends that the witness be present (physically or by some other means, for example by phone or video conference) during the entire consent process, not just the signing of the consent form. The purpose of the witness is generally to attest to the voluntariness of the subject's consent and the adequacy of the consent process by ensuring that the information was accurately conveyed and that the subject's questions were answered.

The subject or the subject's legally authorized representative only signs and dates the short form. (21 CFR 50.27(a) and (b)(2).) The witness must sign both the short form and the summary, and the person obtaining consent must sign the summary. (21 CFR 50.27(b)(2).)

IV. RESPONSIBILITIES FOR INFORMED CONSENTIRBs, clinical investigators, and sponsors have responsibility for ensuring that the informed consent process is adequate and meets FDA's regulatory requirements. The regulatory requirements represent the minimum information to be provided to potential subjects for informed consent. IRBs, sponsors, and investigators should consider providing additional information as appropriate.

A. The IRBFDA requires that an IRB review and approve, require modifications in (to secure approval), or disapprove all research activities covered by the IRB regulations (21 CFR 56.109(a)). A critical part of this responsibility is for the IRB to ensure there is an adequate informed consent process that protects the rights and welfare of subjects participating in clinical investigations (21 CFR 56.109(b) and 56.111(a)(4)).

1. Review of All Informed Consent Materials

IRBs must review all materials used in the informed consent process. 34 This includes recruitment materials 35 and information provided in addition to the informed consent document (for example, a chart explaining what to expect at each study visit or a document explaining the costs to subjects). The IRB's review is to ensure that information given to subjects as part of the consent process contains the elements identified in 21 CFR 50.25 and meets the requirements of 21 CFR 50.20 (see 21 CFR 56.109(a), 56.109(b), and 56.111(a)(4)).

When reviewing clinical investigations, IRBs must ensure that the consent process minimizes the possibility of coercion and undue influence (21 CFR 50.20 and 56.111(a)(4)). When a clinical investigation involves subjects who are likely to be vulnerable to coercion or undue influence, IRBs must determine that additional safeguards have been included in the clinical investigation to protect their rights and welfare. 36 (21 CFR 56.111(b).) In the event an IRB regularly reviews clinical investigations involving vulnerable populations, for such clinical investigations, the IRB membership should include individuals with knowledge about and/or experience working with such subjects, in order to provide expertise and identify techniques for ensuring informed consent.

The IRB has the authority to require that information, in addition to that specifically mentioned in 21 CFR 50.25, be given to subjects when, in the judgment of the IRB, the information would meaningfully add to the protection of the rights and welfare of the subjects (21 CFR 56.109(b)). For example, local circumstances may necessitate the inclusion of additional information relevant to the informed consent process for potential subjects from that particular community.

HHS recommends that IRBs consider whether subjects should be informed of any financial relationships or interests that are associated with the clinical investigation, such as payments for services, equity interests or intellectual property rights. 37 As stated in the HHS guidance referenced in the footnote, some financial interests in the clinical investigation may affect the rights and welfare of subjects and IRBs should consider approaches to assure subjects are adequately protected, including providing subjects with information about the financial relationships and interests. IRBs should determine whether subjects should be provided with information regarding the source of funding, funding arrangements, financial interests of parties involved in the clinical investigation, and any financial interest management techniques applied. The IRB should consider the kind, amount and level of detail of information to be provided to subjects.

a. Adequacy and Appropriateness of Wording

The IRB has the authority and responsibility to require that information given to subjects as part of informed consent be in accordance with 21 CFR 50.25. 38 In its review of a clinical investigation, the IRB can disapprove a clinical investigation if informed consent will not be obtained in accordance with the informed consent regulations. (21 CFR 56.111(a)(4).)

Investigators must use an IRB-approved written consent form when documenting informed consent, in accordance with 21 CFR 50.27, except as provided in 21 CFR 56.109(c). Thus, the IRB should review the adequacy and appropriateness of all wording in the consent materials, as well as the overall length and presentation of information. Consent forms that are long, complex, legalistic, and have a high reading level 39 may overwhelm potential subjects and may inhibit reading of the full document and understanding of the relevant information.

The IRB should ensure that technical and scientific concepts and terms are explained, or common terms substituted, so that the anticipated subject population can understand all provided information (21 CFR 50.20). 40 Pictures or diagrams may be used to improve understanding of medical terms or how an investigational product functions. IRBs may wish to evaluate, through subject interviews, how well the consent materials communicate critical information.

b. Use of Standardized Language

IRBs should also address institutional requirements and applicable Federal, State, and local laws and regulations. (21 CFR 56.103(c) and 56.112.) Institutions may develop standard language or a standard format to use in portions of all consent forms (for example, for those elements that deal with confidentiality, compensation, answers to questions, and the voluntary nature of participation) to meet these requirements.

2. Review of the Consent Process

The investigator should advise the IRB of the consent process to be used. The materials and procedures used for subject recruitment, which typically include advertisements, must be reviewed by the IRB to ensure that these materials are appropriate. 41 The IRB must ensure that investigators seek consent from subjects under circumstances that minimize the possibility of coercion and undue influence (21 CFR 50.20 and 56.111(a)(4)). FDA considers this to include ensuring investigators allow sufficient time for subjects to consider the information, provide time and opportunity for the subjects to ask questions and have those questions answered, and allow time and opportunity for the subjects to consider fully whether to participate. The IRB must review all information given to subjects describing recruitment incentives, such as payments to reimburse potential subjects for expenses and inconveniences related to their participation (21 CFR 56.109(b)). In addition, the IRB must review the proposed amount and schedule of payments to subjects to ensure payments are appropriate to the time commitment and study procedures, and that subjects will not be unduly influenced by these incentives. 42

To approve a clinical investigation, the IRB must find that informed consent will be sought from each prospective subject or the subject's legally authorized representative and that informed consent will be appropriately documented. (21 CFR 56.111(a)(4) and (5).) FDA recommends that the IRB inquire as to who will conduct the consent interview and what procedures will be followed. If procedures other than a face-to-face consent interview are proposed, such as by telephone, the IRB should consider whether the procedures will provide effective communication and accomplish the goals of the informed consent process. Alternative procedures may be of special concern when the clinical investigation involves complex procedures or when risks may be difficult to comprehend.

FDA regulations authorize the IRB to observe or have a third party observe the consent process, as well as the research (21 CFR 56.109(f)). IRBs should consider using this authority when it believes it is appropriate 43 and will enhance the protection provided to subjects (for example, when the investigator is also the treating physician for a potential subject, when the person conducting the consent interview is relatively inexperienced, or when the clinical investigation involves vulnerable subjects). In addition to observing a sample of consent interviews, the IRB could interview subjects to assess the consent process and evaluate the subjects' understanding of the clinical investigation.

3. IRB Review Procedures

All information given to subjects as part of the consent process is to be reviewed and approved by the IRB 44 (21 CFR 56.109(a) and (b)). During the clinical investigation, new information about the research or changes to the clinical investigation may arise that affect the rights or welfare of subjects. FDA recommends that IRBs have procedures in place for the timely, efficient, and effective review of such new information or changes. This would include procedures for the clinical investigator and/or sponsor to notify the IRB of any significant new findings that arise during the clinical investigation relevant to a subject's decision to continue participation and that were provided to subjects (see section III.C.5, Providing Significant New Findings to Subjects). When new information or changes in the clinical investigation require revisions of the consent form (and any accompanying changes to the protocol), such revisions must be reviewed and approved by the IRB before the revisions are initiated, except when necessary to eliminate apparent immediate hazards to subjects. (21 CFR 56.108(a).)

Some changes may be reviewed and approved by expedited means, as provided for by 21 CFR 56.110. For example, an IRB may decide expedited review is appropriate for changes to the consent form that reflect minor changes in the protocol or recruitment plan, such as new advertising for subjects following initiation of the clinical investigation when the advertisement incorporates wording from the approved consent form and the advertisement can be easily compared to the approved consent form. When expedited review is used, if the IRB reviewer is unsure whether the change qualifies for expedited review under 21 CFR 56.110(b), FDA recommends that the reviewer (if other than the IRB chair) consult with the IRB chair. If doubts persist as to whether the change qualifies for expedited review, then the change should be reviewed at a convened meeting of the IRB.

4. Identification of Revised Consent Forms

The IRB should ensure that there is a way to identify a revised consent form so that continued use of a previously approved version does not occur. While not required by FDA regulations, the use of date stamps is one possible mechanism for ensuring use of the most recently approved version of the consent form. The investigator can then photocopy the date-stamped consent form for use in the trial.

B. The Clinical InvestigatorThe clinical investigator is responsible for protecting the rights, safety and welfare of subjects during a clinical investigation, and for ensuring that legally effective informed consent is obtained from each subject before that subject takes part in the clinical investigation (see 21 CFR 50.20, 312.60, and 812.100). The clinical investigator should advise the IRB regarding the consent process, including who will conduct the consent interview. Any information that will be given to subjects to review and discuss as part of informed consent must be submitted to the IRB for review and approval. (21 CFR 56.109(a) and (b).) An investigator may not begin the informed consent process with subjects until the IRB reviews and approves the clinical investigation, consent form, and the information to be given to subjects as part of the consent process. (21 CFR 50.20, 56.103(a), and 56.109.)

The clinical investigator's institution may have standard language or a standard format for consent forms (for example, for those elements that deal with confidentiality, compensation, answers to questions, and the voluntary nature of participation). FDA recognizes that investigators will also need to identify and meet such institutional requirements and incorporate them into the consent form for the IRB's initial review of the clinical investigation.

When organizing the information in the consent form, FDA recommends that the clinical investigator consider the order in which the information is presented so that the elements most significant to the subject's decision to participate are presented first. The clinical investigator is also encouraged to incorporate any additional information of interest to subjects that may affect their rights and welfare. For example, information about financial relationships and interests may be important to the subject (see section IV.B.2, Financial Relationships and Interests).

During the clinical investigation, the investigator may need to revise the consent form to address changes to the protocol or new information, such as significant new findings. The investigator will need to obtain IRB review and approval of the revised form. (21 CFR 56.109.) In addition, because the consent form is being modified to reflect changes to the protocol or new information, either of which may affect the willingness of already enrolled and actively participating subjects to continue in the clinical investigation, the IRB should determine the need to re-consent these enrolled subjects. To diminish confusion about the change, the investigator may use a prepared summary of the change to aid in an informative presentation to the enrolled subject. However, this summary does not constitute the revised informed consent document.

1. Delegation of Consent Interview

FDA regulations require that the investigator obtain or ensure that the legally effective informed consent of subjects is obtained. 45 If the investigator delegates this responsibility, FDA recommends that the individual to whom the responsibility is delegated be qualified by education, training, and experience to perform this activity. The individual obtaining informed consent should be knowledgeable about the clinical investigation and have the appropriate training and credentials; and the investigator should have a detailed plan for the supervision and oversight of the clinical investigation, including the informed consent process. 46 Even when a task is delegated to another individual, the investigator remains responsible for ensuring the clinical investigation is conducted according to applicable FDA regulations and for protecting the rights, safety, and welfare of subjects during the clinical investigation (21 CFR 312.60 and 21 CFR 812.100).

2. Financial Relationships and Interests

The clinical investigator should consider whether information related to financial relationships or interests should be provided to subjects. 47 Clinical investigators should consider the potential effects that a financial relationship might have on the clinical investigation or on interactions with subjects. When there are financial relationships or interests, clinical investigators should consider the following actions:

Including information in the informed consent document, such as:The source of funding and funding arrangements for the conduct and review of the clinical investigation, orInformation about a financial arrangement or interest (e.g., stock in the study sponsor, patent on the investigational product) of an institution or an investigator and how it is being managed.Using special measures to modify the informed consent process when a potential or actual financial conflict exists, such asHaving another individual who does not have a potential or actual conflict of interest involved in the consent process, especially when a potential or actual conflict of interest could influence the tone, presentation, or type of information presented during the consent process.Using independent monitoring of the consent process.C. The SponsorSponsors often provide clinical investigators with a model consent form that may be adapted by the clinical investigator to meet local needs. When the consent form is submitted to FDA for review, FDA's comments are generally directed to the sponsor. See section IV.D.1, Investigational New Drug and Biologics, and section IV.D.2, Investigational Medical Devices. The sponsor should promptly provide FDA's comments to the clinical investigator so that changes can be made to the consent forms. Because the clinical investigator must receive IRB approval before starting the clinical investigation (see 21 CFR 312.66 and 21 CFR 812.110(a)), the sponsor should work closely with the clinical investigator to make certain the modified consent form is reviewed and approved by the IRB. FDA recommends that the clinical investigator provide the sponsor with a copy of the consent form approved by the IRB.

1. Considerations for Multicenter Clinical Investigations

For multicenter clinical investigations, minor changes may need to be made to the consent form to address local and institutional requirements. When IRB review results in substantive modifications to the consent form, i.e. changes that affect the rights, safety, or welfare of the subjects, FDA recommends that the sponsor share the revisions with the investigators and their IRBs. If the clinical investigation has a central IRB working in cooperation with local IRBs, the revisions should be forwarded to the central IRB.48 Alternatively, local issues may be addressed by the central IRB depending on the review agreement between the local IRB(s) and central IRB.

D. The FDASponsors are not required to submit informed consent materials to FDA for all clinical investigations (see, for example, 21 CFR 312.2(b) and 21 CFR 812.2(b) and (c)). FDA's regulations for drug (including biologic) and device investigations have different requirements for the submission of informed consent materials in applications (see sections IV.D.1, Investigational New Drugs and Biologics, and IV.D.2, Investigational Medical Devices, below).

Generally, when informed consent materials are submitted, FDA reviewers assess the adequacy of the consent form by considering its communication of reasonably foreseeable safety issues and other elements required by 21 CFR 50.25. In some situations, FDA may find a consent form to be misleading, inaccurate, or incomplete in a way that makes informed consent inadequate and noncompliant with 21 CFR part 50. In these cases, FDA will require that specific revisions be made to address the concern(s) before the clinical investigation can proceed. (21 CFR 312.42 and 812.30.)

FDA's review of the consent form does not substitute for the responsibility or authority of the IRB to review and approve the consent form and consent process as a condition for the clinical investigation to begin. (21 CFR 56.103(a).) IRBs are responsible for ensuring the adequacy of the information in the consent form and may require modification as appropriate. (21 CFR 56.109.)

1. Investigational New Drugs and Biologics 49

The investigational new drug (IND) regulations (21 CFR part 312) do not specifically require submission to FDA of the consent form with the IND application. However, if FDA determines that review of the consent form is necessary to make the determination of whether the clinical investigation may safely proceed, the Agency will request that the sponsor submit the consent form for review under 21 CFR 312.23(a)(11).

As a general matter, the informed consent form will be reviewed for treatment INDs and treatment protocols (21 CFR part 312, subpart I) and INDs conducted under the exception from informed consent requirements for emergency research (21 CFR 50.24) consistent with 21 CFR 50.25 (see 21 CFR 50.24(a)(6))).

For other clinical investigations, FDA often considers the following factors in determining whether to require submission and review of the consent form:

Nonclinical studies submitted in support of the first administration of a drug in humans identify an unusual toxicity;Unusual known toxicity is associated with the investigational drug, the drug class to which the drug belongs, or with a different drug with characteristics similar to those of the study drug;The study population is particularly vulnerable;The study design is unusual for the therapeutic class;The clinical investigation is a postmarketing safety clinical trial, required under section 505(o) of the FD&C Act to assess a serious risk;The clinical investigation has significant potential for serious risk to human subjects;The clinical investigation involves asking subjects to forego or delay effective treatment that is known to decrease long-term mortality or irreversible morbidity;FDA has other confidential or proprietary information not available to an IRB that affects the assessment of whether the informed consent form adequately addresses risks.After reviewing the consent materials, if the FDA review divisions have specific concerns about the adequacy or compliance of the consent materials with 21 CFR part 50, details about these concerns normally will be conveyed to the sponsor in writing. In rare circumstances, FDA may find a consent form to be misleading, inaccurate or incomplete in a way that makes informed consent inadequate and noncompliant with 21 CFR part 50 in such a manner as subjects would be exposed to an unreasonable and significant risk of illness or injury. In these cases, FDA may require that specific revisions be made to address the concern(s) before the clinical investigation can proceed (21 CFR 312.42).

2. Investigational Medical Devices

For clinical investigations of medical devices for which an investigational device exemption (IDE) application is required to be submitted to FDA, the sponsor must include in the application copies of all forms and informational materials that will be provided to subjects to obtain informed consent. (21 CFR 812.20(b)(11).) FDA reviews the consent form to ensure that it conforms to the requirements of 21 CFR part 50. After review, FDA may send the sponsor a letter citing deficiencies regarding the consent form. (21 CFR 812.30(a) and (b)(4).) The clinical investigation may not begin until the sponsor has corrected these deficiencies. (21 CFR 812.30(a) and 812.42.) In the event an IRB makes substantive changes to the informed consent document after IDE approval by FDA, i.e., changes that affect the rights, safety, or welfare of the subjects, the sponsor must submit the revised informed consent document to FDA for its review and approval prior to implementing the changes to the document. (21 CFR 812.35(a).)

V. Additional considerationsA. Review of Patient RecordsSponsors and investigators may seek to review patient medical records for a variety of reasons related to a clinical investigation. Whether the record review is considered part of the clinical investigation, as defined under FDA's regulations at 21 CFR 50.3(c) and 21 CFR 56.102(c), is determined on a case-by-case basis. If the record review is part of the clinical investigation, then informed consent from the subject for the record review is required under 21 CFR part 50.

A survey of patient records at a site may be performed to determine whether the site has a sufficient number of patients with the condition of interest for the clinical investigation to be feasible. Such a survey is in preparation for a clinical investigation and does not fall within the definition of a clinical investigation and, therefore, does not require informed consent under FDA's regulations. 50 Sponsors and investigators will need to comply with all applicable HIPAA privacy protections in these circumstances.

A patient's records may be reviewed to determine whether the patient is eligible for a clinical investigation. In order to facilitate this process, limited information about the potential subject may be recorded. It should be noted, however, that only information to establish the patient's eligibility for the study and contact information should be recorded. This preliminary review of the patient's record and recording of limited information is considered preparation for a clinical investigation, does not fall within the definition of a clinical investigation, and does not require informed consent. 51 Even though informed consent is not required by FDA in these instances, proper maintenance of these records includes safeguarding the privacy and confidentiality of the patient's information. Many institutions have privacy boards to help fulfill this function or they may give the IRB this responsibility. Review by these entities may be required by the institution prior to these record review activities.

If a patient's record does not include the basic information necessary to determine if he or she is eligible for the clinical investigation, additional information may need to be gathered from the potential subject. Obtaining informed consent may be required prior to obtaining the additional information. Please see the FDA Information Sheet "Screening Tests Prior to Study Enrollment," 52 for a discussion of when informed consent would be required under the regulations.

The records of a subject who was previously enrolled in a clinical investigation may be reviewed retrospectively, without reconsenting the subject, to collect additional information under certain limited circumstances, consistent with the original consent process. If this retrospective review is to gather information that was intended to be collected but was missed (that is, the protocol required collection of the information but it was not reported in the case report form and the purpose of the review is merely to fill in gaps in the record), then this review is considered to be covered by the previous informed consent obtained for the clinical investigation and further consent from the subject is not required. In cases where the additional information goes beyond what was identified in the original protocol and disclosed in the original consent form, obtaining informed consent for the additional information would be required. (21 CFR 50.20 and 50.25.) Where possible, FDA recommends that the clinical investigator anticipate the need for obtaining further information and obtain consent as part of the initial consent process.

In all of the above situations, there are privacy and patient confidentiality issues that need to be addressed. The clinical investigator, sponsor, and institution should consider whether institutional policies or other statutory or regulatory requirements exist to address this (such as under the Health Insurance Portability and Accountability Act (HIPAA), the HIPAA Privacy Rule (45 CFR parts 160 and 164) or HHS human subject protection regulations at 45 CFR part 46). 53

B. Non-English Speaking Subjects 54Individuals who do not understand English may ask or be asked to participate in a clinical trial in locations where English is the predominant language. The investigators and the IRBs that review such research should carefully consider the ethical ramifications of enrolling or excluding potential subjects when a language barrier may exist between the investigator(s) and some or all of the potential subjects. Consistent with the requirement that selection of subjects be equitable (21 CFR 56.111(a)(3)), individuals should not routinely be excluded from participating in research simply because they do not understand English.

When individuals who do not understand English are to be enrolled in a clinical study, IRBs and investigators must ensure that the information given to such prospective subjects or their legally authorized representatives is in language understandable to the subjects or their representatives (21 CFR 50.20). Understandable means the information presented to potential subjects is in a language and at a level they can comprehend, including an explanation of scientific and medical terms.

The IRB must review and approve all English and non-English language versions of any consent documents (long form or short form with written summary) that are to be used by investigators to document the informed consent of subjects (21 CFR 50.27(a) and 21 CFR 56.111(a)(4) and (5)). When reviewing proposed informed consent procedures involving translation of written and oral information that is to be presented to subjects, FDA recommends that the IRB review, and if appropriate, approve procedures for ensuring that the translations will be prepared by a qualified individual or entity.

A protocol amendment in which the investigator proposes to include use of translated informed consent documents for a study already approved by the IRB with English language consent documents may be considered no more than a minor change to the research and may qualify for an expedited review procedure under FDA regulations at 21 CFR 56.110(b).

FDA notes that informed consent should be viewed as an ongoing process throughout the course of a subject's involvement in the research. Therefore, FDA recommends that whenever subjects who do not understand English are involved in research, appropriate interpreter services be made available throughout the course of the research.

1. Informed Consent Procedures when Enrollment of Subjects who do not Understand English is Expected

When investigators reasonably expect that the subject population for a proposed study will include individuals who do not understand English and can anticipate the specific language(s) that they will understand, the investigator should submit to the IRB, prior to its initial review, appropriately translated consent documents (i.e., either a long form or a short form with written summary). The investigators should also provide the IRB with a description of how interpreters for oral communication will be made available to subjects during the research. For example, if the investigators reasonably expect that the subject population for a proposed research protocol will include individuals who only understand Spanish and others who only understand Russian, the investigators should submit to the IRB, prior to its initial review, consent documents (i.e., either a long form or a short form with written summary) translated into Spanish and Russian along with a description of how interpreters for oral communication in Spanish and Russian will be made available during the research.2. Informed Consent Procedures when Enrollment of Subjects who do not Understand English is Unexpected

FDA recognizes that investigators on occasion face circumstances where: (1) an individual who does not understand English is eligible for an IRB-approved research protocol; and (2) the investigator has an IRB-approved English language long form, but does not have an appropriate IRB-approved written translation of the long form, short form, or written summary. This may occur because neither the investigator nor the IRB reasonably expected enrollment of a subject for whom a translation would be needed.

For some research, the time frame for subject enrollment may provide sufficient time for the preparation and IRB review of an appropriately translated long form or an appropriately translated short form and written summary. When this is the case, translated consent forms are to be reviewed and approved by the IRB prior to enrollment of the subject.

For other research, the timeframe for enrollment of a subject who does not understand English may not provide sufficient time for preparation and IRB review of appropriately translated consent documents. As a contingency for this situation, many IRBs have arranged for translation of a generic short form in multiple languages that satisfies the requirements of FDA regulations at 21 CFR 50.27(b)(2) and have prospectively approved the use of such short forms for enrollment of subjects who do not understand English, as needed for any research protocol. In such circumstances, FDA considers procedures that include the following sequential steps to be one acceptable way of obtaining and documenting the informed consent of the subject:

Step 1 '' Determine that there is Sufficient Justification to Enroll the Subject Without Using a Translated Long Form to Document the Subject's Informed Consent

The investigator, in consultation with the IRB chairperson (or another IRB member designated by the chairperson, hereafter referred to as designee) whenever feasible, determines that there is sufficient justification (e.g., due to a limited therapeutic window) for obtaining the subject's consent without waiting for a translated long form to be reviewed and approved by the IRB prior to enrollment of the subject. In making a decision to allow enrollment of a subject who does not understand English into a research protocol without waiting for a written translation of the long form, the investigator (and whenever feasible the IRB chairperson or designee) should consider whether the consent process, under this circumstance, will provide the subject with sufficient opportunity to understand the information being presented. If consent is sought and the investigator believes that the prospective subject has not understood the information presented, then the individual should not be enrolled in the research.

Step 2 '' Obtain and Document the Subject's Informed Consent in Accordance with FDA Regulations at 21 CFR 50.25 and 21 CFR 50.27 Using a Translated Short Form and the English Language Version of the Long Form as the Written Summary

In accordance with the requirements of 21 CFR 50.27(b)(2), informed consent is documented using a short form that has been translated into a language understandable to the prospective subject and approved by the IRB. As a prerequisite to using this procedure, the investigator must have available a short form written in a language understandable to the prospective subject and previously approved by the IRB (21 CFR 50.27(a)). To meet this prerequisite, the IRB or investigator must have arranged for translation of a generic short form into a language understandable by the prospective subject and the IRB must have approved the prospective use of such short forms for enrollment of subjects who do not understand English, as needed. Additionally, the IRB must approve a written summary of what is to be said to the subject or the legally authorized representative. (21 CFR 50.27(b)(2).) The IRB-approved long form can be used as this written summary.

The procedure for obtaining and documenting the subject's informed consent with a translated short form and an English version of the long form, then includes the following:

(1) The investigator obtaining informed consent, with the assistance of an interpreter if needed, provides orally to the subject the elements of informed consent required by FDA regulations at 21 CFR 50.25 and any additional pertinent information included in the IRB-approved English version of the long form. This presentation may be an oral translation of the IRB-approved English version of the long form. The oral presentation must be in language understandable to the subject (21 CFR 50.20). The investigator, with the assistance of an interpreter if needed, answers any questions from the prospective subject. There must be a witness to the oral presentation who must not be the person obtaining informed consent (21 CFR 50.27(b)(2)). Furthermore, the witness should be fluent in the language of the oral presentation.

(2) At the time informed consent is sought, the subject is given the IRB-approved translated short form and a copy of the IRB-approved English version of the long form, which serves as the written summary.

(3) The short form is signed and dated by the subject.

(4) The witness signs both the short form and the copy of the IRB-approved English version of the long form. (Note that when an interpreter assists the person obtaining consent, the interpreter may serve as the witness, but is not required to do so.)

(5) The person actually obtaining consent signs the copy of the IRB-approved English version of the long form.

Step 3 '' Take Additional Actions Following Subject Enrollment

After the subject has been enrolled in the research, the investigator takes the following additional actions:

(1) If a subject was enrolled in the research without waiting for a translated long form (which served as the written summary) to be reviewed and approved by the IRB, and if the investigator did not consult with the IRB chairperson (or designee) prior to enrollment of the subject who does not understand English, the investigator should promptly notify the IRB chairperson (or designee) that such a subject was enrolled.

(2) For FDA-regulated research, the investigator must promptly obtain a translated copy of the IRB-approved English version of the long form, which served as the written summary. The investigator promptly submits it to the IRB for review and approval. Once the translated long form/written summary is approved by the IRB, the investigator provides it to the subject as soon as possible. FDA considers this step essential to the requirement that informed consent be documented by the use of a written consent document and that the subject be provided a copy (21 CFR 50.27). Many of the clinical investigations regulated by FDA involve ongoing interventions and may involve long-term follow-up. FDA believes that translation of the long form is critically important as a means of providing subjects an ongoing source of information understandable to them.

C. Subjects with Low Literacy and NumeracyAlthough a competent person who does not read and write well can give informed consent and enroll in a clinical investigation, the sponsor, clinical investigator and IRB should consider whether any modifications to the informed consent process are necessary to ensure that the informed consent process is understandable.

For subjects with apparent low literacy, oral presentation of the information contained in the consent form is especially important. When the elements of informed consent are presented orally to the subject or the subject's legally authorized representative, the IRB may want to consider approving the use of a short form and written summary (21 CFR 50.27(b)(2)), which includes a witness to the oral presentation of the informed consent elements who also signs the consent form (see section III.D.4.b, Short Form). It should be noted that, even if the information is presented orally, the subject or the subject's legally authorized representative is required to sign the consent form (whether the long form or short form is used) unless the IRB has waived documentation of informed consent under 21 CFR 56.109(c).

Subjects who cannot write, can indicate their consent by "making their mark" on the consent form, when consistent with applicable State law. In this situation, a progress note in the subject's case history should indicate the reason for the lack of a signature.

D. Physically Challenged SubjectsA person who is physically challenged (for example, physically unable to talk or write or has hearing or visual loss) can enroll in a clinical investigation if competent and able to signal consent when consistent with applicable State law. The records relating to the clinical investigation must include documentation of the informed consent process (21 CFR 50.27) unless excepted under 21 CFR 56.109(c). FDA recommends that the subject's case history include a description of the specific means by which the prospective subject communicated agreement to take part in the clinical investigation and how questions were answered. FDA recommends that investigators accommodate the specific needs of the study population. For example, the investigator could use an audio tape of the contents of the consent form or a form with enlarged font, depending on the level of impairment of the visually impaired subjects.

E. Impaired Consent Capacity 55Consent capacity is a person's ability to understand information relevant to the decision to enroll in a study, that is, to weigh the risks and benefits of participation, to appreciate the available alternatives (including nonparticipation), to reach an informed and voluntary decision regarding participation, and to communicate that decision. Consent capacity also depends, in part, on the complexity of the decision that confronts the individual, which may take into account such factors as study design, risks, and anticipated benefits.

Impaired consent capacity may involve partial impairment, impairment that fluctuates over time, or complete impairment. For example, consent capacity can be affected by a wide range of disorders and conditions, such as dementia, stroke, traumatic brain injury, developmental disorders, serious mental illness, intoxication, and delirium.

Enrollment of subjects with partial impairment may require modifications to the consent form and process to enable those subjects to consent on their own behalf. When a subject's consent capacity is sufficiently impaired that the subject is unable to provide legally effective informed consent, the subject may not be enrolled unless the subject's legally authorized representative consents on the subject's behalf. (21 CFR 50.3(l) and 50.20.)

FDA regulations expressly identify "mentally disabled persons" as a vulnerable category of subjects in clinical investigations for which IRBs may need to assume increased responsibilities. (21 CFR 56.107(a) and 56.111(b).) For example, when reviewing studies that involve "mentally disabled persons" who are likely to be vulnerable to coercion or undue influence, IRBs must ensure that additional safeguards have been included in the study, which may include modifying the informed consent process, to protect the subjects' rights and welfare. (21 CFR 56.111(b).)

IRBs and investigators should carefully consider whether the inclusion in research of individuals who lack consent capacity is ethically appropriate and scientifically necessary. Whenever individuals with impaired consent capacity (partial, fluctuating, or complete) are or may be enrolled in clinical studies, ethical and procedural challenges arise. Considerations that may help address these challenges, and provide additional safeguards, include:

Assessing consent capacity of potential subjects, for example, through use of an independent, qualified professional 56 and a process that includes: (i) documentation of elements of capacity (such as understanding information, showing evidence of choice, showing rational reasoning, understanding the nature of the situation, and showing reasonable understanding of outcome of choice); and (ii) assessments at the time of consent, at periodic intervals, and when a subject's family member expresses concern about the subject's study participation.Establishing a waiting period in the decision-making process to allow additional time for decision-making.Using methods to enhance consent capacity, for example, through (i) simplification and/or repetition of information, (ii) involvement of a subject advocate or trusted family member/friend to assist when sharing information about the clinical investigation, and (iii) refraining from discussions during periods ofAssessing a subject's understanding after information about the clinical investigation has been imparted, for example, through use of a questionnaire.Re-assessing consent capacity after initiation of the clinical investigation for subjects with progressive disorders whose cognition may decline.Involving a legally authorized representative either initially or later in the clinical investigation if consent capacity diminishes.Assessing whether individuals who cannot provide legally effective consent on their own behalf may nonetheless be able to provide some form of oral agreement (e.g., assent) at the outset of the study and, as appropriate, throughout the course of the research (e.g., for subjects with progressive disorders), and how such oral agreement would be documented. In such a circumstance, a legally authorized representative would need to provide documented written consent.Determining whether the IRB or a third party should observe the consent process (see section IV.A.2, Review of the Consent Process, for more information).F. Children as Subjects 57If a child is to be enrolled in a clinical investigation, the parent(s) or guardian must provide permission, with the assent of the child when appropriate. (21 CFR 50.55). Parental or guardian permission must be obtained in accordance with the requirements for informed consent (21 CFR 50.55(e)) 58 and be documented in accordance with 21 CFR 50.27. (21 CFR 50.55(f)).) FDA regulations provide these safeguards for children enrolled in clinical investigations, as described in 21 CFR part 50, subpart D. 59 As with informed consent, the exceptions under 21 CFR 50.23 or 21 CFR 50.24 also apply to the requirement for parental permission. 60 (21 CFR 50.55(e).) FDA regulations also require the IRB to determine whether the assent of the child participant is appropriate as discussed below. (21 CFR 50.55(a).)

The IRB may determine that the permission of one parent is sufficient for clinical investigations involving no greater than minimal risk to children (21 CFR 50.51) or clinical investigations involving greater than minimal risk to children but presenting the prospect of direct benefit to individual subjects (21 CFR 50.52). (21 CFR 50.55(e)(1).)

For clinical investigations approved by the IRB under either 21 CFR 50.53 or 21 CFR 50.54, 61 where permission is to be obtained from parents, the permission of both parents is required unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. (21 CFR 50.55(e)(2).)

The general requirements for informed consent, found in 21 CFR 50.20, 21 CFR 50.25 and 21 CFR 50.27, apply to parental permission. (21 CFR 50.55(e).) When obtaining parental permission, in the event the parents of a child do not understand English, the parental permission must be obtained and documented in language that is understandable to the parents. (21 CFR 50.20.) FDA recommends that a child not be used as a translator, even if the child is fluent in English and may be able to assent. Similarly, if child assent is required, the information given to the child should be in language that is understandable to the child.

"Assent" means a child's affirmative agreement to take part in a clinical investigation, not just the failure to object. (21 CFR 50.3(n).) Child assent, when appropriate, and parental (or guardian) permission taken together meet the ethical requirement to obtain informed consent. Absent a waiver of the assent requirement (21 CFR 50.55(d)), the IRB must determine that there are adequate provisions for soliciting the assent of children when, in the IRB's judgment, the children are capable of providing assent. (21 CFR 50.55(a).) In deciding whether children are capable of providing assent, the IRB must consider the ages, maturity, and psychological state of the children to be involved in the clinical investigation. 62 (21 CFR 50.55(b).) A child does not need to fully understand the clinical investigation in order to provide assent provided the child is capable of understanding the interventions and the related procedures. For a complex clinical trial, a child may be able to understand and provide assent if he/she appreciates and agrees to the interventions and/or procedures in the trial (e.g., drawing a blood sample for a test), even though he/she may not be capable of understanding a randomized clinical trial.

An IRB may determine that assent is not necessary or may waive the assent requirement in certain situations. (21 CFR 50.55(c) and (d).) For example, the assent of children is not a necessary condition for proceeding with a clinical investigation if the IRB determines that the intervention or procedure involved in the clinical investigation holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the clinical investigation. (21 CFR 50.55(c)(2).) Also, the IRB can waive the assent requirement for children capable of assenting if the IRB finds and documents that the clinical investigation involves no more than minimal risk to the subjects; the waiver will not adversely affect the rights and welfare of the subjects; the clinical investigation could not practicably be carried out without the waiver; and, when appropriate, the subjects will be provided with additional pertinent information after participation. (21 CFR 50.55(d).) Parental permission requirements remain in these circumstances.

When the IRB determines that assent is required, it must also determine whether and how assent must be documented. (21 CFR 50.55(g).) Some of the same considerations noted above for determining capability of children to provide assent should be considered when determining whether assent should be in writing or oral. If the IRB determines oral assent is appropriate, the assent process should be described and noted in the subject's records relating to the clinical investigation. For clinical investigations involving children from whom the IRB has determined written assent is required, a permission form that follows the regulations at 21 CFR 50.20 and 50.25 for parents to give permission is required, and FDA recommends that an assent form for children that outlines the clinical investigation be used.

FDA does not require the use of a written assent form (see 21 CFR 50.55(g)); however, when a written assent process is appropriate or required by the IRB, FDA strongly encourages the use of a separate assent form that is "child-oriented" and developmentally appropriate. A separate assent form does not need to include all of the elements of a consent form, but should focus on those aspects of the clinical investigation that may impact on a child's willingness to participate.

Children who are wards of the State or any other agency, institution, or entity can be included in a clinical investigation that is approved under 21 CFR 50.53 and 50.54 provided that two conditions are met. First, the clinical investigation is either: (1) related to their status as wards; or (2) conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards. (21 CFR 50.56(a)(1) and (2).) In other words, children who are wards may only be enrolled in clinical investigations involving greater than minimal risk and no prospect of direct benefit, but likely to yield generalizable knowledge about the subjects' disorder or condition (21 CFR 50.53) or clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children (21 CFR 50.54), if one of these two conditions is met.

Second, if the IRB approves an investigation under 21 CFR 50.53 or 50.54 after determining 21 CFR 50.56(a) is met, the IRB must require that an advocate is appointed for each child who is a ward. (21 CFR 50.56(b).) The IRB must ensure that such an advocate is in place, but the IRB itself does not need to appoint the advocate. The advocate, who can serve as an advocate for more than one child, serves in addition to any other individual acting on behalf of the child as guardian or in loco parentis (i.e., has the legal authority and responsibility to act in the place of a parent). (21 CFR 50.56(b)(1) and (2).) The advocate must be an individual who has the background and experience to act in, and agrees to act in, the best interest of the child for the duration of the child's participation in the clinical investigation. The appropriate expertise for an advocate may include, but is not limited to, education and/or experience in: pediatric medicine, law, child advocacy, foster parenting, behavioral sciences, or child psychology. The advocate should be adequately informed about the potential risks and benefits of the proposed clinical investigation, and in how the intervention is likely to affect the individual child. The advocate must not be associated in any way (except in the role as advocate or member of the IRB) with the clinical investigation, the investigator(s), or the guardian organization.

FDA regulations do not address the appointment of an advocate for children involved in clinical investigations approved under 21 CFR 50.51 (i.e., research involving no more than minimal risk) or 21 CFR 50.52 (i.e., research involving greater than minimal risk but presenting the prospect of direct benefit). However, IRBs should consider the appointment of an advocate in such clinical investigations in order to ensure that there is someone who will act in the best interest of the ward(s) for the duration of their participation in the clinical investigation. Before enrolling any child who is a ward in a clinical investigation, IRBs should ensure that each child has a guardian and/or advocate with the background, experience and commitment to act in the best interest of the child.

Parental permission and child assent should be viewed as an ongoing process throughout the duration of a clinical investigation. If and when a child who was enrolled in a clinical investigation with parental permission reaches the legal age of consent, that subject is no longer considered a child for purposes of 21 CFR part 50 Subpart D, see 21 CFR 50.3(o), and the investigator must obtain the subject's informed consent under 21 CFR part 50, subpart B, prior to performing any further research interventions and/or procedures involving that subject. (21 CFR 50.20.)

G. Subject Participation in More Than One Clinical InvestigationSome subjects may wish to participate simultaneously in more than one clinical trial or enroll in a single clinical investigation multiple times. FDA strongly discourages these practices as enrollment in more than one clinical investigation could increase risks to subjects, particularly because they may be exposed to more than one investigational product for which the safety profile may not be well understood. In addition, the subjects may find it difficult to understand all the risks and proposed benefits, much less meet the demands, of multiple protocols. Moreover, there may be potential drug or device interactions, and the simultaneous use of more than one investigational product may confound the results of the clinical investigations.

Sponsors generally include prohibitions related to the use of concomitant medications in the protocol or restrict (via exclusion criteria) inclusion of subjects who have participated in another clinical investigation within a specified period of time (for example, the washout period before a subject can enroll in a new clinical investigation). Implied in the prohibitions on concomitant medications is the idea that subjects should not participate in more than one clinical investigation at a time. Investigators should inquire about multiple enrollments and discourage this practice in the consent form and during any informed consent discussions.

H. Suspension/Termination of a Study 63A clinical trial may be suspended and possibly terminated for a variety of reasons. Such reasons could include the identification of a significant safety issue, lack of effectiveness, or a concern about investigator misconduct. Often, when one of these issues is first identified, a study may be temporarily suspended while the issue is investigated. Depending upon the type and seriousness of the concern, changes to the study protocol or to the informed consent (due to significant new findings as discussed previously in section III.C.5) may be needed, or a decision may be made to terminate the study. In other cases, a sponsor may terminate a study or entirely abandon development of a product for business reasons.

When a study is suspended, IRBs, sponsors and investigators should consider whether subjects should be notified, and if so, when, especially given that during a study suspension complete information may not be available. All parties should consider what information should be shared with subjects in order to ensure that their rights and welfare are protected, that they are not put at risk, and that they receive appropriate care, if indicated. The parties involved, including the subjects' treating physicians (if different from the investigator), as appropriate, may need to determine whether it is in the best interests of currently enrolled subjects to (a) continue receiving the interventions that were being administered to subjects under the study at the present site, (b) be transferred to another study-site so that participation of the subjects in the study may continue, or (c) be transitioned to medical management outside of the research context. Continuation of subjects on the test article may be appropriate, for example, when the test article holds out the prospect of direct benefit to the study subjects or when withholding the test article poses increased risk to study subjects. In general, information about these considerations should be shared with subjects so that they may understand the changes affecting their participation in the study and allow them to make informed decisions about their continued participation.

If a study is terminated, study subjects should be provided with as much information as possible regarding the reason for the termination. Such a discussion not only recognizes their valuable participation in the study but also helps explain the scientific value of the information obtained due to their willingness to participate in clinical research. Moreover, such a discussion provides an opportunity to address questions subjects may have about the investigational product that was administered to them (e.g., immediate safety concerns, ability to participate in another clinical trial and appropriate waiting period to do so) and what long-term follow-up may be available or necessary. If the reason for the study termination involves a safety concern that may impact the future medical care of the study subjects, appropriate follow-up procedures would need to be discussed with the subjects and possibly the subject's primary care provider.

I. Data Retention upon the Withdrawal of SubjectsUnder FDA regulations, data collected on subjects up to the time of withdrawal from the clinical investigation must remain in the study database. 64 See 21 CFR 312.62(b) and 812.140(a)(3). If a subject withdraws from a study, removal of data that were already collected may undermine the scientific, and therefore the ethical, integrity of the research. Such removal of data could also put enrolled subjects, future subjects, and eventual users of marketed products at an unreasonable risk and could compromise FDA's ability to perform its mission to protect public health and safety by assuring the safety and effectiveness of regulated products.

Subjects should be advised in the consent document that the data collected on them up until the point of their withdrawal remains part of the study database and may not be removed. An investigator should ask a subject who is withdrawing whether he/she wishes to withdraw from the investigational interventions only and is willing to continue in the clinical investigation for follow-up of associated clinical outcome information. If a subject withdraws from the interventional portion of the clinical investigation but agrees to continued follow-up not addressed in the original consent form, the investigator must obtain the subject's informed consent for this limited participation using an IRB-approved consent form. (21 CFR 50.25(a)(1).) If a subject withdraws from the interventional portion of a clinical investigation and does not consent to continued follow-up of associated clinical outcome information, the investigator must not access the subject's medical record or other confidential records that would require additional consent from the subject. (21 CFR 50.20 and 50.25(a)(1).) However, such records may be accessed consistent with the original consent process, without additional consent, to obtain information collected prior to the subject's withdrawal from the study.

An investigator may consult publicly available sources of information to determine a subject's vital status (and if deceased, cause of death) after a subject withdraws from a clinical investigation. This activity does not require subject consent because the information is publicly available.

K. Reporting Aggregate Results of the Clinical InvestigationFDA recognizes that subjects are frequently interested in the aggregate results of the clinical investigation in which they were enrolled. Aggregate research results should be returned to subjects in a clear and comprehensible manner. Title VIII of FDAAA requires the "responsible party" (usually the sponsor or principal investigator) of certain clinical trials of drugs, devices, and biological products (referred to in FDAAA as "applicable clinical trials") to register the trials and submit summary results to the government-operated clinical trials databank, www.ClinicalTrials.gov, within a certain time period. 65 The summary results of these clinical trials will be made publicly available in the databank. 66 As explained above in section III.D (Element of Informed Consent for "Applicable Clinical Trials") of this guidance, FDA has issued a final rule 67 that amends the informed consent regulations (21 CFR 50.25) to require that the informed consent documents for applicable drug, biologic, and device clinical trials include the specific statement that is provided in the regulation that clinical trial information for such clinical investigations will be available at www.ClinicalTrials.gov. This website will not include information that can identify enrollees individually.

For clinical trials that are not "applicable clinical trials," subject to Title VIII of FDAAA, the sponsor or principal investigator may voluntarily register and report results to the databank. If a sponsor or principal investigator plans to submit trial results voluntarily, nothing would prevent an investigator, sponsor, or IRB from informing potential subjects of the plan to submit such information in an appropriate manner. Informed consent forms can direct subjects to www.ClinicalTrials.gov, where subjects can obtain certain overall study results. Investigators and sponsors can describe other plans in the consent document for informing subjects of the outcomes of the clinical investigation.

Footnotes1. This guidance document was developed by the Office of Medical Products and Tobacco (OMPT), the Office of Good Clinical Practice (OGCP), in coordination with the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and the Center for Drug Evaluation and Research (CDER).

2. 21 CFR part 50 "applies to all clinical investigations regulated by the Food and Drug Administration under sections 505(i) and 520(g) of the Federal Food, Drug, and Cosmetic Act, as well as clinical investigations that support applications for research or marketing permits for products regulated by the Food and Drug Administration, including foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products." (21 CFR 50.1).

3. See the FDA Information Sheet "Recruiting Study Subjects," for further information.

4. The regulations allow use of a "short form" consent form when the elements of informed consent are presented orally to the subject. For a discussion of the short form written consent, see section III.E.4.b, Short Form.

5. See section III.A.1, Exceptions to Informed Consent, for further information.

6. For further information, see section III.D, Element of Informed Consent for "Applicable Clinical Trials."

7. See "Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research."

8. The term "therapeutic misconception" is used to describe the assumption of research subjects that decisions about their care are being made solely with their benefit in mind. See Appelbaum, PS, Roth, LH, and Lidz, C, "The Therapeutic Misconception: Informed Consent in Psychiatric Research," International Journal of Law and Psychiatry Vol. 5, (1982): 319-329.

9. Also, see section IV.A.1.a, "Adequacy and Appropriateness of Wording," section V.B, "Non-English Speaking Subjects," and section V.C, "Subjects with Low Literacy and Numeracy."

10. Kutner, M, Greenberg, E, Jin, Y, and Paulsen, C, (2006) The Health Literacy of America's Adults: Results From the 2003 National Assessment of Adult Literacy (NCES 2006-483). U.S. Department of Education, Washington, DC, National Center for Education Statistics.

11. Ibid.

12. Ibid.

13. For additional discussion of exculpatory language, see the joint draft guidance from the Office of Human Research Protections (OHRP) and FDA, "Guidance on Exculpatory Language in Informed Consent." When that guidance is finalized, these examples may be revised.

14. For the purposes of this guidance only, medically recognized standard of care is one evidenced by publication in a peer reviewed journal or recognition by a professional medical society.

15. See the FDA Information Sheet "Payment to Research Subjects," for further information.

16. FDA notes that OHRP may hold a different interpretation of "appropriate alternative procedures or courses or treatment" as noted in their regulatory correspondence.

17. For the purposes of this guidance only, medically recognized standard of care is one evidenced by publication in a peer reviewed journal or recognition by a professional medical society.

18. As FDA has recognized in prior guidance, "[O]ff-label uses or treatment regimens may be important and may even constitute medically recognized standard of care." FDA Guidance, "Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices."

19. Federal Register, "Protection of Human Subjects; Informed Consent" (46 FR 8942, January 27, 1981). See response to comment 23.

20. FDA expects investigators to ensure that subjects have access to reasonable medical care during their participation in the clinical investigation. See pages 7-8 of FDA's "Guidance for Industry Investigator Responsibilities '' Protecting the Rights, Safety, and Welfare of Study Subjects."

21. For additional discussion of exculpatory language, see the joint draft guidance from the Office of Human Research Protections (OHRP) and FDA, "Guidance on Exculpatory Language in Informed Consent." When that guidance is finalized, these examples may be revised.

22. See pages 7-8 of FDA's "Guidance for Industry Investigator Responsibilities '' Protecting the Rights, Safety, and Welfare of Study Subjects."

23. The Patient Protection and Affordable Care Act added section 2709 to the Public Health Service Act. This section, "coverage for individuals participating in approved clinical trials," in general, will prohibit health insurance issuers from dropping coverage because an individual (who requires treatment for cancer or another life-threatening condition) chooses to participate in a clinical trial. Health insurance issuers also may not deny coverage for routine care that they would otherwise provide because an individual is enrolled in a clinical trial.

24. Sponsors of expanded access investigational new drug applications (INDs) and treatment protocols may recover other costs than these direct costs. See 21 CFR 312.8(d)(2).

25. For further information, see FDA's guidance, "Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c)."

26. It is the responsibility of sponsors and investigators to determine if their clinical trial meets the definition of an "applicable clinical trial" and to ensure compliance with the most current applicable statutory and regulatory requirements. Information on "applicable clinical trials" is available at ClinicalTrials.gov, FDAAA 801 Requirements and the document "Elaboration of Definitions of Responsible Party and Applicable Clinical Trial" (see pages 4-10).

27. Please note that this statement is not required for child assent.

28. 21 CFR 56.109(c) states, "An IRB shall require documentation of informed consent in accordance with section 50.27 of this chapter, except as follows:"(1) The IRB may, for some or all subjects, waive the requirement that the subject, or the subject's legally authorized representative, sign a written consent form if it finds that the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context; or"(2) The IRB may, for some or all subjects, find that the requirements in 50.24 of this chapter for an exception from informed consent for emergency research are met."

29. See 21 CFR Part 11, Electronic Records; Electronic Signature. Guidance is also available on the FDA Website, entitled "Guidance for Industry Part 11, Electronic Records; Electronic Signatures '' Scope and Application."

30. Documentation requirements related to emergency research, as mentioned in 21 CFR 56.109(c)(2), can be found in 21 CFR 50.24. Discussion of these studies is in a separate guidance, "Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research."

31. The FDA review division for the product area that is the subject of the investigation may be contacted to discuss alternative methods of obtaining informed consent.

32. The potential subject should have sufficient opportunity and time to consider enrollment in the research, such that coercion and undue influence are minimized. See section III.A.2, Coercion and Undue Influence.

33. See preamble to final rule in the Federal Register, January 27, 1981 (46 FR 8949).

34. IRBs are not required to review stand-alone Health Insurance Portability and Accountability Act (HIPAA) authorizations under 21 CFR part 56 so long as an IRB's written procedures, adopted pursuant to 21 CFR 56.108(a), do not require such review and approval. See page 8 of FDA's "Guidance for Industry IRB Review of Stand-Alone HIPAA Authorizations Under FDA Regulations."

35. As described in the FDA Information Sheet "Recruiting Study Subjects," FDA considers advertising, including but not necessarily limited to newspaper, radio, TV, bulletin boards, posters, flyers, and internet postings, to be part of the consent process. However, FDA does not consider listings of basic information about clinical investigations to be advertising for recruitment. Basic information about a clinical investigation is: the title of the clinical investigation, purpose of the clinical investigation, protocol summary, basic eligibility criteria, investigational site locations, and how to contact the site for further information. An example of a basic information listing is the National Institutes of Health clinical trial registry (http://clinicaltrials.gov/), where many FDA-regulated clinical investigations are required to be registered. Any posting about a clinical investigation where the format limits the information provided to basic information does not need to be reviewed by the IRB. Any posting that provides more than basic information is subject to IRB review.

36. Vulnerable populations identified in FDA regulations include children, prisoners, pregnant women, handicapped or mentally disabled persons, or economically or educationally disadvantaged persons (21 CFR 56.111(a)(3) and (b)); however, IRBs may consider additional populations to be vulnerable to undue influence and may decide to provide additional protections to these populations.

37. This topic is addressed in the Department of Health and Human Services guidance document, "Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection," which applies to FDA-regulated clinical investigations.

38. See 21 CFR 56.109(b).

39. A recommendation that consent forms be written at an eighth grade or lower reading level was made by the working group formed by the National Cancer Institute (NCI), along with the Office for Protection from Research Risks (now the Office of Human Research Protections, OHRP) and FDA in the 1998 "Recommendations for the Development of Informed Consent Documents for Cancer Clinical Trials."

40. Various strategies exist to improve communication with patients, for example, see Doak, CC, Doak, LG, Friedell, GH, Meade, CD, "Improving Comprehension for Cancer Patients with Low Literacy Skills: Strategies for Clinicians," Cancer: A Journal for Clinicians Vol. 48, No. 3 (May/June 1998): 151-162.

41. For further information, see the FDA Information Sheet "Recruiting Study Subjects."

42. For further information, see the FDA Information Sheet "Payment to Research Subjects."

43. In the "Institutional Review Board; Report and Recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research," published in the Federal Register, November 30, 1978 (43 FR 56174), the Commission stated:Observation of the consent process or conduct of research is both a difficult and delicate task. The designation of staff or members of the IRB to observe research activities can impose a substantial strain on the limited resources of the IRB. Further, such observation may intrude on confidential relationships or the privacy of individual subjects. IRBs should take these factors into account when determining appropriate means for continuing review of a protocol, and alternatives such as investigator reporting requirements should be considered. However, certain research will warrant observation to assure the protection of subjects, and in such cases IRBs have an obligation to take suitable measures. Id. at 56179.

44. This would include all addenda to the consent form and other materials used in the consent process.

45. See 21 CFR 312.60 and 812.100.

46. See FDA's "Guidance for Industry Investigator Responsibilities '' Protecting the Rights, Safety, and Welfare of Study Subjects," October 2009.

47. This topic is addressed in the Department of Health and Human Services guidance document, "Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection," which applies to FDA-regulated research.

48. See "Guidance for Industry: Using a Centralized IRB Review Process in Multicenter Clinical Trials."

49. For the purposes of this document, unless otherwise specified, all references to "drugs" or "drug products" include human drug products and biological products that are also drugs.

50. For a clinical investigation that is conducted or supported by HHS, the activities described here generally would be considered research involving human subjects, but could be exempt under 45 CFR 46.101(b)(4). If the study is not exempt, the requirements for obtaining and documenting the informed consent of the subjects (or the requirements for waiving the informed consent requirements) under the HHS regulations would need to be satisfied in order for these activities to be conducted.

51. Ibid.

52. This Information Sheet is available at Guidance for Institutional Review Boards and Clinical Investigators: Screening Tests Prior to Study Enrollment.

53. Please contact the Office for Civil Rights for additional information on HIPAA and the Privacy Rule or the Office for Human Research Protections for additional information on 45 CFR part 46.

54. For HHS-funded or -conducted research, see OHRP's guidance, "Obtaining and Documenting Informed Consent of Subjects Who Do Not Speak English." FDA notes that OHRP's guidance document on this topic is unchanged.

55. For further information on consent capacity, see "Research Involving Individuals with Questionable Capacity to Consent: Points to Consider," National Institutes of Health (NIH), Office of Extramural Research.

56. A professional with the appropriate background, training and experience in working with individuals with impaired consent capacity. See reference in footnote 55 for additional information.

57. For purposes of 21 CFR part 50, children means "persons who have not attained the legal age for consent to treatments or procedures involved in clinical investigations, under the applicable law of the jurisdiction in which the clinical investigation will be conducted." See 21 CFR 50.3(o).

58. Note that the waiver of parental permission found in 45 CFR 46.408(c) is not available under FDA's regulations.

59. FDA adopted 21 CFR part 50 subpart D, "Additional Safeguards for Children in Clinical Investigations", as an interim final rule in April 2001 (21 CFR part 50, subpart D) (subpart D) (see 66 FR 20598, April 24, 2001), and issued a final rule in February 2013 (see 78 FR 12937, February 26,2013).

60. The exception under 21 CFR 50.23 involves certain life-threatening situations where there is no suitable alternative therapy and there is insufficient time to obtain informed consent, military operations, and public health emergencies. The exception under 21 CFR 50.24 involves emergency research.

61. 21 CFR 50.53 applies to clinical investigations presenting greater than minimal risk and no prospect of direct benefit to the individual subject, but that are likely to yield generalizable knowledge about the subjects' disorder or condition. 21 CFR 50.54 applies to clinical investigations that do not fall within the scope of 21 CFR 50.51, 50.52, or 50.53 but present a reasonable opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.

62. FDA recognizes that IRBs may adopt procedures setting an age below which children are presumed incapable of providing assent.

63. For further discussion, see "Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review after Clinical Investigation Approval." See section III.H.2, "Suspension or Termination of IRB Approval."

64. For further discussion, see "Guidance for Sponsors, Clinical Investigators, and IRBs: Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials." FDA regulations (see, for example, 21 CFR 312.62 and 812.140(a)(3)) require investigators to prepare and maintain adequate case histories recording all observations and other data pertinent to the investigation on each individual treated with the drug or exposed to the device. Please also see OHRP's guidance on this topic, "Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues."

65. See section 801(a) of the Food and Drug Administration Amendments Act of 2007, Pub. L. 110-85, adding 42 U.S.C. §282(j).

66. 42 U.S.C. §282(j)(2)(A)(ii)(ll).

67. The final rule is available at Federal Register, Volume 76, pages 256-270 on the Federal Register website.

Reference Information

About this Guidance DocumentThis draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's or Agency's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed under "For Questions Regarding This Document" below.

How to CommentComments and suggestions regarding this draft document should be submitted by Sept. 15, 2014. To submit your comments electronically, go to docket number FDA-2006-D-0031 at regulations.gov, or click on the "Comment Now" button below to go directly to the comments page.

Comment now

To submit your comments to the docket by mail, the following address should be used. Be sure to include docket number FDA-2006-D-0031 on each page of your written comments.

Division of Dockets Management (HFA-305)Food and Drug Administration5630 Fishers Lane, rm. 1061Rockville, MD 20852.

Docket FDA-2006-D-0031 (regulations.gov)Federal Register notice of availability ( 79 FR 41291, July 15, 2014) For Questions Regarding this DocumentFor questions regarding this draft document contact (OGCP) Marsha Melvin at marsha.melvin@fda.hhs.gov, (CDER) Kristen Miller at 301-796-0762, (CBER) Office of Communication, Outreach and Development at 800-835-4709 or 240-402-7800, or (CDRH) Sheila Brown at 301-796-6563 (CDRH).

To Obtain Copies of This DocumentAdditional copies are available from:

Office of Good Clinical PracticeOffice of Special Medical Programs, Office of Medical Products and TobaccoFood and Drug Administration10903 New Hampshire AvenueWO32-5103Silver Spring, MD 20993(Tel) (301) 796-8340

FDA Offices Issuing This GuidanceU.S. Department of Health and Human ServicesFood and Drug AdministrationOffice of Good Clinical PracticeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and ResearchCenter for Devices and Radiological Health

When you watch the whole video of joe falling up the stairs of AF1, pay special attention to the few seconds BEFORE he starts up the stairs. Focus on his left foot and ankle. It is hard to see unless you really try. It is clear that he was having problems before the stairs. He is dragging his left leg. The foot actually looks askew. That is why he un customarily used the right railing to hold on for support. He never does or never used to. Also after the third fall notice that he tries and fails to grab the left railing with his left hand. His grip fails.

It appears his left side of his body had neurological issues. Probably a brain bleed from the blood thinner he’s taking to prevent the reoccurrence of blood clots that has been documented as a result of his prior brain surgeries.

Link to Article

Archived Version

Fri, 19 Mar 2021 01:11

News

By Mark Moore

March 18, 2021 | 3:52pm

The White House shut down a request by Russia's Vladimir Putin to hold a public conversation '' perhaps on Zoom '' with President Biden, saying the commander-in-chief is ''quite busy.''

Putin went on state-TV after Biden referred to him as a ''killer'' in an interview Wednesday and said he was ready to hold talks with Biden on the relationship between the two countries and other regional conflicts.

He said said he would have his foreign ministry set something up for Friday or Monday.

But White House press secretary Jen Psaki quickly rebuffed the invitation and the tiff over the ''killer'' comments, saying Putin and Biden have ''different perspectives on their respective countries.''

''We are confident that we can continue to look for ways where there's a mutual interest '' mutual national interest,'‹'''‹ Psaki said. '‹'''‹But the president is not going to hold back, clearly, when he has concerns, whether it is with words or actions.''

She also said that Biden and Putin talked in January ''even as there are more world leaders that he has not yet engaged with.''

The White House will not hold a public video conference between Joe Biden and Vladimir Putin. Donat Sorokin/TASS via Getty Images'''‹I don't have anything to report to you in terms of a future meeting. The president will, of course, be in Georgia tomorrow and quite busy'‹,'' Psaki added. '‹

In the interview with ABC's George Stephanopoulos, Biden '‹was asked if he thought Putin was a ''killer.''

''I do,'' the president said.

Biden also claimed he and the Russian leader had a conversation about the fact that he doesn't believe Putin has a soul.

Biden said he told the Russian leader, ''I said, 'I looked through your eyes, and I don't think you have a soul,' '' the president told ABC's George Stephanopoulos '-- and Putin looked back and replied, ''We understand each other.''

Putin went on Russian TV to shoot back, telling Biden ''it take'‹s'‹ one to know one'' and wishing the US president ''good health'' without ''any irony or joke.''

''We always see our own traits in other people and think they are like how we really are. And as a result, we assess (a person's) activities and give assessments,'' Putin said.

Russia has recalled its ambassador to Washington, DC in retaliation and demanded that Biden apologize to Putin for the ''killer'' comment.

The latest tiff marks a new low point in the relationship between the two countries that has been declining for more than a decade because of Moscow's illegal annexation of Crimea, its support of pro-Russian forces in Ukraine and its meddling in the 2016 election.

The Biden administration slapped sanctions on Russian officials and businesses earlier this month after the US intelligence community determined that a Russian spy agency was behind the poisoning of dissident Alexei Navalny.

With Post wires

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Source: Natural Gas World - Latest News

Fri, 19 Mar 2021 14:06

Russia's Gazprom and Anglo-Dutch Shell have signed a five-year strategic co-operation agreement, the former company said on March 16.

The agreement covers the study of energy markets, "projects along the entire value chain," the digitalisation of technologies and the reduction of greenhouse gas emissions, Gazprom said.

Gazprom and Shell are partners at the Sakhalin LNG plant in the Russian Far East. Gazprom's oil arm Gazprom Neft also has joint upstream activities with the oil major.

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Sat, 20 Mar 2021 11:48

Donald Trump was a tool in a long-running Russian campaign to weaken the United States. That’s been documented in Republican-led investigative reports, and now it has been updated with new evidence, thanks to the U.S. Intelligence Community’s assessment of the 2020 election. The report, drafted by the CIA, the FBI, and several other agencies, was released in unclassified form on Tuesday, but it was presented in classified form on Jan. 7. In other words, it was compiled, written, and edited during Trump’s administration. It destroys his lies about the election, and it exposes him as a Russian asset.

The report debunks conspiracy theories, promoted by Trump and his lawyers, that hackers in other countries robbed him of victory. “We have no indications that any foreign actor attempted to interfere in the 2020 US elections by altering any technical aspect of the voting process,” including “ballot casting, vote tabulation, or reporting results,” says the document. A separate analysis released by the Department of Justice reaches the same conclusion. The IC report adds that evidence of such operations, if they existed, would have shown up in U.S. surveillance or in “post-election audits of electronic results and paper backups.” The report implicitly mocks insinuations from Trump’s lawyers that former Venezuelan dictator Hugo Chavez, who died in 2013, somehow rigged Trump’s defeat. “We have no information,” it notes drily, that “current or former Venezuelan regimes were involved in attempts to compromise US election infrastructure.”

During the campaign, Trump, his national security appointees, and his allies in Congress insisted that China was meddling in the election to help Joe Biden. They even claimed that China’s interference was more dangerous than Russia’s. The report shreds that fiction. China “did not deploy influence efforts intended to change the outcome of the US Presidential election,” says the assessment. It finds no attempt by China to “provide funding to any candidates or parties,” and it challenges the Republican spin that China feared Trump because he was too tough. It argues, to the contrary, that Beijing saw Trump as a weaker adversary because he “would alienate US partners,” whereas Biden “would pose a greater challenge over the long run because he would be more successful in mobilizing a global alliance against China.”

As to Russia, the report leaves no doubt: In 2020, as in 2016, “President Putin authorized, and a range of Russian government organizations conducted, influence operations” to help Trump and hurt his Democratic opponent. For example, “Shortly after the 2018 midterm elections, Russian intelligence cyber actors attempted to hack organizations primarily affiliated with the Democratic Party.” Then, in late 2019, Russia’s military intelligence service, the GRU, “conducted a phishing campaign against subsidiaries of Burisma holdings, likely in an attempt to gather information related to President Biden’s family.” Throughout the 2020 election, agents “connected to the Russian Federal Security Service,” FSB, planted negative stories about Biden. Internet operatives working for the Kremlin, including the troll farm that had boosted Trump in 2016, continued to promote “Trump and his commentary, including repeating his political messaging.”

Attacks on Biden and his son, Hunter, were part of this operation. Through “US officials and prominent US individuals, some of whom were close to former President Trump and his administration,” the report says Russia’s intelligence services “repeatedly spread unsubstantiated or misleading claims about President Biden and his family’s alleged wrongdoing related to Ukraine.” In this way, Trump’s circle “laundered” the Russian-planted stories, which were then recirculated—and promoted by Russia’s online proxies—as American news.

One section of the report zeroes in on two Russian agents, Andriy Derkach and Konstantin Kilimnik, along with their associates. It says they met with and passed materials to people linked to the Trump administration to advocate for government investigations. Derkach peddled audio recordings that were edited to make Biden look corrupt, and he “worked to initiate legal proceedings in Ukraine and the US related to these allegations.” The report doesn’t name the Americans who collaborated with the Russian agents, but it’s easy to identify them from news reports. Trump’s lawyer, Rudy Giuliani, met with Derkach twice. Donald Trump Jr. promoted Derkach’s tapes. Trump’s 2016 campaign manager, Paul Manafort, gave Kilimnik inside information on the campaign. Trump, in a 2019 phone call, pressed Ukraine’s president to open an investigation of Biden, as Derkach proposed. And congressional Republicans, led by Reps. Jim Jordan and Devin Nunes, parroted a Russian-planted narrative “to falsely blame Ukraine for interfering in the 2016 US presidential election.”

Trump also helped Putin discredit American democracy. That was a major goal of Russia’s 2016 and 2020 operations, the report explains: “Throughout the election, Russia’s online influence actors sought to amplify mistrust in the electoral process by denigrating mail-in ballots, highlighting alleged irregularities, and accusing the Democratic Party of voter fraud.” Trump peddled the same fears. After the election, as “Russian online influence actors continued to promote narratives questioning the election results,” Trump duplicated that message. Russia’s agents also hyped “allegations of social media censorship,” as Trump did.

The IC assessment doesn’t address what Trump knew about the Russian influence campaign. But according to former officials who spoke last fall to the Washington Post and the New York Times, he was directly warned. In a December 2019 conversation, then–national security adviser Robert O’Brien told Trump that Giuliani had been “worked by Russian assets in Ukraine.” Trump shrugged and went on promoting the allegations Giuliani was feeding him. That makes Trump more than a Russian asset. It makes him, in technical terms, an agent of a foreign power.

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Sat, 20 Mar 2021 14:13

Not-President Greenscreen has been reading some tough lines about the Russian leader. But the historical reality is just a little bit different:

I documented what happened at Joe Biden’s one and only meeting with Vladimir Putin in my book Joe Biden Unauthorized. I can attest that the title of my chapter on the incident – Bitch Slapped in Moscow – is the actual truth.

Biden got bitch slapped, and he’s pretending he didn’t.

Putin knows what happened. He was there. He knows he compromised Joe Biden, who appeared unprepared to deal with the ruthless, former-KGB agent. Regardless, Joe continues to perpetuate his “I was the tough guy” lie.

As Joe Biden’s White House stenographer, I stood directly behind Putin at a distance of five feet. Biden, seated across from Putin at an elegant conference table, was about 12 feet from me.

About 10 minutes into the meeting, Vice President Biden attempted to start lecturing about his decades-old part in U.S.-Russian negotiations with the dreaded phrase, “I’ve been around a long time. The first time I was here…”

And… cut.

Joe Biden got about one sentence further into that spiel when off went his microphone, off went the lights for the TV cameras, and stern Russian voices were commanding the press to leave. And leave they did.

They went out quickly and efficiently, with videocameras popping off of tripods. Equipment snapping shut. Portable lights clattering down retractable poles. No one spoke, and no one dared linger.

This was Putin in all his KGB ruthlessness. Whether by some prearranged signal or simply an undisclosed time limit, he had pulled the plug and done the unthinkable: he’d stolen Joe Biden’s audience and rendered him speechless. Shut him down in mid-sentence with the flick of an invisible switch.

Across the table, I could see Vice President of the United States Joe Biden, in the now dimly lit room, looking as duped as an exhausted fish in the bottom of a boat. No protest, no complaint. No, hey, I wasn’t finished. Nothing. He was humiliated.

To me, the revelation was the premeditated precision of the snub. Putin or his team had likely plotted this all out. They knew exactly what bait to use, exactly how Joe Biden would take it, and then when he did, they reeled him helplessly in.

The Russian President and his delegation sat calmly and coldly as their American counterparts realized their blustery leader’s big moment had been stolen right out from under him. The most powerful man in Russia had neither fear nor respect for Joe Biden. He had just played with him for sport.

Putin knows. He knows a lot more about what's actually going on than we do. 

Labels: history, trainwreck

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Sun, 21 Mar 2021 11:55

As vaccines are rolled out, public health experts understand that they are in a race against time, but what has stunned them is a populist backlash against experts who have become identified with intellectual arrogance. What's the role of expertise in democracies and how should science inform political decisions? The COVID-19 pandemic continues to challenge public and private sector leaders around the globe. The cautious optimism around mass vaccination programmes is countered by growing concerns over the spread of more contagious variants. Public health experts understand that they are in a race against time, but what has stunned them is a ''populist backlash against experts who have become identified with elitism and intellectual arrogance.''

Despite the United States experiencing more than half a million COVID-related deaths, such views have hardened in the country, even after the recent presidential elections. Political pundits there continue to espouse narratives such as this view by Wall Street Journal writer Barton Swaim:

''The great theme of the Trump years, the one historians will note a century from now, was the failure of America's expert class. The people who were supposed to know what they were talking about, didn't.''

The popular backlash against the notion of ''expertise'' is not unique to the US. It is also a growing concern in Europe, where the EU is funding a research project to study the role of expertise in democracies and how science should inform political decisions.

Worldwide trust in societal leaders across most disciplines, including religious leaders, has declined, according to the latest survey findings of the Edelman Trust Barometer. Surprisingly, trust in business (61%) is higher than in government (53%), while business was also considered by respondents to be both more ethical and competent.

Interestingly, business also recognizes the relationship between expertise and elite leadership far better than most other institutions. By law, companies must maintain a board of directors but many also have boards of advisors. As one blogger observed:

''[A]dvisors are nominally experts, while directors are nominally elites. Directors are far more powerful, are lobbied far more strongly, and are paid a lot more too. No boards of advisors are usually not asked for advise, they are mainly there to add prestige to an organization. But prestige via their expertise, rather than their general eliteness.''

Image: Ipsos MORI

What then are elites? Elites are the individuals and coalitions operating the business models that produce the highest levels of value creation in the economy. Except, of course, that sometimes ''elite business models'' are extractive. In the abstract, elites provide the coordination capacity that is needed to address complicated governance challenges. They generate and rely on expertise, otherwise their business models are not sustainable.

Specifically, elites include entrepreneurs, top civil servants, union leaders, financiers, generals, thought leaders, religious heads or top executives. They are so controversial that even the word itself is divisive. Throughout modern history they have been blamed variously for society's maladies, selfishly running business models that maximize their own wealth at the expense of society. Is there truth is such an indictment? Or on the contrary, could elites have been the key experts, the drivers of economic and technological development throughout history? Relatedly, we might compare elites across the world and ask today in which countries elites are of ''high quality.''

A global network under the academic leadership of the University of St.Gallen has produced an index - the 'Elite Quality Index' (EQx) - that ranks nations based on the value creation of their elite business models. This novel EQx is a political economy index that shows whether the sum of elites in a country enlarges the country's overall economic pie for all stakeholders, or whether elites just grow their own slice for themselves.

How does the EQx assess elites?

EQx uses a published transparent methodology that re-evaluates existing datasets through the lens of value creation versus value extraction. At present 72 existing indicators are collected, interpreted, collated and organized around the four index areas. The final outputs are the EQx country scores and a global rank. EQx consists of two important sub-indices - ''power'' and ''value''.

The first sub-index measures dominance of elites and at high levels it penalizes the country because ''power'' is conceived as future rent seeking potential. The second sub-index measures ''value'' creation through production, exchange, human capital development, creative destruction, free competition, innovation and the like. ''Value'' extraction is conceived as transfers away from value creators evidenced by tariffs, regulation, theft, discrimination, monopolies, subsidies and the like.

Without elite business model leadership, there are no vaccines, no Teslas, no e-commerce platforms, no security, and arguably less incentive to engage experts.

This is why ''anti-elitism'' narratives prove to be unsustainable over the long term. Even political, intellectual or religious movements advocating a class-less society have had to invariably turn themselves into society's vanguard. Since elites are a given in any country, the question the index addresses then is not one of ''elites'' versus ''no elites'', but rather one of ''low-quality'' versus ''high-quality'' elites. ''Are elites value creators?'' is the key question we ask.

In some instances, elites are quite dominant, and in EQx they are given a middling ''power'' score. Yet rather than abusing their power, some countries' powerful elites do the exact opposite and produce among the highest value creation business models imaginable. This is the case of Singapore where capital, labour and producer markets see some of the lowest levels of rent seeking of any nation, as evidenced by a multitude of indicators including trade freedom, globalization and FDI inflows.

In another remarkable case, China's powerful elites manage to produce the highest levels of value creation relative to (purchasing power parity adjusted) GDP per capita. The country's elite quality is comparable to some advanced EU states on account of indicators pointing to high levels of productivity growth through innovation (i.e. creative destruction) and to a government that wisely allocates expenditures. As a result of high elite quality, both countries have been positive outliers in the context of economic and technological development.

UpLink is a digital platform to crowdsource innovations in an effort to address the world's most pressing challenges.

It is an open platform designed to engage anyone who wants to offer a contribution for the global public good. The core objective is to link up the best innovators to networks of decision-makers, who can implement the change needed for the next decade. As a global platform, UpLink serves to aggregate and guide ideas and impactful activities, and make connections to scale-up impact.

Hosted by the World Economic Forum, UpLink is being designed and developed in collaboration with Salesforce, Deloitte and LinkedIn.

We have seen with COVID-19 how some emerging countries maintain an elite system that runs in the opposite direction: it is very powerful and uses that power to either give favourable treatment to special interests or extract inordinate amounts of rents from the broad population. Countries can either prosper on account of high elite quality or can stagnate because of low elite quality.

The EQx scores of Europe reflect a deep and interesting split, one that is ignored in the public discourse and is exemplified by Germany and France, who show astonishingly dissimilar levels of elite quality, Germany scoring higher than its neighbour on account of significantly lower levels of rent seeking by both producer and labour coalitions. The policy implication cannot be overlooked: the European Union must assume that rent-seeking models dominate and lurk in many of its member states. Hence, it might not be the European citizens but rather the extractive local elites of certain EU member states that benefit from well-intended policies such as the COVID-19 recovery packages.

An underlying theoretical assumption of EQx is that elite quality determines the quality of institutions. Elites that run value creation business models will lobby for institutions that are consistent with the promotion of industry innovation or international trade. Such institutions will make life difficult for rent-seeking elites that distort the economy for us all. Countries with elites that run extractive business models, on the other hand, will suffer from excessive regulation and taxation, obstacles to creative destruction, low and inefficient investments in human capital, education and healthcare, as well as assorted forms of discrimination, which is an ultimate form of value extraction.

Policy-makers and political and knowledge elites must evaluate every new rule and policy through the lens of value creation. The message to economic elites is one of business model transformation: use your expertise and coordination capacity to run increased value creation models.

It is no coincidence that the concept of stakeholder capitalism has captured the imagination of a new generation of business leaders and that non-financial metrics are being adopted to help ''companies measure and demonstrate their contribution to a more prosperous and fulfilled society and a more sustainable relationship with our planet.'' Paraphrasing Joseph Schumpeter: elites are capable of raising the welfare of all social classes and therefore they must strive to do so.

This article was first published in Caixin Global.

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Sat, 20 Mar 2021 02:57

Vice President Kamala Harris joined the president in forcefully condemning the killings in Atlanta. ''Racism is real in America, and it has always been,'' she said.

Vice President Kamala Harris and President Biden on Friday in Atlanta. ''Xenophobia is real in America, and always has been,'' Ms. Harris said. ''Sexism, too.'' Credit... Doug Mills/The New York Times March 19, 2021 Updated 9:48 p.m. ET WASHINGTON '-- President Biden and Vice President Kamala Harris traveled on Friday to Atlanta to express grief for the victims of a mass shooting that left eight people dead, six of them women of Asian descent, describing the tragedy as part of an increase in racially motivated violence and pledging to take action against hate and discrimination.

The gruesome shootings on Tuesday in Atlanta thrust Mr. Biden and Ms. Harris into the middle of a national struggle to confront the harassment and violence against Asian-Americans from people angry about the coronavirus pandemic that has killed more than a half-million people.

''They've been attacked, blamed, scapegoated and harassed. They've been verbally assaulted, physically assaulted, killed,'' Mr. Biden lamented after a meeting with leaders of Atlanta's Asian-American community that he described as heart-wrenching to be part of.

''It's been a year of living in fear for their lives,'' the president said.

Mr. Biden expressed empathy for the victims' families, who he said were left with ''broken hearts and unanswered questions.'' And he said Americans should take responsibility for failing to express enough outrage about the targeting of people of Asian descent during the pandemic that has gripped the country.

''Because our silence is complicity,'' he said. ''We cannot be complicit. We have to speak out. We have to act.''

Mr. Biden had by his side the nation's first vice president of Asian descent, who was '-- just through her presence '-- a powerful symbol of efforts to reject racial animosity and bias.

''Racism is real in America, and it has always been,'' Ms. Harris said, speaking before Mr. Biden. ''Xenophobia is real in America, and always has been. Sexism, too.''

Ms. Harris, whose mother was born in India, confronted the doubts expressed by some, including the F.B.I. director, Christopher A. Wray, about whether the killings in Atlanta were racially motivated. Investigators in Cherokee County, Ga., where some of the victims were targeted at a spa, have said that the gunman told them that he had a ''sexual addiction'' and had carried out the attacks as a way to eliminate temptation.

The vice president offered little doubt about what she believed and whom she blamed for stoking the violence, alluding to '-- without directly naming '-- former President Donald J. Trump, who repeatedly blamed the pandemic on what he called the ''China virus.''

''For the last year, we've had people in positions of incredible power scapegoating Asian-Americans,'' she said. ''People with the biggest pulpits spreading this kind of hate.''

The Biden administration, she said, would not ''stand by'' in the face of racial violence.

''Whatever the killer's motive, these facts are clear,'' she said. ''Six out of the eight people killed on Tuesday night were of Asian descent. Seven were women. The shootings took place in businesses owned by Asian-Americans. The shootings took place as violent hate crimes and discrimination against Asian-Americans has risen dramatically over the last year.''

Anti-Asian attacks have soared during the past year, part of a pattern that Mr. Biden called ''wrong'' and ''un-American'' last week during a speech at the White House. On Friday, he, too, appeared to blame Mr. Trump and his supporters without naming them directly, saying, ''We've always known words have consequences.''

The moment is a delicate one for Mr. Biden '-- a new president commanding the country's most important bully pulpit in the middle of grieving and racial reckoning.

Among those who met privately with Mr. Biden and Ms. Harris before the speeches was Marvin Lim, a Georgia state lawmaker who said that he felt ''powerful and privileged'' to represent the Asian-American community at such a raw time, and that he felt gratified that the new administration had taken the time to come and listen.

He said he was touched by Ms. Harris, who he said ended their session by asking those present to tell their community members that ''they are not alone.''

After his public remarks about the shootings and Asian-American violence, Mr. Biden made an abrupt shift in topic, highlighting the administration's progress in getting people vaccinated and promoting the passage of the $1.9 trillion ''American Rescue Plan.''

For all that he promised to act to curb racially motivated violence, Mr. Biden has few quick or easy ways to do so.

The debate over how best to curb mass shootings and hate crimes involves, among other issues, gun rights, mental health treatments, red-flag laws and background checks, all of which tend to be met in Congress with gridlock.

During his first week in office, Mr. Biden signed an executive order directing his government to work toward stopping ''anti-Asian bias, xenophobia and harassment.'' On Friday, he urged Congress to pass the Covid-19 Hate Crimes Act, which he said would ''expedite the federal government's response to the rise of hate crimes exacerbated during the pandemic.''

A Rise in Attacks Against Asian-AmericansEight people, including six women of Asian descent, were killed in the Atlanta massage parlor shootings. The suspect's motives are under investigation, but Asian communities across the United States are on alert because of a surge in attacks against Asian-Americans over the past year.A torrent of hate and violence against Asian-Americans around the U.S. began last spring, in the early days of the coronavirus pandemic. Community leaders say the bigotry was spurred by the rhetoric of former President Trump, who referred to the coronavirus as the ''China virus.''In New York, a wave of xenophobia and violence has been compounded by the economic fallout of the pandemic, which has dealt a severe blow to New York's Asian-American communities. Many community leaders say racist assaults are being overlooked by the authorities.In January, an 84-year-old man from Thailand was violently slammed to the ground in San Francisco, resulting in his death at a hospital two days later. The attack, captured on video, has become a rallying cry.The legislation, which was sponsored by two Asian-American lawmakers '-- Senator Mazie K. Hirono of Hawaii and Representative Grace Meng of New York, both Democrats '-- would make it easier for people to report hate crimes linked to the pandemic by helping to establish online threat-reporting systems. It would also direct administration officials to review existing federal, state and local hate crime laws.

Still, the trip to Georgia was the president's first opportunity to serve in the grim role of ''consoler in chief'' for yet another grieving community suffering through the horrific aftermath of a mass shooting.

For Mr. Biden, soothing the nation is a responsibility that plays to his strengths: a life forged by personal loss of the kind that most people never endure created a political career in which he has repeatedly been called upon to eulogize the fallen, often with the whispery, cracking voice that betrays his own emotions.

On Friday, he closed his remarks with assurances aimed at the relatives of those killed in the Atlanta attacks.

''I know they feel like there's a black hole in their chest they're being sucked into, and things will never get better,'' he said. ''But our prayers are with you. And I assure you, the one you lost will always be with you, always be with you.''

The president's ability to project empathy toward those who are suffering stands in contrast to Mr. Trump, who struggled to convey a sense of somber support at such moments. (His grinning, thumbs-up photograph at a hospital after a mass shooting in El Paso generated a backlash of angry commentary about his visit.) During a campaign played out against a backdrop of grief because of the pandemic, Mr. Biden often accused his opponent of having no real empathy for those who were suffering.

Mr. Biden also accused his predecessor of embracing and fomenting the very racial strife that has roiled the country and inspired acts of violence like the one that erupted across Atlanta on Tuesday. It was Mr. Trump's reaction to racist violence in 2017 in Charlottesville, Va. '-- and especially his comment about ''good people'' among the white supremacist rioters '-- that motivated him to run for president, Mr. Biden has often said.

Moments of mourning after mass shootings can be a special challenge for any president. They require the ability to comfort those who are grieving the loss of their loved ones while at the same time offering optimism and hope to a nation that is often badly shaken by the horror of what has just happened.

In 2012, after 20 young children were killed by a gunman in Newtown, Conn., President Barack Obama concluded remarks at a memorial service by slowly reading their names, one by one, while some in the audience wept.

Three years later, after finishing his eulogy for the Rev. Clementa Pinckney, who was gunned down along with eight others during a Bible study in a Charleston, S.C., church, Mr. Obama sang some of ''Amazing Grace,'' bringing the church to its feet and touching the heart of the country.

Much like that moment, Mr. Biden now faces not only a gruesome killing spree, but an episode wrapped in racial tensions. And like during Mr. Obama's tenure, the words of empathy will be followed by tough questions about what the federal government can or should do to prevent the tragic scene from being repeated again.

Sabrina Tavernise contributed reporting from Atlanta.

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Sun, 21 Mar 2021 10:57

Media Criticism

The full video shows that Jay Baker was paraphrasing what Robert Aaron Long told investigators about his motivations. Robby Soave | 3.19.2021 5:17 PM

(Screenshot via YouTube)

A moment from the Cherokee County Sheriff's Office press conference on Wednesday quickly went viral: Jay Baker, a spokesperson for the police department handling the investigation into the horrific Atlanta spa murders, said that suspect Robert Aaron Long was having a bad day.

"He was pretty much fed up, kind of at the end of his rope, and yesterday was a really bad day for him and this is what he did," said Baker.

The comment struck many people as overly sympathetic toward Long, as if Baker was making excuses for someone who stands accused of killing six Asian-American women in cold blood. A 20-second video clip of Baker's statement was shared on Twitter by Vox journalist Aaron Rupar and swiftly went viral, earning widespread condemnation. Many saw it as evidence that cops are desperate to discount the culpability of white male criminals. For instance, Kimberl(C) Crenshaw, a law professor and inventor of the term "intersectionality," described Baker's comments as "bone-chilling," and castigated him for refusing to acknowledge "the misogynistic dimensions of anti-Asian racism."

A police officer excusing Long's actions as merely the result of him having a "bad day" would indeed be contemptible. But that's not what Baker did. In fact, many of the people so infuriated about the quote were misled by Rupar's edit of the video.

The full video (the relevant section starts at about 13:50) makes clear that Baker was not providing his own commentary, but rather summarizing what Long had told the investigators. The "bad day" line was proceeded by a clarification that this was Long's own explanation, as related to the police. Baker did not endorse it.

Nor did the captain endorse Long's statement that the killings were unrelated to racism. He makes clear he's relaying comments from Long. "He claims that'--and as the chief said this is still early'--but he does claim that it was not racially motivated," said Baker. Again, the police spokesman is telling reporters what Long said, not applying his own spin. Later, when another reporter asked about this, Baker stepped aside so that Atlanta Mayor Keisha Lance Bottoms could explain the efforts being undertaken to protect Asian Americans at this time of heightened concern.

It would be naive of the police'--or the public, or anyone else'--to accept what alleged killers say at face value. It's similarly naive to assume that the sex and ethnicity of the victims tells us everything we need to know about the crime. The police should investigate the matter dispassionately, and relay to the public whatever information they gather. Too often, law enforcement uses such press conferences to engage in wild speculation; this was a refreshing example of the cops not doing that.

But media coverage of the "bad day" comment gave almost zero indication that it was a paraphrase of Long's confession. The Washington Post, for instance, wrote about Baker being taken off the case and used this headline: "Captain who said spa shootings suspect had 'bad day' no longer a spokesman on case, official says." The article's introduction contains no context, and incorrectly parrots Rupar's bad framing:

The backlash began with the sheriff spokesman's statement to reporters that the mass shooting suspect was having a "bad day."

"He was pretty much fed up and kind of at the end of his rope. Yesterday was a really bad day for him and this is what he did," Cherokee County Sheriff's Office Capt. Jay Baker said Wednesday. He was describing the 21-year-old man accused of killing eight people, mostly Asian and almost all women, in a rampage across three Atlanta-area spas.

The New York magazine and BuzzFeed News versions of the story repeated the error.

Baker is no longer the spokesperson for this case, and he is also under fire for previously posting a picture in a shirt that read "Covid 19: Imported virus from CHY-NA." The big issue here is not really that Baker got a raw deal'--he may well be ill-suited to serve as a police spokesman'--but that countless mainstream journalists, beginning with Rupar, engaged in malpractice. They manipulated readers and viewers to be outraged about something that isn't actually outrageous.

This matters because social media platforms have recently come under tremendous fire from both well-regarded journalists and Democratic lawmakers who assert that Facebook, Twitter, YouTube (and even Clubhouse) allow misinformation to spread unchecked. In mainstream circles, it is now common to believe that Big Tech must be compelled to take stronger action against misleading news.

But this view elides all the ways in which the traditional media spreads misinformation'--and this story is a perfect example. Numerous writers, in their zeal to assert that the spa killings were absolutely, positively the result of anti-Asian racism, wrongly dinged a police officer for declining to provide support for this theory.

Baker's performance in the press conference was skewered due to a misleading clip widely circulated by the very same journalists who assert that the loss of the mainstream media's information-gatekeeping function is a serious threat to democracy. It's hard to take these people seriously when they continue to make such mistakes.

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Fri, 19 Mar 2021 09:58

I think of myself as having decent critical faculties, but somehow I got suckered again by a bog-standard publishing venture masquerading as a useful communications tool. I'm referring, of course, to the Substack debacle -- and my inadvertent role in it.

The debacleAs you may already know, Substack is a tool for publishing email newsletters like this one. The idea is that anyone can start a newsletter, using Substack's (very nice) interface, and we have the option to charge subscribers. Substack advertises itself as a tool, an app, that functions like a marketplace. Using the app, readers can find topics of interest, and creators can get compensated for the labor we put into our creations. All that Substack asks is for a percentage of our subscription income, to pay for maintaining the site, support, etc. Honestly, a fair deal.

Except Substack is not merely an app. It's actually a publication. Why do I say that? Because Substack's leadership pays a secret, select group of people to write for the platform. They call this group of writers the ''Substack Pro'' group, and they are rewarded with ''advances'' that Substack co-founder Hamish McKenzie calls ''an upfront sum to cover their first year on the platform [that's] more attractive to a writer than a salary, so they don't have to stay in a job (or take one) that's less interesting to them than being independent.'' In other words, it's enough money to quit their day jobs. They also get exposure through Substack's now-considerable online reach.

By doing this, Substack is creating a de facto editorial policy. Their leadership -- let's call them editors -- are deciding what kinds of writing and writers are worthy of financial compensation. And you don't know who those people are. That's right -- Substack is taking an editorial stance, paying writers who fit that stance, and refusing to be transparent about who those people are. Hamish writes:

We don't disclose the names of the writers with whom we've done deals because it is their private information and up to them whether or not they want it publicly known.

He makes it sound like this is about protecting writers' anonymity, but it's not. Substack could easily allow their writers to publish anonymously, but still identify them by the names of their publications.

This is an abdication of editorial responsibility that is both ethically repugnant and part of an overall scammy business practice. First, let me address the ethical issue and then I'll get into the scam.

One of the most important elements of ethical journalism is transparency at all levels. Writers should share who their sources are, or in those few cases where they can't share, they should be honest about why they can't reveal them. Writers should be explicit about any bias they have, too. Editors, for their part, must be honest about what their publication's policies are, including who they are paying and what kinds of gatekeeping they do to hire those writers. This kind of openness is not complex. For example, newspapers generally share the names of their editorial staff, with ways to contact them, so that anyone can contact an editor with a story idea or question. There is a masthead with staff writers' names on it.

All of this is to say that when a story appears in a publication, we know that's because it has passed through an editorial process -- usually involving payment, but possibly some other arrangement -- and that publication is putting its brand or imprimatur on the story. The publication takes responsibility for what it publishes, in both ethical and legal ways. When this process breaks down, it's a big deal. People get fired.

Not at Substack, where their editorial policy is to cover up who writes for them. How can Substack be held accountable for what they pay to publish if the writers they pay -- let's call them staff writers -- could be literally anyone on the site? The answer is that they can't.

But, you might be saying, Substack mostly publishes tons of people who are not staff writers. Look at the thousands of newsletters on the site that are clearly not written by staff! No, it does not matter that technically anyone can jump on Substack and get paid by subscribers. Technically anyone can sing on the street corner and get paid by passerby, but that doesn't mean they are on a level playing field with Megan Thee Stallion. An elite group of Substack Pro staffers, handpicked by editors, have been given the resources to write full time. Everyone else on Substack has to do it for free until they manage to claw and scrape their way into a subscriber base that pays.

Realistically, almost nobody will reach that point. The vast majority of Substack newsletter writers will never make money that's equivalent to a year's salary, which is what the staffers get. Instead, they will provide Substack with free content, hoping to get that sweet subscriber cash one day. And Substack will dangle its ''successful'' writers in front of its rank-and-file membership to keep them going. You too could have a Substack that's as financially successful as this guy's Substack! Except you don't know whether this ''successful'' Substack was bankrolled by the company or not. There's no transparency about that.

For all we know, every single one of Substack's top newsletters is supported by money from Substack. Until Substack reveals who exactly is on its payroll, its promises that anyone can make money on a newsletter are tainted. We don't have enough data to judge whether to invest our creative energies in Substack because the company is putting its thumb on the scale by, in Hamish's own words, giving a secret group of ''financially constrained writers the ability to start building a sustainable enterprise.'' We are, not to put too fine a point on it, being scammed.

Here's where I come into this awful taleLike a lot of writers, I want to stay in touch with my readers on a semi-regular basis to let them know when I've published something new. But I can't use my plain old email account to do that because nearly all email providers have anti-spam measures that prevent an individual from sending out the same email to more than a few dozen people at once.

So I needed a platform that would send out mail for me, and circumvent those spam filters. What about a blog? Been there, done that. I used to work for a company called Gawker Media, where I spent seven years running a blog called io9. It was fun! But for a whole variety of reasons -- the death of Google Reader, Facebook's fraudulent ''pivot to video'' -- the media world moved away from blogs as a genre and so did I.

And so finally, last year, I started to consider Substack. Many writers I admire had started using it, and I thought: ''Here's a good way to send bulk email without getting caught in a spam filter.'' That's all I wanted -- a decent platform that wasn't complicated like MailChimp, and didn't charge high monthly rates to send more than 1,000 e-mails.

I didn't pay much attention to Substack's subscriber model because I wasn't going to use this newsletter as a revenue stream. I already have plenty of paying gigs. All I wanted was a way to let you folks know what I'm up to, and occasionally tell you a story for free that I personally wanted to tell. What clinched it for me was that Substack had attracted such a big, engaged readership with high-profile writers like Daniel M. Lavery, Emily Atkin, and Heather Cox Richardson.

Substack's nice interface and large community made it easy for content to go viral. And that's what I wanted. I didn't need to be paid, but I wanted to get some of my weirder ideas in front of a broad audience. What I'm saying is that Substack suckered me in with the promise of growing my readership, and the bait was that they had so many great writers with huge followings. But now I'm left wondering how many of those huge followings were made possible by payouts from Substack.

And then things got really creepyBefore Substack came clean about its Pro program, I had already started to hear things from journalist friends about how certain people were getting massive amounts of money to write for the platform. Sure, they could call their newsletter by any name they wanted, but Substack was paying them to do it. And yet Substack was pretending that its successful newsletters were all bootstrapped. That sounded like shenanigans to me.

It got worse when some of the Pro writers started to reveal themselves, because Substack's secret paid elite all seemed to be cut from the same cloth.

As Jude Doyle explained in their newsletter:

Substack has become famous for giving massive advances '-- the kind that were never once offered to me or my colleagues, not up front and not after the platform took off '-- to people who actively hate trans people and women, argue ceaselessly against our civil rights, and in many cases, have a public history of directly, viciously abusing trans people and/or cis women in their industry.

Glenn Greenwald started his Substack by inveighing against trans rights and/or ACLU lawyer Chase Strangio, is currently using it to direct harassment at a female New York Times reporter, and has repeatedly used his platform to whitewash alleged rapists and domestic abusers. Freddie de Boer is an anti-''identity politics'' crusader who became so infamous for harassing colleagues, particularly women, that he briefly promised to retire from the Internet to avoid causing any more harm; he's currently using his ''generous financial offer'' from Substack to argue against ''censoring'' Nazis while pursuing a personal vendetta against the cis writer Sarah Jones. Matt Yglesias, who publicly cites polite pushback from a trans femme colleague as the Problem With Media Today '-- exposing the woman he named to massive harassment from Fox News and online TERFs alike '-- reportedly got a $250,000 advance from Substack. It's become the preferred platform for men who can't work in diverse environments without getting calls from HR.

Doyle notes that Substack also seems to have a secret list of writers who are allowed to violate the company's terms of service. These people dish out hate speech, but remain on the platform with paid subscribers. Among them is Graham Linehan, who was already booted from Twitter for hate speech against trans people, and whose Substack is entirely devoted to the idea that trans women are a danger to cis women and should be stopped.

This is precisely the kind of thing that happens in organizations that lack transparency and accountability.

Hamish and the other Substack editors have responded to their community's concerns about transphobia by saying that their paid staff writers come from all across the political spectrum. Which, by the way, is an editorial policy. Of course, we can't verify that it's true because Substack refuses to be transparent about which newsletter writers are on staff.

So Substack has an editorial policy, but no accountability. And they have terms of service, but no enforcement. If you listen to Hamish, they don't even hire writers! They just give money to people who write things that happen to be on Substack. It's the usual Silicon Valley sleight-of-hand move, very similar to Uber reps claiming drivers aren't ''core'' to their business. I'm sure Substack is paying a writer right now to come up with a catchy way of saying that Substack doesn't pay writers.

So what's next?Substack's business is a scam. They claim to offer writers a level playing field for making a living, and instead they pay an elite, secret group of writers to be on the platform and make newsletter writing appear to be more lucrative than it is. They claim to be an app when they are a publication with an editorial policy. They claim in their terms of service that they will protect writers from abuse, but they don't.

I have never paid Substack anything. I never intended to pay them anything. I just wanted a way to send out my irregularly-updated newsletter to a couple thousand subscribers without getting caught in a spam filter. Still, I did give them some pretty damn good articles, a couple of which went viral and brought more subscribers to their scammy platform. I guess I'd call it a wash.

Obviously I can't stay here. I'm still trying to figure out what I'm going to do about running a free newsletter because all the best options like Ghost require a pretty steep monthly payment -- essentially, they expect me to charge my subscribers, which I don't want to do. For now I'm going to do more research, and I'll be turning my upcoming newsletter ideas into segments on my podcast, Our Opinions Are Correct. So if you want more of this, definitely subscribe to the pod. And you can follow me on Twitter or Instagram.

This is all far from over.

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Source: Vox Popoli

Sat, 20 Mar 2021 14:01

Note that the individual being accused of targeting minors is the #4 Creator on Patreon, with 22,377 patrons as of today and 819 posts on the Patreon platform:

YouTuber Yagami Yato has spoken out about accusations of providing sexually explicit material to children and of grooming minors.

Yagami Yato is a voice artist who produces voiceovers for animation videos, usually from anime. Her popular YouTube Channel has over 800,000 followers. Some of her work is considered to be NSFW (not safe for work), which has led to the recent controversy around accusations she has been promoting obscene material to children.

Her Patreon account is for more explicitly adult work, whereas her YouTube Channel is meant for material appropriate for all ages.

Fuel was added to the fire a few days ago when an anonymous Twitter account referring to themselves as Yagami Yato Confessions claimed that Yato had groomed them when they joined her Discord server as a teenager in high school. They claimed that Yato used many minors as her moderators....

Yagami Yato stated that all her NSFW material will now be locked behind her Patreon account, which has adequate safeguards.

Patreon currently has 45,054 self-identified NSFW creators with one or more patrons, which represents 23.6 percent of its 190,961 creators, and six of the top 25. A considerable number of those NSFW creators feature content on the Patreon platform that is wildly in violation of Patreon's Community Guidelines, despite Patreon's public claim to have "zero tolerance" for such content. 

What is significant is that Patreon was previously called on the carpet by its payment processors back in 2017, and in response, pretended to have dealt with the issue by banning a few porn stars and prostitutes. 

Patreon has begun a fresh crackdown on users who make and sell adult-related content services on its crowdsourced patronage platform. The company has begun to suspend and report users who use the site to sell suggestive material, including Vex Ashley, creator of Four Chambers. According to Motherboard, users have been told that the reason for their suspension is "implied nudity."

This story begins last September, when Patreon raised $60 million from investors in order to further grow its business. Not long after, the company altered its content policy, replacing vague prohibitions on the sale of illegal adult content with more specific terms. This included a ban on the platform to sell images, video and other material, as well as services such as webcam sessions.

The move was surprising, since Patreon had allegedly courted, and engaged with, sex workers and performers. These people had come to rely upon Patreon as a source of income, and when the new terms were published, it caused shockwaves in the industry. After a series of news reports, the company attempted to walk back its stance. CEO Jack Conte said that it "broke" his "heart" that the individuals involved were left fearing for their livelihoods, and lives.

When Engadget spoke to a Patreon spokesperson on the matter, they said that the "the TL;DR is that if what you were doing before was okay, then probably what you're continuing to do is okay." There appeared to be an implication, too, that Patreon would only crack down on illegal content, such as bestiality. And that moderators would essentially turn a blind eye to content that took place between consenting adults.

But even a cursory review of the Patreon site today is sufficient to prove otherwise. For example, this is a description of a feature in the #94 creator's NFSW adult game, Breeders of the Nephelym, despite Patreon claiming to have a zero-tolerance policy for rape. 

Wild Nephelym can be found around the Spawning Shrines. Nephelym can be caught using two different approaches, namely:

Surprise Sex.Giving the Nephelym their preferred liquid. 

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Fri, 19 Mar 2021 12:59

Madison Avenue is paying more money to podcasting. Now a group of people focused on the industry wants advertisers to pay more attention.

The Media Roundtable, a group of organizations that aims to promote civility and stronger dialogue in media, is launching a chart of what it considers to be the podcasts that display the most and least bias. The debut of the chart, prepared by the research organization Ad Fontes Media, is part of a bid to get advertisers to support content of a better quality in an era when the proliferation of niche outlets makes such stuff more difficult to track.

''Oftentimes, the best performing programs for an advertiser are the ones that have the strongest opinions and often can be very polarizing. It's very alluring. There are a lot of businesses that have built their companies on the back of polarizing personalities,'' says Dan Granger, CEO of Oxford Road, a media buying agency that does a lot of work with podcasters and is a member of the Roundtable. ''Then you wake up one day and you see something trending on Twitter because the host of one of these shows said something controversial and all of a sudden, everyone freaks out.''

Ad Fontes Media assigns a team of analysts with viewpoints from across the political spectrum to listen to various podcasts and examine the reliability of the information presented as well as whether hosts engage in rhetoric that is ''dehumanizing, vilifying,'' says Vanessa Otero, founder and CEO of the organization. ''We are trying to make noise saying advertisers have to be more responsible about the money that's flowing to certain news sources,'' she says. The group's analysis tends to rate general-news programs from mainstream news outlets as less biased and programs from specific partisan hosts as more biased.

The goal of the organizers is to help advertisers find a way to monitor content and avoid boycotts launched by activists and consumers, who often call out sponsors on Twitter and other social-media outlets. The National Institute for Civil Discourse and the Cambridge Negotiation Institute are also involved in the Roundtable.

Madison Avenue's potential podcast woes highlight the growing influence of so-called ''direct to consumer'' marketers, a category of advertising that is growing as more companies employ e-commerce techniques. These advertisers include companies that go on to become the next Warby Parker, Purple or Casper and generally graduate to TV and video advertising after spending several years employing direct-response techniques. They can sometimes focus more on spurring transactions than on developing a broader brand profile and are less finicky about where their commercials appear.

The Media Roundtable's effort surfaces as advertisers' media plans are under tightening scrutiny. In November, shareholders in home-improvement retailer Home Depot and advertising holding company Omnicom Group filed resolutions calling on the companies to ''commission third-party reports investigating whether their ad buys contribute to 'violations of civil or human rights' on social media platforms like Facebook, YouTube, and Twitter,'' according to Open MIC, an advocacy organization that helped coordinate the effort. Advertisers whose pitches accompany disinformation or hate speech are often called out by organizations like Sleeping Giants.

Podcasts have been a challenging place for advertisers. Listeners have a very direct, personal connection with hosts and narrators, and commercials can get in the way of that relationship. Podcasts typically run with just a handful of spots and sometimes the host is the one who delivers them.

The medium, while smaller than other venues, is in the midst of a surge that is expected to continue for the next few years. PricewaterhouseCoopers forecasts $800 million will be spent this year on podcast ads in the U.S. By 2024, the total is projected to be $1.7 billion. ''Podcasts have the ability to get very specialized,'' says CJ Bangah, a principal of technology, entertainment, and media at the consulting firm. ''If you want to reach consumers with certain goals or interests, it can be a very powerful platform.''

Advertisers can block digital venues from their media plan by isolating content that contains certain keywords. The same feat isn't all that possible with podcasts, according to executives. The sheer number of individual producers and episodes they make means that ''no matter how big your staff is, it's almost impossible to follow all of thta, especially on a daily or weekly basis'' says Scott McDonell, chief marketing officer and co-founder of BizCounsel, and former vice president of marketing at LegalZoom.com. ''I think a guide is sorely needed so brands can make their own decisions aligned with what they feel comfortable with.''

Oxford Road's Granger hopes the new idea will get advertisers to think harder about where the place their money and send more dollars to media of higher quality. ''All we need to do is reward better behavior in media through an increased opportunity for ad dollars,'' he says.

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Source: Vox Popoli

Fri, 19 Mar 2021 14:06

The Devil Mouse is now practicing Zero History on its own intellectual property. It's a bold move, Cotton.

Now Aladdin is racist. So much so that Disney+ added a warning label before the film starts.

“This program includes negative depictions and/or mistreatment of people or cultures. These stereotypes were wrong then and are wrong now. Rather than remove this content, we want to acknowledge its harmful impact, learn from it and spark conversations to create a more inclusive future together.”

And here’s where it gets funny.

“Disney is committed to creating stories with inspirational and aspirational themes that reflect the rich diversity of the human experience around the globe. To learn more about how stories have impacted society visit Disney.com/storiesmatter”

When did Disney become educational?

First off, when did Disney suddenly become a Civil Rights movement? We coulda sworn we went to Disneyland and waited in line for two hours to be entertained–not for an “education.”

But maybe that’s the issue that Disney and other major corporations can’t seem to understand. They’re suddenly switching lanes (without putting on their signal, I should add) and trying to educate when they should just be creating a fun environment. Disney+ wants to say they’re focused on inspirational themes while half the children in Disney films have dead parents.

It's not a question of the converged corpocracy not understanding anything. Converged organizations simply have very different goals than outsiders who don't understand the concept of corporate cancer grasp. A converged organization always sacrifices its ability to perform its primary objective, so it should come as no surprise that a converged entertainment company like the Devil Mouse is increasingly losing its ability to entertain anyone. 

Labels: corpocracy, Devil Mouse, SJW

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Source: Signs of the Times

Fri, 19 Mar 2021 14:07

A Milwaukee County Children's Court judge and former president and CEO of the Cream City Foundation, which runs the city's drag queen story hour program, has been arrested on seven counts of child pornography.

Brett Blomme, 38, was arrested on Tuesday for allegedly uploading 27 images and videos of children being sexually abused on the messaging app Kik.

Blomme was held overnight and released with a signature. He has been ordered to stay off social media and file-sharing services and is not allowed near any children except the two that he adopted with his husband.

"The couple has two adopted children. Court records do not suggest they are part of any of the illegal images. Child Protective Services is involved with their current placement, defense attorney Christopher Van Wagner said during the court hearing," the Milwaukee Journal Sentinel reports.

Blomme is accused of uploading the images both from his home and from the judge's chambers.

The alleged pedophile judge was the president and CEO of the Cream City Foundation, which runs the Milwaukee Drag Queen Story Hour for local children. As of early Thursday morning, however, all articles and mentions of him had been scrubbed from their website. The links were still cached by Google's search engine and his role remained detailed on his LinkedIn page.

According to his LinkedIn profile, Blomme served as the president and CEO of the drag story hour foundation until August 2020, when he left to become a judge.

"Brett Blomme is the President & CEO of Cream City Foundation. He has nearly 15 years of experience in philanthropy, community organizing, law, and nonprofit management. Before joining CCF, Brett served as the Director of Major Gifts for the AIDS Resource Center of Wisconsin (ARCW)," his profile states.

Assistant Attorney General David Maas, who is prosecuting the case, has argued that Blomme should not have any unsupervised contact with children '-- including the two that he and his husband adopted.

"A 44-page search warrant filed Friday by a DCI special agent said investigators found Blomme, using the name 'dommasterbb,' uploaded 27 videos and images containing child pornography. Two of the files were uploaded at a Milwaukee County government building, the search warrant said," the Journal Sentinel report continues. "The special agent sought permission to search Blomme's courtroom, chambers, houses in Milwaukee and Dane counties and his 2017 Audi. Blomme is currently assigned to Milwaukee County Children's Court."

A preliminary hearing has been set for May 29. The state Supreme Court has suspended Blomme from any judicial duties, without pay, per the high court's "superintending and administrative authority."

Milwaukee Mayor Tom Barrett, who advocated for Blomme's election, said that the charges were "a complete surprise."

"The allegations are alarming," Milwaukee Mayor Tom Barrett said. "Before he was elected to the bench, the judge served as chair of the Board of Zoning Appeals, an appointed board in City Government. The reports of the arrest came as a complete surprise."

If convicted, Blomme faces up to 25 years in prison for each count.

Cassandra Fairbanks is a former leftist who came out in support of Donald Trump in 2016. She has been published in the International Business Times, RT, Sputnik, The Independent and countless other publications.

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Sat, 20 Mar 2021 14:12

PIERRE, S.D. (KELO) '-- The most controversial bill from the 2021 legislative session is not being signed into law by Gov. Kristi Noem.

On Friday afternoon, Gov. Noem announced she is sending House Bill 1217 back to the lawmakers for suggested ''style and form changes.'' You can see her full letter to lawmakers on the bill attached below.

If lawmakers agree with the changes, the measure will only need a simple majority to become law. It will no longer need the Governor's signature.

In a news release, Gov. Noem said ''the proposed revisions limit the bill to elementary and secondary school athletics, which are primarily conducted among South Dakota schools and at the high school level are governed by the South Dakota High School Activities Association, a creature of South Dakota law. The proposed revisions will also remedy the vague language regarding civil liability and the use of performance-enhancing drugs.''

She said she supports HB 1217 with changes that show ''empathy for youths struggling with what they understand to be their gender identity.''

The bill called 'fairness in women's sports' passed in both the House and Senate. Critics have raised questions about potential fallout for South Dakota being able to host future NCAA events and stopping other businesses from coming to the state.

Opponents of HB 1217 have directly pointed out HB 1217, while not mentioning transgender women specifically, is mainly targeted at discriminating against them. The bill specifically requires anyone looking to participating in sanctioned sports to provide an annual signed waiver confirming a student's age and the student's ''biological sex, as ascertained at or before birth in accordance with the student's genetics and reproductive biology.''

''Dear Legislators,

I respectfully return to you House Bill 1217 with the following recommendations as to STYLE and FORM.

I believe that boys should play boys' sports, and girls should play girls' sports. As the legislative findings in the original version of the bill set out, ''[w]ith respect to biological sex, one is either male or female[,]'' and ''[p]hysiological differences between males and females include 'those most important for success in sport: categorically different strength, speed, and endurance.'''

That is why House Bill 1217 properly provides that females should have opportunities to play youth sports on teams comprised of females and against teams of females. Unfortunately, as I have studied this legislation and conferred with legal experts over the past several days, I have become concerned that this bill's vague and overly broad language could have significant unintended consequences.

For example, Section 2 of House Bill 1217 requires a student athlete to verify, each year, that the student ''is not taking and has not taken, during the preceding twelve months, any performance enhancing drugs, including anabolic steroids.''

Presumably, this requirement was included to address a student taking these drugs as a part of a gender transition, but House Bill 1217 is not limited in this way. Rather, if a male student athlete failed to make the football team, and later learned that another student on the team was taking steroids without disclosing it, the student who didn't make the team would be entitled to sue both the school and the steroid-using student for damages.

In addition, Section 2 creates an unworkable administrative burden on schools, who under its terms must collect verification forms from every student athlete, every year, as to age, biological sex, and use of performance-enhancing drugs; and furthermore must monitor these disclosures throughout the year so that if ''reasonable cause'' is found of a false or misleading form, the school can take action to avoid civil liability.

I am also concerned that the approach House Bill 1217 takes is unrealistic in the context of collegiate athletics. In South Dakota, we are proud of our universities' athletic programs, and in particular the great strides we have taken to gain national exposure and increase opportunities for our next generation over the past two decades.

South Dakota has shown that our student athletes can compete with anyone in the country, but competing on the national stage means compliance with the national governing bodies that oversee collegiate athletics. While I certainly do not always agree with the actions these sanctioning bodies take, I understand that collegiate athletics requires such a system '' a fifty-state patchwork is not workable.

To achieve the legislative intent of protecting girls' sports, while simultaneously avoiding potential unintended consequences, I recommend the following Style and Form changes to the Enrolled version of House Bill 1217:

Revise Section 1 to read:13-67-1 Athletic teams and sports-''Designation by sex''Participation.

Any athletic team or sport that is sponsored or sanctioned by an accredited elementary or secondary school public school, a school district, or an association meeting the requirements of § 13-36-4, or an institution of higher education under the control of the Board of Regents or the South Dakota Board of Technical Education must be expressly designated as being:

(1) A male team or sport;

(2) A female team or sport; or

(3) A coeducational team or sport.

A team or sport designated as being female is available only to participants who are female, based on their biological sex, as reflected on the birth certificate or affidavit provided upon initial enrollment in accordance with verified in accordance with § 13-27-3.1 13-67-2.

2. Strike Section 2;

3. Revise former Section 3 to read:

13-67-2 3 Complaint'--Investigation'--Adverse Action.

A governmental entity, licensing or accrediting organization, or athletic association or organization may not entertain a complaint, open an investigation, or take any adverse action against an accredited elementary or secondary school, or a school district, or an association meeting the requirements of § 13-36-4 or an institution of higher education, or against any person employed by, or a governing board member of, such an elementary or secondary school, or school district, or institution, or an association meeting the requirements of § 13-36-4, for maintaining athletic teams or sports in accordance with § 13-67-1.

4. Strike Section 4.

The proposed revisions limit House Bill 1217 to elementary and secondary school athletics, which are primarily conducted among South Dakota schools and at the high school level are governed by the South Dakota High School Activities Association, a creature of South Dakota law. The proposed revisions will also remedy the vague language regarding civil liability and the use of performance-enhancing drugs.

Overall, these style and form clarifications protect women sports while also showing empathy for youths struggling with what they understand to be their gender identity. But showing empathy does not mean a biologically-female-at birth woman should face an unbalanced playing field that effectively undermines the advances made by women and for women since the implementation of Title IX in 1972. The Supreme Court of the United States has recognized that the Equal Protection Clause of the Fourteenth Amendment allows for the law to treat women and men differently, and in this instance that equal protection afforded women absolutely should apply on our state's elementary and high school playing fields.

I support this legislation and hope that House Bill 1217, with the changes I am proposing, becomes law. I respectfully request that you concur with my recommendations as to STYLE and FORM.

Respectfully submitted,

Governor Kristi Noem''

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Source: Phys.org - latest science and technology news stories

Sat, 20 Mar 2021 14:58

Enjoyment of the great outdoors has become a key part of the Finnish brand of happiness

Once notorious for its bland food and long, harsh winters, Finland's repeated success in the annual happiness rankings has helped transform the country's global reputation, boosting tourism and business.

The UN-sponsored World Happiness Report elicited some raised eyebrows when it first placed Finland at the top of its listings in 2018: many of the Nordic country's 5.5 million people freely describe themselves as taciturn and prone to melancholy, and admit to eyeing public displays of joyfulness with suspicion.

"When I first heard'--and I'm not alone, I would say'--I had a big laugh," television producer Tony Ilmoni told AFP on the still-snowy streets of the capital Helsinki on Friday, when Finland was crowned the happiest nation on earth for the fourth year running.

But the worldwide survey in fact seeks to quantify individuals' personal freedom and satisfaction with their lives, using survey data from 149 countries alongside measures such as GDP, social support and perceptions of corruption.

Finland excels with its quietly world-class public services, low levels of crime and inequality, and high levels of trust in authority.

"The basics are really good here: we don't have anyone living in the streets, we do have unemployment but the health service works, the big things like that," flower seller Riitta Matilainen told AFP.

"But we could be a bit more outgoing and joyful!"

The northern country's long dark winters were once reputed to be behind high levels of alcoholism and suicide, but a decade-long public health drive has helped cut rates by more than half.

Ranking of countries and territories on the annual UN-sponsored World Happiness Report, topped by Finland for a fourth-year running.

'Who wouldn't want to live here?'

For tourism and country-branding chiefs, the "world's happiest" title has been a blessing they were quick to capitalise on.

"It's a really powerful, emotional, evocative thing to say you're the happiest country in the world. Why would anyone not want to live in the happiest country in the world?" said Joel Willans, a British digital marketer and creator of the "Very Finnish Problems" social media page, who has lived in Finland since the early 2000s.

"Awareness of Finland has grown during the past few years," Paavo Virkkunen, head of Finland Promotion Services at Business Finland, told AFP.

After four years, the happiness trope has been used by countless Finnish businesses to market lifestyle products and to try to attract workers to relocate and join the country's tech sector.

Finland's unflashy cuisine was once derided as something to "endure" by Italian then-president Silvio Berlusconi, and slammed by his French counterpart Jacques Chirac.

But restaurateurs and product manufacturers now tout the simplicity and natural ingredients of Finnish cooking, claiming it as key to the country's no-nonsense approach to wellbeing.

Finland excels with its quietly world-class public services, low levels of crime and inequality

The happiness marketing drive has been led, however, by the travel industry, with Finland's tourist office appointing Finnish 'happiness ambassadors' tasked with introducing visitors to the secrets of Finnish wellbeing.

"People are curious about (our happiness) and they want to learn about it," Virkkunen said.

Key to the Finnish brand of happiness is going outdoors to enjoy the country's vast forests and thousands of lakes, as well as the traditional Finnish steam bath, the sauna.

By the start of 2020, tourism to Lapland in northern Finland had reached record levels and the country was attracting more foreign direct investment projects than anywhere else in the Nordics.

While pausing international visitors, the pandemic has, if anything, increased overseas interest in Finland's clean, sparsely populated nature, leading tourist providers to offer virtual tours.

"Even though people are not able to travel now, you are able to dream about Finland and the happiness of a true connection with nature, where you can really unwind," said Virkkunen.

Tourism to Lapland in northern Finland had reached record levels before the start of the pandemic

Bubble easily burst

Finland's four-year dominance in the happiness stakes leaves one problem, however'--where to go from here?

When this year's results were announced, "it would've been more news if Finland had been knocked off the top spot," Joel Willans joked.

The long-time Finnish resident believes that the country's well-functioning, low-stress society has in fact lowered Finns' tolerance for when things do go wrong.

"They get really aggrieved," he said. "Their happiness bubble is easily pricked when things don't go perfectly."

But the benefits of the world happiness title will be long-lasting, Virkkunen believes.

"I think we have grown as a nation, understanding the basics of happiness a bit better than we understood before," he said.

(C) 2021 AFP

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Archived Version

Sat, 20 Mar 2021 20:00

The video ''What is the Great Reset?'' is a bizarre piece of PR / propaganda. At face value, it appears to say ''don't worry about the Great Reset, we love you all very much''. However, through coercive words and powerful symbols, the message most people get is ''we're doing this '... whether you like it or not''.

Through its condescending tone and obnoxious, over-simplistic phrasing, the video is basically about the elite talking down to the peasants, especially those who dare question its plans. And, if the goal of this video was to quell concerns about the Great Reset, it failed miserably. Proof: About 99.9% of the comments on YouTube are extremely negative. Here are some examples.

Here's the video:

This video is important and worth analyzing for several reasons. First, it was produced by the World Economic Forum (WEF) itself. As stated in several past articles, the WEF is one of those non-democratic elite organizations that set social and economic policies on a global level. In other words, if the WEF releases a video about something, it has the power to actually make it happen. In fact, it is probably already happening.

Second, this is not one of those feel-good ''let's fight the pandemic together'' videos. It actually announces the ''death of capitalism as we know it'' '' in those very words. It announces drastic, historical, and structural changes on a global level. It announces a New World Order.

This is the video description on YouTube:

The pandemic has radically changed the world as we know it, and the actions we take today, as we work to recover, will define our generation. It's why the World Economic Forum is calling for a new form of capitalism, one that puts people and planet first, as we come together to rebuild the world after COVID-19.

The first sentence of this description sets the overarching narrative: The pandemic destroyed the world and the elite is going to fix it. However, that description contains one glaring omission: The pandemic itself did not ''radically change the world'' '' it is the response to it that changed it. And this response was dictated by the very elite that is now lecturing us about a Great Reset.

Indeed, instead of tackling the pandemic with a balanced and targeted approach that's focused on people who are actually at risk, the elite insisted on shutting down small and medium businesses for months, eliminating millions of jobs in the process. Meanwhile, elite-owned mega-corporations were allowed to strive.

Then, after suffocating the masses for nearly a full year, the WEF says that the system is broken. But they broke it. And before they broke it, we were actually in the midst of the longest economic recovery on record.'¯ I am not saying that capitalism as we know is perfect. However, we are being presented a ''solution'' to a problem they've purposely created. In short: Order of out chaos.

Here's a look at this video.

Usually, PR efforts by elite organizations hide their true intentions with flowery words and meaningless sentences. But this thing is blatant.

Of course, it has to start with the elite's complete obsession with seeing the entire world wearing masks. They're particularly excited when children wear them.

At the beginning of the video, we see a bunch of people donning masks in a semi-ritualistic manner: A sign of submission to the elite.

Then, we hear UN Secretary-General, Antonio Guterres describing the pandemic as an ''opportunity''.

In a weird shot that includes a massive full-moon, Guterres talks about ''hope'' brought by vaccines. He also adds: ''there's no vaccine for the planet, nature needs a bailout''. In other words: If COVID hysteria ever goes away, it will immediately be replaced by global warming hysteria.

Then, the video treats us with the image of a building crumbling down as the narrator says: ''With everything falling apart, we can reshape the world in ways we couldn't before''. That's powerful, near-subliminal imagery.

Not unlike the building above, the world is actually being subjected to controlled demolition. And they've placed the dynamites themselves. Why?

The narrator then says: ''That's why so many are calling for a Great Reset''.

Nobody (except for the elite) is calling for a Great Reset. Everybody (except for the elite) is calling for the complete restoration of freedoms.

Then, in a bizarre twist, the narrator talks about how the Great Reset sounds like a conspiracy.

''Great Reset? That sounds more like buzzword bingo masking some nefarious plan for world domination''.

While these words are uttered, powerful symbols are displayed.

While this image is meant to ridicule theories regarding the Great Reset, it actually depicts, with relative accuracy, what the Great Reset would achieve: The hand of the elite pulling the strings of the global economy.

Then, a fake newspaper with the headline: ''Global Elite's Plan For Your Future''.

Once again, while this headline is meant to address critics, it is also unconsciously assimilated by viewers to the first degree. The contents of this fake article are quite revealing:

The Great Reset is well-documented.

The Great Reset has been labeled a conspiracy theory and parts of it sounds like a conspiracy theory, but everything we know about it comes from the global elites themselves, who have been quite open about it.

''This is not a conspiracy theory, this is a well-documented movement among many of the world's most powerful people,'' says Justin Haskins, the editorial director at the Heartland Institute and a leading authority on the Great Reset, ''fundamentally, this is a radical and complete transformation of everything that we do in our society,'' Haskins adds, ''it will change the way businesses are evaluated, it will coerce businesses to pursue left-wing causes.''

The Great Reset was unveiled at the World Economic Forum in Davos, Switzerland, where many of the world's most powerful people go to offer solutions to the world's problems. They have said that the coronavirus pandemic as a historic opportunity to change the way the world operates.

COVID-19 pandemic as an ''opportunity'' to change everything.

A World Economic Forum video warns, ''Right now we're facing a crisis of international proportions. It's going to have a long-term impact on us''.

And their solution is essentially global socialism. Think of the Green New Deal combined with the COVID-19 lockdown restrictions and throw in something called the Fourth Industrial Revolution, in which technology is supposed to radically change the way we live and work.

Haskins says: ''The elites, the technocrats in society, the most educated people'', see the chance to ''control and manipulate society, pull the levers in society so that it's in their minds, perfect.''

As you can see, the contents of this newspaper are not gibberish. It mentions Justin Haskins of Heartland Institute, a researcher from an actual think tank who has been warning about the massive scope of the Great Reset.

Right after, the video replicates a classic scene from the movie They Live (read my article about it here). Through the lens of truth, the words ''Great Reset'' turn into ''Obey!''

So the video acknowledges that the Great Reset sounds like a massive conspiracy to use COVID-19 to usher in global socialism. Then, instead of quelling these concerns, the video basically confirms them.

The narrator argues that the World Economic Forum is about ''bringing people together''. She says:

''Whether its politicians, CEOs, academics, activists or you, we're all about getting people toghter.''

Were YOU invited to the WEF? No, you weren't. They don't even want you to leave your house.

To illustrate people ''coming together'', the video shows us this collage of powerful people (and elite-owned pawns).

Then, citing the pandemic and global warming, the video gets rather extreme.

The video says: ''Capitalism as we know it is dead''. To make things perfectly clear for us peasants, they've literally depicted a tombstone that says Capitalism RIP 2020.

About 23 seconds prior, the video was ''addressing'' critics claiming that the Great Reset was about global socialism. Then it literally shows a tombstone with the words ''Capitalism RIP''. Once again, powerful imagery coming from a powerful place.

Then, the video introduces ''stakeholder capitalism'' '' a system that would drastically change the way businesses and economies function.

''It's for these reasons that the forum talks about something called stakeholder capitalism which would shift businesses away from just profit because, if we want to change where the focus of our recovery will go, then we need a new dashboard for the new economy. And that needs to encompass people, planet, prosperity, and institutions.''

While capitalism is based on a self-regulating system of offer and demand, the Great Reset looks to redefine the way businesses are evaluated through new parameters. The main one: Compliance to the elite's social and political agendas.

Shortly after, the narrator utters this enigmatic sentence:

''And that's all about getting the right people in the right place at the right time''.

While the video doesn't quite explain what this sentence actually means in real-life situations, its implications are rather chilling. Instead of allowing successful individuals and businesses to grow organically, the elite's system would interfere to ''get the right people at the right place at the right time'', in accordance with its agenda. In other words, the system would be rigged and compliance to a wider agenda would be mandatory in a new economy.

The video ends with a call to viewers to get involved. However, of course, you're not actually invited to the WEF. What they really want you to do is to shut up, wear a mask and stay home.

If one watches the various videos posted by the World Economic Forum on YouTube, a common thread is easily discernable. 1- Scare people with catastrophic disasters (this video focused on COVID and global warming). 2- Present a drastic solution that involves a non-democratic elite entity regulating the entire world.

To justify the Great Reset, the WEF mentions ''economic disparities'' caused by COVID-19. However, these disparities were caused by economy-killing policies dictated by the World Health Organization '' another elite organization that is largely funded by China. By forcing massive lockdowns, they knew exactly what would happen. They created chaos, and now they're looking to restore order.

Despite all of the words being thrown around, the real issue at hand is freedom. A free market allows any citizen to create a business and make a living from it. And, as long as there's a demand for it, the business can grow and everyone involved prospers. Free enterprise is a vector of freedom and allows those who succeed to live a comfortable life '' no matter their social or political allegiances. It is all about numbers.

The Great Reset is looking to break this vector of freedom by introducing social and political components to the free market. If you do not comply, you do not succeed. Instead, they'll put ''the right person, at the right place, at the right time''.

P.S. The economic crisis caused by COVID-19 has caused a massive drop in advertising revenues, making it difficult for independent websites such as The Vigilant Citizen to remain afloat. If you appreciated this article, please consider showing your support through a small monthly donation on Patreon. If you prefer, you can also make a one-time donation here. Your support will help this site navigate these difficult times as it continues to provide vital information and analysis on a regular basis. Thank you!

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Archived Version

Fri, 19 Mar 2021 12:06

By Shifaan Ryklief 20h ago

CAPE TOWN, March 18 (ANA) - Researchers in Thailand have successfully trained six sniffer Labrador retrievers as part of a six-month pilot project to identify the coronavirus in just two seconds.

According to Channel NewsAsia (CNA), researchers from Thailand's Chulalongkorn University led by Professor Kaywalee Chatdarong said coronavirus patients emitted a distinct scent through their perspiration which allowed the sniffer dogs to detect the virus.

''The dogs are different from the usual temperature-screening methods in that they can detect those who may have the virus but are asymptomatic, with no fever,'' Chatdarong told CNA on Wednesday.

''The dogs will be able to detect these people. Their accuracy rate of detecting patients is 94.8%,'' she said.

She added that the team is looking to send the sniffer dogs to spaces with large groups of people such as airports, and that the dogs need not sniff people directly but could screen samples of sweat.

The researchers believe the sniffer dogs would be a more efficient method in these cases than temperature checks.

Thailand is not the first country to adopt the sniffer dog method. Countries such as India and Chile have also reportedly trained dogs to be used at airports.

Meanwhile, Thailand has started its Covid-19 vaccination programme for front-line health workers after Prime Minister Prayuth Chan-ocha received the first AstraZeneca jab on Tuesday.

Prayuth, along with his cabinet, were vaccinated from the 117,300 imported AstraZeneca vaccine doses received for emergency use.

Thailand will receive 800,000 CoronaVac doses later this month from China.

'' African News Agency (ANA); Editing by Yaron Blecher

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Archived Version

Fri, 19 Mar 2021 13:22

BANGKOK (Reuters) - Thai sniffer dogs trained to detect COVID-19 in human sweat proved nearly 95% accurate during training and could be used to identify coronavirus infections at busy transport hubs within seconds, the head of a pilot project said.

Six Labrador Retrievers participated in a six-month project that included unleashing them to test an infected patient's sweat on a spinning wheel of six canned vessels.

''The dogs take only one to two seconds to detect the virus,'' Professor Kaywalee Chatdarong, the leader of the project at the veterinary faculty of Thailand's Chulalongkorn University, told Reuters.

''Within a minute, they will manage to go through 60 samples.''

The dogs can detect a volatile organic compound secreted in the sweat of COVID-19 sufferers, even in the absence of disease symptoms, the Thai researcher said.

The dogs would not need to directly sniff people, but could screen samples of sweat, a task that should not be difficult in a tropical country such as Thailand, she added.

Chile, Finland and India are other countries that have also launched efforts to get sniffer dogs to detect the virus, with a German veterinary clinic saying last month its sniffer dogs had achieved 94% detection accuracy in human saliva.

''The next step is we will put them out in the field,'' said Kaywalee.

''In the future, when we send them to airports or ports, where there is an influx of commuters, they will be much faster and more precise in detecting the virus than temperature checks.''

Thailand has been relatively successful in containing the virus, with a new wave of infections in the first two months of the year now levelling off and after recording 88 deaths.

The southeast Asian nation has also started vaccinating front-line health workers and hopes to find a way to let visitors return in greater numbers after its tourism-dependent economy was battered by the pandemic.

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Sat, 20 Mar 2021 15:36

A sick cat at the San Diego Humane Society. Cats and dogs have been found harboring the B.1.1.7 SARS-CoV-2 variant.

ARIANA DREHSLER/AFP via Getty Images By David GrimmMar. 19, 2021 , 4:10 PM

Science's COVID-19 reporting is supported by the Heising-Simons Foundation.

The variants of SARS-CoV-2 that keep emerging aren't just a human problem. Two reports released this week have found the first evidence that dogs and cats can become infected by B.1.1.7, a recent variant of the pandemic coronavirus that transmits more readily between people and also appears more lethal in them. The finds mark the first time one of the several major variants of concern has been seen outside of humans.

B.1.1.7 was first identified in the United Kingdom and that's where some of the variant-infected pets were found. The U.K. animals suffered myocarditis'--an inflammation of the heart tissue that, in serious cases, can cause heart failure. But the reports offer no proof that the SARS-CoV-2 variant is responsible, nor that it's more transmissible or dangerous in animals. ''It's an interesting hypothesis, but there's no evidence that the virus is causing these problems,'' says Scott Weese, a veterinarian at the University of Guelph's Ontario Veterinary College who specializes in emerging infectious diseases.

Related Since December 2020, scientists have identified multiple variants of concern that appear more transmissible or are able to evade some immune response. B.1.351, for example, was first detected in South Africa, and a strain called P.1 was first found in Brazil. The B.1.1.7 variant drew early attention because of its rapid rise in the United Kingdom; it now comprises about 95% of all new infections there.

So far the impact of these variants on pets has been unclear. Though there have now been more than 120 million cases of COVID-19 around the world, only a handful of pets have tested positive for the original SARS-CoV-2'--probably because no one is testing them. Infected pets appear to have symptoms ranging from mild to nonexistent, and infectious disease experts say companion animals are likely playing little, if any, role in spreading the coronavirus to people.

The new variants might change that equation, says Eric Leroy, a virologist at the French National Research Institute for Sustainable Development who specializes in zoonotic diseases. In one of the new studies, he and colleagues analyzed pets admitted to the cardiology unit of the Ralph Veterinary Referral Centre in the outskirts of London. The hospital had noticed a sharp uptick in the number of dogs and cats presenting with myocarditis: From December 2020 to February, the incidence of the condition jumped from 1.4% to 12.8%.

That coincided with a surge of the B.1.1.7 variant in the United Kingdom. So the team looked at 11 pets: eight cats and three dogs. None of the animals had a previous history of heart disease, yet all had come down with symptoms ranging from lethargy and loss of appetite to rapid breathing and fainting. Lab tests revealed cardiac abnormalities, including irregular heartbeats and fluid in the lungs, all symptoms seen in human cases of COVID-19.

Seven of the animals got polymerase chain reaction tests, and three came back positive for SARS-CoV-2'--all with the B.1.1.7 variant, team reported yesterday on the preprint server bioRxiv. SARS-CoV-2 antibody tests on four of the other animals picked up evidence that two of them had been infected with the virus. Earlier this week, researchers at Texas A&M University detected the B.1.1.7 variant in a cat and a dog from the same home in the state's Brazos county.

The Texas owner was diagnosed with COVID-19, and owners of five of the 11 U.K. pets tested positive for SARS-CoV-2'--all before their animals developed symptoms. The Texas pets showed no symptoms at the time they were tested, though they both began to sneeze several weeks later. All of the U.S. and U.K. animals have since recovered, though one of the U.K. cats relapsed and had to be euthanized.

Leroy says it's unclear whether B.1.1.7 is more transmissible than the original strain between humans and animals, or vice versa. It's ''impossible to say'' that pets infected with B.1.1.7 might play a more serious role in the pandemic, he adds, but ''this hypothesis has to be seriously raised.''

Shelley Rankin, a microbiologist at the University of Pennsylvania School of Veterinary Medicine, points out that the researchers have shown only a correlation between B.1.1.7 infection and myocarditis, and that they didn't rule out other causes for the condition. ''There is no evidence pets were sick because of the virus,'' she says.

Weese agrees that neither the Texas nor U.K. findings should sound any alarms about pets endangering their owners. ''The risk of them being a source of infection remains very low,'' he says. ''If my dog has it, he probably got it from me. And I'm much more likely to infect my family and neighbors before he does.''

Still, he says scientists and veterinarians should do studies on what role, if any, SARS-CoV-2 and its variants play in myocarditis among pets. There is evidence that the virus can cause the condition in people, Weese notes, so it's worth exploring in companion animals. ''It might be real,'' he says, ''but there's no reason for people to freak out right now.''

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Archived Version

Sun, 21 Mar 2021 11:48

Author of the article:

Lorrie Goldstein

Publishing date:

Mar 17, 2021

'

3 days ago

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3 minute read

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177 Comments

This Jan. 26, 2009 file photo shows the exhaust pipe of a car in Erfurt, Germany. Photo by Jens Meyer / THE ASSOCIATED PRESS When Prime Minister Justin Trudeau said in December that now is not the time to raise taxes on Canadians because of the COVID-19 pandemic, he excluded his carbon tax.

That's because the carbon tax is scheduled to increase by 33% on April 1, up from its current level of $30 per tonne of industrial greenhouse gas emissions to $40 per tonne.

According to the Canada Revenue Agency, this year's $10 per tonne hike will increase the total federal carbon tax charge for gasoline to 8.8 cents per litre.

Prior to the 2019 election, the Trudeau government said it would freeze the carbon tax at $50 per tonne on April 1, 2022.

After the election, Trudeau announced he will raise it by $15 per tonne annually starting on April 1, 2023, until it reaches $170 per tonne in 2030.

That will increase the total federal carbon charge on gasoline to almost 38 cents per litre.

The carbon tax is also levied on 21 other fossil fuels, including natural gas used for home heating, light and heavy fuel oil, propane and aviation fuel.

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Trudeau's carbon tax applies in Ontario, Alberta, Manitoba and Saskatchewan with a combined population of 21.48 million people, or 57% of all Canadians.

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The other provinces have federally approved carbon-pricing schemes.

The government claims its carbon tax is revenue neutral and 80% of households end up better off financially through rebates known as climate action incentives.

In fact, the carbon tax isn't revenue neutral because it doesn't include in the rebates money raised by the federal goods and services tax, which is applied on top of the carbon tax.

This year alone, according to independent, non-partisan Parliamentary budget officer Yves Giroux, that will raise $235 million for the federal government.

As for Trudeau's long-term commitment to keeping his carbon tax revenue neutral, excluding GST revenue, keep in mind that he modelled his carbon tax to a large extent on British Columbia's, which started out as revenue neutral in 2008, but no longer is.

The Trudeau government's claim that 80% of households are better off financially because of rebates is based on the direct costs of the carbon tax to Canadians '-- mainly on gasoline and home heating fuels such as natural gas.

But when you factor in indirect costs, the federal government says the number of households who end up better off financially falls to 70%.

Giroux said last year that while ''most'' households still end up better off financially with rebates, once you include the impact of the GST and provincial sales taxes, placed on top of the carbon tax, the actual net transfers to households decrease.

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A chart in Giroux's report indicates in Ontario, the number of households that end up better off financially because of rebates is down to 60%.

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In addition, Giroux's calculations were based on Trudeau's carbon tax remaining at $50 per tonne annually post-2022, which is what Trudeau said would happen at the time Giroux released his report '-- as opposed to his new policy to raise the carbon tax to $170 per tonne by 2030.

Trudeau's looming second carbon tax '-- the Clean Fuel Standard '-- intended to reduce the carbon intensity of liquid fossil fuels starting next year '-- doesn't include rebates.

An environment ministry report last year warned it will increase energy poverty in Canada, disproportionately impacting low-income households, seniors, single mothers, rural Canadians, oil, gas and freight transport workers, single family homeowners and tenants.

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Archived Version

Source: Sputnik News - World News, Breaking News & Top Stories

Sat, 20 Mar 2021 14:18

President Joe Biden's administration has been playing down the emergency situation triggered by a dramatic influx of migrant children and families at the border with Mexico as a ''challenge'', not a crisis, while scrambling to manage overcrowding in Border Patrol facilities that was warned as being ''not sustainable''.

The Biden administration is reportedly mulling sending planeloads of migrants to states closer to neighboring Canada for processing as an emergency measure amid a surge in attempted crossings at the southern border, reported The Washington Post.

The options were weighed after Friday morning witnessed at least 1,000 unaccompanied minors and family units cross the Rio Grande into Texas, while another 1,000 were still awaiting processing from the night before, according to two cited Department of Homeland Security officials.

The outlet also cited an email as suggesting that border officials had requested air support from US Immigration and Customs Enforcement (ICE) due to the challenges posed by the extraordinary volume of unauthorised border crossings in recent days, which have resulted in overwhelmed facilities in Texas.

Children and families were reportedly forced to wait outdoors for hours as a backlog has been compounded by a record number of over 4,500 unaccompanied minors held in detention cells and border tent sites.

The Biden administration has been using a pandemic-related health order dating to Trump's White House tenure - Title 42 - to automatically deport anyone caught illegally crossing the border, applying it to adults and families, but not to unaccompanied children.

According to the cited email, there is no indication as to whether United States Customs and Border Protection (CBP) has determined which northern and coastal states could receive the reported flights.

Internal DHS communications seen by The Washington Post allegedly warned that overcrowding at border facilities had spiralled into a life-or-death emergency.

The reported airlifting initiative is not new, as at the height of the 2019 border surge during the tenure of then-president Donald Trump, ICE Air flights were resorted to, albeit during warmer months, with migrants sent to different border sectors, depending on capacity reports.

Recently, migrant families had been airlifted on ICE planes from the crowded Rio Grande Valley facilities to the El Paso area, writes the outlet.

Border Patrol chief in the Rio Grande Valley Brian Hastings tweeted to say more than 2,000 migrants were taken into custody on 18 March, with 10,000 arrests and detentions in less than a week.

RGV agents remained busy on Thursday, apprehending over 2000 illegal aliens. Thursday's encounters pushed RGV's weekly total over 10K apprehensions! March monthly totals are now over 34K for #RGV Sector alone.#crossingyourborders pic.twitter.com/nga2wgBI6A

'-- Chief Patrol Agent Brian Hastings (@USBPChiefRGV) March 19, 2021'‹According to Hastings, over 34,000 migrants have been taken in at the specific sector of the border this month so far - twice as high as the data for all of January.

US law enforcement agents encountered over 100,000 migrants at the border with Mexico in February - the highest monthly total since the historic surge in mid-2019.

CBP said in a Friday statement that ''currently there are no plans to transfer migrants from the Southwest border to the Northern or Coastal borders.''

'Challenge, Not a Crisis'The challenging border situation was described as being ''under control'' by Democratic leaders on Friday, amid an inspection trip by Homeland Security Secretary Alejandro Mayorkas to the southern border facilities.

''The Biden administration has this under control. It will take some '-- it is change and it will take some time. But it is values-based, humanitarian in its aspects and pragmatic with a plan to get things done,'' House Speaker Nancy Pelosi (D-Calif.) was cited as saying by AP, as the Biden administration continued to downplay the current developments as a ''challenge,'' not a ''crisis''.

However, critics have slammed Mayorkas' trip for being closed to the press, with a growing chorus of Republicans and some Democrats warning that the situation is spiralling out of control.

Senators from the bipartisan delegation comprising members of the Senate Homeland Security and the Governmental Affairs Committee in El Paso have given dismayed accounts of what they observed as they accompanied Alejandro Mayorkas to the southern border.

I respectfully ask US Customs and Border Protection to stop blocking media access to their border operations. I have photographed CBP under Bush, Obama and Trump but now - zero access is granted to media. These long lens images taken from the Mexican side. @CBP #gettyimagesnews pic.twitter.com/cWa90TlfeS

'-- John Moore (@jbmoorephoto) March 19, 2021'‹Sen. Chris Murphy (D-Conn.) witnessed hundreds of children ''packed into big open rooms'' and ''fought back tears''.

2/ The desperation these kids and families are fleeing is hard to describe. The memory of that 13 yr old girl will be w me forever. So long as conditions are abysmal in places south, people will find a way to get here, no matter how high the wall is or how many border agents.

'-- Chris Murphy (@ChrisMurphyCT) March 19, 2021'‹Sen. Shelley Moore Capito (R-W.V.) decried the spike of minors ''a tragedy,'' writing on Twitter that ''swift action'' was required. ''Swift action needs to be taken NOW to end this humanitarian crisis,'' she said on Twitter.

The surge of unaccompanied children at our southern border is a tragedy. Swift action needs to be taken NOW to end this humanitarian crisis. pic.twitter.com/LjZXtYmsYv

'-- Shelley Moore Capito (@SenCapito) March 19, 2021'‹Plug Pulled on 'Trump-Era' PoliciesThis comes as on 18 March the House of Representatives passed bills seeking to create an eight-year path to citizenship for undocumented immigrants who arrived in the US prior to 1 January 2021.

Some Republicans warn this will bring about a ''return to the radical left-wing policies that will incentivise illegal immigration and promote an unending flood of foreign nationals into the United States.''

(C) REUTERS / JOSE LUIS GONZALEZ

Migrants from Central America, under the Migrant Protection Protocols (MPP) program, walk across the Paso del Norte international border bridge from the Mexican side to continue their asylum request in the United States, in Ciudad Juarez, Mexico February 26, 2021.

In February, Joe Biden terminated Donald Trump's ''Remain in Mexico'' policy, requiring the asylum seekers to stay on native soil while US courts reviewed their claims.

After having campaigned on a vow to overhaul his predecessor's tough immigration agenda, Biden halted construction of the Mexico border wall and issued an order affirming the 2012 Deferred Action for Childhood Arrivals programme. The latter gives work permits and protection from deportation to people brought illegally to the US as minors.

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Archived Version

Thu, 18 Mar 2021 21:23

** Disclaimer ** The below references my opinion and is for information purposes only. It is not intended to be investment or financial advice. Seek a licensed professional for investment or financial advice.

I wrote this for my family and friends to show them why I believe bitcoin is worth looking into and to try to help answer their questions. I am no expert, I have just been able to listen to a lot of podcasts lately. Please do your own research (DYOR). I think it could help others so I am sharing it. Bitcoin community, please send corrections so I can update! Thanks, Delly

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The Modern Gold RushI grew up in a town called Maryborough, Victoria, Australia in the Central Goldfields Shire. It's about a 30 minute drive from where the World's biggest golden nugget was found, the Welcome Stranger in 1869. I have heard stories about this time period and have always wondered what it would be like to grow up in the gold rush era. With what I'm learning about bitcoin, now I feel like I am.

My first bitcoin purchase was at the beginning of January 2018. I bought a small amount of the cryptocurrency that is a digital store of value at the absolute top of the market. I only knew that it was going up fast and there were only 21 million bitcoin. Unfortunately, I did not spend the time then to dive deeper and really try to understand why bitcoin is important.

Moving forward to the middle of 2020, I started looking into gold as an investment when I couldn't figure out why the stock market was continuing to go up when so many people weren't able to work due to COVID. This eventually brought me back to look into bitcoin. Luckily, I have been curious enough this time to dive deep and learn as much as I can. I've gone into detail about what I've learned so far below. I am hoping this helps you dive a little deeper too and/or is another resource to help you explain bitcoin to your family and friends.

This is how I'm sure I looked to family & friends when I first tried to explain BitcoinGold 2.0To better understand bitcoin, it's important to understand gold. Gold is so valuable because, apart from its many uses, it has been a proven store of value for thousands of years. A good store of value is something you can put your money into and you will still have the same amount of purchasing power in the future. If you measured the stock market's value in gold (and bitcoin), it is down over the last 3 years even though it is way up in dollar terms, as Mark Yusko explains below.

Bitcoin is emerging as the new store of value for the whole world. It has some advantages compared to gold:

Easily verifiable- All public on the blockchain. Gold you have to melt down to make sure it is real, someone can't send fake bitcoin.

It's more scarce- The supply of Bitcoin can't be increased (there will only ever be 21 million total Bitcoin). The supply of gold increases about 2% on average every year. If there is more demand for gold, miners can invest more in trying to meet demand.

Easier to send -Bitcoin can be sent easily from person to person using your phone or computer. It is a lot more complicated to send a gold nugget from the USA to AUS.

Easier to divide up -There are 100,000,000 satoshis (sats) in 1 bitcoin (BTC). You can't divide up a gold nugget and send $10 to a friend.

For market size reference, all of the gold in the world has an estimated value of around 11.5 Trillion US dollars (40% of Gold is for Financial use) as the World's reserve asset (store of value) for 1000s of years. Bitcoin is about to cross 1 Trillion US dollars and has been around for 12 years. Most countries around the world hold gold in their reserve assets, I think they will eventually HODL (bitcoin slang for hold) bitcoin as well, if they don't already.

I feel extremely grateful to be growing up in a modern gold rush. Inflation = Increases In PricesTo better understand why there is a need for a store of value, like Bitcoin, you have to understand inflation. The stated goal in the USA by the Federal Reserve is to have 2% inflation each year. That means each year that goes by you'll have to spend more dollars to buy the same good or service. Inflation is why the price of your favourite chocolate bar costs more now than when you were a kid.

The rise of bitcoin is set against the back drop of unprecedented fiat money printing/creation from all the countries around the world (which they did to try to help people get through COVID). Some estimates say 22% of the total M1 money supply in the USA has been created in the last 12 months.

Unfortunately, a lot people predict this will and seems to have already caused an increase in prices (inflation) of the below things. The result is more money in the system chasing the same amount of assets which drives the price higher.

Interest rates are also at all time lows which enables individuals, businesses, and governments to take on more debt for lower repayment costs. This contributes to and increases the wealth gap due to something called the Cantillon effect - where wealthier people get access first to this new, cheaper money. Great thread by Sahil Bloom below.

Some people have suggested that the Chapwood Index (@crypto_martian) is a better measure of inflation than CPI (Consumer Price Inflation). Below is how the Chapwood Index measures inflation.

Over two years, we collected data from friends and associates across the country on over 4,000 items to see what they spent money on in their daily lives. We then narrowed these items down to the top 500 most frequently used and relevant items. Those items became the basis of the Chapwood Index.

Every six months, we take the precise price for the same item quarter by quarter and calculate the increase or decrease, then developed a weighted index based on price. These items include basically everything that most Americans consumer during the course of their lives.

The Chapwood Index has a different inflation rate for each city in the US. They put most cities' inflation rates over the last 5 years in the 7-12% range.

Michael Saylor (MicroStrategy CEO who has bought 71,000+BTC for his company) talks about how everyone's personal inflation rate is different depending on what you're buying in an incredible podcast with Preston Pysh. For example, the inflation rate for a college kid living with his parents (tuition, netflix, take away food) will be different than a family of 5 looking to buy a house (house, healthcare, baby supplies).

In Australia, property prices have grown at a compounded annual growth rate of 7.7% in Melbourne and 6.95% in Sydney over the last 40 years (h/t Ben Kingsley, Property Couch Podcast). If you want to buy a house and prices are going 6-7% a year - that goes into your personal inflation rate along with anything else you want to spend your money on in the future. It makes it really hard to save for a deposit if your wage isn't growing at that same 6-7% rate each year.

When a house goes up in value with no improvements made, it's not the house that is getting more valuable, it's the land that the house is on. Land is a scarce asset like bitcoin, people can't create more of it. When there is an increase in the money supply it flows into scarce assets.

The more inflation grows (or fiat money that floods the system), the less purchasing power you have. Bitcoin is a way to hedge against inflation and store the value of your hard earned money. While bitcoin has a fixed supply of 21 million, there is no limit on the amount of dollars created. That is what makes investing and personal finance hard. If you are financially conservative, want to be safe and take no risks, just saving in dollars is like a guaranteed loss of purchasing power of:

2% a year if you go by the CPI (Consumer Price Index)

7-12% per year by the Chapwood Index the last 5 years

Saylor estimates in the last year it has been 15%+!!

In the interview below with Saylor, the host, Julia Chatterly asks him ''So you're basically saying you would prefer to have a volatile appreciating asset (bitcoin) vs a stable depreciating asset (cash).''

Something that people say contributed to inflation is when the USA went off the gold standard in 1971.

what that means: You used to be able to redeem an ounce of gold for $35 dollars, now it's just fiat money not backed by gold or any other asset.

what has happened since then: https://wtfhappenedin1971.com/ . Check out this link to see some crazy graphs.

Bitcoin, in a way, helps you to think longer term because you can store the hard work you do now, and know that you can use it in the future, instead of your hard work melting away in cash.

Why Is Bitcoin Going On A Crazy Run?The crazy runs bitcoin goes on seems impossible unless you know these three things:

4 year halving cycle

Why bitcoiners HODL (hold long term, try not to sell)

Rate of bitcoin adoption

4 Year Halving Cycle (Approximately)There will only ever be 21million bitcoin.

There are 18.6m bitcoin currently in circulation or about 88.5% of the total supply.

In 2012-2016= 3600 were released per day

2016-2020= 1800 a day

2020-2024= 900 a day

2024-2028 = 450 a day

2028-2032 = 225 a day

2032- 2036 = 112.5 a day etc

All 21 million bitcoin will be released by the year 2140.

2012 price at halving $12, spiked to a high of $1023 in December 2013, dropped back to $170 in January 2015.

2016 price at halving $663, spiked to a high of $19,700 in December 2017, dropped back to $3,257 in December 2018.

(There was a drop of $4,860 in the market sell off on March 12th 2020).

On the 11th of May 2020 price at halving $8,600, and the price at the time of writing is around $47,000. (h/t -StormGain)

Because the market is impossible to time, one strategy I've read that is recommended is to Dollar Cost Average and set up daily, weekly or monthly automatic buys. If you try to sell at the top and buy at the bottom, you will also create a tax bill for yourself. There were 6 29+% drops in the 2017 run up (h/t @real_vijay)

Here is a really interesting chart from PlanB tracking the progress after the halving and what happens if bitcoin follows the 2012/2016 growth after halving and his different pricing models.

In February 2020, the supply on exchanges (considered liquid, can sell at a press of a button) was around 3 million. A year later the supply on exchanges is around 2.35 million. So about 650,000 bitcoin has been moved off exchanges and been put into cold storage/other places which is the equivalent of buying gold and putting it into a safe (holding onto it, not trading it in the near future) (Chart: Glassnode).

This drop in supply and increase in demand from companies (MicroStrategy, Tesla!! can keep track here), institutional investors, university endowments and now cities like Miami has caused the price to spike. I think countries will be next, I hope Australia is one of the early adopters!

Dan Held, thinks that this cycle could be a Bitcoin Supercycle in his article, here.

Why Do Bitcoiners HODL(Bitcoin Slang For Hold)? I saw a lot of passion on Twitter for bitcoin but didn't fully know why the term HODL (hold) is important.

Bitcoiners think the price will go up

You can earn interest or borrow money against your bitcoin

The thing that changed my thinking was investing in BlockFi, a Crypto Platform (thanks Pomp for the intro!) You can earn 6% interest annually on your bitcoin (first 2.5 bitcoin, 3% after that) paid out in bitcoin or stablecoin monthly or you can borrow money against your bitcoin. This means that you have more options than selling your bitcoin - I'm not sure if this was around in the last cycle? Just like people can borrow money against their house if it goes up in value, platforms like BlockFi are now enabling people to borrow money against their bitcoin. This allows people to HODL their bitcoin. Something I have learned is wealthy people don't sell their assets (stocks, real estate, etc) unless they really have to because when you sell you create a taxable event.

Last month BlockFi paid out 400 bitcoin in interest to customers. That is roughly 1/67th of the new supply for that month coming into the system. If they pay out the same 400 bitcoin a month in 2024 after the halving it would be 1/33.5th of the new supply for that month.

They also are coming out with a credit card that people can earn 1.5% back in bitcoin rewards on all purchases so that will further eat into the supply. Do your own research, I'm a very happy BlockFi investor so I'm biased!

If you see negative things about Bitcoin, you should ask yourself why is the person or the article spreading FUD (Fear, Uncertainty, Doubt) about Bitcoin. Potential reasons are:

They don't understand it

Bitcoin's success could effect their job or disrupt their industry

They are trying to buy bitcoin at a lower price

Check out the timeline of Guggenheim CIO, Scott Minerd's comments below.

Am I Too Late? No. It's Still Early.Bitcoin has the same amount of users (135 million) as the internet had in 1997 but Bitcoin user adoption is growing faster. Do you remember in the late 90s/ early 2000s that dial up tone when you wanted to get on the internet? Now look at what is possible.

It took the internet 8 years to reach 1 billion users in 2005.

Willy projects bitcoin to hit 1 billion users in 4 years in 2025. @Woonomic, great follow on Twitter!

Bitcoin will eventually eat a little bit of other assets that are used to store value (real estate, stocks, bonds, art, etc), just like the mobile phone is now used for your calendar, alarm clock, newspaper, listening to music etc.

It is a global store of value that is available to everyone with a phone and internet connection, you can buy $5 (or less maybe) or 1.5 billion dollars like Tesla. I'm not sure if there has been a global asset that has been so accessible to so many people around the whole world.

There are a lot more options of where to buy and it is easier to buy than in 2017. Do your own research on where is best but make sure you are able to send your bitcoin off the platform to other people/addresses.

Whenever I hear someone say Bitcoin is too risky or a gamble, (THERE IS RISK TO EVERYTHING), I ask them if they know that the current market cap (total value) of Bitcoin is more than the current market cap (total value) of Facebook.

If You Want To Own Bitcoin But Don't Have Any Spare Cash Check out the Fold App (I am NOT an investor) - you can spin a wheel to win free bitcoin (or sats) or get bitcoin back in rewards for purchases you would make anyway for a couple of extra steps (Amazon etc).

1 BTC (Bitcoin) = 100,000,000 Sats (Satoshis)

Frequently Asked Questions Or Concerns''Can't see or or touch it'': Just a number on a screen the same as your bank account. When you get paid from your employer, do you get to ''see or touch'' that cash?

You don't have you buy a whole coin: It is possible to buy $5 or $10 worth.

Energy consumption concerns: Follow @Melt_Dem and her website with resources https://www.bitcoinwillnotboiltheocean.com/

BTC= Bitcoin

Other cryptos: I don't know and haven't done enough research to have an opinion. Bitcoin has a great 12 year track record so far. I would learn more about Bitcoin before moving on to others. When looking at other cryptos, check their price denominated against Bitcoin (BTC).

Volatility: ''It's too volatile''- Yes, it does go up and down but it continues to climb (see the graph below). You could look at it like a basketball season, would you rather:

Alternate between a win and a loss for the whole season and finish with 41 wins, 41 losses with less volatility.

Win 5, lose 2, win 4, lose 3, win 8, lose 4 etc and finish the season with 60 wins, 22 losses with more volatility.

Top 4 Things I Send To People To Learn More (Currently)These are the 4 things I've been sending people as an intro to why bitcoin is important (if you have good resources please send to me):

Pomp's letter - The Investment Case For Bitcoin

Preston push - Michael Saylor Podcast - lot of topics covered but really dives into inflation

@Croesus_BTC article - Am I too late for Bitcoin

Pomp Podcast - Episode #236 with Raoul Pal

Also, it is complicated but at some point it is important to read the original Bitcoin whitepaper.

ConclusionI hope you learned something. I'm still learning, so please send any corrections you have. This was NOT FINANCIAL ADVICE. Bitcoin is something you have to do your own research on.

Final Thoughts:

Do Your Own Research (DYOR) - your money, your responsibility

Security on accounts - use a strong password that is different to other accounts, set up 2 Factor Authentication (2FA)

Learn about how to keep you bitcoin safe and treat it like it could be worth more in the future, not what it is worth now - others can better explain that

There are a lot of places to buy bitcoin. Make sure you can take control of your bitcoin and send it off the platform (Robinhood doesn't offer this currently)

''Not your keys, not your coins'' - having complete control of your bitcoin, not an exchange, other people can explain this better, so you will have to DYOR

For Aussies, follow Alex Saunders (NuggetNews) on where the best options to get bitcoin are in Australia. CoinSpot is one option, DYOR.

For the USA, 3 of the biggest exchanges are Coinbase (CoinbasePro has lower fees), Gemini and Kraken, DYOR.

Thanks to everyone who has helped me learn about bitcoin through conversations or their tweets/podcasts/articles, in particular Pomp, Reuben, Alex, Michael, Zac, Bryan, Katelyn and Adam! The best way to say thank you is by paying it forward and help others who want to learn about bitcoin 👍

Also, big thanks to Pomp, my family, and friends for reading this over and giving me their feedback!

Topics I'm looking forward to learning more about:

Lightning Network

Mining

Energy

And if you want a glimpse into the future, check out what @JackMallers is doing with his company, Strike.

Thanks for reading, make sure to subscribe here and to The Delly Podcast - Delly 👍 Share

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Fri, 19 Mar 2021 13:45

NASHVILLE, TN'--The Federal Bureau of Investigation, U.S. Attorney's Office for the Middle District of Tennessee, Bureau of Alcohol, Tobacco, Firearms and Explosives, Metro Nashville Police Department, Tennessee Highway Patrol, and the Tennessee Bureau of Investigation have concluded a significant portion of the investigation into the explosion that occurred on December 25, 2020, at approximately 6:30 a.m. Central Time, in downtown Nashville, Tennessee.

Following the explosion, the FBI worked closely with our law enforcement partners on a coordinated and comprehensive investigation. After recovering more than 3,000 pounds of evidence from the blast site, combing through more than 2,500 tips, and conducting more than 250 interviews, the investigative team has reached the following conclusions.

The investigation found that Anthony Quinn Warner of Antioch, Tennessee, acting alone, built and ultimately detonated the vehicle-borne improvised explosive device. His actions were determined to not be related to terrorism.

The investigative team took diligent steps to determine the reason or reasons why Warner decided to construct and ultimately detonate his device in downtown Nashville on December 25, 2020. The FBI's Behavioral Analysis Unit, based in Quantico, Virginia, further assisted the local investigative team in answering this question.

Based on analysis of the information and evidence gathered throughout the investigation, the FBI assesses Warner's detonation of the improvised explosive device was an intentional act in an effort to end his own life, driven in part by a totality of life stressors '' including paranoia, long-held individualized beliefs adopted from several eccentric conspiracy theories, and the loss of stabilizing anchors and deteriorating interpersonal relationships.

The FBI assesses Warner specifically chose the location and timing of the bombing so that it would be impactful, while still minimizing the likelihood of causing undue injury. The FBI's analysis did not reveal indications of a broader ideological motive to use violence to bring about social or political change, nor does it reveal indications of a specific personal grievance focused on individuals or entities in and around the location of the explosion.

It is important to note that only Warner knows the real reason why he detonated his explosive device. However, at this time, the FBI is confident, based on evidence collected, Warner's own writings, and interviews with those who knew him best, that the above assessment is accurate.

Special Agent in Charge Douglas Korneski of the FBI Memphis Field Office stated, ''The FBI would like to thank the citizens and private sector partners of Nashville, Tennessee, for their support during the response and investigation, especially those who provided tips and volunteered their time and resources. Additionally, the collaborative efforts of all local, state and federal agencies who responded to this incident, and the hundreds of hours dedicated by their men and women, were truly invaluable to this unified effort. They exemplified the tireless dedication we've come to expect from those who respond to these types of critical incidents.''

Resources by Agency

Federal Bureau of Investigation (FBI)

The FBI Memphis Field Office immediately responded with personnel in Nashville arriving on scene within the hour of the explosion. Assets from multiple field offices and headquarters components were quickly deployed, along with specialized evidence collection and communications equipment. In total, 277 Special Agents, Task Force Officers, Analysts, and Professional Staff responded. This included specialty units such as the Evidence Response Team, SWAT, Bomb Technicians, Crisis Negotiation, Behavioral Analysis, and Victim Assistance.

130 personnel responded from the FBI Memphis Field Office, augmented by 147 personnel from the following FBI field offices and headquarters components:

FBI Field Offices: AlbuquerqueAtlantaBaltimoreBirminghamCincinnatiClevelandDallasDenverDetroitIndianapolisJacksonKnoxvilleLittle RockLouisvilleMiamiNew OrleansPortlandSalt Lake CitySan FranciscoSt. LouisFBI Headquarters: Counterterrorism DivisionCritical Incident Response GroupLaboratory DivisionOffice of the General CounselOffice of Public AffairsOperational Technology DivisionVictim Services DivisionWeapons of Mass Destruction DirectorateU.S. Attorney's Office for the Middle District of Tennessee (USAO)

The U.S. Attorney's Office (USAO) provided significant support and deployed Assistant U.S. Attorneys, intelligence and research personnel and legal support staff to the Command Center. USAO staff worked to provide legal guidance and issued legal process such as subpoenas and search warrants necessary to allow investigators to recover evidence and conduct a comprehensive investigation. USAO Public Affairs also worked with partner agencies to coordinate and manage the flow of information to the media and the community as details from the investigation emerged.

Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF)

The National Response Team (NRT) which was comprised of 40 members including Certified Fire Investigators and Certified Explosives Specialists focused on the processing of explosives at the scene. The NRT was supported by subject matter experts from the National Center for Explosives Training and Research (NCETR) and the U.S. Bomb Data Center both located in Huntsville, Alabama. Due to the extent of the scene the ATF mobile command vehicle was on site to provide additional support both from the communications as well as analytical perspectives. Additional ATF resources included explosives canines, representatives to ESF-13 and ESF-15 as well as the behavioral analysis unit. ATF public and governmental affairs consistently worked with the partnering agencies focusing on the media and congressional inquiries. Finally, the ATF Nashville Field Division had over 60 personnel both onsite and offsite working this incident.

National Response Team mobile truckExplosives Canine Teams: 2Mobile Command Vehicle with personnelSupport and Subject Matter Experts (SME) from the National Center for Explosives Training and Research (NCETR)Analytical and intelligence support from the United States Bomb Data CenterATF representative to the Behavior Analysis Unit (BAU)Analytical and intelligence support from the Nashville Intelligence unitPublic and governmental affairs resources both onsite and from ATF HQ levelATF representative from ESF-13 Law EnforcementATF representative from ESF-15 CommunicationsNashville Field Division: Approximately 60 personnel both onsite and offsiteDepartment of Justice

Department of Justice Counterterrorism Section (CTS) deployed staff from Washington, D.C. alongside FBI personnel. CTS staffed the FBI command post in Nashville and worked with the U.S. Attorney's Office for the Middle District of Tennessee throughout the investigation.

Metro Nashville Police Department (MNPD)

Six MNPD personnel from the Central Precinct, a sergeant and five officers, were on the scene when the RV exploded at 6:30 a.m. on December 25, 2020. The response from the MNPD grew exponentially in the minutes and hours following the blast. Hazardous Devices Unit (HDU) officers, who were en route to 2nd Avenue prior to the explosion, started to lockdown the inner perimeter surrounding the actual blast site. All 10 HDU officers responded to the scene and began coordinating initial sweeps of the downtown area looking for any secondary devices with assistance from explosive detection canine teams from the MNPD & Tennessee Highway Patrol. Additional police personnel were requested to expand the perimeter to the interstate with assistance from the Tennessee Highway Patrol. Tennessee Task Force 2 Urban Search & Rescue personnel from the Metropolitan Police & Fire Departments responded to assist any persons trapped by the explosion (thankfully, no one was found). Specialized Investigations Division personnel began work at intelligence gathering to determine if the bombing was part of a larger criminal act.

The response command structure was divided into 6 elements on Christmas morning, with resources assigned to each:Overall Command (based at Nissan Stadium)Unified Command (based at the Emergency Operations Center)Staging & Logistics BranchTraffic BranchSpecial Operations Division/Urban Search & Rescue BranchSecurity BranchThirty-two (32) traffic posts were established to secure the area. As days passed, the number of traffic posts declined as the perimeter shrank and businesses were allowed to reopen.More than 500 MNPD personnel were part of the response to this incident between December 25 and December 29, 2020.Tennessee Highway Patrol (THP)

Commissioner Jeff Long and Tennessee Highway Patrol Colonel Matt Perry immediately called the department into action once notified of the bombing and the Tennessee Department of Safety and Homeland Security sent a rotation of troopers and agents to assist with the investigation and security of Nashville after the bombing.

Tennessee Highway Patrol (THP) troopers staffed perimeters, intersections, flew aviation details and cleared downtown buildings with EOD K-9s.The THP's Criminal Investigation Division worked with local, state and federal agencies to help identify a 17-digit number from parts and pieces of the bombed vehicle. That 17-digit number was used to build and identify a vehicle identification number (VIN) with the National Insurance Crime Bureau (NICB).The Tennessee Office of Homeland Security had agents that responded to the command post and coordinated with multiple local, state and federal partners along with the Tennessee Fusion Center during the investigation.43 Troopers worked 658.5 hours on the Nashville Explosion.Tennessee Bureau of Investigation (TBI)

In support of the FBI-led effort, the Tennessee Bureau of Investigation provided key technical support and expertise in the aftermath of the Nashville bombing. In total, TBI personnel provided 680 hours of work to this investigation, across several divisions:

12 TBI Special Agent/Forensic Scientists, assigned to a variety of disciplines, provided a combined 64 hours of work to support efforts to identify and document evidence in the case, including identification of the suspect's vehicle, specialized photography, fiber analysis, and the DNA process and review that resulted in the confirmation of the suspect's identity.13 TBI Special Agents, assigned to the TBI's Criminal Investigation Division, provided investigative support in the aftermath of the bombing, conducted interviews, vetted leads, and gathered and reviewed preliminary video footage of the incident.Intelligence Analysts and Special Agents from TBI's Criminal Intelligence Unit and its Technical Services Unit, assigned to either the FBI Joint Terrorism Task Force and Joint CyberCrime Task Force, provided direct support to the investigation, vetted cyber leads and secured and reviewed digital evidence, including relevant cell phone records.In the immediate aftermath, Agents assigned to TBI's Aviation Unit deployed to use the Bureau's aircraft and drones to assist in documenting the bombing site, blast radius, and search for potential victims.

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Sun, 21 Mar 2021 12:04

What to KnowAllegations of bullying by Gov. Andrew Cuomo were again suggested after new audio was released of a phone call from 2018 The governor does not remember making the threat and "was clearly being hyperbolic," a spokesperson for Cuomo told NBC New YorkThe audio surfaced as a second current aide to the governor made accusations of Cuomo acting inappropriatelyNew audio obtained by NBC New York of a reported 2018 phone call between Gov. Andrew Cuomo and leaders of the Working Families Party displays what critics say is another example of the New York leader's penchant for hostility.

Near the end of February, The New York Times reported on a phone conversation where Cuomo used stark language in response to the progressive group's decision to back him in the then upcoming general election as a better alternative to Republican Marc Molinaro.

"If you ever say, 'Well he's better than a Republican' again, then I'm gonna say, 'You're better than a child rapist.' How about that?" Cuomo is heard saying on the call, obtained late Friday by NBC New York.

''Governor, I apologize, but I gotta clarify one thing,'' the leader of the Working Families Party is heard responding to the governor on the call. ''You're free to say whatever you want, governor, but I just want to be clear. Our line is going to be that we have differences with you, but our differences with Republicans are far greater.''

As the governor continues to face political pressure to resign, it appears his public support is slipping as well, with a new poll showing a lower percentage of New Yorkers wanting Cuomo to stay in office than a different poll showed just two weeks ago. NBC New York's Jonathan Dienst reports.

The snippet of the 2018 call was first made public on Friday, almost a month after the Times reported the outburst and the governor's spokespeople denied the reporting. The Times first shared the audio in an episode of The Daily podcast that aired Friday morning.

Rich Azzopardi, a regular spokesperson for the governor, says Cuomo doesn't remember the exchange.

"This three-year-old conversation happened after a very contentious political campaign where things were charged on all sides. He doesn't remember it occurring, but from how it has been described he was clearly being hyperbolic to illustrate the offensive nature of the WFP's own name calling," Azzopardi told NBC New York.

New York City Mayor Bill de Blasio did not seem surprised about what the governor was heard saying, saying it's a toxic attitude that has gone too far.

"That's what I've seen playing out now, but it's all behavior we've seen different versions of before that has gotten worse and worse," de Blasio said.

The audio surfaced as a second current aide to the governor made accusations of Cuomo acting inappropriately. The New York Times reported late Friday that Alyssa McGrath accused the governor of "ogling her body, remarking on her looks, and making suggestive comments to her and another woman in his office."

McGrath's accusations come after an unnamed aide accused the governor of groping her when they were alone late last year, The Times Union of Albany reported last week. McGrath, who is the first current aide whose name was made public, told The New York Times the unnamed aide described the alleged encounter with her after it went public last week.

The 33-year-old McGrath claims the governor told her co-worker not to talk to McGrath about the incident. The two reportedly work closely and often with one another. McGrath's own account, as described in the report, paints her own picture of sexual harassment while supporting claims made by her co-worker.

Another woman - this time a current aide in the Governor's Mansion - has accused him of sexual harassment. Andrew Siff reports.

McGrath has not accused Cuomo of making inappropriate contact, but described exchanges with the governor that she described as sexual harassment. She claims the governor is known for "mixing flirtatious banter with more personal comments." A lawyer for the governor reportedly told the Times he often greets men and women with hugs and kisses and "uses Italian phrases like 'ciao Bella.'"

"The governor's deflections are not credible," McGrath's lawyer, Mariann Wang, told NBC New York. "This was not just friendly banter. Ms. McGrath understands the common phrase "ciao Bella." As she herself says: "I would not call my parents to find out what that phrase means. I know what that phrase means."

McGrath also detailed an alleged exchange between herself, the governor and her co-worker last year on the Saturday before the state's first confirmed case of COVID-19 when the two women were asked to work over the weekend at the mansion. She claims the governor asked if McGrath was going to "mingle" with any men at an upcoming work trip to Florida and that, for the rest of the day, he referred to both women as "mingle mamas."

McGrath is the eighth woman to allege the governor acted inappropriately around her. As investigations into those allegations continue, the FBI is looking into claims of a numbers cover-up regarding the administration's reporting of nursing home COVID death numbers last year. The FBI may also be looking into how the administration helped get a provision into last year's budget that gave nursing home operators immunity from COVID-related lawsuits.

De Blasio, a frequent Cuomo critic even before the allegations, said nursing home operators were big donors to the governor.

A request for comment has been sent to Gov. Cuomo's legal counsel.

"We did speak about the budget, it was fine," Stewart-Cousins said. "People of New York expect us to do that and that's where we are focused."

New York Attorney General Tish James made her first on-camera public comments Monday on the independent investigation into the governor.

"The investigation is ongoing. We are still interviewing witnesses. Other than that, not more to report other than it will continue," she said.

Cuomo's aides insist the governor is cooperating with investigations and focused on his job, an assertion confirmed by state Senate Leader Andrea Stewart-Cousins who, despite calling on Cuomo to resign, said she is communicating with the governor.

"We did speak about the budget - it was fine," Stewart-Cousins said Monday. "People of New York expect us to do that and that's where we are focused."

Meanwhile, polling suggests that while Cuomo's support slipped following the allegation of groping at the Executive Mansion, his political base hasn't abandoned him.

A Quinnipiac University poll of 905 registered voters found that while 43 percent believe he should resign, 36 percent of women polled said he should quit and nearly a quarter of Democrats in the state wanted him to resign. Just under half of respondents (49 percent) said they did not want Cuomo to step down, according to the poll.

Among respondents of all political affiliations, 36m percent said Cuomo should be impeached and removed from office. The poll was conducted before McGrath's allegations were made public.

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Sat, 20 Mar 2021 13:35

This hour-long documentary provides an in-depth look at Dr. Anthony Fauci's life story and career. Informative and engaging on-camera interviews with some of Dr. Fauci's colleagues and friends, including Dr. John Gallin, Dr. Michael Osterholm, and medical historian Victoria Harden, offer insight into his career and family life, while the compelling images and videos archived by the Associated Press give an expansive view of the true depth and breadth of his contributions and service to this country and the world. This program sheds light on the many battles fought, challenges overcome, and significant discoveries made during Fauci's esteemed career.

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Sat, 20 Mar 2021 13:12

This hour-long documentary provides an in-depth look at Dr. Anthony Fauci's life story and career. Informative and engaging on-camera interviews with some of Dr. Fauci's colleagues and friends, including Dr. John Gallin, Dr. Michael Osterholm, and medical historian Victoria Harden, offer insight into his career and family life, while the compelling images and videos archived by the Associated Press give an expansive view of the true depth and breadth of his contributions and service to this country and the world. This program sheds light on the many battles fought, challenges overcome, and significant discoveries made during Fauci's esteemed career.

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Fri, 19 Mar 2021 16:23

March 18, 2021 2021-03-19T10:31:51-04:00 https://images.c-span.org/Files/bf3/1616165707.jpg Secretary of State Antony Blinken and National Security Advisor Jake Sullivan meet in Alaska with Chinese Foreign Minister and State Councilor Wang Yi and Yang Jiechi, director of the Central Foreign Affairs Commission of the Chinese Communist Party.Secretary of State Antony Blinken and National Security Advisor Jake Sullivan meet in Alaska with Chinese Foreign Minister and State Councilor Wang Yi and Yang Jiechi, director of the Central Foreign Affairs Commission of the Chinese Communist Party.

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Fri, 19 Mar 2021 13:29

JustABuzz : @TrumpJew2 @adamcurry 'President Harris' ðŸ‚

Fri Mar 19 10:03:31 +0000 2021

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Fri, 19 Mar 2021 13:21

/ France Issued on: 17/03/2021 - 17:29

This picture from May 31, 2020 shows a closed restaurant in Paris during the first coronavirus lockdown. (C) Bertrand Guay, AFP The French government will impose tougher restrictions for some regions including Paris from this weekend to counter the accelerating spread of COVID-19 infections, spokesman Gabriel Attal said on Wednesday after a cabinet meeting.

The announcement paves the way for new curbs in the greater Paris region, where intensive care wards are full and the hospital system is buckling with an incident rate of more than 400 cases per 100,000 inhabitants.

Attal said the new measures for Paris could include some form of lockdown. Weekend lockdowns have already been imposed on top of a nationwide nightly curfew along parts of the Mediterranean Riviera and some areas of the north.

President Emmanuel Macron had hoped a vaccination drive could stave off a new pandemic wave triggered by more contagious variants, and prevent France from resorting to more measures that risk slowing the economy and cooping up citizens.

That approach is now being tested. The vaccine rollout has been slowed by an onerous European Union procurement process, supply difficulties, public scepticism and, most recently, the suspension of vaccinations using AstraZeneca shots in more than a dozen EU states including France.

00:36

Macron on Wednesday defended the EU COVID-19 vaccine strategy and said that within a few months Europe would be among the regions producing the most doses.

"We are living through the hardest weeks now. We know it," Macron said after welcoming Poland's prime minister at the Elysee Palace.

The new restrictions will be announced by the prime minister on Thursday. They will not include school closures, Attal said.

The head of public hospitals in Paris earlier warned that the virus was running amok in the capital and surrounding departments, an area that accounts for about a third of economic activity.

"The virus is not under control," Martin Hirsch said.

(REUTERS)

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Fri, 19 Mar 2021 13:11

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Fri, 19 Mar 2021 09:42

TINA TURNER bids a final farewell to her fans in a touching new film that shows how she has overcome her painful past and finally found happiness.

In the feature-length documentary, simply titled Tina, the singer looks back on camera for the first time at her younger years filled with struggle and pain, then the true love and global fame she found as a middle-aged woman.

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Tina Turner performing in 1964 Credit: Michael Ochs Archives - GettyNow 81 and plagued by ill health, including a stroke and cancer, the soul and rock music legend also suffered kidney failure which led to a transplant in 2017.

In the film she tells how she wants to enter the third and final chapter of her life out of the spotlight, and it is revealed that she has a form of post-traumatic stress disorder from the domestic abuse she suffered at the hands of her first husband and music partner, Ike Turner.

Looking back, Tina reflects: ''It wasn't a good life. The good did not balance the bad.

''I had an abusive life, there's no other way to tell the story. It's a reality. It's a truth. That's what you've got, so you have to accept it.

'I SHOULD BE PROUD'''Some people say the life that I lived and the performances that I gave, the appreciation, is blasting with the people. And yeah, I should be proud of that. I am.

''But when do you stop being proud? I mean, when do you, how do you bow out slowly? Just go away?''

In the documentary, which airs on Sky this month, Tina is seen for the first time talking with the man who finally brought her happiness, her second husband, Erwin Bach.

The couple make a farewell trip to the US for the Broadway premiere of her stage show, The Tina Turner Story, and Erwin, 65, reveals on camera: ''She said, 'I'm going to America to say goodbye to my American fans and I'll wrap it up'. And I think this documentary and the play, this is it '-- it's a closure.''

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Tina wows fans at Wembley Arena in 2001 Credit: Getty - ContributorThe details of Tina's life have been chronicled before, first in her 1986 autobiography, I, Tina, and in the 1993 biopic What's Love Got To Do With It? with Angela Bassett as Tina.

But Tina has always been loath to discuss them on camera until now. This documentary will have been painful to make, but is a parting gift to her global army of fans.

She is bringing down the curtain on a career which saw her sell more than 100million records, and at her peak in the Eighties sell out arenas around the globe.

Tina was born Anna Mae Bullock, and her childhood was filled with poverty and misery, picking cotton in the fields around Nutbush, Tennessee.

'MOM WAS NOT KIND...SHE DIDN'T LIKE ME'Her mother, Zelma, suffered domestic abuse at the hands of her father, Floyd Bullock, before they both abandoned her as a child. Even when Tina was reunited with her mother when she was a superstar, Zelma was cold and unloving.

Tina says in the documentary: ''Mom was not kind. When I became a star, of course back then she was happy because I bought her a house. I did all kinds of things for her, she was my mother.

''I was trying to make her comfortable because she didn't have a husband, she was alone, but she still didn't like me.

''Even after I became Tina, Ma was still a little bit like, 'Who did that?' and 'Who did this?' And I said, 'I did that, Mom!' I was happy to show my mother what I did. I had a house, I had got a car, and she said, 'No, I don't believe it. No, you're my daughter, no you didn't!'

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Tina with first hubby Ike in the 1960s Credit: Michael Ochs Archives - Getty''She didn't want me, she didn't want to be around me, even though she wanted my success. But I did for her as if she loved me.''

This childhood filled with cruelty and violence may explain why Tina initially seemed to accept the mental and physical torture she put up with after she married Ike in 1962.

The marriage saw Anna Mae Bullock reborn as Tina Turner, in a duo who would become soul stars for almost three decades.

Her new name was so important to her that when she finally found the will to start divorce proceedings against Ike in 1976 '-- after years of beatings and psychological torture '-- it was all she asked to take from their stormy union.

'IT'S LIKE A CURSE'Leaving him was made harder by the fact that they had a son, Ronnie, and she adopted two of Ike's children, Ike Jr and Michael, from his previous relationship. She already had a son, Craig, from a previous relationship.

Erwin tells the programme she still has nightmares about those dark days and is suffering from something similar to the post-traumatic stress disorder that cripples battle victims.

He says: ''She has dreams about it, they're not pleasant. It's like when soldiers come back from the war. It's not an easy time to have those in your memory and then try to forget.''

Tina, who first tried to escape from Ike with a sleeping pill overdose in 1968, admits: ''That scene comes back. You're dreaming it. The real picture is there, it's like a curse.''

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The legend with her second husband Erwin in 2005 Credit: Rex FeaturesBut the greatest antidote to the trauma is forgiveness, and she claims to be at peace with Ike, who died of an accidental drug overdose in 2007.

Tina says: ''For a long time I did hate Ike, I have to say that. But then, after he died, I really realised that he was an ill person. He did get me started and he was good to me in the beginning. So I have some good thoughts. Maybe it was a good thing that I met him, that I don't know.

''It hurts to have to remember those times, but at a certain stage forgiveness takes over, forgiving means not having to hold on.

''It was letting go, because it only hurts you. By not forgiving, you suffer, because you think about it over and over. And for what?''

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Tina in the farewell film to her fans Credit: Altitude Film Entertainment / SkIn the Eighties Tina reinvented herself as a solo artist. With hit albums such as Private Dancer and Break Every Rule, she joined the pantheon of global music icons.

She even became a film star, appearing with Mel Gibson in the 1985 action movie Mad Max: Beyond Thunderdome.

Her career has seen her win a dozen Grammys Awards, get a star on the Hollywood Walk of Fame and become the first black artist and first woman to appear on the cover of Rolling Stone magazine.

But in 1986 '-- at the peak of her fame '-- she was incredibly lonely.

'HE WAS SO GOOD LOOKING. MY HEART WENT BA-BUM'That all changed when she met German record producer Erwin while visiting Europe. She was 46 and he was 30, but it was love at first sight '-- though they didn't marry until 2013.

Tina recalls: ''He had the prettiest face. It was like, 'Where did he come from?' He was so good looking. My heart went ba-bum. It means that a soul has met. When he found out that I liked him he came to America and we were in Nashville and I said to him, 'When you come to LA I want you to make love to me'.

''I thought that I could say that because I was a free woman, I didn't have a boyfriend, I liked him.

''There was nothing wrong with it '-- it was just sex. And he looked at me as if he didn't believe what he was hearing.

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Ike and Tina with boys, clockwise from bottom left, Michael, Ike Jr, Craig and Ronnie in around 1972 Credit: Getty - Contributor''He was just so different, so laid back, so comfortable, so unpre- tentious, and that was the beginning of our relationship.''

As love blossomed, Tina started to wind up her recording career, making her last album in 1999, aged 59. She gave her final performance in 2009.

Last year, aged 80, she briefly returned to recording, collaborating with producer Kygo on a dance reinvention of her 1984 anthem, What's Love Got To Do With It.

The documentary also explores how originally she was deeply unsure about recording the song '-- which went on to be her only US solo No1 '-- as it was a pop track first recorded by British Eurovision winners Bucks Fizz.

'HE WILL ALWAYS BE MY BABY'Nowadays Tina spends most of her time in Switzerland with Erwin, where she lives permanently, having renounced her US citizenship.

But she has still known trauma in her life. In 2018 her son Craig committed suicide in Los Angeles, and after she scattered his ashes off the California coast, she said: ''My saddest moment as a mother. He was 59 when he died so tragically, but he will always be my baby.''

Her most recent illness led to her kidney transplant, with Erwin as the donor. It was a risky process for such an elderly couple, but an inevitability, given that they remain madly in love.

Erwin says: ''It's something we both have for each other. I always refer to it as an electrical charge. I still have it.''

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Tina dueting with Mick Jagger in 1985 Credit: Rex FeaturesBefore the operation, Tina had been so ill that she was considering assisted suicide '-- which is legal in Switzerland, where she now has full citizenship.

She joined the assisted-suicide organisation Exit, and recalled in a book three years ago: ''It wasn't my idea of life but the toxins in my body had started taking over. I couldn't eat.

''I was surviving, but not living. I began to think about death. If my kidneys were going, and it was time for me to die, I could accept that, it was OK. When it's time, it's really time.''

The new documentary gives a glimpse inside the couple's beautiful house on the edge of Lake Zurich.

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Turner with Mick Jagger in 1985 Credit: Rex PICKING SIDESAngelina Jolie's son Maddox, 19, 'testified against Brad' in custody battle

WEIGHT JOSSJacqueline Jossa shows off impressive 8lb weight loss modelling clothing range

JOLLY MOLLIEMollie King sizzles in racy lingerie as she reunites with fiance Stuart Broad

FIGHTING SPIRITSarah Harding reveals she wants 'FFS' to be written on her gravestone

'part of me'Katie Price fans convinced she's pregnant after she holds 'bump' in new post

MAGIC NUMBERLove Island's Megan Barton-Hanson boasts of sex SIX times in a day

Filled with homely furniture, flower arrangements and ornaments, it looks a million miles from the dusty tracks of Tennessee or the glitzy homes of Tinseltown.

But there is also a wall filled with gold discs and shelves covered with awards '-- a reminder that Tina will always be a star, in or out of the spotlight.

Tina is on Sky Documentaries, Now TV and via altitude.film on March 28.ANNA MAE'S WAY TO TOP

1939: Born Anna Mae Bullock in Brownsville, Tennessee

1950: Mother abandons her, father had already left

1957: Tina sees Ike Turner play at a club in Illinois and months later sings with his band

1958: Makes first recording, under the name Little Ann. Dates saxophonist Raymond Hill and has a son, Craig

1960: Begins dating Ike and they create the duo, Ike and Tina Turner. They have a son, Ronnie, and marry in 1962

1966: Biggest UK success with the single, River Deep '' Mountain High, produced by Phil Spector

1967: First female and black artist on the cover of Rolling Stone magazine

1971: The duo create another anthem with their cover version of Proud Mary

1976: Leaves Ike and divorces him two years later

1983: Reinvents herself as a rock and pop star and a year later has a US No1 with What's Love Got To Do With It

1985: Stars in Mad Max: Beyond Thunderdome

1986: Gets a star on the Hollywood Walk of Fame and meets future husband Erwin Bach

1991: Inducted into the Rock & Roll Hall of Fame with Ike

1995: Moves to Switzerland with Erwin

2009: Retires after 50th anniversary tour

2013: Marries Erwin

Aberdeen residents create hilarious Tina Turner tribute video to encourage donations to foodbankGOT a story? RING The Sun on 0207 782 4104 or WHATSAPP on 07423720250 or EMAIL exclusive@the-sun.co.uk

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Thu, 18 Mar 2021 20:55

HET VERZET : @EchteSuperjan @adamcurry https://t.co/sZgNmN2LTX

Thu Mar 18 18:37:02 +0000 2021

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Thu, 18 Mar 2021 20:54

Dini De Visser : @EchteSuperjan @adamcurry Kijk hier even naar en volgens mij zijn alle vaccins doodeng. https://t.co/13rbnU0Rrk

Thu Mar 18 18:51:14 +0000 2021

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Thu, 18 Mar 2021 20:52

Jordan Schachtel : Real life doctor versus government bureaucrat doctor. Goes as expected. KO. This clip is incredible. https://t.co/y7250oWtb9

Thu Mar 18 15:33:32 +0000 2021

SmallCapUnderdog : @JordanSchachtel The video content is no longer available. Do not challenge Fauci!

Thu Mar 18 20:24:13 +0000 2021

D Meyer : @JordanSchachtel Listen, I'm as anti Fauci/anti mask/pro vaccine safety, as they come, his rebuttal wasn't ridiculo'... https://t.co/vacYPCF9zB

Thu Mar 18 19:49:07 +0000 2021

McHaley : @JordanSchachtel Twerps who think Fauci is their loving Grandpa, get real. "Anthony Fauci, you are a murderer becau'... https://t.co/0gonnREXNW

Thu Mar 18 19:35:30 +0000 2021

ɟɥnɹ'¾Æ† 'š¸ðŸ--‘ : @JordanSchachtel Not the first time he cornered Fauci in his own lies. Watch him pretending that T-cell immunity do'... https://t.co/vPkKm9f6cT

Thu Mar 18 19:34:59 +0000 2021

Conserv Rebelation : @JordanSchachtel The masks you are wearing are completely worthless air is being expelled from all around it and th'... https://t.co/4IyD2hOxWp

Thu Mar 18 19:32:25 +0000 2021

McHaley : @JordanSchachtel Remind Fauci of his track record in the 1980's killing people with AZT -a known lethal, chemo drug'... https://t.co/ci95ycG10r

Thu Mar 18 19:30:54 +0000 2021

Conserv Rebelation : @JordanSchachtel In the study they did in South Africa they found out which they knew all the time that hydroxychlo'... https://t.co/VnVUKXjClm

Thu Mar 18 19:28:11 +0000 2021

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Sun, 21 Mar 2021 11:52

Cerebral venous sinus thrombosis led to a halt to Astrazeneca's vaccine in many countries. But what exactly are these thromboses? And was the emergency halt of the vaccine too hasty?

For safety reasons, vaccination with the Oxford vaccine from AstraZeneca has been suspended in many countries until further notice. For Germany, this decision was made on March 15 by Health Minister Jens Spahn.

Why? Seven cases of a rare thrombosis, all within a short time of vaccination, had been reported to Germany's vaccine regulatory authority, the Paul-Ehrlich-Institute (PEI). Three of them ended fatally for those affected.

This is what is known so far about the connection between the vaccine and thrombosis.

Blood clotting in the brain: What exactly was observed?So far, seven cases of so-called Cerebral venous sinus thrombosis (CVST) have occurred in 1.6 million people vaccinated with AstraZeneca. At the same time, the affected individuals were also found to be deficient in platelets, which can affect blood clotting.

In CVST, a blood clot clogs the veins in the brain that are normally the route oxygen-depleted blood takes to drain to the heart. However, if the blood can no longer drain properly, the pressure in the brain increases and further bleeding can occur there. In the worst case, CVST leads to fatal strokes.

However, this type of thrombosis is considered rather rare, looking at its incidence: It is estimated that two to five people per 1 million experience CVST over the course of a year. However, recent studies indicate a higher number of people affected. As many as 15.7 cases per million people per year have been reported in an Australian study, says Paul Hunter, professor of medicine at the University of East Anglia. That would mean the current incidence is underestimated by four to eight times, according to Hunter.

Does thrombosis always equal thrombosis?Since the announcement of the vaccination suspension, there has been much discussion. Especially on social media, there were many angry responses: Why is the contraception pill still prescribed, even though it is known that roughly 1,100 women will suffer thrombosis among every 1 million who take it. In comparison: Why do authorities throw the entire vaccination strategy out the window after only seven cases of thrombosis in 1.6 million vaccinated people?

SPD health expert Karl Lauterbach criticized this comparison in an interview with German public radio Deutschlandfunk. CVST is not comparable in severity to thromboses caused by the pill, he argued.

When people talk about thrombosis in connection with the contraceptive pill, they are usually referring to leg vein thrombosis. In this case, blood clots clog the veins in the legs and, if they break loose, can travel to the lungs and cause an embolism.

But that is not the entire truth: Taking the pill also increases the risk of the more dangerous CVST. "Women are affected more often than men, and hormones probably play a role. In late pregnancy, in the puerperium and in women taking the contraceptive pill, we see CVST most frequently," Peter Berlit, secretary-general of the German Society for Neurology, told DW. Regardless of gender, younger people are generally affected more often than older people, he said.

Is the vaccination pause justified?Spahn's decision to pause vaccine distribution is, of course, no coincidence. He is referring to a recommendation by the PEI, which tests vaccines and medicines for safety in Germany. And the PEI said in a press release that it "recommends the temporary suspension of vaccinations with the COVID-19 vaccine AstraZeneca after intensive consultations on the serious thrombotic events that have occurred in Germany and Europe."

Lauterbach said in the Deutschlandfunk interview that he thought a link between the vaccination and the thrombosis cases was quite likely. Nevertheless, in his opinion, that was not a good enough reason to suspend the vaccinations: "I would not have decided it that way based on the same data," he continued.

Berlit, who teaches at the University of Duisburg-Essen, also has a hard time with the authorities' decision. "At the moment, from a purely statistical point of view, there are more arguments against a connection than for a connection."

Thus, the current number of cases would still be in the range of the previously known incidence for CVST without vaccinations.

There's still a problem with the comparison, though: Typically, statisticians look at CVST over a full year. The cases associated with vaccinations, however, have all occurred since February of this year. But Berlit has a possible explanation for this, too. "It is known that CVST can also occur frequently in connection with infections. Of course, infections occur more frequently in the seasons of weather change, such as spring and fall. And therefore CVST are also more frequent," he explains.

Researchers have long observed that COVID-19 infections, for example, also lead to more frequent thrombosis. This is presumably due to the fact that in the case of COVID-19, our immune system upregulates a certain defense mechanism that influences blood clotting and can thus lead to more thromboses.

Vaccination strategy: Which decision is the right one?Berlit considers speculation that active ingredients in the vaccine could trigger thrombosis in a similar way to COVID-19 to be speculative. "This is all hypothetical. So far, there are no indications of this. This accumulation has so far only occurred in Germany and not, for example, in England," he says.

The British are largely unimpressed by the current developments '-- with vaccinations continuing there. With 11 million doses administered, only three people have been reported as experiencing CVST.

Hunter, of the University of East Anglia, argues that a possible link needs to be investigated more closely. But he adds that one should also consider the real harm that could be done by delaying vaccination in the face of rising infection rates in Europe.

The European Medicines Agency (EMA) is currently investigating the reported cases in more detail. However, it too sees no reason for AstraZeneca to pause just yet. While its investigations are ongoing, the EMA stated that the benefits of AstraZeneca's vaccine in containing COVID-19 and its associated risks outweigh the side effects. Results are expected within the next two weeks.

"Whether it's the right decision to completely stop giving the vaccine now for the time being, that's more of a political discussion now," Berlit says. "I think the risk of serious neurological complications from COVID-19 infection is statistically higher than from vaccination. Actually, all the data point in that direction."

What should vaccinated individuals be aware of?Those who have already received vaccination with AstraZeneca's vaccine should watch out for the following symptoms, according to Berlit: "People who have persistent and very severe headaches within the first 2-3 weeks after vaccination need to get further evaluation." Similarly, pinpoint-shaped hemorrhages in the skin along with the headache may indicate CVST.

This article was translated from German

Researchers and their self-experiments An oral vaccination against coronavirusCourage, curiosity or complete hubris? It's probably a mixture of all these things that causes many scientists to test their own inventions on themselves first. According to the Global Times, a Chinese doctor not only developed an oral vaccine against the SARS-CoV-2 but also tried it out himself. So far, he hasn't seen any side effects.

Researchers and their self-experiments Laughing-gas party with Humphry Scientific knowledge and private pleasure can go hand in hand. The British chemist Sir Humphry Davy experimented with nitrous oxide between 1795 and 1798. With the help of his self-experiments, he discovered not only the pain-relieving effect of the gas but also its intoxicating qualities.

Researchers and their self-experiments Discoverer of UV radiationThe German physicist Johann Wilhelm Ritter not only discovered ultraviolet radiation in 1801, but also invented the first battery the following year. Ritter was also interested in galvanism '-- a term applied to muscle contractions caused by electric shocks. The fact that he died at the age of 33 is said to have been due in part to the galvanic self-experiments with which he maltreated his body.

Researchers and their self-experiments Freud on cocaineThe Austrian psychologist and doctor Sigmund Freud is known as the founder of psychoanalysis. His methods are still used, discussed and criticized today. Less well known is that Freud researched the effects of cocaine during his time as a doctor at the Vienna General Hospital. Published letters show that Freud himself consumed coke for a long time and in large quantities.

Researchers and their self-experiments Death from yellow fever"I believe that I am on the trail of the true pathogen," wrote the American physician Jesse Lazear on September 8, 1900, in a letter to his wife. Lazear researched malaria and yellow fever. He confirmed that the latter is transmitted by mosquitoes. To study the disease, he intentionally allowed himself to be stung, fell ill and died 17 days after writing the letter. Lazear was only 34 years old.

Researchers and their self-experiments The fastest man on earthJohn Paul Stapp became known as the "fastest man on earth" because of his research on the effects of acceleration forces on the human body '-- including his own: He had himself accelerated on a so-called rocket sled up to more than 1,000 kph (621 mph) and decelerated completely in 1.4 seconds. It is the highest acceleration that a human being has ever voluntarily withstood.

Researchers and their self-experiments Secret heart catheterWerner Forssmann was already considered a troublemaker during his medical training. The German surgeon was determined to prove that a long, flexible catheter could be inserted safely from the crook of the arm to the heart. Although his superiors had expressly forbidden him to carry out the experiment, in 1929 Forssmann was the first person to try it out '-- on himself. Secretly, of course.

Researchers and their self-experiments Nobel Prize winner '-- posthumouslyThe Canadian physician Ralph Steinman fell ill with pancreatic cancer and underwent an immunotherapy he developed himself. According to his physician, this therapy was unable to prevent Steinman's death, but '-- contrary to the prognosis '-- could possibly have prolonged his life by over four years. Steinman died in 2011, a few days before the Nobel Prize was awarded, which he received posthumously.

Author: Julia Vergin (fs)

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Sat, 20 Mar 2021 13:06

Even with airtight forensics and an admission from a former federal agent involved in some of the illegal surveillance, hope for accountability in the case of the government spying on me and my family fades further.

The judge has dismissed the case against two of the defendants: Rod Rosenstein and Shawn Henry.

The court agreed on a variety of fronts with the Department of Justice attorneys defending the pair, who have fought mightily for years, defending the guilty agents rather than holding them accountable: Too much time has passed since the crimes. The venue is wrong. The defendants enjoy immunity.

And, in short, the court is telling us we must prove who, precisely, did which acts where'-- before we are entitled to discovery that would show us who, precisely, did which act where.

As one federal judge who previously agreed with our side said: It's ''Kafkaesque'' and circular reasoning that makes accountability impossible.

I went into this years ago wrongly believing if one has proof (we've proven the government illegally surveilled my computers) there would be immediate accountability.

When the Department of Justice covered up instead of holding its agents accountable, I wrongly believed the proof could be presented to court and the case would, by default, be won.

For years, with the help of a tireless legal team and Fourth Amendment advocates, I have pursued a very expensive case against the Department of Justice and the responsible agents. They use unlimited taxpayer money to make sure my case doesn't succeed.

I have since learned that all the proof in the world, a half dozen independent forensics exams, and even an admission by a guilty party, are not enough to pierce the tilted justice system when powerful interests want a case to go away.

Since I filed my case some years ago, there have been countless other well documented examples of our Justice Department and its personnel breaking rules, laws, and failing to serve the public interest. The surveillance abuses have been confirmed by both Democrat and Republican investigators, as well as the Foreign Intelligence Surveillance Court. They are no longer theoretical.

Read more about the case here.

I firmly believe if the Department of Justice had been forced to properly handle the outrageous incidents of spying on me'-- and hundreds of others unnamed citizens and journalists who didn't have the forensic contacts and connections to obtain proof that I was lucky enough to have'-- we might have been able to prevent the government surveillance abuses that happened post-2014, and likely continue today.

Instead, the government has been given the green light to illegally spy on any journalist, citizen, political figure, judge'-- you name it'-- and there is no way for the ones who are intruded upon to hold the guilty parties accountable.

The guilty parties are, unfortunately, the ones who get to decide justice.

What's left?

There are still claims possible against remaining defendants in my case, but no reason to think that the outcome will be different. My legal team will be deciding the next step soon.

Two years ago this month, Judge James Wynn of the U.S. Court of Appeals commented (in a dissenting opinion that supported my case):

Not only should we disapprove of the tactics the government used to run out the clock on Attkisson's claims, but we should also reject the troubling ''game plan'' it provided for the government and private parties to prevent disclosure of'--and, therefore, responsibility for'--their potentially unconstitutional or illegal electronic surveillance activities...

Beginning in the late 1960s, when the University of North Carolina Tar Heels seized the lead in the second half of a basketball game, Hall of Fame head coach Dean Smith would raise his arm and put up four fingers. Requiring no further instruction, two post players would run to the two corners of the court formed by the baseline and the sidelines, and two wing players would move to the corners formed by the mid-court line and the sidelines. The point guard'--most famously, Phil Ford'--would then dribble the ball at the top of the key as the clock ticked down, occasionally exchanging the ball with one of the wing or post players if the defense applied too much pressure. In this offense'--commonly referred to as the ''Four Corners'''--the clock was the Tar Heels' best friend. The longer the Tar Heels held the ball on offense, the less time their opponent had to try to score and cut into the Tar Heels' lead. The Four Corners proved so successful that college basketball's powers-that-be effectively outlawed it through the adoption of the shot clock in 1985. In this case, the government'--not unlike Dean Smith's Tar Heels'--put up the ''fours'' when Plaintiff-Appellant Sharyl Attkisson, a journalist formerly employed by CBS News, filed suit against unnamed employees and agents of the federal government (the ''Doe Defendants'').

Attkisson alleged that the Doe Defendants conspired to violate her constitutional and statutory rights by accessing and commandeering her home and work internet-connected devices for surveillance purposes. But Attkisson never got a meaningful opportunity to pursue her claims because the government did everything in its power to run out the clock on Attkisson's action'--it filed motions challenging venue and jurisdiction, motions challenging the sufficiency of service, motions for extension of time, motions to dismiss, and motions for protective orders. And just as the Tar Heels had great success running the Four Corners, the government's strategy worked. Although Attkisson diligently sought to identify the Doe Defendants for nearly four years'--including by repeatedly serving discovery on the government and third-parties directed at identifying the Doe Defendants'--the district court dismissed her case with prejudice against the Doe Defendants for failing to comply with a court order to identify the names of the Doe Defendants by a date certain. The district court did so even though the government's delaying tactics deprived Attkisson of any meaningful opportunity to engage in the discovery necessary to identify the Doe Defendants.

Judge James Andrew Wynn, U.S. Court of AppealsSupport Attkisson v. DOJ and FBI

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Sun, 21 Mar 2021 11:48

Transmitting antennas are seen on a cellphone network relay mast in Vertou, near Nantes in France. /Reuters/Stephane Mahe

Transmitting antennas are seen on a cellphone network relay mast in Vertou, near Nantes in France. /Reuters/Stephane Mahe

The latest generation of smartphones using 5G technology can interfere with aircraft altitude instruments and compromise flight safety, the French Civil Aviation Authority warned on Tuesday, saying the devices should be turned off completely during flight or put on "airplane mode."

Altimeters measure how close an aircraft is to the ground, a function that makes these instruments "extremely critical during landing," as the regulator, known by its French acronym DGAC, described them.

5G technology uses a bandwidth which is apparently dangerously close to the frequencies used for air navigation, a proximity that could potentially cause altimeters to record the wrong altitude. Such errors at landing, when altimeters are key to the safety of the operation, could lead to fatal accidents.

Terminal 2 and the control tower of the Roissy Charles-de-Gaulle Airport, north of Paris, where the deployment of 5G was slowed down while regulators studied the impact of the new networks on air navigation. /Joel Saget/AFP

Terminal 2 and the control tower of the Roissy Charles-de-Gaulle Airport, north of Paris, where the deployment of 5G was slowed down while regulators studied the impact of the new networks on air navigation. /Joel Saget/AFP

The road to introduce the new wireless networks has been filled with mistrust and setbacks, amid conspiracy theories that falsely linked it to the spread of COVID-19 and real concerns that it could interfere with weather readings.

The issue of 5G potentially interfering with aircraft altimeters was initially raised in France in November last year, when the deployment of 5G around Nice airport and Paris-Charles de Gaulle was slowed down while regulators assessed its impact on flights.

The French regulator has now outlined the conditions for safely installing 5G networks while limiting the risk of interference with aircraft altitude instruments during landing, with the strength of signals from 5G base stations placed around airports being restricted.

Regulators continue to study how the new technology interacts with aircraft instruments in the National Frequency Agency (ANFR).

Cover image: Zoltan Mathe / MTI via AP

Source(s): AFP