THE MAGA-MAN DONALD TRUMP

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MARKETWATCH

"Trump lashes out amid pandemic at medical research that’s discordant with his views"


By Associated Press

Published: May 22, 2020 at 5:36 p.m. ET

WASHINGTON (AP) — “A Trump-enemy statement,” he said of one study.

Of another: “A political hit job.”

As President Donald Trump pushes to reopen the country despite warnings from doctors about the consequences of moving too quickly during the coronavirus crisis, he has been lashing out at scientists whose conclusions he doesn’t like, while it’s been reported that the Republican Party has been trawling for “extremely pro-Trump” doctors to go on television and express support for Trump’s preferred quick opening of the economy rather than abiding by the cautionary recommendations of mainline public health experts.


Twice this week, Trump has not only dismissed the findings of studies but suggested — without evidence — that their authors were motivated by politics and out to undermine his efforts to roll back coronavirus restrictions.

First it was a study funded in part by his own government’s National Institutes of Health that raised alarms about the use of hydroxychloroquine, finding higher overall mortality in coronavirus patients who took the drug while in Veterans Administration hospitals.

Trump and many of his allies had been touting the drug as a miracle cure, and Trump this week revealed that he has been taking it to try to ward off the virus — despite an FDA warning last month that it should only be used in hospital settings or clinical trials because of the risk of serious side effects, including life-threatening heart problems.


The Lancet, one of the world’s oldest and most well-respected medical journals, published a new study Friday that echoed those findings.

“If you look at the one survey, the only bad survey, they were giving it to people that were in very bad shape."

"They were very old, almost dead,” Trump told reporters Tuesday.

“It was a Trump-enemy statement.”


Trump offered similar pushback Thursday to a new study from Columbia University’s Mailman School of Public Health.

It found that more than 61% of COVID-19 infections and 55% of reported deaths — nearly 36,000 people — could have been been prevented had social distancing measures been put in place one week sooner.

Trump has repeatedly defended his administration’s handling of the virus in the face of persistent criticism that he acted too slowly.

“Columbia’s an institution that’s very liberal,” Trump told reporters Thursday.

“I think it’s just a political hit job, [if] you want to know the truth.”

Trump has long been skeptical of mainstream science — dismissing human-made climate change as a “hoax,” suggesting that noise from wind turbines causes cancer and claiming that exercise can deplete a body’s finite amount of energy.

It’s part of a larger skepticism of expertise and backlash against “elites” that has become increasingly popular among Trump’s base.

But undermining Americans’ trust in the integrity and objectivity of scientists is especially dangerous during a pandemic when the public is relying on its leaders to develop policies based on the best available information, said Larry Gostin, a Georgetown University law professor who is an expert in public health.

“We have every right to expect that our leaders will use the best science to keep us safe and protect us,” Gostin said.

“And so the idea that you reject objective scientific information that could inform policies that have life or death consequences is unfathomable.”

The White House rejected that thinking, noting that Trump has followed his administration’s public health officials’ recommendations through much of the crisis.

“Any suggestion that the president does not value scientific data or the important work of scientists is patently false as evidenced by the many data-driven decision he has made to address the COVID-19 pandemic, including cutting off travel early from highly infected populations, expediting vaccine development, issuing the 15-day and later 30-day guidance to ‘slow the spread,’ and providing governors with a clear, safe road map to opening up America again,” White House spokesman Judd Deere said.

Yet Trump has made clear that, at least when it comes to hydroxychloroquine, he has prioritized anecdotal evidence, including a letter he told reporters he’d received from a doctor in Westchester County in New York claiming success with the drug.

Asked this week what evidence he had that the drug was effective in preventing COVID-19 — contrary to FDA guidance — Trump responded: “Are you ready?"

"Here’s my evidence: I get a lot of positive calls about it.”

“The only negative I’ve heard,” he added, “was the study where they gave it — was it the VA? — with, you know, people that aren’t big Trump fans.”

There is no evidence that the study, funded by grants from the NIH and the University of Virginia, was influenced by anyone’s opinions about Trump.


The retrospective analysis was conducted by researchers at several universities and looked at the impact of hydroxychloroquine in patients at veterans’ hospitals across the nation.

It found no benefit and more deaths among those given hydroxychloroquine versus standard care alone.

That work was posted online for researchers and has not been reviewed by other scientists, but a larger observational study that looked at the outcomes of nearly 100,000 patients in 671 hospitals on six continents published Friday sounded similar alarms.

The Columbia study, in draft form, also hasn’t yet been published or reviewed by other experts.

The researchers ran numbers through a mathematical model, making assumptions about how quickly the coronavirus spreads and how people behave in hypothetical circumstances.

Trump’s criticism of the studies also comes as his allies have been eager to counter messaging from public health experts who say Trump is putting lives at risk by pushing states to quickly reopen in an election year.

Republican political operatives have been recruiting pro-Trump doctors to go on television to advocate for reviving the U.S. economy as quickly as possible, without waiting to meet federal safety benchmarks.

Gostin said Trump should leave it to his public health agencies to assess emerging data and the value of various studies.

“I think there are real dangers,” he said, “for the president to play scientist and doctor on TV.”

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Re: THE MAGA-MAN DONALD TRUMP

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MARKETWATCH

"Hydroxychloroquine, touted by Trump, associated with higher risk of death in study"


By Jaimy Lee

Published: May 22, 2020 at 2:08 p.m. ET

An observational study published Friday in The Lancet and examining 96,032 COVID-19 patients in 671 hospitals across six continents concluded that hydroxychloroquine and chloroquine had no benefit on outcomes while those patients were in the hospital.

The therapies are associated with ventricular arrhythmias and mortality in COVID-19 patients taking them while in the hospital.

"These findings suggest that these drug regimens should not be used outside of clinical trials and urgent confirmation from randomised clinical trials is needed," the researchers wrote.

The drugs, which are approved by the Food and Drug Administration to treat malaria, lupus, and rheumatoid arthritis, were granted emergency authorization during the pandemic and have been regularly touted by President Donald Trump, who said this week that he had been taking hydroxychloroquine.

A number of clinical trials are underway evaluating the medications as both a treatment or a prophylactic for those at high-risk of contracting the virus.

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Re: THE MAGA-MAN DONALD TRUMP

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MARKETWATCH

"Poll finds many Americans wary of taking coronavirus vaccine: report"


By Mike Murphy

Published: May 21, 2020 at 9:15 p.m. ET

Less than two-thirds of Americans are "very" or "somewhat" interested in getting a COVID-19 vaccine if one becomes available, according to a Reuters/Ipsos poll released Thursday.

About a quarter of those surveyed had little or no interest in taking a vaccine, Reuters reported, and more than 40% said the vaccine could be riskier than the disease.

That's a disturbing number, as medical experts say about 70% of the population would need to be immune, either through vaccine or by fending off a previous infection, for herd immunity to prevent the further spread of the coronavirus.

The poll also found a troubling gap in credibility.

While 29% of those "not very" interested in a vaccine said they would be more interested if it had FDA approval, 36% of overall respondents said they would be less inclined to take a vaccine if President Donald Trump said it's safe to do so, according to Reuters.


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Re: THE MAGA-MAN DONALD TRUMP

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THE HILL

"The Hill interview: Fauci on why a vaccine by end of year is 'aspirational'"


Reid Wilson

22 MAY 2020

The nation's top infectious disease expert said Friday that an aggressive investment into the development and production of a vaccine against the coronavirus might make it possible to distribute millions of doses as the year comes to a close.

In an interview with The Hill, Anthony Fauci, the director of the National Institute for Allergy and Infectious Diseases (NIAID), urged caution and said the rapid development of a safe and effective vaccine was not guaranteed.

But he said the government was taking the unprecedented step of beginning production on promising vaccine candidates even before they are proven, a financial risk that would shave months off a typical development schedule.


"In the standard way you develop a vaccine, you do not make major investments in the next step until you are fairly sure that the prior step works and you are satisfied with it," he said.

"If you jump ahead and at least prepare and make investments, for example preparing sites for trial and even beginning to produce vaccine before you even know it's safe and effective, then you're taking a risk, and the risk is a financial risk, it's not a safety risk," Fauci said.

"If you do that, you can cut down by several months the process of getting vaccines available as opposed to waiting until you're fairly sure everything works and then beginning for example manufacturing the doses," he said.

Fauci did add a note of caution: Vaccine candidates, even promising ones, fail more often than they succeed.

The number of "shots on goal," Fauci's preferred metaphor, is meant to boost the odds of developing a vaccine that works, and lasts.

"Any time you develop a vaccine, you always remember, you always have a question that you may not get an effective vaccine."

"Even if you do everything right and you do everything on time, there's no guarantee you're going to have an effective vaccine."

"So when we talk about having a vaccine that might be available in December or January, that's assuming that the vaccine is actually effective," he said.


More than 100 potential vaccine candidates are being tested in laboratories around the globe.

The federal government has identified a handful it sees as the most promising, and it plans to invest in producing those vaccines as phase three trials begin in the coming weeks and months.

Fauci said he was "fairly certain" that if production is started this summer and ramped up, "you could have 100 million doses by the end of the year and maybe a couple of hundred million doses by the beginning of next year."

"I mean that's aspirational," he said.

"The companies think that they can do that with the right financial backing."

President Trump has dubbed the effort "Operation Warp Speed" - and such a fast timetable would certainly set a record for the speed at which a novel vaccine had been developed.

Fauci said he did not love the name of the program or an implication that the process would not follow the rigorous scientific and safety steps needed to ensure a drug doesn't do more harm than good.

"I'm a little concerned by that name because it can imply by warp speed that you're going so fast that you're skipping over important steps and are not paying enough attention to safety, which is absolutely not the case," he said.


"But in this program of hastening the development of the vaccine, it's something that we do feel actually is feasible to get the kinds of doses that you would need."

Developing the vaccine is only the beginning of what will prove to be a heavy logistical lift.

The U.S. government is busy collecting the associated products that it would need to distribute that vaccine across the country - the vials to transport it, the syringes to hold it, the needles to inject it.

To manage the logistical supply chain, the Trump administration has tapped Gen. Gustave Perna, a four-star general who runs the U.S. Army Materiel Command.

Fauci declined to comment on President Trump's decision to take hydroxychloroquine, a drug that studies show is actually associated with higher death rates among those who take it.

A study released Friday in The Lancet, found patients who took the drug were at risk of abnormal heartbeats that could lead to cardiac arrest.

Fauci said he has been routinely tested for the coronavirus.

He tested negative as recently as Thursday.

He warned that states will face a rise in the number of coronavirus cases they see as they seek to reopen their economies, and he said states could keep those resurgent outbreaks to a manageable level if they build both the testing capacity and the contact tracing armies necessary to conduct robust surveillance to identify and isolate those who have been infected.

"It is prudent for states who are at various levels of infection to follow the guidelines that have come out about reopening or opening America again."

"And that is to get past the gateway criteria and then go into the various phases at the rates that are prescribed by the guidelines."

"Obviously if some states don't do that, there is always a risk that you may have a resurgence," Fauci said.

As the national death toll surges past 95,000, Fauci said the future course the virus takes depends on the country's ability to strangle it at local levels.

"One of the things that is going to be important is that as we open up and try to get back to some degree of normality and pull back on the mitigation, is what is our capability?" he sad.

"And I hope it's intact."

"I believe it is in certain areas."

"What is our capability of being able to respond to the inevitable blips that you will see when you pull back on mitigation, and the workforce that can do it to be able to identify, isolate and contact trace."

"If we have that in place and it's good, then there will not be a significantly larger number of infections."

"If we don't handle that well, we could have even more infections than the models are projecting," he said.

He said one model he had quoted had projected between 100,000 and 240,000 deaths.

"Hopefully it doesn't get significantly more than that, but that will depend on how well we respond to the inevitable rebounds that you will see as you pull back," he said.

"If you respond well, you may keep that number relatively low."

Fauci, who has led NIAID under six presidents for nearly 40 years, has become more visible during the coronavirus outbreak than in any of the previous outbreaks he has helped manage.

His likeness has appeared on t-shirts and bobbleheads, and Brad Pitt played him on "Saturday Night Live" after Fauci's off-handed casting advice.

But he has also become the target of President Trump's ire, at times clashing with the White House for offering assessments that are more dire than what the administration would like to claim.

The hashtag #FireFauci has appeared on social media.

Despite the newfound stardom, Fauci said he will keep trying to stay out of politics - but that he is not surprised that a government response to a virus would become so politicized.

"I try to dissociate myself from that, and do what I've done all along, is to try and give the best public health advice and guidance based on data, based on science and based on evidence," he said.

"I've always done that and I've successfully been able to stay out of some of the political whirlwind that happens all the time," he said.

"I'm not surprised this is a political situation."

"It happens, I mean it isn't the first time that it's happened, but I try to dissociate myself with that."

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Re: THE MAGA-MAN DONALD TRUMP

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HuffPost

"Hillary Clinton Puts Donald Trump On Notice Over His Coronavirus Drug Advice"


Lee Moran

23 MAY 2020

Hillary Clinton has made it crystal clear what she thinks of President Donald Trump’s hyping of unproven treatments for the coronavirus.

Trump in recent weeks has repeatedly promoted the use of the anti-malarial drug hydroxychloroquine as a potential cure or treatment for COVID-19, contrary to the advice of the Food and Drug Administration and other government agencies that have warned against its use.

He’s even claimed he’s been taking it himself as protection against the virus.

Clinton called out Trump on Friday, tweeting “the president needs to stop playing a doctor on TV.”

The former secretary of state shared reporting from The Washington Post on a new analysis that discovered that taking the drug is ”linked to increased risk of death in coronavirus patients.”

A study of 96,000 coronavirus patients found that those who received a drug Trump has promoted as a treatment had a “significantly higher risk of death compared with those who did not.”

The president needs to stop playing a doctor on TV.https://t.co/0bimpU2WXG
— Hillary Clinton (@HillaryClinton) May 22, 2020

It was Clinton’s latest in a long line of attacks on Trump’s fumbled response to the pandemic that has now killed more than 97,000 people nationwide.

On Monday, Trump’s Democratic rival in the 2016 election tweeted that “Americans deserve a president who will listen to science and act decisively to mitigate the pandemic ― not waste time, peddle fakes cures, and wish it away.”

Americans deserve a president who will listen to science and act decisively to mitigate the pandemic—not waste time, peddle fake cures, and wish it away. https://t.co/NDxCZYGroS
— Hillary Clinton (@HillaryClinton) May 18, 2020

In March, as cases soared worldwide, Clinton hit Trump on his favorite social media platform for “turning to racist rhetoric to distract from his failures to take the coronavirus seriously early on.”

She also advised Americans not to take medical advice “from a man who looked directly at a solar eclipse” and has repeatedly urged people to vote Trump out in November.

Please do not take medical advice from a man who looked directly at a solar eclipse.
— Hillary Clinton (@HillaryClinton) March 24, 2020

The president is turning to racist rhetoric to distract from his failures to take the coronavirus seriously early on, make tests widely available, and adequately prepare the country for a period of crisis.

Don't fall for it. Don't let your friends and family fall for it.
— Hillary Clinton (@HillaryClinton) March 18, 2020

This article originally appeared on HuffPost.

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Re: THE MAGA-MAN DONALD TRUMP

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GOOD, BECAUSE IT KEEPS THAT MORON OUT OF THE WAY WHERE HE BELONGS ...

THE HILL

"Biden slams Trump in new ad: 'The death toll is still rising.' 'The president is playing golf'"


J. Edward Moreno

24 MAY 2020

Former Vice President Joe Biden released a political attack ad against President Trump Saturday, slamming his decision to play golf on Memorial Day Weekend amid an ever-rising death toll due to the coronavirus in the United States.

The 30-second video shows Trump playing golf at his Virginia club Saturday.

The footage is interspersed with what appears to be frontline healthcare workers walking into hospital rooms, administering COVID-19 tests at drive-thrus and interacting with patients on stretchers.

There also appears to be a small red bar graph increasing in size as the number of coronavirus-related deaths hovers close to 100,000.

"The death toll is still rising," the ad read.

"The president is playing golf."

Nearly 100,000 lives have been lost, and tens of millions are out of work.

Meanwhile, the president spent his day golfing. pic.twitter.com/H1BVNtgVjA
- Joe Biden (@JoeBiden) May 24, 2020

As of Saturday afternoon, the U.S. has recorded 1.6 million confirmed cases of the virus and 96,983 deaths from the disease, according to data compiled by Johns Hopkins University.

The ad released Saturday night is just the latest push from Biden, the presumptive Democratic nominee, framing the president's response to the crisis as inadequate.

Earlier this month, the Biden campaign released an ad accusing the president of mishandling the public health crisis and the economic fallout it caused by failing to implement mitigation measures early on in the outbreak.

"Donald Trump didn't build a great economy."

"His failure to lead destroyed one," that ad said.

The Trump campaign has also begun using to ramp up attacks against the former vice president, highlighting what the president's camp says is Biden's "friendly" stance on China.

At one point the president said China is "desperate" for Biden to win the election.


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Re: THE MAGA-MAN DONALD TRUMP

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FOX NEWS

"Trump says Biden 'not mentally sharp enough' to be POTUS: 'He doesn't know he's alive'"


Ronn Blitzer

24 MAY 2020

President Trump declined to offer any positive words toward his presumptive presidential challenger Joe Biden Sunday when he was asked to state just one meritorious quality of the former vice president who is expected to be on November's ballot.

When asked during a Sunday interview with WJLA what Biden’s strongest feature was as a political opponent, Trump noted that he could have said experience but explained why he did not think it was appropriate.

“Well, I would have said experience, but he doesn't really have experience because I don't think he remembers what he did yesterday,” Trump said.

“So how is that experience?"

"He's been there a long time."

"He was never known as a smart person.”

Host Sharyl Attkisson then again asked Trump to “pick one good thing,” and Trump simply said, “Ah,” without giving an answer.

When asked for Biden’s weakest point, Trump had plenty to say but claimed to have trouble coming up with one in particular.

“I can't tell you,” Trump said.

“I mean, I'm really serious."

"He's got many."

"I can talk about weak points all day long.”

The president then started by saying that Biden is “not mentally sharp enough to be president.”

He then went on to say that the former vice president has problems with China and Russia, but then jumped back to attacking Biden’s intellect.

“Biden doesn't know, I mean, he doesn't know he's alive,” Trump continued.

“I'm against somebody."

"Think of it."

"I'm against somebody that can’t answer simple questions."

"I've never seen anything like it, but here's what I am against."

"I'm against a very powerful party, the Democrats, and they can take this glass of water and say that's your candidate.”

Biden went on the attack against Trump Friday when he posted a campaign ad that claimed the president “froze like a deer in the headlights” when the coronavirus outbreak hit the U.S.

The ad called Trump “unprepared,” “indecisive,” and “paralyzed by his fear of offending the Chinese government.”

The ads are the latest from the Biden campaign and allied super PACs that criticize the president for initially downplaying the severity of the coronavirus outbreak and for fumbling the federal response to the pandemic.

The president, defending his record, has repeatedly pointed to his ban on non-U.S. citizens from flying from China to the U.S., which was implemented on Feb. 2.

Fox News’ Paul Steinhauser and Allie Raffa contributed to this report.

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USA TODAY

"In race for coronavirus vaccine, will Operation Warp Speed focus the work or politicize it?"


Elizabeth Weise, USA TODAY

25 MAY 2020

Four months into one of the largest medical emergencies in United States history, President Donald Trump announced a goal to develop 300 million doses of COVID-19 vaccine by January, enough to protect most Americans.

Charged with this task was Operation Warp Speed, a newly-created program to tie together all major U.S. federal, medical and oversight entities, and the military, into one massive coordinated push for a vaccine and treatments.

However, how the operation functions, its budget, what power it has and what resources it controls have either not been determined or not been made public, a puzzlement to public health and vaccine policy experts.

The hope is that Operation Warp Speed will provide crucial coordination between government entities, create clear lines of responsibility and control, streamline funding and focus work, speeding the timeline.

The fear is it might politicize scientific and logistical processes under an administration that has at times been disdainful of science and its experts, potentially slowing work on a vaccine.

"We just need to ensure that decisions are made thoughtfully and in an apolitical manner so as to not undermine the existing structures and expertise in place to keep vaccines safe," said Lois Privor-Dumm, policy director at the International Vaccine Access Center at Johns Hopkins Bloomberg School of Public Health.


The creation of the project underscores the president's penchant for keeping a firm grip on the experts and bureaucrats coordinating his response, even as he has battled publicly with Health and Human Services Secretary Alex Azar, Centers for Disease Control and Prevention director Robert Redfield and others.

Experts agree facilitation is necessary to bring the combined might of the U.S. academic, medical and pharmaceutical realms to bear on creating a COVID-19 vaccine — the prerequisite for life to return to normal.

That oversight must come from outside the existing agencies, said Dr. Margaret Hamburg, current foreign secretary for the U.S. National Academy of Medicine and the commissioner of the U.S. Food and Drug Administration from 2009 to 2015.

“Any one agency can’t direct sister agencies to do things, can’t knock heads together as required, can’t rise above to see what the landscape looks like and make sure all the different components are being adequately utilized and held accountable,” she said.

Many questions, so far few answers

A week in, the operation made its first announcement — as much as $1.2 billion had been pledged to accelerate a possible vaccine developed at the University of Oxford in England and licensed by AstraZeneca.

Azar called the contract “a major milestone in Operation Warp Speed’s work toward a safe, effective, widely available vaccine by 2021.”

Yet as an example of the lack of transparency, few details about the deal are available beyond those in a news release issued Thursday.

The agreement was with the United States' Biomedical Advanced Research and Development Authority (BARDA), one of the federal programs whose COVID-19 responsibilities now seem to be under the wing of the operation.

Whether the actual agreement was coordinated or organized through Warp Speed wasn’t clarified.

Emails and calls to Health and Human Services were not answered.

Operation Warp Speed does not appear to have its own media contact.

The White House did not answer questions about reports Trump's son-in-law and senior adviser Jared Kushner and his top trade and manufacturing adviser Peter Navarro are helping to lead the effort.

Both have promoted partnerships between government and private industry to address challenges facing the nation.

Neither has prior experience with public health crises.


Who's in charge

What is known about the framework and leadership of the program comes from a release posted on the HHS website on May 15 and a news conference held with Trump in the White House Rose Garden the same day.

There he introduced Warp Speed’s chief advisor, Moncef Slaoui, an expert in molecular biology and immunology who has spent his career developing vaccines and working in pharmaceutical companies.

On the logistics side will be four-star Army General Gustave Perna who will serve as the chief operating officer.

Perna is the commanding general at U.S. Army Materiel Command in Huntsville, Alabama.

Slaoui and Perna may make a great team because Slaoui understands complex research ecosystems and Perna knows how to galvanize big operations and deal with logistical concerns, said Hamburg.

“I just hope the politicians will get out of the way and let them do their work,” she said.

One worry is Slaoui's lack of government experience, said Dr. Andrew Pavia, chief of pediatric infectious diseases at the University of Utah School of Medicine.

Anything that involves all of government has many pieces that need to mesh smoothly.

That’s difficult even for somebody with years of government leadership experience, said Pavia, who has served on the board of the Infectious Disease Society of America and as a member of the National Vaccine Advisory Committee.

Coming from industry, Pavia fears Slaoui may not have a deep understanding of how BARDA, CDC, the FDA, the National Institutes of Health and the Department of Defense work together.

“He is smart and capable but there needs to be a clear set of guidelines in government."

"That has often not been the case,” he said.

14 vaccines winnowed to 8

Warp Speed has so far identified 14 COVID-19 vaccine possibilities.

It will select the eight most promising and provide coordinated government support for their development and testing in early stage small clinical trials.

Large-scale randomized trials will proceed in three to five of them.

As of Thursday, four vaccine coronavirus candidates had received major funding by the U.S. government:

BARDA's up to $1.2 billion for early access to 300 million doses of British drugmaker AstraZeneca's experimental COVID-19 vaccine

Johnson and Johnson through its Janssen Pharmaceutical subsidiary has gotten at least $456 million in coronavirus vaccine funding from the Office of the Assistant Secretary for Preparedness and Response

Moderna received more than $483 million from BARDA

Sanofi has received at least $30 million from BARDA

Whether these four that have been funded represent the semi-finalists is not known.

Operation Warp Speed appears to have access to substantial resources.

Congress has directed almost $10 billion through supplemental funding, including the CARES Act.

In addition, over $6.5 billion was designated for countermeasure development through BARDA and $3 billion for NIH research.

How Warp Speed fits into those agencies usual distribution systems isn’t known.

Will it have the ability to designate which contracts are signed or which projects are funded, or will it merely make suggestions?

The list of institutions involved in the operation includes almost every medical entity within the federal government, including the FDA, CDC, NIH and BARDA as well as DoD, private firms and other federal agencies, including the Department of Agriculture, the Department of Energy, and the Department of Veterans Affairs.

Given the vast number of bureaucratic and organization systems these represent, how “in charge” Slaoui will be is of concern to some.

His role is officially “chief advisor,” said Dr. Harvey Fineberg, an expert on health policy and vaccines, current president of the non-profit Gordon and Betty Moore Foundation and former president of the National Academy of Medicine.

He called the appointment a solid step in the direction of creating a unified command structure but noted that Slaoui’s scope of authority and range of responsibility are unclear.

“Is he advisor to the president, to the vice president, to the secretary of Health and Human Services or to whom?"

"Ulysses Grant was not ‘chief advisor' to President Lincoln; he was general-in-chief and commander of the Union Army,” said Fineberg.

Listening to scientists

There is also concern over the ability of the Warp Speed program to avoid bureaucratic quagmires in the midst of an effort that will require the work of some of the top minds in science.

“You need to recruit the best and brightest in the field and give them some flexibility to act on their own initiative."

"We have to trust them to find the best way to get from A to B and not micromanage,” said Kendall Hoyt, a professor at the Geisel School of Medicine at Dartmouth College where she studies biomedical research and development strategy.

Trump in his speech introducing Operation Warp Speed likened it to World War II's Manhattan Project, which brought together military, public and private organizations to create the atomic bomb.

Warp Speed will be run by a mix of scientists, regulators and the military, with the presumption that only the U.S. military will have the capability to rapidly distribute and deploy a vaccine or vaccines once they are available.

When the project was announced last week, the vaccine development portion of the operation was to be overseen by Dr. Peter Marks, who directs the FDA's Center for Drug Evaluation and Research.

As of Friday he has transitioned out of that role and back to the FDA after helping to set up the initial infrastructure for Operation Warp Speed, FDA said.

On the Department of Defense vaccine side, Dr. Matt Hepburn, project lead for the office for Chemical, Biological Radiological and Nuclear Defense, will be the subject matter expert.

How the program will interface with the White House Coronavirus Task Force, led by Vice President Mike Pence, is not entirely clear.

Ideally, Warp Speed will leverage expertise that has gone underutilized during the epidemic, say some experts.

What about the CDC?

Historically, the public health face of a crisis of this magnitude would have been the CDC, but it has largely been sidelined in coronavirus.

Last weekend Navarro, director of the Office of Trade and Manufacturing Policy and Trump's coordinator on the use of the National Defense Production Act, leveled scathing criticisms at the CDC on NBC News’ “Meet the Press.”


This troubles observers.

“They have thousands of person-years of expertise and it seems that they’ve been marginalized,” said Glenn Melnick, a professor of health economics at the University of Southern California.

The agency that normally would have played a major role in developing a vaccine is HHS' Biomedical Advanced Research and Development Authority, created in 2006 under President George W. Bush to find and develop countermeasures to first bioterrorism and later epidemics and emerging diseases.

It had a political setback when its head of vaccines, Rick Bright, was removed from his position after he opposed the use of chloroquine and hydroxychloroquine – drugs touted by Trump and others in the administration – due to the serious risks associated with taking them.

Both CDC and BARDA are part of the White House Task Force and now Warp Speed, but have not played as large a role as they have in previous public health crises such as the H1N1 influenza, Ebola and Zika.

Under pressure

Also unanswered is how Operation Warp Speed will work with the at least two other large-scale public/private consortia created in the past three months to focus efforts on COVID-19 vaccine and treatments.

On April 17 the NIH launched the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership.

It includes biopharmaceutical companies, the HHS Office of the Assistant Secretary for Preparedness and Response, the CDC, the FDA and the European Medicines Agency.

Its stated goal is to coordinate regulatory processes, create a framework for prioritizing vaccine and drug candidates and streamline clinical trials.

On March 10 the COVID-19 Therapeutics Accelerator was launched by two of the world’s largest health non-profits, the Bill & Melinda Gates Foundation and England’s Wellcome Trust together with the Mastercard Impact Fund.

The Accelerator, with $125 million in seed funding, is committed to coordinating research and development efforts for COVID-19 therapies.

Most experts interviewed said they had hope for a vaccine and were pleased a high-level group was working to cut through red tape and speed the process as much as possible.

The note of caution they all raised was concern that pressure to have a vaccine ready to use within the president’s proposed timeline will either cause corners to be cut or make Americans worry that corners had be cut.

Either could contribute to distrust of vaccines overall.


“Any misstep risks eroding confidence in vaccines that could have lasting implications,” said Privor-Dumm at Johns Hopkins Bloomberg School of Public Health.

In the end, the ability to meet the Trump's desired deadline will depend on the biology of the virus as well as how much authority Slaoui is given and how much control he has over the resources available to him, said Fineberg.

“The first element for success is to establish a unified command structure,” he said.

“The appointments of Dr. Slaoui and General Perna are a step in this direction.”

This article originally appeared on USA TODAY: In race for coronavirus vaccine, will Operation Warp Speed focus the work or politicize it?

http://www.msn.com/en-us/news/politics/ ... &ocid=iehp
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Re: THE MAGA-MAN DONALD TRUMP

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BBC

"Coronavirus: WHO halts trials of hydroxychloroquine over safety fears"


25 May 2020

Testing of the malaria drug hydroxychloroquine as a possible treatment for coronavirus has been halted because of safety fears, the World Health Organization (WHO) says.

Trials in several countries are being "temporarily" suspended as a precaution, the agency said on Monday.

It comes after a recent medical study suggested the drug could increase the risk of patients dying from Covid-19.

President Donald Trump has said he has taken the drug to ward off the virus.

The US president has repeatedly promoted the anti-malarial drug, against medical advice and despite warnings from public health officials that it could cause heart problems.

Last week, a study in medical journal The Lancet said there were no benefits to treating coronavirus patients with hydroxychloroquine, and that taking it might even increase the number of deaths among those in hospital with the disease.

Hydroxychloroquine is safe for malaria, and conditions like lupus or arthritis, but no clinical trials have recommended its use for treating Covid-19.

The WHO, which is running clinical trials of various drugs to assess which might be beneficial in treating the disease, has previously raised concerns over reports of individuals self-medicating and causing themselves serious harm.

On Monday, officials at the UN health agency said hydroxychloroquine would be removed from those trials pending a safety assessment.

The Lancet study involved 96,000 coronavirus patients, nearly 15,000 of whom were given hydroxychloroquine - or a related form chloroquine - either alone or with an antibiotic.

The study found that the patients were more likely to die in hospital and develop heart rhythm complications than other Covid patients in a comparison group.

The death rates of the treated groups were: hydroxychloroquine 18%; chloroquine 16.4%; control group 9%.

Those treated with hydroxychloroquine or chloroquine in combination with antibiotics had an even higher death rate.


The researchers warned that hydroxychloroquine should not be used outside of clinical trials.

https://www.bbc.com/news/amp/health-52799120
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Re: THE MAGA-MAN DONALD TRUMP

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NPR

"WHO Halts Hydroxychloroquine Trial Over Safety Concerns"


Jason Beaubien

May 25, 2020·4:34 PM ET

The World Health Organization says it is temporarily halting its clinical trials that use hydroxychloroquine to treat COVID-19 patients over published concerns that the drug may do more harm than good.

The move comes after the medical journal The Lancet reported on Friday that patients getting hydroxychloroquine were dying at higher rates than other coronavirus patients.


The WHO has 3,500 patients from 17 countries enrolled in what it calls the Solidarity Trial.

This is an effort overseen by the WHO to find new treatments for COVID-19.

The patients in the trial have been randomly assigned to be treated with hydroxychloroquine which is a common malaria drug, or 3 other experimental drugs for treating COVID-19 in various combinations.

Only the hydroxychloroquine part of the trial is being put on hold.

"The review will consider data collected so far in the Solidarity Trial and in particular robust, randomized available data to adequately evaluate the potential benefits and harms from this drug [hydroxycholoroquine]," WHO Director General Tedros Adhanom Ghebreyesus said during an online press conference from Geneva on Monday.

The WHO's chief scientist, Soumya Swaminathan, says the review was prompted by the article in The Lancet, which was not a randomized control trial but still large.

"While it was still a reporting of observational data," Swaminathan says, distinguishing it from the gold-standard randomized controlled trial, "it came from multiple registries and quite a large number of patients, 96,000 patients."

She says the WHO hasn't yet seen data that showed a problem with hydroxychloroquine in its own study but The Lancet article raised questions among many of the investigators involved in the WHO's trial.

"The steering committee met over the weekend, in the light of this uncertainty," Swaminathan says.

"We decided we should be proactive, err on the side of caution and suspend enrollment temporarily into the hydroxychloroquine arm [of the Solidarity trial]."

President Trump has advocated for the use of hydroxychloroquine during the pandemic despite limited research into whether it is effective against the virus.

The president has said he's been taking hydroxychloroquine to protect against the virus.

The trials being put on hold by the WHO are investigating its use as a treatment for patients who are hospitalized with COVID-19, not as a drug to prevent the disease.

The review panel will also check on seven other studies globally including the Recovery Trial in the United Kingdom that are using hydroxychloroquine for COVID-19 patients to see if they are seeing similar problems.

Swaminathan says they expect to decide whether to resume testing hydroxychloroquine in the Solidarity Trial in a week or two.

https://www.npr.org/sections/coronaviru ... y-concerns
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