Tag Archives: covid

Four ways Trump has meddled in pandemic science — and why it matters

Giuliana Viglione, Nature: November 3, 2020


As the United States votes today on who will be its next president, Donald Trump’s response to the COVID-19 pandemic looms large. One issue that resonates with the research community is the extent to which the current president and his administration have meddled with science and scientific advice during the pandemic — often with disastrous results.

Last month, a coronavirus-crisis sub-committee within the US House of Representatives released a report documenting 47 instances in which government scientists had been sidelined or their recommendations altered. And the report notes that the frequency of meddling has been increasing in the lead-up to the US election.

“It’s hard to express how unbelievably demoralizing this experience has been,” says Diana Zuckerman, president of the National Center for Health Research, a non-profit organization in Washington DC.

If Trump wins a second term, researchers fear what that could mean for public health and the scientific enterprise. If Democratic challenger and former vice-president Joe Biden wins, he’ll have his work cut out for him to restore the reputation of the US science agencies that Trump has damaged.

Nature chronicles some of the most significant cases of meddling so far, and assesses their impact.

Scientists sidelined, silenced and ignored

At a campaign rally this week, Trump suggested that if he were re-elected, he would fire much-revered and long-standing infectious-disease expert Anthony Fauci, who has led the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), since 1984. Fauci has earned international acclaim as an adviser on HIV/AIDS to six US presidents, and is one of the most-cited researchers in the world.

This display follows a pattern of Trump attempting to silence and discredit Fauci throughout the pandemic: in May, in an unprecedented move, the administration blocked Fauci from testifying about the US pandemic response in front of the Democrat-led House of Representatives’ appropriations committee. “Never in my 30-plus years here in Washington do I recall ever a White House refusing to let an NIH expert testify before Congress,” says Zuckerman. The White House did not respond to Nature’s request for comment.

From cruise ships to asymptomatic spread: expert advice ignored

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But Trump’s treatment of Fauci is just one example of the administration’s willingness to sideline its world-famous experts and institutions. The Centers for Disease Control and Prevention (CDC) is a world-renowned health agency and typically plays a major role in tracking and responding to outbreaks. In previous crises, its scientists have issued advice and updates directly to the public through regular media briefings. But compared with previous global-health crises, experts at the CDC have been unusually quiet during the COVID-19 pandemic, according to an analysis by the Union of Concerned Scientists (UCS) that was issued in May.

The report found that during the current pandemic, the CDC has held a much smaller proportion of press events than usual. For instance, during the H1N1 pandemic in 2009, the CDC led all but 3 of the 35 press conferences in the first 13 weeks of the pandemic. In contrast, Trump led close to three-quarters of the 69 press events during the same period of the COVID-19 outbreak. CNN reported that the lack of press briefings by the CDC on the coronavirus was due to pressure from the White House. “It is concerning that the scientists that are doing this great work are unable to talk,” says Anita Desikan, a research analyst at the UCS’s Center for Science and Democracy. The CDC did not respond to Nature’s request for comment.

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In August, now-removed guidance appeared on the CDC’s website that stated that asymptomatic people no longer needed to be tested for the virus, counter to the recommendations of public-health experts. A senior CDC official told CNN that this guidance was issued “from the top down”; it was eventually reversed after public outcry. Officials outside the CDC have allegedly inserted their own documents on the CDC website in a move that Samuel Groseclose, a retired epidemiologist who spent 27 years at the agency, calls “bizarre”.

Revered public-health report delayed

The Trump administration has also attempted to meddle with a mainstay of the American public-health community: a weekly, peer-reviewed report that’s meant to facilitate the rapid release of epidemiological data. In September, Politico reported that political appointees in the Department of Health and Human Services, which oversees the CDC, had attempted to delay or halt the release of and retroactively edit the CDC’s Morbidity and Mortality Weekly Report (MMWR). Officials also demanded oversight before some results were published. The MMWR is “revered in the public-health community”, says Liz Borkowski, a public-health researcher at George Washington University in Washington DC, adding that she was “utterly horrified” to hear of the attempted meddling.

[….]

COVID treatments prematurely approved

Convalescent plasma, antibody-laden blood plasma from someone who survived COVID-19, was a promising treatment early in the pandemic. In August, the Trump administration leaned heavily on Food and Drug Administration (FDA) commissioner Stephen Hahn to issue an Emergency Use Authorization (EUA) for the treatment despite a lack of solid evidence that it helps people, as reported by The New York Times and The Washington Post. The FDA issued the EUA, making plasma available to a wide swath of the US population. But evidence from a clinical trial in India1, posted in September, suggests that the treatment has no effect on patient outcomes. Earlier in the pandemic, the agency had to revoke its authorization of hydroxychloroquine, which Trump had touted as a “game changer” for COVID-19, because it, too, was subsequently shown to be ineffectual at treating the disease.

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To many public-health experts, it is clear that the Trump administration’s persistent meddling is responsible for the disastrous way in which the pandemic has unfolded in the United States. “Some of it is probably real and some of it is probably supposition,” Georges Benjamin, the executive director of the American Public Health Association in Washington DC, says of the media reports about interference. “But at the end of the day, this has been one of the worst risk-communications processes that I’ve ever seen. And I think that’s tragic.”

doi: https://doi.org/10.1038/d41586-020-03035-4

References

  1. 1.

Agarwal, A. et al. Preprint at medRxiv https://doi.org/10.1101/2020.09.03.20187252 (2020).

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HEALTH CARE BRIEFING: FDA Vaccine Rules Challenged as Weak

Brandon Lee and Alex Ruoff, Bloomberg Government: October 23, 2020


U.S. vaccine advisers questioned whether safety and efficacy standards set by Food and Drug Administration officials were high enough to warrant emergency authorization of a shot.

About two dozen outside advisers to the FDA with expertise in infectious diseases met yesterday to weigh in on agency standards that require a vaccine to work in at least 50% of people and for drugmakers to collect two months of safety data on at least half of clinical trial volunteers.

“They haven’t gone far enough” in terms of safety, said Hayley Altman-Gans, a panel member and pediatrics professor at Stanford University Medical Center.

Many panel members and outside researchers who commented during the hearing worried that if a vaccine is rushed out that later turns out to have safety problems or to be less effective than promised, it could backfire in a big way, undermining public confidence in Covid-19 vaccines for years to come.

Several panel members expressed concern that the two-month safety follow-up the FDA is calling for before a vaccine gets an emergency authorization is simply not enough. In addition to safety, it means that doctors won’t know whether a vaccine’s efficacy could fade after just a few months.

Diana Zuckerman of the National Center for Health Research told the committee the vaccine trials “have serious design flaws.”

The trials are too geared to preventing mild infections, and may not show whether they prevent severe infections and hospitalizations, she said. Longer follow up may be especially important because some of the first vaccines, including messenger RNA vaccines from Pfizer and Moderna, are based on new technologies that have never been used in an approved product. 

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FDA Panel To Lay Regulatory Groundwork For COVID-19 Vaccine


Noel King and Sydney Lupkin, NPR: October 22, 2020


NOEL KING, HOST:

There are several COVID-19 vaccines in development. But before they are approved, they have to be safe. It’s the FDA’s job to ensure that. Today an FDA advisory panel is meeting for the first time about the coronavirus vaccine. It’ll be making recommendations based not on politically motivated timetables, but on data.

Sydney Lupkin covers the pharmaceutical industry for NPR. Good morning, Sydney.

SYDNEY LUPKIN, BYLINE: Good morning.

KING: So what is the deal with this FDA panel? Who’s on it? What are they going to be doing?

LUPKIN: Well, the FDA regularly turns to committees of outside advisers for guidance. Most often, these panels are asked to evaluate specific drugs or health products, and that helps the agency to decide whether to approve these products. Today’s meeting of the committee that looks at vaccines is going to be a little different.

KING: How?

LUPKIN: Like everything else in this pandemic, it’s a bit unusual. The big difference is that the committee isn’t going to be sifting through data for a specific coronavirus vaccine like it normally would. The meeting will be a broader discussion of how the agency should think about safety and effectiveness of these new kinds of vaccines, particularly safety. Dr. Paul Offit is a committee member who works at the Children’s Hospital of Philadelphia.

PAUL OFFIT: How robust should safety data be? How long, for example, after the first or second dose should patients be followed or participants be followed for any possible safety issue?

LUPKIN: They’ll be discussing FDA’s existing guidance to companies, which includes some of that information. They’ll also discuss how studies should continue after the first vaccine is given the green light. What do you do for patients who got a placebo once a vaccine is widely available? Of course, the FDA usually heeds the advice of these committees, but it doesn’t have to.

KING: So since there’s no vaccine to review, I would think that in ordinary times, we would not know about this meeting. It would not be news at all. It’s very clear that the FDA wants to make public that this is happening. Why do they want to do that?

LUPKIN: Well, I mean, it gives the American public a window into the process. There’s been so much discussion around whether the FDA will put politics ahead of science. So it’s important to see what’s going on. And the FDA has questions that it wants answers to. Here’s Dr. Miles Braun, a former FDA epidemiologist.

MILES BRAUN: There is a level of humility that the FDA is coming to its advisers with. And I think that’s a good thing. And if they find out they’ve missed some important things, they’ll address those.

LUPKIN: Committee members will hear presentations from scientists at the FDA, the Centers for Disease Control and Prevention and the Biomedical Advanced Research and Development Authority. The public will also have an opportunity to weigh in. Diana Zuckerman is the president of the National Center for Health Research, an advocacy group slated to speak.

DIANA ZUCKERMAN: We’ve seen the guidance of what they’re telling companies they’re supposed to be studying. Frankly, they’re not very stringent, so we are concerned about them.

LUPKIN: She hopes the meeting will delve into making sure the clinical trials are diverse, for example. She also questions whether the study approach the FDA suggested to manufacturers is long enough to assess vaccine safety.

[…]

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FDA Promises Strong Safety Standards for Covid-19 Vaccines as It Convenes Advisory Panel

Thomas M. Burton, Wall Street Journal: October 23, 2020


SILVER SPRING, Md.—Food and Drug Administration officials gave fresh assurances Thursday that Covid-19 vaccines will undergo rigorous testing before being made widely available—a message they underscored in a meeting with outside medical experts aimed at bolstering the agency’s credibility.

“Only those vaccines that are demonstrated to be safe and effective” will be licensed by the FDA, said Marion F. Gruber, director of the FDA’s Office of Vaccines Research and Review. But some speakers and panel members raised concerns about whether the FDA’s vaccine guidelines for Covid-19 clinical trials are sufficiently rigorous.

These comments came at the first meeting of a 25-member panel of medical experts, including specialists in fields like virology, infectious diseases and biostatistics. The group, which met remotely via video-conferencing, was  established to make recommendations to the FDA on how best to assess the safety and effectiveness of vaccines.

“The FDA frequently convenes outside panels of medical experts for their advice on products,” said Peter Marks, director of the FDA’s center for biological products. “But normally panels about vaccines are watched by dozens of people. In this case, it’s watched by many thousands.”

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President Trump has pushed to get a vaccine approved quickly, which has drawn concern from some public health experts and political opponents that the FDA would be under pressure to bypass usual precautions to rush a vaccine to market quickly.

FDA officials have vowed not to do so. In addition to convening the advisory panel, they have issued a set of guidelines to govern how vaccine clinical trials will be conducted and evaluated.

They also formulated a set of rigorous standards for the FDA to employ before granting what is known as an emergency-use authorization (EUA) for a vaccine. The EUA is the faster equivalent during the Covid-19 pandemic of a conventional approval by the agency.

[….]

Various speakers questioned whether the shorter EUA test period was sufficient.

“The vaccine trials have serious design flaws,” said Diana Zuckerman, president of the National Center for Health Research in Washington. In addition to the two-month period, she said FDA guidelines focus on measuring milder cases of the disease, and not the most serious cases.  

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