The next 73 days are going to be very difficult for Stephen Hahn.

As the Nov. 3 election nears, the Food and Drug Administration commissioner can expect intensifying pressure from President Trump to approve a vaccine or a drug to combat Covid-19. Desperate to win and angry at criticism of his handling of the pandemic, Trump twice this week complained that the “deep state” may cause a delay.

But on Saturday morning, Trump also singled out the FDA by tweeting, without evidence to support his claim, that the agency is “making it very difficult for drug companies to get people in order to test the vaccines and therapeutics.” To make sure the FDA head got the message, Trump tagged Hahn at the end of the tweet.

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These sorts of self-serving remarks are terribly wrongheaded, because they continually raise the specter of political interference with a key agency during a severe public health crisis. Who would trust a vaccine that is being rushed out the door just so Trump can say he delivered what everyone wants as soon as possible? His tweets are about his re-election, not our well-being.

For Hahn, however, this creates a different kind of crisis, because the political appointee has to work harder than ever to ensure the FDA remains independent.

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“One of the great things about FDA is that decisions are made by full-time civil servants without conflicts,” former FDA commissioner Robert Califf tweeted in response to Trump’s tweet.

But Hahn’s track record gives me pause, and I’m not so sure he can stand up to Trump.

After all, last March, the agency authorized emergency use of hydroxychloroquine, a decades-old malaria tablet that Trump was touting, even though there was only tenuous evidence it could help patients infected with the coronavirus.

Hahn should have fought harder to resist that move. Sure, by late June, the FDA did an about face and revoked the authorization, after more solid data began appearing that made it clear the tablet was not the salve Trump and others thought — and might be harmful.

By then, though, the damage was done. Too much energy was spent testing a tablet simply because Trump had a hunch it could be useful, and this may have precluded researchers from exploring other possibilities that could have yielded something beneficial.

Since then, Hahn has tried to atone.

Earlier this month, he took a double-barreled approach with a pair of editorials targeting the medical community and the political crowd. He co-authored an op-ed in JAMA about upholding standards for vaccine approvals and made the same vow in an op-ed of his own in The Washington Post.

But it was hard to miss that Hahn failed to rule out the possibility of another emergency use authorization. Yes, the FDA needs this authority, but only if it is put to proper use. So this begs the question – will he acquiesce a second time?

Look, I understand Hahn is in a rough spot. Trump is mercurial and selfish. He’s not interested in upholding FDA standards for assuring safe and effective products. He has an election to win.

Ironically, the FDA hardly appears to be an impediment to getting a vaccine or therapy ready. Vaccine makers, for instance, are moving faster than was previously imagined possible to develop and test Covid-19 candidates. And the agency has already scheduled an Oct. 22 meeting to review data from vaccine trials underway.

The challenge for Hahn is to push back and not sign off on any vaccine or drug unless there is credible evidence that it meets the criteria the agency uses to assess safety and effectiveness.

Earlier this month, Peter Marks, who heads the FDA’s Center for Biologics Evaluation and Research and is part of a vaccine working group organized by the National Institutes of Health, threatened to resign if the FDA rubber stamps a Covid-19 vaccine.

Marks didn’t make that threat publicly, but it was subsequently reported and only further raised concerns about the possibility of politicizing any FDA approvals.

Hahn should do the same. Well-placed editorials may preserve views for the record, but Hahn needs to make clear – not only to the public, but to Trump – that FDA decisions are made to serve the public, not help re-elect a president.

After all, Hahn is an experienced oncologist who has helped run a major cancer center. Unlike the millions of Americans out of work right now, he can find another job.

Rather than duck, Hahn needs to push back even more and defend the FDA staff. He should tweet that the agency is not part of the ‘deep state’ and that a vaccine will be approved only when one is ready.

Otherwise, those 73 days are going to be very agonizing – for all of us.

  • Yes, but it is clear that the purity of the pre-Trump FDA is being grossly over-romantized. The idea that the FDA is some sort of conflict free organization run by noble civil servants is absurd. The FDA has responded to all kinds of pressure for all sorts of reasons for years and years. For instance, take a look at the wildly expensive treatments that have been approved for Duchenne Muscular Dystrophy, without a shred of evidence of efficacy for any of them. Should the FDA respond to pressure: No. is this the first time it has ever happened: Hell No.

    • I agree with you that the agency isn’t perfect, that it’s been under pressure before, and that the Duchenne Muscular Dystrophy decisions were problematic on a number of levels. We can look back and see Dr. Francis Kelsey being pressured by industry, and tremendously so, to approve thalidomide. She stood by her guns and refused to do so, and subsequent findings of the teratogenic nature of the drug made her a real US folk hero. The difference here is that it is political pressure from the president, not industry, that is driving the FDA decision making process. Can you think of a similar example in the past where a president did this? With Trump’s reelection chances circling the drain, this decision is getting people worried that even greater pressure will be exerted for a vaccine approval pre-election. An unsafe or ineffective vaccine will be much worse than no vaccine at all. If Trump thinks it will get him four more years, the lies will be flowing like water to convince the FDA to approve, and the public to take, a vaccine that clears neither hurdle.

    • Stewart, I agree that approving a vaccine on shaky data would be a disaster. I also sort of agree with Ed’s editorial, although it’s hard to tell someone else what they ought to be doing without knowing everything they know. I agree that Trump’s tweets are kind of nuts, although I understand why he might suspect that civil servants in the government are trying to undermine him (see, for example, the “resistance”, the FBI, the state department, etc.). In this particular case, we’re talking about plasma that has been used for similar purposes for over a hundred years. We’re talking about using it on very sick folks who may not have other options. And we’re talking about emergency use. So, this approval is not even remotely comparable to approving a vaccine. I’m not the least worried that a vaccine is going to be inappropriately approved no matter how much pressure Trump might apply. And, even if that were to happen, the press storm over it would mean no one would actually use it. Even Republican senators would raise a stink. It’s just not going to happen due to political pressure. The real danger will be from the press, should Trump be re-elected. At that point, the press (which has surrendered any rational, objective impulses they may have possessed to their hatred of Trump) will denounce any vaccine approved as a Trump plot. Then, lots of people won’t take it, we won’t reach herd immunity, and this will just linger on. Should Biden get elected, any approved vaccine will be hailed as a towering achievement, and this will all be over.

    • I’m more worried than you are. Don’t forget that Trump is still promoting HCQ via America’s Leading Doctors and other outlets. This after a great deal of data (gold standard, double blind placebo controlled) that shows little benefit. You suggest Republican Senators would raise a stink; they have failed to do so time and time again on just about every issue. The danger is not the press. The danger is Trump, who has shown he will lie about anything and everything to assuage his ego. Remember, he’s the guy trying to dismantle the ACA in the middle of a pandemic. Despite telling us time, and time, and time, and time again that he’s got a great healthcare plan for the nation, we’ve gotten nothing. For me, the bottom line is the horrific pandemic data itself: US is a bit less than 5% of the worlds population, yet 22% of COVID-19 deaths. The responsibility for that lies with him.

  • Health agencies need to continue taking risks and making bold decisions, but in a smarter way informed by science and social utility, and less by politics. The FDA’s reluctance to provide EUA for lower-sensitivity rapid antigen tests for self-surveillance is highly miscalculated. Agencies running or regulating clinical trials have wasted enormous clinical resources on antivirals and immune therapies a-priori unlikely to work. The CDC and WHO have been very slow to act on our evolving understanding of transmission regarding airborne and presymptomatic/asymptomatic transmission. The WHO continues to assume health-endangering null hypotheses merely to avoid panic. Clinical trials for vaccines is really the only government endeavor that has a well-defined scope and plan and adequate resources.

  • http://www.c19study.com/ Meta-analysis ove over 2 billion patients in which HCQ has been used early
    A few days ago, in early August, 2020, researchers published online (www.c19study.com ) a controlled meta-analysis of 68 published studies (41 peer-reviewed) involving 2.66 billion people, showing a 79% reduction in death rate from Covid-19 in those countries which allowed early use of Hydroxychloroquine for treating Covid-19 compared to those countries which allowed very limited or no early use of HCQ. Most of the studies were using fairly low doses of HCQ. Research over the last 60 years have proven such low doses to be VERY unlikely to cause cardiac arrhythmias or other serious side effects. In fact, HCQ has been safely used in treatment of malaria, systemic Lupus and rheumatoid arthritis in pregnant women, children and fragile elderly patients for about 60 years.

    The death rate from Covid-19 in the USA is presently 506 people per million. If early use of HCQ can reduce the death rate from Covid by 79%, as the new research confirms, then the death rate from Covid-19 should become 106 per million people with the widespread early outpatient use of HCQ for symptomatic Covid-19. According to the CDC website, the death rate for flu in the 2017-2018 “flu” (winter) season was 185 deaths per million (which would represent 75% more deaths from a moderately bad flu season than from the present Covid-19).

    One of the main reasons that people in the USA and around the globe were petrified with fear (and were willing to allow the economy to be shut down) was because of perceived risk of death from Covid-19. With this new information, the Covid-19 death rate can be reduced to less than the seasonal flu. And, because of this study, the corrupt mainstream media will be losing its ability to keep the people of this country controlled by fear of dying from Covid-19.
    How can we have any confidence of the people at the CDC and FDA

    • The C19study meta-analysis, which you refer to, is unfortunately junk science. That’s why it wasn’t published in a journal, and why the authors have chosen to remain anonymous. Don’t you think if you had great data you’d submit it to a well regarded science journal and reap all the accolades that would come your way? That didn’t happen here because the analysis was faulty and this is simply being promoted by unknown parties to push the presidents political agenda. As a doctor you know that clinical trials need to be held to the highest standard. Here’s a detailed deconstruction of this supposed analysis: https://respectfulinsolence.com/2020/08/17/astroturfing-promoting-hydroxychloroquine-to-treat-covid-19-continues-apace/

  • I think from further evaluation that you need to rethink your comments on the President and hydroxychloroquine. He wants safety, people back in their jobs and the FDA has refused to support this drug which works when taken early. Think how many lives could have been saved!! Fauci and group are holding hands with China!!

    • Everyone wants a safe and effective treatment for COVID-19, and for people to get back to work, and for life to resume pretty much as before. Unfortunately, the data from five different randomized, double blinded clinical trials showed no significant benefit of HCQ for the treatment or prevention of this disease. Until we actually have safe and effective treatments, or a safe and effective vaccine, nothing will go back to the way it was.

  • Thanks, Ed, for writing this opinion piece. You are exactly right when you say FDA director Stephen Hahn needed to push back publicly against this “deep state” nonsense in the strongest terms. If he is not capable of doing this, he should resign. His recent actions only serve to delegitimize the agency in the eyes of many people, and an EUA for a vaccine will not cut it. The worst possible outcome here is if the agency allows a not fully tested and vetted vaccine on the market, and it turns out to be neither safe nor effective. This will simply feed into the anti-vaxxer narrative, and will likely result in a decrease in vaccine usage in both the US and worldwide. The resulting toll of injury and death (from the failure of people to use vaccines) will be enormous.

  • Our new RUSSIAN republicans, Republicans prosecuted their own citizens while trading weapons for cocaine to fight an illegal war against the communist in Central America. Now, the shameless republicans in bed with the communist!!!!!

  • Not being part of the ‘deep state’ is the least of what Hahn should assert. That implies there is such a thing.

  • A prescient PHARMALOTVIEW, late a Saturday, but already overtaken by events on Sunday afternoon.
    I think our scribe should have the right “to correct and extend his remarks,” if he chooses.

  • Whoopee!
    And STAT needs to push back on Silverman, pretending to be a “journalist” and not a TDS symptomatic knee jerk reactionist…

    Have no fear, if Mr Sniffly wins in Nov, just like Obummer, the sun will glow brighter, the wind & the sea will obey…

    • May I observe this was an opinion piece, clearly marked, and not a news item.
      It was also spelled correctly, but that’s for another time.

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