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For about 20 minutes on Thursday, President Trump undermined six decades of dogma on the development of safe and effective drugs.

Trump, addressing a nation under shelter and quarantine from the coronavirus pandemic, said a new drug for Covid-19, yet to be proved safe and effective, was now “approved or very close to approved.” Another, also not approved for coronavirus, would be “available almost immediately,” in part because using it is “not going to kill anybody.” 

Then, minutes later, the commissioner of the Food and Drug Administration, Stephen Hahn, took the dais in the White House briefing room and delicately walked back each one of Trump’s statements. Nothing about the FDA’s deliberate process had changed, and no miracle medicine was a pen stroke away from solving the crisis. Pharma stocks that had surged fell back again. 

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The president’s remarks ran afoul of nearly every established FDA norm — prizing data and evidence over rhetoric, for instance, and avoiding promises, let alone those that can’t be kept. But they were also a sign of his long-running impatience with the realities of drug development — an impatience that is flaring at a time when the need for new medications seems more urgent than ever.

“Trump entered the White House fuming at bureaucrats, moaning about the deep state, but in particular trying to bring down the FDA,” said Arthur Caplan, professor of bioethics and the founding head of New York University School of Medicine’s Division of Medical Ethics. “That’s pure ideology, and it turns out that ideology is barren and impotent in the face of a pandemic.” 

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In many ways Trump’s science policy has been defined by his disdain for red tape at the FDA. At nearly every turn he has equated the agency’s success not with its scientific rigor or its role as a watchdog but with faster drug approvals and the slashing of regulations. 

Shortly after being elected, Trump turned to billionaire Peter Thiel to help vet candidates to lead the FDA and other science agencies. Among those candidates was Jim O’Neill, a staunch libertarian, who championed the idea of letting the FDA approve drugs without proving they were effective. During his first address to Congress, in 2017, Trump chided the agency for its “slow and burdensome” approval process, despite the fact that the FDA in recent years had acted faster than ever before. 

And he has repeatedly touted the passage of the so-called “right to try” law — which gives dying patients access to experimental drugs that have completed basic Phase I clinical trials — despite expert concerns about it.

The White House spent months spearheading support for that legislation despite prolonged efforts by patient groups that insisted it was both unnecessary — the FDA already has a process in place to give patients access to experimental drugs — and dangerous because it would open dying patients up to exploitation by unscrupulous companies.

In fact, experts say, the law has had minimal impact, with only a handful of cases in which patients have used it.

The coronavirus pandemic has rekindled Trump’s eagerness to expedite the development of new medicines. But in this case the process of developing new therapies is already moving at an unprecedented pace. The first potential vaccine, developed by Moderna Therapeutics, went from a lab experiment to human trials in less than three months, a process that commonly takes years. Gilead began enrolling thousands of patients in its remdesivir studies just weeks after case studies suggested the drug might help with Covid-19. 

The FDA, once dismissed by Trump as disruptively sluggish, gave its blessing to both trials immediately.

“The FDA has been a global leader in medical product development,” said Jeff Allen, president and CEO of Friends of Cancer Research. “There’s nothing to suggest that they are standing in the way of the important development and access to these therapies.”

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Still, the bracing pace may not be enough for Trump. The Wall Street Journal reported this week that the White House pushed for an executive order dramatically expanding the use of investigational drugs against the coronavirus, but was met with objections from the FDA. And on Thursday, it was up to Hahn to serve as a fact-checker to the commander-in-chief.

“That was a commendable appearance under immense pressure,” said Daniel Carpenter, a professor at Harvard University who studies the history and reputation of the FDA. “Commissioner Hahn did the right thing.”

Most FDA watchers can recite by heart the history of how the agency was granted the ability to review drugs for safety and efficacy in the first place. It wasn’t until a so-called “elixir” that was being promoted to cure sore throats killed over 100 people that Congress acted in 1938 to give the FDA the ability to regulate drugs for safety. Decades later, in the 1960s, a drug promoted to help with morning sickness led to thousands of babies born with lifelong birth defects. The crisis prompted Congress to again boost the FDA’s power. Among those changes were some requiring the FDA to not just consider safety, but also efficacy, when approving drugs. 

Those are responsibilities that the FDA still holds dear. 

“Let me make one thing clear: FDA’s responsibility to the American people is to ensure that products are safe and effective. And we are continuing to do that,” Hahn said Thursday. 

  • Sigmund,

    I have few points:

    1. Women do better. especially in China, for the simple reason most adult men there are heavy cigarette smokers with underlying diseases involving cardiovascular and lung functions. This fact has been quote often by the Chinese health authorities.

    2. if you knew anything about FDA drug approval process, even a small clinical trial with only 10 volunteers requires the IND process. Read up!

    https://www.fda.gov/drugs/drug-information-consumers/fdas-drug-review-process-continued

    • Actually I do know something about the FDA drug approval process but it is from many years ago. I reviewed the process internal to one drug company and I provided general computer consulting to another. In the first case, I became very very familiar with the process within the company. It was a mess. Stacks of paper on people’s desks and who knew if and when anyone would pay attention. Today it is all in the computer but that does not mean that humans work on their queue of reports. Adverse impacts is an important one.

      These were not grad students but very well paid doctors and scientists. They were not highly motivated.

      I assume those working on this virus are highly motivated. It is not the little blue pill.

      Normally it is the P&L that drives things. I assume now there is more of a wartime mentality. So that is good.
      I am not sure about the smoking being the issue. The same general problem is showing up everywhere. I am pretty sure but not certain that they have adjusted for smokers when they run the statistics.

  • I agree with you to some substantial extent.

    My background is commercial and industrial (was a senior executive of a mining company). Now among other things I am an elected official and we have responsibility for seven flood-control dams.

    We always seek competent engineering advice on those matters but often there is a need to act fairly quickly.

    So I do not advocate rash decisions but I do advocate moving ahead with solving problems ASAP.

    Trump has generally been successful at getting agencies to streamline their operations and decision making. I would not give him an A but definitely a B.

    That is a lot more than I would give most Presidents.

    If you have ten candidate drugs that seem to be relatively safe try them on then small groups of volunteers. Generally they can be tried in addition to what you otherwise would be doing for these people. It is risky that is why it must be volunteers. But the potential payoff can be very large.

    I will add one to the list: estrogen. Why are women doing better than men. It may be too little of something or two much of something but some think it is the double X.

  • Written like a couple of baby-millenials sucking up to the medical bureaucratic intelligencia, with no sense of the urgency faced by millions of immediately at risk Americans. Desperate times call for desperate measures and your “process over people” diatribe is most unseemly. When it seems that there is a widely available and known drug with over 70 years of experience of relative safety for patients that shows promise in blunting the effects of a deadly pandemic potentially affecting millions, you say, “how dare he, suggest we bend the protocol to save lives.” This IS medicine is it not.
    For too long bureaucrats have spent years lining their pockets with grants and studies whose only goal is a patentable product rather than a proportionate saved populace. It is YOUR Ideology that’s the problem. PRESIDENT Trump values People’s lives over your Process! If you Ivory Tower Ethicists were clear on the whole topic of HUMANITY, you wouldn’t be allowing yourselves to OVERLOOK the sacrifice millions of unborn children. Americans First !!

  • Maybe if the medical world in the US and elsewhere wasn’t under the control of one Mafia outfit or another Trump might have more respect for it. As for myself I’m tired of hospital doctors trying to kill me with a stroke, just because some murderous thug wants me dead. I get the part about saving lives, but as long as some nurses and doctors are willing to look the other way to be the Mafia’s hitmen, then there can be no real respect.

  • well if he wouldn’t have fired a pandemic team just because a smarter man before him set it up this naybe could have been far less. ge needs to go has the sense of a pea

  • There is an obvious need for an organization like the FDA. And it is obvious that the POTUS lost the thin veil over his patience. As to the real topic at hand: there are several more drugs that already treat viral diseases, that ought to get the leeway to also be tested for Covid-19 use. In order to speed up finding treatment(s) for the fast-spreading virus the scope of potential existing drugs should not be so limited. In this the WHO and the FDA are not thinking broadly enough in my opinion, no matter how these 2 illustrious young writers seem to puke on the man in charge.

    • With respect, that is incorrect.
      Those medications are being tested. Gilead already has medications tested from those used for ebola or others, as are other companies.
      If you follow medical journals you will find this information, or JAMA, NEJM.

    • It is always hard to know what to do during an emergency. Rules that make sense during normal conditions may not make sense during emergency situations. But decisions made under the pressure of an emergency often are not good decisions.

      So perhaps lining up on one side or the other on this matter is not the best approach. The decision by the FDA to relax the use of locally developed tests for the virus could have usefully happened sooner.

      It is always possible to improve. And decisions can be limited to smaller groups to limit the potential negative impacts.

      There is a need for technology transfer from the field to the laboratory.

      We need to work faster and better.

      No one has explained the delays in the first CDC test or how the reagent was manufactured incorrectly. That was very costly. So these agencies can not claim perfection.

      One can look at historical missteps by these agencies. One can for example look at misappropriation of funds by the CDC meant for the study of CFIDS.

      So no one is pure here. We are all human beings and flawed but with the potential to do better.

      So that should be the goal.

      If we can win this battle there will be a lot of glory to go around.

  • I’m with Frank and Warren on this one. STAT usually publishes great content, but a few articles are real lulus. This one definitely falls into the lulu category. Almost anyone currently diagnosed with COVID-19 would be more than happy to try a drug with an established safety profile, even if the viral infection was no real threat to their life. I know I would. So, we have over 10K patients in the US, under medical care. Let’s ask for volunteers and get busy. Today. You can temporarily place your decades of dogma somewhere the sun don’t shine.
    Doug

  • An unconscious blind science with no foundation that steers technology astray! A probabilistic science, this is the reason why biomedical technology struggles to find a solution to cure human from most general viruses!
    The covid-19 is an intelligent system, many scientists are not aware yet of the consequences of this pandemic disease, its structure and its dynamical system and what is trying to target in the future. We should act fast before it is too late!
    There is definitely simple solutions to this complex system.
    Am a mathematical Consultant for the Covid-19, i was awarded recently December 2019 a medal from Australian & European art & science organisations for my asymmetrical theory of everything! My mathematical research focus on the fundamental structure of sciences and the fractal living systems.
    I believe i can decode and find a solution to this pandemic virus!
    My services is to train biomedical researchers & scientists to a right path to steers research in a positive results.
    Salahdin Daouairi
    Mathematical Consultant for Covid-19

    • I agree that AI and 3-D docking studies are part of the future, but they are not good enough now, we cannot start from scratch rigth now.
      The suggestions I have seen from some of the AI/3-D/in silico supercomputer with list of many good suggestions and targets. But you lack clinical experience as some if the suggestions do not make sense or are too risky or it can be a drug with poor penetration or perhaps the target is to narrow. Also this way of studying drugs at the moment seems not adaptiv/dynamic in terms of physical forces, and many drugs change shape that can make a big difference as we see here. That is why we now have to take step back (look-again=research) and use drugs we know are safe. And I think the study from Marseille in France on hydroxycholorquine shows we can move much faster without the FDA, WHO slowing things down. Previously you could only get a new treatment as part of a randomized and double blind study and if the effect had public health value. Well that is old thinking from 2WW, in the US the rigths of the individual has always been well protected, so the freedom to try should be human rigth (granted it is not harmful, narcotic, etc and you understand the risk/benefit, and while you have that freedom you must also assume most of risk with it).

      By the way, no worry I think biotech and new drugs will be very well funded after this. In 2-3 weeks the world has changed, perhaps forever. At least we need to include SarsCoV1-2 in out animal flu shots or have really good medicines.

      Also I think CRISPR/gene drive to eradicate vectors will be om the future agenda.

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