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.
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.”
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.
not just ignorant, but arrogantly ignorant
not just stupid, but arrogantly stupid
not just incompetent, but arrogantly incompetent
Any pretext to attack this president is sufficient for the TDS crowd.
I found your article to be very condescending and disrespectful with regards to our President. Your President. He deserves more than “Trump”.
Also, it is apparent that the FDA finds his dogmatic approach to cut the red tape and save lives with drugs that have already been in use in other countries a stretch. The President is not the only one frustrated with the complacency of the FDA. Maybe his candor is hitting a nerve and its time that some within the agency should move on to greener fields.
>condescending and disrespectful with regards to our President.
Hes President, not Emperor.
Once again, Gilead’s Remdesevir has already proven to be safe when it was used for Ebols clinical trials. Thus, all is required is to prove is efficacy for the coronavirus clinical trials (few in China abs one in US). Then it should be approved by the FDA immediately with minimal and expedited review (no more than a few weeks).
If Stephen Hahn has an issue with it, he should resign as the FDA Commissioner! We don’t need bureaucrats and bureaucracy that stand in the way by obstructing or delaying the inevitable outcome of saving hundreds or even thousands of lives in this crisis!
You imply that the “six decades of dogma” must not be breached. This tells me you are set in your ways and no one is going to convince you otherwise. There are about to be thousands and thousands of people dead because of your stubbornness and stubbornness of others who think like you. Chloroquine has already been approved by the FDA!!! Its been used for decades!!! Its also been tested in the trenches (in other countries) against covid-19. Don’t you realize we’re in a war? And you’re going to say that because we haven’t gone through a “proper Phase 3” test (random double blind with placebos), then no lives can be saved, the doctors and nurses that are on the front line will have to go on with no drug (weapon) against this disease for another month. And people will have to die, because no one can force us to really think about how to do this differently and faster. When thousands die I hope you are proud that you and FDA Commissioner Stephen Hahn have upheld the precious FDA rules of drug testing. If you feel my disdain for you, then you have correctly read this comment.
STAT is Left Leaning.
Thank u
Mike,
I respectfully and totally disagree. The science was there as precedents.
Ditto for overcoming bungling bureaucracy.
We all know from what happened in China and South Korea in terms of testing with tremendous success, don’t we?
I thank and give kudo’s to my amazing CA Governor Newsom and Mayor London Breed (of SF). They both certainly acted fast and decisively (not allowing Global Princess passengers to disembark easily and casually as Japan did with Diamond Princess, immediately quarantine for 14 days for anyone with flu-like symptoms, sanctuary at home policy for the Bay Area first and now the entire state of CA, restricting ay non-essential activity outside of the home for seniors, restricting all elective surgeries, expediting delivery of test kits and permitting Qwest and Lab Corp to conduct testing rathe than restricting just to public health and academic labs, setting up outdoor mobile testing facilities, etc.
I firmly believe the obstacle is excessive sense and entitlement of personal liberty in the US. American citizens simply cannot accept, tolerate, nor stomach, imagine or understand the concept of “martial law”. If our USPTO declared it is a war, then we must act like citizens of a country in a real war.
My first comment on this site, Regardless of what the politicians say, it is those graduate students in colleges around the world that have to do all the work spending so many night to get those scientific journals and research to reach the point where a vaccine and a medication come out to market. On the fast track (FDA and similar agencies focus on it and push other applications for approval away to the side) it needs 6-8 weeks, other wise until mid to late summer 2020 for the medications to come out. You can always volunteer to try the experimental medicine if you want to.
Hbarudi,
Which graduate school do you study at? Have you ever participated in an NDA submissison to the FDA?? What drug or vaccine are you aware of was approved by the FDA only after 6-8 weeks of review?
Time to get schooled boys; the authors need to read a well researched and factual article written competently in The New Yorker, March 16, 2020: “What Went Wrong with the Coronavirus Testing in the U.S.”
The obstacle is not the science, it’s the bureaucracy. That’s where the “faster” lies.
The best initial responses came independently, not from a centralized government sector. But, on February 4th, everything slowed down, because HHS declared a public emergency, and now the regulation was back in the deep-state’s control.
Regulations are intended to protect you, but as proven here, they can kill you just as easily.
>Regulations are intended to protect you
Regs are intended to regulate you. Protection is optional.
Dr. Krich,
Gilead’s Remdesevir was given to some very sick patient as a last resort, compassionate us and thus not rally b3ing “tested”. The patients remarkably recovered but FDA would NEVER approve it simplysbased on these anecdotes. WHhat is being “tested” in CHina and NIH are full blown clinical studies that may take at least two more months to gather efficacy data, analyze them, then the Chinese authority or the FDA may decide to fast track it after a thorough and in-depth review. So I don’t see any possibility of approval until this fall at the earliest. Of course there is the thorny IP/patents issue in China that is not trivial.