If you walked into the offices of the Food and Drug Administration tomorrow and claimed a miracle cure that could save 35 percent of those infected with COVID-19, the first thing the FDA would do is examine those claims rigorously. Validating claims of effectiveness is one of the most important and painstaking of the FDA's jobs. If those claims turned out to be false, your company could face massive civil and criminal liability.
As America enters an election season, Hahn has indicated he is willing to potentially put aside scientific concerns for political ones.
And yet, on Aug. 23, in announcing the emergency use authorization, or EUA, to approve "convalescent plasma," that is exactly what happened. Only the misrepresentation of the treatment's effectiveness wasn't made by a fraudulent company or greedy inventors — it was made by FDA Commissioner Stephen Hahn.
In doing so, Commissioner Hahn has tipped his hand. As America enters an election season with the coronavirus very much out of control, Hahn has indicated that he is willing to potentially put aside scientific concerns for political ones. This is dangerous for a variety of reasons. The most important one is the very real possibility that President Donald Trump may want to lie to the public about a possible vaccine before the election and that Hahn would go along with it.
Let's retrace what happened. In a news conference on the eve of the Republican National Convention, Hahn stood alongside Trump and said "35 out of 100 people" treated with convalescent plasma would survive. Trump labeled this a "breakthrough."
The statement was exactly the kind that would deliver the harshest rebuke from the FDA. Because it was a lie.
In fact, there was so much wrong with the statement that it's hard to know where to start. Rather than show that 35 out of 100 would survive, the study showed only the difference between people who received plasma with high levels of antibodies to those who received plasma with lower levels of antibodies. And that 35 percent surviving factoid? It's fiction. An analysis by the Mayo Clinic showed that fewer than 1 in of 10 very ill patients survived longer when given transfusions soon after diagnosis. Not to mention the actual context of the study, in which half the patients were also being treated with a steroid and 3 out of 10 were being treated with remdesivir, which has shown some marginal benefit.
So which drug was the one that benefited patients? There's no way to know.
Without correcting the record, a day later Hahn used a tweet to acknowledge that what he said was false.
Actual clinical trials of convalescent plasma are taking place right now in England. Given all of this, and the fact that convalescent plasma is already available, Dr. Anthony Fauci and Dr. Francis Collins, who runs the National Institutes of Health, had cautioned against the authorization earlier in August. Evidence suggests that other FDA scientists did, as well. A day before the FDA gave its approval, Trump fired a shot across the bow when he tweeted that the FDA is part of the "deep state." The White House fired a second shot across the bow by taking away the FDA's authority to approve diagnostic lab tests. The screws were getting tightened. The next day, the FDA approved the drug.
The FDA is the organization we are supposed to complain about for being too stubborn and anchored to actual data. But with no overstated benefit, there would have been no political win for the president at his big convention. And this is where Stephen Hahn failed on a grand scale. He amplified the president's false and misleading statements. It wasn't a small, careless mistake. Accurately and precisely representing the risks and benefits of a drug isn't the FDA's side job. It is its main job.
The whole episode lays bare the bullying, the manipulation and the chaos that define the Trump administration. In this White House, perception and spin are far more important than results. That may not feel like news. What is news is that in the face of plenty of costs and an unproven or marginal benefit for a therapy already available, the commissioner of the FDA seemingly played along.
The consequences are real. It should be no surprise to people paying attention that Trump would claim that an unproven treatment pioneered in the 1880s is a breakthrough. But Hahn's role in this lie has some potentially severe consequences — without much benefit.
First, convalescent plasma is already in wide use. All the FDA did, in fact, was change the program that made it available without clinical trials. And because convalescent plasma can't be manufactured — it comes only from recovered COVID-19 patients who donate their own plasma — the president's actions won't increase access to the therapy. The ginning up of this treatment could actually decrease access by making demand skyrocket.
Second, the cost of this action is the squandered trust of the very good men and women of the FDA — at exactly the time we need to rely on them the most. The politicization of FDA decisions was already in question after the emergency use approval of the much-hyped hydroxychloroquine — which the FDA subsequently withdrew. But many, including me, were rallying to the defense of FDA scientists as they begin to consider whether to approve a vaccine by EUA, possibly before the election.
Most important is the question of a vaccine and whether the public will be able to trust the FDA. Trump surely will push for a vaccine to be approved under an EUA before the election, and now Hahn seems likely to go along with it. After all, Hahn has already crossed the river. And a vaccine, no matter how good, is only as good as the public's belief in it. The FDA, staid and steady and above politics, is what we rely on. But Hahn has left the FDA in no position to be relied upon.
The best solution for the country is for Hahn to both resign and to fully correct the record of what happened here with White House interference. Re-establishing the FDA's independence before a vaccine is announced is one of the more important challenges the organization has faced in years. Doing what's best for the country will require courage Hahn hasn't yet shown — but protecting his agency and the public from bullying and lies isn't the worst way to end a career.