If you walk into the offices of the Food and Drug Administration tomorrow and demand a miracle cure that could save 35% of people infected with COVID-19, the first thing the FDA would do is scrutinize these claims. Validating efficacy claims is one of the FDA’s most important and painstaking tasks. If these claims prove to be false, your business could face serious civil and criminal liability.
As America enters an election season, Hahn has indicated that he is prepared to put scientific concerns aside in favor of political concerns.
And yet, on August 23, with the announcement of the Emergency Use Authorization, or EUA, to approve “convalescent plasma,” that’s exactly what happened. Only the misrepresentation of the treatment’s effectiveness was not made by a fraudulent company or greedy inventors – it was made by FDA Commissioner Stephen Hahn.
In doing so, Commissioner Hahn extended his hand. As America enters an election season with the very out of control coronavirus, Hahn has indicated he is prepared to potentially set aside scientific concerns in favor of political concerns. This is dangerous for various reasons. More important is the very real possibility that President Donald Trump wanted to lie to the public about a possible vaccine ahead of the election and that Hahn would accept it.
Let’s go back to what happened. At a press conference on the eve of the Republican National Convention, Hahn stood by Trump and said “35 out of 100” treated with convalescent plasma would survive. Trump called this a “breakthrough”.
The statement was exactly the kind that delivered the FDA’s harshest rebuke. Because it was a lie.
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In fact, there was so much wrong with the statement that it’s hard to know where to start. Rather than showing that 35 out of 100 would survive, the study only showed the difference between people who received plasma with high levels of antibodies and those who received plasma with lower levels of antibodies. And those 35% of surviving factoids? This is fiction. A Mayo Clinic analysis showed that less than 1 in 10 very ill patients survived longer after receiving transfusions soon after diagnosis. Not to mention the real study setting, where half of the patients were also treated with a steroid and 3 in 10 were treated with remdesivir, which showed marginal benefit.
So, which drug has benefited patients? There is no way to know.
Without correcting the record, a day later Hahn used a tweet to admit that what he had said was wrong.
Actual clinical trials on convalescent plasma are currently underway in England. Given all of this and the fact that convalescent plasma is already available, Dr Anthony Fauci and Dr Francis Collins, who heads the National Institutes of Health, warned against permission earlier in August. Evidence suggests that other scientists in the FDA have also done so. A day before the FDA gave its approval, Trump fired across the bow, tweeting that the FDA is part of the “deep state.” The White House fired a second shot across the bow removing the FDA’s authority to approve diagnostic lab tests. The screws tightened. The next day, the FDA approved the drug.
The FDA is the organization we’re supposed to be complaining about because it’s too stubborn and grounded in real data. But without an exaggerated advantage, there would have been no political victory for the president at his grand 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 little reckless mistake. Representing the risks and benefits of a drug accurately and precisely is not the FDA’s side job. It is his main employment.
The entire episode lays bare the bullying, manipulation and chaos that defines the Trump administration. In this White House, perception and spin are far more important than results. This may not sound like news. What is new is that in the face of numerous costs and an unproven or marginal benefit for an already available therapy, the FDA commissioner has apparently played the game.
The consequences are real. People who pay attention shouldn’t be surprised that Trump claims that an unproven treatment launched in the 1880s is a breakthrough. But Hahn’s role in this lie has potentially serious consequences – without much benefit.
First, convalescent plasma is already widely used. All the FDA did, in fact, was change the program that made it available without clinical trials. And since convalescent plasma cannot be manufactured – it only comes from recovered COVID-19 patients who donate their own plasma – the president’s actions will not increase access to therapy. Ginning this treatment could actually decrease access by skyrocketing demand.
Second, the cost of this action is the wasted trust of the great men and women of the FDA – at the precise moment when we must most rely on them. The politicization of the FDA’s decisions was already in question after the approval of the high-profile emergency use of hydroxychloroquine – which the FDA then withdrew. But many, including me, are rallying to the defense of FDA scientists as they begin to consider EUA approval of a vaccine, possibly ahead of the election.
Most important is the question of a vaccine and whether the public can trust the FDA. Trump will surely be pushing for a vaccine to be approved as part of an EUA ahead of the election, and now Hahn looks likely to accept it. After all, Hahn has crossed the river before. And a vaccine, no matter how good, is only as good as the public’s belief in it. The FDA, calm and stable and above politics, is what we rely on. But Hahn did not leave the FDA in a position of trust.
The best solution for the country is for Hahn to step down and completely correct the record of what happened here with the interference of the White House. Restoring FDA independence before a vaccine was announced is one of the most significant challenges the organization has faced in years. Doing what’s best for the country will require courage that Hahn has yet to show – but protecting his agency and the public from bullying and lies isn’t the worst way to end a career.