StemCell Therapy

August 26, 2020

Food and Drug Administration Commissioner Steven Hahn, having been battered around for his egregiously inaccurate endorsement Sunday of a purported COVID-19 treatment pushed by President Donald Trump, walked that endorsement back Monday and Tuesday.

It isnt enough. Hahn has damaged his credibility, possibly beyond repair, and taken the credibility of the FDA down with him at a crucial moment when the agencys trustworthiness may be more important than at any time in its 114-year history.

He has behaved like a Trump sycophant rather than the head of an independent, science-based arm of the federal government, and for that he has to go.

I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma, Hahn tweeted Monday, at the start of an apology round that also took him to CBS This Morning. The criticism is entirely justified, he tweeted. What I should have said better is that the data show a relative risk reduction, not an absolute risk reduction.

On CBS, he said, I could have done a better job and should have done a better job at that press conference explaining what the data show.

Lets take a closer look at what this is all about, and why Hahns most recent statements are insufficient.

The issue involved convalescent plasma, which is blood fluid taken from patients who have recovered from COVID-19. Its then transfused into new COVID-19 patients, with the aim of allowing antibodies the original patients developed during their illness to fight the infection in the new patients.

Sundays White House press conference was called to announce that the FDA had issued an emergency use authorization for convalescent plasma in COVID-19 cases. This move isnt tantamount to FDA clinical approval and has little practical effect, since researchers already were using the substance in clinical trials.

But it does raise the possibility that the general public will think that the FDA has concluded that it works for COVID-19 patients, for which there is still no evidence.

In short, the FDAs announcement benefited no patients or researchers. It smacked of being timed to coincide with the start of the Republican National Convention, which opened Monday with Trumps renomination. Hahn denies that the timing was anything but coincidental.

Convalescent plasma has been used for about 100 years as treatment for other diseases. It has never been a miracle drug or a breakthrough, as Trump has described it. Though researchers have seen some evidence that it may help seriously ill COVID-19 patients, medical experts strongly doubt that it will be a breakthrough drug now.

That brings us to Hahns original error.

As I reported, at a White House press conference Sunday, Hahn stated in Trumps presence that for patients treated with convalescent plasma there was a 35% improvement in survival, which he called a significant clinical benefit. He tried to explain what he meant by adding that, of 100 people who are sick with COVID-19, 35 would have been saved because of the administration of plasma.

None of that is true. The Mayo Clinic study on which his remarks were based says nothing of the kind. It says that preliminary results from its trial show that patients given convalescent plasma with a high concentration of antibodies and receive it within three days of diagnosis with COVID-19 have a 35% better survival rate than those given plasma with a low concentration of antibodies and who receive it four days or more after diagnosis.

The best one could say is that five out of 100 people in the trial but really only three out of 100 would have better survival rates. Even that conclusion is dubious, however, because the Mayo study doesnt compare the patients who received plasma to those who didnt receive it at all it merely compares those who receive different versions of the plasma and on different schedules to each other.

From that, its impossible to tell what benefit convalescent plasma has on COVID-19 patients, if any. Two studies, in China and the Netherlands, that actually tested convalescent plasma against a placebo were both ended early because of safety concerns. But neither showed any positive effect before they were curtailed.

Hahns statement instantly drew a pushback from medical experts. Jonathan Reiner of George Washington University medical school called it shockingly wrong. Eric Topol, head of the Scripps Research Translational Institute in La Jolla, California, called it not only blatantly wrong (but) an egregious public statement.

Hahns original statement was so profoundly wrong that his walkback Monday and Tuesday cant help but increase public confusion.

This is just blatantly wrong and misleading to the public, Topol told me. Millions of people now think that this is a breakthrough miracle treatment, but theres no data to support that. He has to say that there has been no survival advantage established for convalescent plasma, period, stop.

Hahns apology doesnt help, because its couched in technical language. The public doesnt understand the nuances of relative and absolute risk. Until he says that there is no survival advantage established, the public wont get it, Topol says. And he has to say it in public not through Twitter, and not through an exclusive CBS This Morning interview.

As for that interview, Hahn didnt err on Sunday by doing a bad job explaining the data. He completely misrepresented the data. On CBS he described the Mayo Clinic data in a way that was so confusing and incomplete that the lay viewer could still come away with the impression that theres solid evidence for plasmas positive effect. Thats completely unacceptable.

Of the FDAs emergency use authorization, Hahn told Gayle King of the CBS program, I can assure the American people that this decision was made based upon sound science and data.

Can that assurance be taken at face value? Unfortunately, no.

The importance of the FDAs credibility at this moment cant be overstated. At some point within the next year, the agency will be called on to validate the safety and efficacy of any vaccines for COVID-19 that emerge from clinical testing.

In an era in which conspiracy theories animate resistance even to vaccines of proven safety and efficacy, doubts about a new vaccine against a novel disease will threaten public health if they prompt people to refuse immunization. By appearing to truckle to Trumps political demands, Hahn is making it impossible to trust the FDAs judgment on COVID-19 vaccines.

Thats tragedy in the making. Hahns performance this weekend started out shamefully, and has only gotten worse.

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