Warren Buffet once said, “It takes 20 years to build a reputation and 5 minutes to ruin it. If you think about that, you’ll do things differently.”
Unfortunately for all of us, Stephen Hahn, the FDA commissioner, didn’t think about this when it came to his approach to approval of tests and treatments for COVID.
I wanted to spend some time today talking about how the past few days of news have upended my trust in an organization that we all look to in order to keep us safe.
In the early days of this pandemic, I interpreted news from an FDA approval as being grounded in science and a careful consideration of the data regarding efficacy and safety of different tests and treatments.
Unfortunately, the FDA has squandered their reputation and can no longer be trusted to provide a reliable interpretation of the data.
Let’s look at the latest FDA press release
After granting an emergency use authorization on convalescent plasma, the FDA put out a press release that is indistinguishable from propaganda.
Seriously, go read it.
I wrote about this in my newsletter earlier this week on convalescent plasma, but I want to reemphasize this insanity because I’m still incredulous it’s happening.
“The FDA’s emergency authorization for convalescent plasma is a milestone achievement in President Trump’s efforts to save lives from COVID-19,” said Secretary Azar. “The Trump Administration recognized the potential of convalescent plasma early on. Months ago, the FDA, BARDA, and private partners began work on making this product available across the country while continuing to evaluate data through clinical trials. Our work on convalescent plasma has delivered broader access to the product than is available in any other country and reached more than 70,000 American patients so far.
The press release could be out of North Korea.
It’s completely grounded in a fictional version of reality where convalescent plasma has been proven to be a game-changing treatment for COVID that was only discovered through the unparalleled genius of our administration.
This is completely bonkers.
There is no evidence that convalescent plasma helps COVID patients
None.
Zero.
No evidence.
But what about the research touted by the press release?
The trial that is being referenced compared giving convalescent plasma early to giving convalescent plasma late.
In other words, patients treated with convalescent plasma have better survival than patients treated with convalescent plasma
You’re reading that last sentence correctly. This is a complete misrepresentation of the research.
Based on the data from that trial, it is possible that giving convalescent plasma late makes you more likely to die from COVID.
And there are a million other explanations for the findings in the research on convalescent plasma that don’t lead to the conclusion that it saves lives.
You should be angry about this!
The fact that convalescent plasma has been given to over 70,000 Americans without proof of efficacy is infuriating.
The missed opportunity to figure out what treatments work and what treatments don’t work is a catastrophic policy failure.
When we aren’t enrolling patients in trials and are just giving them medicines that you *think* will work, the opportunity cost of never knowing what treatments work lead us to an endless loop of circular reasoning where we never perform trials to learn what’s effective and what’s not.
And while it’s bad that we haven’t done the trials, it’s much worse than our public health leaders are pretending that we did!
The head of the FDA knows better
Take a look at Stephen Hahn’s bio from his Wikipedia page.
This guy is a medical superstar. He has been a standout at the highest reaches of American medicine - chief resident at UCSF, Vice Chair of Radiology at Penn, Chair of Radiation Oncology and then Chief Medical Officer at MD Anderson - before becoming head of the FDA.
You don’t get to those levels without being brilliant and impressing people at every stage of your career in every location you’re in.
He is an NIH funded researcher who has done almost everything a person can do in medicine, including making it to be the head of the FDA.
He is clearly brilliant and has accomplished a huge amount.
Unfortunately, Stephen Hahn is unwilling to be honest with the American people.
Dr. Hahn gave an interview with Bloomberg after the disastrous press release. I want to pull one quote to emphasize:
Bloomberg: You’re a highly trained doctor and researcher. But your quote at the press conference about 35 out of 100 people being saved by this therapy when the benefit is far less, how did that mistake happen? (The data the FDA looked at was two categories of plasma — a higher dose, and a lower one. It only compared how one group did against another, not how great the benefit was versus a placebo.)
Hahn: I was trying to do what I do with patients, because patients often understand things in absolute terms versus relative terms. And I should've been more careful, there's no question about it. What I was trying to get to is that if you look at a hundred patients who receive high titre, and a hundred patients who received low titre, the difference between those two particular subset of patients who had these specific criteria was a 35% reduction in mortality. So I frankly did not do a good job of explaining that.
Now, think about how he framed this. It’s total nonsense and the premise of his response is a lie.
His explanation - “I framed the benefit in relative terms instead of absolute terms” or whatever - is completely incorrect.
Remember: no benefit of convalescent plasma has been proven. None!
But Dr. Hahn isn’t honest about this.
He knows better.
I won’t pretend that I understand his motivations and I’m certainly not going to try to psychoanalyze him. But we can be sure that he’s not making an entry level mistake in scientific reasoning.
I think that Will Ferrell as Mugatu from Zoolander best sums up my feeling about our public health leaders in the time of COVID:
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