Yes, even more blogging about why the FDA needs to approve ASAP

Of course, I’m always happy to see when I’m in accord with David Leonhardt.  Here’s his latest on the FDA:

Why, then, hasn’t the F.D.A. taken the final step of formal approval?

It is following a version of its traditional, cautious process for vaccine approval. That process has historically had some big advantages, reducing the chances that Americans end up taking a faulty drug. To move much more quickly would risk undermining the public’s confidence in the F.D.A. and, by extension, the medicines it approves, Dr. Peter Marks, who oversees the process, has argued.

But I think the F.D.A.’s leaders have failed to understand how most Americans really think about the vaccines. It is different from the way that scientists and epidemiologists do. It’s less technical and based more on an accumulation of the publicly known facts.

It reminds me of another example of expert miscommunication, early in the pandemic. Back then, public health officials made highly technical statements about masks that many people interpreted as discouragement from wearing them. These statements ignored the many reasons to believe that masks could make a difference (like their longtime popularity in Asia to prevent the spread of viruses) and focused instead on the absence of studies showing that masks specifically prevented the spread of Covid.

Later, officials insisted that they were merely “following the data.” In truth, though, they were basing their advice on a narrow reading of the data — and not understanding how most people would interpret their comments.

The long wait to approve the vaccines is similar. F.D.A. officials are acting as if most Americans are experts in the nuances of their approval process and will be shocked if the agency expedites it. In reality, many Americans know almost nothing about that process. But some are understandably confused by the mixed messages that the F.D.A. is sending.

Hundreds of millions of people around the world have been vaccinated. Tens of thousands of them were followed for months in clinical trials. And F.D.A. officials have repeatedly urged other Americans to get vaccinated. “In the history of medicine, few if any biologics (vaccines, antibodies, molecules) have had their safety and efficacy scrutinized to this degree,” Dr. Eric Topol of Scripps Research wrote in The Times.

Yet the agency still has not given formal approval to those same vaccines.

What I really love, though, is that he looks at this through a cost/benefit lens:

Big costs, few benefits

Think of it this way: In the highly unlikely event that the evidence were to change radically — if, say, the vaccines began causing serious side effects about 18 months after people had received a shot — Americans would not react by feeling confident in the F.D.A. and grateful for its caution. They would be outraged that Woodcock and other top officials had urged people to get vaccinated.

The combination means that the F.D.A.’s lack of formal approval has few benefits and large costs: The agency has neither protected its reputation for extreme caution nor maximized the number of Americans who have been protected from Covid. “In my mind, it’s the No. 1 issue in American public health,” Topol told me. “If we got F.D.A. approval, we could get another 20 million vaccinated,” he estimated.

What gives me pause?  For one, a lengthy discussion with BB who is far less gung-ho than I am.  He very much echoed the sentiments of Brendan Nyhan a political scientist I greatly respect who honestly knows a lot more about vaccines and public opinion than me.

And, yet, I’m still with the non political scientists here.  I just don’t see that the FDA moving with extreme alacrity, not “rushed” mind you, just everything they always do on a timetable as fast as humanly possible (I guarantee you they are not doing that) will actually undermine their credibility.  We are drowning in good data on the safety and efficacy of these vaccines.  There’s probably enough good data here to give full approval to 100 different drugs.  Make it happen!  Are people really going to doubt the credibiliby of the FDA if it happens next week instead of next month?

Also, I might as well share one of the few times I disagree with Drum:

I’m not going to pretend to any special expertise either, but I can at least point out a few things:

  • Despite what the Twitterati seem to believe, the folks at the FDA are not idiots. They might be wrong, but they aren’t idiots and they’re well aware of the benefits of granting full approval.
  • There is a documented process for granting full approval. Pfizer and others submitted the data for that approval in May and asked for expedited review. This was granted, of course, which means review will take about six months instead of two years.
  • Like it or not, approval is based on actual scientific studies (RCTs), not just the observation that lots of people have already gotten the vaccine and seem to be OK. This is the only reliable way to do things, and that doesn’t change just because we’d really, really like it to.
  • The FDA, of course, could change the approval process midstream and simply issue a full approval. However, skeptics would rightfully assume that this means the approval is political, not based on science. It would pretty much destroy the FDA’s credibility.

It’s true that the FDA approval process takes a long time. That’s why we also have an emergency use approval process that allows drugs to be prescribed in an emergency if they look promising but haven’t gotten through the full approval process yet. This makes perfect sense, and it’s what we’ve done.


Good points.  And yet… again, we are awash in good data about the safety and efficacy of these vaccines.  The FDA probably has more good data in just this time period about these vaccines than 99% of drugs that they take years to review.  This is not remotely normal and, under these not remotely normal circumstances, taking the normal amount of time is proving a huge disservice to the health and safety of Americans.  No, don’t “change the approval process midstream,” just do everything you always do a hell of a lot faster.  No, they are not idiot.  Rather, they are deeply entrenched bureaucrats within an organization and culture that is excessively (pathologically, in this case) conservative. They can do this. They have the data.  They have the information on manufacturing.  Make it happen!

And, here’s my humility…  Maybe I’m wrong.  People I deeply respect feel otherwise, but this is my read of the situation and I feel pretty strongly about it (as you can tell).  

About Steve Greene
Professor of Political Science at NC State

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