Yglesias vs the FDA

I really like how Yglesias constructs this argument without getting at all into how exactly the FDA approves things, but, rather looking at the big picture of what the FDA looks to accomplish by approving drugs/medicines.  And, here, it’s clearly failing in taking so long.  Since this is actually a public Yglesias post, you should just go read it and I won’t quote as extensively as I would if it were paywalled.  But, still:

The FDA should approve the vaccines

To me, the most striking, glaring, and obvious problem with the current state of the U.S. vaccine rollout is that the Food and Drug Administration has not given official approval to any of the vaccines that we are using. Instead, they have been given Emergency Use Authorization.

Any time you criticize any element of the American public health bureaucracy these days you get assailed by swarms of pro-system tweets, in this case usually accusing me of “not understanding the process.” But I actually think it’s the process-trusters here who don’t understand the process, and if you do you’ll see it’s a process that’s a poor fit for the situation.

After all, when you step back and think about it, the FDA approach to medications is at least a little bit odd. In many cases it’s perfectly legal to sell things that have no scientifically demonstrated medical benefits — that’s the whole world of unregulated supplements. And of course you can sell people things like beer, M&Ms, and cigars that everyone knows are harmful and have no offsetting medical benefits. Selling medicine is subject to a special, unusually high bar because we are trying to safeguard the public interest from a particular class of scam.

For example, a company might come along with a $56,000 Alzheimer’s pill that doesn’t have any clear evidence of efficacy. If you want to try to sell a $56,000 dietary supplement, then that’s between you and your sucker customers. But there is a general presumption that programs like Medicare, Medicaid, and subsidized private insurance plans will cover authorized prescription medications. So there is a real opportunity to damage the public interest with scammy products here. And we need the FDA to protect us. Now as it happens in the case of this drug, the FDA isn’t protecting us. But that’s its function; that’s why we need a fussy scientific agency with a high bar for approval.

But then in a crisis, you maybe want to be less fussy. Hence the FDA, rightly, was handing out EUAs like candy for various Covid treatments all throughout 2020.

In the crisis, we don’t really worry that we might be wasting money on convalescent plasma. We don’t have rigorous evidence that it works, but there are some general medical science reasons to think that it might work. And if a patient and his doctor want to try it, it seems counterproductive to block them. If nothing else, letting the treatment move forward is a good way to gather more data. But the FDA rightly emphasizes that it is not actually endorsing convalescent plasma, just as the FDA does not endorse dietary supplements. They are saying that in light of the emergency, and given that there’s no widely available and clearly superior treatment, they’re not going to stop you from trying the experimental therapy.

But that is not what doctors, scientists, and public officials say or believe about the vaccine.

Everyone wants people to get the vaccine

If you just listen to what anyone is saying about the Covid vaccines, they are endorsing them.

The acting director of the FDA and her Trump-era predecessor are encouraging people to get vaccinated. The director of the CDC and her Trump-era predecessor are encouraging people to get vaccinated. The President of the United States is loudly encouraging people to get vaccinated, and his predecessor is quietly doing so. The Surgeon General says you should get vaccinated. Dr. Fauci says you should get vaccinated. It’s possible these people are all lying and full of shit or something, but as a journalist, I am simply conveying what’s clearly true — all the people in positions of authority are endorsing the Covid vaccines and encouraging you to take them.

In other words, they are acting about the Covid vaccines the same way they’d act about a long-approved antibiotic or the measles vaccine, not the way they’d act about a dietary supplement. They are not saying you are allowed to get vaccinated, they are saying you should get vaccinated. Indeed, that’s not just their medical advice to you — it’s their stated belief (and I agree) that getting vaccinated is a pro-social means of safeguarding your entire community.

So I am saying, with a full understanding of the process, that the FDA ought to bring the official regulatory status of mRNA Covid vaccines into line with the scientific community’s actual understanding and attitude toward the vaccines. [emphases mine]

The government is not worried that Pfizer and Moderna might be running a scam on us. They are charging $20 a dose, not $56,000. We are begging people to take these shots. So we should act like it…

Low-hanging mandate fruit

Another issue about the lack of authorization is that many institutions, including the U.S. military, believe they legally cannot or should not mandate a vaccine that is available exclusively under EUA. There turns out, inconveniently, to not really be any case law on this. But I think it’s understandable that most major institutions want to tread cautiously here in the absence of a clear FDA thumbs up…

But this brings up another example of the utility of full authorization. American media is full of commercial advertising campaigns aimed at getting people to “ask your doctor” about various kinds of prescription drugs.

You can’t market off an EUA, and the vaccine makers have been persuaded to accept low margins for these products. Give a full authorization, bump up the payment rate, and watch the Pfizer and Moderna marketing campaigns explode. Give Donald Trump a bunch of money to be a Moderna pitchman and give LeBron James or whoever a bunch more to do it for Pfizer…

And right now if someone says to you “look, the mayor and the president don’t want to mention this, but these are experimental vaccines that the FDA hasn’t even approved,” that’s not misinformation — that’s true.

Now if I went around tweeting all day “don’t take the vaccines unless you’re highly vulnerable, they’re experimental treatments the FDA hasn’t approved because they say they don’t have enough safety data yet” people would (rightly) get very mad at me. Spreading that message would (rightly) be considered an anti-social and chaotic thing to be doing. But the message is true, and a good way to cut down on its spread would be to make it not be true, rather than trying to informally stigmatize saying it…

Start with the easy stuff

My big point about this is that the elite discussion of vaccine resistance seems a little bit perversely focused on the hardest problems. How do you persuade distrustful people who live in communities where trust and vaccination levels are so low that you need to be obsessed with avoiding political backlash? I’m not sure.

So we should start with the easy stuff.

Get the FDA to stop fueling vaccine resistance. Let institutions that don’t need to worry about backlash roll out mandates.

About Steve Greene
Professor of Political Science at NC State http://faculty.chass.ncsu.edu/shgreene

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