Janet Woodcock, MD
Acting Commissioner of the Food and Drug Administration
10903 New Hampshire Ave
Silver Spring
MD 20993-0002

Dear Dr Woodcock,

You’ve got a problem.

An executive is making unsupported promotional claims for a biological product, indeed one that has yet to be formally licensed by your agency.

Doubtless you have dealt with such a violation before. When a pharmaceutical company tries to stretch an efficacy claim beyond the data, you can put a stop to it. You have tools: warning letters, fines, threats of criminal prosecution.

But the current situation is a bit thorny. The executive is your boss’s boss. That would be President Joe Biden.

There he was at a CNN town hall last week when the following popped out of his mouth: ‘If you’re vaccinated, you’re not going to be hospitalized, you’re not going to be in ICU units and you’re not going to die.’ And later: ‘You’re not going to get COVID if you have these vaccinations.’

Flat statements. No qualifiers.

At least the President skipped past the question about infection. He must know it has been reported that there are breakthrough infections (asymptomatic?) among vaccinated staff in the White House. His press secretary acknowledges them, though she won’t disclose the number.

As to COVID illness, let’s consider a single state, Massachusetts. The Boston Herald, citing data from public-health authorities, has reported that 3,907 fully vaccinated persons were known to have been infected as of mid-June and among them 268 had been hospitalized and 71 had died.

Understand the point I’m making here isn’t that the vaccines aren’t advisable, especially for high-risk populations. It isn’t that vaccines shouldn’t be available for anybody who wants them. It isn’t that vaccines won’t reduce risk of serious illness, no matter that the risk isn’t eliminated.

But to say without reservation that anybody who gets vaccinated can’t get seriously ill, and to make that blatantly false statement on national television — well, I can only imagine how you might react if marketing executives at Pfizer or Moderna or Johnson & Johnson behaved so badly. What imprecations might you mutter to yourself before your temper cooled and you consulted with FDA lawyers about cracking down on the miscreants?

Allow me to speculate about what happened at that town hall. You will recall that during the presidential campaign then candidate Biden sniffed at Operation Warp Speed, asking how anybody could know whether vaccines developed during the administration of the Orange Man would be safe and effective. But no sooner did the candidate become the president-elect than he was sticking out his arm for a shot. So now it’s his shot. He gets excited and starts to tell exaggerated stories about it.

I appreciate what you’re dealing with. The President is an inveterate storyteller — and details short of the truth may slip into the telling. Articulation, moreover, is hardly his strength. Who has not felt the drama of those moments when the leader of the free world sails into the tortuous channel of an English sentence and there is no telling whether he will safely navigate his way out of it?

Also, he ranks you. You can’t really slap him with a fine, even if for now you’re the cop on the beat.

What to do?

Pardon my presumption, but I have a suggestion. You may have observed that the President will sometimes carry notecards. He gets a question. He reaches for a card.

Why not give it a try? The card will have to be brief, only a few talking points. The benefits of COVID vaccines. The potential downside. What’s still unknown. No ‘messaging’. No virtuous lies. Just facts that people can use to think for themselves.

You don’t have to write the card. You’ve got a big staff to help. But the accompanying memo should go out over your name, and I’d suggest the indirect route. Your boss is Xavier Becerra, the secretary of Health and Human Services, right? Send Becerra the memo with card attached and urge that he send the card up the line.

You never know. The card might find its way into the President’s pocket.

Respectfully,

Richard Koenig