Ezekiel Emanuel on vaccines, Trump’s Covid-19 treatment, and what went wrong on the U.S. response

The controversy surrounding the Trump administration response to the Covid-19 pandemic grew still thornier after President Trump contracted the virus himself 11 days ago. The development quickly raised questions about the extent to which accurate information about his health was disclosed and his own access to medicines. And this occurred amid ongoing tumult over accusations that the administration continued to downplay the dangers of the virus while meddling in decision-making at the Food and Drug Administration and the Centers for Disease and Control Prevention. We spoke with Ezekiel Emanuel, a former White House health adviser who now chairs the Department of Medical Ethics and Health Policy at the University of Pennsylvania and is an advisor to the Joe Biden presidential campaign, about the optics and the concerns. This is an edited version of our conversation…

This has been a chaotic week or so. What troubles you the most about what we’re seeing?

I would say what I’m bothered by most is that hundreds of thousands of Americans died unnecessarily. It’s a terrible of waste of life and didn’t have to be that way. We’re having such a terrible response and an inability to implement basic public health measures. … If we’d done a lockdown better across the country, we could have lower transmission rates and then open things up much easier. But … we didn’t.

This ideology of freedom everyone talks about. Well, we have less freedom than they do in Taiwan and New Zealand, and Japan, because they took the right public health measures and we didn’t. There’s got to be a little pain for the gain, and so we have less freedom. That’s the fundamental lesson to be learned. If we had a leader who led, we’d be in better shape. We have data in JAMA comparing the mortality rates in the U.S. with other countries and the U.S. did not look good. It really does show you that instituting public health measures makes a big difference and when you institute them pretty rigorously, you can have a beneficial effect. Tens of thousands of lives hung in the balance.

Okay, let’s talk about Trump and how he was treated for the virus. He received a drug that’s still being tested under compassionate use. What do you make of that decision?

The president took this Regeneron drug as part of a compassionate use program, rather than enrolling in a trial. You get a drug as part of compassionate use when someone doesn’t necessarily qualify for a clinical trial. I’m not the wildest fan of compassionate use, because I think it depends on where it is in developmental stage and its safety profile. But let’s say there is a universe where compassionate use makes sense. The problem with this approach is that you lose knowledge. People are not contributing to understanding whether the drug works or doesn’t work. And that’s the fundamental thing we’re trying to figure out. It’s a good question in his case whether to have used it right away.

The [trial] data suggests it’s only for people who are not having immune reactions and antibodies are low. Were his antibody levels low? And if the levels weren’t low, what was the excuse for using it? But we knew nothing about the decision. It would be important to know the rationale for giving it to him. If that’s true that his antibody levels were low, then he should have been in the trial. He does seem to be the kind of person who would qualify. And we still have ambiguity about when he had the first Covid test. The sequence of events suggests he was diagnosed on [Oct. 1], if not before, because you don’t draw antibody levels willy-nilly.

The data, as I understand it from Regeneron, and all we have is a press release, is that the antibody cocktail is effective in people who don’t have a high response of antibodies to the coronavirus. In that group, it reduced the time of symptoms pretty substantially. So again, it sounds like he qualified [for the trial], especially if we think he got infected at the super-spreader event [at the White House]. That would be the rationale for giving him the Regeneron cocktail so rapidly. But if he qualified for the trial, it would have been better to be in the trial, because the world would have learned something. We would have gotten data as we do in all clinical trials.

Not every one can easily get the drug under such a program, right? But he is the president.

Yes, he is the president and part of being the president is he should get excellent health care, just like every American should get excellent health care. And he should model the right way to do things, which is to enroll in a trial when you’re eligible, especially for a condition for which we know so little how to manage and to learn how to evaluate how whether this drug cocktail works or not. In that regard, if he was eligible for a trial, he wouldn’t be treated any differently. There are how many people enrolled in Regeneron trials? Whatever the number, that would be not treating him any differently. Getting a drug through compassionate use on such a short timeline is treating him differently. He would have been a great role model for the rest of the country, especially if he was going to get it anyway.

But it revealed his underlying selfishness – it’s all about me – and not about other people. There’s a lack of empathy and an attitude that says it’s not about what’s good for the country, which is in stark contrast to the way every other president has behaved.

The dispatches on his treatment and health were also an issue. Why should be concerned?

This was not a normal doctor-patient relationship. He is the president of the United States and, in that sense, he is being trusted with deciding major issues, some of which require immediate decisions. He has possession of the nuclear codes. So the public needed more information. It’s not acceptable that we didn’t know when his last [Covid-19)] test was taken and for several days, whether the results were positive or negative. You can’t hold a press conference and then hide behind [health privacy laws]. That’s ludicrous. It’s perfectly acceptable to share all of the positive information, but none of the negative information? That’s an absurd claim. Those aren’t the kind of privacy claims that a normal patient has. His health has implications for the rest of us. So don’t give us only the happy story.

Let’s talk about vaccines. How should we handle allocation?

That’s going to be a problem. ACIP [the CDC’s Advisory Committee on Immunization Practices] hasn’t come out yet with its recommendation. Unfortunately, our experience with the H1N1 virus wasn’t that great in adhering to the ethical guidelines, partly because the states have to implement those guidelines and if you’re going to get fidelity, the states have to do it well. In the post-op evaluation, we didn’t get an A grade and there were two things, in particular, relevant to this situation. Health care workers didn’t get that much vaccine and there were racial disparities. It’s a decade ago and it’s hard to believe we’ve gotten that much better. So we can’t wait to the last minute to figure this out. It requires federal leadership, which has been woefully lacking here.

You were among numerous academics and scientists who recently wrote open letters (here and here) urging Pfizer and the FDA to maintain standards for monitoring trial participants for two months so there is sufficient safety data. And then Pfizer approached you and some others over criticism the company was moving too quickly. What transpired?

They did reach out. We did talk and they explained from their perspective what their statements [about the possibility of having a vaccine by the election] meant. And I explained to them what I thought the problem was in terms of communications. I think I said pretty clearly they could have done a better job in communicating their point. From their perspective — and now I’m interpreting what I think they said to me — they believe it’s possible they will have a signal on effectiveness by the end of October. But they will not have a signal on safety because they specified a period of time – either a minimum or median of two months — but it won’t be available using either standard until after election. They couldn’t submit to FDA anyway until the end of November or early December, because they just won’t have the safety data. Even if you know its effective, a vaccine is of no use unless you know it’s safe.

So I think they wanted to clarify what they said. I told them they could do a press release or other things so it’s clear. You know, there’s statistical significance, clinical significance, and also psychological significance. People have to be convinced to take these things and convinced it’s safe and effective. Kamala Harris got it right in the debate. She said if the experts look at the data and say it’s safe and effective based on parameters, she would take it. But Trump just says he would take it. But that’s not a statement anyone can rely on, because he’s been wrong over and over about Covid.

This post was updated to note that Emanuel is an advisor to the Biden presidential campaign.