FDA’s Hahn Vows to Stick to the Science Amid Vaccine Pressure

(Bloomberg) -- The U.S. Food and Drug Administration is facing controversy after its commissioner, Stephen Hahn, substantially overstated the benefits of an experimental therapy for Covid-19 patients.

In a press conference with Trump, Hahn said the therapy — blood plasma from recovered patients — could save 35 of every 100 people who would have died. Those high-profile remarks were incorrect, and they were repeated by others in the Trump administration. Hahn late Monday clarified some of what the data on blood plasma actually show.

But the episode has raised questions about how the agency will review a vaccine, as well as its scientific independence as Trump’s reelection hinges on his response to the virus. 

Bloomberg spoke to Hahn by phone. The conversation has been edited and condensed for clarity. 

Bloomberg: You’ve taken a lot of criticism and scrutiny over the 48 hours since the press conference with the president. What’s that been like?

Hahn: It's been a challenge. The thing that has been the most challenging, has been trying to get out the public health message. A lot of things have happened in the last two weeks regarding convalescent plasma. And I think the convergence of all of those things created the impression of political interference. That's the biggest concern because I have complete trust in the scientists at FDA. 

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.

Bloomberg: What was the internal reaction at the FDA to your error? 

Hahn:  We've had frank discussions about it. We're sorting those out. I am going to have to correct that and I'm going to have to accept the fact that I made a mistake and own it. I think that's the first start.

Bloomberg:  Other people in the administration have taken your misstatement and repeated it. Have you asked them to take those statements down or correct them? 

Hahn: I have not spent time talking to others in the administration about this. I did have a conversation with [Health and Human Services] Secretary [Alex] Azar about this. I feel like my job is just to clarify from an FDA point of view, what we meant. The White House is aware of my attempts to clarify the situation. But other than that I have not had any additional conversations.

Bloomberg: What happened in your conversation with Azar? 

Hahn: We just discussed this issue and making sure that the right information is out there.

Bloomberg: It's an incredibly political time, and people are already inclined to distrust what they hear. Do you worry that the public perception of the FDA has been hurt by this?

Hahn: Absolutely, I worry about that. I can only hope that being honest and straightforward lessens that impact. But as you mentioned, we're in an incredibly politicized time, and these are really difficult concepts to explain to the American people.

At the end of the day, I know my patients never cared about relative versus absolute benefits. They just wanted to understand if the juice is worth the squeeze. The totality of data was in support of a promising benefit and safety.

Bloomberg: Do you worry making blood plasma more widely available will make it harder to get patients into clinical trials? If I'm a Covid-19 patient, why would I sign up for a trial and maybe get a placebo? 

Hahn:  Yeah, I do worry about it. We aren't going to be able to twist doctor's arms to enroll their patients. The gold standard of a randomized trial would be incredibly helpful here. We may find that the benefit goes away with more data. If that happens, we're going to reevaluate our EUA.

Bloomberg: President Trump has been a proponent of drugs like hydroxychloroquine, even after the FDA pulled back an emergency authorization when it was found not to be helpful. Do you feel that political pressure and that it could happen with other products?

Hahn:  Yeah, I'm aware of it. I’ve listened to all the conversations. But what I tell internally our folks is they need to make the decisions based upon the data. I have not reversed one of their decisions, nor do I intend to unless I think it's absolutely wrong. So, yeah, I listen to it, but it's not going to change what we do.

Bloomberg: There was a report by Reuters that Peter Marks, who leads the group in the FDA that reviews vaccines, would resign if the agency approved a vaccine without enough safety and efficacy data. Did he say that? 

Hahn: Peter did not say that to me. But it wouldn't surprise me that that is accurate. 

Bloomberg: What would you, personally, do if you felt like you were being asked to rubber-stamp a vaccine?

Hahn: I'm not going to speculate, other than to tell you that it would not be okay for me and I would not participate in any decision that was made any on anything other than the science.

Bloomberg: There was another report, by Axios, that White House adviser Peter Navarro told some FDA officials that “You are all Deep State and you need to get on Trump Time,” accusing the agency of slowing down work to hurt the president politically. Did that happen? 

Hahn: I was not present for that comment. I have heard it reported. I just don’t know when or if occurred. What I can tell you is that I feel very strongly that the 17,000-plus FDA employees are true professionals. None of them wants to delay getting medical products into the hands of Americans.

Bloomberg: What level of evidence is needed to get a vaccine into people's hands, for example on an emergency basis to an at-risk group? More than for blood plasma, or for hydroxychloroquine? 

Hahn: Remember a vaccine is given to healthy individuals. So it's a different clinical circumstance than giving plasma to hospitalized, sick patients. That has to be considered in the decision making.

Bloomberg: Do you think the FDA has more political independence because of its public health role? Should it? And has that changed at all? 

Hahn: The FDA is often caught in the middle of a lot of different conversations. It’s magnified because we're in a significant public health crisis. And what FDA does in a public health crisis is to try to get medical products to address that crisis. FDA always feels under a microscope with respect to its decisions. It’s never gonna make all people happy. 

Bloomberg: Do you think the FDA should be an independent agency, like the Federal Reserve, instead of part of the Health and Human Services Department?

Hahn: I hadn’t really thought about that.

Bloomberg: It might sound good right now.

Hahn: I hadn't really thought about that. I think it's worth consideration, because of the issues that we're talking about. So I don't really have a stance on it because I haven't put much thought into it. I don't want to rush into giving you an opinion about it.

Blomberg:  Have you grappled with the possibility that you’ll have vaccine data right before, or right after, election day, and how you’ll handle that? 

Hahn: Of course I've thought about it. We've been thinking about this, frankly, since the spring and early summer.

It's why we put out vaccine guidance on June 30th, because we wanted to put our marker down. We wanted folks to know what we're going to need to see from a safety, efficacy, patient, or volunteer population point of view. It’s why we feel so strongly about having a vaccine advisory committee review the data with us. And we spent a lot of time internally thinking about how can we adjust our processes to make sure it's all hands on deck when we receive the data.

Bloomberg: Do you think it’s realistic to have a vaccine in the hands of patients by then?

Hahn: I'm a cancer doctor. I tell my patients I don't have a crystal ball, and I most definitely do not have a crystal ball here. I don't think it would be prudent for me to speculate on that because I just don't know.

©2020 Bloomberg L.P.