Political Influence at the FDA, with former FDA Commissioners Mark McClellan and Robert Califf

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In maybe the most heated In the Bubble episode, Andy talks with two former FDA commissioners — Mark McClellan from the George W. Bush administration and Robert Califf from the Obama administration — and confronts them about the politicization of the FDA under President Trump. The former commissioners are hesitant to criticize the current head of the FDA, Stephen Hahn, but Andy pushes them pretty hard on Hahn’s inaccurate statements regarding convalescent plasma and what effect that might have on the public’s trust in the FDA as the agency gears up to approve a COVID-19 vaccine.

Keep up with Andy on Twitter @ASlavitt and Instagram @andyslavitt.

Follow Robert Califf on Twitter @califf001.

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[00:48] Stephen Hahn: We know we’re going to continue to collect data. We knew that for all of our emergency use authorization. So, for example, remdesivir, which was approved or authorized on May 1st. We’re still collecting data and we will continue to do that with plasma as well. So it’s the nuances of the language around the authorization that we use in the legal aspects. So I would say that if you’re one of those 35 out of 100 people who these data suggest will survive as a result of it, this is pretty significant for that person and their family. 


[01:25] Andy Slavitt: Welcome to In the Bubble. This is Andy Slavitt. We have a show today for you about the FDA. Who you just heard from was the commissioner of the FDA, Stephen Hahn, and which you heard was Stephen basically — I don’t know, how do you say it. Lying? He was talking about convalescent plasma and its benefits in a press conference with President Trump. And he said something that wasn’t true, which is really unusual for an FDA commissioner. And so we thought we’d have on two former FDA commissioners today. Rob Califf, who served in the Obama administration with me, and Mark McClellan, who’s been on before and served in the Bush administration. So pretty interesting having these guys on the edge of these questions, right, Kryssy?


[02:11] Kryssy Pease: Yeah. I mean, I was sitting there watching the conversation, listening to you really try and press them. And, you know, they tried to be kind of diplomatic in what they said and say that, you know, perhaps the commissioner misspoke, but man, you would not let them off the hook. 


[02:28] Andy Slavitt: It was a little uncomfortable because they’re both friends of mine. But I feel like you can’t have any friends in the podcast business. 


[02:35] Kryssy Pease: There’s no friends in podcasting! 


[02:40] Andy Slavitt: Look, I know what they’re going through because it’s hard to defend what he did, but there’s a reason why I pressed them. It’s because the public really has to figure out how to interpret what they’re seeing and hearing right now, because we’re going to have a vaccine at some point. And as we know, this is getting pressed to happen before the election. 


[03:02] Kryssy Pease: I think you’re really just kind of really playing — I mean, I think you like playing the role of an antagonist a little bit. But also you are really, you know, stepping in for the listener and asking the questions and trying to get the answers that you know these listeners need. I mean, it’s not light stuff we’re talking about. It’s very serious information. And you want to make sure that the listeners of In the Bubble and the general public knows what’s happening. 


[03:31] Andy Slavitt: Yeah. Here’s an idea. Go back if you have a minute and play the vaccine episode. It’s a little bit back into the archives, scroll down the page a little bit. And I had a conversation with David Agus and Mark McClellan and we talked about what would the criteria need to be for a vaccine to be approved by the FDA. And Mark said very clearly. He answered that question very clearly. Let’s let’s play it right here. 

[03:57] Mark McClellan: Well, I think where FDA is setting the bar is pretty reasonable, and that’s a 50 percent. That means a 50 percent reduction in how likely you are to get infected, or how severe the infection is, 50 percent reduction in having to go into the hospital if you get it. And that’s done with trials that are big enough that you won’t make a mistake. So you could be absolutely sure it’s going to be at least, you know, 20 or 30 percent effective. As you said, I don’t think we should expect these first round of vaccines to be effective in everyone, but they can make a really big difference and they’re still worth taking. I would take it if it met the standards that the FDA is aiming for now, which is really at least a 50 percent reduction. 


[04:44] Andy Slavitt: So go and listen to the whole thing, because it’s fascinating. And what you’ll find now is that a few short weeks later, compare that to what you’re about to hear on this episode and you’ll see why I was pressing him. 


[04:57] Kryssy Pease: You know, Andy, I think this is all really great and interesting, but you are what we say in journalism, burying the lede a little bit. I think you are not telling our listeners something very exciting. 


[05:08] Andy Slavitt: Oh, I don’t know. Do. Do we really want to talk about that? I guess it’s public. OK. I have a book coming out. I say kind of squeamishly. Because I’ve never written a book before. But yeah, I got a book coming out. It’s called Preventable. And let me read to you what it says on this topic. “The inside story of how leadership failures, politics and selfishness doomed the U.S. Coronavirus response.” That’s the name of the book. We’ve just spent the last week obsessing over what color the covers should be. What color did you vote for? 


[05:46] Kryssy Pease: I liked either red or teal. 


[05:48] Andy Slavitt: Yes, I originally liked the teal and then went with the red. 


[05:50] Kryssy Pease: You never listen to me, Andy. 


[05:52] Andy Slavitt: Well, I originally went with the teal, but then the teal got tired on me. So anyway, book should be available for preorder if you want to buy a preorder copy. I think you go anywhere you buy your books on the Internet, and if it’s not there yet then just keep hitting refresh like 100 times until it’s there. Anyway, I’ve got to actually finish the darn book now. Pens down September 30th. So I’m like in a full on, I don’t know, It feels like a deadline.


[06:29] Kryssy Pease: Then Andy, stop wasting time. Finish this intro and get back to writing. 


[06:32] Andy Slavitt: Let’s get to the interviews. Here are Dr. Rob Califf and Dr. Mark McClellan. 


[06:52] Mark McClellan: Hello. Hey, I really apologize. I’m not wearing a sweatshirt like apparently is the uniform today. 

[06:58] Andy Slavitt: All right. Very important conversation. I think people are confused, and I really appreciate Rob Califf and Mark McClellan, both of you joining. I introduced you guys before you came on. And you’re both former FDA commissioners. Tremendous reputations for integrity and science, very plugged into the things that are going on. Had really good tenures at the FDA, Rob, under the Obama administration when I was there, Mark, during W. administration. People are just very, very wired, uptight and confused. And I’m not talking about Washington people or influencers. I’m talking about people who are trying to figure out how to interpret what’s coming out of the FDA right now and what action that should cause them. And before we get into the issues at the moment, I just wonder if we might get like a one minute primer from each of you on what the FDA does, what its authority is, what the authority is in the context of a pandemic and how it should be operating. Maybe, Rob, you want to start your one minute on that? 


[08:04] Robert Califf: You want one minute on that? Oh, my God. 


[08:04] Andy Slavitt: Well, you could take longer. 


[08:07] Robert Califf: I’ll give it a shot, and then I’m sure Mark can fix anything. I’d start by saying, you know, the FDA has authority under the Food Drug and Cosmetics Act to regulate products which are sold across state lines. And that it’s kind of a funny thing to think about, but it has a lot to do with commerce and regulates between 20 and 25 percent of the economy. But fundamentally, the laws that have evolved, each one really coming into place because of a disaster, have given the FDA authority to require that there be evidence of benefit that outweighs risk prior to putting a product on the market. Now, this is most stringent for drugs, a little bit less stringent for devices. But it’s very clear that if you want to sell things across state lines that are medical products, you need to actually generate the evidence before you sell it. And then the FDA grants you the authority to market that product. However, there are times of crisis — nuclear accidents or wars, pandemics, natural disasters like hurricanes — where over the years people have realized, I think appropriately, that the FDA needs to step beyond that and do what’s best when there’s not time to develop the evidence and there’s a real need to get something out there. And so that’s where the EUA, emergency use authorization, comes into play. The FDA has authority to look at the potential benefits. And so, you know, the guidance for the latest guidance on this was put out in the last month of my tenure in the administration. And it’s pretty clear that the FDA has tremendous authority under this guidance to try to do what’s best, weighing the evidence that’s available and staffing beyond the usual evidentiary requirements.


[10:15] Andy Slavitt: It sounds it includes in the context of where we are today, things like tests, things like therapies, things like vaccines, things like masks. And I wonder if you can talk about the FDA’s role in verifying claims so that us as normal people can understand what is known and what is unknown about the drug. What does that mean exactly? 


[10:45] Mark McClellan: Well, as Rob said, the FDA’s regulatory authority amounts to how medical products can typically be marketed and used. And that means what a manufacturer can say about their product. And what they generally want to say, that it’s safe and effective, or at least safe and effective in the use that they’ve studied and gotten FDA authorization to talk about. In a pandemic, because the standard might change, instead of being, you know, there is clear evidence of safety effectiveness, the standard is maybe safe and effective. So you have to require some evidence of that. But, you know, there’s still room for questions. In an ideal world, you’d get more, you’d get more data before, say, making a new diagnostic test available or making sure that mask meets absolutely the usual manufacturing standards. But the FDA tried really hard when it applies these emergency use authorization standards to make sure that they are still being very careful about weighing the benefits versus the risk. That doesn’t mean that in general, all treatments are going to be approved if they have no evidence whatsoever. And it does mean that FDA keeps trying to relook at its decisions to make sure it’s taking account of that totality of evidence that’s available. 


[12:04] Andy Slavitt: But it aims to be very precise in what it says, what is known or what is unknown about the claim. OK. So, Rob, hypothetical question. Let’s say a manufacturer came to the FDA and claimed that a drug saved 35 percent of the lives, 35 out of 100 people that the drug was given to, get the treatment. And that turned out to be patently false. That turned out to be a massive exaggeration. And in fact, it wasn’t 35 out of 100, but it was a dramatically lower number. And in fact, it wasn’t even comparing drug A versus not taking drug, but there were all kinds of other drugs being taken and it was actually comparing the level of the drug versus the not level of the drug. But still, that claim was made. What would the FDA do? 


[12:45] Robert Califf: Well, if someone made that claim and it was patently false, the FDA would get that manufacturer to correct it and to put the correct information and data in there. 


[12:57] Andy Slavitt: Would there be civil and criminal penalties potentially? 


[13:00] Robert Califf: Well, eventually there would be if the manufacturer persisted. But we all make mistakes. And, you know, it’s really important to point out the FDA and the FDA mission, I call it explaining things to people, but try being precise to 330 million people, many speaking different languages at different levels of education and savviness. And, you know, one of the issues that comes up is that interpreting biomedical data from studies involves a degree of sophistication that’s very hard for even doctors to get right, relative and absolute differences, for example.


[13:36] Andy Slavitt: I obviously set you up for a question on the FDA commissioner’s basically false statement on convalescent plasma, where he said in a press conference with the president and Secretary Azar that the benefit of convalescent plasma was that it saved 35 percent of people who took it, would reduce their fatalities. He later corrected that, and said he shouldn’t have said that. But strikes me that, you know, in this world we live, the first time around, you say something, everybody listens, gets lots of press. By the time you correct it, it may be five or six percent of people actually listen and see the correction. And, you know, given the precision required and given the heightened time of the moment, forget questioning whether convalescent plasma should be approved or not. What do you think are the consequences of an FDA commissioner saying something that he had to know wasn’t true? 


[14:32] Robert Califf: Well, I mean, let me first say, I assume Dr. Hahn is an honorable person and he just made a mistake on this one, because that’s a fairly straightforward concept for someone with his experience to know that there’s a difference between the number of lives saved and the relative treatment effect. And by the way, I’m going to be tweeting out a series of tweets because I think this is so hard to explain to people. You have to put it out in little packets at a time to get it right. But to directly answer your question, there’s a reason that there’s 17,000 civil servants in the FDA and a handful of political appointees. The wise people that constructed our government realized that we needed an army of people who are not conflicted, who are not driven by politics, to make scientific and public health decisions. And that is the civil service. And there’s a center at FDA for each of those. And I think there’s a tradition of vetting information very carefully before making public pronouncements by the FDA commissioner because of what you said. The first thing that’s said will have a tremendous impact. And I think a second issue that came up was a new head of public relations at FDA had just been hired with no experience in biomedical science. And she amplified the problem by getting it even more incorrect in what she put out from the FDA. The main message here is we have to get at least the data right. People may interpret it in different ways, but if we don’t get the fundamental data right in what we say, it’s not good for the country. 


[16:11] Andy Slavitt: Let me just press you a little bit just to help people interpret what you’re saying. You’re a gentleman. You’re a polite Southerner. You have respect for your colleagues in the scientific community. But I want to make sure you’re suggesting that you think Commissioner Hahn made an error, not that he wasn’t colored by politics? This is a really important point, as you know, as we talk about a vaccine coming, because if it’s true that he made an error and corrected it — in other words, you can’t know for sure whether or not what motivated him. But unfortunately, given the position we’re in I think it’s important to a lot of people to understand, is there evidence now that the White House is having political influence on the judgments of the FDA?


[16:55] Robert Califf: Well, anyone who thinks there’s not political influence on the FDA 100 percent of the time is naive, Andy. And you know that well from the job that you were in when we were working together. And in fact, one of the FDA commissioner’s most important jobs, I believe, is to protect the civil service from the political influence. So I don’t know how many calls a day Mark got, but I will get more than one call a day from an upset politician somewhere about some issue, often mistakenly upset at the FDA, driven by lobbyists of one kind or another who had complained or something that happened in their district. 


[17:34] Andy Slavitt: The history of this kind of convalescent and plasma situation appears to be that the FDA was reluctant to approve convalescent plasma, though just basically the way the study is done. Again the president tweeted a day prior to the approval that the FDA was “the deep state” and then the next day we saw this. So I guess without having to pin you down about Hahn, how concerned are you? And maybe I’ll give you a rest for a second. We’ll go to Mark. But how concerned are you about political interference now? And I’m talking about inappropriate political interference. Because this is just relevant to the vaccine trust question. And I want to make sure we can help people at least interpret what they’ve seen so far. 


[18:13] Mark McClellan: Yes, I agree with Rob that there’s always pressure on the agency, that just comes with the territory when you’re making so many decisions that affect so many people and some of that pressure can come from the administration. Usually it may be more subtle, but Rob is exactly right about the right response and the role of the commissioner in protecting the agency. And from my standpoint, you’re pretty sure you’re going to be criticized no matter what you do. There are different ways to interpret the scientific evidence that exists, and to find that right balance between going fast and being thorough and getting that evidence. And a lot of being a good FDA commissioner is finding common ground, finding ways to do things better so you can get both the evidence you need and the fast action. But also being that protector of the process. I think one of the challenges that arose here was that we ended up focusing on results and maybe not communicating clearly about them. FDA generally puts out some reviews of how they interpret the evidence. People can criticize those, and I think Rob might be in those upcoming tweets, but none of the FDA documents said something about, you know, a 35 percent benefit. So it’s important, as commissioner to stick to those, and try to stick to communicating as clearly as possible. Well, I did wanna say is one more thing about the process here, you know, with a lot of tweets and things involved in election season, there’s a lot of fog around this. 


[19:54] Mark McClellan: I do think that the staff — at the at least my impression is the staff at the FDA who are directly responsible for overseeing it and interpreting that very important but also very challenging emergency use authorization authority were comfortable with the decision that was made on convalescent plasma. That doesn’t mean that every scientist has the same view. I think some of the NIH leadership in particular thought FDA maybe should have asked for more evidence. I’d love to see NIH do more to support clinical trials that could generate that evidence in the pandemic context, too. I think there are things that everybody could potentially have done better here. But I think what is most important when looking ahead to vaccines is giving the support for that career FDA staff to do their job in this very challenging area to do their job right. 


[20:49] Robert Califf: Yeah, I’m a little less confident than Mark about what he just said. Again, I think the FDA has the authority, but there are two really important things here. One is there’s often differences of opinion within the FDA. And it’s notable that the FDA review had the reviewers’ names redacted, which is almost unheard of in an FDA review. And that indicates to me that there was some pretty strong disagreement from people who were looking at the data. But the second thing that I think is really important, there is a long tradition of FDA commissioners not making decisions about individual products, and there’s a reason for that. The corps generally defers to the FDA because it’s seen as a scientific and public health agency, not a political agency. And if FDA commissioners begin to overrule staff, then there’s no reason for a judge to not also overrule the FDA. And so far, there is a very strong legal precedent for the courts not overturning FDA decisions because they defer to the scientific base. So to directly answer your question, Andy, there should not be direct political interference on the functioning and decisions of the FDA staff. That is abundantly clear. 


[26:27] Andy Slavitt: Let me just restate a couple of things you guys said, because I think they’re important. One is Mark, as you said, the FDA is going to be criticized no matter what. You move too slow and you can’t get enough products approved, or you’re moving too fast and you’re approving things that shouldn’t be approved. So I think we all should understand that these judgments that the FDA is being asked to make, there’s no way to make everybody happy. There’s no way to get them all right. The second thing I think that you delineated, both of you, very, very important, is the massive amount of great FDA scientists that are not at all political. They serve administration in administration out. They’re doing the job with hopefully the protection of the FDA commissioner to just do what they think is right. And it’s also fair to say that they may have disagreements and they may not always be right. But these are the people most qualified to be right. And it’s the people we hire to do the job. And if you think about the absence of the FDA, how would you ever do that job? How would you ever know if it wasn’t for these scientists? So I think you cleared a couple good things up. I just want to ask you, are either one of you willing to be at all critical of Commissioner Hahn and what he’s done here? Or are you both taking the Fifth on that?


[27:50] Robert Califf: Well, Andy, you know that I prefer to be critical on the substance, not the politics, because it’s such a hard job. But, you know, I immediately came out when I saw the error and said, please correct the error. And he did.


[28:09] Mark McClellan: And I appreciate him correcting the error. Just in the same category as Rob was saying, in times like this, especially looking ahead to vaccine uncertainty where we won’t have a vaccine that’s perfect. We are hopeful we’re going to have have multiple vaccines that make a significant difference. But they’re going to have benefits and risks and they’re going to be these same kinds of decisions, both for emergency use authorization, which I think would have to have substantially more evidence than we saw for convalescent plasma. Again, because this involves healthy people and because the trials underway now are about definitive results. And it also includes other processes going forward. It’s really important now not to talk about what the results may or may not be, but to talk about what the process is that FDA is following and the transparency around it and the integrity of the science. 


[29:08] Andy Slavitt: Let’s talk about that. The commissioner came out and said it was reported in the Financial Times, he had said that he had established — he had done a good thing. He established an appropriate standard for an approval of a vaccine, which was 50 percent effectiveness, in other words, effectiveness in at least half the people who took it. And now he’s reported as saying he may not even wait for the Phase 3 data to come in. He may approve an EUA in some form, even without that data. So the process that you guys described in the first 15 minutes of this show, which created a tremendous amount of leniency for the commissioner and for the agency in times of a pandemic, now he’s basically thrown it up in the air and say, I may just make up the process as I go.


[29:54] Robert Califf: Well, but Andy. Wait a minute. Let’s not over-interpret what he said just for hyperbole. 

I mean, the EUA does give the FDA the authority to make decisions. I mean, if we were in a nuclear war, you wouldn’t want the FDA waiting for the evidence before coming forward with countermeasures. And now we have, as you’ve highlighted, over a thousand people a day dying every day in the U.S., not to mention the rest of the world. And so decisions have to be made. What he said was he may not wait for Phase 3 to be completed. So let me talk about a hypothetical situation and see what Mark thinks about it, too. Let’s say you’re two-thirds done with the Phase 3 trials. The interim data shows a clear benefit, greater than 50 percent reduction in infection rate. An analysis of contingency shows that that is unlikely to be reversed as the trial is completed. But the database is not locked. You don’t have all the safety data like you normally do, but you have a clear signal that’s highly unlikely to go away. What would you do in that situation? 


[31:05] Andy Slavitt: Before you answer that, let me just make the question a little more real. There’s one thing that’s as important, and you guys have pointed it out, as the efficacy of the vaccine. Equal from a mathematical standpoint. And that’s the level of trust in the vaccine. So you can have a vaccine with 100 percent effectiveness and 30 percent trust and you’ll have the same outcome as if you have a vaccine with a 30 percent of effectiveness and a 100 percent trust. And so it seems to me that casual statements — and I’m going to be more critical. And I know you both have. There’s a long tradition and history of being careful about criticizing your successors. And you’re absolutely right. He’s in a difficult spot. And the only reason I’m pressing this is honestly because I think people are having a very difficult time knowing how to interpret what’s going on. And so I’m not trying to be overly critical of the commissioner, but I am trying to make it as clear as possible how people should interpret what’s going on. So you take your situation, Rob, exactly as you describe — two-thirds of the way through. It’s not reversible. The data looks good. And you just call it early. Or do something untraditional. And that diminishes the trust that people have in the vaccine, which is not only an asset of this country for today, it’s an asset to this country for the next 100 years that has to be preserved. This is why I feel like it’s so important to understand what’s going on here. And, you know, if you were FDA commissioner still, would you still be focusing on trying to figure out how to make sure you’re preserving that trust as this decision gets made?


[32:38] Robert Califf: Yeah, of course. And so there are two other things I’d say. You don’t have to criticize the commissioner to point out that it’s not the role of the politicians to make these decisions. It’s the role of the civil servants. And the commissioner’s job, to a large extent, is to be the buffer between those two things. And it’s really, really important that that happens. And it’s important for the commissioner to make statements which are not totally ambiguous. And so, you know, I think those are just critical points. But it’s also true that the judgment here needs to be done in the light of sunshine. In other words, if there is an unconventional decision to be made, it had better play out in a public way so that everyone has access to the data. And there can be some sense of confidence in the scientific community that the civil servants have played the critical role and that the uncertainties that are residual — and this is what I’m going to address in my tweets — the residual uncertainties are actually understood by someone who has a responsibility of making sure those uncertainties are resolved over an appropriate period of time. 


[33:49] Mark McClellan: Just to add to Rob, if I’m a member of the public, what I want to know now is there a good decision process in place that everything we talk about I think is reasonable in principle. We’re in an unprecedented pandemic. It calls for unprecedented steps. We’re seeing that with vaccine development, with just enormous acceleration of not cutting corners, but doing very large-scale trials far faster than they’ve ever been done before, and pre-manufacturing millions of doses of vaccine before we even know whether any of these vaccines work. And what is important in the process now is that we’re getting to the right answer. I think the American public should have confidence that FDA is overseeing the clinical trials that are underway in a way that will give us a chance of getting a good answer in a much faster timeframe, because the trials are really large and they’re devised with some really clear endpoints. So the endpoints that matter for these trials are actually reducing the number and severity of infections, as you said, Andy, by 50 percent. That is the way the trials are set up. And by definition, these trials aren’t going to end until they’ve enrolled lots and lots of people and follow them long enough to see number one: is there at least a 50 percent reduction, if not more? And the number and severity of infections and preferably good information on different types of patients, elderly, others with different kinds of health risks and the like. And that there’s not a significant safety problem there would make this dangerous for at least certain kinds of people to take it if they don’t have COVID. There’s gonna be a lot of healthy people who are going to be getting it. 


[35:42] Andy Slavitt: I have a question for both of you. Hey, Mark, before you go, let’s ask you one last question. Just to run an example by you. I’ve been a big proponent of getting reusable, comfortable, breathable masks to the public because in many respects, these washable, reusable, ones people could own, they’re much lower cost. There’s one actually, that’s a sponsor of our program called Livinguard that was approved in the European Union’s body. It’s in front of FDA, but feels like a game changer in that as soon as the FDA approves a product like that, it is essentially sending the message to the country, it’s clearing up for the country the message that got kind of muddled at the beginning, which is that masks do help. They do reduce the spread. And I think having one that is both comfortable, reusable, etc. So a product like that, walk through like the optimal way for a product like that to go through the FDA process. 


[36:54] Mark McClellan: Yeah, well, first off, I really appreciate all you’ve done to try to encourage people to wear masks, to keep that six foot distance or avoid big groups. If just about all of us did that, we’d be in much better shape for the pandemic. That’s an opportunity that’s still there. And we all need to keep working on together. And you don’t actually have to get FDA approval to start wearing a mask. Where the FDA comes in is if the mask manufacturer wants to be clear that, you know, their product has a differential benefit, a differential effect for healthcare workers. There are some N95 masks that were in short supply earlier. FDA took some steps to get additional kinds of masks approved with N95 quality. They rejected a lot of masks, too, that claimed to be that good and really weren’t. And they also approved some ways of reusing these high medical grade, you know, emergency COVID-setting masks. And it’s possible to get some claims maybe below that level along the lines that you’re describing. And I think it could make a difference. I think that the most important thing is people should wear a mask. And remember that not all masks are created equal. The really thin ones are not so good. The ones with vents are definitely not good for protecting people around you. And that the more progress we can make, and hopefully FDA can help us get there with masks that do a good job of stopping droplets and that are easy to wear, the better. So, you know, this is another of the many, many ways in which FDA regulatory oversight, done in a way that keeps up with the science and the needs of the pandemic, is just critically important.


[38:44] Andy Slavitt: Thanks, Mark. I know you gotta run. Rob and I will finish up.


[41:40] Andy Slavitt: There’s probably a 2,000 pound elephant in the room that I haven’t mentioned in the context of this conversation, which is that obviously we’re in an election. And so when you think about the vaccine trust issue — and Hahn is obviously aware of the election, because every other statement that I’ve read from him, he says this is not political. He is trying to make it clear that it’s not political. I don’t know what confidence to have in the commissioner’s ability to resist those entreaties with this election coming. So, you know, you said the most important thing already, which is we gotta look at the data, and we gotta try to put all that stuff out of our heads and have independent minds, say you got to do this in the sunlight, in the light of day, etc.. But if you were the FDA commissioner, is it irresponsible to grant an EUA way in October just before the election? 


[42:29] Robert Califf: Well, the answer is it depends. And, you know, keep in mind a couple of things. Number one, we do have a group of former FDA commissioners who are bonded, despite being appointed in very different administrations, including Scott Gottlieb, who served in the Trump administration. We don’t say a lot, but when we do speak, I think a lot of people better listen. There’s something you go through in this job where you gain greater respect for the institution than you do for any transient political things. Secondly, the group that has to make this decision inside the FDA is led by Peter Marks. I appointed Peter to his job. I have complete confidence in him. And if he is overruled, which, by the way, the law, just to make it clear, there’s a chain of command from the center director to the commissioner to the HHS secretary to the president. It’s totally within the authority of that chain of command to overrule the staff. It has almost never happened in the history of the FDA. Maybe once or twice in the total history of the FDA. If Peter is not comfortable with a decision, he has publicly stated he will resign. And I believe he will do that. And that will be a major signal that people need to look at. I have a lot of confidence that we’ll get the read from what the FDA thinks, regardless of other politics that may intervene. 


[43:58] Andy Slavitt: I worry both ways, Rob. I worry that a vaccine should be approved and is approved and people don’t trust it. And I worry that it should be approved and it’s not clear whether it should be approved. 

[44:09] Robert Califf: You know, I mean, Mark made this point, but the right place to be at the FDA is typically when all sides are pissed off, because that means you have found a right middle ground. Because there’s always going to be differences of opinion about this kind of data. I think a good way to think about FDA is like sports officials. The FDA oversees the game. It plays by a set of rules. The commissioner plays under the rules by setting policies that are general. But the application of the rules in the individual game is on the field officials and those of the FDA staff. Much like good sports officials, they don’t care who wins the game, but they really admire a good play. And they try to make the best decision given the set of rules that they operate under. And, you know, we’ve got a set of rules here with ambiguity, which just emphasizes, again, you have to do this with sunshine, with the light of day. And if the evidence is insufficient, I think the scientific community will rise up. If it’s just 50/50, that will just have to be a decision that’s made. But we better pay attention to the post market if that happens. 


[45:18] Andy Slavitt: But my point about the election is what’s magical about October 23rd that you know, that you would call a Phase 3 trial quits before it was done, if it was weeks or months away from finishing right before an election when you would destroy trust. You may be right that they know where it’s headed. But in the process, they destroy trust in vaccines. 


[45:40] Robert Califf: You know, that brings to mind another thing that’s a dictum at the FDA. The FDA doesn’t adjudicate the integrity of the companies, per se. That is, if a company has a great product, even if they’re scoundrels, you know, you don’t want to deny people access to a great product. And I think in this case, far be it for me to understand exactly why someone would push for a particular time, but if the evidence is clear, we owe it to people to get the vaccine out there. And that should be our primary interest. Of course, there are political implications and motivations. And so that’s again why I say if it’s rushed, and the evidence is not clear and not substantial enough, I think the scientific community will weigh in heavily. 


[46:30] Andy Slavitt: You don’t buy my argument that following the process, even for another four weeks or 30 days, to demonstrate that the FDA did what it said it was going to do, it followed a process, even if it’s a little bit of form over substance, if it enhances trust in the vaccine from, you know, 40 percent to 70 percent or some numbers, which has as much to do with the vaccine effectiveness and achieving herd immunity as the effectiveness of the drug, you don’t buy my argument that that’s just as important factor for the FDA to take into account? 


[47:02] Robert Califf: I think it’s a valid point of view. And I mean, you’re pushing me to say what I would do if I were in the job. And, you know, what I would do is to try to get the trials done as quickly as possible, and have a set of interim analysis rules that were clear and established ahead of time. And they would not be driven by an election day, they would be driven by the percent completeness of the data. That’s the way we normally do interim analyses in clinical trials. I’m just saying that if someone makes that decision, it’s really important for us not to let politics on the other side, the anti-President side deny the public a vaccine that could save lives. That’s all I’m saying. 

[47:44] Andy Slavitt: Yeah, that’s exactly right. Anything else we should’ve talked about? Anything I trapped you into saying that you wish you had said? No, you didn’t. You were so you are more judicious than I’ve ever seen you.


[48:03] Robert Califf: Well, you’re you’re you’re a very political host here, Andy.


[48:07] Andy Slavitt: I don’t think I was being political. I really don’t. I think people are confused and I really worry about long-term trust in vaccines. And if I’m suggesting that I think President Trump is inclined to interfere in the FDA, and you think that’s a political statement, that’s not a political statement.


[48:25] Robert Califf: No, no, no. I think that you’re being provocative in the way you asked the questions, but that’s that’s fine. 


[48:30] Andy Slavitt: That’s because I wasn’t getting clarity for folks on what it meant and whether or not we were in a strange spot or not. And I still don’t think you guys gave clarity. But, you know, I think you guys did the best you could given that, you know, there’s limitations on your ability to be effective with the commissioner and as a public voice, doesn’t allow you to not be even-handed and provide even-handed answers. And I totally get that. And I and I totally respect that. 


[49:05] Robert Califf: All right, man. Hopefully it’ll be helpful to some people that want to get a sort of a balanced sense of where this could go. 


[49:12] Andy Slavitt: Thank you so much. Appreciate it, buddy.


[49:19] Andy Slavitt: All right. I am worked up after that interview. I think that was a really important episode. And I was really pleased we could bring it to your bubble because we have a really controversial question here. Anyway, we will be doing a lot more conversation on the vaccine. On Monday, in fact, we have an episode on testing that is I think really incredible because it’s with two of the bigger innovators who are figuring out where we’re going next. When are we going to finally have testing? What kind of testing we’re gonna have? And when is it gonna be available at home and all of these things? I thought it was great and I would say that’s a pretty positive episode. Then on Wednesday, we have Julián Castro. He has got a new show called Our America, which I think you’re going to want to listen to. And as we roll into the election, it will be interesting to talk to Julián about taking stock of where we are as a country, what we learned this year. The following Monday is someone who I have been dying to get on this show. And I don’t know if everybody’s heard of him, but his name is Ed Yong. If you have, you know why I’m dying to have him on the show. If you haven’t, go search The Atlantic for any of the recent columns that Ed has written. He may go down as one of the best chroniclers of the most salient issues of the pandemic. And I’m really excited to talk to him. You know, I love having people on this show who are just much smarter than me because we just learned so much that way. Anyway, thank you for listening.

[51:08] Andy Slavitt: Thanks for listening to In the Bubble. Hope you rate us highly. We’re a production of Lemonada Media. Kryssy Pease and Alex McOwen, produce the show. Our mix is by Ivan Kuraev. My son Zach Slavitt is emeritus co-host and onsite producer. Improved by the much better Lana Slavitt, my wife. Jessica Cordova Kramer and Stephanie Wittels Wachs still rule our lives and executive produce the show. And our theme was composed by Dan Molad and Oliver Hill, and additional music by Ivan Kuraev. You can find out more about our show on social media @LemonadaMedia. And you can find me @ASlavitt on Twitter or @AndySlavitt on Instagram. If you like what you heard today, most importantly, please tell your friends to come listen. But still tell them at a distance or with a mask. And please stay safe. Share some joy and we will get through this together. #StayHome.

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