The following is a transcript of an interview with former FDA Commissioner Scott Gottlieb that aired Sunday, August 30, 2020, on "Face the Nation."
MARGARET BRENNAN: We go now to former FDA commissioner Dr. Scott Gottlieb, who joins us from Westport, Connecticut. Good morning to you.
DR. SCOTT GOTTLIEB: Good morning.
MARGARET BRENNAN: So we're around 41,000 infections a day, 900 or so deaths a day. How dangerous is it to be taking this level of virus into the fall with us?
DR. GOTTLIEB: Well, I think it's concerning. August should have been a slow month. We should have seen infection levels come down in July and August. They didn't. We saw an epidemic cross over the Sun Belt and we saw infections actually increase. They're coming down now. So that's a good sign. Hospitalizations are coming down. And I think that's the most important thing to be looking at because it's the most objective near-term measure on what the state of the epidemic really is. So hospitalizations are about 36,000 down from their peak. Hopefully they'll continue to come down. But as we head into September and October, kids return to school. People are starting to return to work. We're likely to see infections start to go back up again. And we know that hospitalizations lag infections and so we could see hospitalizations rise as well. The most concerning trend right now is that as we see the cases fall in the Sun Belt, they're picking up in other parts of the country, particularly across the Midwest and the west and particularly in rural parts of the country. And that's a big concern because those parts of the country probably have less health care resources to keep up with the epidemic. They don't have the same kinds of hospitals and same kinds of resources to deal with an epidemic like this.
MARGARET BRENNAN: I want to ask you about an interview that was just posted in the Financial Times with the FDA- current FDA commissioner, Dr. Hahn. He said, or he appears to say, that he is open to approving a vaccine before phase three trials are completed. That's the stage at which the most sort of rigorous testing is done. I mean, Russia and China did this and were criticized. Why would the FDA commissioner say that he's considering doing that here in the US?
DR. GOTTLIEB: Well, I saw the article, I don't know what is meant by saying before the phase three trials are completed. These phase three trials are event-based trials, meaning that they're going to start to read out data after a certain amount of events accrue in the clinical trials. And those events are people getting COVID infection. And so as the trials progress, if we start to see lower rates of COVID infection in the active group, the group that receives the vaccine versus the placebo group, the group that hasn't received the vaccine. The trials could read out earlier if the- if the vaccines are very effective. It's likely that the trials aren't going to read out until October. In order to read out in November- in November, they won't read out until November. In order to read out in October, the vaccines would have to be very effective. And so I'm not sure what he means by approving it earlier than when the trials are completed. They're going to wait for these trials to read out before they can make a decision around the efficacy of these vaccines. Now, it's likely going to be the case that the first authorization of these vaccines are going to be an emergency use authorization for select populations that are at higher risk of the infection, either because of what they do, people who work in health care, for example, health care jobs, or because of comorbidities, people who are older, maybe nursing home patients. So we're likely to see a stepwise progression of authorization of this vaccine for certain select populations that are at higher risk of either contracting it or having a bad outcome before we see a full approval for the general population. I think, again, of full approval for the general population, where people can go to CVS and get a shot, that's really a 2021 event, maybe the first quarter of 2021, probably more likely the first half.
MARGARET BRENNAN: But for the FDA commissioner to say something like this, I mean, it's going to be ultimately his job to approve a vaccine for Americans to go get those shots in the arm whenever they are available. For him to say something that suggests bypassing protocols, isn't that very damaging for the public agency that Americans need to trust?
DR. GOTTLIEB: Well, look, I think that the agency should be speaking to the process and the process is rigorous. The process is well established. The agency has put out very clear guidelines of what the approvable- approvability of these vaccines is, what the metric is that they're going to use as a basis to approve these vaccines. And what they've said is the vaccines need to be 50% effective in either reducing the incidence of COVID disease or reducing infection, reducing people actually getting infected. And so it's- there's very clear, objective criteria that's been put out. I think that's what the agency should be speaking to and its leadership should be speaking to, the process, the fact that it's- it's well articulated. There's clear guidelines put out. It goes through multiple layers of review among professional scientists, career scientists who have been doing this a very long time. And ultimately, the decisions are made by career leadership of the clinical centers, of the biologic center. I think people can have confidence in that process and that's what they should be pointing to, not speaking about, you know, the circumstances in which decisions might be made earlier or later. I think just focusing on the process and the process itself, if we rely on that, it has integrity and rigor to it.
MARGARET BRENNAN: Just to be very clear. Are you saying that the FDA commissioner couldn't do what he seemed to say he would possibly do in this article?
DR. GOTTLIEB: I don't think the FDA commissioner could step in--
MARGARET BRENNAN: OK.
DR. GOTTLIEB: --and obviate a decision by the professional staff.
MARGARET BRENNAN: Gotcha.
DR. GOTTLIEB: And I don't think he can stop these trials early.
MARGARET BRENNAN: Gotcha. I want to ask you about schools. Schools in a number of states have seen some level of outbreak. Is it best practice to shut the school down or to just isolate those kids?
DR. GOTTLIEB: It depends on the precautions that the school has been taking. If schools are doing a better job of trying to control infection within the school, children are wearing masks, they have children in defined cohorts so that if there is an infection in one class, they know that that class hasn't been exposed to other classes. It's just the children in that particular pod. I think they can make a reasonable decision just to maybe have children in one particular class go and get tested, stay home until they clear, until they test negative as opposed to closing down the entire school. And this really speaks to the importance of putting those precautions in place so that they can isolate affect- infection more effectively. And a lot of schools are doing that. I think that's very prudent.
MARGARET BRENNAN: The CDC changed its guidance on testing. Why do you think they did it? Because the American Academy of Pediatrics says they object.
DR. GOTTLIEB: Well, look, I think it's unfortunate because I think that we should be testing asymptomatic people who might be at high risk of contracting the infection and what the new change in the guidance spoke to was the need not to test, purportedly not to test people who might have been exposed to the infection but haven't yet developed symptoms. We should be testing those people to make sure they haven't become infected and aren't asymptomatic carriers because we know that they can spread the infection. They're less likely to spread the infection, but they can still spread the infection. What I'm told by people on the inside is one of the reasons that drove this decision is that businesses were requiring people to test negative for infection before they can return to work. If that's the case and that was a concern, there were more targeted ways to address that and speak to that problem, as opposed to making this very broad, sweeping change in the recommendations, which I think could be misinterpreted by the general public and certainly by public health agencies within states. And so I don't think this- this changed guidance is likely to be followed by many states. I think it's prudent that we test people who might be at high risk of contracting the infection.
MARGARET BRENNAN: Dr. Gottlieb, always good to talk to you. Thank you. We'll be back in a moment.