In an interview on CBS Face the Nation Scott Gottlieb affirmed the position that the Trump administration erred in not directing national drug production of antibody drugs like Regeneron’s.
Due to its priorities toward corporate profiteering, the Trump administration dropped the ball with Regeneron production. Mass production could have been initiated in April with or without the Defense Production Act. All that’s left is finger pointing about a disaster. Now there will be drug rationing, and more deaths.
LEONARD SCHLEIFER (Regeneron CEO): A vaccine- well, it depends on how you acquire this immunity. If you get it in the form of a vaccine, it’s hoped that it might last for years. In some cases, vaccines can last for decades. If you get it in the form of natural immunity, that isn’t known yet.
MARGARET BRENNAN: Right.
SCHLEIFER: Could be months, could be years. If you get it in our vial, if you will, that’s probably going to last you for months.
MARGARET BRENNAN: A few months, OK. The president has also said he wants to make your drug free to anyone who needs it. Have you talked to the president about this idea, and how would it work?
SCHLEIFER: Yeah, well, we’ve talked to the administration a lot about this, and what they decided to do is take some risk. Back in the spring before we actually had any data from randomized trials. They went ahead and said, listen, you start manufacturing the product, we will commit to buy it from you. Stop manufacturing the other products that you’re working on or move them elsewhere. And let us make sure that if it does work, it’ll be available. And what the government said–
MARGARET BRENNAN: That was a 450 million dollar contract that the US taxpayer paid for. So–
MARGARET BRENNAN: But how much supply–
SCHLEIFER: And they will get the drugs–
MARGARET BRENNAN: How much supply did taxpayers just buy? Because the president says he’s making it free to everyone.
SCHLEIFER: Right, well, they bought from us several hundred thousand, maybe around 300,000 doses, which they are going to make it for free. What I think that the administration has been working recently- I saw an announcement with- with AstraZeneca. Look, we need- Regeneron can’t do this alone. We need the entire industry. And I’m so proud the industry has risen. We have companies like Lilly, great companies. We’re partners with Roche, one of the best companies in this whole field. Amgen is involved. AstraZeneca is involved. Black-Scholes is involved. We all have to step up–
MARGARET BRENNAN: Right.
SCHLEIFER: — if we’re going to provide enough of this.
MARGARET BRENNAN: Well, and exactly that point, providing enough is a key question. There were nearly 60,000 people infected in this country on Friday alone, just on Friday. Regeneron in that FDA emergency use authorization application that you said you made this past week, said there are doses ready for 50,000 patients.
MARGARET BRENNAN: That’s not even enough.
SCHLEIFER: It’s not enough.
MARGARET BRENNAN: It’s not even enough for one day of infection. So who decides who’s going to get the supply of your drug?
SCHLEIFER: Right. So I think this is going to be worked out by the government, by- in consultation with the FDA, in consultation with ethical experts. Coming up with a distribution system where we take what’s limited, and we try and give it to the people who most need it, who would most benefit from it. The vulnerable people, elderly people, people who are at high risk, household contacts perhaps. We have to figure out ways to ration this. And we have to get the entire–
MARGARET BRENNAN: And the government would do that from your understanding, decide who gets the drug and who doesn’t?
SCHLEIFER: I think in consultation with local health authorities, that’s what they’ve been doing with remdesivir, Gilead’s drug.
MARGARET BRENNAN: The CDC is not conducting the contact tracing. Washington, D.C. is not. The national security adviser said the White House was doing it, but that he was unable to pinpoint the source of the infection. How important is it to pin that down?
DR. GOTTLIEB: Look, I think they have an obli- this is the President of the United States. This was a gathering of high level officials. I think they have an obligation to understand how the infection was introduced into that environment. They might not be able to pinpoint it, but they should be very aggressive in a forensic analysis right now to try to find what the source of the infection was and see who brought it into that environment. And that's going to be important also to understand who else could be at risk. Are there any people who came out of that event who could be asymptomatic right now and should go get tested to make sure they're not continuing to spread to other officials? There doesn't seem to be a very concerted effort underway. I've talked to a number of officials who are at that event on Saturday, and a lot of focus is around that event as one of the potential places where the introduction was made, and they haven't been called yet by contact tracers. So that's concerning.
MARGARET BRENNAN: That is concerning because that suggests potential further spread. Speaker Pelosi mentioned she had concerns about the type of testing that had been used at the White House. You warned on this program back on May 10, that the Abbott Labs test that the White House was relying on was not sufficient to detect asymptomatic spread of COVID-19. Is it a matter of technology? Why did the procedures fail?
DR. GOTTLIEB Well, look, the Abbott test is a very good test when used appropriately. You have to fit the right test to the right purpose. The White House was relying almost solely on testing as a way to protect the president. They needed a zero-fail testing protocol because they weren't taking any precautions beyond testing people who are going to be in contact with the president. And that requires multiple layers of testing. If you want a- something close to a zero-fail testing protocol, and you're never going to be able to achieve 100%, you would probably be needing to use a PCR-based test at the point of entry at the White House. So the Cepheid GeneXpert probably would be more fit to purpose. But frankly, you'd need double layers of testing. You'd probably want to test people before they depart for the White House, and then test them again when they arrive. And even that wouldn't be 100%, but it would get you closer. Using these kinds of tests and- and they're now using the BinaxNOW as well- the antigen based tests and- and the Abbott ID NOW, using that to screen an asymptomatic population to try to detect virus, you might only have 50% sensitivity, perhaps a little bit better than that. But you're going to–