Remdesivir "could be a drug of no value in a year": Fmr. FDA & CDC Adviser

Dr. Roger Klein, Former Adviser to the FDA & CDC, joins Yahoo Finance’s Seana Smith to discuss the latest developments for a coronavirus vaccine as global cases surpass 4 million, according to John Hopkins.

Video Transcript

SEANA SMITH: I want to bring in Dr. Roger Klein, former advisor to the FDA and CDC. And Dr. Klein, let's just start with what we heard Ethan talking about, this thought out there that the number of cases could be significantly underreported at this point from your data, from what you're watching. What is your-- what are your thoughts on this?

ROGER KLEIN: Hi, Seana. Yeah, so I think there's no question that that's true. The Goldman numbers are really confirming what we already know, that the number of infections is far greater than the number of reported cases. And that's been by design.

I mean, we've-- we've defined cases by people we test. And we've chosen to test only the sickest people. So the estimates are ranging from anywhere from as much as 80 times the number of infections per-- relative to cases. In New York, serology data suggested it was 10 times. So again, I think this really isn't anything new. It's-- it's just confirming what we already know by another means.

SEANA SMITH: Dr. Klein, the number of cases throughout the US and, really, throughout the world, continuing to climb. We did have some positive news last week. And that the fact that remdesivir, the FDA approved it for emergency use. How-- I guess, how encouraging is this news? And then can you also talk to us about the limitations of this, the fact that it's only used or only approved now for emergency use?

ROGER KLEIN: Well, I-- the emergency use part I'll address first. And what it really means is that FDA is allowed to put on the market or to allow a company put on the market a drug that hasn't yet been approved. And that's-- but there-- but the data on which it's based are encouraging.

There was a randomized double-blind controlled trial, which is the best. And what we found was a three-day shortening in the time to recovery. There wasn't a statistically significant-- meaning something that can be firmly established-- benefit to mortality. But the hope is that, if it works and it helps moderate the infection, that it will, in fact, save lives. I think it's actually very encouraging.

SEANA SMITH: What about the distribution plan, so getting it to people in need? It's interesting because Department of Health and Human Services saying that states with the greatest number of cases have been allocated doses of remdesivir, the government now in charge of this distribution. Does that make sense to you?

ROGER KLEIN: Well, I-- in sense, I think that their reason for it-- it's a very interesting dynamic. So you have a-- you have a situation from the pharma industry, from the pharma side, where you have something that hasn't been done before, to my knowledge, at least in modern times, in this way, where you now have government in control of distribution of a drug. So I think that's something to keep one's eye on. It could set precedents that are potentially problematic.

But on the other hand, from Gilead's viewpoint, I think it could be useful. First of all, they don't have to make the decisions as to who gets the drug. So that kind of takes them off the hook.

The second-- to the second point, this drug is not approved. It's given under an emergency-use authorization. And perhaps having the government distribute it gives them somewhat a layer of legal protection in the event that problems ensue from use of the drug in certain settings or people think they do or accuse the drug of causing certain problems.

SEANA SMITH: Dr. Klein, what about supply? Because that's another potential issue here down the road. RBC was out, one of their analysts, saying that the number of doses of remdesivir being allocated to the US is much smaller than what was initially expected and that it could run out by the summer.

ROGER KLEIN: Yeah, so I mean, I think, look, these-- they're going to ramp up manufacturing of this drug, especially if it works. So I mean, you know, I think there's always a concern. But those shortages and those types of shortages tend to be filled relatively quickly. And we've seen that-- you know, we saw that with ventilators, for example.

You know, what ends up happening is the projections tend to overstate the demand. And the ability of the companies to respond tends to be understated. So you know, I think it's a concern. But I think it's probably not, at this point, a serious risk.

SEANA SMITH: Dr. Klein, I also want to ask you about cost because that's still a question out there. And that's something that has been making numerous headlines over the last several days. So how do you think Gilead prices-- how you think Gilead will price remdesivir? Do you think it will, one, set a bar for other coronavirus drugs? And then, from your viewpoint, how do you think this should be done?

ROGER KLEIN: Yeah, so right now, it's free. So that's an interesting way to price it. I've seen modeling-- and you've probably seen the same models-- that have priced it anywhere from $10 a dose to over $4,000 based upon the efficacy and what it accomplishes. I mean, you know, I really do think, in an ideal world, that ladder price point would be the appropriate one in the sense that what the drug accomplishes would be the price of it.

I mean, I think some people have amortized the costs already among-- it was designed for another use. And they've already written off those costs. And so there you would get a very, very low estimate. But I think a lot of these drugs, it takes-- the manufacturer of it is relatively inexpensive.

It's the development costs. And it really-- most drugs fail. Most drugs fail early. You put lots and lots of money into them. And I think it's important to reimburse pharmaceutical products at a price that encourages people to make them. This is going to be a drug that could be of no value in a year. So I think there's a lot of risk to it. And I think we need to encourage the company to go ahead and provide, they and other companies that are working on similar products.

SEANA SMITH: Dr. Klein, I also quickly want to get your thoughts just on the timing of the reopenings because, if you look overseas at some of the data that we're getting, we're seeing fresh outbreaks in South Korea also Germany now seeing a bit of a resurgence. Does this worry you at a time when we're seeing some areas of the country reopen when they're still seeing the number of cases climb?

ROGER KLEIN: The whole thing is worrisome. But also 33 million people filing unemployment claims is worrisome, too. And I think what we need to do is we need to look and understand the health issue in the context of what is a devastating situation from an economic standpoint, where we have, potentially, as much as 18% to 20% unemployment right now if you consider the people who have dropped out of the workforce.

I think I-- we have to be realistic about this virus. The likelihood is-- and I really hope it goes away. The likelihood is it won't. It transmits very easily. And there are way too many mild and asymptomatic cases to just think it's going to disappear. And I think we need to learn to live with it.

And that means moving forward. And then so I would highly encourage municipalities and counties and states to go forward, try to figure out the best ways to deal with it, work really hard to try to protect those who are at most risk. We know this virus really kills a very small maybe 2, 3, 4 out of 1,000 people it infects.

We already know that. We've got lots of data. You have the Goldman data, but they're behind. We've-- we have prisoner data, that of people in Ohio, Marion Correctional Institute, where older, sicker, male population, they've got about a 0.5%, 0.6% death rate. Over 80% of the prisoners that were-- in fact, they tested everybody. 96% presented with no symptoms.

So I think we need to be realistic about this disease. It's very serious for some people. I don't want to underestimate it. But I also think we would be-- it would be reckless to underestimate the severe economic consequences of prolonged shutdowns. These losses, the job losses that people think are temporary, could become permanent.

SEANA SMITH: And well, it goes back to the balancing act that Mayor Wheeler was talking about in the last segment. You just-- you have to weigh the economic impact and then also take into account the public health as well. So Dr. Klein, thanks so much for joining us today.

ROGER KLEIN: Thank you.