The Next Coronavirus Nightmare: There's a Drug Shortage on the Horizon

Reuters
March 18, 2020 Topic: Security Region: Americas Tags: CoronavirusSymptomsTreatmentDrugsTesting

The Next Coronavirus Nightmare: There's a Drug Shortage on the Horizon

Dr. Scott Gottlieb, the former commissioner of the Food and Drug Administration, weighs in on how to tackle the coronavirus pandemic and what the future holds for those Americans who haven't been infected by the virus.

 

And the other side of the equation here is that the immunity you get after you get infected—there is now good evidence that people who even become mildly infected to coronavirus develop a sustainable immunity (and there’s now evidence, in monkeys, in a study that just came out recently, that monkeys who develop the infection and were rechallenged with this virus could not become reinfected). So there is some pretty good evidence and there is also some evidence for humans that suggest that. So there is pretty good evidence to suggest that you develop immunity and you can’t be reinfected, but I think most people believe that that immunity is not a life-long immunity and that it will last for a period of time and then it will wane. And maybe the second time you get the infection it won’t be as severe, but you don’t have enduring immunity. Even if 10–20 percent of the population gets coronavirus—and I hope it’s not that many and that we can keep it down to much less than that—but even if a sizable portion of the population gets coronavirus, and you have a portion that is immune to it after it courses its way through society and around the world, even those people could probably be susceptible to it at some point in the future. 

Heilbrunn: Do you think we are taking drastic enough steps right now to prevent the spread, or would you recommend even more sweeping measures as far as the isolation of the U.S. population? 

 

Gottlieb: I feel more confident now than I felt a week ago because of the aggressive steps that governors and mayors have been taking. If you look at what Andrew Cuomo has done in New York, he’s been very aggressive right from the outset. So I think we’re seeing very aggressive actions on the part of governors and mayors to mitigate the spread of the virus. My only concern is that it’s not uniform across the nation. There are still some cities and some states that probably have a bigger risk, or a bigger threat from major outbreaks, that haven’t been as aggressive, so the weakest link is always the weakest link. So if everyone else is taking aggressive steps and one city doesn’t, and that city becomes the focal point of the epidemic, and continues to seed other parts of America, that puts everyone in a difficult spot, even the cities which have taken aggressive steps. So I think it needs to be consistent across the country.

And it’s not that every part of the nation needs to have schools closed and curfews and bars closed, restaurants closed. There is a component of this where you’re going to be reactive, not just preemptive—there are certain things you want to do that are preemptive—but there are certain things you are going to do that are going to be reactive. You’re going to wait until you have some cases identified or evidence of some community spread before you take certain actions—and that’s appropriate. But certainly for the cities where there is evidence of the same community transmission, where you know you have community spread, you should have a consistent approach to the kinds of mitigation steps that we are taking.

But the fact that San Francisco and New York have taken such aggressive actions, and that we’ve seen such aggressive action in Ohio and Illinois, Boston and Massachusetts, I think that that’s going to bode well for trying to get a handle on this epidemic. And I think in some respects that we’re further ahead of where China was at a relative point in their epidemic, in terms of our ability to identify the spread and the community, or at least acknowledge the spread in their community. I think China identified the spread in their community earlier, but just didn’t acknowledge it and were unwilling to take tough mitigation steps. The point at which China acknowledged there was sustained community transmission, which was long after the fact, and the lockdown in Wuhan was about six weeks. They took a long time to take their mitigation steps.

There are some places that I don’t think we have taken strong enough action relative to the threat. I’ve been very concerned that Seattle didn’t take mitigation steps early enough and still hasn’t taken mitigation steps that are as strenuous as what I think meet the risks they are facing. I think Seattle and New York City look like the biggest hot spots in the country in terms of having sustained community transmission and we are going to start turning over the card on that. We didn’t really have the diagnostics in place to really identify the scope of the spread that was going on in these states, but we are going to have that screening in place by the end of this week. And with increased screening we are going to start seeing a rapid acceleration, I fear, of the number of cases. 

Heilbrunn: Given how reliant we are on overseas drug manufacturing, at a time of crisis like we are now, what about the safety of the drug supply? Should Americans be worried about accessing medicines in the coming months or is that not a huge concern? 

Gottlieb: I think that is a point of concern. I think there is a real risk that we see a series of drug shortages out of what is going on globally. The FDA has talked about twenty sole source drugs from China that are at risk because they are only produced in China. I think the list of drugs that could be at risk is much larger than that. It’s not just drugs that are exclusively manufactured in one location, but drugs where a partial proportion of the total supply is manufactured in one location. If 20 or 30 percent of all the available drug is manufactured in a location offsite, that is enough to sustain a pretty significant shortage of that drug. Because you don’t have a lot of excess capacity in that system where other manufacturers can just easily make it up. But it’s a complicated supply chain and there are disruptions throughout the supply chain because this is a global crisis. In China, a lot of what’s manufactured are the chemicals and inputs that go into drugs, so it gets shipped to India, and the active pharmaceutical ingredients, the actual chemical that is the drug gets manufactured in India, and that API (active pharmaceutical ingredient) get shipped to parts of Europe or other parts of the world and gets tableted, turned into drugs. That’s a complicated supply chain. And at every point in that supply chain, you have had epidemic spread or you’re probably going to have epidemic spread. India looks very suspect right now and there is the potential for disruptions. 

The other thing to think about when we are talking about diagnostic screening and rolling that out on a mass scale is that there are shortages of reagents used to extract the RNA from the samples, the actual viral RNA that is in the sample, such as a nose swab. There are reportedly shortages of the reagents needed to extract that RNA and test that sample. There are also reports of the potential for shortages of the actual swabs used to swab people’s noses to get the same itself.

What it demonstrates is that the weakest point in this complicated supply chain for critical products is often the lowest margin product. Because the high margin products, the [machine that actually performs the diagnostic screening—that’s a machine that costs hundreds of thousands of dollars. That’s going to have a very secure supply chain so they can be sure that they can continue producing those machines. They’ve invested heavily into manufacturing, they have redundant capacity, they have a continuity of business plans. It’s always the lowest-margin product in a supply chain, that’s still a critical product, that ends up being the weak link. In those cases, it’s a consolidated manufacturer who hasn’t invested as much in redundant capacity, who hasn’t invested in manufacturing itself so the manufacturing could be more vulnerable. So in this case, what is the lowest margin product involved in screening a patient for coronavirus? It’s the Q-Tip. So you need to think about what the weakest point in the supply chain is for when you have any critical activity. You can use economics to figure it out because it’s usually the lowest-margin product. 

Heilbrunn: Clearly relying on overseas supply chains can pose risks to domestic drug supply. Given how much money we are investing in the development of these new products, and the urgent need to have them available to patients in the U.S., how confident do you feel that we will have domestic capacity to manufacture the drugs and vaccines to combat this disease?

Gottlieb: The kinds of products that I’m talking about would be branded products made by branded companies. Typically, some of that manufacturing is domestic. Some of the branded companies have business plans in place that allow them to have supplies on hand to continue seamless manufacturing for very extended periods of time—up to a year—Regeneron, for example, the company that I talked about that is developing the antibody, their manufacturing is domestic. Whatever is done outside the United States, I would believe that they would have tight control over their supply chain and the ability to continue manufacturing because you are dealing with higher-margin products and businesses that have invested substantial resources into their manufacturing.