Janine Jackson interviewed Public Citizen’s Peter Maybarduk about the drug industry and Covid-19 for the May 1, 2020, episode of CounterSpin. This is a lightly edited transcript.

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Axios: Gilead CEO says remdesivir has been donated to treat "most urgent" patients

Axios (5/3/20)

Janine Jackson: The CEO of Gilead Sciences says he’s “humbled” their drug remdesivir shows promise of working against Covid-19. That rings rather differently than mere weeks ago, when the company applied for, and received, so-called “orphan drug” status for remdesivir, granting them a seven-year monopoly under a clause meant to encourage production of drugs few were interested in making. Gilead had that status rescinded after elevated public outrage, presumably discovering this humility somewhere along the way.

The behavior of drug companies in this pandemic is reminder that while the virus may be novel, healthcare is a crisis all the time in this country, as profit-driven companies behave like profit-driven companies in a nation where many people can’t afford to both buy their medicine and pay their rent. So not allowing a potential treatment for Covid-19 to be monopolized for years by Gilead is a start. But if that’s where we end up, we’ll still be in trouble.

Here to talk about Big Pharma in the time of the coronavirus is Peter Maybarduk. He’s director of Public Citizen’s Global Access to Medicines Program. He joins us now by phone. Welcome back to Counterspin, Peter Maybarduk.

Peter Maybarduk: Great to be with you.

JJ: What happened with Gilead and remdesivir, and their pushing for so-called orphan status, for a drug that was developed with some public spending, by the way — it just seems emblematic of the perverse incentives and regulatory system failure we have with regard to pharmaceuticals. What was set to happen there, until groups like Public Citizen stepped in and shouted it down, essentially?

PM: Gilead would have earned itself a windfall, an extra two years of monopoly protection over what would have been expected, by gaming the system and, as you said, claiming that a potential treatment for this world-changing pandemic was actually rare in some fashion. They put in the FDA application while there were still fewer than 200,000 cases, I believe is the required number. That number was slated to change in a matter of days, reported cases in the United States. So they got it in just under the wire, as if it were a rare disease, rather than a rapidly expanding pandemic. So Gilead would have been able to exclude generic competition for longer, and count on that boost and potentially higher prices; and, instead, had to back off.

JJ: You had a comment, I saw, saying that having to give up orphan status was a good “first step” for Gilead. What else do you think that they should be doing?

PM: Gilead should be focused on committing its patents and know-how to the public domain to help the world ramp up production of remdesivir, should it prove safe and effective.

It’s a tremendous problem that we operate under a system of monopoly drug development. It’s always a problem as regards price. But in the midst of this pandemic, price is, in a sense, almost the least of our concerns. It’s a concern, it’s real, it’s going to be a problem. But greater problems involve getting up to scale for supplies, so that everyone who needs treatment can get it.

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No corporation has manufacturing capacity sufficient to treat the world. It will be an even greater problem as regards potential vaccines. So we really need companies cooperating with other companies, and with governments, in allowing any qualified manufacturer to produce these treatments. Manufacturing capacity is one part.

The other part is just, we need all the information—all the science, all the know-how, all the technology—in the public domain, so that we can build on it and develop better treatments, better tools, so that someone could make a better remdesivir, or could draw on the lessons of the science for another product, or combine it with another product in some fashion, and keep improving the medical response. All that gets fragmented, the response limited, if companies are monopolizing these treatments, and saying we’re going to enforce our patent, and so on.

JJ: If I could build on that, to get your thoughts on another place where the US can seem out of touch, besides just the whole idea that healthcare and profit-making don’t mix, is the idea of international cooperation. How badly has US isolationism, or exceptionalism, impacted the coronavirus response? Or, to say it differently: How might such international cooperation move us forward here?

Peter Maybarduk

Peter Maybarduk: “If one country fails to control the pandemic, other countries are going to pay a price. And so we all need to be working together on it.”

PM: We’re very concerned about the Trump administration’s maneuvers to potentially pull US funding from the World Health Organization, generally denigrating international cooperation. And there are allegations that the Trump administration tried to purchase a German vaccine manufacturing company, have them move to the United States. The administration has put restrictions on 3M’s ability to export masks to Mexico.

We actually need the integrity of the supply chain preserved. We need global leadership and coordination right now, because no company has sufficient capacity to tend to global need, nor does any given country, in the nature of a pandemic—and this pandemic, too, which seems to come with dangers of reinfection:  The disease courses through one part of the world and comes back. And so if one country fails to control the pandemic, other countries are going to pay a price. And so we all need to be working together on it. And that applies not just to the United States.

It’s in the United States’ interest that we’re working with other countries to have the most robust response possible, to make sure healthcare workers are getting what they need, to make sure the disease is getting tamped down so it doesn’t come back worse and harder here, let alone the economic and security consequences of the pandemic really ravaging vulnerable parts of the world, something that the United States and all countries may have to steward for a very long time to come.

So nationalism is a pretty dangerous idea to be flirting with right now, and there are tremendous positive alternatives if we decide to really go in on this together. We can pool the world’s science and technology to accelerate the development of better medical tools, to ensure that there is ample manufacturing capacity worldwide for personal protective equipment, for masks and ventilators, but also for medicines and vaccines. Not even just those related to coronavirus per se, but medicines that are going into shortage.

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The cost of moving medicines around the world is increasing, supply chains are endangered, we have to redouble our efforts to make sure the supply chains are working. If we work on that together globally, we can make it happen.

There’s a proposal for the World Health Organization to shepherd an open technology platform, where companies like Gilead and entities like the US government, that invest quite a bit of taxpayer dollars in technology, would put all their know-how and tech together, so that qualified manufacturers the world over could say: “I want to use that. I’ve got an idea for how I can build on that to make something better.” Or, “We have manufacturing capacity in our part of the world to produce that technology here as well, to make sure there’s adequate supply in our part of the world.” WHO can lead in that, but it may need US support to do so, and we’re obviously having a hard time getting there under President Trump.

JJ: Yeah, there is another vision, yet another area where there is another vision that is sometimes obscured from us, including by US media.

Let me just ask you, beyond Gilead and remdesivir, I know that Public Citizen has issued a call to big pharmaceutical companies about not price-gouging in a pandemic. And as you’ve just indicated, it’s not just about Covid-19 related drugs, it’s about, really, all drugs as well.

PM: That’s right. It’s standard practice for pharmaceutical companies, across their portfolios, to increase the price of old drugs, an average of 10% per year. That’s an outrageous practice, when you think about it. These aren’t the new drugs. These price increases aren’t contributing anything to innovation, but they do contribute to treatment rationing and people’s suffering. It is literally just a practice and what’s become standard business in the pharmaceutical industry: You raise your prices every year; prices don’t go down over time, they go up. And the monopoly environment obviously helps facilitate that. So we think the bare minimum that the world should be expecting in the pharmaceutical industry, in the midst of this pandemic, is not to make the problem worse.

JJ: Yeah, you might say almost that any price raise is gouging. “Gouging” sounds like some kind of extreme term, but we’re already at a moment where people are going to have less money, some are going to have no job, so a regular—for the industry—a regular old price hike on a drug can really mean a huge difference in someone’s life, yeah?

PM: That’s right. Financial hardship and emotional hardship may get worse as people’s sense of isolation increases. And, of course, we’re suffering historic rates of job loss in the United States right now; many people are getting by without insurance.

Now, even before the pandemic, we had a very serious problem of treatment rationing, close to one in three people reportedly rationing their own access to medicine at some point, due to its cost. Insulin rationing has resulted in a number of people’s deaths in the United States. And, of course, we have a crisis of deaths of despair, of an overdose crisis in the United States.

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Now, we need to make sure that everyone can afford their insulin. We need to make sure that cities can afford Naloxone, and other overdose antidotes, in ample supply—again, so everybody can access them. That is harder if prices are going up, while ability to pay is going down. So it’s just a minimum contribution, to not price-gouge during a pandemic.

JJ: At the end of this write-up recently, in which Gilead’s CEO said that they’re very humbled, and it seems like a real change of tune from just a few weeks ago, the CEO makes these statements about building “a global consortium of pharmaceutical and chemical manufacturers to expand global capacity and production,” and countries working together and “collaborative efforts.” So it sounds like they’re at least saying they’re going to do some of the things that folks would be calling on them to do. So is that a change of tune for them? Or what did we maybe miss on the original go-round on that story?

PM: There is some recognition in the pharmaceutical industry that these are not ordinary times, and that they need to strike a different tone. There are, of course, also areas where scaling up supply matches business interests. There are ways in which Gilead has been a little out ahead of some other companies in its announcements, in its efforts in general to work with suppliers in other parts of the world.

So while we were outraged by the apparent cynicism of the orphan drug exclusivity maneuver, it’s not generally the case that we’re trying to single out Gilead here. There’s a tremendous problem with the business model, and both corporate malfeasance and just too much public acceptance of a really terrible business model.

What Gilead has announced here, their voluntary mechanisms, are not enough to do what we really need to do as a matter of public health in the pandemic. They’re not enough, because it may not be enough supply. It won’t liberate the science the way that we want.

But also, we don’t have any checks and balances; it’s just Gilead telling us, in still rather vague terms, what it hopes to do. We have to actually be in a position to mandate what must be done, because people’s, all of our health is really at stake, if we don’t respond quickly enough. So we shouldn’t just take commitments to very, very loose ideas, and Gilead saying that they’re going to take care of it. We actually have to step in and insist and ensure.

There could be a pretty big difference between Gilead working with a few manufacturers that it has chosen on its terms, and the US government saying, “We are going to ensure that all qualified manufacturers can make it.” That could be a big difference of scale. That could be a big difference in price. That could be a big difference in access to the know-how. So we really need to insist.

JJ: We’ve been speaking with Peter Maybarduk, director of Public Citizen’s Global Access to Medicines Program; find their work online at Citizen.org. Peter Maybarduk,  thank you so much for joining us this week on CounterSpin.

PM: Thank you.

 





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