America’s Perpetual—and Preventable—Cancer Drug Shortage
Reading Time: 7 minutesWhy Cancer Drugs Are Running Dangerously Low, Why cancer drugs are running dangerously low.
Currently, around 14 different chemotherapy drugs are in shortage. These are generic drugs, pretty basic ones, that are absolutely fundamental to chemotherapy treatments for more than a dozen types of cancer—and the current shortage is so dire that it’s threatening the care of hundreds of thousands of patients around the country. But while this shortage is unprecedented in scope and the number of patients affected, the problem itself is nothing new.
On the June 30 episode of What Next: TBD, I spoke with Ed Yong, who covers science for the Atlantic, about how things got so bad and why these kinds of shortages are a feature, not a bug, of the cancer drug market. Our conversation has been edited and condensed for clarity.
Lizzie O’Leary: In your story for the Atlantic, you traced some of the shortages to an Indian drug manufacturer named Intas Pharmaceuticals. What happened?
Ed Yong: Intas Pharmaceuticals manufactures many kinds of generic drugs, including cancer drugs, that are then supplied to the U.S. Last November, the FDA conducted an inspection of Intas’ plant in India, and it found just farcical conditions. Basic steps that are necessary to ensure that the drugs are of high quality, that they’re pure, that they’re at the right dose, that they are free of bacteria and other contaminants—they just weren’t being taken. Sometimes they didn’t exist. Worse still, the plant seemed to be engaged in a cover-up. They had shredded and hidden documents. One quality-control officer admitted to dousing some documents in acid. As a result, Intas was forced to shut down production. It so happened that this company was supplying the U.S. with half of its cisplatin, half of its methotrexate, 20 percent of its carboplatin. It had a huge market share in a lot of these incredibly important drugs, and that was one of the things that precipitated this wave of shortages.
How did a company with those practices capture so much market share?
These kinds of drugs are generics. They are not patented, and they are sold at extremely low prices. That means that they are very, very unprofitable. Those low profits mean that a lot of manufacturers have just left the market entirely, leaving it weak. The other problem is that these drugs are very hard to make. Unlike the kinds of medicines that we can take in oral capsules, cancer chemotherapies are injected into the bloodstream, and usually into the bloodstream of people who are extremely sick. The quality control has to be really exacting. You do not want a single bacterium inside this stuff, but there’s no incentives for companies to actually invest in upgrades or training for quality control. That creates weaknesses. It means that the manufacturers are vulnerable to either spontaneous manufacturing problems or the kind of disastrous inspections that we’ve talked about. If those happen, other manufacturers—of which there probably aren’t very many—can’t compensate, and then you have a shortage.
That’s part of the answer. The other part is that the market is completely opaque. It’s not just that it is small and frail, but that you cannot see either the weaknesses or the strengths of it. A lot of the people who work in this space didn’t know that Intas had 50 percent of the market in cisplatin until the plant went into shutdown.
It seems almost unfathomable that major hospital systems and purchasers wouldn’t have a sense of the durability of the market. Why is that?
I think it is completely unfathomable. We’re not even talking about the high-end, state-of-the-art, super expensive new drugs that patients might struggle to access. These are the basic, vanilla, front-line drugs that have been around for decades, and should be the most accessible.
Let me give you an example of how little we know about these markets. There’s a drug called fludarabine that is currently in shortage. If you look at FDA approvals, there are 12 companies that are licensed to make it, which seems like a strong market. But actually, only five of those companies market the drug. Based on publicly available information, we do not know which of those companies makes how much of that drug. We know a bit more because of a Senate committee inquiry which showed that of those five, one makes the drug itself, two others actually get their drug from Europe, and then one of those two supplies the final two of the five companies.
There is currently no way for any hospital, or any purchaser, to actually see any of that, or to make decisions based on that. Because there’s no quality-rating system or transparency of the data, what happens is that people make decisions based only on price. Then the manufacturers have this massive race to the bottom, where they’re competing solely to lower prices, and that pushes them to cut corners.
It feels obvious that some government agency should be keeping track of this market. Who should be in charge here?
Often, people point the finger at the FDA because they are a regulatory body, they approve medicines, and so on. But the FDA isn’t really an economics agency, and this is fundamentally an economics problem. One simple way of summarizing everything I just told you is that the problem is the inability of the market to observe or reward quality. That is beyond the scope of the FDA. Part of the solution to this problem is identifying some kind of agency that can actually take ownership so that it doesn’t slip between the cracks of different parts of government. One good candidate for that is an agency called ASPR [the Administration for Strategic Preparedness and Response], which currently handles preparedness for emergencies—so, natural disasters, or, hey, a pandemic. ASPR does a lot of things, including shoring up medical supplies, to make sure that the drugs we need are available when we need them. You could very easily argue that this shortage of cancer drugs is just an ongoing emergency created by this dysfunctional market that we’ve ended up with, and thus it falls within the purview of an agency that’s designed to stop these kinds of emergencies from happening.
Where does all this leave patients and doctors right now?
It leaves them in a really bad state. A lot of the cancer treatment apparatus just doesn’t work without a lot of these drugs. Now, the worst-case scenario, of course, is that a patient who gets cancer might just not be able to get treated, which is almost unfathomable. Cancer alone, it’s a horrible diagnosis to receive, and I think one thinks that the question is always ‘Is there a cure?’ I don’t think anyone ever imagines that there might be a cure, but you can’t have it because the drug isn’t in stock.
Currently, what I’ve heard from a lot of oncologists is that hospitals around the country are trying to make this work, and they’re succeeding, but just. Sometimes they are lowering the dose that patients receive. Sometimes they are spreading out the doses over longer intervals. They’re really doing everything they can to make their meager supplies last for as long as possible. They’re pulling every string possible to get more of these drugs. But some of the oncologists have told me that their colleagues are starting to have to ration care. Some of them are having to ration care themselves. An oncologist named Patrick Timmins, who’s a gynecologic oncologist, told me that at his hospital, he can treat people who come in with primary ovarian cancer who just had a new diagnosis, but he no longer can offer these drugs to people with recurrent cancer, because he doesn’t have enough. Even though giving them cisplatin, or carboplatin, might really help to improve their quality of life, might give them a lot more months, or even years, of good-quality life.
Those are the stakes. People’s lives will be shortened. Their treatments might be harder to endure. On top of all of that, there is the psychological cost. Being told you have cancer is shattering. A lot of the time, cancer patients just want a plan. They have to rearrange so much of their lives to get care, and to deal with this horrible problem. To add to that the knowledge that ‘I can treat you now, but maybe I won’t be able to in two or three months unless this thing resolves’—that’s a horrible toll on top of the toll that they already must bear.
What needs to happen to create a less vulnerable and opaque system?
You need to shift all of the incentives in the market in a direction that actually promotes stable manufacturing, that promotes resilience, that stops these ludicrous inspections that lead to shortages. One really important way of doing that is to have some kind of badge of quality. The FDA has actually been working on a program that rates different drugs. Say you have cisplatin from this company. The rating will tell you how reliable the supply chain for that is.
There are also a couple of nonprofits which are doing similar things. There’s one called RISCS, which uses manufacturer data to rate different kinds of generic drug products based on how robust the supply chain is. There’s one called Civica, which is negotiating between hospitals and suppliers to get long-term contracts for lots and lots of drugs that they buy in volume. That gives the supplier a bit of a guarantee. That’s the kind of thing we need to add more stability so that hospitals can now see which manufacturers are going to be most reliable, which ones are not going to go down in a shortage. Again, there is no current way of making that choice, because you just don’t have the information. Getting the information will be really, really important. Then, you have to make it more compelling for hospitals to actually use that information. You could imagine a situation where, say, Medicare has a payment scheme where it reimburses hospitals according to the quality of the drug manufacturers that they choose to use. That would then compel them to use these ratings.
One thing you’re bringing up here is the difficulty of rewarding quality in the American health care system. Why is that such a hard shift to make? Everyday quality is a thing that Americans want, and yet it does not seem to be the thing that the economic structure of the U.S. health care system rewards.
I’m struggling to give you a better answer than just waving my hands and saying, ‘Well, that’s capitalism for you.’ But also, that’s capitalism for you. The structure of the market is so utterly dysfunctional. Unlike the supply chain problems that result from external shocks, like a hurricane or a pandemic, if the shocks are coming from within the market itself, you know they’re going to happen. You know where the problem is, and you know how to fix that. Reports have come out for a decade-plus about how to fix this problem. I hope that the huge stakes of the current shortages will compel more people to actually take these kinds of actions that we all, ultimately, will depend on.
Reference: https://slate.com/technology/2023/07/cancer-drug-shortage-supply-chain.html
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