As a cancer patient, I am really glad there are drugs out there to treat it. That includes chemotherapy drugs like Taxotere and Cytoxan, immunity-increasing drugs like Neulasta, anti-nausea drugs like Zofran, and endocrine therapies like Zoladex and Arimidex. As shitty as some of them are, these drugs have substantially upped my odds of long-term survival after breast cancer.
Yet as I learn more about cancer drugs as a class, I find myself thinking that we’ve gone too far. That—as much as I’m sure I’ll be the first to gratefully agree to a six-figure course of treatment, should my cancer return—we are spending too much on them relative to other treatments and other diseases.
In the last couple of weeks I’ve gone from being shocked by a $15,000 a dose price tag to seeing it as reasonable, relative to $150,000+ courses of treatment. The fact that prices have spiraled ever higher, even as most new drugs don’t greatly extend survival, is an indictment of a broken system.
Some responsibility lies with drug companies—or at least the ever-present pressure for profits. Yet we can’t lay blame entirely at their feet. It is government that structures our healthcare system—however unintentionally—to incentivize these results. Legal scholar Robin Feldman calls our runaway spending on cancer drugs “regulatory failure by success.”
Feldman’s point is that it is rules and regulations that have created a system that 1) allows for super-high prices and long periods without competition, 2) rewards pharma investments in the types of drugs that can charge such prices, and 3) does so without regard to how much benefit they provide for patients. This regulatory environment pulls the entire system toward a focus on cancer drugs, massively driving up costs while only modestly improving outcomes. And that focus necessarily means less focus on other types of treatment—say, antibiotics—with smaller profit margins but that might have greater human benefit.
Feldman identifies four “positive” policies (active regulatory decisions) that have contributed to this “cancer curse,” and two “negative” ones (decisions against particular policies). Several of these we have already touched on, including the difficulty of getting biosimilar drugs approved relative to traditional generics, and the lack of price negotiation by government buyers.
Others I have not yet mentioned. The Orphan Drug Act of 1983, for example, was meant to incentivize research on diseases affecting fewer than 200,000 people with tax credits and extended protection from competition. But over time, as we have come to treat not just “cancer” but increasingly specific subtypes of cancer, staying below the 200,000 threshold has become easier. At the same time, drugs developed and protected as orphan drugs are often repurposed for other treatments—with the result that 7 of the 10 bestselling drugs in 2015—including, notably, Neulasta!—started as specially incentivized “orphan drugs.”
Feldman’s larger framing is that the current cancer drug situation is the product of regulatory success: decisions meant to encourage development have, in fact, made it so profitable that we are now overinvesting and paying way too much. But I think there’s a different lesson to be learned here is well.
This is also about how medicine has developed in the face of a relatively stable regulatory environment: as drug development has shifted toward promising biologics, or genomics has made treatment more precise and treatment groups smaller, the existing framework works less and less well. The regulatory tools no longer fit the scientific landscape. The status quo will eventually stop working.
What, then are our options?
Some of these problems could in theory be fixed with regulatory changes; perhaps 200,000 people is no longer the right threshold for orphan drug benefits, or perhaps we need to limit additional incentives when orphan drugs are approved for other uses.
Others might be helped by more cost-effectiveness analysis—that is, more evaluation that drugs are actually extending/improving life relative to existing alternatives and their prices, something other countries rely on but the U.S. does not. (Yes, I’m suggesting we think a bit more like economists.) This would open up new issues worthy of their own discussion, but relative to the status quo of $150,000 drugs that extend life for three not-very-good months, might be an improvement.
But beyond thinking about investing in drugs that actually provide benefits in proportion to their costs, I can’t help but once again think about “care.” All this money, all this investment—yes, it sometimes cures and other times extends life. But drugs can cause misery as well—side effects often discounted by those who don’t experience them—and there is so much care we don’t provide to people because it isn’t as easily monetized.
For example, an increasingly strong body of evidence shows that exercise substantially reduces the risk of breast cancer recurrence. A drug that produced similar benefits would certainly be covered by insurance, and routinely prescribed. Yet we don’t do much beyond maybe telling people they should exercise; there’s no formal support for encouraging or facilitating this “treatment.”
And this is not even touching on the human side of care—of medical care that treats symptoms as well as diseases, that attends to people as humans and as individuals—which our system is set up so poorly to achieve.
A note moving forward: I will probably not be posting until the new year, unless I am feeling really compelled. But I am looking forward to continuing this writing. I suspect I’ll have more to say on both the personal and the more analytical side. And eventually I’m hoping to walk my way from some of these themes to my existing research, with the goal of reminding myself why I was doing it in the first place. (Cost-effectiveness analysis seems like a good candidate.) It’s all been very therapeutic—thanks for coming along for the ride.