Recently, the New York Times published an illuminating article by Austin Frackt entitled Why Preventing Cancer Is Not the Priority in Drug Development. In it, the author reports on research conducted by an award-winning team of economists from MIT and University of Chicago, who have shown how “economic incentives encourage researchers to focus on treatment rather than prevention.”
He goes on to explain: “The way the patent system interacts with the Food and Drug Administration’s drug approval process skews what kinds of cancer clinical trials are run. There’s more money to be made investing in drugs that will extend cancer patients’ lives by a few months than in drugs that would prevent cancer in the first place.”
How does this work? As the researchers explained in an email to Frakt, ““R & D [research and development] on cancer prevention and treatment of early-stage cancer is very socially valuable, yet our work shows that society provides private firms — perhaps inadvertently — with surprisingly few incentives to conduct this kind of research.”
Indeed, preventing cancer is socially valuable, but apparently not particularly profitable. Why is this?
To secure F.D.A. approval, after patenting a drug, drug companies race the clock to show that their product is safe and effective. The more quickly they can complete those studies, the longer they have until the patent runs out, which is the period of time during which profit margins are highest. Developing drugs to treat late-stage disease is usually much faster than developing drugs to treat early-stage disease or prevention, because late-stage disease is aggressive and progresses rapidly. This allows companies to see results in clinical trials more quickly, even if those results are only small improvements in survival. (NYT)
In other words, since late stage cancer patients are all going to die soon, it doesn’t take long to figure out if the treatment is effective in staving off the inevitable by a statistically significant amount of time. On the other hand, treatments designed to prevent cancer, like the vaccine developed by Cuba, require longitudinal studies which by their very nature take many years to complete, in order to see if the treatment reduced the number of cancer cases versus the control group.
Clearly there are many problems with the U.S. approach. It is always better to prevent a serious disease than it is to treat it after it has developed. “Ms. Williams’s study estimated that the commercialization lag’s incentive to invest in drugs of shorter duration benefit led to 890,000 lost life-years among American patients found to have cancer in 2003 alone.” (NYT) In other words, the profit-based incentive to NOT develop cancer preventing medications is killing people.
A few solutions are proffered in the Times piece. One is to change the way F.D.A. approval is granted. Instead of simply measuring survival rates, clinical trials could look at “indications of improved health that can be measured more quickly than survival — so-called surrogate endpoints, like cancerous white blood cell counts and bone marrow characteristics in leukemia studies.” This does sound promising in that it could help speed up the process of making available potentially beneficial drugs. The downside is the challenge to identify meaningful surrogate endpoints, dependent variables that reliably correlate with survival.
The other solution offered is to pander even more to the pharmaceutical profiteers: “…extend the period of a drug’s market exclusivity to compensate for the commercialization lag. The Hatch-Waxman Act of 1984 already permits a partial extension — a half year for every year in clinical trial, up to a maximum of five additional years.”
Which solutions are left out? Why not take the profit motive out of medicine altogether? As the researchers point out, preventing cancer has significant social value. The only thing holding pharmaceutical researchers back from developing preventive measures is the issue of profitability. This gives us one more reason to struggle to remove the cancerous growth of capitalism from our society.
