Why Preventing Cancer Is Not the Priority in Drug Development
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.
“R & D on cancer prevention and treatment of early-stage cancer is very socially valuable,” the authors told me in an email, “yet our work shows that society provides private firms — perhaps inadvertently — with surprisingly few incentives to conduct this kind of research.”
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 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.
This very lesson is taught in some medicinal chemistry textbooks. For instance, one notes that “some compounds are never developed [into drugs] because the patent protected production time available to recoup the cost of development is too short.”
Another approach is to 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. Ms. Williams’s analysis suggests this is the right idea, but that there are still many potential drugs that receive only very short periods of market exclusivity. The Affordable Care Act includes a provision that grants 12 years of market exclusivity beginning from F.D.A. approval — a half year less than the typical 12.5 years remaining on a patent — but it applies only to biologic drugs.
Drug patents incentivize innovation, and F.D.A. approval is a check regarding drug safety and efficacy. The way they work together affects the incentives for research and could reduce something many would view as highly valuable: cancer prevention.
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Journal of Developing Drugs