Most people would agree that it would be better to prevent cancer, if we could, than to treat it once it developed. Yet economic incentives encourage researchers to focus on treatment rather than prevention.
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, yet our work shows that society provides private firms — perhaps inadvertently — with surprisingly few incentives to conduct this kind of research.”
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.
The clinical trials necessary for the F.D.A. to approve drugs for commercialization take years. Though a patent lasts 20 years (before any extensions), a typical drug comes to market with about 12,5 years of patent life remaining. But would-be innovators have some control over the length of time between receipt of a patent and F.D.A. approval — the “commercialization lag.” By studying patients in whom safety and efficacy can be demonstrated more quickly, innovators can reduce this lag. (Recent studies suggest that commercialization lag times may be decreasing for some types of drugs.)
Many more cancer trials focused on treatments for patients with late-stage cancers than for early-stage cancers, according to the study. The bias toward studies focused on patients with shorter survival duration is more prevalent among privately financed trials than for publicly financed ones.
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.
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.
The same goes for Swedish Läkemedelsverket.