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.
That’s one of the findings from the work of Heidi Williams, an M.I.T. economics professor and recent MacArthur Foundation “genius” grant winner,
who studied the problem along with Eric Budish, a University of Chicago
economics professor, and Ben Roin, assistant professor of technological
innovation, entrepreneurship and strategic management at M.I.T. 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.
Many more cancer trials focused on treatments for patients with
late-stage cancers than for early-stage cancers, according to the study.
Between 1973 and 2011, there were about 12,000 trials for relatively
later-stage patients with a 90 percent chance of dying in five years.
But there were only about 6,000 focused on earlier-stage patients with a
30 percent chance of dying. There were over 17,000 trials of
patients with the lowest chance of survival (those with recurrent
cancers) but only 500 for cancer prevention.
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