NEW YORK — Given the study's findings, you wouldn't expect any cancer prevention drugs to have been developed. In fact, there are six such FDA-approved treatments. But these were either developed with public money, meaning profits weren't a consideration, or gained FDA approval using so-called "surrogate endpoint" trials, where a treatment's effectiveness is determined by a biological marker other than death. That turns out to have been the case for the HPV vaccine. Gardasil, developed by Merck, was approved on the basis of the presence of "atypical cervical cells" rather than patient survival, so the trial lasted only around four years. In fact, for leukemia and other cancers of the blood, where a treatment's efficacy can be shown based on the surrogate endpoint of white blood cell counts, the negative relationship between cancer survival rate and number of trials disappears, as one might expect given that survival time doesn't affect trial length.
Removing this distortion to research incentives would seem to be straightforward: Allow biotech companies to apply for patents at the time of invention, but only start the patent clock ticking after clinical trials are completed. But even if the authors' theory is well-reasoned, legislative practice is quite another matter. Kevin Sharer, CEO of biotech giant Amgen from 2000 to 2012, sums up the prospects of any major patent reform as a "150 foot putt" - in other words, impossible. Many competing factions would surely see any attempt to change patent law as an opportunity to twist the rules in their favor, making intellectual property reform another casualty of Capitol Hill gridlock.
There has been some progress in changing the way the patent system adversely affects research. The FDA can, for example, grant a drug "market exclusivity," which allows the original inventor the exclusive right to market a drug in the United States for a period of time following regulatory approval. Legislation was passed in 2010 that should strengthen the power of those arrangements: Some classes of drugs are now given 12 years of market exclusivity, which puts short- and long-trial drugs on a more equal footing. (This is in addition to a patent extension of 50 percent of the time a treatment spends in trial, for up to an additional five years, as a result of the 1984 Hatch-Waxman Act, which evidently didn't have much of an impact on cancer research at least.) But only about a third of new inventions are covered by the new market exclusivity rules. For the bulk of new discoveries - so-called small molecule drugs - the patent system remains the same as it's been since the early '80s. (And very short trial drugs will still end up with longer market protections. For example, a three-year trial drug like Abiraterone, a prostate cancer treatment, could still get 17 years of exclusivity.)