An interesting letter from Senator Ron Wyden to Francis Collins, the NIH director, brings up the issue of public contributions to private drug discovery research (1). Specifically at issue is Tofacitinib a new anti-arthritis drug that grew out of a collaboration between Pfizer and an NIH funded academic investigator. Senator Wyden asks why isn’t some of the expected $2.5B in revenue from Tofacitinib being funneled back to the NIH. However, this letter underscores a much larger set of issues regarding the evolution of the partnership between academia, the pharmaceutical industry and federal funding agencies.
Currently much of the basic research that leads to new drugs is conducted in academia and is funded by the NIH or charitable foundations (2). Because of the Bayh-Dole act universities can glean some financial benefit by licensing intellectual property rights to companies that want to further develop the research. However, the feds are pretty much frozen out. Further, since much of the academic work deals with early stage research, usually the return on academic IP is small.
While it is clear that the pharmaceutical industry must make major investments to convert early stage academic research to a drug, one wonders if the initial academic/federal component is being properly valued and rewarded. Rather than the haphazard system of shopping university IP around to various companies, a better approach might be to develop collaborative agreements that share both the risk and the reward of drug development. This would allow both academia and federal funding agencies to glean part of the enormous profits associated with successful drug development. Putting these funds back into fundamental research would create a sort of virtuous circle leading to increased numbers of promising drug candidates. An analysis of this type of activity has recently been published (3).
Interestingly the Wyden letter was recently discussed on the popular blog ‘In the Pipeline’. Most of the commentary there stated that Sen. Wyden was wrong and the NIH had no business being compensated for its contributions. I think this is a very shortsighted viewpoint. We clearly need major changes in the drug development process to make it more efficient and less costly. A smoother integration of federal, academic and commercial research, with appropriate rewards to the parties, would go a long way toward that end.
(2) Stevens, A. J. et al. The role of public-sector research in the discovery of drugs and vaccines. N. Engl. J. Med. 364, 535–541 (2011).
(3) R.L. Juliano Pharmaceutical innovation and public policy: The case for a new strategy for drug discovery and development. Science and Public Policy (2013) pp. 1–13 (http://spp.oxfordjournals.org/cgi/content/full/scs125? ijkey=8StCkSiKrZOaKjb&keytype=ref)