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)
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