One sign that the alliance between academia and life-science corporations
has become significantly closer since the 1980s is that industry now provides
about 70% of all funding for clinical drug trials in the United States.1 Similarly, many academic nutrition departments
are entirely underwritten by corporations,2 and
more than half of the advisors to the US Food and Drug Administration have
financial relationships with pharmaceutical companies.3 These
ties may create conflicts of interest that, for instance, compromise the scientific
and peer-review processes, prevent the timely dissemination of data, and complicate
the monitoring of public health advances.
In principle, though, the financial goal of industry—the rapid
development of safe, effective drugs—should happily converge with the
hopes of clinicians and patients for new treatments. But the financial success
of a drug often lies as much in the packaging of its research results as in
its potential therapeutic effect. In this issue of MSJAMA, Sameer Chopra surveys the conflicts of interest that
can arise when industry is directly involved in acquiring and interpreting
data from clinical trials. He underscores the need for transparency and intellectual
freedom in biomedical research and also highlights the role of journal editors
as guardians of research integrity. Peter Whitehouse discusses how investigators
themselves have attempted to rein in financial conflicts during drug development
for Alzheimer disease.
Rigorous extramural or self-imposed oversight of research activities
can go only so far, however, to serve the public health. As long as biomedical
research retains its mostly for-profit structure, the invisible hand of the
market will likely fail to realign research expenditures according to disease
burden. Alexander Iribarne discusses the challenges in developing treatments
for "orphan" conditions, which include diseases that are rare or endemic to
developing countries. He describes how legislative incentives and public-private
partnerships can encourage the development of "orphan" drugs that would otherwise
have low market potential.
Perhaps just as important as showing a robust therapeutic effect of
a new drug over a placebo or first-generation control is a thorough cataloging
of negative clinical trial results. One in 1000 drug candidates goes to trial,
and of these, 80% are rejected at phase 1 or beyond.4 Unfortunately,
clinicians seldom learn of these negative results. Just as a pertinent negative
in a patient's clinical history can whittle down a differential diagnosis
or the publication of a negative genetic association can refocus basic research,
so too could negative trial data nudge researchers toward more promising disease
targets. Active disclosure of such findings could only enhance the alliances
whose financial or altruistic motives ultimately serve the public health.
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