Kenneth A. Getz
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With so much attention during the past several years on the negative influences of industry on clinical research, one would
think that all professionals employed and funded by pharmaceutical and biotechnology companies must be felons of the highest
order.
Widely covered investigations headed by Senator Grassley, daily allegations posted on the Internet, and statements from Marcia
Angell and other outspoken critics suggest that any involvement in the clinical research enterprise by pharmaceutical and
biotechnology companies must be tainted and motivated by greed.1-3
Responding on their own to growing pressures from politicians and the public, many academic institutions have been disclosing
their physicians' business relationships with industry, no matter how trivial the amount. Early in 2009, several academic
institutions jumped to distance themselves further: Harvard and Johns Hopkins, for example, announced much stricter limitations
on faculty acceptance of speaking fees and gifts from industry. This past April, the Institute of Medicine (IOM) recommended
that physicians sever all ties with industry.4
Colleagues in academia have raised numerous concerns about, and have documented, deceptive and unethical industry practices.
Failures to disclose critical information about clinical trial results; distortions and exaggerations of the benefits of new
interventions; and the pervasiveness of conflicts of interest that exist in physicians' relationships with industry are but
a subset of the many questionable practices identified. Taking things a step further, some colleagues are now calling for industry to have NO involvement in clinical research. They
suggest that only academic-based professionals and those employed and supported by the National Institutes of Health are capable
of ensuring probity.
This suggestion is naïve, bordering on delusional. Sadly, deceptive practices can be found throughout the clinical research
enterprise. No stakeholder group is above repute and impunity. Guilt is evenly distributed.
A double standard
In my 20 plus years as an observer of the clinical research enterprise, I have yet to meet a professional currently or formerly
employed by academia and the NIH who doesn't possess deep frustration and concern with government-funded research programs
and the politics and questionable practices associated with them. They are reluctant to speak out, however, fearing the harm
it would bring their reputation and their career.
In fact, over the years there have been numerous scholarly articles and journalistic reports on a variety of questionable
practices including academic institutions misusing and mismanaging federal research grants; unethical practices among professionals
involved with government-funded clinical research; academic medical centers exaggerating and overstating the importance of
their research studies; failure to disclose inspection results and serious adverse events among study subjects participating
in NIH programs; compromised data reporting and misinterpretation of results; and the intense and unfair politics associated
with grant applications and awards.5-10
Peer-review articles and media reports on deceptive industry practices have largely overshadowed those reports on questionable
practices among academia and the NIH. But as industry is scrutinized and pressured to reform and improve its practices and
behaviors, academia and the NIH must do the same.
