17 Pages Posted: 4 Apr 2005 Last revised: 6 Apr 2014
Recent controversies surrounding the safety and efficacy of approved drugs show how commercial interests impact on medical research and raise not only specific research ethics concerns, but also more fundamental concerns about research integrity and the reliability of scientific evidence. These concerns go beyond the strict context of medical research, since scientific integrity underlies the drug regulatory process and the practice of medicine itself. This article first uses some of the recent controversies to illustrate how commercialization affects different stages in the production, sharing and publication of scientific findings. Various mechanisms are then scrutinized that could arguably provide some safeguards: competition in the market; independent scrutiny by peers; research ethics review; registration of clinical trials; and review by drug regulatory agencies. The author discusses, however, why none of these regulatory mechanisms deals sufficiently with the negative impact of commercial interests and how these mechanisms are themselves affected by the problem they are supposed to address. While medical research is fully integrated within a lucrative industry, to some extent it continues to be regulated as if it were a charitable practice with a pure humanitarian mission. Because of the interaction between the various regulatory regimes, and because scientific integrity is a crucial component at all levels, a more fundamental structural change is needed. The author supports recommendations to establish an independent drug testing agency which would create a healthy separation between those with financial interests in research from those conducting the research.
Keywords: Medical research, research ethics, drug regulation, IRB review, conflict of interest, commercialization
Suggested Citation: Suggested Citation
Lemmens, Trudo, Leopards in the Temple: Restoring Scientific Integrity to the Commercialized Research Scene. Journal of Law, Medicine & Ethics, Vol. 32, No. 4, pp. 641-657, 2004. Available at SSRN: https://ssrn.com/abstract=682443