BMJ  2003;326:1220 (31 May), doi:10.1136/bmj.326.7400.1220-a

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Doctors and the drug industry

There is evidence that industry sponsored research leads more often to an outcome favourable to the drug under investigation (p 1167). Studies with low methodological quality tend to overestimate an effect but the methodological quality of studies funded by drug companies is no worse than that of other studies—often it is even better.

Developing new drugs without the industry is unfortunately not realistic. Let's ignore all the preclinical research—this is regulated by good laboratory practice guidelines (www.oecd.org/env/glp). Let's jump directly to clinical research. Good clinical practice (GCP) protects research subjects and is a quality assurance tool. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) "is a unique project that brings together the regulatory authorities of Europe, Japan, and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration." All the relevant guidelines are available in pdf format (www.ich.org).

GCP is here to protect the public from inappropriately investigated drugs. The European Agency for the Evaluation of Medicinal Products is the relevant regulating body in Europe (www.emea.eu.int), the equivalent of the US Food and Drug Administration (www.fda.gov).

Designing a trial according to GCP is not all that difficult but translating this into research practice is no mean feat. Even though the industry spends more on marketing than on research (www.nofreelunch.org), there is still much money going into research and development. It seems that the non-corporate research community still has a long way to go.

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¹ BMJ marcus.muellner{at}univie.ac.at

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Related Article

Pharmaceutical industry sponsorship and research outcome and quality: systematic review

Joel Lexchin, Lisa A Bero, Benjamin Djulbegovic, and Otavio Clark
BMJ 2003 326: 1167-1170. [Abstract] [Full Text] [PDF]

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Correction

Marcus Müllner
bmj.com, 10 Jun 2003 [Full text]