Feature Drug Regulation

Rosiglitazone, marketing, and medical science

BMJ 2010; 340 doi: https://doi.org/10.1136/bmj.c1848 (Published 07 April 2010) Cite this as: BMJ 2010;340:c1848
  1. Ray Moynihan, conjoint lecturer
  1. 1University of Newcastle, Newcastle, Australia
  1. ray.moynihan{at}newcastle.edu.au

    Attempts to play down the potential cardiac risks of a popular diabetes drug raise questions about the need for fundamental changes in drug regulation, writes Ray Moynihan

    Casually following the fortunes of the blockbuster diabetes drug rosiglitazone (Avandia), you can’t help but imagine a Hollywood thriller. There is the scene where a leading scientist secretly records a meeting with drug company executives, a high powered congressional investigation, and a bitter legal battle waiting in the wings. Yet when you look more closely, the facts are even stranger than fiction. An expensive new drug shown to raise the risk of heart failure and suspected of increasing the chance of heart attacks has been taken by millions of people around the world and is being kept on the market by an industry funded regulatory system, despite calls from senior safety experts to withdraw it. For its part, the drug’s manufacturer strongly denies the link with heart attacks and points to evidence to back its claims. But the details of this unfolding real life drama suggest a now familiar merging of medical science and drug marketing.

    Damning congressional report

    Earlier this year a congressional committee in the United States released the results of an investigation into the diabetes drug rosiglitazone and its manufacturer GlaxoSmithKline (GSK).1 Investigators reviewed over 250 000 pages of corporate and government documents and conducted numerous interviews with both officials and anonymous whistleblowers. Central to the investigation was GSK’s internal responses to the growing body of evidence linking its drug to potential heart problems. Revelations about what happened behind closed doors in the days leading up to the publication of an important meta-analysis in 2007 are a particularly illuminating example of the modern day intersection of science and marketing.

    On 2 May 2007, Steven Nissen and Kathy Wolski, of the Cleveland Clinic, Ohio, …

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