Setting the Record Straight [when Glaxo Fakes the Data] / JAMA

Steve Nissen, head of Cardiology at the Cleveland Clinic, authored an editorial in JAMA last month on the means by which GlaxoSmithKline tried to cover up increased cardiac events in patients on its drug Avandia (Rosiglitazone).  JAMA’s editor, Catherine DeAngelis, wrote her own editorial on this issue, noting:

According to the article by Nissen,1 the report of the Senate investigation,2 and published media accounts,89 the manufacturer of rosiglitazone exerted inappropriate influence during the conduct of a pivotal safety study of this drug, the RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes) clinical trial,1011 which included undertaking nonprespecified unblinding of study data; attempting to undermine the authority and responsibilities of the study steering committee; expediting publication of an unscheduled interim analysis,10 specifically to counter2 the publication of a meta-analysis by Nissen and Wolski12 that suggested increased cardiovascular risk associated with rosiglitazone; having employees extensively involved in statistical analysis,11 and preparation of the manuscript10 reporting the results of the trial; and reportedly2 failing to fully acknowledge the significant cardiovascular risk associated with this drug…

Given the circumstances surrounding rosiglitazone12 and the RECORD trial,1011 and perhaps other industry-sponsored trials, it is now time for all editors to require that academic researchers have full access to all trial data and that all industry-sponsored trials include independent statistical analysis and assurance. This approach would add powerful support to the fundamental principle that physicians must first do no harm.

Analyzing data from 42 randomized clinical trials, Nissen et al. found a hazard ratio for myocardial infarction (heart attacks) of 1.43 in patients taking rosiglitazone compared to controls.  In other words, by using a drug to treat diabetes, you significantly increased your risk of having a feared diabetic complication:  a heart attack.  Rosiglitazone had more than $3 billion in annual sales.  So it paid Glaxo to take measures to confuse or obliterate this finding… and they did.

Fortunately, the Senate Finance Committee has released a 334 page investigation of this drug and the manufacturer’s conduct of an important clinical trial.  (But it can no longer be found at the Senate Finance Committee URL listed by DeAngelis and others, unfortunately.)  Fortunately, Dr. Nissen consults for many drug manufacturers, but accepts no honoraria; instead his fees are donated to charity.

Unfortunately, there is only one Dr. Nissen.  We don’t have reports on other drugs for which unscrupulous manufacturers deleted, invented or otherwise manipulated data to support the licensure and use of ineffective and/or unsafe products.

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