Sunday, March 28, 2010

Georgia and USA: JAMA and Avandia (Heart Attack Claims by Some)

A few years ago, the “New England Journal of Medicine", published a study that identified a potential heart risk with Glaxo’s then-blockbuster diabetes pill, Avandia.

In an editorial in the latest issue of "The Journal of the American Medical Association" or JAMA, Drs. Catherine DeAngelis and Phil Fontanarosa call what happened “a disturbing example of inappropriate conduct surrounding an industry-sponsored clinical trial. The circumstances represent another example of corporate motives apparently outweighing scientific standards and perhaps ethical principles, thereby exposing patients to potential harm.”

Find it here:

From the conclusion:

Given the circumstances surrounding rosiglitazone1-2 and the RECORD trial,10-11 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.