Wednesday, March 24, 2010

GSK - Avandia: Mike Huckman writes

The editors of one of the most prominent medical journals are taking British drug giant GlaxoSmithKline to task.

GlaxoSmithKline
Source: Ian Wilson
GlaxoSmithKline

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.

A two-year Senate investigation into Glaxo’s handling of the data recently concluded GSK allegedly tried to downplay Avandia’s safety signals and strong-arm the drug’s critics. Glaxo said the lawmakers’ probe was inaccurate and unbalanced.

But in a scathing 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 serious example of corporate motives apparently outweighing scientific standards and perhaps ethical principles, thereby exposing patients to potential harm.”

They urge all journal editors to require academic researchers to have full access to all clinical trial data and for all company-sponsored studies to be independently reviewed to try to avoid a similar situation from happening again.

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1 comment:

Anonymous said...

What happened to Elizabeth Koller, M.D.?

Did someone have her fired from her job as an FDA reviewer?

Glaxo had very poor relations with her.

www.ahrp.org/infomail/0702/12b.php

pediatrics.aappublications.org/cgi/content/extract/113/2/421

http://jama.ama-assn.org/cgi/content/extract/286/20/2547?hits=10&RESULTFORMAT=&FIRSTINDEX=0&maxtoshow=&HITS=10&fulltext=Dr.+Elizabeth+Koller&searchid=1&resourcetype=HWCIT