Doctor Leaked Sensitive Documents on Avandia Study to GlaxoSmithKline

Doctor Leaked Sensitive Documents on Avandia Study to GlaxoSmithKline

Breaking News for Sunday, January 18, 2009

In early 2007, the New England Journal of Medicine (NEJM) contacted Dr. Stephen Haffner, a researcher at the University of Texas Health Science Center at San Antonio, and asked him to peer review a study by Dr. Steve Nissen of the Cleveland Clinic. The journal was considering for publication Nissen’s now-famous study, which showed that patients taking Avandia had a 43 percent higher risk of suffering a heart attack.

In the peer review process, researchers in the same field attempt to find flaws in the methodology or analysis of new studies, to ensure that all studies published meet good scientific standards. Reviewers promise to keep all research confidential before publication.

Haffner has admitted that he faxed a copy of Nissen’s study to a GlaxoSmithKline employee 17 days ahead of the publication date. Haffner knew the employee due to his own prior work studying Avandia.

The Senate Finance Committee has launched an investigation into Haffner’s actions and sent a letter to GlaxoSmithKline asking for more information about the incident.

“According to documents filed at the FDA, GlaxoSmithKline has paid Dr. Haffner around $75,000 in consulting fees and speaking honoraria since 1999,” committee member Charles Grassley of Iowa wrote. “Did GlaxoSmithKline contact the NEJM to report this violation of publishing ethics?”

GlaxoSmithKline spokesperson Nancy Pekarek told the press that Haffner contacted the company with questions about the study’s methodology, requesting statistical assistance. Pekarek said that the company did not respond to Haffner, nor did it report his actions to the NEJM.



~ by sunil khemaney on January 18, 2009.

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