Glaxo was provided an advance copy of Avandia heart attack study
Although it violated the confidentiality rules of the New England Journal of Medicine, GlaxoSmithKline was provided an advance copy of an article published in May 2007 which linked Avandia to an increased risk of heart attacks. The study was leaked during the peer review process by a Texas doctor who had previously received compensation from the pharmaceutical company.
>>INFORMATION: Avandia Heart Attack Side Effects
The article submitted to the New England Journal of Medicine for publication by Dr. Steven Nissen, who analyzed data from 42 different clinical trials involving Avandia. The results of the meta-analysis indicated that Avandia was linked to a 43% increased risk of heart attacks.
Since the study was published, the FDA has conducted panel meetings to review the safety of the diabetes drug, the Senate Finance Committee has initiated an investigation into Glaxo’s handling of Avandia and a black box warning has been added about the increased risk of heart attacks. Senator Charles Grassley, who became aware of the disclosure as part of the Senate Finance Committee’s investigation, sent a letter on Wednesday to the drug maker requesting information about what they did with the study once they received it.
Glaxo has acknowledged that they were provided the advance copy of the article more than two weeks before the Journal published the study. Dr. Steven Haffner, a professor at the University of Texas Health Science Center in San Antonio, received the article as part of the Journal’s confidential peer review process and faxed it to the drug maker within hours of receiving it. According to Sen. Grassley, Dr. Haffner has received about $75,000 in compensation from Glaxo for consulting services and speaking fees since 1999.
It is common practice for medical journals to have articles reviewed by other researchers before publication to make sure that the studies are solid. It has been suggested that providing the peer review copy of the study to Glaxo, not only violated the confidentiality rules of the New England Journal of Medicine, but also constitutes what many consider a breach of professional ethics.
AVANDIA LAWYERS
The lawyers at Saiontz, Kirk & Miles, P.A. represent individuals who are pursuing an Avandia lawsuit as a result of cardiovascular risks which were not adequately disclosed by the drug maker. If you, a friend or family member have suffered a heart attack, stroke, congestive heart failure or death after taking the diabetes drug, request a free Avandia lawsuit evaluation.
