Scientists dispute Avandia claims

The study published in the May 21, 2007 issue of the New England Journal of Medicine (NEJM) has launched a firestorm of "he said, she said" in the global scientific community. Some say that the NEJM study is a wakeup call for the way drugs are regulated in this country. With the recent increase of falsified, manipulated, and omitted data in several drug company research studies over the last decade and the Food and Drug Administration's (FDA's) inability to effectively regulate prescription medication once it is on the market, doctors and even consumers are looking to third-party sources like medical journals to help them decide which drugs are "safe" and which are not.

On June 5, one day before congressional hearings were to commence investigating the FDA's approval process for Avandia, manufacturer GlaxoSmithKline released a statement claiming Avandia's safety. An interim review of their RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of glycemia in Diabetes) study, also published in the NEJM, reportedly supports Glaxo's claims that Avandia "was not significantly different... in secondary outcomes, including heart attacks."

“Overall, we feel these results are very reassuring,” Dr. Murray Stewart, Glaxo's vice president of clinical development, reportedly told the Associated Press.

Not everyone agrees. "The interim results of the RECORD trial do not provide any assurance of the safety of treatment with rosiglitazone," said Dr. David Nathan in an editorial also published on June 5 in the NEJM. In fact, he wrote, although the analysis cannot be considered conclusive either way, it does "support a concern regarding the safety of [Avandia]."

Heart attack risk is complex

So does Avandia raise heart attack risk? The fact that several different and respected medical experts disagree about this seemingly straightforward question shows how complex the issue is. As Glaxo feared, many people have stopped taking Avandia, including those registered in ongoing clinical trials. Perhaps if they had let people know seven years ago about the possibility of increased heart attack risk, this would have been a non-issue. Better yet, Glaxo or the FDA could have commissioned a study to confirm or deny the possibility. Perhaps, dare consumers ask, this should have been done before it was allowed on the market.

And yet even the latest RECORD study is considered to be inconclusive and flawed by experts. One noted drawback: the study was "open label" as opposed to "blind," which means that doctors and patients knew which drug they were taking. Not only does this affect how patients and doctors report side effects, but those taking Avandia were also taking medication to control cholestreral, which in turn reduces heart attack risk and would seemingly lower Avandia's results.

Contact an Avandia lawyer

The truth is that nobody knows for sure the connection between Avandia and heart attack risks, and many consumers and doctors find this unacceptable after eight-plus years on the market.

If you or a loved one has suffered cardiovascular problems while taking Avandia, contact an Avandia lawyer with Jim S. Adler & Associates for a free review of your case. You may be eligible to collect a fair and just settlement to cover your medical bills and lost wages, as well as compensation for your pain and suffering. Contact JSA before you make your decision and get the facts. Call us directly, or fill out the form on this page with the details of your Avandia injury to start your free case assessment.