FDA Tries to Silence Info Documenting Avandia Deaths: In a reflection of the FDA's enthrallment to Big Pharma, the loss of tens of thousands of lives from Vioxx is being dwarfed.

The FDA appears to have tried to prevent publication of information documenting a significant increase in deaths and cardiovascular disease from Avandia over its competitor, Actos. An FDA employee, Dr. David Graham, claims that an underhanded trick was used in an attempt to keep his paper, which documents significantly increased Avandia risks, from being published.

Dr. Graham is no stranger to attempted suppression of his work by the FDA, which also attempted to suppress his research documenting the dangers of Vioxx, a drug that killed at least 60,000 people, in 2004.

Apparent Sabotage of Publication of Graham’s Avandia Research

A month ago, Dr. Graham claimed that the FDA was trying to prevent or delay publication of the manuscript by the Journal of the American Medical Association (JAMA). Shortly after he went public with his suspicion, the approval needed for publication was given. Note: This is the same thing that the FDA attempted to do against his Vioxx research.

The approval was granted only a short time after Dr. Graham went over the heads of the officials whose approval was required. In desperation, he sent an e-mail to Margaret Hamburg, FDA Commissioner, and Dr. Joshua M. Sharfstein, FDA Principal Deputy Commissioner, to get the study published in time for the anticipated FDA review of Avandia.

Dr. Graham had attached the manuscript of the paper to that e-mail. The manuscript was then leaked to pharmaceutical journalist, Ed Silverman, who promptly published it.

At first glance, that wouldn’t seem like such a big deal. After all, it means that the information unearthed by Dr. Graham is available to the public. However, in the medical publishing world, it’s a critical issue. Major journals like JAMA have a policy to publish only work that has not appeared elsewhere. The premature release of Graham’s work, especially under the circumstances, threatened the official acceptance and recognition of his findings.

On learning of the leak, Graham contacted JAMA and stated that he believed the premature publication had been an act of sabotage. Apparently, the JAMA editors agreed. Graham stated,

In my view, and in the view of JAMA for sure, this was an attempt by people at the FDA to block the publication. The idea was that JAMA would invoke the Ingelfinger* rule, and the paper wouldn’t get published, and it wouldn’t have credibility.

 

*The Ingelfinger rule is that manuscripts are accepted for publication only if they haven’t already been published elsewhere.

 

Graham went on to say that the JAMA editors

were very reassuring and basically at the end of the day said that this is a poison pill and we aren’t going to swallow it. We know it’s an important study, and if this is the length the FDA is going to to stop it, it must even be more important than we recognized.

That’s the point, isn’t it?  …

Read here for more.