Friday, June 08, 2007

Calling off the dogs in the Avandia controversy

Two medical bloggers whom I deeply respect have lamented the deterioration of the public conversation on Avandia. Dr. Roy Poses of Health Care Renewal writes about intimidation by drug companies to suppress information and personal attacks on Dr. Steve Nissen (author of the controversial NEJM Avandia meta-analysis) by individuals with drug company ties.

DB of Med Rants writes:

This should remain a scientific debate. Unfortunately it has become a political debate. Guess what the culprit really is - $$$$$$$$.

Yes, this should have been a scientific debate. Unfortunately, the way the meta-analysis was presented, scientific debate never stood a chance. Politics and money have, to a degree, aligned on opposite sides of the controversy and both are culpable.

Dr. Poses wants to “call off the dogs”. But, unfortunately, once dogs on both sides of the issue have been released into the arena of public debate it may be too late too call them off.

What we need to be asking is how scientific discussion got stifled in the first place. Let’s go back to the beginning. We don’t have details about what transpired between Dr. Nissen and politicians on Capital Hill in the weeks leading up to the release of the meta-analysis. We do know that the meta-analysis and an accompanying editorial by drug safety crusaders with an agenda to reform the FDA were released on line for open access ahead of print without sufficient public health urgency. Worse, according to this Heartwire report the release was timed to precede by two days an anticipated FDA safety report on Avandia. (By Dr. Nissen’s own admission in his testimony before Waxman’s congressional hearing the FDA had all the data he had and more). Moreover, according to Dr. Scott Gottlieb’s Wall Street Journal article Waxman issued a press release immediately after the release of the meta-analysis, suggesting that the whole hyped up mess was orchestrated. (I was unable to find a press release from Waxman on line. However, this press release from the Senate Finance Committee, issued the same day as the meta-analysis, seems a little too detailed and lengthy not to have been planned. Also, this press release from Senator Kennedy appeared the day after the meta-analysis, and this one from Cleveland Clinic appeared the day of).

So I’ll reserve final judgment, as there are some unknowns here, but from where I sit this looks like a case of calculated hype. Among many potential players we don’t know which ones played major roles. And though there are many potential conflicts of interest we can only speculate on the actual ones. Dr. Nissen’s situation, for example, is complex. Were his conflicts political? I don’t know his political leanings. Was it a case of self promotion, or zeal to trump the FDA? (By his own admission the FDA was better equipped than he to analyze Avandia’s risk, so why didn’t he just wait and let the agency do its work?). Financial considerations could have been at play. Dr. Nissen has had ties to Takeda pharmaceuticals, makers of Avandia’s direct competitor Actose, the only other TZD approved in the U.S. (According to this Fox News piece new prescriptions for Actose jumped 50% following release of the meta-analysis).

Unfortunately this mess is self-reinforcing. Propaganda begets propaganda, and there’s been plenty on both sides. I have no pharmaceutical industry ties. Dr. Poses and others have done a commendable job of exposing the pharmaceutical industry’s dirty tricks. The focus of my blog has been non-industry related conflicts of interest. This is not out of any desire to defend the drug companies or minimize problems related to their influence. It is an attempt to balance the debate by addressing a selective outrage which seems to blame industry for virtually all the problems facing health care and under-recognizes other conflicts.

More here from Kevin M.D.

1 comment:

Anonymous said...

I have been in contact with GSK UK.

I believe that there is a potential problem where Avandia is prescribed "off label" as happened with my mother, who was prescribed it even though she was a known heart patient with heart failure. She relied totally on her doctors, and trusted her life to them. Unfortunately she died.