Congressional investigators have been looking into very serious claims that Avandia's maker silenced medical professionals who attempted to speak out about the potential for cardiovascular problems by using the drug.
Dr. Buse, who is about to become the president of the American Diabetes Association, was an early and frequent critic of Avandia after it reached the market in 1999. In a March 2000 letter to the F.D.A., he said Avandia might raise patients' risk of heart attacks, and he criticized the company's marketing, saying it employed "blatant selective manipulation of data" to overstate the drug's benefits and understate its risks.
More recent questions about Avandia's potential risks, as outlined in a New England Journal of Medicine article last week, have prompted the Congressional hearing. The author of that article, Dr. Steven E. Nissen, a heart specialist at the Cleveland Clinic, has also been called to testify. See the full story on the upcoming congressional hearing.











1. "blatant selective manipulation of data" to overstate the drug's benefits and understate its risks."
Glaxo would have been well-served to follow the business model laid down by Eli Lilly. The statement above was equally true for human insulin--but the scientists, FDA, physicians somehow seemed (at the time) to be so enamored of the "new science" that they were effectively silenced. Maybe silenced isn't the correct word: cheerleading seems more appropriate in the human insulin issue.
Where was Dr. Buse when the "need" for human insulin was shown to be miniscule? Where was he when terms like "hypoglycemia unawareness" and "dead-in-bed" syndrome entered the diabetes vernacular? Where were our regulators (FDA) when human insulin was shown to have a higher risks of hypoglycemia UNAWARENESS, even when the studies comprised only a small number of patients. After more than a decade of "silence" it would open floodgates of litigation to speak out now, wouldn't it? The insulin-cartel (in the U.S.) now has absolute power (over diabetics). And what is it they say about absolute power . . . it corrupts ABSOLUTELY?
It will be interesting to see if Dr. Buse represents all diabetics as he takes the helm at ADA (his predecessor certainly did not); or will he be just another quasi-CEO for a quasi-corporation, and a malleable tool for diabusinesses.
Posted at 10:22PM on Jun 3rd 2007 by Melody