Silence! The Intimidation Of An Avandia Critic
4 CommentsBy Ed Silverman // November 16th, 2007 // 3:23 pm
The headline may have grabbed your attention, but the thrust of a report released late yesterday by the Senate Finance Committee is anti-climatic. For those who don’t recall, however, we will remind you that John Buse, a diabetes expert and professor at the University of North Carolina was systematically threatened by Glaxo because he publicly expressed concerns that the Avandia diabetes pill may cause cardiovascular risks.
This became known last spring in the run up to Congressional hearings into the FDA’s review of Avandia, which was linked to a 43 percent increased risk of heart attacks in a controversial meta-analysis published last May in The New England Journal of Medicine. The Glaxo drug now carries two Black Box warnings - for heart failure and heart attack risks. But the hearings revealed an ugly episode.
As the report notes, Glaxo’s “attempt at intimidation appears to have been triggered by speeches that John Buse gave at scientific meetings in 1999. During those meetings, Buse suggested that, aside from its benefit of controlling glucose levels in diabetics, Avandia may carry cardiovascular risks. The effect of silencing this criticism is, in our opinion, extremely serious,” the committee writes. “Had Glaxo considered Avandia’s increased cardiovascular risk more seriously when the issue was first raised in 1999 by Dr. Buse, instead of trying to smother an independent medical opinion, some of these heart attacks may have been avoided.”
UPDATE: A Glaxo spokeswoman writes us to say that the drugmaker disputes the report and did not attempt to silence. “We had a responsibility to correct errors and omissions in data he was presenting to physicians.”
According to emails reviewed by the committee, Glaxo execs labeled Buse a “renegade†and silenced his concerns about Avandia by complaining to his superiors and threatening a lawsuit. “Even more troubling, documents reveal that plans to silence Buse involved discussions by executives at the highest levels of Glaxo, including then and current ceo Jean-Pierre Garnier. Also, Glaxo prepared and required Buse to sign a letter claiming that he was no longer worried about cardiovascular risks associated with Avandia,” the report states. (This is the report).
Who did some of the threatening? Tadataka Yamada, who now heads the global health program at the Bill & Melinda Gates Foundation and today was announced as a board member of the FDA’s new Reagan-Udall Foundation, which is designed to foster drug research.
[By the way, we should have noted earlier that Chuck Grassley, the Republican Senator from Iowa who sits on the Senate Finance committee, has an open-door policy to scientists who feel a drugmaker threatened their career or attacked their reputation if they "raise the alarm" about a "dangerous" drug. If you're one of those, you can fax Chuck at 202-228-2131.]
The Senate Finance Committee investigated the widely publicized episode because it has jurisdiction over Medicare and Medicaid and seeks to make certain the programs pay for safe and effective meds, according to the report. The committee, led by Montana Democrat Max Baucus and Iowa Republican Chuck Grassley, didn’t recommend any action, but fears Avandia is part of a “troubling pattern of behavior by pharmaceutical executives.”
UPDATE: The Glaxo spokeswoman, Nancy Pekarek, write that Glaxo “did not, as the staff report suggests, require Dr. Buse to sign a legal document restricting his ability to speak publicly about the data on Avandia. The document referred to in the staff report simply corrects inaccuracies about data on Avandia in a 1999 Continuing Medical Education presentation by Dr. Buse. Nothing more. As the staff report demonstrates, Dr. Buse continued to publicly discuss his views about Avandia after signing this letter. Further, Glaxo did not “require†Dr. Buse to sign this letter. Glaxo did ask that he consider the letter as an appropriate way to correct the record. We trust that Dr. Buse would not sign anything that he did not believe to be appropriate and factually correct…
“Because of the seriousness of the misstatements, a number of options to address this situation were raised, including possible legal action. Ultimately, Glaxo staff communicated their concerns to Dr. Buse and his supervisor. Dr. Buse clarified and corrected his statements, which the company appreciated. At that time, Dr. Buse also expressed his concern to Glaxo that the interactions had become heated and , in hindsight, we agree that perhaps we could have handled interactions with Dr. Buse better. Glaxo apologized to Dr. Buse, and Dr. Buse accepted the apology eight years ago. Dr. Buse has publicly indicated that he has long since moved on from the events of 1999, and so has Glaxo.” END OF UPDATE
According to The Wall Street Journal, Garnier has no additional comment. Yamada was traveling Friday and unavailable for comment, his assistant tells the paper. And Buse was also traveling and unavailable for comment, according to the Journal.
As the report notes, Buse sent a private e-mail to a colleague describing his dealings with Glaxo: “The company’s leadership contact(ed) my chairman and a short and ugly set of interchanges occurred over a period of about a week ending in my having to sign some legal document in which I agreed not to discuss the issue further in public.” Buse also wrote “I was certainly intimidated by them…It makes me embarrassed to have caved in several years ago.”
Glaxo’s Pekarek says the letter Buse signed wasn’t a legal document and didn’t oblige him to stop speaking about Avandia. It merely corrected inaccurate statements he made about the drug.
Hank
I guess anti-climax is always relative. I thought the report was pretty damning stuff, and also poignant. It includes part of a note that Buse sent Nissen in 2005, after the publication by the latter concerning some of the potential problems of Avandia. Buse profusely praises Nissen and regrets his own (understandable) caving in.
Given all at stake, and as a human document, there was plenty of climax there for me.
MDMD
The Big Pharma bullies treat critics inside their own companies the same way they treat individuals like Dr. Buse on the outside. They set up compliance programs and tell the employees they have to report infractions as part of their job. If you do, they conduct a sham investigation, sweep everything under the carpet, and tell the employees to “shut up.” If you don’t comply, then they threaten you, fire you and make your life miserable.
They don’t want you to be honest and operate with integrity. They want you to sell drugs, regardless of the potential consequences for patients. All their talk is just lip service. I’d love to sahre my story!!
CA
You’ve got it right. The same thing happened to me. I can’t stand the hypocritical Big Pharma bastards!
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