The Senate Finance Committee has jurisdiction over Medicare, Medicaid and the FDA. This makes it an important player in health policy and oversight of the health system. While the Committee’s recent report on “The Intimidation of Dr. John Buse and the Diabetes Drug Avandia” is not as dramatic as John Le Carre’s “The Constant Gardner” (or the excellent film version with Ralph Fiennes), it doesn’t miss by much.
The Committee’s investigation was triggered by a June 14, 2007 New England Journal of Medicine article “Effect of [Avandia] on the Risk of Myocardial Infarction and Death from Cardiovascular Causes.” The article sounded an alarm about the manufacturer (GlaxoSmithKline) and the FDA as well as the drug:
“The manufacturer’s public disclosure of summary results for [Avandia] clinical trials is not sufficient to enable a robust assessment of cardiovascular risks. The manufacturer has all the source data for completed clinical trials and should make these data available to an external academic coordinating center for systematic analysis. The FDA also has access to study reports and other clinical-trial data not within the public domain…”
Six weeks after publication of the New England Journal article, Senators Grassley (R) and Baucus (D) wrote a strong letter to the FDA Commissioner expressing concern about suppression of dissent regarding Avandia. In a statement accompanying release of the letter, Senator Baucus said:
“…under Commissioner von Eschenbach’s leadership it seems that drug manufacturers’ interests may be allowed to trump science. Based on our ongoing investigation, it appears that FDA staff who voiced safety concerns about Avandia were removed from the very jobs that are supposed to protect the American public…”
Happily, someone inside the FDA must have been spilling the beans to Committee staffers.
The November report clearly draws on whistle-blower tips as well. It describes in detail how GlaxoSmithKline sought to silence Dr. Buse, currently president of the American Diabetes Association, who in 1999 was the first to raise concern about increased cardiovascular risk from Avandia. This internal email shows how executives at the company reacted:
“Mention was made of John Buse from UNC who apparently has repeatedly and intentionally misrepresented Avandia data from the speaker’s dias in various fora…the sentiment of the SB [what later became GlaxoSmithKline was then SmithKlineBeecham, i.e., “SB”] group was to write him a firm letter that would warn him about doing this again…with the punishment being that we will complain up his academic line…”
It is probably not often that a Senate Committee Report can be described as a "great read." This one can. Here is another juicy quote -- this one from an email from Dr. Buse to Dr. Steven Nissen, first author of the New England Journal article, describing what happened after he expressed his concerns about Avandia and cardiovascular risk:
"Immediately 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 this issue further in public...It makes me embarrassed to have caved in several years ago."
The pharmaceutical industry is once again shooting itself in the foot. This sorry story -- so well set forth by the Senate Finance Committee -- puts another nail in the coffin of Pharma's reputation. It won't be long before lawsuits start to emerge, just as has happened with Vioxx. We can only wonder how many billions of dollars will have to go into settlements and fines before the pharmaceutical industry cleans up its act.
The happy part of this story is the role of the Senate Finance Committee and the whistle blowers who helped them do their important work. We owe them thanks!