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Saturday, September 15, 2007

GRASSLEY SAYS E-MAILS SHOW GSK SILENCED AVANDIA CRITIC

Thanks to my good friend Stu who sent the following to me:

GRASSLEY SAYS E-MAILS SHOW GSK SILENCED AVANDIA CRITIC

FDA Week - Sep. 14, 2007
Sen. Charles Grassley (IA) said in a Senate floor speech Wednesday (Sept. 12) he has two internal e-mails from GlaxoSmithKline showing the company tried to silence a medical researcher who suggested Avandia may have health risks beyond those stated on the label.

John Buse, a medical researcher at the University of North Carolina, is the subject of the e-mails.

"Based on this e-mail exchange, it seems to me that at least two drug company officials did attempt to silence a critic," said Grassley, ranking Republican on the Finance Committee. "In fact, Dr. Buse stopped making any critical statements about Avandia shortly after this e-mail exchange," which is dated June 25, 1999.

One e-mail, titled "Avandia Renegade," says Buse has "repeatedly and intentionally misrepresented Avandia data."

"The sentiment of the [SmithKlineBeecham] group was to write him a firm letter that would warn him about doing this again...with the punishment that we will complain up his academic line and to the [continuing medical education] granting bodies that accredit his activities. There was a brief mention of a law suit but this was reserved for a later approach," the e-mail states.

SmithKlineBeecham is now part of GSK. The e-mail response states that Buse's supervisor would be spoken to.

"The question comes up as to whether you think this is a sensible strategy, whether you know any of the principals at UNC (I don't), and whether we have other avenues to ensure his accuracy in the future (we don't really do too much work at UNC to make any threats)?" the e-mail continues.

"I think that there are two courses of action. One is to sue him for knowingly defaming our product even after we have set him straight as to the facts--the other is to launch a well planned offensive on behalf of Avandia so that the listeners begin to understand at the very least that there are two sides to this story."

Buse testified in June at a House hearing that company employees threatened and harassed him after he raised concerns in 1999 that Avandia could increase the risk of heart attacks (see FDA Week, June 8). He also said company employees called higher-ups in his department to complain about him.

GSK at the time said Buse misinterpreted their actions.

"Action was taken at the time to correct any misconceptions that may have arisen," according to a GSK statement issued following Buse's testimony.

The Senate Finance Committee launched its investigation the day of the House hearing.

FDA recently announced the drug class that includes Avandia will soon bear stronger "black box warnings" that the drugs should not be prescribed to patients with a history of heart failure.

Also this week, the Journal of the American Medical Association published two studies questioning the safety of the diabetes drug.

GSK says the studies are flawed and Avandia is effective and safe when used appropriately.

Grassley also said on the floor the Avandia e-mails show how drug companies can influence continuing medical education course material.

Senate Finance Committee Chair Max Baucus (D-MT) and Grassley sent a letter in April to the organization that accredits CME stating that its retrospective, self-reported review of CME providers is not adequate to pick up industry influence (see FDA Week, Sept. 4).

Grassley and Sen. Herb Kohl (D-WI) last week introduced the Physicians Payments Sunshine Act. It requires drug and device companies to report payments and other gifts they give to doctors, which Grassley said would bring "a little transparency to the practice of companies such as GlaxoSmithKline."
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