When Dr. John Buse found that a diabetes drug had the side effect of higher risk of heart disease, GlaxoSmithKline officials threatened his integrity and career.
In July 2010, an FDA advisory committee recommended a recall of Avandia, a drug used to treat Type-2 diabetes, and placed severe restrictions on its availability. GlaxoSmithKline, Avandia’s manufacturer, had long known about the drug’s potentially life-threatening side effects. But the company used its power to silence scientists rather than protecting its customers by bringing the harm to light.
A decade earlier, in 1999, Dr. John Buse at the University of North Carolina found that Avandia users had a high risk of heart disease, and published his findings. In response, Buse alleges, a representative from the company contacted his boss, accused him of lying, and threatened to sue him for a $4 billion drop in the company’s stock valuation.
A Senate Finance Committee report confirmed Buse’s charges, revealing that a GlaxoSmithKline official emailed Tadataka Yamada, then the company’s chairman of research and development, urging him to write a “firm letter” to Buse. It would contain a warning that “the punishment will be that we will complain up his academic line and to the CME [continuing medical education] granting bodies that accredit his activities.” Yamada wrote back, “I think 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.” Yamada also called Fred Sparling, the chairman of Buse's department at UNC, and communicated the threat of lawsuits.
After this blatant harassment, Buse felt he had no choice but to sign a letter drafted by the company which walked back his scientific findings. It stated that his comments on the drug “had been taken out of context” and that “only years of use, greater patient exposure and comparative clinical trials” would provide the data needed to allow any drug “into proper perspective.” The letter was used by the industry to persuade financial analysts to change their safety assessment of Avandia, which resulted in its staying on the market another decade.
In 2007, a meta-analysis of 42 randomized controlled trials of the drug confirmed Buse’s findings and revealed that there was a 43 percent increase in the risk of heart disease among diabetics taking Avandia. When questioned on its intimidation of Buse by the Senate Finance Committee in 2007, GlaxoSmithKline released a statement saying, “perhaps we could have handled interactions with Dr. Buse better,” but otherwise denied that it had retaliated against the scientist. After reviewing extensive documents from Buse, the Committee concluded that the behavior of the company was “troubling” and “had Buse been able to continue voicing his concerns, without being characterized as a ‘renegade’ and without the need to sign a ‘retraction letter,’ it appears that the public good would have been better served.”
Ultimately, this case—including the ultimate corroboration of Buse’s findings—spawned thousands of lawsuits charging that GlaxoSmithKline’s handling of the drug caused death and illness in patients. The company has already paid at least $90 million to settle some of them.