June 28, 2008Researcher says he was threatened for Avandia warnings
A leading researcher into the potential side effects of Avandia says that he was threatened by the company which manufacturers the diabetes drug. Dr. John Buse testified before a congressional committee that an executive with GlaxoSmithKline made “disturbing” comments to him after Dr. Buse raised questions about the risk of Avandia side effects.According to his testimony, Dr. Buse investigated a potential link between Avandia and heart problems when it was approved by the Food and Drug Administration in 1999. After he discovered that Avandia could cause 50% more heart problems than other diabetes treatments, Dr. Buse alerted the agency of the potential risk of Avandia side effects and suggested that more research should be done to investigate the diabetes drug’s risk for causing heart problems.
Dr. Buse says that after speaking with the FDA and presenting the findings of his research at two medical conferences, Dr. Tadataka Yamada, an executive at GSK, threatened to sue him for the $4 billion that Yamada claimed Glaxo had lost in stock value because of Dr. Buse’s research. Dr. Buse testified that he was so intimidated by this threat of an Avandia lawsuit that he sent a fax to Yamada, asking him to “please call off the dogs.”
Concerns over the risk of Avandia side effect were reawakened in May when a study published by the New England Journal of Medicine found that patients taking Avandia were 64% more likely to die from heart problems and 43% more likely to suffer a heart attack than other diabetes patients.
In response to the NEJM report about the side effects of Avandia, the FDA has called for “black box” warnings to be added to the diabetes medication and another drug, Actos, to warm patients of the potential risk of heart problems.