Avandia, mudança de bula e ameaças a médico.

O caso Avandia ainda rende: essa semana, o FDA obrigou a empresa a modificar a bula do medicamento com alerta para risco potencial de infarto do miocárdio. Hoje, The Wall Street Journal relembra das pressões sobre pesquisador de diabetes há 8 anos por causa de suas críticas ao medicamento.

Glaxo's Handling of Physician Criticized
By JEANNE WHALENNovember 17, 2007
Over a period of several years, drug maker GlaxoSmithKline PLC was so concerned about a prominent physician's negative views of its diabetes drug that it engaged in a concerted effort to intimidate him and stifle his opinion, a report by the U.S. Senate Finance Committee found. The report offers a window into the rarely acknowledged practice among drug companies of monitoring and seeking to influence the opinions of leading physicians, who can make or break a drug's sales. The report alleges that Glaxo Chief Executive Jean-Pierre Garnier and former research chief Tachi Yamada were involved in the intimidation.The Senate Finance Committee released the report Thursday, after researching Glaxo's relationship with John Buse, a diabetes expert and professor of medicine at the University of North Carolina in Chapel Hill. In 1999, Dr. Buse began expressing concerns about the cardiovascular risks of Avandia, one of Glaxo's top selling drugs. The Senate Finance Committee investigated the matter because it has jurisdiction over Medicare and Medicaid and wants to ensure that they are paying for safe and effective medicines, the report says. The committee, led by Montana Democrat Max Baucus and Iowa Republican Chuck Grassley, didn't recommend any particular action. It said it feared the Avandia case was part of a "troubling pattern of behavior by pharmaceutical executives." "The effect of silencing [Dr. Buse's] criticism is, in our opinion, extremely serious," the report concludes, noting that patients may have needlessly suffered heart attacks during the period. "Had GSK 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," the report says. This week, the Food and Drug Administration forced Glaxo to add a strong new warning to Avandia's prescribing label about potential heart-attack risks for patients taking the drug.
A Glaxo spokeswoman, Nancy Pekarek, said the company strongly disputes the committee's conclusions. She said Glaxo had tried to correct Dr. Buse's "inaccuracies" about Avandia but had never tried to intimidate or silence him. "People at the time were very passionate about this new medicine and could perhaps have handled the interactions with Dr. Buse better," she said. "We did apologize to Dr. Buse for the tone of some of the conversations, and he accepted that apology eight years ago." She said Dr. Garnier had no additional comment. Dr. Yamada, who is now president of the global health program at the Bill & Melinda Gates Foundation, was traveling Friday and unavailable for comment, his assistant said. In an interview last month with Nature magazine, Dr. Yamada said that he never pursued any "diabolical plot" against Dr. Buse. Dr. Buse was also traveling Friday and unavailable for comment.