Another Avandia Critic Says Drug Maker Tried To Shut Her UpNov 19, 2008 | Parker Waichman LLP
Another doctor has come forward to claim that the maker of Avandia tried to silence her criticism of the controversial diabetes drug, The Wall Street Journal reports. This time, an internist at a Hagerstown, Maryland hospital says drug company executives wrote to her superiors to get her to stop talking about her concerns that Avandia was linked to congestive heart failure and other problems.
Avandia’s cardiovascular problems have been the subject of concern since May 2007, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. That summer, GlaxoSmithKline, the maker of Avandia and the Food & Drug Administration (FDA) came under fire for an apparent failure to warn the public about the cardiac risks associated with Avandia.
Last year, we reported that a Senate Finance Committee was investigating whether or not the drug comany tried to silence Dr. 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. The summer before that report was published, the Senate committee heard testimony from Dr. Buse, who said he felt pressured by the drug’s maker, SmithKlineBeecham (now part of GlaxoSmithKline) to sign a clarifying statement drafted by the company that downplayed his concerns. During his testimony, Dr. Buse described name-calling and what he said was the veiled threat of a lawsuit by a high-ranking drug company executive after he had criticized Avandia at a medical meeting. Dr. Buse also testified that the drug complained about him to his supervisors at the University of North Carolina.
Now, internist Mary Money has told The Wall Street Journal about her experience with Glaxo after she and a colleague voiced concerns about Avandia back in 2000. According to Dr. Money, she and another doctor, Stephen Lippman, at Washington County Hospital in Hagerstown, met with representatives of SmithKlineBeecham, and presented data on 85 of their Avandia patients. According to The Wall Street Journal, more than half of the patients had significant edema, or swelling, and about half of that group also had high pulmonary pressure and shortness of breath. Three had been hospitalized for congestive heart failure.
Dr. Money told the Journal that the representatives from the drug maker dismissed her concerns. What's more, the next month, the drug maker wrote to the hospital's chief of staff in an attempt to force Dr. Money to stop talking about her worries with other doctors.
Fortunately, Dr. Money's superiors chose to trust her judgment, and ignored SmithKlineBeecham's letter. According to the Journal, Dr. Money has continued to discourage the use of Avandia when speaking to colleagues.