UK pharmaceutical giant GlaxoSmithKline kept the dangers of its top-selling diabetes drug Avandia out of the public eye and ghostwrote scientific articles about it, US lawmakers charged Tuesday.
The allegations came as the Food and Drug Administration (FDA) opened a two-day meeting of experts, who will weigh whether to pull Avandia from the market over safety concerns.
In a letter dated Monday and addressed to FDA Commissioner Margaret Hamburg, Senators Max Baucus and Charles Grassley accused Glaxo of covering up scientific studies that found problems with Avandia and of including the drug in a "ghost-writing" programme.
Baucus chairs the Senate Finance Committee and Grassley is a ranking member on the committee, which counts oversight of the FDA among its key tasks. Their letter to Hamburg cited several Glaxo internal e-mails which show that the pharmaceutical giant knew that studies had found "problems" with Avandia, but ordered that the studies' findings not be made public.
One study withheld from FDA
Several studies have linked Avandia to an increased risk of heart attack and stroke, but a Glaxo-funded study last year came up with the opposite result.
Some of the Glaxo e-mails date back to 2000, a year after the diabetes drug was brought to market in the United States. One of the studies, which showed that taking Avandia gave patients a worse lipid profile than ACTOS, a comparable diabetes drug made by a competitor, was witheld from the FDA's attention, the letter says.
Higher lipids can contribute to an increased risk of heart attack or stroke.
According to an internal Glaxo email attached to the senators' letter, Glaxo senior management requested that the results of the study "should not see the light of day to anyone outside of GSK."
A note on whether to publish two further studies, which also found problems with Avandia, said bluntly, "Not a chance."
Avandia is a money-spinner for Glaxo, racking up $800 million in sales worldwide last year to make it one of the top-selling diabetes treatments in the world.
Glaxo included Avandia in a "sophisticated ghostwriting programme" set up to promote some of its drugs, the US lawmakers alleged. At least one article was ghostwritten by Glaxo on Avandia, attributed to a practising medical doctor and published in a scientific journal AFP saw copies of ghostwritten articles on Avandia and the internal Glaxo e-mails, which the lawmakers attached to the letter sent to Hamburg.
Earlier Tuesday, the Wall Street Journal reported that former FDA drug-safety official Rosemary Johann-Liang had said in a deposition for lawsuits filed against Glaxo that the British drug company "hadn't given the FDA full information on Avandia's risks in a timely manner."
The paper said Johann-Liang quit her FDA post "after she was unable to convince her superiors about the need for stronger warnings" about Avandia.
The damning letter and the allegations in the Wall Street Journal came as a panel of experts began considering whether Glaxo's star diabetes drug should be pulled from the market.
"The documents we uncovered in our investigation will help arm the FDA with the best information possible as it evaluates Avandia's safety," Baucus said.
The FDA is not bound by recommendations made by the panels of experts it convenes to take a decision on a drug, but usually follows their advice. - (Sapa, July 2010)