From correspondents in Washington: AFP
July 14, 2010
Glaxo 'covered up diabetes drug's risks, conducted secret research'
BRITISH pharmaceutical giant GlaxoSmithKline hid the dangers of its top-selling diabetes drug Avandia and secretly wrote scientific articles about it, two US politicians charged overnight.
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 on 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 "ghostwriting" program.
Mr 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 emails which show that the pharmaceutical giant knew that studies had found "problems" with Avandia but ordered that the findings not be made public.
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 emails date back to 2000, a year after the diabetes drug was brought to market in the US.
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 withheld from the FDA's attention, the letter said.
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 $US800 million ($912.3 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 program" set up to promote some of its drugs, the US politicians alleged.
At least one article was ghostwritten by Glaxo on Avandia, attributed to a practicing medical doctor and published in a scientific journal
AFP saw copies of ghostwritten articles on Avandia and the internal Glaxo emails, which the politicians attached to the letter sent to Hamburg.
The politicians' letter 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," Mr Baucus said.
In a statement posted on its website, Glaxo said the documents were incomplete and misleading and "included drafts and documents taken out of context.
"GSK has been diligent in providing its safety data on Avandia to the FDA and in publishing its clinical trial data in peer-reviewed journals or on its clinical trial website," the company said.
Data from the studies that drew the "not a chance" comment were, in fact, submitted to the FDA in 1999, Glaxo said, while the study that showed that Avandia-takers had worse lipid profiles than diabetics who used the competition's drug was not even about Avandia and heart attacks.
As for ghostwritten articles, Glaxo said it "follows established authorship practices modelled after the International Committee of Medical Journal Editors guidelines."
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.