U.S. Senator Leads Paxil Probe
Wednesday, February 06, 2008
Sen. Charles Grassley of Iowa has been leading a probe into whether GlaxoSmithKline knew about the suicide risks associated with it’s popular antidepressant drug Paxil. One of the main focuses of the investigation is to determine why GlaxoSmithKline waited more than 15 years before warning the public.The British drug maker added warnings to Paxil in 2006 regarding increased rates of suicidal behavior in young adults. Although, Sen. Charles Grassley of Iowa said at the beginning of February 2008 that court documents from a recently dismissed lawsuit suggest the company knew about the risks as early as 1989.
In the documents, a Harvard Medical School psychiatrist make a case Glaxo mishandled reports of suicide in early studies of Paxil. Glaxo has denied any wrongdoing. After reviewing dozens of internal company documents, Dr. Joseph Glenmullen concluded the company inappropriately added reports of suicide to the placebo group of a company trial, so they would appear more in line with the results for patients taking the drug.
Glenmullen reviewed the documents for law firm that was pursuing a lawsuit against Glaxo. A U.S. District Court Judge dismissed the case last month, but several documents from the case were unsealed.
Grassley, a frequent critic of the drug industry, sent a letter to Glaxo Wednesday, asking the company to clarify when it became aware of the suicide risks of its antidepressant. The senator also requests the company provide certain pages from Glenmullen's report which were not made public by the court.
Glenmullen said nearly all of the suicide reports added to the placebo group occurred prior to the start of the trial, and they should have been discarded from the research.
"It's virtually impossible this was an accident because it happened over and over again and the company continued publishing the results for 15 years," said Glenmullen.
If the company had tabulated the suicide reports conventionally, Glenmullen says the data would have shown Paxil patients had an eight times greater risk of suicidal behavior.
Glaxo called the analysis "unscientific and misleading," in a statement.
"Glenmullen has carefully selected excerpts from GSK documents and made his own interpretations, without looking at the totality of the data," said Glaxo spokeswoman Mary Anne Rhyne.
The company said it has always provided accurate and appropriate information on suicide rates to government regulators.
Posted in Dangerous Drugs