Grassley asks FDA to probe Glaxo's Paxil communication.

Sen. Chuck Grassley (R-IA) has asked FDA to dig in on the data that GlaxoSmithKline submitted to the agency about the antidepressant Paxil to determine if the company concealed risk of suicide for users of the drug, "The Wall Street Journal" reported June 12.

Grassley pointed out in a letter to the agency and HHS Secretary Michael Leavitt that the U.K. recently concluded that GSK withheld safety information in its submission for approval in Europe; he wants FDA to investigate whether the company did the same in the U.S. as well.

In Grassley's statement on the Senate floor June 11, he spoke of how drug companies conceal unflattering data. "I don't mean that they actually hide the data," he said, according to a transcript, "but they make these numbers so difficult to find that they might as well be invisible."

He cited a report by a Harvard researcher that argued GSK likely knew about the safety concern back when it asked for FDA approval for Paxil in 1989. Moreover, the report suggested that GSK clouded the numbers by assigning people who had attempted suicide before the study began into the placebo group.

Because a past suicide attempt is a good predictor of future suicide behavior, research shows, this assignment essentially inflated the likelihood of suicide in the placebo group. GSK then compared its Paxil group to this suicide-risk inflated placebo group.

"Essentially, it looks like GlaxoSmithKline bamboozled the FDA," he said to the Senate.

Glaxo said in a statement that it "believes it was candid and transparent in responding to Senator Grassley's request, and regrets if there has been a misunderstanding between the Senator and GSK."