Grassley asks FDA to probe Glaxo's Paxil communication.Sen. Chuck Grassley Charles Ernest "Chuck" Grassley (born September 17 1933) is the senior United States Senator from Iowa. He is a member of the Republican Party. He was chairman of the Finance Committee from January to June 2001, and from January 2003 to December 2006 and currently serves as the (R-IA) has asked FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. to dig in to cover by digging; as, to dig in manure s>.
To entrench oneself so as to give stronger resistance; - used of warfare or negotiating situations.
See also: Dig Dig on the data that GlaxoSmithKline submitted to the agency about the antidepressant antidepressant, any of a wide range of drugs used to treat psychic depression. They are given to elevate mood, counter suicidal thoughts, and increase the effectiveness of psychotherapy. 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 HHS Department of Health and Human Services. Secretary Michael Leavitt that the U.K. recently concluded that GSK GSK GlaxoSmithKline plc (pharmaceutical company)
GSK Glycogen Synthase Kinase
GSK Gruppentraining Sozialer Kompetenzen (Germany)
GSK Greenland Shark (FAO fish species code) 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."