Saturday, January 1, 2005
It's going to be a rough year (and then some) for Eli Lilly, if the British Medical Journal (BMJ) is right about documents that have been missing for 10 years and the journal received from a confidential source last month. According to a news story by Jeanne Lenzer in the current (Jan. 1) issue, officials at Lilly knew about the increased suicide risk associated with Prozac use. According to the article, "Dr Richard Kapit, the FDA clinical reviewer who approved fluoxetine, said he was not given the Lilly data. 'These data are very important. If this report was done by Lilly or for Lilly, it was their responsibility to report it to us and to publish it.'" The article provides a concise review of the past year's Prozac-related developments, including the FDA's recent public health advisory about antidepressants, and an on-going review by a member of Congress:
Congressman Maurice Hinchey's office is currently reviewing the documents to determine whether Lilly withheld data from the public and the FDA. Mr Hinchey (Democrat, New York) said: "This is an alarming study that should have been shared with the public and the FDA from the get-go, not 16 years later.
"This case demonstrates the need for Congress to mandate the complete disclosure of all clinical studies for FDA-approved drugs so that patients and their doctors, not the drug companies, decide whether the benefits of taking a certain medicine outweigh the risks."