May 30, 1991— (Allan Gelberg) Acting Chief, Surveillance and Data Processing Branch, Center for Drug Evaluation and Research (CDER) of the FDA notes that since it was marketed in 1988, Prozac (fluoxetine) has had the highest number of adverse event reports submitted to the FDA National Adverse Drug Reaction Reporting System Database.
June 19, 1991—SKB submits A Review and Evaluation of Clinical Data, Original NDA 0-31, Paroxetine (Aropax). Martin Brecher, M.D., DM Sc. conducts the review. He finds that: "Together the safety and efficacy data allow for the conclusion that paroxetine is safe and efficacious and approvable for marketing." The FDA response by Tom Laughren: "The safety and efficacy findings for paroxetine were presented to the PDAC on this date (10-5-92) and they unanimously agreed that Paroxetine has been demonstrated to be safe and effective." The data reported in the review show a rate of suicidal acts that is 2.5 times higher in the paroxetine group than the placebo group, but the presentation hides this fact.
Sept 20, 1991— FDA Pharmalogic Drugs Advisory Committee holds hearings on the resolution that: "there is credible evidence to support a conclusion that SSRI antidepressant drugs cause the emergence and/or intensification of suicidality and/or other violent behaviors." Five of 9 Advisory Committee members, and 3 of the 6 consultants had clear conflicts of interest re: ownership of drug company shares, but at the hearing, the issue of conflict of interest is set aside as follows: "The following announcement addresses the issue of conflict of interest and is made part of the record to preclude even the appearance of such at this meeting. In accordance with the prepared agenda, there will be no specific issues dealing with a specific product or sponsor presented to the committee for review and evaluation during this meeting. Therefore, it has been determined that all committee members may fully participate in today's meeting without the risk of any conflict of interest, as defined " Despite a day of testimony from many people who have experienced Prozac-induced tragedies of violence and suicide, the Committee votes against the resolution, and no warnings are required for SSRIs. (See Hearings Transcript Page 10)