Wisner Baum’s SSRI Documents
PDF References
Testimony before the Psychopharmacologic Drugs Advisory Committee (PDAC)
Results of FDA’s Ongoing Meta-analysis of Suicidality Data from Adult Antidepressant Trials
December 13, 2006
Wisner Baum (formerly Baum Hedlund)
Prozac Timeline
May 25, 1984
Internal memorandum from Eli Lilly and Company [ pdf 01]
(“Lilly,” the maker of Prozac) regarding Lilly’s efforts to obtain registration of Prozac in Germany: “During the treatment with the preparation [fluoxetine] 16 suicide attempts were made, 2 of these with success. As patients with a risk of suicide were excluded from the studies, it is probable that this high proportion can be attributed to an action of the preparation in the sence (sic) of an deterioration of the clinical condition, which reached its lowest point.”
June 26, 1984
BGA (German equivalent of FDA) Report [ pdf 02]
item # 10: “The BGA [German equivalent of FDA] suspects fluoxetine [Prozac] to be a stimulating/activating drug (side-effect profile, suicides, suicide attempts).” Item # 14 states: “This is a very serious issue in the opinion of the BGA. It might well be that we will have to recommend concomitant tranquilizer intake for the first 2 or 3 weeks in the package literature.”
January 29, 1985
BGA (German equivalent of FDA) Report [pdf 03]
“Two major concerns seem to be the reason that the registration was not accepted,” “efficacy questioned” and “suicidal risk.”
February 26, 1985
BGA (German equivalent of FDA) Report [ pdf 04]
“The use of the preparations seems objectionable, as the increase in agitating effect occurs earlier than the mood elevating effect and therefore an increased risk of suicide exists.”
April 1, 1986
BGA (German equivalent of FDA) Memorandum [ pdf 05]
Under a discussion of safety issues: “Still not resolved is the fact that suicide attempts have been observed more frequently on fluoxetine as compared to imipramine . . . . According to the today’s knowledge [fluoxetine’s “favourable” side effect spectrum] is negatively affected by the increased suicidal risk.”
August 30, 1989
BGA Consultant Group Feedback [ pdf 06]
Item 3 states: “The counterindication because of acute suicidality should become a warning whereby the physicians should be advised that in the absence of sedation, the risk of higher suicidality should be taken into account.”
March 23, 1985
FDA Safety Review of Prozac [ pdf 07]
Conducted by Dr. Richard Kapit: “It is fluoxetine’s particular profile of side effects which may perhaps, in the future, give rise to the greatest clinical liabilities in the use of this medication to treat depression.”
March 23, 1985
FDA Safety Review of Prozac [ pdf 08]
Under “Catastrophic and Serious Events,” Dr. Kapit noted: “… 52 cases were “subjected to review of case reports on microfiche. Certain additional adverse events, not reported by the Company, which were revealed on microfiche, are also included in this tabulation. In most cases, these adverse events involved the onset of an unreported psychotic episode.”
March 23, 1985
FDA Safety Review of Prozac [ pdf 09]
Dr. Kapit explained: “[F]luoxetine’s profile of adverse effects more closely resembles that of a stimulant drug than one that causes sedation and gain of weight,” therefore, “fluoxetine treatment might, at least temporarily, make their illness worse.”
February, 1990
Emergence of Intense Suicidal Preoccupation During Fluoxetine [Prozac] Treatment [ pdf 10]
Notwithstanding the German government’s recognition in the mid-1980’s of an increased risk of suicidality and Dr. Kapit’s concern over Prozac’s side effect profile, the public concern over the risk of antidepressant-induced suicidality did not emerge until 1990 when two prominent Harvard psychiatrists, Drs. Martin Teicher and Jonathan Cole, published a study entitled “Emergence of Intense Suicidal Preoccupation During Fluoxetine [Prozac] Treatment.” From their personal observations of patients taking Prozac, Drs. Teicher and Cole, after first noting that four of the six patients referenced in their study experienced akathisia (a condition marked by profound inner restlessness and agitation), found that “persistent, obsessive, and violent suicidal thoughts emerged in a small minority of patients treated with fluoxetine.”
November 16, 1994
Testimony of Lilly Representative, Dr. Gary Tollefson [ pdf 11]
Lilly assigned Dr. Gary Tollefson to testify at the September 1991PDAC. According to his November 16, 1994 testimony in the Prozac case, Fentress v. Shea et al., Case No. 90-CI-06033, he did not disclose to the FDA the fact that the issue had been raised by the German government in 1984/1985.
October 3, 1990
Through documents obtained in litigation, we learned that the FDA never took this issue seriously. According to a GlaxoSmithKline (GSK) memorandum dated October 3, 1990, the FDA believed the public controversy that had erupted concerning the potential for antidepressants to increase the risk of suicide in adults was, to the FDA, not “a real issue, but rather “a public relations problem.” The FDA’s Dr. Martin Brecher indicated to GSK that the FDA “does not think it is an issue, but it needs to be addressed.”
September 20, 1991
FDA Psychopharmacological Drugs Advisory Committee [ pdf 13]
Although the committee members ultimately voted that there was insufficient data to conclude that Prozac caused suicide (the question posed was: “Is there credible evidence to support a conclusion that antidepressant drugs cause the emergence and/or intensification of suicidality and/or other violent behaviors?”), the FDA stated that it did “not dismiss the possibility that antidepressants in general or fluoxetine in particular may have the capacity to cause untoward injurious behaviors and acts, and/or to intensify them.” The FDA concluded that “more research is needed” and “asked [Lilly] to develop plans to conduct new studies, including clinical trials and epidemiological studies, studies that could provide more direct answers to the questions that have been raised” in the advisory committee meeting.