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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

Harvard Study: 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

FDA Memorandum [ pdf 12]

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.

Biffle vs. Eli Lilly

Defendants Amend and Supplemental Answers to Plaintiffs’ First Interrogatories [ pdf 14]

According to Lilly’s answers to Interrogatories submitted under oath in the lawsuit Biffle v. Eli Lilly: “Discussions were had between Lilly and the FDA regarding possible data analyses or clinical trial designs which would test whether the Teicher assertions are in fact real. The FDA did not request or require any action from Lilly nor suggest a particular analytical of study approach. The discussions and question as to whether additional studies be done were mooted by the findings of the FDA Psychopharmacological Drug Advisory Committee on September 20, 1991. No additional studies were conducted.”

June 3, 1992

Letter from FDA to Public Citizen [ pdf 15]

According to a letter the FDA sent to Public Citizen in June 1992: “There was a consensus [amongst the PDAC above] that more research is needed to further explore the relationship between suicidality and the use of not only Prozac, but other antidepressants as well.” The FDA further stated that it would “continue our careful evaluation of data in our spontaneous reporting system and encourage additional research on this matter.”

January 20, 1994

Pfizer Memorandum [ pdf 16] Obtained in Litigation

Written by Pfizer’s top scientist at the time

According to an internal Pfizer memorandum obtained in litigation and written by Pfizer’s top scientist at the time: “I do not think fluoxetine are ‘out of the woods’ as regards their association with violence/ suicidality. The recent meta-analysis of controlled clinical trials (Beasley et al, BMJ 303: 685-692, 1991) was initially followed by favorable comment but skeptical voices remain. A recent re-analysis of the data from this study using Monte-Carlo simulations demonstrates the conclusions of the Beasley paper to be invalid as this original meta-analysis had low power (LiWan PoA. Pharmacoepidemiology and Drug Safety 2: 78-84, 1994).” January 20, 1994 memo from Roger Lane to Giller regarding Use of Zoloft in Impulsive/ Aggressive Behaviour.

September 11, 1990

FDA Memorandum [ pdf 17]

Obtained through the Freedom of Information Act

Dr. David Graham

The firm [Lilly] reviewed data from NDA studies, prefacing it with the acknowledgment that these trials were not designed for the prospective evaluation of suicidality. In these trials patients with current suicidal ideation were excluded. …The capacity of these trials to identify and describe the quality and intensity of suicidality was low.

November 23, 2006

New England Journal of Medicine:

Dangerous Deception — Hiding the Evidence of Adverse Drug Effects [ pdf 18]

Jeffrey Avorn, MD

First “a drug is approved because it is more effective than placebo.” Then, “worries emerge about its safety.” However, “few or no adequately powered controlled trials [conducted by drug companies] are conducted to address these issues.” Thus, “The health care system has a hard time performing drug safety analyses, in large part because it relies on the pharmaceutical industry to conduct most research on the risks and benefits of medications. It is naive to expect companies to voluntarily fund studies that could sink lucrative products” and further complicating matters is the fact that “the FDA lacks regulatory clout to require them.”

October 14, 2004

New England Journal of Medicine: A Black Box Warning for Antidepressants in Children? [ pdf 20]

Thomas B. Newman, MD, MPH

Dr. Thomas Newman, an epidemiologist from the University of San Francisco and an advisor to the FDA on the issue of child/adolescent suicidality (following recommendations that antidepressants carry black box warnings) noted that, the fact that higher rates of suicidality in those taking antidepressants have emerged from the clinical trials is “striking” and “such a dramatic result would be expected to occur by chance only 1 time in 20,000.”

September 23, 2004

Hearing: House of Representatives Committee on Energy and Commerce

Oversight and Investigations Subcommittee [ pdf 21]

108th Congress

In testimony before Congress resulting from investigations of the FDA’s failure to protect consumers related to the antidepressant suicidality issue, the FDA’s Dr. Robert Temple defended the agency’s failure, stating that although the FDA “had been systematically looking at the adult data for almost that entire decade” and had “not seen a signal in that data,” Dr. Temple admitted that the FDA’s analyses could have been far “better, more structured, [and] more careful, … but we didn’t know to do that.

February 2, 2004

FDA Psychopharmacological Drugs Advisory Committee [ pdf 22]

At the February 2, 2004, FDA advisory committee meeting concerning the risk of suicidality in children and adolescents taking antidepressants, the FDA’s Dr. Thomas Laughren similarly explained: “Just one follow up on a suggestion that has come up from several committee members now about looking at items from the rating scales. That was actually done here, and it turned out not to be very helpful. Now, this was a similar analysis that had been done with the adult data years ago. … ” He explained that this method “did not detect a signal in these trials … ” and admitted that the method was “was not particularly productive.”

May, 2006

GSK Important Prescribing Information [ pdf 23]

For its meta-analysis of suicidality data from the adult clinical trials, the FDA asked companies to submit data only from short term depression studies up to 17 weeks, which had at least 30 patients in the study. GSK decided to do its own blinded analysis of its adult clinical trial data. The results of the new analysis showed: “In adults with MDD (all ages), there is a statistically significant increase in the frequency of suicidal behavior in patients treated with paroxetine compared with placebo.”

July 15, 2002

American Psychological Association:

Antidepressants and Placebos: Secrets, Revelations and Unanswered Questions [ pdf 24]

Irving Kirsch, Alan Scoboria and Thomas J. Moore

July 15, 2005

British Medical Journal:

Efficacy of Antidepressants in Adults [ pdf 25]

Joanna Moncrieff and Irving Kirsch

In an analysis of efficacy data submitted to the FDA between 1987 and 1999 for six of the most popular selective serotonin reuptake inhibitor (SSRI) antidepressants, 75 to 80% of the response to medication was duplicated in placebo groups. (Kirsch and Moore, “The Emperor’s New Drugs: An Analysis of Antidepressant Medication Data Submitted to the U.S. Food and Drug Administration,” Prevention & Treatment, Volume 5, Article 23, July 15, 2002.) These data were the basis on which the medications were approved by the FDA. The researchers explained that the “small difference between the drug response and the placebo response has been a ‘dirty little secret’ known to researchers who conduct clinical trials, FDA reviewers, and a small group of critics who analyzed the published data …”

December 24, 1991

FDA Memorandum [ pdf 26]

FDA approval of these drugs implies that the data were strong enough and reliable enough to warrant approval, however, as one FDA memorandum written by Dr. Paul Leber illustrates, the FDA’s standards for approving antidepressants as effective are not robust: “Approval [of the antidepressant] may … come under attack by constituencies that do not believe the agency is as demanding as it ought to be in regard to its standards for establishing the efficacy of antidepressant drug products.”

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