Thirty years after CCHR sued the FDA for the Prozac files, SSRI side effects are still not fully disclosed.
CCHR was the only organization to fully press for disclosure of the suppressed SSRI evidence both through FOIA and by suing the FDA. It would still take another 12 years before the internal safety data that CCHR had fought to expose finally came to light.
More than 35 years ago, the FDA already possessed substantial evidence that SSRIs could trigger severe adverse effects, including agitation, suicidal ideation, and violence. Internal company documents from the 1980s, clinical trial data, and a rapidly growing volume of adverse reaction reports already pointed to these risks long before the drugs became household names.
Through persistent Freedom of Information Act requests and litigation against the FDA itself, CCHR obtained and publicized critical safety data that regulators and manufacturers already held.
If a mental health industry watchdog could uncover and document these risks, the mental health industry handing out the drugs like candy had every opportunity to do the same—and act on it.
To this day, many psychiatrists and defenders of psychiatry’s ignorance of drug risks claim they “didn’t know” about these dangers. But the data has been there all along for anyone who cared to listen to the patients or press for the facts.
In the 1980s, when Prozac, the first SSRI, came on the market, CCHR began receiving hundreds of case reports of people experiencing severe side effects. These reports, which started accumulating in the late 1980s, described agitation, suicidal ideation, violence, and other serious adverse reactions. If CCHR was receiving this many reports, the psychiatric industry was certainly receiving them too—but took no action. CCHR, on the other hand, responded to these alarming consumer reports by filing a Citizen Petition seeking to remove the drug from the market and pressing the FDA for greater scrutiny of the emerging safety signals.
This pressure contributed to the FDA’s decision to convene its Psychopharmacological Drugs Advisory Committee (PDAC) for a public hearing on 20 September 1991. Dozens of patients and family members gave firsthand testimony describing how Prozac had triggered suicide attempts, completed suicides, and acts of violence. Despite this powerful evidence, the majority of the panel—many of whom had financial ties to pharmaceutical companies and were granted conflict-of-interest waivers—chose to ignore the witnesses. The committee voted that there was no credible evidence linking the drug to suicidality or violence and recommended no changes to the label. (It would take another 13 years for the FDA to finally add safety warnings on SSRIs for suicidal ideation — the black-box warnings — which the American Psychiatric Association protested against.)
Following the hearing, CCHR continued its efforts by submitting a broad FOIA request in June 1992 for all FDA records concerning Prozac, including the clinical trial data submitted by the manufacturer, the New Drug Application files, and the individual adverse-reaction reports. When the agency’s response proved incomplete, CCHR sued. In Citizens Commission on Human Rights v. FDA (45 F.3d 1325, 9th Cir. 1995), the Ninth Circuit largely upheld the FDA and Eli Lilly on the adequacy of the search and most withholdings, but remanded on the individual adverse-reaction reports, which the agency conceded were not exempt.
The largest volume of material kept from public view was protected under FOIA Exemption 4 as trade secrets or confidential commercial information—Lilly’s internal clinical-trial analyses, data tables, and strategic memos. Those documents later surfaced through product-liability discovery and a 2004 leak to the British Medical Journal. They included a November 1988 Lilly report showing that 38% of Prozac patients experienced new “activation” symptoms (agitation, anxiety, insomnia) versus 19% on placebo, internal compilations indicating higher reported rates of suicide attempts and hostility compared with older antidepressants, and company discussions from the 1980s acknowledging these risks and considering how to limit their impact on labeling and prescribing. Psychiatrists and clinical researchers employed by or contracted to the company were directly involved in generating, reviewing, and interpreting the safety data that the company treated as confidential and that only later emerged through litigation.
Had Exemption 4 not been invoked, that internal safety data would have been available to the general public years earlier. The same internal safety data was leaked anonymously to the British Medical Journal in December 2004.
The psychiatric-pharmaceutical industry failed to act then, just like they are failing to act today, dismissing PSSD, and other well documented SSRI side effects as anecdotal while patients continue to be injured by these drugs.