The mental health watchdog calls for reforms to protect public safety, citing decades of antidepressant, electroshock, and psychedelic drug risks.

By CCHR International
The Mental Health Industry Watchdog
November 15, 2024

CCHR International is calling for an overhaul of mental health agencies to eliminate potential conflicts of interest that may be putting patients at risk. Oversight should focus on the Food and Drug Administration (FDA), the agency tasked with ensuring the safety, efficacy, and security of drugs, biological products, and medical devices.

This reform is particularly urgent, given the FDA’s ongoing failure to address critical issues, including the fact that the FDA has yet to ban a skin electroshock device used as painful behavior modification on students with autism and intellectual and mental handicaps. In March 2024, the FDA announced that an electrical stimulation device (ESD) for behavior modification presents an “unreasonable and substantial risk of illness or injury.” It called for submissions but has yet to issue a final order prohibiting it.[1] Meanwhile, children and adults continue to be subjected to it.

This is despite, as early as 2012, Juan Mendez, the United Nations Special Rapporteur on Torture said using this aversion therapy device constituted torture. According to a human rights lawyer, “The passage of electricity through anybody’s body is clearly associated with pain and suffering.”[2] Health agencies and psychiatric associations allow electroconvulsive therapy (ECT) to continue to be given to children and adolescents, as well as to any individual without their consent—a practice the UN also considers coercion and torture. No clinical trials have proven the safety and efficacy of ECT.[3]

CCHR has long advocated for the FDA to recognize the dangers of electroshock and to protect the public from the mass reliance upon antidepressants and other psychotropic drugs that pose significant health risks. The group says critical warnings about the link between antidepressants and increased suicidality and violent behavior have been ignored.

CCHR is concerned at how psychedelic drug applications are advancing through the agency. In June 2024, the FDA granted “Breakthrough Therapy Designation” to the hallucinogen psilocybin as an adjunct to treat “major depressive disorder.” The designation is usually reserved for drugs that substantially improve over existing therapies in treating severe or life-threatening conditions.[4] A year earlier, the FDA published guidelines for researchers to meet challenges in designing psychedelic drug development programs. “Psychedelic drugs may produce psychoactive effects such as mood and cognitive changes, as well as hallucinations. As a result, there is the potential for abuse of these drugs, which is a drug safety issue,” according to the FDA.[5]

The U.S. is already plagued by acts of senseless violence, including school and community shootings, committed by people taking or withdrawing from psychiatric drugs. Psychedelics, if approved, could add to this. For years, the links between antidepressants and suicidality or violent behavior were suppressed, as documented by CCHR and medical experts.

The breakthrough SSRI antidepressant, fluoxetine (Prozac) was approved in December 1987. By 1991, sales of Prozac had reached nearly $1 billion and 3.5 million patients had taken it. The Los Angeles Times reported that Prozac had been dogged by controversy over it being linked to acts of suicide, homicide and other violence. The campaign against it was spearheaded by CCHR, established by the Church of Scientology. “Sales of Prozac would be substantially higher” were it not for this campaign, said Steven Gerber, a securities analyst with Bateman Eichler in Los Angeles. According to the LA Times, “The campaign, which included involvement in dozens of criminal and civil suits, has nonetheless been surprisingly successful, alarming both potential patients and their doctors and contributing to the halt in growth of the drug’s sales in [1991].”[6]

CCHR’s Freedom of Information Act requests, review of court documents and media investigation findings reveal the scandalous history of cover-up. According to documents obtained in litigation, as early as 1984, German regulators had expressed concerns about Prozac and an increased risk of suicidality—three years before fluoxetine was FDA approved. In 1990, the agency’s officer, Dr. David Graham reviewed the clinical trials from Eli Lilly and warned of large-scale under-reporting of suicidality during the clinical trials.[7] An undisclosed Eli Lilly memo admitted a rate of suicide to be 5.6 times higher than for the older tricyclic antidepressant, imipramine.[8] Adverse effects within two years of the drug being approved reached nearly double those for an older antidepressant that had been on the market for 20 years.[9]

In February 1990, a memo written by W. Leigh Thompson, group vice president of Lilly Research Laboratories, stated, “We are now expending enormous efforts fending off attacks because of (1) relationship to murder and (2) inducing suicidal ideation.”[10] A September 1991 FDA Psychopharmacological Drugs Advisory Committee (PDAC) hearing into the issue whitewashed the risks, with committee members steeped in conflicts of interest with antidepressant makers. Psychiatrists warned that any changes in Prozac labeling would undermine the public’s confidence in psychiatric drugs.[11] Drug company and psychiatric profits took precedence over public protections when PDAC voted unanimously that antidepressants did not cause suicidality and violent behavior.

FDA officials continued to find suicide and violence to be of concern, such as Dr. Andrew Mosholder, an FDA Safety Reviewer, who provided his findings to the FDA, but they would not allow him to release them publicly.[12] In 2003, The Hartford Courant exposed how antidepressant makers and the FDA had covered up information about antidepressant risks to deflect media attention away from the drugs’ potential to induce suicide and violence.[13] The brazen refusal to publicly acknowledge the risks came to a head in 2004 when the U.S. House Energy and Commerce Subcommittee on Oversight and Investigations began an investigation.[14] In September, the first of several hearings were held, during which the FDA was accused of “stonewalling, slow rolling, and plain incompetence.”[15] The chairman of the hearing accused the FDA of a lack of cooperation and threatened to ask police officers to go to the agency’s offices to retrieve the records requested. “The FDA’s lack of cooperation with the committee in obtaining relevant and responsive information in a timely fashion on a matter that involves the safety of our children leaves me wondering whether this is sheer ineptitude or something far worse,” he said.[16] Shortly after, the FDA was forced to add a black box warning of suicidality to SSRI antidepressant packaging for those 18 and younger, extending later to age 24.

A comprehensive overhaul of the FDA’s review, approval and monitoring process for psychotropic drugs and psychiatric devices is vital to safeguarding public health and ensuring the protection of patients.

---

References:

[1] https://www.cchrint.org/2024/03/29/fda-again-pursues-ban-on-behavioral-electroshock-device/, “FDA moves again to ban controversial shock therapy devices used by Rotenberg Center,” Sun Chronicle, 26 Mar. 2023, https://www.thesunchronicle.com/news/local_news/fda-moves-again-to-ban-controversial-shock-therapy-devices-used-by-rotenberg-center/article_5b3792d4-3dd0-5745-a92b-332edf69b33f.html

[2] https://www.cchrint.org/2024/03/29/fda-again-pursues-ban-on-behavioral-electroshock-device/; citing https://web.archive.org/web/20120623234442/http://www.myfoxboston.com/story/18840703/2012/06/20/un-investigating-judge-rotenberg-centers-use-of-shocks

[3] https://www.cchrint.org/2023/09/05/study-shows-patients-misled-about-electroshock/; citing https://www.wisnerbaum.com/defective-medical-device-injuries/ect/; citing https://www.who.int/publications/i/item/9789240080737

[4] https://med.uth.edu/psychiatry/2024/06/03/fda-grants-breakthrough-therapy-designation-to-cyb003-a-deuterated-psilocybin-analog-being-investigated-as-an-adjunctive-treatment-for-major-depressive-disorder-mdd/

[5] “FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs
Agency Recommendations Aim to Inform Psychedelic Drug Development,” 23 June 2023,
https://www.fda.gov/news-events/press-announcements/fda-issues-first-draft-guidance-clinical-trials-psychedelic-drugs

[6] Donna K. H. Walters, “New Antidepressants Emerge to Challenge Prozac,” Los Angeles Times, 8 Jan. 1992, https://www.latimes.com/archives/la-xpm-1992-01-08-fi-1610-story.html

[7] Joseph Glenmullen, M.D., Prozac Backlash, (New York, NY: Simon & Schuster, 2000) p. 162; https://www.wisnerbaum.com/our-successes/advocacy-campaigns/antidepressant-trials-adult-suicidality-data/

[8] Dr. Richard DeGrandpre, “Anti-depressants may be hazardous to your health,” Hartford Advocate, 20 Aug 2002

[9] Craig McLaughlin, “The Perils of Prozac,” San Francisco Bay Guardian, 16 May 1996

[10] Baum Hedlund Law Corporation Time-Line citing exhibits in the Forsyth vs Eli Lilly civil suit, Nov. 1990, https://www.wisnerbaum.com/prescription-drugs/prozac-timeline/

[11] Joseph Glenmullen, M.D., Prozac Backlash, (Simon & Schuster, NY, 2000), p. 157

[12] https://www.cchrint.org/cchrs-exposure-of-antidepressant-risks-false-marketing-of-the-chemical-imbalance-theory/

[13] Dave Altimari, Memos Display Drug Firms’ Optimism Officials Were Confident FDA Would Back Them On Suicide, Violence Issues Involving Paxil, Prozac,” Hartford Courant, 21 Sept. 2003

[14] “Barton, Greenwood Seek Info From FDA On Antidepressants,” Rep. Barton’s website, 24 Mar. 2004

[15] “FDA, drugmakers faulted over secrecy, Lawmakers say crucial data on the effectiveness of antidepressants in treating kids was withheld,” Denver Post, 10 Sept. 2004

[16] Gardiner Harris, “Lawmaker Says F.D.A. Held Back Drug Data,” The New York Times, 10 Sept. 2004