The PennZone - CCHR Urges FDA Overhaul to End Psychiatric Drug and Device Harms

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The Mental Health Watchdog calls for reforms to protect public safety, citing decades of antidepressant, electroshock, and psychedelic drug risks.

LOS ANGELES - PennZone -- The Citizens Commission on Human Rights International is calling for an overhaul of mental health agencies to eliminate potential conflicts of interest that may be putting patients at risk. The 55-year mental health industry watchdog said 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, CCHR says, given the FDA's ongoing failure to address critical issues, including the fact that it 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.

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CCHR is concerned about how psychedelic drug applications are advancing through the agency, which, if approved, may increase acts of violence in the community. 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] 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, was approved in December 1987. By 1991, sales of the drug had reached nearly $1 billion and 3.5 million patients had taken it. The Los Angeles Times reported that antidepressants had been dogged by controversy over it being linked to suicide, homicide and other violence. The campaign exposing its risks was spearheaded by CCHR, a watchdog group that was established by the Church of Scientology in 1969 to investigate and expose psychiatric violations of human rights, including the failure to properly inform about treatment risks and harm. Sales "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 a scandalous history of cover-up of adverse drug effects. According to documents obtained in litigation, as early as 1984, German regulators had expressed concerns about fluoxetine and an increased risk of suicidality—three years before it was approved for the U.S. market. In 1990, FDA officer, Dr. David Graham reviewed the clinical trials and warned of large-scale under-reporting of suicidality.[7] An initially undisclosed memo from an antidepressant manufacturer 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 had reached nearly double those for an older antidepressant that had been on the market for 20 years.[9]

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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 these were not released publicly.[10] 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.[11] Shortly after, the FDA added a black box warning of suicidality to SSRI antidepressant packaging for those 18 and younger, extending this later to age 24.

CCHR says that a comprehensive review 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.

Sources:

[1] www.cchrint.org/2024/03/29/fda-again-pursues-ban-on-behavioral-electroshock-device/; 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] web.archive.org/web/20120623234442/http://www.myfoxboston.com/story/18840703/2012/06/20/un-investigating-judge-rotenberg-centers-use-of-shocks
[3] www.wisnerbaum.com/defective-medical-device-injuries/ect/
[4] 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] www.fda.gov/news-events/press-announcements/fda-issues-first-draft-guidance-clinical-trials-psychedelic-drugs
[6] 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; 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] www.cchrint.org/cchrs-exposure-of-antidepressant-risks-false-marketing-of-the-chemical-imbalance-theory/#_edn124
[11] "Barton, Greenwood Seek Info From FDA On Antidepressants," Rep. Barton's website, 24 Mar. 2004

CCHR Urges FDA Overhaul to End Psychiatric Drug and Device HarmsThe PennZone/10288207

CCHR Urges FDA Overhaul to End Psychiatric Drug and Device Harms
The PennZone/10288207