Trending...
- The World's No.1 Superstar Is Celebrating His 21st Birthday for the 28th Time Today!
- Hillside Terrace Senior Living Helps Seniors Navigate the Digital World
- Urban League of Detroit to Celebrate Southeastern Michigan Youth at 59th Annual Guild Gala
The Mental Health Watchdog calls for reforms to protect public safety, citing decades of antidepressant, electroshock, and psychedelic drug risks.
LOS ANGELES - Michimich -- 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.
More on Michimich.com
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]
More on Michimich.com
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
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.
More on Michimich.com
- Daum Group offers Essential Tips for Millennials Looking to Invest in Ann Arbor Real Estate
- The Bridge Chiropractic Shares the Top 5 Causes of Knee Pain
- Shape the Future of OpenSSL: Election Period Open Now!
- Wilderness Construction Shares the Top 5 Things to Keep in Mind When Selecting a Tub or Shower
- Roofman USA Highlights the Top 5 Reasons Homeowners Should Choose a Local Roofing Company
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]
More on Michimich.com
- LIB Empowers Uzbekistan's Automotive Industry: A New Era of Quality Assurance
- Veteran Journalist/Author Berl Falbaum's New Book Covers Trump
- TijaraIQ.com Launches as Iraq's Free Marketplace for Buying, Selling, and Creating Opportunities
- Big News!! Best Sac Homes Group Partners with LPT Realty
- Juventix Regenerative Medical PRP Highlighted in University-Published Research Study
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
Source: Citizens Commission on Human Rights
Filed Under: Health
0 Comments
Latest on Michimich.com
- Comerica Bank to Kick Off Detroit Lions "Double The Impact" My Cause My Cleats Campaign with First $17,500 Donation
- Tween Magazine Launches to Empower and Inspire Preteen Girls
- Pure & Natural Body Essentials Launches Handcrafted, All-Natural Skincare and Grooming Products
- IOTAP (Work 365) Earns SOC 2 Type II Compliance, Reinforcing Data Security Leadership
- Lake Norman Philharmonic - Annual Holiday Concert
- "Federal Complaint Filed: David Medeiros Uncovers Medicaid Mismanagement, ADA Violations, and Systemic Failures in Connecticut"
- Introducing Feelness: A Revolutionary Solution for Physical Self-Care Without the Fitness Lifestyle
- Omnitronics Wins Software Combined 2024 AI Innovation Award
- Annual pops concerts bring holiday cheer to Michigan Philharmonic's 79th season
- Mrs Elemental® USA Rebrands to Empower Married Women Across the Nation
- A Family-Centered Approach at Plymouth Terrace Senior Living
- Hillside Terrace Senior Living Helps Seniors Navigate the Digital World
- Trust Your Brakes: A Life-Saving Reminder for Drivers
- Urban League of Detroit to Celebrate Southeastern Michigan Youth at 59th Annual Guild Gala
- Time to Investigate Mental Health Research Waste on Bizarre Animal Studies
- The World's No.1 Superstar Is Celebrating His 21st Birthday for the 28th Time Today!
- Who is Stan Fitzgerald Georgia Veterans for America First state chapter Political Director
- 4th Annual Pompano Fall Festival: Shirley Murdock, Adina Howard, Jeezy, and Plies Headline Broward County's Top Music Festival
- San Francisco Bay Area Songwriting Duo Razteria and Dave Shul Release Retro Rock Pop Album Prowess Blossoming
- Le trio français de Punk-Metal Psychédélique Joe La Truite signe un contrat de management international