Researchers Report Concern over Antidepressants Causing Long-Lasting Sexual Dysfunction; CCHR Calls on FDA to Act

Posted on October 28, 2024 by cchrstl

Decades after sexual dysfunction caused by antidepressants was first reported to persist after patients stopped taking the drugs, how many people experience continuing sexual problems is still not known.  Citizens Commission on Human Rights calls on the FDA to address the issue without further delay. 

by CCHR National Affairs Office

Researchers active in investigating the adverse effects of psychiatric drugs have expressed concern over the lack of scientific data on the prevalence of antidepressant-caused sexual problems that persist after patients stop taking the drugs.  The condition has caused marriages to break up, and people are known to have committed suicide as a result of it.  Because the antidepressants most at issue are selective serotonin reuptake inhibitors (SSRIs), the condition is called post-SSRI sexual dysfunction (PSSD).

Research indicates that while taking antidepressants, 25%-80% of patients encounter sexual difficulties they had not experienced before taking the drugs.  Patients report that the sexual dysfunction strained their relationships, deepened their depression, lowered their self-esteem, and brought on feelings of failure.

In a recent article in Epidemiology and Psychiatric Sciences, psychiatrist and psychopharmacologist David Healy, M.D., and Dee Mangin, M.D., both professors at McMaster University in Canada, report that “while sexual dysfunction is a well-known side effect of taking selective serotonin reuptake inhibitors (SSRIs), in an undetermined number of patients, sexual function does not return to pre-drug baseline after stopping SSRIs.”

PSSD can comprise a range of sexual symptoms experienced while taking antidepressants that continue after the drugs are no longer used, including a lack of sexual drive, lack of sexual sensation, and problems with sexual performance that were not experienced before starting on the drugs.  In addition to SSRIs, serotonin-norepinephrine reuptake inhibitors (SNRIs) and some older tricyclic antidepressants are also known to cause PSSD.

According to Healy and Mangin, the problem of PSSD has been known for decades, with the condition first reported to the drug regulatory agency in the UK in 1991 and first reported in the medical literature in 2006.  However, there are still no known treatments for the condition.

PSSD can have a devastating impact on patients’ lives.  The researchers write that “PSSD can lead to marriage break-up and job loss.”  Professor Healy reveals that he is “aware of at least 20 cases of people who have committed suicide as a result of the condition.”

“This has never been properly investigated and described, and there is an urgent need to understand the incidence, prevalence and natural history of PSSD, with a focus on informing prevention as well as investigating treatments,” the researchers wrote.

In 2018, Healy and Mangin were among 22 signers of a citizen petition delivered to the U.S. Food and Drug Administration (FDA), calling on the agency to strengthen the warning on antidepressants’ labeling to adequately convey the serious risk of persistent, even permanent sexual side effects after the use of antidepressants has stopped.  The petition also called for the FDA to require SSRI and SNRI manufacturers to send a “Dear Health Care Provider Letter” to inform psychiatrists, family doctors and other prescribers about the risk, placing an obligation on them to fully inform their patients of the risks.

After similar petitions were filed in 2018 with drug regulatory agencies in Europe and Canada, warnings were updated by the European Medicines Agency in 2019 and by Health Canada in 2021 to reflect the risk.  However, the FDA has yet to take final action.

Recently, a lawsuit was filed in the U.S. District Court for the District of Columbia by one of the petition signers, claiming the FDA has failed to take final action on the petition and seeking a court order requiring the FDA to act.

The lawsuit states that antidepressant labeling warns of sexual problems that may be experienced while taking antidepressants, but “current labeling in the United States does not adequately convey the risk of broad, severe, and potentially permanent post-treatment changes to sexual function.” 

“The devastating sexual side effects from antidepressants, harming the sex lives of an untold number of the 45 million Americans taking these psychiatric drugs – side effects that can persist and even become permanent – should have been addressed years ago by the FDA,” said Anne Goedeke, president of the National Affairs Office of the Citizens Commission on Human Rights.  “The FDA needs to act now, without further delay.”

A key rationale for prescribing antidepressants in the first place – to fix a chemical imbalance in the brain – was found to be without scientific merit.  A 2022 comprehensive review of research into whether a lack of the brain chemical serotonin causes depression concluded there was no convincing evidence to support the theory.  This calls into question the prescribing of SSRI and SNRI antidepressants that make more serotonin available in the brain, if no known chemical deficiency exists.

WARNING: Anyone wishing to discontinue or change the dose of an antidepressant or other psychiatric drug is cautioned to do so only under the supervision of a physician because of potentially dangerous withdrawal symptoms.

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Clozapine (Really?) for Schizophrenia

Posted on October 21, 2024 by cchrstl

Clozapine is an FDA-approved atypical antipsychotic drug for treatment-resistant schizophrenia. Clozapine is not the first-line drug of choice due to its range of adverse effects, making compliance an issue for many patients. (Meaning patients will stop taking it because of the bad side effects.) So it is really a drug of last resort.

Psychiatrists rely on dangerous drugs like clozapine but cannot make up their minds if these drugs are safe when they clearly are not. Psychiatrists experiment on our most vulnerable people using a “drug of last resort” when they have likely misdiagnosed a real physical cause of the person’s distress which has a real medical treatment.

Clozapine was first synthesized in 1956. Initial FDA approval was in 1989. Shortly after its introduction, clozapine was linked to a serious life-threatening side effect, and it was withdrawn from the market temporarily in the same year. It was re-approved with strict monitoring requirements later in 1989. While clozapine is not considered addictive, abruptly stopping clozapine can lead to withdrawal symptoms; which may be why psychiatrists often use the euphemism “discontinuation symptoms” instead of “withdrawal symptoms” in order to avoid saying a drug may be addictive.

The clozapine controversy is not over; the FDA is hosting an in-person advisory committee meeting on November 19, 2024, to discuss reevaluation of the Clozapine Risk Evaluation and Mitigation Strategy, which is the protocol for mitigating clozapine’s serious adverse side effects.

Clozapine is primarily metabolized in the liver involving the cytochrome P450 enzyme system in order to be eliminated from the body. Abnormal CYP450 metabolism, either ultrarapid and/or diminished, can lead to the drug or its metabolites reaching a toxic level in hours or days, correlating with the onset of intense dysphoria [unease or generalized dissatisfaction with life] and akathisia [an inability to remain still]. A person genetically deficient in these enzymes, or who has an ultrarapid drug metabolism, or who is taking other (legal or illegal) drugs that diminish CYP450 enzyme activity, is at risk of a toxic accumulation of the drug leading to more severe side effects.

Clozapine is a dopamine and serotonin receptor antagonist, which means it blocks certain receptors in the brain for dopamine and serotonin. By interfering with these neurotransmitters in the brain the psychiatric theory supposes this is beneficial; however, the body must maintain strict balances of these chemicals because a surplus or deficiency of either can have disastrous side effects. So forcing the body into a different balance is like playing Russian Roulette with one’s brain.

This theory is called “The dopaminergic hypothesis of schizophrenia.” Unfortunately, it is not based on any true understanding of what schizophrenia actually is.

The condition was first called “dementia praecox” by German psychiatrist Emil Kraepelin in the late 1800’s, and labeled “schizophrenia” by Swiss psychiatrist Eugen Bleuler in 1908.

Robert Whitaker, author of Mad in America, says the patients that Kraepelin diagnosed with dementia praecox were actually suffering from a virus, encephalitis lethargica (brain inflammation causing lethargy) which was unknown to doctors at the time.

Psychiatry never revisited Kraepelin’s material to see that schizophrenia was simply an undiagnosed and untreated physical problem. “Schizophrenia was a concept too vital to the profession’s claim of medical legitimacy. The physical symptoms of the disease were quietly dropped. What remained, as the foremost distinguishing features, were the mental symptoms: hallucinations, delusions, and bizarre thoughts,” says Whitaker. Psychiatrists remain committed to calling “schizophrenia” a mental disease despite, after a century of research, the complete absence of objective proof that it exists as a physical brain abnormality.

Today, psychiatry clings tenaciously to antipsychotics as the treatment for “schizophrenia,” despite their proven risks and studies which show that when patients stop taking these drugs, they improve.

The late Professor Thomas Szasz stated that “schizophrenia is defined so vaguely that, in actuality, it is a term often applied to almost any kind of behavior of which the speaker disapproves.”

These are normal people with medical, disciplinary, educational, or spiritual problems that can and must be resolved without recourse to drugs. Deceiving and drugging is not the practice of medicine. It is criminal.

Any medical doctor who takes the time to conduct a thorough physical examination of a person exhibiting signs of what a psychiatrist calls Schizophrenia can find undiagnosed, untreated physical conditions. Any person labeled with so-called Schizophrenia needs to receive a thorough physical examination by a competent medical -not psychiatric- doctor to first determine what underlying physical condition is causing the manifestation.

No one denies that people can have difficult problems in their lives, that at times they can be mentally unstable, subject to unreasonable depression, anxiety or panic. Mental health care is therefore both valid and necessary. However, the emphasis must be on workable mental healing methods that improve and strengthen individuals and thereby society by restoring people to personal strength, ability, competence, confidence, stability, responsibility and spiritual well–being. Psychiatric drugs and psychiatric treatments are not workable.

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New Study Warns of High Dose “ADHD” Drugs Inducing Psychosis

Posted on October 14, 2024 by cchrstl

CCHR has documented psychosis and violent behavior linked to any dose of the drugs and wants them prohibited as a treatment for the 3.1 million American children put at risk by taking them.

By CCHR International

Taking a high dose of drugs to treat Attention Deficit Hyperactivity Disorder (ADHD) is linked to more than five times greater risk of developing psychosis or mania, according to a new study published in the American Journal of Psychiatry. The research is among the first to find a relationship between escalating doses of the drugs—amphetamines, in particular—and a greater likelihood of psychotic symptoms. Lead researcher, Dr. Lauren Moran stresses the need for a warning label to raise awareness of this serious risk.

CCHR supports the call for a stronger warning label, but given its own documented findings that stimulants are also linked to acts of senseless violence, including school shootings, says the drugs should be removed from the market. Acts of violence are detailed in its comprehensive report, Psychotropic Drugs Create Violence and Suicide.

The ADHD drugs referenced in the study include Adderall, Vyvanse and generic amphetamines, such as dextroamphetamine. Adderall prescriptions in the U.S. soared 27% from 2019 to 2022, according to IQVia, a clinical analytics company. IQVia also reports that 3.15 million 0-17-year-olds took ADHD stimulants, including methylphenidate (Ritalin) in 2020.

Moran apparently found no increased risk of psychosis or mania in prescriptions for methylphenidate (Ritalin). However, there are already international drug regulatory warnings about the drug causing mania or psychosis. A 2023 study published in Cureus advised every medical practitioner prescribing psychostimulants to inform the patient and caregiver about psychosis as a threatening side effect.

The Food and Drug Administration’s (FDA) Medication Guides (Med Guides) for several brand-name ADHD drugs list side effects such as new or worse aggressive behavior or hostility for all patients. For children and teens, there is the warning: new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms.

The link between amphetamines and psychosis isn’t new. Amphetamines increase levels of dopamine in the brain and is implicated in psychosis. Moran said that, according to an analysis of national insurance claim data, about 6% of patients taking amphetamines are prescribed the highest dosages and about 22% are prescribed the medium dosages. Patients taking the highest dosages—more than 40 milligrams of Adderall, 100 mg of Vyvanse or 30 mg of dextroamphetamine—were 5.3 times more likely to develop psychosis than patients taking no stimulants. The medium dosage—20 mg to 40 mg of Adderall, 50 mg to 100 mg of Vyvanse or 15 mg to 30 mg of dextroamphetamine—was linked to a 3.5 times higher risk.

However, patients also had a nearly 63% increased risk of psychosis or mania if they took any prescription amphetamine but those on heavy doses of amphetamines were at even greater peril of a psychotic episode, with an 81% increased risk, results show. Vyvanse is also linked to suicidality.

The psychosis could explain why some mass shootings and acts of violence have occurred. According to a Public Library of Science ONE study, researchers took the FDA Adverse Event Reporting System data and identified 31 prescription drugs that were disproportionately associated with violence, of which 25 were psychotropic drugs. The drugs included 11 antidepressants, six sedatives/hypnotics and three drugs for treatment of ADHD, including amphetamines, which were 9.6 times more likely to be linked to violent side effects.

David Kirschner, Ph.D., a New York psychologist stated: “As a forensic psychologist, I have tested/evaluated 30 teenage and young adult murderers, and almost all of them had been in some kind of ‘treatment,’ usually short term and psychoactive drug-oriented, before they killed.” He stressed “Most of the young murderers I have personally examined had…been in ‘treatment’ and were using prescribed stimulant/amphetamine type drugs before and during the killing events. These medications did not prevent but instead contributed to the violence by disinhibiting normal, frontal cortex control mechanisms.”

[See References Here]

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Exhibit Exposes Psychiatric Human Rights Abuses at Congressional Black Caucus Foundation Conference

Posted on October 7, 2024 by cchrstl

Citizens Commission on Human Rights’ exhibit exposes the history to the present day of harmful and racist practices in the mental health system that constitute human rights violations, and calls for laws to ban harmful practices, in line with international human rights standards.

by CCHR National Affairs Office 

Human rights abuses in mental healthcare were the focus of a global traveling exhibit by the Citizens Commission on Human Rights (CCHR), an international mental health industry watchdog.  The exhibit was displayed recently at the Walter E. Washington Convention Center in Washington, DC, in conjunction with the Congressional Black Caucus Foundation Annual Legislative Conference. 

The exhibit brings to light the history to the present day of human rights abuses from psychiatric practices.  Today, those practices include forcibly admitting people – even children – to psychiatric facilities, forcing them to take harmful drugs against their will, and subjecting them to seclusion and restraints, which have caused injury and death.  Mental health patients can even be subjected to involuntary electroconvulsive therapy (ECT, or electroshock). 

Coercive mental health practices violate international human rights standards, with the World Health Organization and the United Nations High Commissioner for Human Rights calling for an end to all involuntary mental health treatment.  CCHR advocates for state and federal laws to eliminate coercive practices and ban electroshock.

At the exhibit opening ceremony, Dr. E. Gail Anderson Holness, Pastor at Adams Inspirational AME Church in Washington, DC, and former Faith Based Outreach Coordinator at the DC Department of Behavioral Health emphasized, “We believe mental health is a human rights issue,” also adding, “We support recovery because recovery is possible.”

Adrienne L. Schaffer Esq. (Col. Ret. USA), Founder and Executive Director of the Military Children’s Six Foundation and former US Army Judge Advocate General (JAG) Corps Officer, talked about her organization advocating for the well-being of military children and youth, as well as educating and empowering them to self-advocate, stand up for others, and ultimately take on rights-based leadership roles.  These rights could include human rights in the field of mental health.

“As these young individuals mature into roles of leadership or influence, whether within their home countries or abroad, they can act as change agents and ambassadors for human and child rights,” she said.

Joseph Cecala, a Chicago civil rights attorney, fights in court for his clients’ right to make their own medical decisions.  “The most important issue that confronts society today is the human rights of people that are in the mental health system,“ he said.  “It is a failed philosophy that needs to change.”

The damage caused by coerced mental health treatment was the reason behind the 2023 call by the World Health Organization and the Office of the United Nations High Commissioner for Human Rights for nations to end all forced mental health treatment, the organizations saying that coercive practices “violate the right to be protected from torture or cruel, inhumane and degrading treatment.” 

Facts presented in the CCHR exhibit detail the sordid history of human rights violations in psychiatric practices, including brain-damaging psychosurgery and electroshock, and reveal the prime role of psychiatrists in instigating and perpetuating the systemic racism still ingrained in today’s mental health system.  In 2021, both the American Psychiatric Association and the American Psychological Association admitted to long histories of racial abuse and to the systemic racism still present in their practices.

Many convention visitors viewing the exhibit reached out to CCHR for help in protecting mental health human rights in their states.  Many had their own distressful stories of family members or friends who were harmed in the mental health system.

“Damaging and potentially fatal procedures that are passed off as mental health treatment must stop,” said Anne Goedeke, president of the CCHR National Affairs Office.  “CCHR is dedicated to ending abusive psychiatric treatments and practices and restoring human rights to mental healthcare.”

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Investigation Exposes Psychiatric Facilities that Wrongly Held Patients Against Their Will

Posted on September 23, 2024 by cchrstl

Involuntary commitments to psychiatric facilities have increased over the last decade.  Evidence indicates many are unlawful detainments, but facilities bill patients and their insurance providers.

by CCHR National Affairs Office

A disturbing new exposé, published in the New York Times, sheds light on psychiatric facilities that admit and hold people against their will without any valid reason under the law, billing patients and their insurance providers for unnecessary, unwanted confinements that can traumatize detained individuals. 

The Times investigation focuses on Acadia Healthcare, one of the largest chains of for-profit behavioral health facilities in the U.S. Medical records and interviews with patients and past and present employees appeared to show that many patients did not meet the criteria currently set by law that allows people who are an imminent danger to themselves or others to be involuntarily committed to a psychiatric facility. “Acadia has lured patients into its facilities and held them against their will, even when detaining them was not medically necessary,” the Times reported.

Insurance billing was maximized by using various excuses to claim patients needed to stay longer, often holding them until their insurance ran out, according to current and former Acadia employees interviewed by the Times. Acadia reportedly charges as much as $2,200 a day for some patients. With the bulk of Acadia’s revenue coming from government insurance plans, including Medicaid and Medicare, taxpayers are footing the bill for most of these unlawful detainments. This year, Acadia reportedly has tentatively agreed to settle U.S. Department of Justice allegations that include billing for unnecessary patient stays. 

One of the Acadia psychiatric facilities mentioned in the New York Times article, North Tampa Behavioral Health Hospital, was the subject of a 2019 investigation by the Tampa Bay Times, which found that the facility illegally cut patients off from their families, held them longer than legally allowed, and ran up their bills while the confined patients were unable to fight back.

Acadia is not the only behavioral health company accused of billing government insurance plans for unlawful involuntary patient stays.  In 2020, another of the largest U.S. for-profit chains of psychiatric facilities, Universal Health Services, agreed to pay $122 million to settle Justice Department allegations that included billing for medically unnecessary inpatient admissions and failing to discharge patients when they no longer required inpatient care.

It is estimated that over half (57%) of admissions to psychiatric facilities in the U.S. were involuntary – 16% came via the criminal justice system and 41% were civil commitments, a figure that rose by 27% over the last decade. 

The increased risk for suicide in the period following discharge from psychiatric hospitalization is well recognized, but people admitted to a psychiatric facility against their will are even more likely to attempt suicide after discharge.

In a 2017 report, the UN Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health called for the elimination of nonconsensual mental health treatment, stating: “Coercion in psychiatry perpetuates power imbalances in care relationships, causes mistrust, exacerbates stigma and discrimination and has made many turn away, fearful of seeking help within mainstream mental health services.”

In 2019, the Council of Europe (COE) adopted a resolution that called on its member nations “to immediately start to transition to the abolition of coercive methods in mental health settings.” 

More recently, the World Health Organization (WHO) issued guidance in 2021, advising countries to end coercive mental health practices, which it said are used “despite the lack of evidence that they offer any benefits, and the significant evidence that they lead to physical and psychological harm and even death.”  The WHO guidance extends its call for prohibiting coercion even to those in mental health crisis.

Explaining its stand, WHO states: “People subjected to coercive practices report feelings of dehumanization, disempowerment and being disrespected.  Many experience it as a form of trauma or re-traumatization leading to a worsening of their condition and increased experiences of distress.”

“CCHR is committed to ending the human rights abuse of coercive practices in the mental health system, including the incarceration of patients for profit,” said Anne Goedeke, president of the organization’s National Affairs Office.

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Jealousy and Psychiatry

Posted on September 16, 2024 by cchrstl

Like most English words, “jealousy” has multiple definitions.
– zealous vigilance in guarding or keeping
– anger or bitterness resulting from loss or threat of loss
– anger or bitterness resulting from unfulfilled desire
– resentment or envy of another’s success or advantage
– uneasiness from suspicion or fear of rivalry or unfaithfulness

[Derivation: Middle English jelous, from Old French gelos, from Vulgar Latin z?l?sus, from Late Latin z?lus “zeal”]

Research has identified many root causes of extreme jealousy, a primary one being “fear of loss.” Another manifestation would be “destructive or invalidative criticism.” Not to mention just plain prejudice.

In any case, we think that jealousy is an unpleasant, negative and non-survival human characteristic that an individual should recognize for its harmful nature and work to rise above it.

Jealousy and Psychiatry

Jealousy has been examined extensively in the field of psychiatry as a complex emotional state. There is so much discussion about jealousy in psychiatric research and writings that we can be sure that there is a general lack of true understanding about it, not least because psychiatric viewpoints on jealousy do not generally include “fear of loss,” which we know to be a basic characteristic of the state.

Psychiatrists may think of jealousy as a positive evolutionary attribute, for example protecting against infidelity.

Psychiatrists may think that early childhood experiences are a generative factor. While childhood bad experiences may certainly play a part, this does not lead to a predictable and consistent resolution.

Psychiatrists may point to the neurobiology of the brain as a significant contributing factor. Unfortunately, such brain-based theories have never been proven, and lead to harmful psychotropic drugs.

Cognitive psychiatry theorizes that various beliefs and thought patterns are to blame, but again these are theories and have not been validated in real life. The psychiatric pre-occupation with “low self-esteem” has so thoroughly corrupted our educational system that it cannot be given any credence.

Psychiatrists may also consider that cultural norms and societal values, particularly those involving tolerance and intolerance, may be root causes. We have previously addressed the subject of tolerance and intolerance in psychiatry; one would do well to review this here.

Psychiatrists may point to poor communication skills as an enabler of jealousy; well, we can certainly agree with that. In fact, poor communication skills are an enabler of pretty much any bad situation, no thanks to any psychiatric treatments. Common coercive psychiatric interventions such as psychotropic drugs, electro-convulsive therapy, and involuntary commitment, if anything, are aimed at suppressing communication rather than enhancing it.

So what is an appropriate way to address one’s feelings of jealousy? First, examine the situation in terms of fear of loss. And then communicate about it.

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What is Free Will?

Posted on September 9, 2024 by cchrstl

Robert Sapolsky, a professor of biology at Stanford University, claims that his research reveals that there is no such thing as free will; that all our choices are determined by our genetics, experience, and environment.

Perhaps he has not considered all the available evidence.

John Horgan, a science journalist, says, “But Sapolsky hasn’t proved that free will is illusory; he has merely confirmed that it exists on a sliding scale.” Which is a much more realistic appraisal.

What is meant by “free will?” One standard definition is “freedom of humans to make choices that are not determined by prior causes or by divine intervention.”

What is meant by a “sliding scale?” This is another term for “gradient scale”, which is a gradual increasing or decreasing degree of something.

The term “free will” has some religious overtones. We need another neutral term here, which is “self-determinism.” This is an individual’s ability to direct themself; as opposed to “other-determinism”, which occurs when someone or something else determines what an individual thinks, says or does.

We should be able to see immediately that self-determinism, and thus the related free will, is a gradient scale. The top of the scale would be an individual making all thoughts, decisions and actions solely by themself. The bottom of the scale would be all of an individual’s thoughts, decisions and actions made for them solely by someone or something else. In the (hugely) extensive middle of this scale would be an individual having thoughts and making decisions and actions partly on their own determinism and partly from the input and influence of others.

The most important aspect of Education is to increase the self-determinism of the individual. In fact, the common denominator of all life impulses is self-determinism. This is the opposite of non-living physical universe objects – i.e. non-living objects have no self-determinism, as they are unthinking things.

For convenience, humans can adopt habits, which are automatic mechanisms to accomplish thoughts, decisions and actions on a repetitive basis, without having to determine each one with a new conscious effort. Necessarily they reduce some self-determinism in return for efficiency, or to relieve the boredom of repetition. However, it was a self-determined effort that established the habit in the first place.

What Does This Have To Do With Psychiatry?

Psychiatric thought complicates this whole discussion by relating free will to mental health or mental illness. For example, one psychiatrist says that mental disorders are conditions that compromise free will; but of course concluding that further research is necessary.

Another psychiatrist finds that mental health professionals’ beliefs concerning free will can influence their clinical practice.

Another psychiatrist calls it “the dangerous illusion of free will,” saying that there cannot be free will since a person cannot just decide not to have a mental illness.

The point here is that psychiatry in general is as confused by “free will” as the rest of society. Placing one’s trust in psychiatry is as misplaced as saying either it is all and only free will, or there is no free will.

There doesn’t have to be such confusion. A way out is to recognize the gradient scale nature of self-determinism, and take the necessary actions to increase it with education.

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CCHR Calls on FDA to Release Results of Investigation into Alleged Sexual Assault, Research Misconduct in Psychedelic Clinical Trials

Posted on September 2, 2024 by cchrstl

Evidence presented to the U.S. drug regulatory agency alleging sexual assault and suppression of adverse events in clinical trials of ecstasy raises urgent concerns about the safety of patients in psychedelic-assisted psychotherapy. Citizens Commission on Human Rights calls for public release of FDA investigation results.

by CCHR National Affairs Office

Citizens Commission on Human Rights (CCHR) is calling on the U.S. Food and Drug Administration (FDA) to release the results of any investigation done after allegations surfaced of sexual assault and suppression of adverse events in clinical trials of the psychedelic drug MDMA, commonly known as ecstasy or molly, as treatment for post-traumatic stress. Patients in the clinical trials received psychotherapy while under the influence of ecstasy, a drug known to lower inhibitions and increase sexual desire.

Evidence of alleged research misconduct was presented in documents and witness testimony at a hearing held by FDA’s independent advisory committee, convened to address the concerns as a matter of public health and safety. The advisory committee voted overwhelmingly that the company which applied for drug approval, Lykos Therapeutics, failed in its clinical trials to prove the treatment was effective, and that benefits from the drug therapy did not outweigh the risks. 

The FDA subsequently notified Lykos that MDMA “could not be approved based on data submitted to date” and asked the company to conduct another late-stage study.  In a statement, the agency wrote it “will continue to encourage research and drug development that will further innovation for psychedelic treatments.”

However, before the FDA moves forward with encouraging psychedelic research, CCHR is questioning whether the agency gave adequate attention to the serious issues now raised about such research.  Several weeks before the FDA announced its rejection of the use of MDMA in psychedelic-assisted psychotherapy, STAT News reported that FDA investigators had not yet spoken with patients and others alleging misconduct in the MDMA trials, including a respected think tank, the Institute for Clinical and Economic Review, which had sent FDA its numerous concerns in an evidence report. 

CCHR is especially concerned about the reported incident of sexual assault, which occurred during clinical trials that should have been conducted according to strict protocols – a forewarning of what can be expected if the drug is ultimately FDA-approved and ends up in even more widespread and casual use.

MDMA (ecstasy) is known to lower inhibition and increase sexual desire, making the individual under its influence more suggestible and sexually vulnerable.  Ecstasy has earned a reputation as a date-rape drug, used to commit drug-facilitated sexual assault. The National Institute of Drug Abuse (NIDA) lists mental and emotional adverse effects from the drug that include reduced perception and judgment and risky sexual behavior. 

Vulnerable, sexually aroused patients under the influence of MDMA in rooms with psychotherapists for hours-long sessions are conditions ripe for ethical boundary violations, including sexual assault, by the psychiatrists or therapists conducting the sessions. Nese Devenot, a researcher at Johns Hopkins University who petitioned the FDA to hold the public hearing on MDMA, told NPR that psychotherapy with a patient on ecstasy “incentivized boundary violations.”

Ecstasy is not the only psychedelic drug linked to unbridled emotions.  Psychedelic drugs in general cause profound distortions in a person’s perceptions, moods, and thought processes. This impaired perception and judgment while high on psychedelics can lead to dangerous behavior, including individuals getting sexually involved with someone they otherwise would not, according to NIDA.

Even without psychedelic drugs as part of psychotherapy, a significant number of psychiatrists and psychologists who conduct therapy are known to have sexual contact with patients, despite laws making the contact a crime and licensing boards that can revoke professional licenses over sexual boundary violations.

One study determined that over 3% of psychologists have sexual contact with a patient, apparently taking advantage of the psychological intimacy of psychotherapy.  Another study found that psychiatrists, along with family planning physicians and obstetricians/gynecologists, generate the highest proportion of sexual complaints.

A review of clinical and research data reported that 7%-10% of male therapists and 1%-3% of female therapists admitted having sexual intercourse with one or more of their patients. A full 70% of therapists reported they knew of at least one patient who had been sexually involved with a previous therapist.

Besides sexual effects from ecstasy, NIDA’s “MDMA (Ecstasy) Abuse Research Report,” curiously recently removed from its website, listed a wide range of potential acute adverse effects, which would not be predictable for a given individual prior to taking the drug. Physical adverse effects include hypertension, involuntary jaw clenching, restless legs, muscle stiffness, loss of consciousness, seizures, kidney failure and swelling of the brain. MDMA may have adverse effects on a developing fetus if used by a pregnant woman.

In the week following use of the drug, depression, impaired attention and memory, anxiety, aggression, and irritability are reported by many people, NIDA said. One study found that one-third of participants who took MDMA over the weekend experienced some mid-week depression.

It is not known how the drug is supposed to work to relieve post-traumatic stress.

“FDA should provide transparency on its investigation, if any, into the alleged underreporting of harms, including sexual assault, in the MDMA clinical trials, as a matter of public health and safety,” said Anne Goedeke, president of the CCHR National Affairs Office. “FDA should consider banning, not encouraging, psychedelic drug research when vulnerable patients in altered mental states are known to be at such substantial risk of harm.”

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Psychiatric Diagnosis is Meaningless

Posted on August 26, 2024 by cchrstl

The most recent psychiatric billing bible, providing the official diagnoses that can be used for insurance reimbursements, is The Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR, Text Revision of 2022).

Diagnostic categories within the DSM are heterogeneous. Diagnostic heterogeneity is the idea that diagnostic labels can capture different syndromes with different causes under the same heading.
[Heterogeneous = Made up of elements that are not alike.]

For example, there are almost 24,000 possible combinations of symptoms for panic disorder in DSM-5, making it extremely difficult to assign any specific cause to the condition; and thus making it extremely difficult to confidently recommend any particular treatment. Two different people could receive the same diagnosis without sharing any common symptoms, meaning that the category “Panic Disorder” is scientifically meaningless.

You can see that such diagnostic heterogeneity is problematic for both research and clinical practice.

We refer to the research paper “Heterogeneity in psychiatric diagnostic classification“, by Allsopp, Read, Corcoran, and Kinderman (published 3 July 2019).

The study concludes that psychiatric diagnoses are scientifically worthless as tools to identify discrete mental health disorders. Lead researcher Dr. Kate Allsopp, University of Liverpool, said: “Although diagnostic labels create the illusion of an explanation they are scientifically meaningless and can create stigma and prejudice.”

Psychiatrists excuse this lack of rigor by saying it allows for “clinical judgment.”

In point of fact, such “judgment” is worthless, as it relies upon opinions. What is the alternative? Since there are no clinical tests for these fraudulent psychiatric diagnoses, the correct action on a mentally disturbed person is a full searching clinical examination by a competent non-psychiatric health care practitioner, in order to find and treat any undiagnosed and untreated real medical conditions.

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CCHR Commends FDA Decision: Psychedelic Drug Ecstasy Not Proven Safe or Effective Treatment for Traumatized Patients

Posted on August 19, 2024 by cchrstl

The U.S. drug regulatory agency examined evidence presented by the company requesting approval for MDMA (ecstasy) and reports from experts examining that evidence before denying approval for the drug as mental health treatment. A medical journal has just retracted three MDMA therapy research papers for ethical violations.

by CCHR National Affairs Office

The U.S. Food and Drug Administration (FDA) has rejected the psychedelic drug MDMA, commonly known as ecstasy or molly, as treatment for post-traumatic stress, a decision that Citizens Commission on Human Rights (CCHR) advocated in its statement submitted to the FDA during a public comment period earlier this year. The FDA’s decision ends the first attempt to gain the agency’s approval for a psychedelic drug treatment.

The FDA concurred with the findings of its advisory committee of independent experts, which held a public hearing in June on the use of MDMA for psychedelic-assisted psychotherapy. The committee voted overwhelmingly that the company which applied for drug approval, Lykos Therapeutics, failed in its clinical trials to prove the treatment was effective, and that benefits from the drug therapy did not outweigh the risks.

A briefing document prepared by FDA staff and issued prior to the hearing pointed to a number of drawbacks in the data from the Lykos clinical trials. Claims of efficacy could be skewed by a large majority of trial participants knowing whether they had received MDMA or placebo, the staff observed. The cardiovascular risks of MDMA, which acts as a stimulant, and the underreporting of adverse effects were also concerns. 

During the hearing, committee members discussed allegations of ethical misconduct in the clinical trials, including claims that participants were pressured not to report adverse effects. The Wall Street Journal recently reported that three people participating in the Lykos clinical trials felt more suicidal during or after the testing, but felt pressured to report positive outcomes. Their adverse effects were not reflected in the research results.

Another patient was allegedly sexually assaulted by the two psychotherapists who stayed in the room with her as part of the MDMA treatment. MDMA is known to lower inhibition and increase sexual desire.  Nese Devenot, a researcher at Johns Hopkins University who petitioned the FDA to hold the public hearing, told NPR that psychotherapy with a patient on MDMA “incentivized boundary violations.”

In June, ahead of the advisory committee hearing, the Institute for Clinical and Economic Review, an independent research organization that reviews health care interventions, issued a report that also was critical of the Lykos clinical trial data and results, concluding there was insufficient evidence to support approval of the MDMA treatment.

Additionally, Lykos was criticized by advisory committee members for the failure to follow the instructions, or protocol, for conducting its studies. Shortly after the FDA’s decision, the journal Psychopharmacology retracted three research papers it had published about MDMA-assisted psychotherapy due to “protocol violations amounting to unethical conduct” during the clinical trials. Many of the authors of the papers are reportedly affiliated with Lykos.

The FDA also had to contend with the fact that it regulates drugs, but cannot regulate the psychotherapy component of the proposed treatment. 

The FDA’s decision not to approve this use of MDMA with psychotherapy was made despite massive lobbying by the psychopharmaceutical industry.  Companies developing psychedelic drugs for therapy have attracted millions of dollars from investors hoping to cash in on a “psychedelic revolution.”  Some veteran groups also advocated for approval because existing psychiatric drugs and practices have failed to handle veterans’ mental health issues. 

“The FDA is commended for not caving in to the psychopharmaceutical industry’s pressure for approval of MDMA-assisted psychotherapy when safety and efficacy of the drug have not been established,” said Anne Goedeke, president of the CCHR National Affairs Office. “Psychedelic drugs are being pushed because psychiatric drugs and practices have failed to handle the mental health issues of many traumatized veterans; but our veterans deserve better treatment than the risk of further damage to their mental health from a use of psychedelics that has not proven safe or effective.”

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