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.
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.”