Tuesday, June 4, 2024

By Don Sapatkin

Plus: TV shows are doing better with mental health storylines and diagnosed characters.U.S. adult suicides and mental health concerns outpace those in other high-income countries. PTSD has surged on American campuses. Patients with nine psychiatric diagnoses substantially improved after taking placebo pills. And drug dealers are marketing “clean” pills on social media using fake fentanyl test strips.

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A Big Day for Psychedelics

Lykos Therapeutics is seeking to win FDA approval to market MDMA – once better known as the party drug ecstasy – in conjunction with psychotherapy, for the treatment of PTSD.

Approval would signal a massive change in the nation’s fraught relationship with psychedelics. In the 1970s, President Richard Nixon launched his “War on Drugs” and criminalized psychedelics. In 1985, the Drug Enforcement Administration classified MDMA as a Schedule 1 “controlled substance” with “no currently accepted medical use and a high potential for abuse.”

Rejection also would be huge, shaking up the emerging field of psychedelic medicine and rattling investors who have bet millions of dollars on its success.

Public interest in psychedelics has soared in recent years as small studies have found substantial benefits for mental illnesses when psychedelics are paired with talk therapy. But many experts have warned against psychedelic hype, including National Institute on Drug Abuse Director Nora Volkow who suggested last week that enthusiasm about the apparent benefits has gotten ahead of the research.

Reports from FDA staff and Lykos are among the briefing materials for today’s all-day meeting posted on the web page off the Psychopharmacologic Drugs Advisory Committee. Public comments received so far are posted separately. The FDA typically follows the advice of its expert panels, but not always. It also can impose significant restrictions when approving drugs. You can watch today’s meeting live starting at 8:30 a.m.

Advisory committee meetings are highly technical affairs, and this one will be as well. In this case, panelists will wrestle with a thorny problem unique to psychedelics: Most clinical trial participants can guess whether they received the drug or a placebo, which can bias the study results. An FDA analysis released Friday suggested that had happened in studies submitted to support the drug’s approval, the New York Times reported.

The staff report noted increases in blood pressure and pulse rates that could trigger cardiovascular events, although most experts generally consider MDMA safe and non-addictive. But evidence for its effectiveness in treating PTSD was questioned by the influential Institute for Clinical and Economic Review which considers it  “insufficient,” the group’s lowest rating. Public comments on the application range widely, The Microdose newsletter reported,

The last two studies that Lykos submitted to the FDA included around 200 patients who took either the drug or a placebo during three eight-hour sessions, four weeks apart. They also had three appointments to prepare for the therapy and nine more to discuss what they’d learned. The most recent of those trials found a measurable reduction in symptoms in 86% of those who received MDMA, with 71% improving enough that they no longer met the criteria for a PTSD diagnosis. But 69% of those who got the placebo also reported reductions in symptoms, and nearly 48% no longer qualified for a diagnosis.

“It’s easy enough to point out cracks in the study, but there is no doubt that MDMA is helping a lot of people with PTSD,” Jesse Gould, a former Army Ranger who runs Heroic Hearts, an organization that helps veterans access psychedelic treatments, mostly outside the country, told the Times. “With no other drugs in the pipeline and with 17 to 22 veterans killing themselves each day, we desperately need new treatment options.” The VA – which estimates that roughly 5% of Americans have PTSD in a given year, with veterans disproportionately represented – announced in January plans to fund research on psychedelics to treat depression and PTSD.

The FDA is expected to reach a formal decision on MDMA in mid-August.

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Love, Your Mind: Pro Sports Leagues Join Mental Health Awareness Campaign

“Our country is facing a pervasive mental health crisis. We can help one another by talking about the rituals we embrace to support our mental health,” William A. Smith, the institute’s chief executive administrator, said in a press release. “Many sports fans look up to their favorite athletes, so we’re honored to partner with many of them today to share their mental health rituals and stories to normalize talking about and taking care of our minds.”

The Love, Your Mind campaign features expert guidance on dealing with 15 “emotions and moods” (i.e. anger, guilt, loneliness) and “life challenges” (i.e. chronic health issues & disabilities, relationship issues & breakups, trauma) along with several first-person stories by people who have overcome them.

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TV portrayals of characters with mental health problems are … improving!

The goal: “to better understand the challenges and opportunities in creating nuanced, authentic, and entertaining narratives about mental health.” It also sought to quantify the impact of a Guide to Mental Health Storytelling that the initiative released in 2021.

Among the findings: Industry professionals see a shift toward more inclusive and responsible portrayals of mental health. TV and movie scripts showed a 39% increase in mental health “keywords” such as conditions or treatments and a 15% decrease in derogatory language from the 2015-19 period to 2021-22. People who watched mental health story lines that followed the guide’s recommendations displayed more knowledge of mental health topics, reduced stigma toward those receiving treatment and greater willingness to seek help. The depth and relatability of characters, which leads to “feelings of friendship with TV characters,” contributed to the stigma reduction and increased openness to seeking help, the study found.

Based on their research, the authors recommend that content creators showcase a diverse range of characters facing mental health challenges and receiving support from communities – a strength, I think, of one of my favorite Netflix series, “Sex Education.” The researchers also suggest that shows realistically depict the process of seeking mental health support, address the barriers and normalize conversations about mental health.

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In other news…

American adults have the highest suicide rate of 10 high-income countries and significantly higher mental health needs than adults in nine of them, a Commonwealth Fund survey has found. Australia, Canada, France, Germany, the Netherlands, New Zealand, Sweden, Switzerland and the U.K. all had lower suicide rates in recent years. As recently as 2008, the U.S. was in the middle of the pack, but suicide rates have risen steadily since then. Mental health concerns have increased globally in recent years, and nearly all countries surveyed struggle with ways to improve social support for people with mental health needs. About half of Black and Hispanic adults in the U.S. and half of all adults in France with mental health needs reported at least one social need, compared with 1 in 5 adults in Germany.

PTSD diagnoses among college students surged in recent years, Forbes reported. The prevalence of PTSD more than doubled between the 2017-18 and 2021-22 school years, according to a JAMA Network Open research letter that relied on data from five waves of college students participating in a survey at 332 colleges and universities. Although the rate of diagnosed students increased throughout the study period, from 3.4% to 7.5%, about three-quarters of the rise came during the study period’s last three years – a time when the pandemic threw students’ lives into turmoil.

The placebo effect is particularly powerful in psychiatric treatment. For some diagnoses, patients feel so much improvement after receiving a placebo pill they think is real (and sometimes even when they know it’s not) that a co-author of a new study told CNN it would be legally and medically justified for them to enroll in controlled studies that assign half the participants to receive placebos. Clinicians often discourage such participation if they believe the drug being tested would provide clear benefits that recipients of placebo pills would miss out on. The analysis in JAMA Psychiatry of 90 high-quality studies found significant improvement on placebo for nine mental health conditions. Patients with major depressive disorder got the greatest placebo benefit, followed by those with generalized anxiety disorder, panic disorder, ADHD, PTSD, social phobia, mania, and OCD, while patients with schizophrenia benefited the least.

Drug dealers are advertising “clean pills” by posting fentanyl test strip photos on social media that show negative results for presence of the deadly opioid. But the results are fake, law enforcement officials told NBC News. Fentanyl test strips came on the scene several years ago as a public health measure to detect the presence of fentanyl in a street drug that is labeled as something else. They are easily (and legally) purchased online in most states – with the notable exception of Texas. Health departments nationwide have spent millions of dollars to provide free test strips to drug users as fentanyl-spiked versions of Xanax, Oxycontin and Percocet have flooded the street market. While some users seek out fentanyl, most are afraid of it – but more afraid of withdrawal sickness if they can’t find some kind of opioid, deadly or not.

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If you or someone you know is in crisis or experiencing suicidal thoughts, call or text 988 to reach the 988 Suicide & Crisis Lifeline and connect in English or Spanish. If you’re a veteran press 1. If you’re deaf or hard of hearing dial 711, then 988. Services are free and available 24/7.

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