Psychedelic drug MDMA faces questions as FDA considers approval for PTSD

https://apnews.com/article/mdma-fda-psychedelic-therapy-ptsd-treatment-drug-bc2d7495035a9532876c3dcaf52a9761

>This photo provided by the Center for Psychedelic Therapy Research shows a Yehuda Lab MDMA-assisted therapy treatment room at the James J. Peters Department of Veterans Affairs Medical Center in the Bronx borough of New York. (OH Prema, Center for Psychedelic Therapy Research via AP)

WASHINGTON (AP) — Federal health regulators are questioning the safety and evidence behind the first bid to use MDMA, the mind-altering club drug, as a treatment for PTSD, part of a decadeslong effort by advocates to move psychedelic drugs into the medical mainstream.

The Food and Drug Administration posted its initial review of the drug Friday, ahead of a meeting of outside advisers who could help decide whether MDMA — currently illegal under federal law — becomes the first drug of its kind to win U.S. approval as a medication.

In their assessment, FDA scientists said that patients who received MDMA and talk therapy showed “rapid, clinically meaningful, durable improvements in their PTSD symptoms.” But they also called the research “challenging to interpret,” and questioned how long the benefits might last.

They said it’s difficult to know how much of the improvement came from MDMA versus simply undergoing intensive therapy, and also raised several safety concerns, including MDMA’s heart risks and potential for abuse.

The outside experts will take a nonbinding vote on the drug’s overall benefits and risks during Tuesday’s meeting. The FDA will make the final decision, likely in August.

Antidepressants are now the only FDA-approved drugs for post-traumatic stress disorder, which is closely linked to depression, anxiety and suicidal thinking and is more prevalent among women and veterans

If approved, MDMA would be reclassified as a prescription medicine and made available to specially certified doctors and therapists. Currently, the drug is in the same ultra-restrictive category as heroin and other substances the federal government deems prone to abuse and devoid of any medical use.

MDMA, also known as ecstasy or molly, is the first in a series of psychedelics that are expected to be reviewed by the FDA in coming years. It’s part of a resurgence of research into the potential of psychedelics for hard-to-treat conditions like depression, addiction and anxiety. MDMA’s main effect is triggering feelings of intimacy, connection and euphoria.

Companies are studying MDMA, psilocybin, LSD and other mind-expanding drugs for numerous mental health problems.

Until recently, psychedelic research was mainly funded by a handful of nonprofit advocacy groups, including Multidisciplinary Association for Psychedelic Studies, or MAPS. The company seeking approval for MDMA, Lykos Therapeutics, is essentially a corporate spinoff of MAPS, which conducted all the studies submitted for FDA review.

In two MAPS studies, patients received MDMA as part of an intensive, four-month course of talk therapy lasting more than a dozen sessions, only three of which involved taking the drug. The drug is thought to help patients come to terms with their trauma and let go of disturbing thoughts and memories.

The group studied its approach in 195 adults with moderate-to-severe PTSD who were randomly assigned to undergo the therapy with MDMA or with a dummy pill. Following treatment, patients who received MDMA had significantly lower PTSD scores and were more likely to be in remission.

But FDA reviewers noted that the vast majority of patients correctly guessed whether they had received MDMA or a dummy pill, making it “nearly impossible” to maintain the so-called “blinded” objectivity considered essential for high-quality drug research. The agency also questioned how long the drug’s benefits might last. MAPS tracked some patients for up to two years, but reviewers noted that about a quarter of patients quickly dropped out of the follow-up study, limiting the usefulness of the results.

The most common side effects of MDMA included headache, nausea, muscle tightness and decreased appetite. More serious issues included heart palpitations and elevated blood pressure, which FDA reviewers said had the “potential to trigger” life-threatening heart problems.

They also raised concerns about the potential for patients to abuse MDMA, which functions similarly to amphetamines and other stimulants.

https://pressroom.cancer.org/LGBTQReport2024

American Cancer Society Releases Pioneering LGBTQ+ Cancer Report: Unique Stressors, Discrimination Likely Increase Cancer Risk

May 31, 2024

• LGBTQ+ individuals in the United States have elevated prevalence of smoking, excess body weight, and other factors that increase cancer risk. For example, bisexual women are twice as likely as heterosexual women to smoke cigarettes (23% versus 10%) and drink heavily (14% versus 6%)

For the start of Pride month in June, the ACS report highlights critical issues concerning cancer prevention, treatment and care for this population.

ATLANTA, May 31, 2024 — In a first-of-its-kind study, the American Cancer Society (ACS) today released “Cancer in People who Identify as Lesbian, Gay, Bisexual, Transgender, Queer or Gender-nonconforming (LGBTQ+)”. The article provides the latest statistics on the prevalence of cancer screening and modifiable risk factors in LGBTQ+ populations, as well as a review of literature on cancer occurrence and obstacles to cancer prevention and treatment. These important findings are published in the journal Cancer, alongside its consumer-friendly companion, Cancer Facts & Figures 2024 Special Section: Cancer in People Who Identify as LGBTQ+.

Perhaps the greatest health disparity faced by LGBTQ+ communities is the presumption-of-care gap, which is the fear that a provider will refuse care due to gender identity or sexual orientation. The concern is especially valid for the 20% of this population who reside in the nine states where it is legal to refuse care to LGBTQ+ individuals due to “conscience clauses” that allow healthcare providers, staff and insurers to deny care and services based on personal and religious beliefs.

“One of the biggest take-aways from our report is that LGBTQ+ people are probably at higher risk for cancer, yet experience multiple barriers to high-quality healthcare access like discrimination and shortfalls in provider knowledge of their unique medical needs,” said Rebecca Siegel, senior scientific director, cancer surveillance at the American Cancer Society and senior author of the study. “Everyone deserves an equal opportunity to prevent and detect cancer early, which is why it’s so important to remove these roadblocks for this population.”

LGBTQ+ individuals in the United States have elevated prevalence of smoking, excess body weight, and other factors that increase cancer risk. For example, bisexual women are twice as likely as heterosexual women to smoke cigarettes (23% versus 10%) and drink heavily (14% versus 6%). “Minority stress” is a likely contributor to behaviors like smoking that increase cancer risk according to other studies. Although these findings suggest cancer disparities, cancer incidence and mortality for this population are not available because sexual orientation and gender identity are not routinely collected in healthcare settings, despite the community’s willingness to report this information.

“We are very proud of this report,” said Tyler Kratzer, associate scientist II, cancer surveillance research at the American Cancer Society and lead author of the study. "It is meant to facilitate critical conversations around the need to improve the routine collection of sexual orientation and gender identity data at all levels of healthcare.”

For the study, researchers examined prevalence of risk factors across the U.S. based on the National Health Interview Survey (for information on sexual orientation) and the Behavioral Risk Factor Surveillance System (for gender identity), which are both collected by the Centers for Disease Control and Prevention (CDC).

Other highlights from the report include:

• Excess body weight appears to be elevated among bisexual women according to one national survey, although the gold-standard source for this metric that includes an in-person physical exam – the National Health and Nutrition Examination Survey – does not collect data on sexual orientation or gender identity.

• The prevalence of cancer-causing infections, such as human immunodeficiency virus (HIV), human papillomavirus (HPV), and hepatitis C virus (HCV) are considerably higher in some LGBTQ+ population groups. According to the CDC, for example, 70% of HIV infections are attributed to male-to-male sexual contact (versus 22% to heterosexual contact and 7% to injection drug use). HIV-infected individuals are at a higher risk for at least 10 cancers.

• Screening for some cancers is low among transgender people; for example, 46% of transgender men are up-to-date on colorectal cancer screening compared to 60% of cisgender men and 68% of transgender men with a cervix are current for cervical cancer screening compared to 87% of cisgender women.

• Only 25% of medical students are confident in the healthcare needs of transgender patients and 30% are not comfortable treating transgender patients according to one study.

Zambia’s former first lady and daughter arrested over properties worth more than $2 million

https://apnews.com/article/zambia-first-lady-lungu-arrested-7ec8e96a54aacb2fbfb94a7710d99900

LUSAKA, Zambia (AP) — Zambia’s former first lady and one of her daughters have been arrested over their ownership of several properties worth more than $2 million that a law enforcement agency says are suspected to be proceeds of crime.

Esther Lungu, the wife of former Zambian President Edgar Lungu, daughter Chiyeso Katete and a family friend were arrested on Thursday, said the Drug Enforcement Commission, a law enforcement agency which also has a mandate to investigate money laundering allegations.

The properties owned by Esther Lungu that are under investigation include 15 apartments worth $1.5 million in a district near the capital, Lusaka, the DEC said in a statement. It said she couldn’t give a reasonable explanation for how she acquired the properties.

Katete and family friend Charles Phiri were accused of having properties worth more than $570,000 that were proceeds of crime. The DEC said another daughter of Edgar and Esther Lungu was facing related charges and was ordered to hand herself in to authorities by Monday.

Edgar Lungu was Zambia’s leader from 2015 to 2021, when he lost an election to current President Hakainde Hichilema, a longtime political rival. He has embarked on a political comeback and is aiming to stand against Hichilema in the southern African country’s 2026 presidential election.

see also: https://www.bbc.com/news/articles/c3ggpp00ry5o

[MZ]

New Mexico judge grants Mark Zuckerberg’s request to be dropped from child safety lawsuit

https://apnews.com/article/meta-new-mexico-facebook-zuckerberg-children-b3d194055cbeecae4836558fa0e20430

ALBUQUERQUE, N.M. (AP) — A New Mexico judge on Thursday granted Mark Zuckerberg’s request to be dropped from a lawsuit that alleges his company has failed to protect young users on its social media platforms from sexual exploitation.

The case is one of many filed by states, school districts and parents against Meta and its platforms over concerns about child exploitation. Beyond courtrooms around the U.S., the issue has been a topic of congressional hearings as lawmakers and parents are growing increasingly concerned about the effects of social media on young people’s lives.

In New Mexico, Attorney General Raúl Torrez sued Meta and Zuckerberg late last year following an undercover online investigation.

While granting Zuckerberg’s request, Judge Bryan Biedscheid dismissed Meta’s motion seeking to dismiss the state’s claims, marking what Torrez described as a crucial step for the case to proceed against the social media giant. “For decades, Meta Platforms have prevented nearly every legal challenge against them from proceeding,” Torrez said in a statement. “Today, the New Mexico Department of Justice brought that era to an end and is the first case by a state attorney general to raise child sexual exploitation claims, which can now be addressed. All social media platforms that harm their users should be on notice.”

Torrez’s office said it will continue to assess whether Zuckerberg should be named individually in the future.