Policy News Roundup: June 6, 2024

Key reads

FDA advisory panel votes against MDMA for PTSD

An expert advisory committee for the Food and Drug Administration (FDA) voted 9-2 that Lykos Therapeutic’s regimen of talk therapy and MDMA is not an effective post-traumatic stress disorder treatment and 10-1 that the therapy’s risks outweigh its benefits. The advisers found that Lykos’ trials most likely suffered from expectation bias since patients were able to figure out they received it, rather than a placebo, and that might have made them more likely to say it was beneficial. The committee praised the promise of MDMA but struggled with concerns about missing safety data, allegations of trial manipulation, the potential risk for misconduct among therapy practitioners and how the psychotherapy, which is not regulated by the FDA, would be incorporated into the drug’s approval. The committee’s votes are not binding, but the FDA typically does follow its recommendations. The FDA expects to make a decision by mid-August.

Source: The psychedelic medicine revolution just took a big loss (Politico)

States should prioritize protecting youth as they legalize marijuana

As states establish legal marijuana markets, their main priority should be protecting youth. Evidence from tobacco and alcohol policies have demonstrated what works to protect kids from legal and commercialized addictive products, as well as lapses in protection, but states are not heeding those lessons for marijuana. A Partnership to End Addiction report outlines evidence-based recommendations for legislative and regulatory measures to help protect young people in states that have legalized marijuana, as well as national survey findings demonstrating support for the recommendations and a review of state provisions that do and don’t align with the recommendations. Despite strong research and public support for the recommendations, too many of them have not been widely adopted by states. As they legalize marijuana, states have a unique opportunity and responsibility to create a system that does not repeat past mistakes. Policymakers should adopt and effectively enforce provisions that protect youth.

Source: As states legalize recreational marijuana use for adults, they must prioritize protecting kids (STAT)

Federal government moves away from abstinence-based approach

The Biden administration has started to open the door to addiction treatment that acknowledges positive outcomes beyond total abstinence. Through public statements, official agency guidance, new regulations and instructions to pharmaceutical companies for developing new treatments, the federal government is making clear that reductions in substance use can be a meaningful endpoint. The policies are in line with the administration’s unprecedented embrace of harm reduction tactics. But they are also distinct — harm reduction often focuses on reducing risk among people not seeking treatment, while these policies focus on people seeking addiction care in a medical setting. Kicking people out of treatment for continued substance use (as often happens) is harmful. Using treatment to curtail substance use can significantly reduce risk, even if a patient’s substance use does not stop. While the changes to federal policy are substantive, they must be implemented on the ground to have a meaningful impact on patients.

Source: Drug treatment that insists on abstinence? Federal agencies are just saying no (STAT)

10 states added to CCBHC demonstration

The Department of Health and Human Services (HHS) welcomed 10 new states to the Certified Community Behavioral Health Clinic (CCBHC) Medicaid Demonstration Program. The program provides states with sustainable funding that helps them expand access to mental health and substance use disorder services. CCBHCs must ensure access to a comprehensive range of services, providing care coordination and incorporating evidence-based practices and other supports based on a community needs assessment. This includes 24/7 crisis services. CCBHCs are also required to provide routine outpatient care within 10 business days. The 2022 Bipartisan Safer Communities Act gave HHS the authority to add 10 new states to the demonstration program every 2 years, starting with the 10 announced today. All of these states had previously received planning grants. The 10 states join 8 states already in the demonstration.

Source: Biden-Harris Administration Expands Access to Mental Health and Substance Use Services with Addition of 10 New States to CCBHC Medicaid Demonstration Program (Substance Abuse and Mental Health Services Administration)

Overdoses hitting older Black men in Baltimore particularly hard

Overdoses in Baltimore have hit Black men in their mid-50s to early 70s (born 1951-1970) especially hard. While just 7% of the city’s population, they account for nearly 30% of substance use fatalities, a death rate 20 times that of the rest of the country. Half a century ago, manufacturing jobs began to disappear in an industrial city where Black families had few other opportunities to build wealth. By 1980, nearly half of Baltimore’s Black men under the age of 30 were out of work. At the same time, an influx of highly addictive illegal substances created a lucrative shadow economy. Some young people turned to dealing drugs and then using them. Many were arrested and incarcerated. Baltimore’s Black men of this generation have been dying of overdoses at some of the highest rates in the country ever since. Many of these men can now afford only subsidized apartments in complexes for senior citizens that are often awash with substances, which are now increasingly deadly with the proliferation of fentanyl. There has been little targeted outreach to older people from health officials.

Source: In Baltimore’s Senior Homes, Overdoses Plague a Forgotten Generation (The New York Times)

Many states' drug paraphernalia laws limit access to drug checking equipment

A review of state drug paraphernalia laws in all 50 states and D.C. as of November 2023 found that 48 states have criminal penalties for violation of drug paraphernalia prohibitions. Thirty states include needles, syringes or hypodermic devices in the definition of drug paraphernalia, and 40 include equipment for injection in the definition. Fifteen states explicitly exclude syringes, needles, hypodermic devices or objects used for injecting substances in the definition of drug paraphernalia. Forty-five states’ definitions explicitly refer to drug checking, analyzing or testing equipment. Twenty-nine states’ laws explicitly exempt drug testing equipment from the definition of drug paraphernalia, with 14 states exempting fentanyl test strips, 1 exempting single-use drug test strips, 9 exempting drug testing equipment, 12 exempting any drug testing equipment to determine the presence of fentanyl or fentanyl analog and 1 exempting any drug testing equipment meant to test for a synthetic opioid.

Source: Drug Paraphernalia Laws And Access To Drug Checking Equipment (Center for Public Health Law Research)

Washington program expands access to MOUD in the ER

The Washington State Health Care Authority is launching ScalaNW, a program that equips emergency room (ER) clinicians with tools to treat patients for opioid use disorder (OUD) and connect them to community-based care. ScalaNW is a bridge program with tools to close the gap between emergency initiation of medications for OUD and ongoing, outpatient clinical care. The program offers evidence-backed protocols for clinicians to determine how and when to provide the medications, collaborates with the University of Washington Psychiatry Consultation Line to offer 24/7 live clinical support and works with the Washington Recovery Helpline to provide 24/7 scheduling that allows follow-up appointments to be made before ER discharge. ScalaNW will provide all Washington hospitals with 24/7 clinical consultation and practice guidelines, along with educational resources for both patients and providers. Hospitals that join the ScalaNW network will also receive technical assistance with policies, billing and implementation, support for staff education and 24/7 scheduling for follow-up appointments.

Source: New Washington State program expands access to lifesaving treatment for people with opioid use disorder (Washington State Health Care Authority)

A third of Americans report personal overdose loss

A 2023 survey of 2,326 adults found that 32% reported any personal overdose loss, translating to 82.7 million U.S. adults. A total of 18.9% of all respondents, translating to 48.9 million U.S. adults, reported having a family member or close friend die of overdose. Personal overdose loss was more prevalent among groups with lower income. The experience of overdose loss did not differ across political party groups. Experiencing overdose loss was associated with greater odds of viewing addiction as an extremely or very important policy issue, after adjustment for sociodemographic and geographic characteristics and political party affiliation. Findings suggest that mobilization of those who have experienced personal overdose loss may be an avenue to facilitate greater policy change.

Source: Experience of Personal Loss Due to Drug Overdose Among US Adults (JAMA)

The addiction crisis extends beyond overdose deaths

Overdose deaths as a measure of the opioid crisis do not capture the implications for the health care system and the economy, or the enormous burden on individuals, families and communities. For example, overdose deaths do not include people who die of endocarditis or alcohol, which regularly kills more people than overdoses. Seventeen percent of the population intentionally misuses or is addicted to substances. There is a huge emotional and financial toll on those impacted by a loved one’s substance use. Millions of children have lost a parent to overdose or live with parents who have substance use disorder (SUD). This contributes to childhood trauma, a major risk factor for addiction. One-third of adults and nearly half of young adults had mental illness or SUD in the past year, and 22 million people had both. Mental health and SUD often feed off one another. The crisis is now a multi-substance crisis, with stimulant use and deaths on the rise. GLP-1s (e.g., Ozempic, Wegovy) could one day help treat SUD, with early animal studies finding that they reduce the rewarding component of addictive substances, but more research is needed.

Source: 1 big thing: Addiction crisis reality check (Axios)

CCBHCs serve 3 million people

A new report found that Certified Community Behavioral Health Clinics (CCBHCs) are providing an estimated 3 million people with behavioral health care, with 79% of clinics serving more people after becoming a CCBHC. Eighty-seven percent of CCBHCs report offering at least one form of medication for opioid use disorder, compared to only 64% of addiction treatment facilities nationwide. Sixty percent have already implemented the new requirement that individuals/families have access to naloxone, ahead of the July 2024 deadline. Fifty-six percent provide support following a nonfatal overdose after an individual is medically stable. Eighty-three percent provided services in schools, childcare or other youth-serving settings. Sixty-four percent reported that the number of youth they serve has increased. More than 80% are working in partnership with 988 call centers and 29% have added mobile crisis response. Seventy-five percent reported increased outreach for individuals in historically underserved communities. Sixty-seven percent hired staff with a substance use focus.

Source: 3 Million People Now Served by Innovative Model of Care (National Council for Mental Wellbeing)

New drug mix causing overdoses

Public health officials are warning about a new substance increasingly being mixed into the illicit drug supply — medetomidine. The animal tranquilizer can slow the heart rate to dangerous levels and is more powerful than xylazine. It is impossible for people who use substances to detect it, and the long-term health effects are unknown. Medetomidine was previously detected in the illicit drug supply as early as 2022 but only rarely and in small amounts. It now appears to be spreading rapidly. In April and May, medetomidine mixed with fentanyl and other substances triggered a new wave of overdose deaths in Philadelphia, Chicago and Pittsburgh. Cartels are moving fast to create new combinations of powerful synthetic substances, often using chemicals like medetomidine that are not yet regulated or tightly controlled under U.S. law.

Source: Gangs mix another potent sedative into U.S. street drugs causing ‘mass overdoses’ (NPR)