Greetings from the 3-0-5. I’m David Ovalle, a reporter covering addiction, substance use and the Food and Drug Administration from Miami. Today’s newsletter touches on psychedelics, research and, in a (tasty?) twist, tofu. But first: got tips? Send to david.ovalle@washpost.com.
Today’s edition: The CEO of Steward Health Care will skip an upcoming Senate hearing despite a subpoena to testify. What Medicare advisers to Congress are focusing on this cycle. But first …
The ‘tofu of psychedelics’ gets a closer look
First in the Health Brief: The FDA has approved an early-stage clinical trial involving the little-known psychedelic compound 5-MeO-MiPT, which biotech firm Mindstate Design Labs is slated to announce Thursday. Researchers will study whether the drug, also known as moxy, can treat depression, anxiety, post-traumatic stress disorder and other mental health conditions.
Why it matters: Psychedelics are having a moment as government and investors pour tens of millions of dollars into researching compounds such as psilocybin, LSD and ibogaine to treat mental health.
Efforts absorbed a blow last month, however, when the FDA rejected MDMA, or ecstasy, combined with talk therapy to treat PTSD. An independent advisory board raised concerns about clinical trials run by Lykos Therapeutics, which hoped its application would mark the first psychedelic approved by the FDA for mainstream medical use.
But those researching psychedelics remain bullish even as they have distanced themselves from Lykos. The company still hopes for approval — the FDA requested more study of the drug. Lykos has since brought in pharmaceutical industry veteran David Hough to shepherd the application as an adviser — he happens to also lead Mindstate’s moxy research.
What is moxy? The compound, discovered by psychedelics pioneers Alexander and Ann Shulgin, belongs to a class of hallucinogenic compounds known as tryptamines. (One naturally occurring chemical cousin includes a substance found in the skin of certain toads.)
Research on moxy was almost derailed two years ago when the Drug Enforcement Administration tried to designate the compound and four similar ones as among the riskiest of controlled substances. After a backlash, the DEA reversed plans and asked the Department of Health and Human Services for a new scientific review of tryptamines.
Mindstate CEO Dillan DiNardo calls moxy “the tofu of psychedelics” because in clinical doses, it has a more muted effect on users than mind-benders such as LSD.
Recreational users normally pair moxy with other substances. Mindstate said it has used artificial intelligence to analyze online posts about tens of thousands of “trips” involving psychedelic drugs including moxy. DiNardo said the company is researching how moxy affects the brain when combined with mainstream drugs that target brain function. Researchers will test those combinations on people in clinical trials, he said.
“Moxy is not the entire medicine,” DiNardo said. “Moxy is the first part of a number of different medicines that we’ll be making.”
The initial-stage trial, which focuses on safety, is scheduled to start this year at the Center for Human Drug Research in the Netherlands. The company also has the approval of the European Medicines Agency, the continent’s FDA counterpart.
Researchers will give doses to 52 participants and scan their brains.
What now? The drug is probably a couple of years away from late-stage trials pivotal to FDA approval. Mindstate, based in San Francisco, said it has raised more than $11 million from investors, including founders of prominent tech companies OpenAI and Neuralink.
On the Hill
Steward CEO refuses to testify until bankruptcy proceedings conclude
Steward CEO Ralph de la Torre told senators that he will skip a hearing next week investigating the bankruptcy of the nation’s largest physician-led hospital system.
Key context: In July, the Senate Health, Education, Labor and Pensions Committee voted to launch a bipartisan investigation into Steward and subpoena de la Torre, alleging that the company’s executives had mismanaged the system’s finances and put patient care at risk.
The CEO’s lawyers sent a letter Wednesday to HELP Committee Chair Bernie Sanders (I-Vt.), saying senators appeared “determined to turn the hearing into a pseudo-criminal proceeding in which they use the time, not to gather facts, but to convict Dr. de la Torre in the eyes of public opinion,” per Bloomberg News’s Jonathan Randles.
The letter also notes that Steward’s policies prevent de la Torre from discussing the bankruptcy and requests that the hearing be postponed until after the proceedings have concluded.
The view from Sanders: The senator released a statement saying he is “disappointed, but not surprised” by de la Torre’s refusal to testify, adding that he’s working with committee members to “determine the best path forward.”
Defying a congressional subpoena to avoid testifying is consistent with a disregard for norms. With a disregard for doing the right thing. Communities depended on these hospitals & there are allegations that assets were drained to profit Dr. de la Torre. He should address this. https://t.co/AUYQBFipah
— U.S. Senator Bill Cassidy, M.D. (@SenBillCassidy) September 4, 2024
Data point
New this a.m.: In 2021-2022, 88.6 percent of U.S. adults 65 and older were on prescription medications. Of them, 82.7 percent had some form of drug coverage, according to an analysis by the National Center for Health Statistics.
Financial barriers continued to affect access to medications for older adults: 3.6 percent couldn’t afford prescriptions in the past year, and 3.4 percent didn’t take them as prescribed because of cost. For both measures, cost-related nonadherence was six times higher among older adults facing food insecurity and more than twice as common among those in fair or poor health or with disabilities.
Industry Rx
MedPAC launches new cycle with discussions on critical access hospitals, rural providers
On tap today: The Medicare Payment Advisory Commission (MedPAC) is convening in D.C. for its first public meeting of the 2024-2025 cycle.
The independent advisory board will kick things off by reviewing the short- and long-term outlooks for Medicare payment policy, laying the groundwork for its discussions and recommendations to Congress during the coming year.
In the afternoon, members will dive into two key issues: cost-sharing for outpatient services at critical access hospitals and measuring quality at Medicare rural providers.
On our radar: MedPAC has a packed agenda during the coming months. The commission is required to deliver two reports to Congress — one by March 15 and the other by June 15. In the run-up, the panel will evaluate the adequacy of Medicare’s fee-for-service payments and provide status updates on Medicare Advantage, the Part D program and ambulatory surgical centers.
MedPAC will also launch work on several hot-button issues, including care for Medicare beneficiaries in nursing homes, Medigap policies, hospice care for beneficiaries with end-stage renal disease, staffing levels at skilled nursing facilities and Medicare’s coverage of FDA-approved software. The commission will also examine Medicare’s 190-day coverage limit for inpatient psychiatric services at free-standing facilities and its support for rural hospitals.
In other health news
- New this a.m.: More than 850 physicians with the Committee to Protect Health Care are out with a video ad endorsing Vice President Kamala Harris and criticizing former president Donald Trump’s health policy record.
- In competing developments about reproductive rights, Alaska Gov. Mike Dunleavy (R) vetoed a bill to expand birth control access while a judge struck down decades-old restrictions on who could perform abortions in the state, Becky Bohrer and Gene Johnson report for The Associated Press.
- Walgreens is facing a proposed class-action lawsuit by customers who say they weren’t warned that the pharmacy chain’s generic Mucinex cold medicine contains benzene, a cancer-causing chemical, Diana Novak Jones reports for Reuters.
Health reads
Sugar rush
@docschmidt There’s a reason why healthcare is a team sport #healthcare #nursesoftiktok #pharmacy
♬ original sound - Doc Schmidt
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