Axios Vitals

August 07, 2024
Midweek already, gang. Today's newsletter is 975 words or a 3.5-minute read.
1 big thing: Lobbying on MDMA decision hits peak
Lobbying around using ecstasy to treat PTSD is reaching a fever pitch this week ahead of an FDA deadline that could be a milestone for psychedelic drugs.
Why it matters: Psychedelics — combined with psychotherapy — have shown promise for treating a range of addictions and mental health disorders. But no treatment has won the FDA's approval yet.
- PTSD is of particular concern for veterans. Almost 6,400 died by suicide in 2021, according the most recent available data from the Department of Veterans Affairs.
State of play: The FDA faces an Aug. 11 deadline for deciding whether to give Lykos Therapeutics the green light for a post-traumatic stress disorder treatment that combines talk therapy with the drug commonly known as ecstasy or MDMA.
- An FDA advisory panel in June overwhelmingly recommended against approving the treatment, citing missing safety data, allegations of misconduct in clinical trials, and difficulty parsing how much the reported benefits stemmed from the drug versus the accompanying therapy.
The latest: Congress has joined the fray. More than 60 members of the House of Representatives and 19 senators in letters this week highlighted the potential promise of MDMA-assisted therapy and urged the FDA to follow the science.
- Prominent figures in mental health and psychedelics, plus a few billionaires on social media, have also weighed in.
The other side: A vocal contingency of opponents say approving Lykos' application would do more harm than good and could put vulnerable, traumatized patients at risk.
2. Tim Walz's record on health care
Minnesota Gov. Tim Walz is a favorite of progressives and has racked up a slew of health care accomplishments with a fully Democratic state legislature, Peter Sullivan wrote first on Pro.
Why it matters: He has a record of taking on health care providers over costs, though many of the efforts are still in the early stages.
Driving the news: Walz and the Minnesota legislature created a Prescription Drug Affordability Board last year, with the power to cap prices.
- The board is still getting up and running, but it has unsurprisingly drawn stiff resistance from the pharmaceutical industry.
- In 2020, Walz signed legislation to cap out-of-pocket insulin costs, before the Inflation Reduction Act took similar action on a federal level.
- Walz and the legislature also sparred with the Mayo Clinic, the state's crown jewel hospital, over a proposed health care affordability board with power over hospital and other provider costs.
- The legislature and Walz also created a state-based public option last year.
Walz is a supporter of abortion rights and in 2022 signed an executive order seeking to protect people who travel to Minnesota for abortions from being prosecuted by their home states.
- He also signed a law last year enshrining abortion rights in state statute.
Minnesota's uninsured rate hit an all-time low of 3.8% this year, and the state's health insurance marketplace MNsure had record enrollment for 2024.
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3. Hims & Hers eyes pharmacy for weight-loss drugs
Hims & Hers plans to acquire a compounding pharmacy as the telehealth company doubles down on weight-loss drugs.
Why it matters: The growing GLP-1 space offers significant sales potential for Hims & Hers, but the company has come under scrutiny over the alternatives it's offering customers.
Driving the news: Hims & Hers, which said in May that it would begin selling compounded versions of GLP-1 injections, recently revealed a plan to buy an undisclosed U.S.-based compounding facility registered with the FDA.
Friction point: Compounded drugs have come under fire recently for quality standards. And hedge fund Hunterbrook reported in June that Hims & Hers was relying on a supplier "with previously unreported ties to fraud."
- The supplier said it was following safety protocols.
Hims & Hers acknowledged Monday in the SEC filing that "certain compounding pharmacies" have experienced product quality issues in recent years.
Our thought bubble: This compounding push focuses on "personalization" of GLP-1 dosages, raising the question about how that affects drug adherence. Studies have shown the bulk of patients on GLP-1s drop them within a year.
- While brand-name GLP-1s are typically delivered via pre-dosed injectable pens, Hims & Hers co-founder and CEO Andrew Dudum told Axios' Hope King that personalized doses can help "mitigate side effects" like nausea and vomiting and "optimize results."
4. How discharged patients bring superbugs home
Discharged hospital patients can carry superbugs home and infect relatives or caregivers, even if they weren't sickened by the bacteria, per a study in Infection Control & Hospital Epidemiology.
Why it matters: The findings put an exclamation point on the concerns about the role hospitals play in the spread of antibiotic-resistant infections — and need to play in prevention, the authors say.
What they found: University of Iowa-led researchers examined more than 158 million insurance claims between 2001 and 2021 and found methicillin-resistant staph, or MRSA, in more than 424,000 patients.
- The researchers looked specifically at families where two or more members of the household were enrolled in the same insurance plan for a month.
- Those who had a hospitalized family member with MRSA within the last 30 days were 71 times more likely to get the infection themselves.
What they're saying: The researchers recommended hospitals improve testing for MRSA colonization, especially at discharge, even when a patient in asymptomatic.
5. Tweet du jour: Gabby gets gold
Gabby Thomas, the Olympian with a master's in public health, got a shoutout from the CDC for winning the women's 200-meter race in Paris on Tuesday. The Harvard grad has focused on health disparities and provided primary care at the Volunteer Healthcare Clinic in Austin, Texas, while she was training, per NBC.
6. Catch up quick
💉 Pfizer, GSK and Moderna executives remain optimistic about RSV vaccines despite narrower-than-expected CDC age recommendations. (PharmaVoice)
💰 Bloomberg is donating $600 million to four historically Black medical schools. (WSJ)
🥤 Public health experts want the International Olympics Committee to end its partnership with Coca-Cola, saying sugary beverages linked to diabetes shouldn't be promoted. (Wired)
Thanks for reading Axios Vitals, and to senior health care editor Adriel Bettelheim and copy editor Matt Piper. Please ask your friends and colleagues to sign up.
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