MDMA not approved by the FDA: On Tuesday, an advisory panel from the Food and Drug Administration (FDA) rejected approval for MDMA to be used to treat post-traumatic stress disorder (PTSD). (Technically, this is not a binding decision just yet, but the FDA is expected to follow the advisory panel's ruling and fully reject the drug in August).
"The panel voted 9-2 on whether the MDMA-assisted therapy was effective, and voted 10-1 on whether the proposed treatment's benefits outweighed its risks," reports The New York Times. The result represents a huge setback for MDMA activists, clinicians, patients, and even recreational users who had been anxiously awaiting possible FDA approval and greater acceptance of the drug.
Several issues plagued Lykos Therapeutics, namely its failure to get lab samples from patients and the fact that several people enrolled in the trial refused to submit to a follow-up study meant to assess longer-term effects (and whether they'd sought the drug outside a clinical setting). A sexual misconduct scandal involving some of the therapists associated with the clinical trial back in 2018 cast a pall over the whole thing.
Members of the FDA panel raised concerns about the design of the trials run by Lykos as well as the drug's potential for abuse.
"Psychedelics present fundamental challenges to running placebo-controlled trials," writes Bloomberg's Lisa Jarvis. "The most basic is that their mind-altering qualities mean people know when they're getting them."
"Another issue complicating matters is that MDMA on its own doesn't resolve PTSD, but allows people to confront and process difficult and intrusive memories in the context of a licensed therapist," continues Jarvis. "But there are also some fundamental unknowns about what that therapy looked like in the trial—and should look like in the real world. Are certain types of talk therapy more effective than others? How much does the trust built between a therapist and patient matter to MDMA's benefits?" Therapy, of course, isn't regulated by the FDA (nor should it be). But some experts who testified questioned whether patients' mental health improvements could be attributed to the drug itself vs. intense and consistent therapy.
Though it's fair to flag these issues, it's hard not to look at this panel's rejection as colored by lingering drug war stigma. MDMA currently remains a Schedule 1 drug, with no accepted medical use (though the FDA did release draft guidance last year as to how clinical trials ought to be designed, which is a promising sign). For the thousands or possibly millions of people in the U.S. who have used the drug—on their own, outside of a clinical trial, without supervision—to combat PTSD, depression, and anxiety, the fact that the authorities claim there's no "accepted medical use" is reason to doubt not the drug itself, but the credibility of the authorities. Let's hope this setback doesn't mar future research.
Netanyahu sets sights on Lebanon: "Whoever thinks he can hurt us and we will respond by sitting on our hands is making a big mistake," Israeli Prime Minister Benjamin Netanyahu said yesterday in response to escalating Hezbollah strikes. "We are prepared for very intense action in the north."
"We are approaching the point in which a decision needs to be made, and the I.D.F. is ready and prepared for that decision," Lt. Gen. Herzi Halevi, chief of staff for the Israeli military, said earlier this week.
Netanyahu's government has not publicly said it accepts the U.S.-brokered ceasefire that President Joe Biden has proposed, which Hamas has indicated it is open to. Members of the far-right political coalition that Netanyahu relies on have indicated that any deal that leaves the terrorist group intact is a nonstarter. But now, Israel may be preparing to fight a war in the north as it continues a ground offensive in Gaza.
"Iran is trying to choke us and encircle us and we are fighting back directly and with its proxies," Netanyahu said, according to The Times of Israel. "We can't accept the continuation of the situation in the north, it won't continue. We will return the resident to their homes and bring back security." He's referring to the fact that many Israelis in the north have been evacuated from their homes for more than six months due to Hezbollah strikes in the wake of October 7. But Netanyahu will have to also contend with political realities—the fact that the U.S. is putting pressure on Israel to halt its campaign in Gaza—and logistical ones, like the fact that fighting a two-front war would be tough to pull off.
Scenes from New York: Congestion pricing delayed, in a surprise move by Gov. Kathy Hochul.
The level of political malpractice here just astounds me:
-A congestion pricing delay outrages advocates while failing to please detractors
-The nakedly political reason for the delay makes it easy to attack Democrats from both sides of the issue
-Hochul's alternative revenue…— Josh Barro (@jbarro) June 5, 2024
QUICK HITS
- "Biden's [immigration] order will face legal challenges akin to those that greeted Trump's efforts to use presidential authority to suspend migrant access to the US," reports Bloomberg. "Although the Biden administration has tailored its order to anticipate possible challenges, the courts will likely prevent implementation until cases against it have been heard and made their way up the judicial chain—a process that could take months and end up at the Supreme Court."
- New IMBY just dropped: GIMBYism.
GIMBYISM: THE CASE FOR _REDUCING_ URBAN HOUSING DENSITY
You've all heard the YIMBY story: increasing population density in cities will lower housing costs, reduce inequality, and save the planet. In this thread I'll make the case for its opposite. No, not NIMBYism. GIMBYism. pic.twitter.com/smE1exh443
— J. Sanilac (@Sanilac_J) May 11, 2024
- Inside the long-held grudges between the Didions and the Dunnes.
- Pew has a new report out on the state of the American middle class. TL;DR: "The increase in the share who are upper income was greater than the increase in the share who are lower income."
The post Rolling Backward appeared first on Reason.com.
