The VA is undeterred on psychedelics

The Department of Veterans Affairs remains convinced that psychedelic therapy can help treat veterans with post-traumatic stress disorder — and it’s going to try to prove it.

That commitment comes despite the FDA’s August rejection of a drug company’s plan to offer a psychedelic regimen for PTSD.

How so? The VA is funding a study on whether MDMA, also known as ecstasy, combined with talk therapy is an effective treatment for PTSD and alcohol-use disorder, Dr. Shereef Elnahal, the VA undersecretary for health, announced on LinkedIn.

“The U.S. Department of Veterans Affairs must lead on this encouraging area of investigation so that we can continue to build trust with Veterans contending with these severe health conditions,” he wrote, adding: “And we will.”

Researchers at Providence VA Medical Center in Rhode Island will lead the study.

Why it matters: The Food and Drug Administration rejected an MDMA and talk therapy treatment from Lykos Therapeutics after the agency’s outside advisers found the regimen wasn’t effective and the company hadn’t shown that its benefits outweighed its risks.

Lykos subsequently laid off 75 percent of its staff, and its top leaders left. The FDA told the company it would need to conduct an additional Phase III clinical trial to have its application reconsidered.

Some lawmakers who support the treatment were disappointed with the FDA’s decision.

The backstory: In January, the VA announced it would fund psychedelic research for PTSD and depression for the first time since the 1960s. In addition to being the largest health system in the country, the VA serves a population with disproportionately high PTSD rates.

Elnahal received a standing ovation at a conference of psychedelics enthusiasts in May when he delivered encouraging words about the drugs’ effectiveness as mental health treatments.

What’s next? Elnahal thinks the VA might help fill some gaps in Lykos’ research.

For example: FDA outside advisers criticized Lykos’ application, calling its studies “functionally unblinded,” which means that study participants and researchers could figure out who received MDMA and who received a placebo because MDMA produces noticeable effects.

The Rhode Island researchers plan to administer low-dose MDMA to the placebo group to better conceal which group they’re in.

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EXAM ROOM

Athenahealth, an electronic health records company focused on ambulatory outpatient providers, said Wednesday that doctors using its software would have access to two artificial intelligence scribes to help them with notetaking, Suki Assistant and iScribe AI.

The company wants to foster competition and innovation, hoping to offer its customers the best of what’s on the market by helping doctors evaluate the available offerings, Paul Brient, chief product officer at the company, told Daniel.

Why it matters: Without any formal regulation or validation of many AI tools, including scribes, doctors are concerned about reliability, accuracy and safety.

Athenahealth’s approach allows it to test the AI assistants before rolling them out to doctors — and in turn, gives providers more confidence that the systems can be trusted.

Even so: Doctors must still review the AI-generated suggestions to ensure accuracy instead of blindly accepting them, Brient said.

Athenahealth will work to monitor whether doctors are doing that.

What’s next? Athenahealth plans to offer more scribe tools soon, Brient said.

WASHINGTON WATCH

The Biden administration announced one of its final cancer moonshot initiatives this week: a pilot program to prevent pediatric cancer drug shortages.

The private sector pilot will test whether identifying shortage risks, promoting transparency around drug inventory and maintaining consistent drug distribution can help patients secure uninterrupted access to seven critical pediatric cancer medications.

How it works: The nonprofit End Drug Shortages Alliance will act as a coordinating hub for the providers and drug wholesalers involved in the project.

“Our goal is to build a collaborative, scalable, and transparent ecosystem that will provide effective treatment and improved care for children and families impacted by cancer,” Danielle Carnival, deputy assistant to the president for the cancer moonshot and deputy director for health outcomes at the Office of Science and Technology Policy, said in a statement.

“This new pilot will improve our supply chain, provide more timely and uninterrupted care to children facing cancer, and, ultimately, save lives.”

Big picture: It remains to be seen whether a Harris or Trump administration will continue to prioritize the cancer moonshot, which aims to cut the cancer death rate by half over 25 years.

The effort is deeply personal for President Joe Biden. He launched the program when he was then-President Barack Obama’s vice president in the wake of his son Beau’s death from brain cancer, then reignited it as president in 2022.

What’s next? The pilot will launch before the end of the year and run into 2025, according to the White House. End Drug Shortages Alliance will publish its findings after the pilot ends.