Q&A: Bergman on pushing the FDA on psychedelics

The ideas and innovators shaping health care

Aug 08, 2024 View in browser   By Ruth Reader, Erin Schumaker, Daniel Payne, Toni Odejimi and Carmen Paun WASHINGTON WATCH Bergman | Francis Chung/POLITICO The FDA is expected to decide this week whether to approve an MDMA, or psychedelic, therapy for post-traumatic stress disorder, which affects about 7 percent of veterans. Rep. Jack Bergman (R-Mich.) supports the therapeutic use of psychedelic drugs — and thinks the FDA should get on board. He says he’s been interested in veteran mental health since 2003, when as a retired Marine Corps general, he decided to look into how members of the Individual Ready Reserve were doing in their off-duty lives. "These fine young marines had served their time and left active duty, and they were kind of out there in the darkness," he said. "That’s when I started to really take a look at what can we do to cut the suicide rate." He is among a group of federal legislators who have put pressure on the FDA to approve MDMA therapy for PTSD, despite concerns raised by an agency advisory committee in June. He sat down with Ruth to talk about veterans’ experiences and why he thinks MDMA can help. This interview has been edited for length and clarity.  You’ve been advocating for a variety of approaches to mental health. In addition to MDMA therapy, there’s mental health therapy like prolonged exposure therapy for PTSD. PE has an over 70 percent success rate but has high dropout rates. Why chase approval for psychedelic therapy instead of bolstering existing therapies? My interactions with veterans and some others who have told their stories of one [medication] cocktail after another. "Here, take this pill [and then when it] doesn’t work, take that pill. If that pill doesn’t work, take two of these." The body can only handle so much input before it begins to, I believe, to not accept any input that will allow for a long-term solution. So maybe I’m a little biased that I haven’t seen the breakthrough therapies that we need. What was your sense of the FDA advisory committee’s recommendation on MDMA for PTSD? They’re acting like a normal advisory panel [that] doesn’t want to assume risk. I'm not antibureaucracy, don’t get me wrong, but a good bureaucracy takes input, turns it around and gives output. But a bureaucracy has to be prodded. Congressmen [Lou] Correa [D-Calif.] and [Jimmy] Panetta [D-Calif.] and [Morgan] Luttrell [R-Texas] and I … we’re trying to create a situation in Congress to let the bureaucracies know it’s OK to assume some logical risk. We’re going to put some funding behind this effort, but we’ve got literally lives at stake here. MDMA therapy may be very expensive because in part it requires long hours from psychotherapists. How will the VA pay for this? When I was a flight instructor and somebody put a cost on a human life: What does it cost if you train a pilot in the Navy or Marine Corps, and what does it cost if they die? You can’t look at it that way. You have to look at what is the benefit. I’m on the budget committee as well, and chairman of the oversight improper payment task force, so I could give you hundreds of billions of dollars right away that we could remove that are either wasteful, fraudulent or unnecessary government spending. It’s not all about adding, it’s about also reducing in areas. What if the FDA rejects the application for MDMA therapy? The VA is going to continue to move forward with some of the research it’s been doing; they’re not going to stop. We will find another way to approach this. It’s not going to stop, because we have lives on the line every day.   During unprecedented times, POLITICO Pro Analysis gives you the insights you need to focus your policy strategy. Live briefings, policy trackers, and and people intelligence secures your seat at the table. Learn more.     WELCOME TO FUTURE PULSE Brooklyn, N.Y. | Erin Schumaker/POLITICO This is where we explore the ideas and innovators shaping health care. Watermelon who? As if we needed another reason to stock up on end-of-summer produce at the farmer’s market this weekend, The New York Times reports that tomatoes are more hydrating than watermelon. Share any thoughts, news, tips and feedback with Carmen Paun at cpaun@politico.com, Daniel Payne at dpayne@politico.com, Ruth Reader at rreader@politico.com, Erin Schumaker at eschumaker@politico.com, or Toni Odejimi at aodejimi@politico.com. Send tips securely through SecureDrop, Signal, Telegram or WhatsApp. CONNECTING THE DOTS Clinicians often aren't coding for housing insecurity, according to new research. | AP Photo Clinicians often don’t use identifying codes for patients to track housing instability, according to a new study in JAMA Network Open. Researchers looked at how frequently doctors assigned Z59 codes to designate patients without stable housing and how accurately they identified those with housing issues. The study found that patients assigned Z59 codes were correctly identified as having housing trouble, but nearly three-quarters of patients with housing problems weren’t identified. "Health care is now starting, for the first time, to reckon with these social determinants of health that exist outside the walls of the hospital or the clinic," Dr. Matthew O’Brien, study coauthor and associate professor at Northwestern University's Feinberg School of Medicine, told Toni. The study is the first to examine Z59 codes being used with patient-reported data, according to the researchers. Still, Z59 housing codes aren’t widely adopted because of doctors’ time constraints, budgets and unfamiliarity with them, O’Brien said. What’s next: AI could help track patients’ housing stability, O’Brien said. His team wants to use AI to collect and aggregate data from clinicians’ notes. Meanwhile, industry leaders plan to collaborate on a database to identify barriers to care. “You could train an AI model to kind of identify all of these various data elements, from medical diagnostic codes to free text language that’s being written by health care providers, and a number of other things to try to predict … who's experiencing homelessness,” O’Brien said.   SUBSCRIBE TO GLOBAL PLAYBOOK: Don’t miss out on POLITICO’s Global Playbook, our newsletter taking you inside pivotal discussions at the most influential gatherings in the world. Suzanne Lynch delivers the world's elite and influential moments directly to you. Stay in the global loop. SUBSCRIBE NOW.     THE LAB Researchers are questioning the benefits of two treatments for Alzheimer's disease. | AP Researchers from the University of Cambridge in England are casting doubts about two drugs used to treat Alzheimer’s disease, POLITICO’s Claudia Chiappa reports. Key context: Lecanemab and donanemab are the most recent medicines to enter the market to treat Alzheimer’s disease. With populations increasingly aging, effective treatments for the disease are urgently needed. But the researchers question whether either drug will have any great impact. The criticisms: The researchers raised concerns about the side effects associated with the medications, lack of data showing substantial benefits and challenges in administering the drugs. “Based on current evidence, it is far from clear whether [these types of therapies] can ever significantly reduce population-level dementia morbidity at scale,” they wrote. Background: Both drugs target a protein called amyloid that builds up to form plaques in the brain. Some scientists hypothesize that those plaques are a main cause of Alzheimer’s. Late-stage trials of the two drugs showed they slowed the progression of Alzheimer’s. For donanemab, developed by Eli Lilly, participants in a Phase III trial who received the drug showed a 22 to 29 percent slowing in cognitive decline after 76 weeks compared with those who received a placebo. For lecanemab, developed by Japan’s Eisai and U.S. biotech Biogen, those who received the drug declined 1.21 points on an 18-point cognition scale, while those who received the placebo declined 1.66 points, the companies reported.   Follow us on Twitter Carmen Paun @carmenpaun Daniel Payne @_daniel_payne Ruth Reader @RuthReader Erin Schumaker @erinlschumaker   Follow us

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