MDMA meets the advisory committee

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Jun 04, 2024 View in browser   By David Lim Presented by  With Erin Schumaker and Megan R. Wilson Driving The Day Reps. Dan Crenshaw (from left) Lou Correa and Alexandria Ocasio-Cortez are early proponents of psychedelic therapy research. | Chip Somodevilla/Getty Images FDA ADVISERS WEIGH MDMA TREATMENT — The FDA is convening an advisory committee today tasked with weighing whether Lykos Therapeutics’ MDMA treatment is an effective treatment for people with post-traumatic stress disorder. We sat down with Erin to discuss her reporting on the potential therapy. What's the top line with this potential treatment? Why is it significant for veterans? Lykos Therapeutics submitted compelling clinical trial data to the FDA, which suggests that when combined with talk therapy, MDMA, also known as ecstasy, could be an effective post-traumatic stress disorder treatment. There’s a profound need for better PTSD treatments, which don’t work that well. Therapy is a common treatment, but veterans with PTSD and their families have high dropout rates. Veterans are at an increased risk for PTSD compared to the general population and at higher risk for suicide — 18 veterans die by suicide every day, according to the Department of Veterans Affairs. The FDA put out briefing documents ahead of the advisory committee today. What do they indicate? The FDA appears to have serious concerns about Lykos’ application. In briefing documents, the FDA said Lykos’ data was “challenging to interpret” and cited MDMA’s heart risks and abuse potential as safety concerns. The agency also noted that it’s hard to discern how much of the study participants’ improvement came from MDMA combined with therapy versus therapy alone. But the FDA also offered a message that advocates in the psychedelics community might interpret as hopeful, writing: “Based on the clinical trial data submitted with this application, participants appear to experience rapid, clinically meaningful, durable improvement in their PTSD symptoms.” Why are the clinical trials for this medicine being questioned? For starters, it’s hard to do double-blind studies with psychedelic drugs. It’s almost always evident who got the placebo and who got the real thing. That happened in Lykos’ trials, which were “functionally unblinded,” according to the FDA. Not having truly blind trials means bias might have infiltrated the research and skewed the results. The nonpartisan Institute for Clinical and Economic Review has also questioned the validity of Lykos’ results. They cited safety, ethical and cost concerns and projected difficulty in widely implementing the treatment. Congress seems interested in this MDMA treatment. Why is that? There’s a cohort of members in the House, including Reps. Lou Correa (D-Calif.), Alexandria Ocasio-Cortez (D-N.Y.), Jack Bergman (R-Mich.), Dan Crenshaw (R-Texas) and Morgan Luttrell (R-Texas), who have emerged as early champions of psychedelic research. I think that’s because if it works, veterans stand to benefit. The VA also appears to be on board with MDMA treatment, and MDMA studies are underway at the VA. Dr. Shereef Elnahal, the VA’s undersecretary for health, was a speaker at a psychedelics conference in New York I went to last month. Elnahal said that if the FDA approves Lykos’ application, he wants the VA to lead the way on the treatment. IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. How many members of the San Francisco Giants can get injured this season? Send moral support, news and tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM). A message from CVS Health: CVS Caremark is driving biosimilar adoption and reducing costs. Our health plan sponsors, like employers, have already saved more than $315 million, and many patients now have a $0 co-pay. In the first three weeks of April, we dispensed more biosimilars than the entire market combined in 2023. We are redesigning the pharmaceutical landscape to help clients and members realize savings by increasing biosimilar adoption. Learn more.   In Congress Rep. Brad Wenstrup has introduced legislation to prohibit the U.S. from doing business with foreign adversaries' biotech companies of concern. | Amanda Andrade-Rhoades/AP BIOSECURE MARCHES ON — An effort is underway to build additional momentum behind a bipartisan measure meant to crack down on China-based biotech firms, known as the BIOSECURE Act, Megan reports. Rep. Brad Wenstrup (R-Ohio) offered the legislation as an amendment to the massive National Defense Authorization Act, according to the House Rules Committee, which is expected to review proposed amendments to the bill next week. It comes amid growing scrutiny of companies, including WuXi AppTec, used by drugmakers to develop and bring medicines to market. The BIOSECURE Act advanced out of the House Oversight and Accountability Committee last month, and a Senate panel approved the legislation in May. The pharmaceutical industry has successfully secured several tweaks to the measure, including a provision that would grandfather existing contracts with the companies blacklisted by the bill, in addition to an eight-year implementation period during which to cut ties. Meanwhile, companies, including WuXi AppTec and Complete Genomics, have been lobbying lawmakers, arguing that they do not have connections to China or its government and should not be listed in the bill. SCHUMER SETS UP CONTRACEPTION VOTE — The Senate is slated to vote Wednesday on legislation guaranteeing access to birth control, Majority Leader Chuck Schumer said Sunday. "Democrats will never relent until we reverse the immense damage MAGA Republicans and the Supreme Court have inflicted," Schumer wrote in a dear colleague letter, "and we remain absolutely committed to doing everything we can to protect women, families, and reproductive freedom."   THE GOLD STANDARD OF HEALTHCARE POLICY REPORTING & INTELLIGENCE: POLITICO has more than 500 journalists delivering unrivaled reporting and illuminating the policy and regulatory landscape for those who need to know what’s next. Throughout the election and the legislative and regulatory pushes that will follow, POLITICO Pro is indispensable to those who need to make informed decisions fast. The Pro platform dives deeper into critical and quickly evolving sectors and industries, like healthcare, equipping policymakers and those who shape legislation and regulation with essential news and intelligence from the world’s best politics and policy journalists. Our newsroom is deeper, more experienced and better sourced than any other. Our healthcare reporting team—including Alice Miranda Ollstein, Megan Messerly and Robert King—is embedded with the market-moving legislative committees and agencies in Washington and across states, delivering unparalleled coverage of health policy and the healthcare industry. We bring subscribers inside the conversations that determine policy outcomes and the future of industries, providing insight that cannot be found anywhere else. Get the premier news and policy intelligence service, SUBSCRIBE TO POLITICO PRO TODAY.     Eye on the FDA PRIDE FLAG FLOWN AT FDA — Less than a year after the top Republican on the House Appropriations Subcommittee in charge of FDA funding sought to bar the agency from flying certain flags, FDA Commissioner Robert Califf touted the flying of the Progress Pride flag at his agency’s headquarters Monday to mark the start of Pride Month. “I am proud that we will fly this flag as it symbolizes the values of pride, tolerance & harmony,” Califf tweeted. “I want to recognize and thank all the LGBTQIA+ employees at the FDA who are making important contributions to protecting the nation’s public health.” The office of Rep. Andy Harris (R-Md.) — who penned the Republican manager’s amendment that sought to restrict some flags from being flown — did not respond to a request to comment.   A message from CVS Health:   Pharma Worldwide PANDEMIC TREATY TALKS CONTINUE — World Health Organization members are taking another year to attempt to reach a global pandemic agreement, but during the past two years, nations have become more entrenched in their positions on intellectual property protections and other issues like sharing vaccines in a future crisis, POLITICO’s Rory O’Neill reports. Various nations wanted a deal to be finished sooner: African countries wanted a deal this year. But the U.S. wanted an extension of one to two years to hash out disagreements.   JOIN US ON 6/13 FOR A TALK ON THE FUTURE OF HEALTH CARE: As Congress and the White House work to strengthen health care affordability and access, innovative technologies and treatments are increasingly important for patient health and lower costs. What barriers are appearing as new tech emerges? Is the Medicare payment process keeping up with new technologies and procedures? Join us on June 13 as POLITICO convenes a panel of lawmakers, officials and experts to discuss what policy solutions could expand access to innovative therapies and tech. REGISTER HERE.     WHAT WE'RE READING A Delaware judge is allowing more than 70,000 lawsuits alleging that GSK’s Zantac caused cancer to proceed, a decision the company on Monday said it would appeal, Reuters’ Yadarisa Shabong and Maggie Fick report. Healthcare waste services company Stericycle is being acquired by WM for approximately $7.2 billion, Waste Dive’s Megan Quinn reports. BD is buying Edward Lifesciences’ critical care business unit for $4.2 billion, MedTech Dive’s Ricky Zipp reports. A message from CVS Health: CVS Caremark is moving the market to lower cost alternatives, and our bold biosimilar strategy continues to deliver savings without compromising care. Our health plan sponsors, like employers, have already saved more than $315 million, and many patients now have a $0 co-pay. In the first three weeks of April, we dispensed more biosimilars than the entire market combined in 2023. Learn more about how CVS Health is supporting clients, patients, and providers through this formulary change and innovations to come. Learn more.   Document Drawer Health care advocacy group Power to the Patients will meet with the White House Office of Information and Regulatory Affairs on Wednesday to discuss the proposed rule on CMS’ Medicare hospital outpatient prospective payment system.   Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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