Rebuke of psychedelic treatment explained

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Jun 05, 2024 View in browser   By Ben Leonard and Chelsea Cirruzzo Presented by  Driving the Day An FDA advisory panel casts doubt on the agency approving MDMA therapy for post-traumatic stress disorder. | Cole Burston/AFP via Getty Images TOUGH DAY FOR ECSTASY — An FDA advisory committee dealt a severe blow to psychedelic medicine on Tuesday, finding that MDMA, also known as ecstasy, is not an effective treatment for post-traumatic stress disorder, POLITICO’s Erin Schumaker reports. The expert committee voted 9-2 that Lykos Therapeutics’ combo regimen of therapy and MDMA is not effective and 10-1 that the treatment’s risks outweigh its benefits. “Premature introduction of a treatment can actually stifle development and stifle innovation,” said Dr. Paul Holtzheimer, committee member and deputy director for research in the executive division of the Department of Veterans Affairs’ National Center for PTSD. The FDA typically follows the advice of its advisers in deciding whether to approve a new treatment. The agency expects to decide on the drug therapy’s use by mid-August. The no vote could upend a burgeoning industry that’s testing numerous mind-altering drugs as treatments for mental illnesses, including depression, anxiety and addiction. It’s also a blow to the VA, which is seeking better treatments for the huge number of veterans with PTSD, and to lawmakers touting psychedelics. Here are three takeaways: 1. Experts are wary of “expectation bias.” In double-blind studies, the gold standard for clinical trials, drug study participants don’t know whether they’ve received the drug or a placebo. But it’s hard to do double-blind studies with psychedelics, whose effects are so pronounced that participants can usually figure out whether they received the drug. People who know they received the drug may have an expectation bias toward its effectiveness, the FDA advisers said. 2. The public expressed mixed views on Lykos and MDMA therapy. During the public hearing section of the meeting, the advisory committee heard from groups in support of psychedelic medicine — and against it. Veterans’ advocacy groups pointed to the acute need for better PTSD treatments, which have had no significant updates in more than 20 years. Critics of MDMA therapy and Lykos, including psychedelic researchers, expressed concern about alleged misconduct in Lykos’ clinical trials, including that researchers may have pressured subjects not to report negative effects. 3. The FDA shied away from regulating therapy. The FDA said Tuesday that the psychotherapy portion of Lykos’ application wouldn’t fall under the agency’s purview. State medical boards and, in case of misconduct, the courts, would need to play a role. “The FDA can’t regulate everything,” said Dr. Tiffany Farchione, director of the FDA’s psychiatry division. Lykos responds: In a statement after the advisory committee votes, Lykos CEO Amy Emerson said the firm was disappointed but "committed to continuing to collaborate with the FDA with their ongoing review." She added that Lykos would work with the FDA to answer questions raised at the committee meeting. Lykos, she said, was in ongoing discussions with the FDA about a risk evaluation and mitigation strategy program that would seek to reduce the chance of adverse events stemming from its treatment. WELCOME TO WEDNESDAY PULSE. The Congressional Sneaker Caucus is hosting a “sneaker day” on the Hill next week. We’re glad Congress is focusing on the important things. Reach us and send us your tips, news and scoops at bleonard@politico.com or ccirruzzo@politico.com. Follow along @_BenLeonard_ and @ChelseaCirruzzo.   A message from the American Health Care Association: America’s seniors need our help – now. The Administration’s federal staffing mandate will force more nursing homes to close and displace hundreds of thousands of residents. Nursing homes need targeted investments, not blanket mandates. Learn more about our workforce solutions.   In Congress VA Secretary Denis McDonough requested a watchdog review of the agency after large monetary incentives were distributed to some senior officials. | Anna Moneymaker/Getty Images HOUSE HITS VA OVER BONUSES — The Department of Veterans Affairs doled out hefty bonuses to top officials — a practice that leading Democrats and Republicans criticized in a hearing Tuesday. The context: The VA Inspector General found that the agency gave $10.8 million in incentives ranging from nearly $39,000 to more than $100,000 to 182 senior officials last year, with “only the most cursory justification.” Those incentives were intended to help retain staff and came under new authority from the PACT Act, which also expanded benefits for servicemembers exposed to toxins. The VA admitted it made a “policy error,” prompting VA Secretary Denis McDonough to ask the watchdog for a review. McDonough had delegated approval of the incentives to undersecretaries. The watchdog said the “blanket” incentives were “inconsistent with law and policy.” Congress’ take: House Veterans’ Affairs Chair Mike Bost (R-Ill.) called the behavior “criminal.” The watchdog referred the facts to the U.S. Attorney’s Office for the District of Columbia, which declined to open an investigation. Ranking member Mark Takano (D-Calif.) said he’s concerned about the VA’s “missteps,” but he’s “grateful” McDonough reported the issue. The VA’s stance: McDonough said that 99.7 percent of incentive payments have gone to non-executives, and the VA canceled payments to senior executives “as soon as we identified this error.” “This was a series of massive mistakes,” McDonough said Tuesday. HOUSE CONTRACEPTION VOTE BID — House Democrats are trying to force a vote in the Republican-led chamber on contraception as the Senate is set to vote on the legislation Wednesday. Minority Whip Katherine Clark (D-Mass.) and Rep. Kathy Manning (D-N.C.) introduced a discharge petition Tuesday on the Right to Contraception Act, which has more than 200 Democratic sponsors. The procedural move to force a floor vote would need some House GOP support to succeed, but no Republicans have signed onto the bill, which would protect contraception access and bar the federal government and states from restricting it. It’s unclear whether the effort in either chamber will be successful, but it’s the latest example of Democrats attempting to bring reproductive rights to the forefront in an election year. A previous version of the bill passed the House in 2022 with some Republican support.   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.     HEALTH TECH WHO’S AUDITING THE AI AUDITOR? Electronic health care records giant Epic recently said it’s launching an artificial intelligence “trust and assurance suite” to help health care organizations test their AI tools. The software analyzes the tools by demographics, including race and sex, and automates data collection and mapping, allowing health care organizations to avoid some of the most burdensome steps in validating AI. The move comes as lawmakers and federal agencies eye regulating AI and hope to make the most of the technology while mitigating its risks. Epic’s open-source software is another attempt by the private sector to ensure AI works as intended, following the Coalition for Health AI’s public-private partnership involving AI assurance labs, which validate and monitor AI. A key question for such efforts is how to ensure the testing is effective. Seth Hain, senior vice president of R&D at Epic, told Pulse that the company has processes to validate the toolset, but the suite is intended to augment health systems’ existing governance. Open-sourcing the software is important in helping lower-resourced organizations implement AI tools safely, Hain said, but it’s “not sufficient.” He said the company is working with a number of groups to help “open the door.” “It’s incumbent on the large health systems to lead the way,” Cherodeep Goswami, chief information and digital officer at the University of Wisconsin Health System, told Pulse.   A message from the American Health Care Association:   Medicare MEDICARE SOLVENCY ON THE MIND — A growing share of American adults is concerned about the future of Medicare, according to a poll released today from Gallup. The share of overall adults “worried” or “extremely worried” about being able to get Medicare benefits when they become eligible grew six percentage points between 2022 and 2024, well outside the margin of sampling error at 1.7 percent. The growth in fear was particularly pronounced among Americans ages 40 to 49, with 83 percent saying they’re “extremely worried” or “worried” this year about not being able to receive the benefits. The bigger picture: The growing anxiety ahead of the November elections is more pronounced among groups that are more likely to show up at the ballot box, as older voters proportionately have made up a larger share of the electorate. President Joe Biden has portrayed former President Donald Trump as a threat to Medicare and the Affordable Care Act and has pledged to safeguard both. Trump floated cuts to entitlements in an interview earlier this year—comments that the Biden campaign has seized on — but has also pledged to never do anything that would put Medicare at risk.   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.     AROUND THE AGENCIES HHS NOT FOLLOWING RECOMMENDATIONS — The Government Accountability Office said HHS has implemented just seven of 45 recommendations it noted as priorities for the agency last May. In a letter released Tuesday, the GAO said HHS acted on recommendations to better prepare for emergencies and minimize dependence on foreign manufacturers for medical supplies, among others. But the watchdog said HHS still has a lot of work to do, including: — Improving the accuracy of adjustment for Medicare Advantage payments — Creating a way to manage risks surrounding the Strategic National Stockpile to bolster preparedness around public health emergencies — Changing its policies to better coordinate with other agencies on cybersecurity HHS’ take: In a statement, HHS said the agency is becoming “more efficient and effective” and is “continually exploring new opportunities to accomplish our mission.” It said it will work with the GAO to implement more recommendations. As of late last year, the agency had implemented 68 percent of overall recommendations, including those that the GAO hasn't deemed priorities. Names in the News Rebecca Buck is joining the Better Medicare Alliance as senior VP of communications. She previously was senior director at the Penta Group. Former Sen. Mel Martinez (R-Fla.) has been appointed to the board of Dwyer Workforce Development. Type 1 diabetes advocacy group JDRF is rebranding as Breakthrough T1D. The move is aimed at better conveying the group’s ability to work for “the entire type 1 diabetes community,” as the disease used to be known as “juvenile diabetes.” WHAT WE'RE READING Chelsea has three takeaways from the Energy and Commerce Committee’s 340B subcommittee hearing. STAT reports on a device maker sending patients with chronic pain unwanted supplies and surprise bills.   A message from the American Health Care Association: America’s seniors need our help – now. The Administration’s federal staffing mandate will worsen the ongoing labor crisis in nursing homes, forcing more facilities to downsize or close. Hundreds of thousands of residents will be displaced – and seniors’ access to care restricted – if lawmakers fail to act. An unfunded mandate won’t create more caregivers. Congress: Protect seniors’ access to care – before it’s too late. Learn more about the issue.     Follow us on Twitter Dan Goldberg @dancgoldberg Chelsea Cirruzzo @chelseacirruzzo Lauren Gardner @Gardner_LM Sophie Gardner @sophie_gardnerj Kelly Hooper @kelhoops Robert King @rking_19 Ben Leonard @_BenLeonard_ David Lim @davidalim Megan Messerly @meganmesserly Alice Miranda Ollstein @aliceollstein Carmen Paun @carmenpaun Daniel Payne @_daniel_payne Ruth Reader @RuthReader Erin Schumaker @erinlschumaker Megan R. Wilson @misswilson   Follow us

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