| | | | |  | | By Erin Schumaker, Shawn Zeller, Daniel Payne and Ruth Reader | | | | | 
The VA's Elnahal (right) got a warm reception at a psychedelics conference in New York today. | Erin Schumaker/POLITICO | | | “The more you continue to prove the case on this and the more you help us set up the case for veterans, the easier the VA will be able to take this and run with it.” Dr. Shereef Elnahal, the undersecretary for health at the Department of Veterans Affairs | | Dr. Shereef Elnahal, the undersecretary for health at the Department of Veterans Affairs, found kindred spirits at a conference in New York today put on by the Horizons Center Public Benefit Corp., which promotes psychedelic drugs. How so? The VA announced in January that it would fund research into psychedelics like MDMA, also known as ecstasy, and psilocybin as potential treatments for post-traumatic stress disorder and depression. While outside groups have funded studies at the VA, it's the first time since the 1960s that the agency has put money toward psychedelic research. The agency has about 13 psychedelic studies underway and is looking to expand, Elnahal said Friday. For that work, Elnahal received a standing ovation. "We keep proving the science. We keep surprising the folks who are skeptical," he told the crowd. Why the VA matters: It's the largest health system in the country and serves a population with disproportionately high rates of PTSD. About 5 percent of Americans have PTSD in any given year, according to the Department of Veterans Affairs. Veterans, especially those who have deployed, are more likely than civilians to have PTSD. Both male and female veterans with PTSD are at a higher risk for suicide than veterans without the condition. Current treatments for PTSD, like antidepressants, carry side effects and don't work for everyone. Jeff George, chairman of the board at drugmaker Lykos Therapeutics, whose new drug application for MDMA combined with therapy the Food and Drug Administration is considering, highlighted the importance of agency support in bringing psychedelic medicine to the mainstream during the Horizons conference. In addition to the FDA, "the VA plays a huge role," he said. It's not just veterans, he added, noting that a large proportion of doctors train in the VA system. In a divided Congress, psychedelic research is also a rare bipartisan issue, George and Elnahal pointed out. "There aren't a lot of purple issues that bring together Trumpers and the left-wing like psychedelics," George said. Bipartisan congressional support should motivate the scientific community to conduct rigorous and ethical work, Elnahal said: "As long as we do that, bipartisan support will only get stronger." What's next? The FDA is holding an advisory committee meeting on June 4 to consider Lykos' application. If the FDA approves, the Drug Enforcement Administration would still have to reschedule MDMA before doctors could prescribe it to patients. "The moment FDA approves MDMA — and I don’t have any insight into that," Elnahal said, "We’re going to see demand for this go through the roof, especially among the veteran population."
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New Harbor, Maine | Shawn Zeller/POLITICO | This is where we explore the ideas and innovators shaping health care. Medieval English red squirrels may have spread leprosy to humans, according to research published this month in Current Biology. In England at that time, pet squirrels and squirrel-lined clothing were common. 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 or Erin Schumaker at eschumaker@politico.com. Send tips securely through SecureDrop, Signal, Telegram or WhatsApp.
| | |  Tai wants feedback on how to fix the world's supply chains. | Simon Wohlfahrt/AFP via Getty Images | The world’s biggest drug companies aren’t keen on a Biden administration push to secure global supply chains. How’s that? The leading trade group for drugmakers, the Pharmaceutical Research and Manufacturers of America, blasted U.S. Trade Representative Katherine Tai last month for departing from “longstanding and bipartisan U.S. trade objectives by deprioritizing, and in certain instances proactively opposing, the very trade policies that best promote resilient biopharmaceutical supply chains.” The broadside, which stressed the need for trade agreements the administration has opposed, came in PhRMA comments from Douglas Petersen, the group’s deputy vice president, on Tai’s March request for comment on how to bolster supply chains after the Covid pandemic exposed their frailty. Tai’s take: The March notice, many industry officials believe, signaled hostility to new trade deals and preferences for tariffs or other means of bringing manufacturing back to the United States. It criticized past U.S. trade and investment policy as too focused on short-term cost efficiency and tariff liberalization, our Doug Palmer reported. That, the March notice said, has facilitated a “race to the bottom” and a “hollowing out of the American industrial base” that “leaves critical sectors vulnerable to non-market policies and practices, economic coercion, and other unfair trade practices, and deprives consumers of goods whose production reflects our core values.” Industry pushback: Other industry groups, including the trade group for medical device makers, AdvaMed, and the Trade Alliance for Health, didn’t echo PhRMA’s criticism, but they amplified its message in their comments to the agency. Abby Pratt, AdvaMed senior vice president global strategy and analysis, said, “The U.S. should not miss the opportunity to enforce or expand existing trade agreements.” The trade alliance, which represents both drug and device makers, said it was unrealistic to think policy could make domestic manufacturers self-sufficient. Instead, it advocated “friend-shoring” — ensuring critical supplies come from allied nations. All three groups endorsed legislation by Sen. Tom Carper (D-Del.) and Rep. Michelle Steel (R-Calif.), the Medical Supply Chain Resiliency Act, which promotes new trade agreements. What’s next? The U.S. trade representative’s office held its first hearing last week and plans three more before the end of May. At the first hearing, Tai’s special counsel in charge of supply chain policy, Victor Ban, said the agency was open-minded on the issue. “We want to understand from all of you where the challenges and pain points are and where potential solutions may lie, whether through existing trade tools or potentially new ones,” Ban said.
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Hospitals are integrating AI into patient care at a rapid clip. | The American Hospital Association has some ideas for Congress on how to regulate artificial intelligence in health care. In response to Rep. Ami Bera’s inquiry, the association this week offered an industry perspective on how regulators and lawmakers should tackle the issue. The hospital group told the California Democrat it believes government rules for AI should be: — Flexible, so they can change with technological change — Risk-sensitive, so more scrutiny is given to technologies that pose more risk to people and less to those that pose fewer dangers — Adaptive, so rules are tailored to health care — Familiar, since it’s preferable to regulate using existing systems whenever possible instead of creating new ones “If, or perhaps when, existing frameworks prove inadequate for the continually evolving landscape of AI, then it might be necessary for Congress to amend them or create new ones,” wrote Lisa Kidder Hrobsky, the hospital association’s senior vice president for legislative and political affairs. | | | | Follow us on Twitter | | | | Follow us | | | | |
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