| | | | |  | | By Erin Schumaker, Daniel Payne and Ruth Reader | Presented by 340B Health | | | | | | 
The FDA's got a decision to make about a psychedelic therapy. | Sarah Silbiger/Getty Images | A psychedelic drug selected by artificial intelligence for its promise to precisely target mental illness faces a critical test at the Food and Drug Administration. The FDA is expected to decide in the next few weeks whether to approve an application by San Francisco-based Mindstate Design Labs for a clinical trial of the psychedelic drug 5-MeO-MiPT. Why it matters: Approval would mark a win for two hot areas in drug development: psychedelics thought to have promise in treating conditions like depression and post-traumatic stress disorder, and AI, which drugmakers hope will speed products to market. Mindstate Design Labs picked the drug, also known as moxy, using an AI model it built and trained on more than 70,000 “trip reports” of people using psychedelics pulled from drug forums, books, clinical trials, Reddit and the dark web, Mindstate CEO Dillan DiNardo told Erin. Should the FDA sign off, the plan is to conduct a 50-participant Phase I trial at the Centre for Human Drug Research in the Netherlands. Participants will receive moxy and undergo brain imaging to help the researchers better understand how the drug affects brain activity. Future trials would explore combining 5-MeO-MiPT with other drugs that affect brain function. The goal is to create treatments for mental health conditions such as depression, anxiety or PTSD. If it works, the technology could allow Mindstate to pursue more targeted conditions like stuttering. About 1 in 5 adults in the U.S. experience some form of mental illness, according to the National Institute of Mental Health. What's next? If the Mindstate team can show their machine-learning model works to predict the effects of moxy in combination with other drugs, it will open new treatment possibilities. “For the first time then, we have this proven ability to intentionally design states of consciousness,” DiNardo said. “From there, many opportunities open up, in different therapeutic areas, commercial areas, maybe even eventually turning around and using that computational architecture to develop better AI systems.”
| | | | A message from 340B Health: Support the 340B PATIENTS Act The 340B PATIENTS Act eliminates harmful big pharma restrictions on 340B savings that are vital for expanding health care and support for patients and rural communities in need. By restricting 340B pharmacy partnerships, drugmakers have siphoned billions from the health care safety net solely to bolster their profits. The 340B PATIENTS Act stops this damaging behavior. We call on Congress to support this vital legislation. Learn more. | | | | | | | 
Washington, D.C. | Shawn Zeller/POLITICO | This is where we explore the ideas and innovators shaping health care. Pint-sized pineapple: Food company Del Monte has a new 1.5-pound pineapple variety that’s roughly half the size of the traditional fruit. Why size down? In addition to being extremely cute, precious honeyglow pineapples are aimed at people who live alone and don’t want to waste fruit. 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.
| | | | A message from 340B Health:   | | | | | | |  Microsoft's a charter member of a new group promoting responsible AI. | Drew Angerer/Getty Images | Microsoft is joining a host of health providers — including the Cleveland Clinic, Johns Hopkins Medicine, Mass General Brigham and Vanderbilt University Medical Center — to improve artificial intelligence’s safety, efficiency, reliability and trustworthiness. That’s the goal of the new initiative, the Trustworthy & Responsible AI Network, the group is forming. Additionally, OCHIN, a nonprofit that tracks patient outcomes, and TruBridge, a company that helps providers manage revenue cycles, will collaborate. TRAIN plans to: — Offer the ability to register AI uses in clinical care online — Develop tools to measure the effectiveness of AI before and after it’s deployed, with a focus on how it affects patients in different demographic groups — Create a registry for members to share the real-world results of their AI tools, including efficacy and safety data — Share best practices for using AI technology and tracking its performance and reliability Why it matters: TRAIN represents the latest example of health and tech groups sharing their AI knowledge. TRAIN’s approach could offer clues as to how the industry might self-regulate AI in the absence of government rules.
| | | | A message from 340B Health: Support the 340B PATIENTS Act
340B hospitals are the backbone of the nation’s health care safety net, providing essential services to patients with low incomes and those living in rural America. 340B hospitals play a vital role in delivering 77% of Medicaid hospital care, providing 67% of the nation’s unpaid care, and offering comprehensive specialty services that otherwise might not be available. 340B helps lower health care costs and enable doctors, nurses, and pharmacists to provide expanded care for the benefit of their community—all at no cost to the taxpayer.
The 340B PATIENTS Act will end harmful drug company restrictions on 340B savings that are vital for protecting patients and communities. By restricting 340B pharmacy partnerships, big pharma has siphoned billions from the health care safety net solely to bolster its profits. The 340B PATIENTS Act stops this damaging behavior. We call on Congress to support this vital legislation. Learn more. | | | | | | | JOIN US ON 3/21 FOR A TALK ON FINANCIAL LITERACY: Americans from all communities should be able to save, build wealth, and escape generational poverty, but doing so requires financial literacy. How can government and industry ensure access to digital financial tools to help all Americans achieve this? Join POLITICO on March 21 as we explore how Congress, regulators, financial institutions and nonprofits are working to improve financial literacy education for all. REGISTER HERE. | | | | | | | | |  Europe has an AI treaty ready to go, but its scope is limited. | AP | The Council of Europe reached a deal last week to pursue a treaty requiring AI developers and those deploying the technology to respect human dignity, privacy, the rule of law and democracy. But the agreement won’t apply to private companies unless they’re working directly with governments, our European colleagues report. The backstory: The private-sector exemption was a price the United States exacted in exchange for its consideration. The 46 member nations that negotiated the deal hope the U.S., an observer at the council, will sign on to the treaty because of America’s importance in the development of artificial intelligence. As a result, the treaty will apply only to “public authorities or private actors acting on their behalf,” according to two people who participated in the negotiations and were granted anonymity to discuss confidential talks. While there is no binding rule for private actors, governments must still “address” potential risks arising from companies’ AI use and submit a declaration to the Council of Europe specifying how they intend to abide by this requirement. The treaty has other big exemptions. It won’t apply to AI systems developed or used for national security or research activities, the two people involved in negotiations told POLITICO. What’s next? Countries must sign the agreement before it becomes binding.
| | | | DON’T MISS AN IMPORTANT TALK ON ACCESS TO AFFORDABLE PRESCRIPTION DRUGS IN CA: Join POLITICO on March 19 to dive into the challenges of affordable prescription drugs accessibility across the state. While Washington continues to debate legislative action, POLITICO will explore the challenges unique to California, along with the potential pitfalls and solutions the CA Legislature must examine to address prescription drug affordability for its constituents. REGISTER HERE. | | | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
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