Swapping risky research for AI

The ideas and innovators shaping health care

Dec 05, 2024 View in browser   By Carmen Paun, Ruth Reader and Erin Schumaker PANDEMIC Sen. Rand Paul (R-Ky.) wants to use his Homeland Security Committee leadership role to investigate Covid-19's origins. | Francis Chung/POLITICO The federal government should encourage scientists to study dangerous pathogens by using artificial intelligence and machine learning instead of enhancing them. That’s one of the recommendations from the final GOP report of the House Select Subcommittee on the Coronavirus Pandemic, which the panel endorsed by voice vote Wednesday. Live viral research should be allowed only when needed, the report says. It’s an idea that panel chair Brad Wenstrup (R-Ohio) discussed with Carmen earlier this year. The final committee report endorses Wenstrup and other Republican subcommittee members’ view that a leak at a Chinese lab conducting gain-of-function research — which deliberately enhances pathogens, making them more deadly or transmissible to aid in developing vaccines or drugs to fight them — caused the Covid-19 pandemic. Scientists haven’t yet found any conclusive evidence supporting either a lab leak or an infected animal-to-human transmission. Other report recommendations include pausing gain-of-function research until it can be regulated to increase safety and reduce accident risk. NIH reform: The recommendations also target the National Institutes of Health, which has been on Republicans’ hit list since the pandemic’s early days. The agency could see significant restructuring once the GOP governing trifecta starts in January. The subcommittee says the NIH should be reformed “to provide for great accountability and transparency,” and the federal government should consider splitting the National Institute of Allergy and Infectious Diseases, which Dr. Anthony Fauci led for decades, in two. The government should also consider term limits for NIH institutes and center directors, the report says. It also suggested overhauling the federal grant peer-review process, which was scrutinized for funding coronavirus research at the Wuhan, China-based lab at the center of the lab-leak theory. The grant process must be more accountable, secure and transparent, the report says. Why it matters: The GOP subcommittee report provides fodder for the incoming Congress and Trump administration to further investigate the pandemic’s origins and the Biden administration’s pandemic response. Sen. Rand Paul (R-Ky.) has already announced plans to prioritize uncovering Covid’s origin once he leads the Homeland Security Committee in January. Paul previously secured Democratic support for his bill to establish a new panel to be appointed by the president that would oversee gain-of-function research. In September, the Homeland Security and Governmental Affairs Committee approved the panel’s creation. What’s next: Paul will likely push his bill again next year when its chances of consideration by the full Senate increase under GOP control. WELCOME TO FUTURE PULSE Easton, N.Y. | Richard Schumaker This is where we explore the ideas and innovators shaping health care. A new AI tool from Google DeepMind outperformed the best 15-day weather predictions, The New York Times reports. 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.   REGISTER NOW: As the 118th Congress ends, major decisions loom, including healthcare appropriations. Key focus: site neutrality. Can aligning hospital and clinic costs cut federal spending, reflect physician costs, and lower patient expenses? Join policymakers and providers to discuss.     POLICY PUZZLE Whether insurers cover treatment for rare childhood diseases may depend on where you live. | AP Many insurers don’t cover an experimental treatment for a rare childhood disease known as PANS — unless state legislatures force them to. The antibody treatment, known as intravenous immune globulin, or IVIG, has shown promise in early studies for treating pediatric acute-onset neuropsychiatric syndrome, a condition where the immune system attacks a child's brain. But with monthly costs running up to $20,000 and insurers labeling IVIG experimental, families and doctors are increasingly turning to state legislators to mandate coverage — highlighting the growing tension between emerging treatments for rare diseases and insurance companies’ evidence requirements. Twelve states have put laws on the books mandating coverage for PANS since 2017. More could be coming. One family’s battle: Eight months ago, doctors prescribed IVIG to Logan Coulter’s 13-year-old daughter, who has PANS. The disease can cause children to develop tics, obsessive-compulsive disorder, anxiety and other symptoms that mimic a mental health issue. In the case of Coulter’s daughter, she enters a distressed state and rocks or moans for hours. The family’s insurance company, Cigna, repeatedly denied coverage citing IVIG for PANS as an experimental treatment. Coulter lives in Idaho, where the state doesn’t compel insurers to cover rare disease therapies. He’s considered moving 45 minutes away to Oregon, which mandates that insurers cover the treatment. Why it matters: Several ongoing clinical trials aim to demonstrate IVIG’s effectiveness as a treatment for PANS and its related condition, PANDAS, which occurs after a strep infection. Small studies have shown that the therapy can send the condition into remission. The Food and Drug Administration has approved IVIG for several autoimmune disorders but not for PANS. IVIG is expensive, and some patients need infusions for years. Coulter says it costs him $15,000 to $20,000 a month out of pocket. What’s next: Colorado and West Virginia introduced such bills this year, while Michigan and New York legislatures failed to advance their bills. When asked by Ruth whether it would change its policy on PANS therapy, Cigna said it couldn’t comment on individual cases but noted that overturned denials help build precedent for future cases. Hurdle cleared: Cigna eventually reversed its decision and agreed to cover the treatment for Coulter’s daughter, but it’s unclear why Cigna did so. Coulter’s experience received widespread attention after it went viral on LinkedIn. A company that assists with claims called Claimable, offered additional assistance. Cigna said Coulter’s claim was elevated to the highest level, but declined to provide further detail on what led to the change in its decision.   Billions in spending. Critical foreign aid. Immigration reform. The final weeks of 2024 could bring major policy changes. Inside Congress provides daily insights into how Congressional leaders are navigating these high-stakes issues. Subscribe today.     WASHINGTON WATCH A new report recommends creating a new NIH institute focused on women's health research. | Francis Chung/POLITICO The National Academies of Sciences, Engineering, and Medicine has advice for the National Institutes of Health on advancing women's health research — an underfunded and understudied area of study. The NIH-backed report, released today and compiled by the Committee on Assessment of NIH Research on Women’s Health, examined the agency’s funding for women’s health research, program structures, policies and research priorities. "The NIH is underspending on women's health research, which is leading to an underinvestment in filling significant gaps in knowledge about women's health," Alina Salganicoff, committee co-chair and director of the Women’s Health Policy Program at KFF, a health policy think tank, said Thursday. Still, she added: "Increasing funding alone is not enough to make significant progress in women's health, and the current structure of the NIH limits its ability to address the women's health research gap." The report’s recommendations include: — Urge Congress to elevate the Office of Research on Women’s Health to an NIH institute, with a budget of at least $4 billion over its first five years — Appropriate $11.4 billion in congressional funding over five years for interdisciplinary women’s health research — Encourage the NIH director and institute and center directors to prioritize women’s health research and set annual benchmarks for its funding. — Develop a more transparent and data-driven process for setting women’s health research priorities — Promote female investigators and develop new grant programs for projects related to women’s health — Prioritize basic research, including animal studies, as well as clinical population-level research aimed at understanding female-specific health conditions Why it matters: Women have long been underrepresented in all forms of biomedical research, from basic research to population-level studies. Even lab rats are overwhelmingly male. That means many drugs and treatments aren’t developed with women in mind, and some are less effective and safe for women. Women are also more likely to be misdiagnosed or go undiagnosed. Yes, but: It’s unclear whether women’s health is among Republicans’ top health priorities in the next Congress. Instead, Dr. Jay Bhattacharya, President-elect Donald Trump’s pick to lead the NIH; Robert F. Kennedy Jr., Trump’s HHS secretary choice for nominee; and Republicans in House and Senate health leadership positions have indicated they’re keen to reform the NIH. Notably, the House NIH reform proposal seeks to shrink the agency, not add institutes. The proposal, which Rep. Robert Aderholt (R-Ala.), an appropriator who oversees the agency’s funding, is shepherding, suggests consolidating the NIH’s 27 institutes and centers into 15.   Follow us on Twitter Carmen Paun @carmenpaun Daniel Payne @_daniel_payne Ruth Reader @RuthReader Erin Schumaker @erinlschumaker   Follow us

To change your alert settings, please log in at https://login.politico.com/?redirect=https%3A%2F%2Fwww.politico.com/settings This email was sent to edwardlorilla1986.paxforex@blogger.com by: POLITICO, LLC 1000 Wilson Blvd. Arlington, VA, 22209, USA Unsubscribe | Privacy Policy | Terms of Service