The Cuban drug that could come to America

The ideas and innovators shaping health care

Jun 10, 2024 View in browser   By Carmen Paun, Daniel Payne, Toni Odejimi, Erin Schumaker and Ruth Reader INNOVATORS In the U.S., 1.6 million people are affected by diabetes foot ulcers. About half of diabetic foot ulcers become infected, and 1 in 5 of those lead to amputation. Filippo Monteforte | AFP via Getty Images Relief for Americans with foot wounds caused by diabetes might come from an unlikely place: Cuba. A U.S. biotech company received Food and Drug Administration approval recently to run a clinical trial in America for Heberprot-P, a drug developed in Cuba nearly two decades ago that helps heal diabetes foot ulcers that could otherwise lead to amputation. Why it matters: About 1 in 3 people with diabetes develop a foot ulcer during their lives, according to an article last year in JAMA. In the U.S., 1.6 million people are affected. About half of diabetic foot ulcers become infected, and 1 in 5 of those lead to amputation. “There’s really nothing in America to treat these diabetic foot ulcers,” said Lee Weingart, a former Ohio county commissioner and current lobbyist who co-founded Discovery Therapeutics Caribe, which will run the clinical trial for the Cuban drug. Heberprot-P reduced amputations by 72 percent in foreign studies, he told an audience at a recent event promoting the island’s biotech at the Cuban embassy in Washington. The drug is available in more than two dozen other countries, but the decades-old U.S. sanctions on Cuba have hindered its path to America. However, former President Barack Obama in 2016 allowed U.S. and Cuban organizations to cooperate on medical projects, which underpins the effort to bring the Cuban drug to the U.S., according to Weingart. What’s next? Weingart hopes to have it on the U.S. market by the end of 2028 after running the clinical trial, which will enroll about 180 people nationwide. The FDA didn’t question any clinical data from seven Cuban clinical trials, so Discovery Therapeutics needs only to prove the drug is safe, he said.   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.     WELCOME TO FUTURE PULSE Zion National Park, Utah | Erin Schumaker This is where we explore the ideas and innovators shaping health care. Researchers in the U.K. are sampling the air for pieces of DNA that show what type of microorganisms live in a certain area. That could help make food cheaper in the future, the BBC 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, Erin Schumaker at eschumaker@politico.com, or Toni Odejimi at aodejimi@politico.com. Send tips securely through SecureDrop, Signal, Telegram or WhatsApp.  FORWARD THINKING Researchers in Italy concluded that AI was very good in classifying unintentional injuries that sent patients to the emergency room. | AP Photo Advanced artificial intelligence could help public health experts collect otherwise hard-to-organize data on patients in emergency rooms across the U.S. to help them detect trends. How so? When ER clinicians take notes on patient visits, many don't use a standardized system to capture that information, making it difficult for public health professionals to make sense of population-level trends or threats. A new analysis published in JAMA Network Open found that a language-focused AI system could make sense of it all. Researchers in Italy used AI to evaluate and classify injuries documented in records at a pediatric ER. They concluded that the system’s performance was “very good” in classifying unintentional injuries that sent patients to the hospital. The classification was performed on nearly 8,200 records. The system classified them almost perfectly compared with manual human classifications, the researchers found. Why it matters: The ability to make sense of emergency room data could speed up recognition of emerging health threats and help policymakers develop preventive measures. Even so: Researchers suggested that their data was based on a single center and that outcomes may differ in another setting.   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.     WORLD VIEW Heat puts older people at risk of heart complications and breathing problems, according to the World Health Organization. Ahmad AL-RUBAYE | AFP via Getty Images Climate change has damaged the health of at-risk groups, such as children, pregnant women and older people, according to the World Health Organization. How so? Hotter weather affects each group differently, but all are vulnerable because they have weaker immune systems. — Older people are at risk of heart complications and breathing problems. — Children face cognitive and learning challenges. — Pregnant women are more likely to give birth to children with birth defects. “While awareness of climate change has increased, actions to safeguard the lives of those at most risk has barely scratched the surface of what’s needed,” Dr. Anshu Banerjee, director of maternal, newborn, child and adolescent health and aging at the WHO, said in a release. He said addressing it was a matter of “climate justice.” Last year was the hottest in more than 170 years, according to the WHO.   Follow us on Twitter Carmen Paun @carmenpaun Daniel Payne @_daniel_payne Ruth Reader @RuthReader Erin Schumaker @erinlschumaker   Follow us

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