‘Real challenges’: Bird flu questions linger

Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

Jul 30, 2024 View in browser   By Lauren Gardner and David Lim Driving The Day There's been a recent uptick of bird flu in Colorado poultry farms. | Paco Serinelli/AFP via Getty Images BIRD FLU CHECK-IN — More cows and humans continue to test positive for avian influenza, but the CDC maintains that the risk to the public remains low. We checked in with several infectious disease experts to learn more about what the recent outbreak at poultry farms in Colorado means for the U.S. response to the virus. There have been several infections at two poultry farms in Colorado. What should the public take away from these cases?  Jennifer Nuzzo, a professor of epidemiology and director of the Pandemic Center at Brown University School of Public Health: “The number of cases that we’re seeing in Colorado, and the involvement of a large number of people with symptoms at the same time at multiple farms, screams at us that this virus is not going away — that this is becoming a recurring hazard for farmworkers.” Dr. Michael Mina, chief science officer at digital health company eMed: “What is hard for the public generally to understand is that’s the current situation right now. The risk is low to the public, but it doesn’t mean that there is a low risk of some spread in the future.” Michael Osterholm, director of the University of Minnesota Center for Infectious Disease Research and Policy: “One of the real challenges we have today with this issue is it has to be nuanced … no one really knows what the likelihood will be of H5N1 becoming a flu virus transmitted to people by people.” HHS recently made it easier for the FDA to authorize avian flu vaccines. If and when do you think they should be rolled out to those with high exposure to the virus? Nuzzo: “It should be rolled out before we have any indication of severe illness.” Mina: “Administering them right now … is a little bit putting the cart before the horse, relative to some other mitigation strategies we can take. The most important thing is to really improve our surveillance.” Osterholm: “If you’re going to vaccinate people to keep them from being infected, our current flu vaccine technology doesn’t permit that. If you’re going to try to keep them from having serious illness, we haven’t seen any serious illness yet in any of these individuals. And so I think the challenge is, what are we trying to do with these vaccines?”  Do you think that we have a better understanding of the spread of the virus than we did in recent months? What do we still not understand?  Nuzzo: “How is this moving between farms? We have a vague sense of the type of practices that may contribute, but they haven’t done definitive studies that show, yes, this is how it’s spreading. This is really important.” Dr. Marcus Plescia, chief medical officer for the Association of State and Territorial Health Officials: “The one thing that I do think that is clearly coming away from this is that it’s increasingly appearing that the disease, or the infection, is not as virulent as some of the H5N1 human infections we’ve seen in the past. The mortality rate used to be very, very high.” Mina: “We have a better understanding of the spread of the virus only insofar as we know that it’s very, very widespread.” Osterholm: “I don’t think we do. We have more questions now than ever.” IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Watch out, parents: Hand, foot and mouth disease is, well, afoot in the Washington area. Send news and tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).   Live briefings, policy trackers, and procedural, industry, and people intelligence from POLITICO Pro Analysis gives you the insights you need to focus your policy strategy this election cycle. Secure your seat.      Industry Intel Researchers say they've developed a blood test that can diagnose Alzheimer's disease. | Guillaume Souvant/AFP via Getty Images ALZHEIMER’S DEVELOPMENTS — A new study published in JAMA shows that a blood test had about a 90 percent diagnostic accuracy rate in detecting Alzheimer’s disease compared with in-office cognitive tests, a finding that could pave the way for earlier diagnosis, especially by primary care physicians. The newest drug regimens for Alzheimer’s — monoclonal antibodies administered at infusion centers — are intended for patients in the disease’s early course to potentially slow its progression. But the condition can be difficult to diagnose as other neurological and cognitive impairments must be ruled out. Dr. Howard Fillit, chief science officer at the Alzheimer's Drug Discovery Foundation, who wasn’t involved in the study led by Swedish researchers, called the test a “revolutionary breakthrough” that could enable early diagnosis and an easier path for patients to secure reimbursement from Medicare. “Five or 10 years ago, we never would have thought that would happen,” he told Prescription Pulse. Yes but: A key drug committee at the European Medicines Agency on Friday recommended against approving Leqembi, the amyloid antibody by Biogen and Eisai that the FDA approved last year. The panel determined the drug’s risks, which include brain bleeding and swelling, outweighed any benefits. Eisai seeks a reexamination of the opinion before the EMA makes a final decision. The EU body is also considering whether to approve Eli Lilly’s Alzheimer’s antibody, sold in the U.S. as Kisunla. Fillit suggested that treatment innovations toward under-the-skin administration instead of infusions could change the cost-benefit calculus for European regulators. Eye on the FDA BARTH SYNDROME DRUG — The FDA plans to hold an advisory committee meeting this fall to review Stealth BioTherapeutics’ application to make the first therapy for Barth syndrome, the company said Monday. Barth syndrome is an ultra-rare and progressive cardioskeletal disease that primarily affects males. The mortality rate is high for children, and those who live past age 4 typically face a life expectancy into their 40s. The FDA granted priority review for the new drug application for elamipretide, which aims to improve heart and muscle functions and increase exercise tolerance. The FDA is scheduled to decide on the therapy by Jan. 29. ANOTHER THERAPY ON DECK — The agency’s Genetic Metabolic Diseases Advisory Committee will meet Friday to consider Zevra Therapeutics’ investigational drug arimoclomol to help slow the progression of Niemann-Pick disease type C. The rare disorder is marked by the body’s inability to break down and move fats like cholesterol and lipids inside of cells, spurring abnormal accumulations of the substances within tissues. The disease’s presentation can vary depending on the age of onset but is one of many conditions that can cause childhood dementia. NEW COLORECTAL CANCER TEST — The FDA approved a blood test that can screen for colorectal cancer in adults ages 45 and older at average risk for the disease, manufacturer Guardant Health said Monday. A study published in The New England Journal of Medicine showed the test had an 83 percent sensitivity to detect colorectal cancer, with a 90 percent specificity for advanced neoplasia, or abnormal tissue masses. The approval follows a 7-2 FDA advisory committee vote that the test's benefits outweigh its risks. The blood test is the first to receive a primary screening indication from the FDA. Pharma in the States ALABAMA SCREENING INITIATIVE — The Alabama Department of Public Health began screening newborns Monday for two rare but treatable genetic disorders. The blood panel for newborns will now also cover two enzyme deficiencies — mucopolysaccharidosis type I and Pompe disease, which can be fatal without prompt diagnosis and treatment. Alabama joins a growing number of states — now 36, plus Washington — adding the conditions to their testing regimens for newborns. HHS updated the recommended uniform screening panel, the national guideline for newborn screening, in 2015 and 2016 to add Pompe disease and MPS I, respectively.   SUBSCRIBE TO GLOBAL PLAYBOOK: Don’t miss out on POLITICO’s Global Playbook, our newsletter taking you inside pivotal discussions at the most influential gatherings in the world. Suzanne Lynch delivers the world's elite and influential moments directly to you. Stay in the global loop. SUBSCRI     WHAT WE'RE READING The federal government is funding a vast surveillance network to search for the next dangerous designer drug before it kills anyone, POLITICO’s Gregory Svirnovskiy reports. Document Drawer The FDA updated discontinuation and relisting features in its electronic portal for registration and listing of cosmetic products and facilities. The FDA renewed the charter for its Pharmacy Compounding Advisory Committee for an additional two years.   Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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