CDC’s Daskalakis talks bird flu

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Oct 18, 2024 View in browser   By Lauren Gardner and David Lim Presented by  Driving The Day Top CDC official Dr. Demetre Daskalakis says the strategy of using symptoms to guide testing for bird flu is the right strategy. | Kevin Dietsch/Getty Images CHECKING IN ON AVIAN FLU — With the number of confirmed human bird flu infections in California climbing to 11 since the start of the month, we spoke with Dr. Demetre Daskalakis, the director of the CDC’s National Center for Immunization and Respiratory Diseases, about the agency’s avian flu response. This interview has been edited for length and clarity. California officials told us 25 individuals were tested for avian flu between March and Oct. 14 — is a broader testing effort needed to understand how the virus is spreading?  The strategy of using symptoms to guide testing, I think, is still the right strategy. You’re seeing really good public health doing the work on the ground, identifying people with respiratory or eye symptoms, and then moving them quickly to testing. The right strategy, I think, is to make sure that we're monitoring individuals with known exposures. Of course, that’s also supplemented by over 50,000 tests that are happening in basic flu surveillance across the country not at all focused on exposure. We obviously would love to continue doing more serologic work. So I think Missouri is one example, but we have other serological studies that are happening to really help further inform strategy. The CDC disclosed you anticipate the results are coming mid-month to the end of this month. Is that timeline still accurate?  That’s exactly what we’re anticipating; I think we’re on target. I would expect that, as billed, mid-late month or late month we should have the science to be able to communicate results. In California, 105 herds have tested positive for avian flu, and the state public health department anticipates additional human infections will be detected moving forward. Does the CDC agree with that assessment?  We do agree. The number of herds are increasing at a very high rate in California. Based on what we’re seeing in this new era of H5N1 and this specific exposure, I think it’s fair to say more herds, more monitoring, more testing means we’re probably going to detect more infections. As we’ve been saying for a while across public health and elsewhere in CDC, though the risk to the general population is low — definitely there seems to be a connection to occupational ... or other exposures to infected animals. The work that California has done and their engagement with farmworkers ... if folks are more comfortable coming forward with like pink eye, and that triggers testing, I think that’s how we’re going to detect more of these infections. That gives us the opportunity to offer people Tamiflu for treatment and provide the appropriate advice and strategies to keep themselves and their loved ones safe. IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Welcome back to Mr. Autumn Man season. Send tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM). A message from Alliance for Pharmacy Compounding: FDA says the tirzepatide shortage is over. We beg to differ. Hear from four pharmacists about how FDA’s abrupt action is causing chaos — and driving some patients to dangerous alternatives. What you need to know.   BIRD FLU The CDC is focused on protecting farmworkers from becoming infected with avian flu while awaiting the development of a vaccine. | Cole Burston/Getty Images WAITING ON CLINICAL TRIALS — Interim results from vaccine maker CSL Seqirus’ Phase II clinical trial of its avian flu vaccine candidate are expected by year-end — but Daskalakis said that while the data will be welcome, it won’t change the CDC’s stance on the potential targeted deployment of the immunization. The agency continuously weighs multiple factors, he noted, such as whether there is even limited evidence of human-to-human spread or an increase in the infection’s severity. “At this time, based on what we’re seeing, even with the numbers increasing in California, the solutions to that tend to really be increasing protection for farmworkers, making sure that there’s access to testing, and also, when necessary, deploying Tamiflu,” Daskalakis said. “I’m excited for more data; I hope that data is favorable and that adds another tool in our toolkit in the event that we need to open it.” Eye on the FDA LAUNCHING THE RARE-DISEASE HUB — The Reagan-Udall Foundation for the FDA, a congressionally chartered nonprofit dedicated to supporting the agency’s work, brought together rare-disease advocates and biotech executives this week to talk with FDA officials about the new effort to foster intra-agency communication about drug development. Dr. Carole Ho, chief medical officer at neurological biotech Denali Therapeutics, sat down with Lauren to discuss what’s next for the Rare Disease Innovation Hub and the rare-disease community’s asks. Denali is developing two therapies targeting genetic enzyme deficiencies causing neurodegenerative disorders. What the FDA will do with the hub is still being determined, Ho said. Agency officials heard comments Wednesday from about 20 representatives of companies, patient advocates and researchers, and they’re taking submissions until the end of the month. The FDA plans to craft a proposal once it considers those comments. The directors of the agency’s drugs and biologics centers, Drs. Patrizia Cavazzoni and Peter Marks, have discussed the need to collaborate across divisions on rare-disease applications, Ho said. “You have programs that are being developed that have interventional therapeutics, yet the data is not shared or even sometimes made aware across two divisions of the FDA that geographically are next to each other, but because of the infrastructure and the process, they don’t necessarily see each other’s data,” she said. Like many rare disease-focused companies, Denali has urged the agency to accept clinical trials based on a biomarker — in this case, how its Sanfilippo syndrome drug candidate reduces the accumulation of large sugar molecules that causes the disorder — for its accelerated approval pathway. But Denali and its competitors in the enzyme-deficiency space faced some pushback from the FDA over whether evidence suggests clinical benefit before the FDA Foundation brought regulators and companies together in February to discuss the issue , Ho said. Some firms are moving forward with accelerated approval bids. “What we need to see is really this balance of what is possible in a rare disease … with scientific rigor,” Ho said.   A message from Alliance for Pharmacy Compounding:   Tobacco YOUTH TOBACCO USE HITS 25-YEAR LOW — Middle and high schoolers across the U.S. use fewer tobacco products than in recent years, driven by drops in e-cigarette and hookah use. In 2024, 2.25 million students reported using any tobacco product, a drop compared with the 2.8 million that reported using them in 2023. Only 1.4 percent of students reported smoking cigarettes in 2024. “We’re headed in the right direction when it comes to reducing tobacco product use among our nation’s youth,” said Brian King, director of the FDA’s Center for Tobacco Products. “But we can’t take our foot off the gas. Continued vigilance is needed to continue to reduce all forms of tobacco product use among youth.” Nancy Brown, CEO of the American Heart Association, described the data as a highly encouraging trend but cautioned more needs to be done. “We continue to urge the White House to finalize strong rules that will end the sale of menthol cigarettes and all flavored cigars,” Brown said. “We also implore the FDA to complete its review of all premarket tobacco applications and remove all unauthorized tobacco products from the market. On Capitol Hill, Reps. Debbie Wasserman Schultz (D-Fla.) and Diana DeGette (D-Colo.) led a group of 65 lawmakers calling on the FDA in a Thursday letter to complete its review of outstanding premarket tobacco product applications for e-cigarette products and accelerate enforcement against illegal flavored e-cigarettes on the market. Document Drawer The FDA published final guidance for generic drugmakers who wish to request reconsideration of an abbreviated new drug application review. The FDA published final guidance for drugmakers outlining recommendations on how to collect a set of patient-reported clinical outcomes in cancer clinical trials. A message from Alliance for Pharmacy Compounding: FDA says the tirzepatide shortage is over. But it’s not over. Since FDA declared an end to the shortage on October 2, pharmacies have had no or severely limited access to Mounjaro® and Zepbound®, the FDA-approved versions, from their drug wholesalers. A drug that is not accessible to pharmacists and patients is not available. Hear compounding pharmacists talk about the uncertainty FDA’s abrupt resolution of the shortage is creating for their patients — and how the continued unavailability of the FDA-approved version is putting those patients at risk. What you need to know.   WHAT WE'RE READING Sage Therapeutics is laying off about a third of its workforce, BioPharma Dive’s Delilah Alvarado reports. Los Angeles Times' Jenny Gold explores the explosion in toddlers’ consumption of food pouches and what the potential health implications may be in the future.   Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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