Friday, October 25, 2024

CDC avian flu blood test leads to more questions

Presented by Express Scripts by Evernorth: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.
Oct 25, 2024 View in browser
 
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By David Lim

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Driving The Day

A dairy worker is pictured walking by cows in a barn.

Public health experts are relieved at no evidence of person-to-person bird flu transmission in Missouri but concerned about increasing infections and the growing threat to farmworkers. | Daniel Acker/Bloomberg via Getty Images | Getty

CDC: NO PERSON-TO-PERSON SPREAD — Public health experts say they would “love” more answers about why a close contact of a Missouri avian flu patient had antibodies against the virus — but they’re relieved that the CDC found no evidence of person-to-person spread of the virus.

The fact that five health care workers exposed to the Missouri patient had no antibodies to bird flu reduces the level of concern, said Jennifer Nuzzo, a professor of epidemiology and director of the Pandemic Center at Brown University School of Public Health.

“I would love to better understand how these two people became infected,” Nuzzo said. “Not knowing that makes it hard for me to say, ‘Well, OK, this is just a freak thing that’ll never happen again.’ We just literally don’t know.”

Dr. Michael Mina, chief science officer at digital health firm eMed, said he wants to know why more individuals in Missouri were not tested with the serology test. He also wanted the CDC to disclose more data on the thresholds for positivity on the antibody tests.

“They could have collected from 1,000 people to do a [serology] survey,” Mina said. “Clearly, the person got infected somewhere.”

Health officials took three weeks to develop reverse genetic viruses that were then used to test blood samples from the Missouri patient, their household contact and five health care workers. Both the Missouri avian flu patient and the household contact had evidence of an immune response to avian flu and an identical symptom onset date.

The CDC said that following the serological tests, the risk of avian flu for the public and people without contact with an infected animal remains low. But those exposed to infected animals have a higher risk of infection.

“These similar immunologic results coupled with the epidemiologic data that these two individuals had identical symptom onset dates support a single common exposure to bird flu rather than person-to-person spread within the household,” the agency said in its report on the Missouri blood testing.

Nuzzo acknowledged that it is unlikely health officials will ever figure out how the two individuals were potentially exposed to bird flu. Both individuals did not have a known exposure to animals.

Government officials cautioned that more human infections could emerge from Washington state — where seven workers at a farm with infected poultry tested presumptively positive for bird flu. Two of those cases have been confirmed by the CDC, which is working to conduct testing on other samples.

“It’s growing at an enormous clip,” Nuzzo said. “This is here to stay, this is going to be a persistent occupational threat to farmworkers and it is going to be an increasing cause of economic losses for the agriculture industry.”

IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Hearing any transition rumors? Please let us know. We’ll keep you out of it.

Send tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).

 

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In 2023, four in five Express Scripts by Evernorth patients spent less than $250 a year out-of-pocket for all their medications. Yes, despite the median annual price of new drugs to market soaring to an average of $300K. That's not a middleman. That's an advocate. Express Scripts is advocating to make medications more affordable. Learn how here.

 
MEDICAL DEVICES

A nurse hooks up an IV to a flu patient at a hospital.

Baxter's North Carolina IV fluid manufacturing plant has restored staffing to pre-hurricane levels. | David Goldman/AP

BAXTER: PRE-HELENE STAFFING LEVELS AT IV PLANT — A key manufacturer of IV fluid solutions said Thursday that staffing levels at a North Carolina manufacturing plant have returned to pre-Hurricane Helene levels.

“We are encouraged to report that, barring any unanticipated developments, Baxter anticipates restarting the highest-throughput IV solutions manufacturing line within the next week,” the company said in a press release.

HHS Secretary Xavier Becerra said the timeline is more rapid than initially expected. But Baxter said a timeline for when the plant will reach full pre-hurricane production levels hasn’t yet been established.

“There’s more to do, including meeting regulatory requirements of the product manufactured on the restarted line, but this is good news for partners and patients,” Becerra said.

In Congress

LAWMAKERS EYE E&C HEALTH SUBCOMMITTEE — Reps. Gus Bilirakis (R-Fla.), Morgan Griffith (R-Va.) and Buddy Carter (R-Ga.) are pressing for the top GOP slot on the House Energy and Commerce Health Subcommittee next Congress, POLITICO’s Ben Leonard reports.

Griffith is the most senior of the three, and Bilirakis has the seniority edge over Carter. Carter, a pharmacist, and Bilirakis back Rep. Brett Guthrie (R-Ky.) to be the chair or ranking member of the full committee. Guthrie currently chairs the Health Subcommittee. Griffith has not endorsed in the race.

Carter and Bilirakis’ support is a potential boost for Guthrie, who is in a tight race with Ohioan Bob Latta to be the top Republican on the powerful panel. Some insiders have said Guthrie has an edge, but both are popular among House Republicans. Rep. Richard Hudson (R-N.C.) is also mulling a run.

Carter told Prescription Pulse in April he would run for the top GOP slot on the subcommittee.

AROUND THE AGENCIES

MENINGOCOCCAL VAX RECOMMENDED — The CDC’s outside advisers unanimously voted, 15-0, to recommend GlaxoSmithKline’s meningococcal vaccine, Bexsero, as a two-dose shot for healthy adolescents and young adults ages 16 to 23 in consultation with a doctor.

They also recommended the product as a three-dose shot for ages 10 or under at increased risk for serogroup B meningococcal disease.

The advisers also approved the recommended child and adolescent immunization schedule for 2025 and the corresponding adult vaccine schedule.

 

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Pharma Moves

Dr. Steven Kozlowski is the new FDA acting chief scientist. He previously was the director of the Office of Product Quality Assessment III within the agency’s Center for Drug Evaluation and Research. Dr. David Strauss, the former acting chief scientist, announced on LinkedIn he is moving to a new role outside the FDA after 14 years at the agency.

Document Drawer

The FDA published final guidance with recommendations for tattoo ink manufacturers and distributors on how to recognize unsanitary conditions where tattoo ink could be contaminated and pose a health risk.

Insurers with Medicare Advantage plans collected billions in risk-adjusted payments for in-home services that lacked follow-up visits, procedures, tests or supplies, the HHS Office of Inspector General found in a report released Thursday.

WHAT WE'RE READING

Top FDA biologics regulator Dr. Peter Marks warned that the cost of expensive gene therapies might not be sustainable for a large number of people, calling for more efficient manufacturing methods to help reduce development costs, Inside Health Policy’s Maaisha Osman reports.

POLITICO’s Brendan Bordelon and Adam Cancryn report on Federal Trade Commission Chair Lina Khan’s support — or lack thereof — from Vice President Kamala Harris and Democrats on the campaign trail.

 

A message from Express Scripts by Evernorth:

Want to know something unhealthy? The median annual price of a new drug reached $300K in 2023. Yes, $300,000. Yet millions of Americans paid less than $250 a year out-of-pocket for all their medications combined. How? Express Scripts by Evernorth. Express Scripts by Evernorth is the primary line of defense for millions of Americans against rising health costs – advocating every day to make their medications more affordable and accessible. And they’re not stopping anytime soon. That’s not a middleman. That’s an advocate.

See how Express Scripts is advocating to make medication more affordable for millions here.

 
 

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