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| Presented By PhRMA |
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| Axios Vitals |
| By Tina Reed · Dec 02, 2022 |
| Happy Friday, Vitals readers. ⚽ 1 World Cup thing: HHS is partnering with the U.S. national men's soccer team to promote vaccinations, Axios' Oriana Gonzalez writes. Today's newsletter is 1,253 words or a 5-minute read. |
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| 1 big thing: FDA moves to ease blood donor restrictions amid national shortage |
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| Illustration: Allie Carl/Axios |
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| The Food and Drug Administration is weighing a series of moves to make it easier for gay and bisexual men and other individuals to donate blood amid a nationwide blood shortage, Axios' Oriana Gonzalez writes. Driving the news: At issue are blood donor screening restrictions for men who have sex with men that originated during the HIV/AIDS crisis in the 1980s. - An option under discussion is moving from a three-month deferral period to individual risk assessments based on questionnaires about recent sexual activity, the agency confirmed to Axios.
- Approximately 25% of community blood centers across the U.S. have a one-day supply or less as of Thursday afternoon, according to the America's Blood Centers' daily tracker.
- If the FDA lifts the three-month deferral period, the annual blood supply would increase by 2% to 4% annually, according to the Williams Institute, a research center at the UCLA School of Law.
Zoom out: The FDA has lifted blood donor restrictions in other situations while other federal health services have more broadly reevaluated medically disqualifying conditions, including HIV. - The FDA recently removed restrictions for people who lived in European countries that had had outbreaks of Mad Cow Disease, a brain disorder, for fear of transmission.
- The U.S. Public Health Service on Thursday said it is changing its medical standards to accept future applicants living with chronic hepatitis B and HIV, citing treatments that have made both manageable chronic conditions.
What we know: An FDA spokesperson told Axios that the potential new screening policy "will be gender neutral and science-based." - "The FDA remains committed to evaluating alternatives to the time-based deferral policy by helping to facilitate the generation of the scientific evidence that might support an individual risk assessment-based blood donor questionnaire," the agency said in an emailed statement.
What's next: The agency said it expects to issue updated draft guidance "in the coming months," once it finishes its study review. Read the rest. |
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| 2. Bill could increase addiction treatment access |
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| Illustration: Shoshana Gordon/Axios |
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| A bipartisan bill to increase access to treatment for opioid addiction has a good chance of being rolled into a year-end package during the lame-duck session, congressional aides tell Axios' Peter Sullivan. Why it matters: Advocates point to federal data showing only one in 10 people with opioid use disorder receive medication for it. How it works: The bill would remove a requirement that health care providers get a special waiver from the Drug Enforcement Administration before they can prescribe buprenorphine, an addiction treatment that reduces the risk of future overdoses. The path forward: Backers say they have not encountered a large amount of opposition, but there is still a lot of uncertainty around how big the end-of-year package will be and what will make it in. - There is at least some opposition from certain House Republicans, including members who are doctors, like Indiana Rep. Larry Bucshon. Bucshon said earlier this year that the bill is "making it easier to prescribe a medication known to be highly diverted and misused."
- At least at the moment, though, backers do not think the opposition will be enough to stop it from making it into the bill.
This story was published first on Axios Pro. Get breaking news like this by subscribing. Use code POLICYLAUNCH to get $200 off. |
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| 3. How the pandemic aged teen brains |
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| Illustration: Allie Carl/Axios |
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| The stress of living through the pandemic physically changed adolescents' brains and prematurely aged them by at least three or four years, according to a Stanford University study, Axios' Sabrina Moreno writes. Why it matters: While the behavioral effects of the pandemic are well-documented, data on youths' neurological development has been scarce. What they found: In a comparison of 163 teenage MRI scans, half of which were taken before the pandemic and half after, the "after" group displayed accelerated signs of aging commonly seen in children experiencing violence and neglect. - A 16-year-old girl's brain might be the equivalent of a 19 or 20-year-old's before COVID, with an enlarged hippocampus — deemed the center of memory and learning — and amygdala, which processes emotions.
Be smart: Accelerated aging of the brain itself is not necessarily a bad thing, said Ian Gotlib, the study's lead author and a psychology professor at Stanford. - "These are 16-, 18-year-olds. They're not atrophying in the alarmist sense," Gotlib told Axios. "For me, the cause for concern is their higher rates of depression and anxiety and sadness … it makes it even more important that we address that."
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| A message from PhRMA |
| Data shows insurers and their PBMs shift costs to patients |
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| Costly OOP expenses tied to deductible and coinsurance requirements are a leading concern for patients with commercial insurance. These harmful practices put in place by insurers and pharmacy benefit managers (PBMs) are even causing patients to abandon their medicines. Learn more. |
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| 4. Stanford president faces research probe |
| Stanford University president Marc Tessier-Lavigne is under investigation by the university and a prominent scientific journal after questions were raised about altered research photos in studies he co-authored. Why it matters: In addition to leading one of the top universities in the world, Tessier-Lavigne is known for his work on proteins that govern the growth of key nerve fibers in the developing spinal cord, Science writes. Driving the news: The student newspaper The Stanford Daily reported earlier this week that a prominent research journal was investigating a paper co-authored by Tessier-Lavigne. - It also reported that a science misconduct investigator, Elisabeth Bik, identified "serious problems" in three other studies the president was an author on.
- "I would testify in court that's been digitally altered," Bik told STAT about a paper published in Cell that she flagged, which has been cited in other research more than 850 times. "This actually changes everything. … It's a more severe level of digital altering."
The other side: In an emailed statement to Axios, officials said "the university will assess the allegations presented in the media." - "Scientific integrity is of the utmost importance both to the university and to me personally. I support this process and will fully cooperate with it," Tessier-Lavigne said in the emailed statement.
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| 5. Nursing home oversight falls short nationwide |
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| Illustration: Gabriella Turrisi/Axios |
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| Nursing homes across the U.S. are chronically short-staffed beyond legal limits, but rarely penalized for it, a USA Today investigation found. By the numbers: For example, more than three-quarters — or nearly 12,000 nursing homes — had fewer nurses and aides in 2021 than expected under Medicare's payment formula, per USA Today. - But fewer than 600 were cited by regulators for it.
What they're saying: "What you're looking at is the bare minimum," Charlene Harrington, a researcher on staffing levels and nursing home quality, told USA Today, saying the true problem was likely worse than the investigation showed. What they're saying: "CMS has taken significant actions to ensure nursing homes provide required staffing, and we will move forward with stronger requirements in the near future," said CMS Administrator Chiquita Brooks-LaSure in an emailed statement. "Further we have made increased funding for nursing home survey and enforcement a top budget priority, which we are very hopeful Congress will act on." The big picture: As we've recently reported, elder care in the U.S. is facing a major crisis as the number of caregivers falls far short of demand among aging baby boomers. What to watch: The Biden administration has said it plans to push staffing minimums for nursing homes. But the industry has pushed back, saying this would drive up costs and worsen shortages. |
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| 6. Dog of the week |
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| Lexi. Photo: Lauren Bauer |
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| Meet Lexi, a five-year-old hound-border collie-German shepherd mix rescue who lives with her humans outside of Baltimore. - "Lexi is a truly one-of-a-kind," writes human Lauren Bauer. "She loves to chase squirrels, sunbathe, and especially loves watching TV. "
Do you have a one-of-a-kind pup? Email pics and some details and your furry friend might be featured in a future dog of the week, too. |
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| A message from PhRMA |
| Patients are frustrated |
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| New data from IQVIA reveal patients with deductibles and coinsurance are more likely to abandon their medicines than patients with copays. The reason: Insurers and their PBMs shift the costs of covered medicines onto their patients. That's not fair. Learn more. |
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| 👋 Thanks for reading, and thanks to senior editor Adriel Bettelheim and copy editor Nick Aspinwall for the edits. Did someone forward this email to you? Here's how to sign up. |
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