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| Presented By Kaiser Permanente |
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| Axios Vitals |
| By Tina Reed · May 19, 2023 |
| 😎 Happy Friday, Vitals readers. Today's newsletter is 1,246 words or a 4½-minute read. Situational awareness: The Supreme Court ruled against Amgen yesterday in a dispute over its patents for cholesterol drug Repatha. - The case "makes it more difficult for makes it more difficult for pharmaceutical companies to obtain broadly worded patents used to block competitors," the Wall Street Journal reports.
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| 1 big thing: Interest grows in hearing tech after OTC rule change |
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| A pair of behind-the-ear hearing aids. Photo: Shuran Huang for The Washington Post via Getty Images |
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| Consumer electronics giants like Sony, Bose and Jabra have rushed to stake out a piece of the new market for over-the-counter hearing aids, disrupting a $10 billion segment that's been dominated by niche audiology companies. The big picture: An FDA rule finalized seven months ago created more options for the 30 million people in the U.S. suffering from hearing loss — and is making devices that once carried a stigma more of a modern lifestyle convenience. - But the change has left consumers navigating the burgeoning market on their own and evaluating products that until recently were only available with a doctor's guidance.
Driving the news: Only about 20% of adults who could benefit from hearing aids actually use them, many because of access and affordability issues and also, because they don't realize or want to admit they need them. - OTC hearing aids retail for $1,000-3,000 a pair, less than many prescription hearing aids that can cost as much as $4,000.
- Making hearing products available without a prescription helped increase uptake, and the products proved to be cost-effective as long as they're at least roughly half as beneficial to patient quality of life as traditional hearing aids, a study published Thursday in JAMA Otolaryngology–Head & Neck Surgery found.
- Another study last month in the American Journal of Audiology found individuals with mild to moderate hearing loss were able to use self-fitted hearing aids effectively.
- "Hearing aids are not what we're used to 10, 20 years ago where they're big clunky things behind your ears," De Wet Swanepoel, a co-author of the study and a professor of audiology at the University of Pretoria in South Africa, told Axios.
- Both prescription models and over-the-counter hearing aids have evolved to allow users to use Bluetooth to stream calls or music, as well as rechargeable batteries.
Yes, but: It's still early in the evolution of the over-the-counter offerings, but Kristen Conners, a licensed audiologist in Palos Park, Illinois, said they can't yet match what patients get seeing a doctor. - She expects people who have never been treated for hearing loss may be most curious about devices sold directly to consumers. But she said she doesn't believe existing hearing aid users will gravitate to that market after having the in-office experience of having aids custom-fitted and programmed for their level of hearing loss.
- "They're not going to want to sacrifice something they already have," she said.
Be smart: The pandemic experience helped prime this market as people became more comfortable taking charge of their health care from their homes, Swanepoel said. Stigma is also lifting. - "Previously people didn't recognize what these hearing aid brands were," he said. "Now you see a Bose logo on a device, or Jabra or Sony, that does change the narrative for people. It makes it a little more acceptable."
Go deeper. |
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| 2. FDA advisers endorse 1st RSV maternal vaccine |
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| Illustration: Sarah Grillo/Axios |
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| FDA advisers on Thursday endorsed giving pregnant people an experimental Pfizer vaccine to protect infants against respiratory syncytial virus, despite concerns about insufficient data on safety risks, Axios' Sabrina Moreno writes. Why it matters: RSV is a leading cause of death for infants worldwide, particularly those under six months, but finding an effective vaccine has challenged scientists for decades. How it works: Pfizer's vaccine would prevent severe illness in infants in their first six months by creating neutralizing antibodies that can be transferred in the womb. Yes, but: While the FDA's 14 outside advisers unanimously voted the shot was effective, four voted no on the question of whether it was safe, saying there wasn't enough data. - Some panelists noted concerns about preterm births — a safety risk which led GlaxoSmithKline to halt a trial of an RSV vaccine last year. A Pfizer official said there is no definitive evidence of increased risk.
- Other members, including Holly Janes, a biostatistician at Fred Hutchinson Cancer Center, said the stated optimal timing for administering the vaccine is still unclear.
- "I'm uncomfortable with the notion of kicking the can down the road" and relying on surveillance studies instead of trial data to confirm its safety, Janes said.
Go deeper: Race for RSV shots heats up with maternal vaccine |
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| 3. House panel approves FDA spending bill |
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| Illustration: Sarah Grillo/Axios |
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| The House Appropriations subcommittee in charge of FDA funding easily approved a fiscal 2024 spending bill Thursday that would reverse the agency's decision to allow mail-order mifepristone, Axios' Maya Goldman writes. - The bill would also prevent HHS from banning menthol in cigarettes and from setting a maximum nicotine level in cigarettes.
The big picture: Although committee Democrats protested the riders — and many other elements of the 113-page bill — they did not offer any amendments that would strike the conservative policies. - The bill sailed through to the full committee in a voice vote.
Zoom out: In 2021, the FDA committed to banning menthol cigarettes. The following year, the agency proposed a ceiling on nicotine level in cigarettes. What they're saying: "I strongly oppose both these riders in the interest of public health," Appropriations Committee Ranking Member Rosa DeLauro (D-Conn.) said during Thursday's markup. Of note: The bill would provide about $6.6 billion to the FDA in fiscal 2024. President Biden's 2024 budget requested $7.2 billion total for the agency. A version of this story was published first on Axios Pro. Get news like this by subscribing. Use code POLICY100 which gives you $100 off. |
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| A message from Kaiser Permanente |
| See all that health care can be |
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| Some health care experiences can be fragmented and impersonal, with the responsibility on the patient to make it work. But at Kaiser Permanente, everything works together to provide equitable, high-quality, affordable care and coverage that support the unique needs of each member. See how. |
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| 4. "No clear agreement" on LGBTQ opinions |
 Data: Axios/Ipsos poll; Chart: Axios Visuals Many Americans lack fully developed views on LGBTQ issues and sexual identity as more states enact laws restricting access to transgender health care, Axios' Oriana González writes from the latest Axios-Ipsos American Health Index. Why it matters: The views of a large segment of voters could be highly malleable as politicians elevate the issue in the run-up to the 2024 elections. - There's "no clear agreement" among Americans around how a person chooses to identify, said Mallory Newall, vice president of Ipsos U.S. Public Affairs.
- While 63% of Americans say they feel comfortable around LGBTQ people, "that level of comfort and their own attitudes toward gender identity and gender expression are not yet fully formed," she added.
The big picture: A plurality of Americans believe that people should be able to decide their gender identity, but when asked specifically about teenagers, support waned. - 44% agree that people should be able to choose their gender identity, 31% disagree and 24% don't take a position.
- When it comes to teens choosing, 44% disagree, 33% agree and 22% neither agree nor disagree.
Read the rest. |
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| 5. FDA warns kids can overdose on fentanyl patches |
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| Illustration: Eniola Odetunde/Axios |
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| Children are accidentally overdosing on fentanyl patches used for pain relief, the FDA warned Thursday, Sabrina writes. Why it matters: Unintentional exposure to opioids has increasingly become the source of fatal poisoning among young kids as the opioid epidemic escalates. What's happening: Children are putting new and used fentanyl patches in their mouths or sticking them on their skin, which the FDA said can result in the potentially lethal slowing of breathing and blood oxygen levels. - The FDA urged patients to properly store the product in a lockbox that's out of sight and to dispose of used patches by flushing them down the toilet.
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| 6. Dog of the week |
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| Woodley. Photo: Jason Alinsky |
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| Meet Woodley, a six-month-old golden retriever who hails from Woodley Park in Washington, D.C., pictured with the cherry blossoms. - "Woods is an avid fan of any stick she can find," writes her human Jason Alinsky. She's also "never met a stranger but only new friends; dogs, human, or anything in between." And she's got an Instagram!
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| A message from Kaiser Permanente |
| See all that health care can be |
| |
| |
| |
| Some health care experiences can be fragmented and impersonal, with the responsibility on the patient to make it work. But at Kaiser Permanente, everything works together to provide equitable, high-quality, affordable care and coverage that support the unique needs of each member. See how. |
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| Thanks for reading Axios Vitals, and to senior editor Adriel Bettelheim and senior copy editor Bryan McBournie. Please ask your friends and colleagues to sign up. |
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