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The ideas and innovators shaping health care | | | | |  | | By Ben Leonard, Ruth Reader, Carmen Paun and Erin Schumaker | | | | | 
Similac made at a Michigan plant was recalled last year. | Mark Duncan/AP Photo | ANSWERS WANTED: Parents of dozens of babies who suffered illnesses last year are convinced that the infant formula crisis was worse than FDA officials have acknowledged, Helena Bottemiller Evich reported for POLITICO. The parents believe that the fallout from what the Food and Drug Administration called “unsanitary” conditions at an Abbott Nutrition plant in Michigan was more extensive than Abbott and federal health officials have determined. Abbott has maintained that there’s no proof its products caused any infant illnesses, telling POLITICO that “no sealed, distributed product from our Sturgis, Mich., facility has tested positive for the presence of either Cronobacter or Salmonella.” An FDA spokesperson said the agency was “implementing improvements both internally and with industry involvement that will lead to a safer and more resilient infant formula supply.” The FDA shut down the Abbott plant in February, setting off formula shortages. The agency says four infant hospitalizations and two deaths are linked to infant formula from the plant, but the families believe many more babies were sickened. They say federal officials have dismissed their children’s illnesses and they have gotten no follow-up from the government and only denials from Abbott.
|  Lobbyists are worried about the new chair of the Senate HELP Committee. | Getty Images | CORPORATE AMERICA’S SCOURGE: Health care lobbyists representing insurers, drugmakers and a range of powerful industry interests are steeling themselves for a Senate chair immune to their usual charms — Bernie Sanders, POLITICO’s Megan R. Wilson reported. The Vermont independent, and longtime critic of corporate America, now sits at the helm of the Senate’s Health, Education, Labor and Pensions Committee. Sanders’ well-chronicled antagonism toward lobbyists has some concerned they’ll be unable to blunt criticism of their clients’ profits or corporate executive salaries. They’re anxious Sanders might seek to revive proposals like importing drugs from Canada and other nations, an idea loathed by drugmakers. Lobbyists also worry they’ll struggle to get traction on any push to make changes to a drug discount program involving pharmaceutical companies and hospitals or revisit association health plans after a Trump-era rule around them was voided. Michaeleen Crowell, a lobbyist at S-3 Group, a lobbying and public affairs firm, served as Sanders’ chief of staff for more than five years. She said the culture in Sanders’ office “is one where lobbyists are mistrusted, and they’re more likely to discount what they hear directly from companies.”
|  Travelers are on the move in China, thanks to the end of the country's "zero-Covid" policy. | AP | EUROPE ON CHINA’S COVID WAVE: The end of China’s “zero-Covid” policy, and a subsequent explosion in infections there, havetested European countries’ pledge to work together on health crises, POLITICO’s Helen Collis reported. After China ended its strict pandemic control measures last month, European countries initially moved separately to set rules for Chinese travelers. Then, at a crisis meeting in Brussels on Wednesday, diplomats agreed on a “coordinated precautionary approach” that includes pre-departure testing for travelers from China, masks on flights and analyzing wastewater for new variants. But the rules aren’t mandatory, and it’s not clear how coordinated the European response will be. The U.S. mandated Covid testing of travelers from China last month.
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Wompatuck State Park, Hingham, Mass. | Shawn Zeller | This is where we explore the ideas and innovators shaping health care. Is it time for a more environmentally friendly burial? Some funeral services disruptors think so, Grid reports. Share any other thoughts, news, tips and feedback with Ben Leonard at bleonard@politico.com, Ruth Reader at rreader@politico.com, Carmen Paun at cpaun@politico.com, or Erin Schumaker at eschumaker@politico.com. Send tips securely through SecureDrop, Signal, Telegram or WhatsApp. Today on our Pulse Check podcast, Lauren Gardner talks with Daniel Payne about the results of a survey from the Substance Abuse and Mental Health Services Administration, which shows that 1 in 3 Americans had a substance abuse disorder or mental illness in 2021. Plus, Ben talks with Amy Abernethy, president of Verily’s clinical research business and the former No. 2 at the FDA, about barriers to improving trials, the new Advanced Research Projects Agency for Health and more.
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A new law could help lactation consultants win customers. | AP Photo/M. Spencer Green | | | “Breastfeeding isn’t a ‘nice to have’ for a woman expressing milk.” – SimpliFed CEO Andrea Ippolito | | Companies that provide virtual breastfeeding support hope a provision in the fiscal 2023 omnibus spending law will prompt new mothers to take advantage of their services. Congress boosted breastfeeding mothers’ rights to pump milk at work when it added a bill by Sen. Jeff Merkley (D-Ore.) and then-Rep. Carolyn Maloney (D-N.Y.) to the omnibus spending package. What’s the law say? The legislation requires more types of employers to offer “reasonable break time” and accommodation for pumping than before, building on requirements from the Affordable Care Act to include millions more employees — nurses, farmworkers and teachers. Market opportunity: Virtual consultations could appeal more to women at their workplaces than in-person visits. It could be a boon for health tech companies like SimpliFed, which connect breastfeeding mothers with lactation consultants via telehealth, if it prompts more women to seek a consultant's help in learning to pump milk. “When a woman who is breastfeeding cannot express milk in the workplace, this places her health at risk,” said SimpliFed CEO Andrea Ippolito. Even so: The legislation includes exceptions for companies with fewer than 50 employees — meaning a substantial portion of employers don’t have to provide the accommodation “if such requirements would impose an undue hardship.” Jada Shapiro, the founder of boober — another platform connecting parents with lactation consultants — told Ben that, while the legislation was “another solid step” forward in bolstering maternal health, she’d like to see Congress pass another law preventing insurers from restricting the number of consultants that mothers can hire.
| | | |  The Apple Watch measures blood oxygen levels. | Getty Images | Research over several decades has shown that pulse oximeters overestimate blood oxygen levels in patients with dark skin, which can cause doctors to miss distress signals. New York attorney Spencer Sheehan is spearheading a class-action lawsuit claiming that Apple — which makes a watch that reads blood oxygen levels — has misled consumers by failing to acknowledge that deficiency. The suit, on behalf of consumer Alex Morales and other buyers of the Apple Watch, alleges that Apple “misrepresented” the device’s capabilities by not warning that pulse oximeters aren’t as accurate for people with darker skin. It seeks “monetary, statutory and/or punitive damages” on behalf of people in New York who bought the watch, as well as those protected by anti-fraud laws in Iowa, North Dakota, Wyoming, Idaho, Alaska, Arkansas, North Carolina, Utah and Mississippi. Apple said in an October white paper that it used subjects with a “wide range of skin types and tones” to ensure accuracy. It also uses technology to account for differences across skin tones. Why it matters: Pulse oximeters caused problems during the Covid-19 pandemic when people of color sought treatment. Research published in December 2020 showed that providers were about three times more likely to miss low blood oxygen levels in Black patients than in white patients. An FDA advisory panel concluded in November that the devices don’t work as well for patients with darker skin tones and the agency should mandate higher performance standards for pulse oximeters. The agency said it’s “reviewing the committee’s recommendations and will consider additional actions as needed.” | | | | Follow us on Twitter | | | | Follow us | | | | |  |
