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| Presented By Emergent |
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| Axios Vitals |
| By Tina Reed · Mar 23, 2023 |
| Good morning, Vitals readers. Today's newsletter is 8765 words or a 3½-minute read. 💻 Tune in: Join me and Axios' Adriel Bettelheim today at 8am ET in Washington, D.C., for an event exploring how the U.S. can improve its public health preparedness. - Guests include HHS Assistant Secretary Dawn O'Connell, the Bipartisan Commission on Biodefense executive director Asha George, and Johns Hopkins Center for Health Security director Tom Inglesby. Register here to livestream the event or attend in person.
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| 1 big thing: Transplant breakup |
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| Illustration: Sarah Grillo/Axios |
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| From IT failures that cost patients a chance at a life-saving organ to doctors salvaging kidneys from a battered box with tire tracks on it, the nation's organ transplant system has come to be defined by harrowing anecdotes. Not to mention inequities and mismatched supply and demand. Driving the news: After years of complaints from transplant surgeons and patient advocates, the Biden administration is breaking up the monopoly held for nearly four decades by the non-profit United Network for Organ Sharing (UNOS). - The federal plan would open the system up to competitive bidding and make an immediate priority of upgrading the computer system which matches patients and organs.
What they're saying: "The announcement to break up the national organ monopoly is a huge win for patients," Jennifer Erickson, a senior fellow at the Federation of American Scientists who served in the Obama White House Office of Science and Technology Policy working on organ donation policy, told Axios. - She called a Senate Finance Committee investigation, which blamed transplant screening mistakes for 70 deaths and another 249 patients developing diseases, "damning." UNOS' "failures have led to thousands of unnecessary patient deaths, which fall disproportionately on patients of color," she said.
The big picture: More than 100,000 people are awaiting organ transplants in the U.S. with about 117 transplants a day, per UNOS. The organization, which Congress created in 1984 and works with local procurement groups, marked its 1 millionth transplant last fall. - With about 5,000 a people a year dying on waiting lists, advocates argue the number of transplants could be much higher.
- "If we had a fully effective system, we could actually fully service the waiting list for hearts, lungs and livers within a couple of years," said Greg Segal, co-founder of Organize, a non-profit patient advocacy group.
The other side: "We welcome a competitive and open bidding process," UNOS said in a statement. "We believe we have the experience and expertise required to best serve the nation's patients and to help implement HRSA's proposed initiatives." What we're watching: Health Resources and Services Administration chief Carole Johnson told the New York Times she envisions multiple bidders for different transplant system tasks with her agency setting the standards. Share this story. |
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| 2. FDA advisers give partial backing to ALS drug |
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| Photo: Sarah Silbiger/Getty Images |
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| FDA advisers on Wednesday signaled openness to expediting an experimental drug from Biogen that targets a rare form of ALS, or Lou Gehrig's disease, Axios' Adriel Bettelheim writes. Why it matters: ALS is a progressive and fatal neurological disease. There are no approved therapies for this genetic form of the condition. The drug tofersen didn't achieve the main goal of a late-stage trial last year and carries the risk of serious side effects. Driving the news: The Peripheral and Central Nervous System Drug Advisory Committee gave partial backing to the drug by voting 9-0 that reduction of a protein biomarker in tofersen-treated patients likely predicts it has clinical benefit. - But the panel later voted 5-3 with one abstention that clinical data from the placebo-controlled study and other results didn't provide convincing evidence of effectiveness.
- FDA staff earlier this week said the concerns shouldn't stand in the way of expedited approval.
What's next: The FDA will consider the committee's recommendations, with a final decision due next month. Don't forget: The FDA's fast-track approval process has drawn concern and comment for the way it can put unproven drugs in consumers' hands, and was targeted for limited changes by Congress last year. Share this story. |
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| 3. Nearly half of Americans live with obesity |
 Data: NORC; Chart: Rahul Mukherjee/Axios More than 4 in 10 U.S. adults are obese, with states in the South and Midwest showing some of the highest prevalence, according to a new analysis from NORC at the University of Chicago, Axios' Arielle Dreher writes. Why it matters: Obesity is associated with hypertension, cardiovascular disease, stroke and other conditions that are among the leading causes of preventable, premature death. But strategies for treating obesity are changing, with doctors prescribing a new class of drugs in record numbers despite questions about their long-term effects and a hefty price tag. The details: West Virginia and Mississippi have the highest obesity rates at 51%. The District of Columbia had the lowest obesity rate at 33%, followed by Colorado at 34%. - Obesity disproportionately impacts Black and Hispanic Americans, the analysis found.
- Obesity rates are determined in part by using Body Mass Index ranges, which have been called into question for correlating weight and health too closely, the New Yorker reported.
Of note: The NORC analysis was produced with funding from Novo Nordisk, a company that produces both insulin and Ozempic, one of the popular weight-loss drugs. |
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| A message from Emergent |
| We perceive. We prepare. We protect |
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| From emerging viruses to the risk of chemical or biological attacks, public health threats can arise anywhere. At any time. That's why Emergent has spent the last 25 years developing, manufacturing and delivering protections against the things we hope never happen — just in case they ever do. |
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| 4. Quote du jour: What the market will bear |
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| Stéphane Bancel. Photo: Chip Somodevilla/Getty Images |
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| "The price will depend on the value in each country. The cost of health care is different in each country." — Moderna CEO Stéphane Bancel told the Senate HELP Committee when asked if the U.S. would pay less than other countries for his company's COVID-19 vaccine when government purchases end. He wouldn't commit to reconsidering a decision to roughly quadruple the price of shots, Axios' Maya Goldman writes. |
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| 5. Catch up quick |
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| White House COVID-19 response coordinator Ashish Jha. Photo: Oliver Contreras/Sipa/Bloomberg via Getty Images |
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| 👉 The White House is disbanding its COVID-19 team in May. (Washington Post) 💊 Rising rate of drug shortages is framed as a national security threat. (New York Times) 👀 Sen. Elizabeth Warren wants an FTC review of primary care deals, but one state probe already found more choice and patient access. (Forbes) |
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| A message from Emergent |
| We perceive. We prepare. We protect |
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| From emerging viruses to the risk of chemical or biological attacks, public health threats can arise anywhere. At any time. That's why Emergent has spent the last 25 years developing, manufacturing and delivering protections against the things we hope never happen — just in case they ever do. |
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| 🙉 1 last thing: A new study published in JACC: Advances found road noise can make your blood pressure rise — literally. - The study found an association between long-term exposure to road traffic noise and the incidence of hypertension, with a stronger effect when also associated with air pollution.
Thanks for reading, and thanks to senior health care editor Adriel Bettelheim and senior copy editor Bryan McBournie for the edits. |
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