Elsewhere in health care There's a battle brewing over where a new health research agency should be housed.President Biden is set on reviving a former Trump administration proposal: the creation of the Advance Research Projects Agency for Health (ARPA-H). "In the administration's debut budget proposal, the National Institutes of Health received $6.5 billion to launch the new agency modeled after the military's Defense Advanced Research Projects Agency (DARPA)," our Power Up colleague Jacqueline Alemany writes. "ARPA-H would accelerate the development of medical treatments for Alzheimer's disease, cancer, cardiovascular disease, and more." NIH Director Francis Collins holds up a model of the coronavirus as he testifies before a Senate Appropriations Subcommittee in May. (Photo by Sarah Silbiger-Pool/Getty Images) | "For Biden, whose son Beau died of brain cancer in 2015, the potential creation of the agency is personal. Biden and his wife Jill founded the Biden Cancer Initiative in 2017 to continue the Obama administration's "cancer moonshot," which Biden led as vice president," she adds." "…But there's a battle brewing over where exactly the agency should be housed — and how it should be structured to have the most impact. Some medical experts and some lawmakers believe that for the agency to successfully innovate, it should be a stand-alone entity within the Department of Health and Human Services, and free of what many experts view as NIH's bureaucratic and time-consuming approach to innovation and research. The FDA released new information on its decision to approve a controversial Alzheimer's drug."But the new information, included in interviews with agency officials and 83 pages of internal documents, might not quiet a furor over the drug Aduhelm that has drawn in Alzheimer's doctors and patients, members of Congress, Medicare officials, and the agency itself," The Post's Laurie McGinley reports. Agency officials opted against full approval, given conflicting evidence of the drug's benefit to patients. Instead, they opted for an "accelerated approval" based on a judgment that the drug's success in reducing amyloid beta plaque in the brain made it "reasonably likely" to slow cognitive decline. But some scientists say that even a conditional approval is not warranted given numerous studies showing that amyloid-targeting drugs don't help patients. Marc Archambault was one of the first people to receive Aduhelm. (Jessica Rinaldi/Pool/Reuters) | Peter Stein, director of the Food and Drug Administration's Office of New Drugs, cited the "substantial and urgent" need for new therapies in a memo explaining why the agency decided to approve a drug whose benefits are uncertain. "FDA has heard the voices of many patients afflicted with [Alzheimer's disease] who express a desperate desire for an effective treatment," Stein said. The stakes of the approval are high, not only for the patients who may receive treatment, but also for the broader health system. At $56,000 a year, the drug is costly, and the potential market numbers in the millions. The New York Times reported that projections estimate Medicare could spend more on Aduhelm than the entire government budget for NASA. Elite American nonprofit hospitals are looking to make money abroad.Cleveland Clinic is launching a $1 billion project to open a hospital in London. The hospital will primarily offer elective surgeries and other profitable treatments, while forgoing less lucrative services, such as emergency care, Kaiser Health News's Jordan Rau reports. And Cleveland Clinic is not alone. It's one of three dozen elite hospitals and health systems seeking patients and insurers overseas who are able to pay high prices. "These foreign forays prompt questions about why American nonprofit health systems, which pay little or no taxes in their hometowns, are indulging in such nakedly commercial ventures overseas," Jordan writes. The majority of U.S. hospitals are exempt from taxes because they provide charity care and benefits to their local communities, but it's not clear that these communities benefit from international expansion. |
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