closer look
Opinion: We need primary care providers involved early in Alzheimer's care
Even President Biden's widely covered annual physical last month didn't include a cognitive assessment. But the political debate about which presidential candidate might be mentally fitter for office overlooks questions about the role of primary care providers in cognitive testing, a policy researcher writes in a STAT First Opinion.
The first drugs approved for Alzheimer's, despite a litany of limitations, are designed to work in the early stages of the disease, Katherine O'Malley of the Boston University School of Public Health notes. And while primary care providers are critical to prompt diagnosis and treatment, "this workforce isn't currently up to the challenge," she writes. The clinicians may lack training, and their patients, especially if they live in rural areas, may not be able to find them. Read more.
research
FDA is still behind on inspections of clinical research sites, watchdog says
The FDA has inspected far fewer clinical research operations in hospitals and clinics in recent years, the Government Accountability Office reports, a shortfall blamed on pandemic disruption and difficulty retaining investigators needed to keep up this kind of oversight. In 2022, the FDA inspected 537 hospitals and clinics engaged in studies of experimental drugs their manufacturers hoped would win approval. That compares to 976 clinical study sites inspected in 2017.
Also, from fiscal year 2018 through July 2023, the FDA couldn't complete 30% of one type of common inspection within the requested time frames. GAO's new report follows last year's discovery that the FDA inspects relatively few institutional review boards, the bodies that vet ethical and safety issues in trials. The GAO does say the FDA has taken steps to increase recruitment and retain investigators, but attrition remains a "persistent" problem. STAT's Ed Silverman has more.
health
Update: FDA approves Merck's drug for a rare cardiovascular disorder
In a development we told you to expect yesterday, the agency approved Merck's drug to treat a rare cardiovascular disorder called pulmonary arterial hypertension Tuesday, making available a new approach to treat a deadly condition whose causes have been challenging to address. Merck will sell the drug, called sotatercept, under the brand name Winrevair. It will be priced at $14,000 per vial, which is injected every three weeks.
"[Winrevair] is the first medicine to act on the basis of the disease, on what is happening in the blood vessel wall that causes the problem," Eliav Barr, Merck's chief medical officer, told STAT's Elaine Chen. "It's a really huge step forward in the treatment of pulmonary arterial hypertension." Read more.
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