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Thursday, Aug 17 2023

Full Issue

March Recall Of Phillips Ventilators Associated With At Least One Death

Over 73,000 ventilators were recalled in March, but new FDA data show the issue is associated with at least one death and two injuries. Among other news: the FDA approved the first treatment for a rare bone disease; the American Red Cross tussles with the Justice Dept. over antitrust; and more.

In March, Philips recalled more than 73,000 ventilators that absorbed dust and dirt into breathing tubes. This week, the Food and Drug Administration reported that the issue has been associated with at least one death and two injuries. (Lawrence, 8/16)

In other news from the FDA and Justice Department 鈥

U.S. regulators on Wednesday approved the first treatment for an ultra-rare disease that causes people to grow bone where it otherwise shouldn鈥檛 be, extending an option to patients who have been advocating for access to the medicine. (Joseph and Garde, 8/16)

For only the fifth time, the Food and Drug Administration recently threatened to fine a company or clinical trial investigator for failing to post study results on a federal government database. And transparency advocates say this is the latest proof that the agency needs to step up enforcement. (Silverman, 8/16)

The dispute is unfolding in a lawsuit against the Red Cross, the country's largest supplier of blood, by blood-testing company Verax Biomedical. Verax's Feb. 14 complaint in Boston federal court alleges that the Red Cross is using its dominance in the market for blood platelets to squelch competition for anti-contamination services. The Red Cross has asked the court to dismiss the case, arguing that it acts as an "instrumentality" of the U.S. government. (Scarcella, 8/16)

More pharmaceutical news 鈥

The first Alzheimer鈥檚 drugs meant to slow the progression of the fatal disease may only be available to a tiny fraction of patients, a study published Wednesday in the journal Neurology suggests. The drugs, Eisai鈥檚 Leqembi and Biogen鈥檚 Aduhelm, are approved for older adults with mild cognitive impairment or early-stage Alzheimer鈥檚 disease but, according to the study, less than 1 in 10 patients at this point in the disease may be prescribed them.聽(Lovelace Jr., 8/16)

Spend enough time searching for Ozempic, Wegovy or Mounjaro, and you鈥檒l find dozens of websites selling knock-off versions of the popular drugs without a prescription. These websites are part of a robust online marketplace for what have been called weight-loss miracles, selling raw ingredients that cost far less than the brand-name drugs. They market to customers on social media, emphasizing discounts and 鈥減harmaceutical grade鈥 quality while stating that their products are 鈥渇or research purposes鈥 only.聽(Winkler and O'Brien, 8/16)

The empty auditoriums, Gila monsters, resistant pharmaceutical executives and enigmas that led to Ozempic and other drugs that may change how society thinks about obesity. (Kolata, 8/17)

While the surge in prescriptions for ADHD drugs during the pandemic has often been attributed to expanded telehealth access, new research finds there has been little difference in prescribing rates for in-person or virtual care at large health centers since 2020. (Dreher, 8/17)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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