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.
Stat:
The Latest Recall Of Philips Ventilators Reveals One Death, Two Injuries
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 —
Stat:
FDA Approves First Treatment For Ultra-Rare Bone Disease
U.S. regulators on Wednesday approved the first treatment for an ultra-rare disease that causes people to grow bone where it otherwise shouldn’t be, extending an option to patients who have been advocating for access to the medicine. (Joseph and Garde, 8/16)
Stat:
In A Rare Move, FDA Threatens To Fine A Company For Failing To Report Clinical Trial Results
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)
Reuters:
American Red Cross Spars With US Justice Dept Over Scope Of Antitrust Law
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 —
NBC News:
Few Patients May Qualify To Get New Alzheimer’s Drugs, Study Suggests
The first Alzheimer’s 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’s Leqembi and Biogen’s Aduhelm, are approved for older adults with mild cognitive impairment or early-stage Alzheimer’s disease but, according to the study, less than 1 in 10 patients at this point in the disease may be prescribed them. (Lovelace Jr., 8/16)
The Wall Street Journal:
Ozempic Without A Prescription: Dozens Of Websites Selling Knock-Off Weight Loss Drugs
Spend enough time searching for Ozempic, Wegovy or Mounjaro, and you’ll 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 “pharmaceutical grade” quality while stating that their products are “for research purposes” only. (Winkler and O'Brien, 8/16)
The New York Times:
We Know Where New Weight Loss Drugs Came From, but Not Why They Work
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)
Axios:
Telehealth Didn't Drive Up ADHD Prescriptions At Large Health Centers: Study
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)
