Morning Briefing
Summaries of health policy coverage from major news organizations
Many New Drugs Were Approved After Just One Study, Analysis Finds
CIDRAP: More Than Two-Thirds Of New Drugs Approved By FDA In 2024 Were Based On A Single Study
More than two-thirds of new drugs approved by the US Food and Drug Administration (FDA) in 2024 were sanctioned based on findings from a single study, according to a new analysis that found that the number of studies used to grant approval has steadily declined since 2016. The findings, published this week in PLOS One, also show a sharp rise in industry-sponsored studies, a decrease in studies sponsored by the National Institutes of Health (NIH), and delays in reporting study results to the public. (Bergeson, 8/28)
More pharmaceutical news —
Stat: Reynolds, Other Vape Manufacturers Able To Dodge FDA Guidelines
Some states sell vaping products by Reynolds American even though they aren’t authorized by the Food and Drug Administration. (Todd, 9/8)
The Hill: Epinephrine Injection Recalled Over Potentially Fatal Health Risks
A pharmaceutical company is voluntarily recalling three lots of epinephrine injections, USP 30 mg/30 mL, over sterility concerns and the potential presence of particulate matter. American Regent initiated the nationwide recall after customers complained about “leaking and cracked vials,” according to a company notice posted by the U.S. Food and Drug Administration. “The firm’s investigation also revealed the presence of particulate matter identified as Nylon, Cellulosic, Acrylic, Polyethylene and Glass,” the company said. (Kaplan, 9/4)
The New York Times: The Heart Drug Pelacarsen Fails, Shocking Novartis And Cardiologists
The drug blocks a protein called lipoprotein (a) that is a powerful risk factor for heart disease. Every study short of a randomized clinical trial indicated that lowering Lp(a) would protect people from developing the disease. (Kolata, 9/7)
CIDRAP: Think You Have A Penicillin Allergy? You Probably Don’t
The vast majority of people who think they’re allergic to penicillin could take it safely, after an appropriate evaluation, said Nonie Arora, MD, MBA, an allergist and immunologist at the Michigan Allergy, Asthma and Immunology Center. Although 10% of Americans believe they’re allergic to penicillin, research shows the actual rate is less than 1%, according to the Centers for Disease Control and Prevention. (Szabo, 9/4)
The Wall Street Journal: Patients Are Flying To China For The Latest Cancer Treatment
Michael Walters, 25, had just begun his first full-time job out of university when he was diagnosed last year with non-Hodgkin lymphoma, a blood cancer. Walters, who hails from New Zealand, underwent several unsuccessful rounds of chemotherapy, radiotherapy and immunotherapy in Auckland. Then doctors told him about CAR-T treatment, in which a patient’s immune cells are extracted, re-engineered in a laboratory and reintroduced into the body to fight cancer cells. (Cheng, 9/6)
On the controversial new film about Theranos founder Elizabeth Holmes —
The Washington Post: Elizabeth Holmes Documentary ‘You Can See Everything’ Offers Shocking Access
A new documentary is offering unprecedented behind-the-scenes access to disgraced Theranos founder Elizabeth Holmes, beginning in her final weeks before going to prison. The film, titled “You Can See Everything,” was unveiled Sunday during a screening at the Telluride Film Festival. ... Holmes, 42, rose to prominence as a health care innovator and self-made business executive, only to fall from grace when reports revealed in 2015 that her blood-testing technology did not work as had been claimed. In 2022, she was convicted of fraud and conspiracy charges and sentenced to more than 11 years in prison. She reported to a prison camp in Texas in 2023. (Walsh, 9/7)
