Morning Briefing
Summaries of health policy coverage from major news organizations
Experts Call For FDA Safety Review Of Alzheimer's Drug Lecanemab
Doctors and scientists are urging the Food and Drug Administration to convene an expert panel to review safety concerns around an Alzheimer's drug that won fast-track approval in January. It's the latest concern over whether the FDA is cutting corners evaluating Alzheimer's drugs, prompted by its controversial 2021 approval of Biogen's Aduhelm, which came over the objections of an advisory panel and without evidence the drug actually slowed the decline of memory and brain function. (Gonzalez, 2/6)
The first drug proven to slow Alzheimer鈥檚 is on sale, but most U.S. patients will not be able to receive the treatment for several months. Experts say some reasons behind the slow debut for Leqembi, from Japanese drugmaker Eisai, are minimal insurance coverage and many health systems requiring a setup that takes a long time. (Mion, 2/6)
In other pharmaceutical news 鈥
Stephanie Hathaway knows the agony of postpartum depression all too well, having been tormented by intrusive suicidal thoughts after each of her two daughters were born. Both bouts were excruciating, but the second, in 2017, was unremitting. (Cross and Saltzman, 2/4)
Plaintiff Deborah Smith鈥檚 case was held up for 15 months because of the attempted maneuver, a legal strategy colloquially known as the Texas Two-Step. J&J鈥檚 approach relied on the creation of a subsidiary called LTL Management that could take on the liability for talc-related legal claims. Within days of its creation in 2021, LTL filed for Chapter 11 bankruptcy. (Bendix and Wile, 2/4)
Doctors don鈥檛 always offer cancer-preventing or cancer-treating vaccines to patients鈥攄ue to lack of knowledge, or bias against certain racial, gender, or age groups. 鈥淧atients need to advocate for themselves,鈥 says Dr. Nina Bhardwaj, director of immunotherapy at the Vaccine and Cell Therapy Laboratory and co-director of the Cancer Immunology Program at The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai in New York City. (Prater, 2/4)
In 2021, Craig Gibbons was diagnosed with Lyme disease. His doctor prescribed him antibiotics, but the medication failed to eliminate one of his most debilitating symptoms: a lasting brain fog that made it difficult for him to focus or recall information. So he went with a different approach: at-home brain stimulation. (Lovelace Jr., 2/4)