Recent Postings

A recent report highlights how up to 45% of dementia cases could be prevented or delayed by attention to 14 potentially modifiable factors. The factors are untreated vision loss, high LDL cholesterol, physical inactivity, smoking, excessive alcohol consumption, hypertension, diabetes, obesity, hearing loss, depression, traumatic brain injury, social isolation, less education, and air pollution.

The editor’s column discusses a disturbing failure of informed consent during clinical trials of two recently approved drugs for Alzheimer’s disease; participants were not told whether their genetic profiles increased their risks of brain injuries from receiving the drugs. Investigators and institutional review boards should learn from the informed consent failure and ensure that research subjects are fully informed about their risks.

Learn how the Food and Drug Administration reviews drugs and medical devices before they can be marketed in the United States, and the similarities and differences between the drug approval process and the medical device approval and clearance process.

In February 2024 the FDA finally responded to a 2011 petition from Public Citizen’s Health Research Group to require additional safety warnings on the labels of glucocorticosteroids. The FDA granted the petition in part, prompting belated safety labeling changes.

Some prescription and over-the-counter medications are associated with symptoms of cognitive impairment in older adults, such as confusion, memory loss, problems paying attention or difficulty thinking. Drugs to be aware of include anticholinergic drugs, benzodiazepines and Z-drugs, proton pump inhibitors, and certain combinations of drugs.

The editor’s column discusses a Viewpoint article in JAMA about the origins of “confidential commercial information” at the Food and Drug Administration (FDA). The article makes the case for a “long overdue” and “more balanced” approach to the public disclosure of company information. Dating from 1974, the FDA’s approach to information sharing should be revised.

Learn about compounded injectable semaglutide (OZEMPIC, WEGOVY) and tirzepatide (MOUNJARO, ZEPBOUND) products that are widely marketed for type 2 diabetes and weight loss. Compounded drug products are subject to a lower regulatory standard than FDA-approved drug products and are not approved by the agency. Public Citizen’s Health Research Group recommends that you do not use compounded injectable semaglutide or tirzepatide products or any such products that are purchased without a prescription.

In August 2024 the FDA approved an epinephrine nasal spray (NEFFY) for the immediate treatment of certain life-threatening allergic reactions, including anaphylaxis. Learn about the epinephrine nasal spray, which Public Citizen’s Health Research Group has classified as Do Not Use for Seven Years because of the limited clinical data available.

In July 2024 the Food and Drug Administration approved donanemab (KISUNLA) to treat Alzheimer’s disease in patients with mild cognitive impairment or who were in the mild stages of the disease. Public Citizen’s Health Research Group has classified donanemab as a Do Not Use drug because it has minimal benefit and substantial health risks, including brain swelling and bleeding.

Created in August 2013 as part of the Affordable Care Act, the Open Payments database archives industry payments to U.S. physicians, non-physician practitioners and teaching hospitals. Data for 2023 cover an astounding 15.64 million records of payments with a total value of $12.75 billion. The editor’s column discusses why the public availability of payment data has done little to curb industry influence over physicians.

In 2023, Public Citizen’s Health Research Group petitioned the FDA to strengthen safety warnings for BOTOX and related drugs. Learn about a Centers for Disease Control and Prevention (CDC) investigation of adverse effects in clusters of people related to what the agency characterized as “counterfeit or mishandled botulinum toxin injections.” Public Citizen has urged the CDC to be more transparent about all the cases it has investigated and to disclose whether any of the patients received recommended doses of Food and Drug Administration-approved botulinum toxin products.

In July 2024 the FDA approved a blood test (SHIELD) to detect colorectal cancer or precancer in patients with average risk of such cancer. Learn about the new test and why it is not as good as colonoscopy. Stool- or blood-based screening for colorectal cancer should not be relied upon as a replacement for regular colonoscopy at the recommended intervals.

The oral drugs valproic acid (generics only) and divalproex (DEPAKOTE and generics) are used to treat certain kinds of seizures. Children born to mothers who took valproate drugs during pregnancy have higher risks of reduced intelligence and birth defects. A new post-marketing study suggests an increased risk of neurodevelopmental disorders (mental or developmental disorders that begin in early childhood) in children of fathers treated with valproate drugs during the three months prior to conception.