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The American Diabetes Association’s annual event kicks off today. STAT’s Elizabeth Cooney will be reporting directly from New Orleans, delivering three ADA in 30 newsletters. Elaine Chen will assist in covering the weekend’s key agenda items. To keep up with the updates, sign up here.
The quiet decline of America’s research ethics watchdog
In just over a year, the federal office tasked with overseeing the extensive research funded by the Department of Health and Human Services — crucial for ensuring participant safety — has unraveled.
The Office of Human Research Protections has seen more than half of its staff leave due to downsizing, resignations, or early retirements. Key leaders have departed, and the advisory committee has been disbanded. One former committee member described the office as “decimated.”
What are the consequences when oversight is lacking? And what legacy does this lesser-known office leave, having been vital in exposing malpractice and safeguarding clinical trial participants? STAT’s Megan Molteni explores these questions. Read more.
Drug companies and patients critique review system
Feedback is in: Drug companies and patient advocacy groups are not impressed with the expedited drug review program initiated by former FDA Commissioner Marty Makary.
During a recent FDA listening session, 17 speakers from patient groups, pharmaceutical companies, and academic organizations shared their views. While some responses were positive, most called for a halt to the program, advocating for its reintroduction through standard regulatory processes that allow for public input.
The Commissioner’s National Priority Voucher program, launched about a year ago, offers one- to two-month FDA reviews for drugs aligning with national priorities. The White House has used this program to incentivize companies contributing to political goals, like reducing prices for GLP-1 obesity drugs and infertility treatments.
STAT’s Lizzy Lawrence provides further insights from the town hall. Read more.
Texas AG investigates energy drinks
Texas Attorney General and U.S. Senate nominee Ken Paxton (R) has initiated an investigation into Celsius, an energy drink company, to “protect Texas children from dangerous caffeine levels.”
This announcement follows a lawsuit by a Texas family against Celsius, claiming their 17-year-old died from an enlarged heart caused by excessive caffeine intake from Alani Nu’s drink, which contains 200mg of caffeine.
It appears Paxton has been following STAT. Last spring, Sarah Todd highlighted concerns from health experts about the rise of wellness-branded energy drinks with high caffeine content, specifically mentioning Celsius and Alani Nu. Despite their “better for you ingredients” like biotin and lion’s mane, the risks remain significant.
Daily Ebola update
Federal health officials confirmed yesterday that Americans with high-risk Ebola exposures will have access to experimental therapy.
The antibody treatment, MBP-134, is produced by San Diego-based Mapp Biopharmaceuticals, funded by the Biomedical Advanced Research and Development Authority, an HHS agency developing medical countermeasures for rare diseases and biological threats. The current stock of MBP-134 doses is uncertain. Read more from STAT’s Helen Branswell.
1 in 5
According to a Commonwealth Fund survey released today, 21% of U.S. adults with private health insurance are denied coverage for doctor-recommended care. The survey, which included nearly 4,600 adult participants aged 19 to 64, examined both prior authorization denials and post-care claim denials.
For 43% of those whose claims were denied, this resulted in ongoing medical debt. For 41% of those denied prior authorization, it led to delayed medical care, and 28% reported worsening health conditions as a result.
Sara Collins, a co-author of the study, stated, “We need greater transparency, expansion of appeal rights, and standardization of utilization review processes across all insurance plans to help patients trust that their insurance will enable them to stay healthy and avoid medical debt.” Read the full report.
What we’re reading
- RFK Jr. seeks to examine Americans’ medical records for clues on autism and vaccines, KFF Health News
- Three studies used by RFK Jr. and allies to justify controversial vaccine policy changes face new scrutiny, The Guardian
- Nearly 60 Idaho residents fall ill after drinking raw milk in the past two weeks, officials say, Idaho Capital Sun
- Otsuka kidney drug slowed loss of function, but less than expected, in late-stage trial, STAT
