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The American Diabetes Association’s annual conference starts today. STAT’s Elizabeth Cooney will be embedded in New Orleans to file three ADA in 30 newsletters, with help from Elaine Chen covering newsworthy items on the weekend’s agenda. If you want a newsletter to follow along, sign up here.
The quiet collapse of America’s research ethics watchdog
In little over a year, the federal office responsible for overseeing the vast research enterprise bankrolled by the Department of Health and Human Services — including keeping study participants safe — has collapsed.
The Office of Human Research Protections has lost more than half of its employees, either through reductions in force, resignations, or early retirements. Many of the top leaders are gone, and the office’s advisory committee has also been disbanded. One former advisory committee called the office “decimated.”
What happens when the watchdogs are no longer watching? And what’s the legacy of this little-known office that’s been so critical at rooting out malfeasance and protecting clinical trial participants? STAT’s Megan Molteni has you covered.
Drug companies, patients sound off on review system
Reviews are in: Drug companies and patient advocacy groups are not fans of the speedy drug review program put in place by former Food and Drug Administration Commissioner Marty Makary.
The criticism came during a listening session at the FDA yesterday that featured 17 speakers representing patient groups, drug companies, and academic organizations. Some had positive feedback, but most asked the agency to pause the program, and then bring it back through normal regulatory procedures that require public feedback.
The Commissioner’s National Priority Voucher program launched about a year ago, offering one- to two-month FDA reviews to companies that could prove their drugs “align with national priorities.” Align they have, as the White House has leveraged the voucher program to reward companies that help achieve political goals, such as lowering the price of GLP-1 obesity drugs and infertility treatments.
STAT’s Lizzy Lawrence has more takeaways from the town hall. Read more.
Texas AG investigating energy drinks
Texas Attorney General and U.S. Senate nominee Ken Paxton (R) is launching an “investigation” into energy drink company Celsius in a bid to “protect Texas children from dangerous levels of caffeine.”
The announcement is coming after a Texas family sued Celsius, alleging that their 17-year-old child died from an enlarged heart brought on by excessive caffeine consumption of the Alani Nu drink, which contains 200mg of caffeine.
Clearly, Paxton has been reading STAT. Sarah Todd wrote a story last spring about how health experts were worried about the proliferation of wellness-branded energy drinks with “supercharged doses of caffeine,” specifically naming Celsius and Alani Nu. The risks are real, even if the energy drinks have nutrition labels that camouflage the risks in “better for you ingredients” like biotin and lion’s mane.
Daily Ebola update
Americans with high-risk Ebola exposures will be able to access experimental therapy, federal health officials confirmed yesterday.
The antibody treatment, known as MBP-134, is made by San Diego-based Mapp Biopharmaceuticals, with funding from the Biomedical Advanced Research and Development Authority, an agency within HHS that helps develop medical countermeasures for rare and emerging diseases and biological threats. It is not clear how many doses of MBP-134 exist at present. Read more from STAT’s Helen Branswell.
1 in 5
That’s how many U.S. adults (21%) with private health insurance are denied coverage for doctor-recommended care, according to a Commonwealth Fund survey released today. The survey, which included responses from nearly 4,600 adults ages 19 to 64, looked at both prior authorization denials (before care) and claim denials (after care).
For 43% who experienced a claim denial, it led to medical debt they’re still paying off. For 41% of people who experienced a prior authorization denial, it led to a delay in medical care. And 28% of people said a health problem got worse because of it.
“We need greater transparency, expansion of appeal rights, and standardization of utilization review processes across all insurance plans to help patients have confidence in their insurance — that it will enable them to stay healthy and avoid medical debt,” said Sara Collins, one of the study co-authors. Read the full report for yourself.
What we’re reading
- RFK Jr. seeks to peek at 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 facing new scrutiny, The Guardian
- Nearly 60 Idahoans sick after drinking raw milk in past two weeks, officials say, Idaho Capital Sun
- Otsuka kidney drug slowed loss of function, but less than expected, in late-stage trial, STAT