RESEARCH

The quiet collapse of America's research ethics watchdog

Greg Kahn for STAT

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.

FDA

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.

WELLNESS

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.