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The American Diabetes Association’s annual conference begins today. STAT’s Elizabeth Cooney will be in New Orleans and will file three ADAs in 30 newsletters, with help from Elaine Chen, who will cover newsworthy items on the weekend agenda. If you would like to receive our newsletter, please sign up here.
The quiet collapse of America’s research ethics watchdog
In just over a year, the federal agency responsible for overseeing the vast research enterprise funded by the Department of Health and Human Services, including ensuring the safety of research participants, has collapsed.
The Office for Human Research Protections has lost more than half its staff through downsizing, resignations and early retirement. Many top leaders have left and the government’s advisory committees have also been disbanded. One former advisory board member called the office “devastating.”
What happens when watchdogs no longer monitor? And what is the legacy of this little-known office that has played such a vital role in rooting out fraud and protecting clinical trial participants? STAT’s Megan Molteni helps.
Pharmaceutical companies, patients criticize review system
Under review: Pharmaceutical companies and patient advocacy groups do not support the expedited drug review program introduced by former Food and Drug Administration Secretary Marty McCulley.
The criticism came yesterday during a listening session at the FDA attended by 17 speakers representing patient groups, drug companies, and academic groups. While some comments were positive, most called on the agency to pause the program and reinstate it through the normal regulatory process that requires public feedback.
The Secretary’s National Priorities Voucher Program was launched about a year ago to provide one to two months of FDA review to companies that can demonstrate that their drugs are “aligned with national priorities.” They agree, as the White House leverages a voucher program that rewards companies that help achieve political goals, such as lowering the price of GLP-1 obesity drugs and fertility drugs.
STAT’s Lizzie Lawrence has more from City Hall. read more.
Texas investigates energy drinks
Texas Attorney General and U.S. Senate candidate Ken Paxton (R) is launching an “investigation” into energy drink company Celsius to “protect Texas children from dangerous levels of caffeine.”
The announcement came after a Texas family sued Celsius, alleging that their 17-year-old child died from heart enlargement caused by excessive caffeine consumption of Alani Nu drinks, which contain 200 mg of caffeine.
Clearly, Paxton had been reading STAT. Sarah Todd wrote an article last spring about how health experts are concerned about the proliferation of wellness-branded energy drinks containing “overdoses of caffeine,” naming Celsius and Alani Nou among others. Even if energy drinks come with nutrition labels that disguise the risks of “good-for-you ingredients” like biotin or lion’s mane, the risks are real.
Daily Ebola updates
Americans at high risk of contracting Ebola will now have access to experimental treatments, federal health officials confirmed yesterday.
The antibody treatment, known as MBP-134, was manufactured by San Diego-based Mapp Biopharmaceuticals with funding from the Biomedical Advanced Research and Development Authority, an agency within HHS that supports the development of medical countermeasures against rare and emerging diseases and biological threats. It is currently unknown how many doses of MBP-134 exist. Read more from STAT’s Helen Branswell.
one fifth
That’s the same number of U.S. adults with private health insurance who are denied coverage for treatment recommended by their doctors (21%), according to a Commonwealth Fund study released today. The survey included responses from approximately 4,600 adults between the ages of 19 and 64 and looked at both previous authorization denials (pre-care) and claim denials (post-care).
For the 43% who have had their claims denied, it has resulted in medical debt that they are still paying off. For 41% of those who experienced a previous denial of approval, it led to delays in medical care. Additionally, 28% of people said it made their health problems worse.
“We need greater transparency across all insurance plans, expanded appeal rights, and standardized access review processes to give patients confidence in their insurance,” said Sarah Collins, one of the study’s co-authors. “Insurance helps people stay healthy and avoid medical debt.” Please read the full report for yourself.
what we are reading
- RFK Jr. looks into Americans’ medical records for clues about autism and vaccines, KFF Health News
- Three studies used by RFK Jr. and his allies to justify controversial vaccine policy changes face new scrutiny, The Guardian
- Nearly 60 Idahoans have gotten sick from drinking raw milk in the past two weeks, officials say, Idaho Capital Sun
- Otsuka’s renal drug slowed loss of function, but slower than expected in late-stage STAT study
