pharma

Five burning questions on the Covid-19 vaccine framework

Matt Rourke/AP

FDA Commissioner Marty Makary promised stakeholders last week that the agency’s new Covid-19 vaccine framework would answer all of their questions. But as STAT’s Lizzy Lawrence and Helen Branswell report, it’s created maybe just as much confusion as clarity. 

Some of STAT’s most pressing questions are: What does this mean for Covid-19 vaccines already on the market? What happens if companies making Covid-19 vaccines decide they don’t want to run more studies? And will adults under 65 without risk factors be able to get vaccinated against Covid-19 anymore? 

Read more from Lizzy and Helen, who run through what we do and don’t know on each burning question. Plus: Alex Hogan made a great short video on the framework, and Jonathan Wosen explained how we know mRNA vaccines are safe and effective.

Keep an eye out for more news today, as the FDA’s vaccines expert panel is meeting to discuss if Covid-19 vaccines should be updated for the coming fall. Experts and industry figures will be watching the meeting closely, hoping to glean more about the framework.

mental health

Surprising results from private equity-owned psych hospitals

Private equity ownership of psychiatric hospitals grew rapidly from 2013 to 2021, but the quality of care did not diminish when compared to facilities not owned by private equity, according to a JAMA Psychiatry study published yesterday.

The study found that the facilities had higher occupancy rates and a lower staff-to-patient ratio compared to non-private equity owned facilities during the eight-year period. However, the facilities’ care quality did not decline, including lower usage of restraints and equal rates of seclusion, though the authors were quick to note that this data is self-reported and prone to tampering.

The authors also noted that the results were somewhat surprising, given private equity’s track record in health care. Private equity firms’ ownership often coincides with poorer health outcomes for many populations, including people with developmental disabilities, psychiatric care, and autism. More data is needed to determine the impact of private equity on psychiatric hospitals’ financials and quality of care. — O. Rose Broderick 

policy

LGBTQ+ researchers sue HHS, NIH over grant cuts

A group of physicians and researchers sued the NIH and HHS on Tuesday over the sweeping grant terminations that have impacted medical research on queer people as part of the implementation of President Trump’s executive orders targeting transgender people and diversity initiatives. It’s the second lawsuit to specifically focus on how the cuts have affected LGBTQ+ research, after another group sued in mid-May. 

The plaintiffs argue that the government action violates the Constitution’s Fifth Amendment guaranteeing equal protection on the basis of sex, sexual orientation, and gender identity, as well as the due process clause. Read more from me.