labs
One small step for mousekind?
Robert F. Bukaty/AP
The FDA said in a press release yesterday that it would replace or limit animal testing requirements for starting human trials of antibodies and certain other drugs, if there are good alternative ways of modeling their safety in the lab. Those could include AI-based computational models of toxicity, as well as testing in miniature lab-grown organoids. The agency will also rely on real-world evidence from other countries when available to make evaluations on efficacy.
The move appears to be part of a years-long effort to spare our rodent cousins the ravages of drug development whenever possible, first instituted with the FDA Modernization Act 2.0 passed in 2022.
It's never a good day to be a lab rat, but today, it's a slightly less bad day. And it's a terrible day to be a stockholder of Charles River Labs, the company that conducts animal studies for much of the pharmaceutical industry. Its stock plummeted nearly 30% in about 30 minutes Thursday afternoon.
disability
HHS rejects gender dysphoria update to disability law
The Department of Health and Human Services will issue a ruling Friday morning that could upend a lawsuit against a key disability law. In November, Texas and 16 other states filed a suit arguing that the Biden administration adding gender dysphoria to the Section 504 of the Rehabilitation Act of 1973 was unconstitutional. Friday's rule clarification essentially strikes down this update, which lawyers say will render the suit moot. But experts are unclear how states will proceed because the suit's language is broad enough to include Section 504's integration mandate, which has helped shift the community's health care from institutions to community settings. (More info in this Q&A.)
We should have more clarity on April 21, when the states provide their next update and reveal their hand on whether they are only interested in striking down protections for trans people or if they will seek to disrupt life for millions of disabled people. — O. Rose Broderick
global aid
What happens with USAID gone?
The Trump Administration's decision to dismantle the United States Agency for International Development, or USAID, has left an enormous vacuum. The 64-year-old agency employed 14,000 aid workers, providing food and other critical aid to nearly 180 countries. No one country or entity can fill that gap, writes STAT contributor Arjun Sharma. But collectively, "the rest of the world's wealthy nations must work together to take its place."
Sharma, an infectious diseases physician at the University of Toronto, points to a 1970 World Bank report proposing that developed countries spend 0.7% of their gross national income on aid, a benchmark then adopted by the U.N. Most countries still fall far short, and if donor nations actually spent that, global aid would almost double. Even the U.S. was only spending 0.24% before gutting USAID. "If foreign assistance is viewed for its collective benefit — to security interests, humanitarian values, and public health — it is best to understand it, perhaps, as a collective obligation," Sharma writes.
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