fda
No vaccines for you!
Lizzy Lawrence just published an investigative story about how two top FDA officials are quietly upending vaccine regulation.
She opens with a previously unreported meeting at which Tracy Beth Høeg, a lieutenant of Makary, laid out plans to change the label of all Covid-19 vaccines to warn that its risks outweigh the benefits for men ages 12 to 24, effectively taking it away from this group.
Hoeg backed down after the career scientists at the meeting pushed back and biologics chief Vinay Prasad said the move wasn't necessary because he had already limited access to the shots.
Lizzy interviewed more than 20 current and former FDA employees, contractors, and vaccine experts, and reviewed surveillance data, contracting data, regulatory documents, internal memos, and emails to piece together the ways that Prasad and Høeg are challenging current vaccine regulation.
The FDA, Prasad, and Høeg did not respond to STAT's requests for comment.
Read more.
drug regulation
An old hand takes the reins at the FDA's drug center
Richard Pazdur has been at the FDA for 26 years. He founded the agency's Oncology Center of Excellence, where he's overseen cancer therapies ever since. Now he will be the agency's top drug regulator, Lizzy reports.
It's been a tumultuous year at the FDA, and Lizzy has expertly followed it all. Pazdur is the third person to lead the drug center this year. The previous director, George Tidmarsh, exited the agency amid accusations of using his regulatory authority to attack a former business associate and amid infighting with biologics center director Vinay Prasad, who also departed the FDA only to return two weeks later.
Read more about how Pazdur's appointment came about.
food
How Kennedy's dietary guidelines might impact school lunches
Kennedy has promised to change U.S. dietary guidelines to encourage consumption of more saturated fat by year's end. Nutrition scientists tell Sarah Todd that the changes could make school lunches, and the kids who eat them, much less healthy.
There are legitimate debates in the nutrition field over the health effects of saturated fat in whole-fat dairy in particular. An HHS spokesperson said Kennedy is committed to new dietary recommendations that are rooted in rigorous science.
But nutrition experts who spoke to Sarah fear the implications of jettisoning 75 years worth of data that show saturated fat raises are linked to a higher risk of strokes and heart disease. Read more.
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