Hello, everyone, and how are you today? We are doing just fine, thank you, especially since the middle of the week is upon us. After all, we have made it this far so we are determined to hang on for another couple of days. And why not? The alternatives — at least those we can identify — are not particularly appetizing. And what better way to make the time fly than to keep busy. So grab that cup of stimulation and get started. And there appears to be good reason to fire up the kettle sooner than later. Our flavor today, by the way, is pistachio creme — sweets for the sweet, you know? And now … onward. Here are a few items of interest to help you get started. We hope you have a lovely day, and do keep in touch. …
In a wide-ranging interview, Robert Califf, the departing U.S. Food and Drug Administration commissioner, defended the agency’s record under his leadership, praised the agency’s progress in changing the way it regulates food, and worried about the impact of the coming Trump administration, STAT tells us. He also articulated a very specific doctrine about the role of an FDA commissioner, one that is limited in its power and leaves many controversial decisions to career government officials. Califf said he would not directly comment on any individual, and said he was going to be “guarded” until after the transition to the new administration. But he echoed the fears of other critics of the Trump administration, saying brain drain in the government was a legitimate concern, including at the FDA. “It’s already happening. I mean, we’re seeing an increase in early retirements and loss of good people. So I’m worried about it. A lot of people are sticking it out, and I’ve encouraged them to do so. And you know, sometimes you get surprised by how well things work that you thought might not work so well. So it’s worth it, given the mission.”
GSK and Pfizer vaccines for respiratory syncytial virus will carry warnings that they can increase the risk of developing a rare neurological disorder, Reuters writes. The FDA conducted a post-marketing trial that suggested an increased risk of Guillain-Barré syndrome 42 days following vaccination, although the available evidence was insufficient to establish a causal relationship. The risks flagged in the prescribing information of GSK’s Arexvy and Pfizer’s Abrysvo are not the regulator’s strictest “boxed” warnings. GBS is a rare disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis. RSV, which typically causes cold-like symptoms, is a leading cause of pneumonia in toddlers and older adults. In Arexvy’s clinical trial, a participant had developed GBS after receiving the vaccine, while in Abrysvo’s trial, one participant developed the disease and another got a variant of it. Last year, advisers to the U.S. Centers for Disease Control and Prevention postponed endorsing Arexvy for the 50-to-59 age group. They had also flagged the risk of GBS.
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