drug shortages
DEA's flip-flop on quota policy
The Drug Enforcement Agency has reversed a policy that was meant to mitigate shortages of opioids that hospitals commonly use, but that was paradoxically about to make those shortages worse, my colleague John Wilkerson reports.
The DEA sets the quantity of controlled substances that drug companies are allowed to make. Until this year, those quotas were set annually for Schedule II drugs, including morphine and other injectable opioids that hospitals regularly use. The agency said some companies were not manufacturing to the limits of their annual quotas, which was creating shortages, so the DEA tightened the quotas to quarterly amounts to fix that problem.
FDA had approved companies to make those drugs in larger quantities than could be made in quarterly batches. The DEA agreed to revert back to annual quotas for injectable opioids and to set semi-annual quotas for the rest of Schedule II controlled substances.
politics
A veteran physician-reporter's tough questions for the presidential candidates
Larry Altman, who has covered the health of every U.S. president since Reagan in his capacity as a medical doctor and former New York Times reporter, spoke with our illustrious executive editor Rick Berke at our D.C. event this week about his biggest unanswered questions for both former President Trump and President Biden.
- For President Biden: "Why do you think so many people think you're so old when you have demonstrated on television that you can communicate with people… Why from your point of view, do you think people are reacting the way they are?"
- For former President Trump: "Have you kept to the diet at the White House had for you as president, and what effect has that had? Have you lost or gained any weight? If you've changed weight, why?... Are you still putting ketchup on everything and are you still eating hamburgers right and left?"
science
FDA raised concerns about brain biopsies
Mount Sinai has been collecting brain biopsies on live patients for research purposes in a way that the FDA was concerned could introduce "serious risks to the human subjects," Katherine Eban writes for STAT.
The subjects were vulnerable and may not understand the consequences of losing brain tissue, an FDA review concluded. But the review was apparently never communicated to Mount Sinai and the biopsies continued. The Living Brain Project has collected over 600 brain samples.
Eban investigates statements that Mount Sinai researchers repeatedly made that some neurosurgeons were at least ambiguous, and at worst untrue, about the risk of taking the biopsies.
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