内容摘要：And when there’s already a proven vaccine for the same disease, it’s unethical to test a new version against a placebo, he said.

And when there’s already a proven vaccine for the same disease, it’s unethical to test a new version against a placebo, he said.

Back in 2022, Griffith had a hard time figuring out how to ask a dying patient if he’d consider undergoing the world’s first transplant of a gene-edited pig heart.“I was so afraid to mention the word pig heart,” Griffith said. He marveled that patient David Bennett responded with a joke about oinking and made clear if the

failed that “maybe you’ll learn something for others like me.”Fast forward to late 2023, when patients at a National Kidney Foundation meeting with FDA officials and pig developers described a life so miserable on dialysis that they, too, would chance an animal organ.“Why not try? That was really what we took back,” said Mike Curtis, CEO of eGenesis, one of the companies developing organs. “It was like we really almost have an obligation to try.”

“The patients pushed us to go ahead,” agreed Dr. Tatsuo Kawai, a Mass General surgeon who’d been reluctant to even broach the idea – but last March, four months after that meeting, gave a longtime patient the first gene-edited pig kidney.In Palm Springs, California, Carl McNew emailed NYU to ask about volunteering while he’s still fairly healthy.

McNew donated a kidney to his husband in 2015 but later his remaining kidney began declining, something very rare in living donors. Medications and intermittent dialysis are helping but McNew knows he’ll eventually need a transplant.

Carl McNew watches television with his husband Steve Hunter in Palm Springs. (AP Photo/Shelby Lum)More than 6 million people in the United States and millions more around the world have Alzheimer’s, the most common form of dementia.

The new test, from Fujirebio Diagnostics, Inc., identifies a sticky brain plaque, known as beta-amyloid, that is a key marker for Alzheimer’s. Previously, the only FDA-approved methods for detecting amyloid were invasive tests of spinal fluid or expensive PET scans.The lower costs and convenience of a blood test could also help expand use of two new drugs, Leqembi and Kisunla, which have been shown to slightly slow the progression of Alzheimer’s by clearing amyloid from the brain. Doctors are required to test patients for the plaque before prescribing the drugs, which require regular IV infusions.

“Today’s clearance is an important step for Alzheimer’s disease diagnosis, making it easier and potentially more accessible for U.S. patients earlier in the disease,” said Dr. Michelle Tarver, of FDA’s center for devices.A number of specialty hospitals and laboratories have already developed their own in-house tests for amyloid in recent years. But those tests aren’t reviewed by the FDA and generally aren’t covered by insurance. Doctors have also had little data to judge which tests are reliable and accurate, leading to an unregulated marketplace that some have called a “wild west.”