Such doctors face “a dilemma,” said Dr. Karlawish, “a moment when there is no decision that solves all uncertainties and all ethical concerns.”
“That puts us in a bad position,” agreed Dr. Karina Bishop, a geriatrician at the University of Nebraska Medical Center, added. From an ethical point of view, she added, “If this drug were available now, I would not be able to prescribe it.”
As individual doctors delve into advising patients, hospitals and health systems are developing protocols in case Aduhelm is likely to become more widely available within weeks.
At the Mayo Clinic, Dr. Ronald Petersen, a neurologist who heads the Alzheimer’s research center there, “we will be sticking fairly closely to the study inclusion and exclusion criteria.”
This means that only patients with mild cognitive impairment or early Alzheimer’s disease after an M.R.I. to exclude certain conditions and risks, and a P.E.T. Scan or lumbar puncture to confirm the presence of amyloid. The Mayo protocols, like the clinical trials, would exclude people taking blood thinners like warfarin or Eliquis.
“It’s not like you come in and say, ‘I’m a little forgetful,’ and we say, ‘Here’s this drug,'” said Dr. Petersen. But not every provider, he admitted, would take such security precautions.
Dr. Eric Widera, a geriatrician at the University of California, San Francisco, expressed a similar concern: “If doctors were extremely careful and restricted this drug, under very careful monitoring, to the specific population enrolled in the study, it would be the first time in the medicine that has ever been made. “