“It puts us in a bad place,” agreed Dr. Karina Bishop, a geriatrician at the University of Nebraska Medical Center. Ethically, she added, “if this drug was available right now, I would not feel able to prescribe it.”
Even as individual doctors grapple with advising patients, hospitals and health systems are devising protocols for when Aduhelm becomes available, probably within weeks.
At the Mayo Clinic, said Dr. Ronald Petersen, a neurologist who directs the Alzheimer’s Disease Research Center there, “we’re going to stick pretty close to the inclusion and exclusion criteria used in the trial.”
That means only patients with mild cognitive impairment or early Alzheimer’s disease would qualify, after an M.R.I. to rule out 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 acknowledged, will employ such safeguards.
Dr. Eric Widera, a geriatrician at the University of California, San Francisco, expressed a similar concern: “If doctors were extremely cautious and limited this drug to the very specific population included in the study, with very careful monitoring, it would be the first time in medicine that was ever done.”
He pointed out another consequence of federal approval: a rift between some doctors and the Alzheimer’s Association, the national advocacy group, which this spring mounted a campaign it called More Time. Intended to demonstrate public support for approval of aducanumab, the effort included newspaper ads and social media posts.