“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 grapple with advising patients, hospitals and health systems are developing protocols of when Aduhelm is likely to be 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 are eligible after an MRI to rule out certain diseases and risks and a PET 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 medicine that has ever been done. “
He pointed to another consequence of the federal approval: a rift between some doctors and the Alzheimer’s Association, the national advocacy group, which launched a campaign called More Time this spring. To demonstrate public support for aducanumab’s approval, efforts included newspaper ads and social media posts.