Groups representing Alzheimer’s patients were predictably outraged earlier this month when the Centers for Medicare and Medicaid Services (CMS) announced it would limit its coverage of Biogen’s controversial drug, Aduhelm, to patients enrolled in approved clinical trials. The ruling is “an unprecedented and terrible draft decision,” Alzheimer’s Association CEO Harry Johns told Reuters. “[It] usurps [the] FDA’s role in drug approvals.”
Johns and his ilk are choosing to ignore the fact that the Food and Drug Administration’s approval of Aduhelm last summer came despite nearly unanimous opposition from its advisory board, which pointed to sketchy results in Biogen’s clinical trials. And uncertainty about the drug’s effectiveness — not to mention its $56,000 price tag for a year’s worth of infusions — considerably dampened consumer demand once the drug became available. Major healthcare organizations panned the treatment, which is designed for patients displaying mild cognitive dysfunction, and few people could afford it.
Biogen last month slashed the drug’s price to $28,200 in an effort to gain some market traction, but CMS coverage was key, because Medicare beneficiaries were its obvious target audience and would be on the hook for only 20 percent of the bill. That’s still a hefty copay, but it’s not hard to imagine that plenty of desperate Alzheimer’s patients and their loved ones would eventually gamble on the drug’s potential benefits, allowing the company to recoup its investment.
Anyone who’s been paying attention to this saga knows the Aduhelm treatment regimen is a crapshoot. Biogen’s own trials produced enough mixed results and fearful side effects to roil the FDA’s entire approval process. The drug reportedly reduced the beta-amyloid brain plaque that may contribute to Alzheimer’s, but it didn’t slow the disease’s progression. And about four in 10 patients suffered from brain swelling during the trials; one 75-year-old woman died.
And yet you can argue that all pharma research is by nature somewhat dicey, and the drugs its efforts produce offer no guarantee of benefits or certainty of harms. The scientific method is, after all, a process built upon trial and error: You might even say it’s an inexact science.
So, I found it almost synchronistic last week that, amid the Aduhelm kerfuffle, a new study emerged that touted similar benefits for older adults hoping to avoid — or at least delay — the scourge that is Alzheimer’s. The findings of this research, however, will never face FDA or CMS scrutiny. You can’t bottle exercise.
As lead study author Kaitlin Casaletto, PhD, explains in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association, physical activity produces the proteins that build the gray matter necessary to keep the synapses firing, connecting the neurons that enable cognitive function.
“Our work is the first that uses human data to show that synaptic protein regulation is related to physical activity and may drive the beneficial cognitive outcomes we see,” notes Casaletto, an assistant professor of neurology at the University of California San Francisco. “Maintaining the integrity of these connections between neurons may be vital to fending off dementia, since the synapse is really the site where cognition happens. Physical activity — a readily available tool — may help boost this synaptic functioning.”
Using data from the Rush Memory and Aging Project, Casaletto and her team analyzed the brain tissue of 404 deceased older adults who had completed an activity-monitoring program just prior to their deaths. The brains of those who had exercised regularly during the last two years of their life, the researchers discovered, contained levels of “presynaptic protein” associated with strong cognitive function. Exercise, in other words, may do just what Biogen claims it developed Aduhelm to do: mitigate the development of Alzheimer’s.
“Individuals who are just beginning to display cognitive symptoms (MCI) may represent a particularly plastic therapeutic window of opportunity ideal for physical-activity interventions targeting synaptic functioning,” Casaletto writes.
Or it may all be just a coincidence. Because her study was observational, Casaletto can’t be sure whether it was exercise that produced the cognitive benefits or whether efficient cognitive functioning spurred the seniors to exercise. “Physical activity and synapse relationships are likely highly dynamic and bidirectional in nature,” she admits, “and our observational study design precludes conclusions regarding causality.”
More research, as they say, is necessary.
CMS is collecting public comments on its preliminary Aduhelm ruling, and the agency is expected to announce a final decision on April 11. If it succumbs to what is shaping up to be a tsunami of lobbying by advocates for Alzheimer’s patients and expands Medicare coverage for the drug, we may eventually learn whether the drug can really deliver relief for at least some of those who need it. Meanwhile, it’s probably not a bad idea for seniors worried about maintaining all their marbles to get up off the couch on a regular basis and move around some. Maybe it’ll help, and it surely can’t hurt.
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