With as many as 14 million Americans potentially suffering from various forms of dementia by 2040, including the common Alzheimer’s disease, and with the costs of the care for them forecast to soar soon to more than $500 billion, a frenzied race is on for ways to deal with the debilitating cognitive syndromes. But will individual initiative or Big Pharma products matter most for seniors and their loved ones in the days ahead?
Industry analysts and patient advocates alike were stunned when drug maker Biogen reversed itself and announced that it would seek federal Food and Drug Administration approval for aducanumab, which the New York Times reported “is a monoclonal antibody, an expensive type of drug that attaches to specific proteins in order to disable them. The drug clears a key protein in Alzheimer’s disease — beta amyloid — that accumulates in plaques in patients’ brains. Aducanumab is given as an intravenous infusion once a month.”
Biogen had spent heavily on multiple tests of this drug, suddenly pulling the plug on it last spring, declaring with the counsel of an independent advisory board that the prospective prescription medication — and possibly the line of inquiry about beta amyloids and Alzheimer’s that had led to its creation — was a failure.
That left patients and researchers glum, as Biogen was among the last Big Pharma firms standing in the quest for a drug treatment for Alzheimer’s.
Just as suddenly, however, the firm said it had spent months re-evaluating its test data, including on the dosage that patients could tolerate. The firm said it now was convinced that aducanumab can help delay or arrest mild cognitive decline and the FDA should grant approval for its experimental use. That might allow as many as 10 million Americans to try the drug, in hopes that it helps them, as it apparently did for test subjects interviewed by various media outlets.
The FDA approval is not a foregone conclusion, and the company, among other things, will need to fully disclose its data. It also may need to deal with objections that, despite the testing aducanumab already has been subjected to, the product still has been under tight and limited study. Biogen already has said it is unsure how its product works in the brain and body, and the firm does not pretend the drug prevents or reverses Alzheimer’s, the New York Times reported. Biogen also has not said how much the drug might cost.
While Biogen’s resurrection of aducanumab also may fan embers of the dimming but once, red-hot theory of amyloids, knots, and wayward brain proteins as the central cause of Alzheimer’s and other dementia conditions, this medical scientific hypothesis has taken a beating in research. RJ Tesi, a doctor and CEO and cofounder of a biotech company that is working on other ideas about tackling Alzheimer’s described his skepticism in an opinion piece for the health and science news site Stat, writing of amyloid proponents:
“Yet the harder they looked, the more difficult it became to defend the role of amyloid as a cause of Alzheimer’s. One big problem is that almost 40% of patients with dementia do not have amyloid plaques in their brains while many people who die with normal cognition do have them. Other confusing findings, such as the fact that amyloid levels in the cerebral spinal fluid surrounding the brain go down as people get dementia, also made for uncomfortable explanations. Although this is the opposite of what would be expected, it was explained away by experts. A comfortable partnership developed between believers in the amyloid hypothesis, funding agencies, and drug companies, so that only programs supporting this hypothesis were funded. Even today, the largest amount of NIH funding for Alzheimer’s disease research goes to amyloid-0related research. Following the advice of their academic advisers — most of them members of the amyloid cabal — drug companies dutifully developed drugs to target amyloid with the goal of treating Alzheimer’s disease. They believed it was only a matter of time before the Alzheimer’s problem was solved. Other ideas were starved of funding or greeted with polite rolling of the eyes.”
So, is inflammation somewhere in the body or the brain to blame in Alzheimer’s and dementia, as Tesi and colleagues suggest it might? Does the problem and its solution lie in the gut and the human microbiome? Might there be multiple factors to be identified and treated?
Why physical exercise may matter more than brain exercise in slowing cognitive decline
A popular approach to staving off age-related cognitive decline, of course, has led to a flourishing, $2 billion market in “brain training” software, computer or online programs, and apps. But Austin Frakt — an economist, health policy researcher, and writer for the evidence-based New York Times “Upshot” column — looks at the data on whether seniors benefit by sitting around and fussing with mind games.
He says the studies suggest that they might benefit more by standing up and walking around. Lots. Here’s why:
“Instead of mind games, moving your body is among the most helpful things you can do. At least 150 minutes of moderate physical activity per week, including strength training, yields not just physical benefits but cognitive ones as well. But to be most effective, you need to do it before cognitive decline starts, according to the [World Health Organization]. Some evidence to support this recommendation comes from short-term studies. Several randomized studies of tai chi for older adults found it yielded cognitive benefits. Likewise, randomized studies of aerobic exercise for older adults found short-term improvements in cognitive performance. A systematic review published this year in PLOS One examined 36 randomized studies of exercise programs that were as short as four weeks and as long as a year. It found cognitive benefits of activities such as bicycling, walking, jogging, swimming and weight training.”
Now, as Frakt points out, these findings are based on “an association not necessarily causation” between an active life and a sound mind for a long time. Still, the evidence is good, including lots of small studies about exercise and benefits for, say, the cardiovascular system. The findings also suggest another key reason activity is so important: It makes seniors more social, too.
“One [key finding], suggested by a nearly 10-year study of almost 500 people over 79, is that physical activity is a gateway for social and cognitive engagement. The study found that participants who were more physically active also had more social contact that engaged their brains. In other words, physical activity brings us in closer proximity to others, with whom we then interact socially — think running clubs, adult soccer leagues, basketball pickup games or doubles tennis. And the social part, not just the physical one, may help keep our minds active.”
Be careful if you’re out walking or biking for exercise, by the way, as safety concerns are rising on the streets and highways of the nation and Washington, D.C.
In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damage that can be inflicted on them and their loved ones by nursing home abuse and neglect. Seniors — as we all do — may find great benefit by staying out of institutional care, including nursing homes and hospitals, for as much and as long as possible. Every medical care giving encounter, alas, is fraught with the potential for health care (hospital) acquired infections or real and problematic, even lethal medical error. Ask any senior, too, whether they would like to be on more or fewer prescription medications, too many of which are dangerous drugs, and you’ll get an earful about excessive pills and the perils of “polypharmacy.”
That said, dementia is one of the most feared debilitations of those aging now. With 10,000 baby boomers turning age 65 every day and this trend continuing for a decade, the nation has tons of work to do to provide the needed care and well-being of the aged, with, we hope, advances to ensure they are sound in body and mind.