Despite very questionable evidence and opposition from its own advisory group, the FDA recently approved the use of Aduhelm to treat patients with Alzheimer’s disease.
A cynical explanation for this sequence would be conflicts of interest, the influence of big pharma, and inevitably profits. A drug to treat Alzheimer’s disease would fill a vacant niche; There has been no significant progress in this area for almost 20 years. It would resonate with a large population in need and generate a fortune in revenue at a cost of over $ 50,000 per recipient per year.
But the same admixture, the pent-up public demand, the lack of other advances, something that comes close to desperation in the many of us who either suffer from Alzheimer’s or caring for someone, offers an alternative and more generous explanation. The harm to medicine can occur in two ways: commissioning and omission. Harm occurs both when treatment with a potential benefit is refused and when treatment is approved that does not bring any benefit and involves risks.
In all areas where treatments abound and public emergency is not urgently needed, the FDA is required to apply careful filters. These standards make sense when patient needs are not neglected when there are reasonably safe and effective treatment options.
However, the calculation changes when the need is urgent and unmet and treatment options are lacking. This area is the basis for the “extended access” provisions of the FDA regulation, often referred to as “compassionate use”. Medicines and devices, despite the relative lack of evidence, can be made available to those in dire need for the simple reason that sometimes almost anything that gives hope is better than nothing. If we are inclined to be generous in our judgments, perhaps the FDA had similar motivations regarding Aduhelm.
However, there is one important perspective missing from the troubled aducanumab drama. Because there is a better way to even take our brain into account. Extensive research brings the risk factors for Alzheimer’s disease in line with the risk factors for cardiometabolic diseases. Two issues are in the foreground, one suggests that Alzheimer’s is closely related to coronary artery disease, the other suggests a closer relationship with insulin resistance and diabetes. Given the close links between diabetes, obesity, systemic inflammation, vascular injury, and coronary disease, perhaps these two issues are really just variants of one.
Either way, the conclusion is the same: Lifestyle can prevent and prevent dementia, Alzheimer’s and others in most cases. The evidence comes from a wide variety of research including mechanisms, animal models, intervention studies, and observational epidemiology. It also extends to ethnography, the observed fate of entire populations across generations. Although the residents of the Blue Zones live longer than the rest of us, they generally retain their cognitive and physical vitality. This combination is not a coincidence; The basis for mental vitality is physical vitality. Like the brain, the mind goes, and the brain derives its health from the general health of the vascular system, the immune system, the neuroendocrine system, the microbiome, and all the rest of the inevitably attached to the neck.
The formula is as effective as it is known: an optimal diet with whole foods, predominantly plant-based; routine physical activity; adequate sleep; Relief from stress; Avoidance of toxins; strong social connections. Denoted by different names, these are the same pillars that support the rightly revered lifestyle such as medicine. We will of course still need treatment progress. No matter how proactive or conscientious we may be, bad things – including dementia – will sometimes happen anyway. New therapies are imperative for many of us already grappling with this scourge among those we love.
But far fewer of us would be able to monitor the FDA’s actions so closely if we took matters into our own hands early on, did the consistent, rewarding work of relying on lifestyle as our primary medicine – and to think better of our own body and brain.
Dr. David L. Katz
is a Specialist in Preventive Medicine / Public Health and a past President of the American College of Lifestyle Medicine
