Pursuing the Alzheimer Cure

By: 
Al Jacobs

On June 7, The U.S, Food and Drug Administration (FDA) approved the drug aducanumab for the treatment of Alzheimer’s disease. This is the first new drug to be authorized by the agency since 2003. As a condition of approval, the FDA is requiring the drug’s maker, Biogen, to conduct studies to confirm an actual clinical improvement from its use, or such approval may subsequently be withdrawn. The medicine, to be marketed under the trade name Aduhelm, will be used to treat only the very early stages of the disease.

Before we go further, you might note this action by the FDA is not without controversy. The only undisputed function the drug performs is to show progress in reducing the sticky brain plaques, known as beta-amyloid – one of the hallmarks of the disease. Understandably, reducing amyloid is not the same things as eradicating symptoms of dementia. There is no firm evidence the drug either slows or reverses the progression of the ailment.

More to the point, specialists are not certain whether the amyloid is a cause or a symptom of the disease. And be aware that more than two decades of clinical trials of amyloid-reducing drugs failed to address symptoms. Furthermore, two extensive studies of aducanumab offer conflicting evidence as to whether such treatment is even capable of slowing the declines in memory or thinking.

For these reasons the neurological experts on the FDA’s advisory panel recommended in November 2020 that the agency not approve the drug. In addition, Dr. Jason Karlawish, professor of medicine and medical ethics and an Alzheimer’s expert at the University of Pennsylvania’s Perelman Schools of medicine, just announced he would not prescribe aducanumab to his patients, even with FDA approval, due to the risks of bleeding in the brain as well as its financial cost and uncertain benefits.

As with all controversial subjects, there are both pros and cons. Despite the essentially unfavorable prognosis of the drug, the FDA expressed concerns which could not be ignored. Although the agency acknowledged the uncertainties about the medication, it contended its approval to be justified because of the seriousness of the disease and the dearth of options for treating it.

According to Dr. Patrizia Cavazzomi, director of the FDA Center for Drug Evaluation and Research, “We are extremely aware of the gradual and cumulative destruction that Alzheimer’s disease causes. The need for treatment is urgent: right now more than six million Americans are living with Alzheimer’s disease and this number is expected to grow as the population ages.”

A somewhat similar attitude can be seen in the approval of Dr. Richard Hodes, director of the National Institute on Aging, when he said “This is a sign of hope but not the final answer. Amyloid is important but not the only contributing factor.” He further implied that what must be done is to mobilize the nation’s efforts and its funds to combat the ailments impairing our advanced years.

It is clear the nation’s federal health leadership cannot ignore these situations of profound upheaval. Something must be done to display concern, regardless of whether anything of consequence results.

As a concluding thought on this controversy, let me add several predictions:

1)  Millions of sufferers and their families will avail themselves of the drug.

2)  The drug will impart no beneficial medical result whatever.

3)  Biogen’s decision to price the drug’s annual cost at $56,000 will not hold.

4)  The FDA will eventually disallow its approval of aducanumab.

5)  No single drug will ever be found to ameliorate Alzheimer’s disease.

Though we have concluded our analysis of Biogen’s gift to the world, we are not finished with our pursuit of the Alzheimer saga. Without a doubt, it is an horrendous ailment, but it became so only over the past half-century or so. The reason for this is purely age-related. This disease normally affects persons in the later stages of life – normally in the late-60s and beyond … and these people were not around back then.

What you must realize is that prior to the mid-20th century, most persons did not live to a ripe old age. Perhaps you wonder why the Social Security system, established in 1935, provided for retirement payment to commence at age 65. It is because this was average actuarial life expectancy at the time.

When then-President Franklin Roosevelt set the system up, he expected it to remain solvent indefinitely, as most anticipated recipients would be long dead before they ever collected much from Social Security. You may now inform the tens of thousands of today’s octogenarians of this fact.

Strangely enough, a major problem in treating this ailment is due to its name – Alzheimer’s disease. Named for the German neuropathologist Alois Alzheimer, who first described the condition in 1902, it became assigned to individuals who displayed symptoms of senile dementia between the ages of 45 and 65. The terminology changed in 1977 following a conference of professionals in the field, who concluded the symptoms observed seemed much the same independent of age.

Thereafter the term Alzheimer’s disease became universally used. However, for this reason, it raises the implication it is a singular ailment and, accordingly, will be cured with a single medication. This best explains why most of the research dedicated to its alleviation is relegated in this fashion.

My belief is dementia is a multitude of ailments, so no single treatment will ever begin to offer any effectiveness. In this respect it is much like the expression death by old age – this actually being a failure of numerous bodily functions, each of which must be treated separately. It’s my suspicion that if the latter had been named “Methuselah syndrome,” there would be a well-funded organization by that name, operating on a plethora of massive grants, diligently searching for a single ingredient to magically end all human fatalities.

What you may find interesting is a 2015 research study from the National Institutes of Health (NIH) revealing overweight or obesity at age fifty increases the risk a person may develop Alzheimer’s disease in later years. They concluded more midlife pounds translates to an earlier onset of the disease. In addition, a 2019 report from the same organization disclosed two-thirds of Americans with Alzheimer’s disease are women. The long-held presumption that this is because of longer female life expectancy is now questioned.

Although Alzheimer’s research dates back many years, the cause of the ailment is unknown and no treatment to delay or halt its progression is available … but for one exception: A division of NIH reports “Physical activity is associated with a reduced risk.”

Let me now offer a theory for consideration. It is well known that cerebral hypoxia – impairment of brain function – can result from acute oxygen deprivation. Is it therefore not possible long-term oxygen reduction may result in those symptoms identified with Alzheimer’s? As women may be less likely than men to engage in cardiovascular exercise over a lifetime, there’ll be less oxygen flowing to their brains. 

And isn’t it equally possible middle-age weight gain results from an individual slowing down, while the circulatory system pumps less oxygen-carrying blood to all parts of the body? In addition, the accumulating fat is not restricted to the body’s mid-section. It also lines the walls of the blood vessels, specifically the two carotid arteries transmitting blood to the brain. 

As we are aware, untold sums are devoted to research studies in an attempt to find a cure for this devastating affliction. Is it possible some effort might be undertaken to focus on the simple effect I’ve postulated? If it could be determined a meaningful portion of an effective treatment might be the result of so simple a factor as I’ve proposed, would that not be welcomed by all?

At the risk of sounding cynical, I’ll offer a negative response to my question. It is my belief the army of researchers, patient aides, drug testers, lobbyists, involved scientists, fund raisers, hospital administrators, and others who provide oversight, guidance, materials and services of all sorts would be devastated if an actual cure materialized. There are fortunes being garnered in studies conducted, research reports, testing and retesting, drug experimentation, and all the allied activity lobbied through Congress.

The possibility that so simple a solution as I’ve proposed could be even partially accurate would destroy an entire research industry – and disrupt the cascade of dollars flowing to the thousands of persons involved. No, the studies to be conducted must continue to be as complex and imponderable as can be devised, for there is not much profit to be reaped by encouraging oldsters to vigorously walk four miles at a clip or visit the local YMCA for a daily swim.

Just as the highly prestigious March of Dimes organization attempted, in the mid-1950s, to suppress the Salk vaccine’s effective treatment for the poliomyelitis scourge, the Alzheimer’s researchers will do what they can to extend their quest for the impossible dream to the outer limits of infinity.

 

Al Jacobs, a professional investor for nearly a half-century, issues weekly financial articles in which he shares his financial knowledge and experience. Al may be contacted at al@abjacobs.com

 

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