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If a physical change affects half of all people as they age, this would seem to suggest that it is a normal variant of human aging, which to the best of our knowledge is an accumulation of metabolic and genetic errors that accrue as we get older until some sub-unit(s) of the processes reach a threshold at which continued functioning of the body is impossible. Our current regulatory apparatus remains trapped in a 20th century mindset which fails to recognize how various diseases are nothing more than unfortunate variants of the aging process that all of us will one day fall prey to.
For example, in Alzheimer's "Disease" errors of metabolism (malformed proteins) in neurons in the brain lead to an accumulation of defective protein parts which eventually disrupt the functioning of the neuron, ultimately killing it. When this process has gone on long enough to have damaged and destroyed some as yet unknown fraction of the brain, the person becomes neurologically symptomatic. This "Disease" is not communicable, nor is it caused by an exogenous agent. The damage to the brain occurs as the result of biological failure that all of us will have to face in one form or another. The New York Times yesterday reported on a glimmer of recognition of these facts while describing new guidelines for diagnosing early and prodromal Alzheimer's "Disease":
For the first time in 25 years, medical experts are proposing a major change in the criteria for Alzheimer’s disease, part of a new movement to diagnose and, eventually, treat the disease earlier.
The current formal criteria for diagnosing Alzheimer’s require steadily progressing dementia — memory loss and an inability to carry out day-to-day activities, like dressing or bathing — along with a pathologist’s report of plaque and another abnormality, known as tangles, in the brain after death.
But researchers are now convinced that the disease is present a decade or more before dementia.
“Our thinking has changed dramatically,” said Dr. Paul Aisen, an Alzheimer’s researcher at the University of California, San Diego, and a member of one of the groups formulating the new guidelines. “We now view dementia as a late stage in the process.”
The new guidelines include criteria for three stages of the disease: preclinical disease, mild cognitive impairment due to Alzheimer’s disease and, lastly, Alzheimer’s dementia. The guidelines should make diagnosing the final stage of the disease in people who have dementia more definitive. But, the guidelines also say that the earlier a diagnosis is made the less certain it is. And so the new effort to diagnose the disease earlier could, at least initially, lead to more mistaken diagnoses.
Under the new guidelines, for the first time, diagnoses will aim to identify the disease as it is developing by using results from so-called biomarkers — tests like brain scans, M.R.I. scans and spinal taps that reveal telltale brain changes.
The biomarkers were developed and tested only recently and none have been formally approved for Alzheimer’s diagnosis. One of the newest, a PET scan, shows plaque in the brain — a unique sign of Alzheimer’s brain pathology. The others provide strong indications that Alzheimer’s is present, even when patients do not yet have dementia or even much memory loss.
This is a dead end street. The FDA does not recognize aging as a treatable condition and only approves treatment for "Disease." Since Alzheimer's is not a Disease but a predictable variant of aging, the only treatments allowed and currently being developed are those that slow down the progression of the "Disease." Alzheimer's could quite likely be cured if the money now spent developing means to slow down the condition were devoted to finding ways to directly remove the toxic neurofibrillary tangles that form the Alzheimer's plaques.
It gets worse. Because the FDA only evaluates treatments for Diseases, and its definition of disease versus aging is completely arbitrary (why is Type II Diabetes a disease while Sarcopenia, the loss of muscle mass and function that accompanies aging, is not?) we are forced to develop treatments that primarily address symptoms rather than either repairing damage or rejuvenating systems. In such a bureaucratized environment we might well be better off as mice than men:
Gene Therapy Trains Immune Cells Against Cancer
Researchers at UCLA’s Jonsson Comprehensive Cancer Center created a large, well armed battalion of tumor-seeking immune system cells and watched, in real time using Positron Emission Tomography (PET), as the special forces traveled throughout the body to locate and attack dangerous melanomas.
But for now this sort of thing only gets done for those tricky lab mice who have done such a great job of convincing researchers into developing medical treatments for them first.
If I had terminal cancer and a large sum of money I'd hire medical researchers to do this to my own immune system.
The gene therapy work, done with melanomas grown in mice, employed a crippled HIV-like virus to serve as a vehicle to arm the lymphocytes with T cell receptors, which caused the lymphocytes to become specific killers of cancerous cells....
“The novelty of our work is that we were able to pack together the cancer specific T cell receptor and the PET reporter genes in a single vector and use it in mice with an intact immune system that closely resembles what we would see in real patients,” said Dr. Richard Koya, an assistant professor of surgical oncology at UCLA’s David Geffen School of Medicine and first author of the study. “We were also gladly surprised to see the targeted tumors literally melt away and disappear, underscoring the power of the combined approach of immune and gene therapy to control cancer.”
Time to do this in humans who have a few months to live. Maybe Chinese researchers will do it without waiting a long time to do more animal tests.
Metastatic Melanoma is a death sentence, usually offering mere months of pain before death. The FDA is, first and foremost, a bureaucracy. Its primary purpose is to protect itself and its prerogatives. It is always safer for a bureaucrat to say 'No' and suffer invisible opportunity costs than to say 'Yes' and risk having to answer for poor outcomes. I am sure the members of the FDA boards are smart, well meaning people, but they operate under the aegis of the Precautionary Principle which has been slowing down the development of biological developments since the Thalidomide disaster. Can you imagine the FDA approving emergency experimental treatment for a terminally ill human with an HIV-like virus? They would have nightmares of headlines in the New York Times should something go wrong (which it almost certainly would in the first attempts, which is why such attempts would be reserved for the terminally ill); the facts of the case would be immaterial once the news media hysterics and the tort lawyers got their hands on it.
We desperately need the FDA to realize that aging is an unnecessary Disease. In fact, aging may be the cause of the vast majority of "Diseases" that healthy First World citizens will eventually succumb to. Furthermore, aging may well be amenable to treatment. Our descendants may well regard the catastrophe of aging from the same remove as we view once deadly scourges like Scurvy and Bubonic Plague: archaic, now very rare, easily treatable conditions.
The bureaucratization of health care promises to destroy the Golden Goose of Medical innovation and technology that is currently giving us a 25% ROI. We are gaining 3 months of increased life expectancy for every year that passes. It is criminally suicidal to allow such a bounty to be destroyed or impaired.