No surprise that the FDA doesn't recognize aging as a medical condition. They don't even recognize that our own stem cells aren't drugs as they continue to interfere with the practice of medicine.

FightAging!
10-8-17

In recent years numerous groups have made a start on the long road of changing the public view of aging, from considering it a normal state to considering it a pathological state. To have it recognized as a harmful medical condition that can in principle be treated - that medical technologies can be developed for this purpose soon enough to matter. This is a process of unofficial advocacy and persuasion on the one hand, to change minds and educate people, but on the other there is also a strong component of formalism, of working with regulatory definitions. Medical research and development is, sadly, heavily regulated. The structure of regulation shapes the ability to raise funding and carry out meaningful work on the creation of means to treat aging. The US FDA, for example, doesn't recognize aging as a condition that can or should be treated, though the first cracks in that position are taking shape in the form of the TAME metformin trial. Yet the current position still mea ns that efforts to treat aging struggle to find the necessary resources to proceed.

Since most agencies base their regulation on the World Health Organization's (WHO's) International Statistical Classification of Diseases and Related Health Problems, with ICD-11 being the latest edition in the process of being finalized, some initiatives have focused on placing aging into that document as a formally defined disease. This would be in a definitive way, unlike the one or two present entries that might be interpreted as referring to aging, given the right light, but in practice are disregarded. Whether or not aging is called a disease is a matter of semantics, and in this the powers that be and the fellow in the street both seem quite willing to designate numerous specific aspects of aging as diseases, with fashion rather than logic dictating what is a portion of normal aging and what is a disease. But when it comes to the ICD, these semantics drive policy and regulation. That has material consequences, more is the pity. Things would move forward a lot more rapi dly absent the heavy restrictions placed upon medical research and development, I feel. There are already ample laws covering fraud and harm in the conduct of any human action. Why all the rest layered on top? It feels like control for the sake of control, institutions perpetuating themselves simply because they can.

Ultimately, rules follow opinions, or at least those opinions prevalent among the rule-making class. They are swayed by the zeitgeist. So a shift of public opinion and awareness about aging - and about the advent of near-future rejuvenation therapies that actually work - is important. In the ideal world, the fellow in the street would think of aging in the same way as he thinks of cancer: that someone should do something about it, because it is a painful, undesirable thing, and it is both good and generous to help the laboratories and clinics and funding institutions to make progress on this front. As things stand, we're a fair way from that goal, unfortunately. It will be very interesting to watch how matters progress in public opinion should the first human trials of senolytics produce good data and proof of effectiveness. Meanwhile, there are people toiling in the maze of regulatory definition, trying to carve out a path, a way to adjust the present stifling system of rule s and statements:

Recognizing Degenerative Aging as a Treatable Medical Condition: Methodology and Policy

Given the rapid aging of the world population and the accompanying rise of aging-related diseases and disabilities, the task of increasing the healthy and productive period of life becomes an urgent global priority. It is becoming increasingly clear that in order to accomplish this purpose, there is an urgent need for effective therapies against degenerative aging processes underlying major aging related diseases, including heart disease, neurodegenerative diseases, type 2 diabetes, cancer, pulmonary obstructive diseases.

One facilitating possibility may be to recognize the degenerative aging process itself as a medical problem to be addressed. Such recognition may accelerate research, development and distribution in several aspects: 1) the general public will be encouraged to actively demand and intelligently apply aging-ameliorating, preventive therapies; 2) the pharmaceutical and medical technology industry will be encouraged to develop and bring effective aging-ameliorating therapies and technologies to the market; 3) health insurance, life insurance and healthcare systems will obtain a new area for reimbursement practices, which will encourage them and their subjects to promote healthy longevity; 4) regulators and policy makers will be encouraged to prioritize and increase investments of public funds into aging-related research and development; 5) scientists and students will be encouraged to tackle a scientifically exciting and practically vital problem of aging.

Yet, in order for the degenerative aging process to be recognized as a diagnosable and treatable medical condition and therefore an indication for research, development and treatment, a necessary condition appears to be the development of evidence-based diagnostic criteria and definitions for degenerative aging. Such commonly accepted criteria and definitions are currently lacking. Yet without such scientifically grounded and clinically applicable criteria, the discussions about "ameliorating" or even "curing" degenerative aging processes will be mere slogans. Such criteria are explicitly requested by major regulatory frameworks, such as the International Classification of Diseases (ICD), the Global Strategy and Action Plan on Ageing and Health (GSAP), the European Medicines Agency (EMA), the US Food and Drug Administration (FDA). Nonetheless, nobody has yet done the necessary work of devising such criteria.

"Senility," tantamount to degenerative aging, is already a part of the current ICD-10 listing. In the draft ICD-11 version (to be finalized by 2018), the code MJ43 refers to "Old age," synonymous with "senescence" and "senile debility." The nearly 40 associated index terms in the ICD-11 draft also include "ageing" itself, "senility," "senile degeneration," "senile decay," "frailty of old age," and others. Still, the current definitions, such as "senility," seem to be rather deficient in terms of their clinical utility. This may be the reason why "senility" has been commonly considered a garbage code, e.g. in the Global Burden of Disease (GBD) studies. The reason "senility" has been considered a garbage code is likely because there have been no reliable, clinically applicable and scientifically grounded criteria for diagnosis of "senility" or of "senile degeneration." Consequently, there could be no official case finding lists. Hence, in order to successfully use this code in practice, it appears to be necessary to be able to develop formal and measurable, biomarkers-based and function-based diagnostic criteria for "senility" or "senile degeneration," as well as measurable agreed means to test the effectiveness of interventions against this condition.