Insight into the Machinations of Classifying Aging as a Disease
The open access paper quoted here provides some insight into present attempts to change the regulatory classification of aging in the lab and the clinic: the prospect for meaningful progress in the science is real, but regulation is holding things back, which is why so many articles have appeared of late on whether or not aging is a disease.
The bureaucracy of what is and is not officially a disease is baroque and slow-moving, a many-faceted entity with areas of different importance depending on whether clinical medicine or research or translation or funding is being considered. There is considerable interest at the present time in doing something about that fact that aging is generally not accepted to be a treatable medical condition in most parts of the system that matter, which is to say those relating to the flow of money into early stage and translational research. That flow of money is tiny at this time; there is very little support for developing any of the clear paths towards treating aging as a medical condition, and this has a lot to do with regulatory barriers. If it is illegal to treat aging, none of the big for-profit concerns are going to go all in on building potential therapies, for example.
Aging is a complex continuous multifactorial process leading to loss of function and crystalizing into the many age-related diseases. Here, we explore the arguments for classifying aging as a disease in the context of the upcoming World Health Organization's (WHO)'s 11th International Statistical Classification of Diseases and Related Health Problems (ICD-11), expected to be finalized in 2018. We hypothesize that classifying aging as a disease will result in new approaches and business models for addressing aging as a treatable condition, which will lead to both economic and healthcare benefits for all stakeholders. Classification of aging as a disease may lead to more efficient allocation of resources by enabling funding bodies and other stakeholders to use quality-adjusted life years (QALYs) and healthy-years equivalent (HYE) as metrics when evaluating both research and clinical programs. We propose forming a Task Force to interface the WHO in order to develop a multidisciplinary framework for classifying aging as a diseaseThe recognition of a condition or a chronic process as a disease is an important milestone for the pharmaceutical industry, academic community, healthcare and insurance companies, policy makers,and individual, as the presence of a condition in disease nomenclature and classification greatly impacts the way it is treated, researched and reimbursed. However, achieving a satisfactory definition of disease is challenging, primarily due to the vague definitions of the state of health and disease.
Despite the growing abundance of biomarkers of aging, classifying aging as a disease will be challenging due to the absence of the "ideal norm." Despite significant effort from the academic and industry communities, sarcopenia is still not classified as a disease despite clear clinical and molecular representation and similarity with premature musculoskeletal aging and myotonic disorders. One approach to address this challenge is to assume an "ideal" disease-free physiological state at a certain age, for example, 25 years of age, and develop a set of interventions to keep the patients as close to that state as possible. Considering the WHO definition of health, it may be possible to agree on the optimal set of biomarkers that would be characteristic to the "state of complete physical, mental and social well-being, not merely the absence of infirmity" and agree on the physiological threshold after which the net totality of deviation of these biomarkers from norm can be considered a disease.
When do you see this changing, if ever? If aging isn't classified as a disease, could it be classified as a treatable condition or something along those lines? Or is there no real difference in those classifications? It seems odd to me that a company like Calico would invest all this money to intervene in aging only to be told that treating aging is illegal a few years down the road. I've spoken with Michael from SENS, and he didn't seem to think that the regulatory bodies would be as big of an issue as most of us seem to think, given how and why the SENS treatments would be administered. I'd still like to hear about the FDA meeting in June. I haven't been getting my hopes up, but you never know.
@Ham: For my part I think that working around the regulatory bodies via medical tourism is the way to go, as happened for stem cell therapies. Make the system adapt to the availability, not the other way around.
That's never going to be a popular view in academia, however.
Yeah that likely won't fly in academia. I might be wrong, but isn't bioviva planning on doing their trials offshore in Mexico or somewhere in South America with FDA oversight? Im pretty sure Liz Parrish said something along those lines in her presentation at people unlimited. Would it even be considered medical tourism if the FDA is overseeing trials despite it not being in the U.S.? I'm prepared to go the tourism route in 30-40 years if I need to, but obviously I would prefer not to.
But if there are things shown to work, do you think the regulatory bodies would change their opinions? It just seems like a lot of money to invest only to be told it's illegal to treat aging a few years down the line. If the regulatory bodies don't change their stance, I wonder if more companies would move offshore to get around it b
@Ham yes Bioviva is conducting trials in Mexico with an IRB, outside the FDA but to FDA standards under the Mexican compassionate care laws. As Liz has stated in interviews they want to do the work now, get the data then use that to help go through official channels. I guess they did not like the idea of waiting decades to get things done not to mention the insanely inflated costs involved in clinical trials.
Regulatory bodies would be forced to change their stance through public pressure, voting pressure and so on. A government who refused to make changes and incorporate proven technology into their systems would no doubt rapidly find themselves voted out. A party that did not make such therapy available as part of their manifesto would essentially be committing electoral suicide. This is something Aubrey has talked about a number of times and how democracy is an excellent tool for regenerative medicine.
Hopefully bioviva has good results on their tests, and those results parlay into breakthrough fast track status with the FDA. Wishful thinking, I know. I hope that the regulatory systems change and allow aging to be treated and all of that, but I'm not expecting it to come from voting and outcry from the public... At least not for a while. Too many people are unaware or hostile to the idea. Yet some of the people who are hostile are people who will spend and do whatever it takes to LOOK younger, and feed the cosmetic and plastic surgery industries money. Mind boggling to me, but that's another topic for another day, I suppose.
Also, hopefully the 21st century cures act will actually speed things up, and force the FDA to be more flexible and look at things a little differently.
I am glad to say the situation in the UK is somewhat more open to longevity research, most people here tend to be ok with the idea of living longer. I think its a lot to due with this country not being overly religious, we have no "bible belt" as such here so attitudes are often more receptive to technology. A sweeping generalization of course but the socialized medical service is also another factor IMO.
I seem to recall Michael from SENS saying it is not as bleak as people may think regarding the situation. But I can only comment on the situation as I see it and I see a lot of problems with red tape getting in the way of research.
No, you're right. Michael has said the same thing to me about regulations not being as big of a deal as many of us seem to think. Mostly because whatever treatments there are will likely have rejuvenation as a side effect of treating something else, or in a preventative manner I suppose. If red tape holds things up forever, someone will end up doing treatments offshore eventually I'm sure. I'd be willing go the tourism route (I really wouldn't want to be the first person though, unless I HAD to) if it came down to it though.
It's good the UK seems more open to it, but yeah, it seems like the US and Austrailia are way more opposed to it for sure. I guess that's what happens when you mix politics and religion (Another rant for another day). Judging by comments on any aging article it seems like most people everywhere are against it, but again, internet comments don't speak for the entire population... so who knows. Hopefully opinion changes when robust mouse rejuvenation happens... but if I had to venture a guess on what happens after RMR, I'd put my money on getting many more "moral and ethical" debates or moratoriums on whether it should be researched in humans holding up actual research forever.
@Reason: "Make the system adapt to the availability, not the other way around."
I agree 100%.