Towards the Recognition of Aging as a Treatable Medical Condition
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 means 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 rapidly 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 rules 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.
I really think that things will get held up if aging doesn't make it into icd 11. If it doesn't you're going to have a ton of different treatments based on something like senolytics for various specific indications, instead of the overall indication of aging. Regulatory issues are what makes me the most nervous now. I anticipate lots of challenges in this area.
Oh man,
More terrors today, but I want to stay on topic here.
This part is on topic...
If they don't we are horribly screwed. They damn us, them, Western Civilization, everyone.
Business as usual can't carry on with what is coming down the pipe. It simply can't. If they are too blind, or ignorant or traditional, its curtains for our species. It won't take long for society to devolve into a horrible mess.
I've been to several hospitals in the Niagara region today dealing with issues for my mom.
Every one is full.
90% of the beds are filled with people over 50. Greatest Gen, Boomers and soon Gen X. 15 years from now, Gen Y's vast numbers will be coming too.
They leave aging out of ICD 11, you might want to find somewhere else to live, or just leave the planet.
Time is up. We can't delay. its now or never.
Sadly, how often does logic prevail in Government?
I made a serious decision today to start saving as much cash as I can so I can expat if needed.
Empty pension coffers, over taxed young people, rationed health care. That's the future.
Unless they start to Logan's Run us or turn us into Soylent.
The rigidity of the FDA MUST bend, or its game over.
"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."
I can't quite agree. Think about organic foods, or homeopathy, or acupuncture. They make claims that are demonstrably false, but still they sold their BS without problems, because they are outside medical regulations. Another big fraud (probably the biggest of all) is religion, not so clearly demonstrated false (because its sellers can allways use the "it's a parable" trump card) but also never demostrated true. And its "sales" are huge: https://www.weforum.org/agenda/2017/01/religion-bigger-business-than-we-thought/
Guys, the more we discuss controversial subjects like this, the more likely we are to discourage future investors. We can't afford to become affiliated with any one political view on anything.
On topic with Mark's anecdotes, think of the international instability caused by the Silver Wave. If the Great Filter theory is correct, we may be looking at it. /speculation
This is truly a big waste of energy, time, and focus.
Even if aging was classified as such tomorrow, it would have little to no bearing on how regulatory agencies would approve your new drug.
That is not the way the teams at FDA work, and anyone who has experience at the FDA presenting knows this.
You don't just show up at the end of Phase III and say, "Hello. Approve my compound for X."
They are intimately involved in guiding the process from pre-IND / day 1 and are always "suggesting" next development steps that "may work better than others" and "might allow you to proceed" and not make you go back for 10 more years and start over.
Do yourself a favor - If your drug works well for something, get the claim - even if it is for something obscure - if the data is good, get the claim and go to market - don't waste time on trying to get it classified for aging if the supporting data is average it puts you another decade or more back.
Just how far are we in the journey to the Escape Velocity of aging and death anyway? With all the current anti-aging research going on in the World, and implementation of many life-prolonging techniques already available. we must be half way there already, and many people living today may live to well over 100 years.
"and implementation of many life-prolonging techniques already available"
Huh? What techniques? AFAIK, only senolytics are fully developed, and only the more primitive ones.
If aging is recognized as a treatable condition getting money for research and creating companies with a focus on treating aging might become easier. The regulatory involvement in the West is more or less irrelevant in the near future. We are playing the long game here.
@Biotechy "Just how far are we in the journey to the Escape Velocity of aging and death anyway?"
I'd say we're at the starting line currently.
Which is further ahead than where we were a decade ago.
Progress is progress.
It's hard to estimate impact on lifespan. The best we can do is look to 1st generation SENS-styled therapies. I like to list the following as the full 'compliment' of 1st gen in a perfect world (assuming none of the technologies fall through):
OSKM (???)
GAIM & Glucosepane Breakers (proclarabio has gotten GAIM to stage 1 clinical trials, Aubrey's reported monoclonal antibodies and good evidence of breakers)
mitoSENS (2/13 of the genes are done. 3 others have good progress. We're nearing halfway)
Senolytics (UNITY biotech is pushing these. Reason has estimated 5 years)
Stem Cell (? - OSKM and Senolytics may delay the need for this)
Add the recent thymus regeneration to that list.
AFAIK, there are no antibodies nor breakers for glucosepane yet.
Usefulness (and, above all, safety) of Yamanaka factors as antiaging therapy is highly dubious to me. But time will tell.
@Patrick,
Thanks for the estimated status of what needs to be done and time line. I think Reason said 5 years for medical tourism for Senolytics and 10 years from now for FDA approval of it within the U.S.
It would be nice to have timelines for the others, but I understand it is quite difficult w/o a crystal ball.
@Antonio
The Yale team has antibodies. 'Ya really need to take a look at https://www.leafscience.org/sens-where-are-we-now/
I knew that interview, but the antibodies aren't yet useable, maybe at the end of the year they will:
"Yale already has some antibodies against glucosepane; it is anticipated that, by the end of the year, monoclonal antibodies will be available, and there is strong evidence for bacteria with enzymes that can break glucosepane."
@Patrick,
Thank you for the link. And thank you very much LeafScience and Steve H for the update and moving forward. Reading the status for each of the 7 causes gives me great hope that we will have a legit treatment for aging within 20 years.
Indeed, they started a project to develop those antibodies 3 weeks ago: http://www.sens.org/outreach/press-releases/srf-and-spiegel-lab-to-collaborate-on-antibodies-to-glucosepane
So they are still at a preliminary stage and not yet available.
@Antonio
Ah, guess I misinterpreted his words. Looks like I got it from a livestream where he stated that they were "able to fund a group to the extent of being able to create monoclonal antibodies" - Thanks for the correction. Sours it a little, but still looking good...
Hey there, 2 cents,
''2) the pharmaceutical and medical technology industry will be encouraged to develop and bring effective aging-ameliorating therapies and technologies to the market''
Pharmaceutical, not too sure about that. Medical technology industry, yes.
It is again a question of money vs life.
'' 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;''
Hoping healthcare systems 'hold' because they are at full capacity/maxed out.
SENS is essentially about lessening the 'burden' on the healthcare systems.
I am bit confused there - it is suppose to help the healthcare system or not,
from this article it would help because elderly people would live longer and 'be productive',
contributing 'richness/money' which would fuel gov and health care services - if they needed
them. And, they will need them Less and Less, because they will live longer and Healthier;
thus, not require 'late' health cares (i.e. 'decrepiting stage/becoming old and frail' where you need health care assistance as you become Very old),
The way I figure it (and I could be completely 'out there in the field/lost'), health
care would (should?) become a 'safety net' just 'in case' you become ill; but since you
would of Perfect Health and Living over 150 years old - why would you need the services
of health cares; you won't, you will never step in a hospital again (like so many elders do and, go die there).
As such the whole 'health care' thing needs to be rethought or it'S basically misunderstood,
or it passed 'under the radar' to the fact that health cares system woud 'disappear' as we know them,
they would just be 'pit stop 'chekc ups'' - very summary and quick - and very empty rooms (unlike now where hospital are filled to the max).
It will be a 'desert' - hospitals will almost 'beg' for anyone to get sick as they 'close down'..since no one is getting 'sick' anymore from old age
and diseases are nearly 100% cured.
Pharma = disappearance or mutating in a very different light form.
Hospital = disppareance/funds going to that will reduce, same for pharma...pharma drug business will lose billions of dollars which it will fight to the death to not lose it (it makes me think of cigarette company, the fought to keep smokes still available when all know it is more harmful than good - a money/business; some thing for oil/petroleum and electric cars still not really around. We continue to sell bad stuff because it makes cash/jobs even so (our conscience takes a hike as we stay in denial and nothing changes 'same ol same ol'' (or rather, they do (stay in denial))).
If a business can seel you a drug and can kill you, that's a side effect. The biggest side effect for this company is making cash from your (now gone) soul.
New model = 'light' health cares, while tere would be ''aging' therapies' here and there in private
companies; because, before hospital do these anti-aging rejuvenation therapies it could be a long time (FDA bureaucraty nightmare...).
I just don'T understand this whole bureaucractic thing, it is so bloated and kills everything 'in the egg'.
Reason's words '' 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.''
That they would be careful and now zealous, I can fully understand; hence them making so many 'hoops' to jump before anything 'they approve' (after many trials)...I understand and can appreciate there sense of security for us but there is 'pushing' and pushing.
I think there are pushing it so far/too far and it is one (if not) the worse problem SENS faces; how can even get the therapies out
when a huge body likef FDA can't even recognize 'aging' as a condition or ...anything for that matter... I think I know why, they think aging is immuable and compltely 'nothing you can do about it' - you die, period.
They continue to hold the fatalist view. And like Mark said, FDA got realize quick because they are the thorn in the figurative...
FDA are basically just about 'healthy aging', period, they promote bs like metformin, that's it...what is this ?...
metformin my father takes that, it is some miracule cure, no. why it is so hard to understand.
BEcause they are hard headed and on purpose. They are hard headedness will be our demise.
Probably also $$$$$$ mullla, yes, there must be a question of money somewhere (they don'T want to lose the cash flow from 'untested' rejuvenation and other 'fantasy' like things like that. How do they view Aubrey de Grey, so far, it seems not very highly.
I understand that we must be 'Approved' by FDA, but all the frickin facts are laid out on the table for them and still not capable of doing anything more.).
It's like trying to talk to a deaf man or ask a blind person for directions... it is self-defeating, you can only bang your head against the wall (the FDA wall), and realize that your dream is but shattered.
I find it almost utter ignorance to not see all the proof and sort of brush it aside as if Aging was nothing and that, anyway, we die.
That's fda and others for you. Helping you 'Live Healthy' with pills and other bs - and you Die, after (they won'T say it, I am saying it for them; and THEY die too, #$?#\!\\!!, all people working behind these agencies are dying TOO; Aging is something they don't realize or understand, even if it happens to them too - a blind man looking himself in the mirror or a deaf person having talking conversion with another deaf ''Talk louder I don't hear!!'')).
I will admit my knowledge onf regulatory processes and gov is very small (compared to my interest#knowdlege of biogerontology; I just feel we are tied hands behind the back and not f..of a lot we can do but weep or change things through vote/law/gov reforming (abysmal results)). We are like insignificant, pawns are almost attached to puppet strings and puppet master pulling them. And like a marionette we move our limbs but we don't want them to move that way or at all. Cut the strings and bygone the master. I sometimes have a feeling that a certain revolution is coming, be it like the French Revolution or the American Civil war; where peple just had enough that things did not budge/move and they would die/age because of regulatory bodies/authorities 'deciding' so for them. Is this not a form being hostage, despite all the 'well meaning' intentions of these bodies. Perhaps, there times are revoluted and a revolution is just the next Evolved step. Because REjuveantion is a Revolution anyway you see it.
@Biotechy
Hi Biotechy !
''Just how far are we in the journey to the Escape Velocity of aging and death anyway?''
I think we are still 'on the strings' sadly and not much escaped of anything. The thérapies so far are senolytics and it is advancing, also mitochondrial allotopic expression is showing progress as said. But, overall Escape Velocity seems far like... a 100 year far. We are not in Velocity more, more like slomow mode. A long life seems much closer, and SENS will ofter that, but that is still not in at least 10-20 years it not more. It is very pressing and Dire. Any people who say no no we got time...are fooling themselves, time is precious and each second goes someone dies from a Deadly disease (I have one, atherosclerosis the deadliest of bunch a silent one, where you can collapse like that). But most people don't care and if they die tomorrow 'so be it' sad but true, it is auto defeatist fatalist attitude - live Fast Die Young...that sounds so Cool but so wrong onall levels. LEV is the Ultimate Holey Grail, and I hope to live to a 100 and be there that it would happen by then (which I believe my chances are about 0.00001% but I still keep the faith even if grimm prospects/odds and dangers abound (like getting killed on the street by accident or shot by sniper in a concert. The Times we are living in makse me think we must Shield ourselvse and prepare for long Lonely lives because the world does not give 2 sh*ts)).
Just 2 cents.
@Anonymoose
"If aging is recognized as a treatable condition getting money for research and creating companies with a focus on treating aging might become easier."
Nonsense!
The funds for research and creating companies will continue to flow from the same wells (life science VC, private equity, and "cross-over" public investors) who are all ex-big pharma and ex-biotech folks who know the regulatory dynamics and will only invest and charter any company towards the fastest approvable claims and path to market to recoup their investments
"The regulatory involvement in the West is more or less irrelevant in the near future"
If you beleive that, you should get out of the game immediately - those regulators currently oversee 75% of all drug biopharma registration - they're not disappearing or becomming irrelevant any time soon
@Drugdev
Very short sighted. The median age in Europe in 2030 is projected to be 50. I don't need to tell you anyone with a bit of money and a sense for the market has noticed that.
Regulators have absolutely no choice in the matter at this point, political and economic lobbies will crush them by the end of next decade.
Not to mention EMA has already has been shaken by the Brexit. And it was never an all encompassing regulator to begin with EU countries can ignore EMA regulations. And have done so in the past.
Europe is a medical tourism hub. Even if USAs regulatory agencies remain as rigid as they are - ours won't.
I suppose that when a group of people are desperate enough to get a policy enacted, regulation rescinded, or funding for a project (or even just to get their product or service sold), they will attempt to convince a large number of people that their view of the world is the 'only way' and that by the sheer force of that 'persuasion' they will facilitate a type of tidal wave of assent/ dissent (as applicable) to somehow create an atmosphere of legitimacy and therefore lubricate a pathway of regulatory acceptance to that end. Which is rare, and more importantly, a shame when we live (as I would assume many in this blog do) in one of the limited number of places in the world where one needs only to determine what people actually want and pursue that end rather than coerce them into what they believe they need and therefore get funding for it. Of course, i get it. Consumerism is the underlying mechanism of all the technology that has created nearly everything of value in our westernized (and others now) society - and the underlying accelerator of that consumerism is persuasion. But somehow getting public funding for such an enterprise, while not wrong on its face, is somehow disingenuous when a product/ service such as ageing treatment is so fundamentally empowering to the individual. Though I am from what many would consider a 'welfare state' -and support it's existence vehemently- I believe that there is something fundamentally ignoble about seeking government funding first before reaching out to the market and consumer to create a worldly good that people should/would purchase as a service rather than expect as an entitlement. It is not the government's job to make the world a better place, but to make the citizens' place in their individual country, and to some degree the world, a less worse one. Witness the creation of the birth control pill. Though I am too young to have even my parents lives changed by it, the main reason for its success was not to help with family planning or female empowerment or even reducing unwanted pregnancy - though many may cite these noble causes and even advocate for coverages based on these society affirming goals. No you idiots - it was the free and unencumbered and uninhibited sex that was suddenly available and expected and even promoted as the solution to an otherwise prudish and over-structured existence. It was this release and acceptance of a person's wants and wishes made real as a pharmaceutical that was the underlying reason for its success. And so with anti-ageing research: dispense with the false nobility of unrealized public funding solutions to one of society's greatest ills and endless tirades of nursing homes filled with decaying creatures of unfulfilled potential - like famine victims in those endless charity adverts. It is people's validation of their own lifestyles that will sell anything and bring the money, academic and business interest, inter-industry/clinic competition, and widespread realization and acceptance forth. If indeed some aspect of eliminating ageing is in damage-reversal (which I am convinced is only a small part - and likely to add decades of life at huge financial and time commitment) then why not sell the idea of removing damage from everyone?!? Do not sell living forever. Sell rejuvenation of people's otherwise decadent and destructive lifestyles - that likely make up the majority of all people and the vast majority of all disposable income and wealth. Sell rejuvenation and extra years to the food gluttons, the couch sloths, the health failures, and the 'too busy' to exercise majority. Going to live to only 65 due to your lifestyle choices? No problem - undertake SENS (or whatever the successful refinement that will provide some part of the answer) to add years or decades to your life WITHOUT ANY NEED TO CHANGE YOUR HABITS. Funding will be a barely tethered deluge. And if healthy and devoted people can extend their healthy lifestyle from 90 to 130 in the next 10 - 20 years on the backs of the great hordes of self-destructives seeking only a few more years, why complain? For as I have been known to proselytize: people are greedy, lazy, and stupid - but not evil and it is not their fault. And it has made the world a better place for all; for their weaknesses and indiscretions and pursuit of decadence has funded an infrastructure of health, well-being, and entrepreneurial/ technological greatness.
Jer,
You my friend have hit the nail on the head. While some may view your points as a negative critique on humankind it is what it is. If you want money from me for treatment research, appeal to my basic wants and needs. Tell me that your treatment will make me young, vibrant, sexy, appealing. Now you have my attention and money. At this stage in the race go for the money. Later you can tell me that, as a side effect I will be healthier and live longer.
Figure out how to do that without looking like (and being) a charlatan.
Should be an easy sell after that "little" road block.
Aging is a treatable condition. Well at least the point of view of an accelerated (which we see a lot of in western culture) or decelerated aging process. We all have the ability to make daily lifestyle habits that directly affect the status of our aging process. The habits that most directly affect it are nutrition and for lack of a better word, mindfulness. We see this in countless studies. Much of the relationship is rooted in good: getting a higher concentration of nutrients, minerals, enzymes, and more positive/productive hormones being released and generated. or bad:filling our bodies with things that lead to inflammation and oxidative stress and experiences that release detrimental hormones and so on. These are all things that any individual can take control of and change easily through their own day to day habits. Why even keep talking about it like it's an event that is controlled by something outside of ourselves and that we need pills, research and policy to make the daily choices that support our own vitality.
@Kristen Becker
Because when we say treat aging - we mean treat aging.
You can keep on with your "healthy" lifestyle - I know it gives peace of mind to a lot of people, like many other lies we like to tell to ourselves about life - but statistically a healthy lifestyle translates to a couple more months to years of life and slightly lessened severity of symptoms. But is definitely void in any disease prevention capabilities and anyone who says so at this point should be ignored like the charlatan that he is. Statistics do not lie. Next time someone advertises a diet book to you - take it with a large chunk of Himalayan salt - which by the way is in no way superior to table salt. Except that it looks prettier.
When asked if they lead a healthy lifestyle most scientist working on aging gladly admit they do not. The closest to a healthnut in the biogerontology field I've come across is probably Cynthia Kenyon - she makes a conscious effort to eat low carb. Doesn't mean she never eats carbs though. She just avoids them.
But anyway I digressed. When we say treat aging we mean - reversing diseases of aging, arthritis, osteoporosis, frailty, dementia, diabetes, and so on. Giving the old a chance to regain fitness and mental acuity. Currently that is impossible regardless of lifestyle, and in some part that is caused by the lack of regulations - what's the point of screening for drugs or evaluating therapies if you cannot sell them?
A lot of these diseases (more correctly I'd call them aspects of aging) seem to be completely preventable and reversible in animals - when treated presymptomatically that is. Waiting for people to crash is not in any way logical, nowadays your general practitioner could probably tell you what exactly when you'll get a severe condition years beforehand.
Regulation is also impeding research in general. Most techniques for producing stem cells for instance are to this day banned in most of Europe and the United States. As far as I know this was done with very little public discourse and debate and most people don't even know that field has been under heavy regulation since 2000 or so. Aging being regulated as a disease can shift sentiments for certain types of research, albeit slowly - better than being stuck in limbo.
And ultimately aging being regulated as a disease will also popularize the idea, that it can in fact be treated. Most people, I think you are included in that group, don't know the field has advanced a fair bit in the last decade or two. Mostly in animals up to this point and hopefully with regulation we can translate it into humans.