More on Efforts to Lobby the FDA to Accept Aging as a Medical Condition that Can and Should Be Treated

It seems that after some years of researchers feeling more comfortable talking in public about the goal of treating aging as a medical condition, the community is also beginning to feel constrained by the present regulatory and funding situations. Both are ridiculous. In the US the Food and Drug Administration (FDA) only approves treatments for specific uses and defined medical conditions. Aging is not a defined medical condition, therefore you can't legally deploy new technologies to treat it. That has a stifling effect on the ability to raise funds all the way along the development chain that leads from early stage research to commercialization.

Not that aging research receives anywhere near as much funding as it merits in the first place, regardless of the FDA situation: medical research is in general funded to a fraction of what even a moderately utilitarian view would suggest is a good plan. Aging research makes up a tiny fraction of that medical research funding, and efforts to actually treat rather than merely investigate aging garner a small portion of even that pittance. This is a society of beer and circuses, not one of respect for the sciences, at least if you look at the flows of money and other resources. The amounts spent on the above-board and regulated bribery of the last US presidential election summed to about twice the funding for the National Institute on Aging in that year, for example, and were probably roughly in the same ballpark as the sum of all aging research funding in the US that year, public and private.

In any case, those researchers who consider themselves stuck with working within the institutional funding system are of late gearing up to more seriously lobby the FDA to change the rules. This makes sense in their world: a change opens more doors in the future when it comes to seeking grants or establishing for-profit ventures based on their research. I am not optimistic that this is anything but the start of a very long, expensive, and distracting process for those who take on the lion's share of the responsibility for it, however. We have the example of sarcopenia to consider, this being the name given to the characteristic loss of muscle mass and strength that takes place with aging. Lobbying the FDA to consider this a medical condition and thus allow commercialization of treatments in the US has been underway for a long time indeed, with no sign that FDA bureaucrats are going to do anything more than continue to hold meetings, request expensive data, and waste time.

As I have long said, I think that the better road ahead is to commercialize treatments outside the US on the back of a strong medical tourism industry. The stem cell marketplace could grow into that, but has yet to organize to the point at which it can influence the research community sufficiently to close the funding circle. It absolutely should be any US researcher's expectation that their primary and best avenue for commercial application of medical research is outside the US. Further, a robust trade on that front is the only way to drive back the ever-increasing demands of the FDA. Regulatory competition with other regions is the only argument that bureaucrats reliably listen to: the point at which they look like fools for holding out further. I expect we'd still be waiting on legalization of stem cell treatments of any sort in the US if they hadn't been widely available for years in reliable clinics and hospitals across both land borders and the Pacific.

In any case, here is more on the topic of lobbying the FDA on approval for therapies that might treat aging. This is all some years in advance of anything that can actually effectively move the needle, so far as my view of the situation is concerned, but no harm in getting the groundwork laid early. Though, as noted above, I think they'll be at this for a while, and past the time at which initial treatments to partially treat some aspects of degenerative aging are available overseas via medical tourism.

Anti-ageing pill pushed as bona fide drug, regulators asked to consider ageing a treatable condition

Doctors and scientists want drug regulators and research funding agencies to consider medicines that delay ageing-related disease as legitimate drugs. Such treatments have a physiological basis, researchers say, and could extend a person's healthy years by slowing down the processes that underlie common diseases of ageing - making them worthy of government approval. On 24 June, researchers will meet with regulators from the US Food and Drug Administration (FDA) to make the case for a clinical trial designed to show the validity of the approach.

Current treatments for diseases related to ageing "just exchange one disease for another", says physician Nir Barzilai of the Albert Einstein College of Medicine in New York. That is because people treated for one age-related disease often go on to die from another relatively soon thereafter. "What we want to show is that if we delay ageing, that's the best way to delay disease."

Barzilai and other researchers plan to test that notion in a clinical trial called Targeting Aging with Metformin, or TAME. They will give the drug metformin to thousands of people who already have one or two of three conditions - cancer, heart disease or cognitive impairment - or are at risk of them. People with type 2 diabetes cannot be enrolled because metformin is already used to treat that disease. The participants will then be monitored to see whether the medication forestalls the illnesses they do not already have, as well as diabetes and death.

On 24 June, researchers will try to convince FDA officials that if the trial succeeds, they will have proved that a drug can delay ageing. That would set a precedent that ageing is a disorder that can be treated with medicines, and perhaps spur progress and funding for ageing research.

To be clear, I don't think metformin is going to do much for anyone when it comes to aging. The evidence in human and animal studies for metformin to slow aging is all over the map, and pretty weak overall if you ask me. Even if the best outcomes observed in these studies actually happened in all humans, which they won't, this isn't anything to write home about. It's not even as good as exercise or calorie restriction, both of which are free and backed by the gold standard of weight of evidence when it comes to benefits to health. But you might consider this as an example of reaching for the tools immediately to hand in order to make inroads into the regulatory process.

Comments

While Metaformin will probably be almost useless, hopefully this effort will pave the way for SENS style treatments like senescent cell removal that are not yet near the clinic.

Posted by: Jim at June 17th, 2015 8:16 PM

It's going to cost 50 million to run a trial on something that's probably going to have negligible effects... I guess it's not all lost if it gets the FDA thinking about considering aging as a disease though...

Posted by: HaM at June 17th, 2015 8:19 PM

I can only agree with the above two posters, Metformin is unlikely to yield much longevity but it could bring with it a change of attitude towards aging research.

There are some big companies investigating senescent cell removal too from what I have heard so more power to TAME even if as has been said before it isn't going to achieve much per se.

Posted by: Steve H at June 18th, 2015 5:34 AM

Talking of Government agencies and the hope they will embrace Biotech DARPA has recently launched it's new Bio technology Office which is developing some very high tech stuff not just for military application either.

http://hplusmagazine.com/2015/02/15/biology-technology-darpa-back-game-big-vision-h/

Oracular implants, synthetic organs, organs on chips, gene therapies, robotics and tons more. There appears to be a lot of opportunity here for forward thinking companies interested in taking their technology to them. They also express interest in the Transhuman community too though the political aspect could be problematic. Very interesting article all the same and shows evidence that things are indeed changing. In particular George Church talking about gene drives and transgenic organs grown in pigs are very interesting.

Posted by: Steve H at June 18th, 2015 5:40 AM

This story is at the top of reddits futurology subreddit ATM. As usual people are split on the issue. I encourage you guys to check that out. I've noticed that so many people use the term immortality though. It seems like any news or discussion on aging or longevity turns into becoming immortal. It's wrong, but that's where the average readers mind seems to go, which is not helping our cause. I think that's a large part of why some people view this field the way they do. No one is expecting immortality just aging without horrible diseases. It's hard to convey this message so people comprehend that.

Posted by: Ham at June 18th, 2015 8:58 AM

Well to be fair Ham the ideal we are working towards here is effective control of aging and ideally reaching homeostasis to maintain the balance. Not Immortality because as ADG says he works on health not on stopping you being run down by a truck. However I think the ultimate aim should always be robust rejuvenation with a view to indefinite biological sustainability. Indefinite to the best of our ability of course trucks and accidents aside.

Posted by: Steve H at June 18th, 2015 1:20 PM

Well, I think we can (and should) try to eliminate or make harmless other threats to our life apart from aging (trucks, earthquakes, etc.). Why not? A society that has reached escape velocity and master nanotechnology and medicine, surely can find a way to make totally antiseismic buildings, much more secure transportation than we have now, biomechanical bodies, etc. I'm not affraid to use the word immortality and to support research on means to obtain (be it SENS, cryonics, robotics, nanotechnology or whatever we need to achieve that goal).

Posted by: Antonio at June 18th, 2015 2:52 PM

I know that ideally most of us here would like indefinite biological sustainability... but that doesn't compute with most people now. They see "longevity" and associate it with "immortality" and other fun buzzwords like overpopulation, stagnation, scarcity, etc. It would be great to get people to stop using the term immortality when talking about articles like this though... especially when the odds are metformin isn't going to contribute much to longevity. That said, even if it helped delay some diseases by a few years, and it gets the FDA thinking about aging, then it's still a win.

This brings me to my next comment/question. How do you guys think the first wave of people with indefinite lifespan, or at least extended is going to happen...? I ask because a lot of people on other sites seem to have this illusion that suddenly 7 billion people are all going to be 120 years old overnight, and that humanity will be stagnant. I think initial first pass patient procedures are going to be an accumulation of various piecemeal treatments and ongoing processes like potentially replacing/regrowing organs if needed, or maybe gene therapies, etc. until there's a totally comprehensive suite available. I picture it all going along almost unnoticed (like most standard, common medical procedures today) until people realize "Wow, there are a lot more healthy 100 year olds"... or something to that effect. Almost like we don't realize that we've actually obtained life extension.

Posted by: Ham at June 18th, 2015 3:31 PM

I think it happen like that ham with therapies adding more years as they arrive.

Posted by: steve h at June 19th, 2015 12:41 AM

Metformin lot likely to be entirely useless. Metformin primarily works by elevating a metabolic-sensing molecule called AMPK. Resveratrol and other polyphenols elevate AMPK 50-200 fold better.

Posted by: Bill Sardi at June 21st, 2015 11:28 AM

I would be interested to know what is the real motivation of the person who writes or edits the Fight Aging! newsletter to insist that a lack of funding to address causes of aging has something to do with FDA not recognizing aging as disease. While I cannot speak for FDA but aging is codified very clearly in the international Classification of Disease (ICD) nomenclature and has an assigned disease code 797. I pasted the relevant information below, hope that helps to refocus the writer to search for the true reasons why aging is not being diagnosed by health practitioners as a disease that it is. Until the health practitioners start diagnosing their old patients as "being old" and including 797 into the list of diagnoses - and death certificates! - aging will remain an extremely rare and rather benign condition, especially when compared with such dreaded ailments as heart disease or cancer. FDA may have many problems but this problem has nothing to do with them, so please, stop flocking the dead horse and focus on true reasons why aging is not recognized as a disease by the medical community.

Specific code 2015 ICD-9-CM Diagnosis Code 797
Senility without mention of psychosis
2015Billable Code
ICD-9-CM 797 will be replaced by an equivalent ICD-10-CM code (or codes) when the United States transitions from ICD-9-CM to ICD-10-CM on October 1, 2015.
ICD-9-CM 797 is a billable medical code that can be used to specify a diagnosis on a reimbursement claim.

Disease Synonyms
Cautious gait (finding)
Decline in functional status
Frailty
Gait disturbance, senile
Clinical Information
An age group comprised by people 65 years of age and older
An age group comprised by people 65 years of age and older. (nci)
The state of being old
797 Excludes
senile psychoses (290.0-290.9)
Applies To
Frailty
Old age
Senescence
Senile asthenia
Senile:
debility
exhaustion

Posted by: Andrius Baskys, MD, PhD at June 21st, 2015 6:37 PM

"We have the example of sarcopenia to consider, this being the name given to the characteristic loss of muscle mass and strength that takes place with aging. Lobbying the FDA to consider this a medical condition and thus allow commercialization of treatments in the US has been underway for a long time indeed, with no sign that FDA bureaucrats are going to do anything more than continue to hold meetings, request expensive data, and waste time. As I have long said, I think that the better road ahead is to commercialize treatments outside the US on the back of a strong medical tourism industry."

For sarcopenia, look into SARMs -- Selective Androgen Receptor Modifiers -- exciting new class of drugs, available easily at fair-to-cheap prices in the U.S., over the internet, no expensive vacation required. Beneficial effects similar to anabolic steroids, with few or no side effects.
Species of interest, oldest:
- ostarine (MK 2866)
- andarine (S-4)
- cardarine (GW501516)
- ligandrol (LGD 4033)
Newcomers:
- YK11
- RAD140
- SR9009

Also, take a look at the new oral GH-releaser, ibutamoren, or MK 677. Great stuff. Possibly better than injecting HGH itself. Can be had very reasonably, e.g.:
http://toweringlabs.com/Buy-Raw-MK677-Powder-Cheapest-MK677-Ibutamoren.html

Total cost of therapy with a cocktail of SARMs, plus MK 677: perhaps $1-2 per day. Less than a starbucks latte. Total cost of therapy for a year: circa 10-20% of a single overseas medical vacation.

"Do what you can, with what you have, where you are".

Posted by: alan2102 at August 5th, 2015 5:32 PM

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