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.