Will Success in Reversing Aging Shape the Regulatory System to Accommodate It?

A sizable fraction of the therapies produced by the medical industry are, not to put too fine a point on it, garbage. The benefit is not worth the cost of diverting the resources into the full scale production of the drug, versus those resources going towards some better form of medical research and development. Giving a cancer patient an extra month or two of life, reducing fibrosis in the liver by 10% over a year of treatment, incrementally improving mitophagy to half the degree that exercise achieves, and so forth. Small molecule development in particular excels at producing this sort out outcome, as the effects on gene expression and protein interactions produced by small molecules tend to be much smaller than the effects produced by genetic interventions carried out during proof of concept studies in the lab.

The overbearing, overburdened regulatory system for medical development has become optimized towards determining the difference between a garbage therapy that produces a small positive effect and a garbage therapy that has no positive effect. That goal is an expensive proposition in principle, even setting aside all of the unnecessary costs imposed by regulators. When that regulatory system starts from the position of "first, do no harm," one can see how it may evolve to use the lever of imposed cost to discourage an influx of treatments that are not really expected to meet a sane cost-benefit threshold. Many of us feel that it isn't the role of government employees to be making that decision for everyone, but that is the situation, alas.

Given evident, clear success in medical development, however, the system becomes far less of a roadblock. When a new therapy definitively cures a rare disease, as happens ever more often in this era of progress in biotechnology, the sponsoring team might find regulators moving directly from a phase II trial in 20 or so patients right into clinical approval. The usual obstacles and further costs put in place for marginal therapies melt away in this situation. Severe diseases tend to be accompanied by clear success criteria in the form of disease symptoms and patient mortality. It is obvious that a therapy has produced a cure, or managed the condition down to negligible pathology.

Will this also be the case for the first therapies to produce meaningful rejuvenation? The immediate issue here is that there is no practical, consensus measure of rejuvenation. Yes, epigenetic clocks exist alongside clocks derived from other omics data, but we are nowhere near the point at which the world, or regulators, would accept a reliable ten year reversal of epigenetic age in patients at face value, as representing actual rejuvenation. But the real question is whether a proven rejuvenation therapy would in fact produce a melting away of regulatory obstacles, given that yet to be established consensus measure of age-related decline.

People will think very differently about a cure for multiple sclerosis versus a rejuvenation therapy that grants ten additional healthy years, on balance. Multiple sclerosis exhibits what regulators call "high unmet need," a condition that disables and kills, and for which current treatments do too little. A robust cure for multiple sclerosis would rapidly reverse disabling symptoms in an obvious way. In comparison, a therapy that gives people ten additional years, and turns back the clock in terms of measures of aging, has (a) less evident immediate benefit, and (b) will be used by far more people if approved by regulators. That changes the calculus in the minds of regulators.

It is interesting to contemplate future obstacles, or lack of same, but the first step remains the production of working rejuvenation therapies. The most important of those presently heading towards significant, widespread clinical use in the 2030s are senolytics and perhaps the first uses of partial reprogramming. It will remain to be seen as to how great an improvement they produce in late life human health, and how much of a roadblock is put in their way by regulatory bodies.


Big Pharma is as crooked as they come and would rather not see something that eliminated most old age conditions. I do wonder how quick the general public will push to get things like that off label though once they are approved for treating disease

As far as showing the rejuvenation that may take some time and would it in theory restore an old facial bone structure to a more youthful appearance or just increase the bone density of where the bone loss happened. A lot of the appearance of skin originates from the dermis. What happens there - just a slight improvement or would there be big gains in collagen and elastin because collagen starts dropping a lot in your 20s I think.

Posted by: Mike Best at June 19th, 2023 8:18 PM

I said it before. If there's a proven working rejuvenation the regulators will not be able to stop it. Then in a few years all the celebrities will use it and the general eventuality learn about it and demand it.

Of course, there might be some jurisdictions banning those treatments or making them out of pocket.

As for senolytics and partial reprogramming, they will be used in first place where there's most benefit. Namely, reducing some clinically measured inflammation. Reducing backpain , tendinitis and such. For those will be virtually no pushback. No promotion either, though. But then the path to of label will be short

Posted by: Cuberat at June 20th, 2023 5:34 AM

Forget about the clocks, if a person doesn't LOOK younger there wasn't rejuvenation. Video AI analysis of a person moving around, facial and skin appearance, plus a few physical measures will convince regulators.

It will be a little tricky in that I doubt that when rejuvenation comes that you will look different over night. Could take years for the body to rebuild you younger.

Do the proposed rejuvenation trial as treatment for Alzheimer's and if it works all the rest will take care of itself. Is there a more widespread, expensive, burdensome disease than the dementia's?

Posted by: Lee at June 20th, 2023 3:41 PM

Regulators are corrupted by revolving door pharma and research is not far behind with grants.

Why speed up a working therapy when you can block it and speed up a therapy that doesn't work at all and get paid lavishly with money and power?
And because it doesn't work there is more work to do in the future.

What we really need is competition and a way to reward honesty and full data publications.

I would trust more life insurances to make an informed decision about drugs than the government / big pharma establishment.
They have an incentive to make people insured live longer, be able to work longer and have less sick days.
At least, if they are wrong, they must pay for deaths and lives.

Posted by: painlord2k at June 23rd, 2023 4:54 AM
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