The Decade to Come in Which Treatments for Aging Exist, But Are Largely Illegal

We are fairly close to the existence of the first meaningful treatments for aging, therapies that align with the SENS approach of repairing the fundamental forms of damage in tissues and cells that cause aging. From the speculative list I put forward a year or two ago, we could look at the first item, removal of senescent cells. Nothing much would have to change about research funding or current directions for a therapy based on targeted removal of senescent cells to be entering human clinical trials in the mid 2020s. That therapy will be aimed at one specific age-related condition, not aging itself, because that is how medical regulation works: it is illegal to try to treat aging, there is no path to gain approval to treat aging, and so any promising technology is sidelined into use as a late stage treatment for people who are especially sick. Which is to say they are damaged enough by aging, and manifest one of its outcomes to a large enough degree that we give it a name and call it a disease or a condition. Whereupon it becomes legal to try to treat just that one facet of aging - or at least to try to convince regulators you should be allowed to treat it. Everyone who is damaged by aging to a lesser degree is called healthy and denied access to therapies.

This world of ours is packed with iniquity, unfairness, and stupidity, but the organization of medical regulation is of particular note. So, I'd predict that by 2025 there will probably exist a treatment for removal of senescent cells that would be of benefit to everyone much over the age of 30. However, it will be highly restricted - essentially illegal for use, illegal to provide to people, and illegal to aid people in using it. That is the state of the law for any advanced medical technology not approved by the FDA.

Now consider the way in which research and the clinical application of stem cell treatments has progressed over the past decade. Medical tourism emerged even in the comparatively early days, as soon as the trend towards greater reliability and lower cost for stem cell transplants started in earnest. Many clinics of varying levels of sophistication outside the US have for years offered procedures that until comparatively recently remained forbidden and illegal within the US. I'd judge that it was largely the existence of that growing market that pressured the FDA into allowing the use of these technologies - long years after they became available elsewhere. FDA leaders operate under incentives that don't align with yours: they are driven by how much public disfavor they receive, which means approving as few new technologies as possible, as they are blamed for any consequences, until such time as being a roadblock earns more disfavor than letting things through. Quality of medicine and any other declared aims of the organization are somewhat lower in the decision tree. You can look at the rapidly increasing cost of regulatory compliance, capricious demands placed on developers, and the falling number of approvals for technologies, drugs, and so forth as evidence for this viewpoint.

Given how things went for stem cells, it will be interesting to see what will happen in the case of legitimate treatments for aging that we would expect to lengthen human life in every recipient, but which are only available for the most damaged and closest to death. By 2025 we will know how much senescent cell removal lengthens life in rodents, but it will be speculation as to what exactly the benefit is for people in the long term: short term biomarker changes will be measured and found to be supportive of the idea that the treatment is improving health and turning back metabolic metrics of biological age, but that still doesn't say much about what the outcome is at the end of the day. Improvement in health is expected, but I think that the current view of SENS is that only complete implementation should be expected to radically lengthen life.

Still, imagine the availability of a "stem cell treatment for everyone" that would benefit you just as much as the stem cell transplants of five to ten years ago were of benefit to victims of heart disease. This will happen, and comparatively soon. It might be worth considering how to accelerate the wave, or use it to gain greater funding and interest for the other lines of SENS research aimed at human rejuvenation.

Comments

One hopeful development is that Japan (the world's second largest healthcare market) recently changed its laws to allow the use of stem cell therapies after they have been through safety testing, but have not yet had efficency proved in a stage 3 trial.

http://www.abc.net.au/news/2013-11-22/mesoblast-pins-hopes-on-regulation-changes/5111524

"The change means such products might be approved for the Japanese market without having to complete "phase-three" trials.

"That's a very exciting prospect for us, it potentially shaves off several years and very large expenditures in getting our products into the Japanese market which is really the second largest mature market in the world after the United States," Mr Itescu said."

See also:

http://www.proactiveinvestors.com.au/companies/news/50506/regeneus-to-fast-track-human-stem-cell-osteoarthritis-therapies-in-japan-50506.html

Posted by: Jim at February 10th, 2014 5:26 PM

@jim

Thanks for sharing.

The U.S. is going to be forced to adapt or die. Anything can happen, but it's hard to be optimistic about the future of this country. Regardless, powerful people with a lot of money will want these treatments. In this country money makes the wheel turn.

Posted by: johnathan at February 10th, 2014 8:31 PM

Given the extreme lengths people will go to in order to look younger, if removing senescent cells has any cosmetic effect on skin, then I reckon it could take off in Asia or even illegally in the US long before the mid 2020s.

http://www.sciencedaily.com/releases/2012/10/121003082728.htm

"According to the researchers, who designed the nanodevice can also be useful for developing therapies topical cosmetic care and beautification of the skin and hair, as anti-wrinkle or anti-aging, and radiation shielding UV or to address alopecia, all associated with the accumulation of senescent cells, conclude Martinez Máñez and Murguia."

Posted by: Jim at February 10th, 2014 9:39 PM

I believe that, in the U.S., the tide is turning with relation to this issue. I think that within another 10 or 15 years, the majority of the population will favor using pharmaceuticals/procedures to slow the aging process (and not just to treat a specific disease). Regardless, if an anti-aging treatment is effective at preventing/treating a certain disease type, eg. heart disease or dementia, the drug companies and physicians will push insurance companies to approve the drug for use on healthy, at risk, populations. With regards to heart disease, Alzheimer's, etc., almost all adults are "at risk..." Hence, almost everyone could make a case for getting a prescription. We see that happening today with statins. Drug companies and physicians are pushing insurance companies to cover statin use for a wide section of the population, including 20-somethings who have only very moderately elevated cholesterol levels.

IMO only...

Anthony

Posted by: Anthony Hopper at February 10th, 2014 9:47 PM

I agree with the foregoing, nevertheless it's disheartening to see a young man like Mark Zuckerberg give almost a billion dollars this past year and not a dime to anti-aging research. In fact, only a small percentage of his organization's dollars go to medical research of any kind.

The man's a 29 year old multi-billionaire. If anyone can push SENS forward and personally benefit from it, it's him.

Posted by: Therapsid at February 10th, 2014 10:34 PM

I'm not sure that a deregulated health market will help research and clinical applications. I fear a world where every clinic may promise miracle treatments and a lot of people that will believe them until in the end it become impossible to find out what is scam and what really work. Here in Italy the recent Stamina case is a good example of that outcome. Lot of money has been spent on a completely unscientific treatment while the good research is starving.
That said, I agree that FDA and other similar organization are badly hampering research in the aging field but it is possible that all things considered they are the lesser evil.

Posted by: Aury78 at February 11th, 2014 2:13 AM

This is a non issue. Senescent cells are associated with various pathologies so if their wholesale removal modifies a single pathology it can be prescribed for that. The only way it could possibly not be approved would be if it didn't modify the morbidity of any disease.

This is just an error of definitions. For this kind of thing you should consider that aging is the 7 types of accumulating damage that causes the myriad of age related diseases and approval for these kinds of therapies that treat them will be the same as most other approvals. Aging IS heart disease, cancer, arthritis et al. It is not something that can be cured separately.

I am disappointed in this invoking of Zuckerberg to solve our problems. If you want SENS therapies to be real become a monthly subscriber for a small nominal fee and don't wait for these billionaires to. They just aren't going to do it and you have to accept it. Success for SENS is a few hundred thousand people, just be one of them.

Posted by: Michael at February 11th, 2014 6:00 AM

If you want SENS therapies to be real become a monthly subscriber for a small nominal fee and don't wait for these billionaires to. They just aren't going to do it and you have to accept it. Success for SENS is a few hundred thousand people, just be one of them.

Small donations work much better with the use of bitcoin, a donator wouldn't have to pay transaction fees, assuming that the route to donating sens involves transaction fees.

Posted by: nickdino at February 11th, 2014 7:11 AM

How much money does SENS get from small donations? I mean - you get online campaigns for *video games* which make millions. How hard could it be to get funding for (a perhaps somewhat speculative) attempt at curing aging?

Posted by: Mark at February 11th, 2014 7:46 AM

@Michael - are you Micheal Rae?

Posted by: Jim at February 11th, 2014 9:01 AM

@Mark - A kickstarter campaign has to provide a product in some timeframe. I don't know if a piece of research fits this.

Also producing a product or service only has money and management skills as constraining inputs. SENS has not been (strongly) proved yet, so others can challenge it and say that it is impossible. Similarly other theories of aging such as the DNA Damage theory of aging have not yet been disproved strongly.

I think Michael's idea of 100,000 people donating $10 a month could be good. But I don't know if the SENS foundation would want to be directly involved in that. They'd be open to the charge that they are not informing the people they accept money from of the chances for success and timeframe (and no one actually knows these definitely). No that is not actually the case, these kind of donations are raised for cancer research... I don't know why, but I get the feeling that there are a few PR bear traps to be avoiding when going down that route.

Posted by: Jim at February 11th, 2014 9:24 AM

I'm not Michael Rae no. I'm just another monthly subscriber to SENS. The last annual report stated around $160,000 dollars was received from unsolicited donations. It would be so easy if most people who supported SENS also subscribed something like 20 dollars and moved on with their lives. That is literally the only problem now, financing. Approvals and public resistance no longer matter once there is adequate funding. We are very close just subscribe or, at the very least, make a one off donation. I think it's pointless berating Sergey Brin, Zuckerberg or whoever else becuase ordinary people have it within their means to solve this problem, people like ourselves, at anytime.

Posted by: Michael at February 11th, 2014 5:07 PM

Where are you guys getting this notion that it will be "illegal" to use a treatment on a condition for which it wasn't approved? Have you never heard of off-label prescribing? It happens all the time.

Is the Wild West model of medicine, where scam stem cell clinics pop up all over Asia what you really want? Has the outcome of that model in the stem cell space produced anything of significant value, adjusted for the harms it has created? Convince the American public that they would be better served by such a model, and the FDA will go away.

The US would be better served if we followed the Japanese, and allowed use after a (perhaps somewhat extended) Phase 2 safety trial, with a more robust Post-Marketing phase with better monitoring and reporting requirements to serve as a replacement for costly phase 3 trials. There is a growing awareness that the risk-reward tradeoff in the US has tipped too far in the direction of risk aversion.

Posted by: William at January 1st, 2015 11:13 AM
Comment Submission

Post a comment; thoughtful, considered opinions are valued. New comments can be edited for a few minutes following submission. Comments incorporating ad hominem attacks, advertising, and other forms of inappropriate behavior are likely to be deleted.

Note that there is a comment feed for those who like to keep up with conversations.