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This is a question that crops up regularly - and it does so entirely because of the regulatory structure that exists in much of the Western world, such as that
by reasonattlm 14y ago
This is a question that crops up regularly - and it does so entirely because of the regulatory structure that exists in much of the Western world, such as that imposed by the FDA. In essence the FDA only approves medicines for specific, recognized, named diseases. Therefore you cannot legally, commercially treat aging in the US, as aging is not recognized by the FDA as a disease, and there is no path towards reversing that situation.
(Though let us be clear, the idea of a named disease is a nebulous entity: "Alzheimer's" probably covers at least three distinct conditions, for example, and it's much the same for Parkinson's and many other diseases that were named early and only now are being split out into their various etiologies. Ultimately at the level biotech is moving into now, names for collections of symptoms and similar-looking damage go away in favor of treating specific mechanisms that get you there).
To show just how much of a cost the FDA imposes just by this regulatory aspect, you might look at sarcopenia: it has cost millions of dollars and years to date and will cost millions and years more to lobby the FDA (meaning put dollars into the pockets of lawyers and appointees) to recognize sarcopenia as a condition. Until that happens, there will be no serious commercial research into the numerous potential mechanisms and therapies, because you can't sell the results in the US.
Now multiply that by the thousands of potential named conditions you could carve off the bulk of mechanisms that is called aging. Look at the SENS Foundation research pages for a primer on the underpinnings:
http://sens.org/sens-research/research-themes http://sens.org/sens-research/research-themes
So given this ridiculous state of affairs, pretty much par for the course for big government, therapies for aging will never happen in the US for so long as the present regulatory structure exists, and for so long as there is no massive medical tourism and global research and development exchange devoted to circumventing it. That latter community is only just getting started, when considered in the grand scheme of things.
But most people are blind to all of this, and think that the FDA is actually a force for good - because they don't see the opportunity cost and the progress that didn't happen. In fact, the FDA and its equivalents overseas are the biggest obstacle to significant medical progress in this age of revolutionary advances in biotechnology.
http://www.fightaging.org/archives/2012/04/the-fda-is-a-destructive-force.php http://www.fightaging.org/archives/2012/04/the-fda-is-a-dest...
For more reading on the "is aging a disease" thing, you might look at:
http://www.fightaging.org/archives/2010/05/talking-point-is-aging-a-disease.php http://www.fightaging.org/archives/2010/05/talking-point-is-...
"Because aging is not viewed as a disease, the whole process of bringing drugs to market can't be applied to drugs that treat aging. This creates a disincentive to pharmaceutical companies to develop drugs to treat it," said Gems.
http://www.fightaging.org/archives/2009/07/sage-crossroads-podcasts-on-the-pharmaceutical-industry-and-aging.php http://www.fightaging.org/archives/2009/07/sage-crossroads-p...
Why, despite the great range of potential applicable biotechnology, do we not see hundreds of millions of dollars invested in startups attempting to address the aging process? The answer is buried in this New York Times article on Sirtris: "Dr. Westphal and Mr. Sinclair stress that they are not working to 'cure' aging, a condition that, so far at least, is common to all humanity and that most physicians do not consider a disease. 'Curing aging is not an endpoint the federal drug agency would recognize,' Dr. Westphal says dryly. Instead, both men say, they are working to ameliorate the diseases of aging."
...
LARRY MILLER: [When] I was heading aging at Glaxo Smith Kline, the issues that I faced were that I was very interested in developing medications for frailty and weakness in muscle for when people get old because when people get weak they usually stop eating and then they fall and break a hip and end up in the hospital and die potentially, but the regulatory apparatus isn't there yet. Sarcopenia isn’t recognized as an official disease by the FDA, so the pathway to get drugs approved for frailty and to get more people mobile and into society is just not there.
- rsanchez1 14y agoWell, they can say that anti-aging treatments are just supplements for "healthy aging", since such treatments don't cure a specific disease and supplements don't have as many regulations as medical drugs. The bonus is that these supplements would actually work as advertised as opposed to vitamin pills.
- reasonattlm 14y agoGood luck trying to convince the FDA that a gene therapy to allotopically express mitochondrial genes throughout the patient's cells and add suitable RNA mechanisms to transport the relevant gene products back to the mitochondria again is a supplement. The FDA is already trying very hard to regulate the supplement industry in any case - that's a lucrative battle for lobbyists these past few years. The moment that it looks like "real medicine" is being marketed as supplements, the FDA will gain its mandate to regulate supplements and suddenly you won't be able to freely buy them anymore. That is pretty much the endgame anyway, given the rapacious ratcheted growth of government in the US, but there are certainly ways in which it could be accelerated.
- leoedin 14y agoSort of connected to this, but from the other end, our requirement to classify everything as a disease has pretty terrible repercussions across society. As an example, my mum's a doctor and has worked in wards in which old people die. There's a requirement for a "cause of death" for each person to die in a hospital. Often this was given as pneumonia or similar for people who essentially died of old age. Unfortunately, someone looked at the statistics and discovering that lots of people were dying of pneumonia decided that it needed to be treated, and so now with aggressive treatments people who are at the very end of their lives are kept alive until something else comes along and kills them. The reality is, once your body has reached a certain point likelyhood of survival falls very quickly, and treating a single disease is simply a very brief and ineffective way of dealing with that. Interestingly, although human lifespan has been increasing year on year, it's not an indication that we're actually living longer. What's happened is that things that kill you in early to mid life - heart attacks in 50 year olds, viruses and infections and injuries that 20 years ago would have been deadly - have been reduced. The outlook in terms of years of life for someone that actually manages to reach 80 or 90 has increased very little - perhaps 1 or 2 years over the last 50. (I read this somewhere but I've lost the source - I'll try and find it). The single thing to treat, the thing that is the precursor to all other things, is ageing.