Announcing Open Cures
I'm pleased to announce that Open Cures has launched. This is the volunteer initiative sprung from discussion of the Vegas Group concept that has been taking place here for the past few months.
More than a dozen ways to extend life in mice have been demonstrated in laboratoriesYet the US Food and Drug Administration (FDA) forbids commercial therapies for aging
Thus the best biotechnologies for human longevity languish, undeveloped...But this is a shrinking world, linked by the internet and medical tourism
Advanced, safe clinical development takes place in many countries
We can work around the FDA, and this is how it will be done »
Looking at the future of commercial medical development and rejuvenation biotechnology, it seems clear that something has to be done. The present state of affairs with respect to regulation of research and commercial development of biotechnologies in the US has forced to the sidelines any number of lines of research aimed at intervening in the aging process. These nascent biotechnologies, demonstrated on mice, cannot cost-effectively be commercially developed in the US - or cannot be developed at all, since the FDA will not approve treatments for aging. That fact is well known and has the predictable effect on the number of investors willing to pony up for the privilege of running into a brick wall.
Outside the US there are a number of developed nations which in which commercial medical development is less regulated. China for example - and US citizens of a certain age will no doubt feel sad that we can now point to modern day China as an example of comparative freedom in human endeavor. Not sad for the Chinese, but sad for us. Other nations in that part of the world are similarly more open than the US when it comes to commercial development of new medical technology: even India, despite its bureaucracy.
When we look to the future of commercial longevity-enhancing medical technologies - or indeed any cutting edge biotechnology - I think that we are looking at the process of building a bridge between the less restricted parts of the world and the output of the US research community. That bridge is forged of medical tourism, venture investment, and a flow of knowledge. Without it, little will be developed: there must be an outlet for new science to become new technology, and that outlet is being progressively narrowed in the US with each passing year.
We don't need to do anything about medical tourism or venture investment, as those fields are quite capable of looking after themselves and are growing rapidly, but where we are needed is to help build that flow of knowledge between regions. If we want to see real results in the clinic, we must establish a bridge between the potential longevity-enhancing technologies that have been demonstrated in the laboratory - but can never be fully realized in the US - and the developers half a world away who are free to translate the fruits of research into clinical application. This is a matter of documentation, of building relationships, and of pulling out the most interesting technology demonstrations into the light - as despite this shrinking world, it is still far from the case that researchers on opposite sides of the globe have a good view into what has and hasn't been accomplished.
There is a great that might be done to help this large-scale process along, especially now that we are moving in earnest into an age of open biotechnology. The impetus, as in software development, will be towards openly shared knowledge and designs, because the economic advantages are enormous. Accompanying this shift we will see an accelerating growth of the present community of lab collectives, semi-professional developers, and hobbyists in biotechnology. They already exist in the form of the , but that is just the earliest manifestation of what is to come, more akin to the Homebrew Computer Club of the 1970s that spawned computing hardware companies and the rampant growth that followed.
There is a wave coming, a vast growth in medical tourism and open development in biotechnology. We can help that wave form, and ride it to achieve our goals as it arrives.
All this considered, and the need for action very clear, I decided to launch Open Cures as a volunteer initiative, an open collaboration for everyone interested in accelerating the clinical development of the best longevity science demonstrated in laboratories. Our initial focus is on establishing the organizational basics and producing a good, open-access Creative Commons body of work that explains exactly how to carry out a range of biotechnologies shown to extend life or reverse specific biological aspects of aging in laboratory animals.
To that end, Open Cures patrons, starting with myself, are offering bounties on documentation outlines: if you are a life science graduate or post-graduate level student or an interested volunteer with a good knowledge of the field, I encourage you to drop by the Open Cures discussion group and introduce yourself.
Bounties are funded by Open Cures patrons as a way of speeding up work and attracting new volunteers to the initiative. At the present time, bounties focus on documentation needs: each award is made to the writer who first posts sufficiently good material to the Open Cures discussion group. Writers should expect some back and forth, questions asked, and friendly conversation when they do so. The bounty is then awarded when the writer releases their posted work under an open license; until that time, he or she retains copyright.The primary purpose of awarding bounties is to discover good life science freelance writers, and who can therefore be paid a modest rate to produce further work on an ongoing, occasional basis. It is important to build lasting relationships with enthusiastic freelance writers who know the ins and outs of practical biotechnology - so when you submit good work that arrives too late to win a specific bounty, or is beaten out by another author, you are still a candidate for future writing projects.
Since the FDA does not recognize aging as a disease, doesn't that mean that products intended to slow or reverse aging would be classified as dietary supplements, and therefore legal to sell as long as the FDA can't prove them to be unsafe?
@Brandon Berg: unfortunately not. The types of meaningful therapy we're talking about here are things like the use of vectors and gene engineering to replace all copies of mitochondrial DNA in your cells, or the use of engineered enzymes harvested from bacteria to break down intracellular materials, or varying forms of foreseeable stem cell therapies. Things that the FDA does clearly hold dominion over, in other words.
Do you know of the top 3 reasons/explanations for not recognizing ageing as a disease beyond definitional issues?
Have you talked to anyone with any power or connections to persons with influence within the FDA?
My guess:
1) too risky (moral/bioethical concerns, too many unknowns)
2) too expensive (those believe ageing is not inevitable also believe it would
cost trillions of dollars to fix
3) they believe ageing is not treatable
And finally, maybe its simply because they don't want to seem like they don't know - a status based argument for doing nothing.
But that is speculation. Does anyone really know anyone who would really know why based upon actual decision-makers in the FDA?