[ExI] Open Cures @ h+ Magazine

[Reason]

An introductory overview:

 

http://hplusmagazine.com/2011/05/31/open-cures-an-initiative-to-speed-clinic
al-development-of-longevity-science/

 

You may recognize me as the author-slash-editor of
<http://www.fightaging.org/> Fight Aging!, a long-running news and advocacy
site focused on progress towards reversal of aging and engineering longer
human lives. There is more to progress in the general sense than just the
underlying science, however, and with that in mind I recently announced the
launch of  <https://www.opencures.org/> Open Cures, a volunteer initiative
with the aim of greatly speeding up the development of clinical applications
of longevity science. Participation is open to anyone who can help with the
goals listed in the  <https://www.opencures.org/roadmap> Open Cures roadmap:
for example, we're presently looking for life science writers and people
familiar with the medical tourism industry, amongst others.

But why, in this age of biotechnology and accelerating progress, it is even
necessary to build an organization to help speed matters along? What is the
roadblock that stands in the way of the clinical development of
longevity-enhancing biotechnology?

The Biotechnologies of Longevity, Undeveloped

When we look at work on aging and longevity in the laboratory, we can see
that more than a dozen ways to use biotechnology to extend the lifespan of
mice have been demonstrated over the past decade. About half of those
methods appear to lack serious side-effects, delivering only longer lives,
lower cancer risk, improved health and vigor, and little else. Similarly, a
range of laboratory demonstrations conducted since the turn of the century
have reversed specific, measurable biological changes that occur with age in
mice: damaged mitochondrial DNA replaced throughout the body, the function
of cellular garbage collection mechanisms restored to youthful levels in
liver tissue, and so on. We live in an era of rapidly improving
biotechnology - and it is delivering the goods, in the laboratory at least.

But there is one common theme to all of these advances: none are undergoing
further development for clinical use in healthy humans for the purpose of
slowing or reversing degenerative aging, and thereby extending healthy life
span. Why is this? You would imagine, given the size of the market for
medicine, that a hundred start-up biotech companies would be leaping upon
these opportunities, giving rise to an era in which "anti-aging" fakes and
frauds finally start to fade away in favor of a market built upon true
rejuvenation science. This is not happening, however, as there is a
gargantuan roadblock that stands in the way.

The Nature of the Roadblock

In the US, where much of the research most directly relevant to engineered
longevity takes place, this roadblock is called the FDA: the Food and Drug
Administration. Appointed FDA bureaucrats have absolute control over the
commercial deployment of medical technology in the US: only those
technologies formally approved by the FDA can be sold for clinical use.
Further, the FDA only approves a new medical technology for narrow usage in
treating a specific, defined disease in a specific, defined way. Obtaining
even this narrow approval is a staggeringly expensive process. For one, that
list of diseases changes only very slowly, and an entire industry of
lobbyists exists solely to try to add new medical conditions to that list -
burning money that would better used for research and development.

Consider sarcopenia, for example, the characteristic age-related loss of
muscle mass and strength. Sarcopenia was first named as a distinct condition
a decade ago or so, and expensive efforts have been ongoing for some years
to convince the FDA to add it to the approved list of diseases. There seems
little prospect of this happening any time soon, however, and so the
lobbying efforts continue. There are potential therapies for sarcopenia, or
at the least the scientific basis for potential therapies that might prove
useful in humans, but little to no private funding to further develop these
leads - as there is no market on which to sell any resulting treatments.
Even if a storybook industrial philanthropist turned up tomorrow to devote
his entire net worth to pushing through development of a therapy for
sarcopenia, it would still be illegal to offer the resulting medical
technology for human use in the US.

Aging itself as a medical condition is in the same boat. Aging is not a
disease, per the FDA - and therefore, no one is legally permitted to treat
aging in humans with biotechnology in the US. The present state of the
lobbying game, as illustrated by the situation for sarcopenia, is that it
will take years and millions of dollars in to carve off one tiny component
of aging and have FDA bureaucrats grudgingly allow commercial development to
proceed. Thus what comparatively little development of longevity science
does take place - such as work on sirtuins and other possible calorie
restriction mimetics - sees applications of the underlying research
shoehorned into treatments for late-stage diseases of aging, whether it fits
or not. Even if successful, the resulting therapies will not be legally
available for use by healthy or younger people for the purposes of treating
aging itself.

The Mirage of Reform

 

Numerous organizations and advocates (such as  <http://www.fastercures.org/>
FasterCures, for example) have been trying for years to reform the FDA, or
at least make it less obstructionist - to try to make it possible for new
therapies to emerge without the stifling costs in years and hundreds of
millions of dollars, or to emerge at all where they are not recognized by
the FDA. These initiatives are all failing: over the course of time that
they have been active, and despite the funds and efforts poured into them,
the FDA has only become worse, approving fewer and fewer new technologies,
and continually raising the bar and the cost for approval. The fundamental
incentives that shape the actions of FDA political appointees are these:
they suffer very few problems due to medical technologies that are
suppressed or denied approval, but take a great risk to their career in
approving any new application of medicine or biotechnology. The rest of this
undesirable state of affairs unfolds from that basis - bureaucrats will
follow their incentives, regardless of the harm it causes.

Meanwhile, the years pass, funds are consumed by political processes rather
than being spent on actual research, and we're all getting older - our
bodies slowly sabotaged by the processes of aging.

All in all, working with the FDA is not a game that we win by playing. A
system so entrenched and badly broken cannot be reformed through existing
channels, and efforts to change it by playing within the rules do little but
provide the FDA with additional legitimacy. The only way to win here is to
refuse to play the game, and take an entirely different approach - which
brings us back to Open Cures, which is exactly that: an entirely different
approach to the roadblocks put in the path of development by the FDA and its
counterparts in other highly regulated countries.

The Rise of Medical Tourism

I'll restate the primary challenge: that it is illegal to commercially offer
medical treatments for aging in the US, and based on the lack of progress in
effecting change to date, this situation will persist for the foreseeable
future - regardless of how much money and effort is expended on lobbying
within the system. In turn, that the clinical application of longevity
science is forbidden means that there is little to no investment available
to develop laboratory demonstrations into therapies. Thus the most promising
and advanced biotechnologies shown to extend life or reverse specific
biochemical aspects of aging in mice languish unexplored and undeveloped.

Yet if we look beyond America and Europe, we see regions in which clinical
development of therapies based on cutting edge science is both possible and
less restricted. To pick one example, stem cell therapies that will not be
commercially available in the US for years yet have been offered for a
number of years by responsible, skilled groups in China, Vietnam, Thailand,
and other countries. You might look at Beike Biotech or Vescell, for
example. It should make American citizens of a certain age sad that China
has become an example of freedom outshining the US in any field of endeavor
- not sad for the Chinese, but sad for what has become of medical
development in America.

This is a shrinking world we live in. Air fares are cheap, tourism growing,
and the internet links together cultures, movements, and businesses ever
more efficiently with each passing year. When the cost of travel is low
compared to the cost of newly available medical technologies, we see the
growth of medical tourism. Clinical development will occur wherever capable
institutions exist and local law permits it, and patients will travel from
restricted regions like the US to receive treatments that are not available
at home.

Medical tourism is a growing business in the US precisely because forbidding
and regulating medical development is also a growth concern: medicine is
only expensive and unavailable because bureaucrats make it that way. Medical
tourism is still a comparatively young industry, however, feeling its way
and largely focused on a few major and well-known fields of medicine (such
as the early therapeutic uses of stem cell transplants). It is far from the
case that people are taking advantage of the full range of cost-savings and
possibilities, and this is due in part to all the standard challenges
inherent in establishing important business relationships across a great
distance.

When you stop to think about it, however, you'll notice that all of these
problems are well solved for traditional tourism - even where comparatively
large sums of money are involved, such as in the much maligned timeshare
business. People comfortably travel great distances and expect to rely on
critical services at their destination: this works because intricate,
long-standing industries of communication, organization, and education make
that possible. It will one day be the same when people routinely travel to
obtain medical services from far removed locations.

Now consider this: there is no technical barrier to, for example, clinical
development of a way to replace all damaged mitochondrial DNA in humans -
the basic technology has existed, demonstrated in mice, for six years. The
work is published, fairly well known in the small part of the field where it
matters, and were it made into a therapy there would be tens of thousands
lining up to pay for it. Yet in countries where it is both possible and
legal to move ahead with that commercial development, and where there is
already an established, albeit nascent, medical tourism industry, that
development has not yet happened. Why is this?

A Material Role for Open Biotechnology Movements

When it comes to the passage of information, we do not live in a
frictionless world. Scientists and medical development groups in widely
separated regions do not in fact necessarily have good insight into the work
of their far-removed peers, or even know that the work exists in the first
place. They are separated by distance, culture, and language - far less so
than in the past, thanks to the internet, but separated nonetheless.

The effects this has on a given field of research and development are a
matter of degree: smaller fields are more affected than the larger ones, as
more researchers, more funding, and more public interest means more
transmission of information. Aging research and longevity science is not a
very large field, as it happens, at least not in comparison to stem cell
medicine or cancer research - and you can see the difference that makes in
cooperation and organization across national boundaries in the resulting
levels of medical tourism. The relationships for development and
transmission of knowledge that exist for stem cell research, to pick one
example, dwarf those developed for longevity research. Thus you don't see
clinical projects outside the US and Europe that are analogous in scope and
ambition to those that presently take place in the field of stem cell
medicine.

But all is not doom and gloom: I do not expect the gaps in the transmission
of knowledge to last. Institutions and cultural forces will arise to close
these communication gaps, and they will arise from present-day open
biotechnology movements. These movements are still young and small, but very
similar in aims and ethos to the open software engineering cultures that
first formed in the 1970s in the US: information and designs are freely
shared, there is an emphasis on moving the ability to produce significant
products out of the ivory tower and large institutions, and the result is a
massive body of work that greatly lowers the barriers to entry for hobbyists
and professionals alike. Software development, once an arcane art practiced
only within large organizations and universities, became possible as a
garage industry, and then as a hobbyist activity - which in time gave rise
to a vast breadth of knowledge and practice, a staggering pace of
innovation, and a community of developers that has grown in size and
sophistication by leaps and bounds.

The last 40 years in the culture of developing software is a snapshot that
will be repeated for the next 40 years in the development of biotechnology.
Costs of equipment and processes will fall, garage developers and hobbyists
will come to greatly outnumber institutional professionals, and the pace of
innovation will accelerate dramatically. On the way to that end result, open
biotechnology movements (such as the DIYbio groups) will play an important
role in bridging the communication gaps that exist between life science
professionals and clinical developers in different parts of the world.

How will this happen? Consider that in software development today, there are
no secrets and no specialty so small that it doesn't have a hundred skilled
observers in the broader open community - watching, talking, and tinkering
on their own time. When an important new advance arrives, it will be echoed
around the world, dissected, analyzed, and evaluated. The best new
strategies rise to the top very rapidly indeed exactly because the community
is very large. Unfortunately, this state of affairs is not yet realized for
biotechnology and the life sciences, but that is only because the open
community of demi-professionals and hobbyists is still comparatively small.
It won't remain small for many more years, however, and as the community
grows, it will become increasingly unlikely that any promising
biotechnologies will remain buried in scientific papers, undeveloped.

So in short, it is my conjecture that the present scientific demonstrations
that might possibly be applied to extend life or reverse aspects of aging in
healthy humans go undeveloped because they haven't been brought out into the
open by a community of thousands: they haven't been discussed, picked over,
buffed up, and presented far and wide in overseas regions where provision of
clinical therapies for aging is not illegal. This process would happen as a
matter of course given a much larger open development community associated
with the biotechnology industry, but until that community arrives, a helping
hand is needed.

Information and Relationships: the Role of Open Cures

And here we come to the point of the exercise: the reason for Open Cures.
The high-level goal of the Open Cures initiative is to produce the
communication, examination of research, and relationship building in
longevity science that would naturally emerge from a larger open
biotechnology community - but which is nowhere in evidence today, and will
not arrive on its own for a long time yet.

The foundational items on the Open Cures to-do list are as follows:

.         - Establish a repository of how-to documentation for
longevity-enhancing biotechnologies demonstrated on mice in the lab, with
sufficient detail and explanation to make it comprehensible and useful for
garage biotech groups, DIYbio practictioners, and overseas developers.

.          

.         - Establish a network of relationships with the open biotechnology
community, overseas developers, and the movers and shakers who are building
the medical tourism industry rooted in the US.

That might not seem like much, but we stand at a fulcrum point in the growth
of three large movements: regulation of medicine, medical tourism, and open
biotechnology, all driven in their changes by accelerating technological
progress in computing and biotechnology. The initial Open Cures projects are
a lever for that fulcrum, a foundation for the construction of lasting
bridges between researchers who discover and demonstrate the biotechnologies
of engineered longevity and overseas development groups who can translate
that science into new medicine for clinical use.

The bottom line is that the groundwork for a range of potentially
life-extending therapies exists already, and the development groups legally
able and capable of turning this science into therapies exist already:
something must be done to bring these two sides together, and ensure that
they build further ties for future development. If this were a better world,
therapies built upon replacement of mitochondrial DNA would already be
emerging, today, for example - there is no technical reason why that could
not have been the case. That this has not happened is a challenge of people
and organization: regulation, relationships, fundraising, the transmission
of knowledge and experience.

My vision for the future of Open Cures is a long-term process of growth in
establishing a self-sustaining community around the process of rescuing
longevity science from its current fate: discovered and published, yet
unheralded and undeveloped for use. This is analogous to the long-term
vision of the SENS Foundation, which is as much about the development of a
culture and community of longevity research as it is about the development
of true rejuvenation biotechnology capable of repairing the biochemical
damage of aging. When the scientific research of SENS is complete in its
first phase, perhaps twenty years from now, we want to be living in a world
in which potential biotechnologies of longevity are routinely and eagerly
developed into clinical applications, no matter where they were initially
researched, and no matter what destructive games the regulators and
bureaucrats have found to play.

 

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