Distributed Full Disclosure Medical Development
In a time of rapid progress in biotechnology, the Hippocratic pledge of "first do no harm" kills a lot of people. It just doesn't kill them as directly as more obvious means. Taken to its extreme, "first do no harm" is a strong precautionary principle, it forbids progress, it forbids the testing of new therapies. While we are not at the point of forbiddance yet, regulators have been heading in that direction for years. Officials at the FDA and similar regulatory bodies are willing to accept great ongoing suffering and death in the service of reducing the risk of harm due to new therapies to as close to zero as possible. The costs of regulatory compliance and degree of proof required for novel medical technologies scale upward year after year, and, accordingly, the pace of progress slows while patients continue to die. Medicine in the clinic lags far behind what is possible in the laboratory.
This isn't the best way forward for an era of revolutionary advances in biotechnology, information science, communication technologies. A different paradigm must emerge, one that will lead to more rapid development of new medicines and a lower overall toll of death and suffering. Consider the following, which I will call Distributed Full Disclosure Medical Development, in which information is the currency by which, on an ongoing and incremental basis, the safety and success or failure of therapies can be judged, and patients can make their own informed decisions, guided or unguided by specialists. There are no clinical trials, because there need to be no clinical trials - the entire life span of a therapy to date is the data by which future patients make their decisions. Someone will have to be brave, and be first, but that is no different than today's environment:
1) Anyone can propose, manufacture, and sell a therapy. The only requirement is to publish all of the preclinical data.
2) Any organization can set itself up as a reviewer of therapies.
3) Any provider can offer therapies, provided that the patient signs a disclaimer, agrees to open publication of their medical data, and that data is in fact published.
4) Any organization can set itself up as a clearinghouse and analyst of all of this medical and developmental data.
This is clearly possible in principle. It requires no new technology, only a commitment to the incentives of publishing. Reviewers and clearinghouses steer patients to better providers and therapies, and providers and developers are thus incentivized to prove to reviewers and clearinghouses that what they do is good. Abuses will always happen, people being people, but modern legal systems financially incentivize victims and third parties alike to vigorously attack abusers. Nothing new is needed there. This describes a very normal market in an information age society - and we should perhaps look at the medical markets we have and consider that they are aberrant and strange for our era.
Present day clinical trials leading to regulatory approval, and further studies of approved therapies, form a broken system. It is not full disclosure, because companies keep trade secrets. It is slow and expensive, and data is hidden for years before being only partially released, usually summarized. The infrastructure of clinical trials is an awkward concession to the reality that every medicine must be tested in humans for the first time. People have died when this happens, with the best of preparations. People will continue to die in the future. People will die in a Distributed Full Disclosure Medical Development system. But, I think, far fewer than die now. The primary issue of present regulatory systems, characterized by a central authority wherein "first do no harm" is a goal considerably more important than the development of new therapies, is that the resulting bureaucracy is so slow and expensive that people die waiting on treatments, while development of many potential treatments is never even undertaken, as the onerous requirements make it too expensive to do so. In a better system, cures would be discovered and tested more rapidly. Getting rid of the gatekeeper is necessary.
Yet the medical tourism concerns of the world, medicine absent that primary gatekeeper, also form a broken system. Overseas clinics and regulatory arbitrage is a necessary rebellion against US and EU regulators and their slow, lumbering clinical trial ecosystem, but so far this rebellion has proven just as unable to produce the desired outcome of more rapid, useful progress. There are even more secrets than is the case in the regulated world of medical development. Data is never published, unless extraordinary and beneficial to the clinic. Patients are are more free, but even more in the dark when it comes to making informed choices.
Neither of these systems is likely to change much. The short-term incentives are what they are: no overseas clinic wants to publish anything other than carefully cherry-picked data, and the trend of regulatory bodies in the US and EU continues to be for ever greater costs, ever more burdensome requirements, and ever fewer approved new therapies, in the service of trying to achieve the impossible goal of risk-free new medicine. Yet it is easy enough to describe the principles of a potentially far better system; it can be done in a paragraph or two. In an era of computation, communication, and biotechnology, we are somehow still stuck with the two options of (a) lumbering regulatory systems that kill patients by slowing progress to a crawl, and (b) secretive clinics performing work that is impossible to assess in any useful way. This seems ridiculous, and something that can and should be changed with the advent of a new third way, and with the growth of organizations that encourage and support that third way.
Well the problem is that the medical provider wii try to cheat and lie and the desperate and misinformed patients will go for bogus or outright dangerous treatments. There is right balance, and were are too far on the conservative side. But no control would be a mess too
so, what could charity do to fix this problem?
Maybe start a non-profit that analyzes both US/UK medicines and also medical tourism options, and makes educated recommendations?
@Gregory
Itd be awesome to have a grassroots startup with superstar resources and well known like Elon ( I know he has little interest in longevity, ( still too young, hasn't felt reality yet). But, love your thoughts Gregory and Reason certainly raised some valid, yet depressing realities of the medical research environment:(
As we saw, hurry up, I ain't getting any younger ( yet).
https://medium.com/mosaic-science/a-plutocratic-proposal-deba1f979bff
This is/was an interesting charity idea. People pay for experimental treatments, but pay enough so that 10 other people can be stuck in the experimental arm of a trial, ensuring actual useful data comes out of paid for trials.
The big problem is big regulators in developed countries everywhere with no real incentives to allow experiments. So some aspect of medical tourism is probably necessary, but also a big problem as a lot of people won't trust overseas clinics, due to a lot a whacky and scammy clinics being out there already.
"But you have missed the bigger idea!" exclaimed Peter Lanciano, grabbing the pepper grinder and banging it on the table. "The problem isn't how to get my drug into Mr Pepperpot. The problem is how to protect me from being sued if Mr Pepperpot dies."
I agree with Cuberat.
The problem of this approach is that the big majority of patients are idiots. We saw that very clearly during the pandemics and afterwards. The amount of morons, ignoramuses, luddites and conspiracy theorists out there is simply awful.
So I prefer something in the middle, maybe return to the 50s or 60s status quo.
A vision for the furthering of the knowledge in a field which:
- (target: user demand) - does have not compelling support by the majority of the public in any clearly defined way (people not wanting to die or suffer is not the same as people wanting to have interventions to help them have longer and healthier lives (i.e. 1 is pro-active, the other is reactive)) - this would be a minimum for any government support even before regulatory loosening or a culture change to 'pro-active'
- (target: supplier resources) - does not have a coordinated, mutually-supporting network of researchers, staff, and clinics to 'make several inroads into a common problem' with overlap and adjacency identified and optimized, as possibly in a single lab of many departments (or even under a determined focus, but scattered approach, as previously with developing a covid-19 vaccine (quite a remarkable, never-to-be-duplicated effort))
- (target: funding) - relies on short-term investments, politically-/cultishly- motivated investors, groups often far removed from the experimenters and actual enthusiasts (mostly), varying and unpredictable in most given years
Problems: motivated and focused research programs are most productive/ creative when done with an incentive-based, knowledge-ownership, politically-agnostic team system - (i.e. bring me the best researchers, show me the money, vest us into future success with knowledge gained, and no save-the-worlders- which means: science and solutions for science and solutions' sake. This is not aligned with a hyper-transparent, voluntary, pro-equality research initiative/ vision.
Problems: huge bottlenecks in research due to burdensome regulations and client/ researcher reticence. This means taking research away from the resources and client bases most reliable as in the developed world.
Solutions: Stop trying to save the world in an egalitarian and equitable manner, and making speeches to that effect. An extremely effective means of technology roll-out is 'trickle down' - a solution first, distribution second, mentality. Whether an anti-aging therapy is affordable or regulatory-appropriate or popularly-established is utterly counter-productive.
Solutions: interest, funding, and solutions are very effectively accelerated by gathering and promoting, by invitation, in convention/ research-collaborating/ medical-facilities-rich/ regulations-free environment. Combining public-enthusiast/ researcher/ clinic gathering with libertarian dream of off-shore, modern, living/working community - obviously a Longevity Ship; a continuously-sailing medical/ research/ advocacy cruise-like facility that brings together public, investor, researcher, private-enterprise in a low-regulation/ low-oversight, ultra-tech environment.
Congratulations Reason for your great proposal. I would add only one condition: 1) Anyone can propose, manufacture, and sell a therapy. The only requirement((s)) is ((are)) to publish all of the preclinical data ((and to receive the approbation of a medical doctor)).
Why?
In most countries, only medical doctors can prescribe medication. But also, in most countries, medical doctors can prescribe most medication without real strong limits.
I know, it will be sometimes difficult to have a medical doctor approving a new therapy. But let's be honest, if the therapy looks without big hope for all medical doctors of one country, the chance, this is good for longevity is really small.
This is my idea. But I can understand your simpler proposal. And, on the other side, you do not need any prescription to binge drink, smoke...
Parrish et al already started something like this, was her masters thesis. Called the BCM bestchoicemedicine.org
@Didier Coeurnelle
try convincing your typical MD prescribing you rapamycin. Btw,Pfizer charges 1300 for something india sells for a few bucks ?
Cuberat: The largest medical trial in history was conducted on the world population with far less information and consent than anything that is being proposed here. Still, a small percentage did their own research and made the right decision. As a libertarian, I both support the idea proposed by Reason and refuse to pay for the consequences of any ones' bad decisions. Health and life insurance companies, and there other customers, have an interest in expecting new customers to disclose their treatment history as a condition of accepting their risks.
I think this could work for therapies that have massive, obvious, unmissable effects. (Which are the best kind.)
But many / most interventions have small effects, right? Whether positive or negative, they're not large. And this system by abolishing trials requires observational methods - which, bluntly, don't work. I don't trust observational results very far because it's so easy for them to be wrong.
Is the point that this dynamic would push development toward therapies that have gigantic, rapid, clearly visible effects? (Because those are the only ones you could reliably find?)