Fight Aging!

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.