The Portions of Government Focused on Preventing New Medicine

When forceful, powerful government intrudes into any field of human endeavor, the end results are much the same: ruination. The only questions relate to how long it takes to get there and the small details of how that ruin unfolds. The incentives of bureaucrats are almost exactly in opposition to the direction of progress, and the existence of a powerful regulator distorts all surrounding endeavors.

Regulatory bodies like the FDA have every incentive to stop the release of new medicine: the government employees involved suffer far more from bad press for an approved medical technology than they do from the largely unexamined consequences of heavy regulation. These consequences go far beyond the obvious and announced disapproval of specific medical technologies: the far greater cost lies in all the research, innovation and development that was never undertaken because regulatory burdens ensure there would be no profit for the developer. Personal gain for the regulator is thus to destroy the gains of people they will never meet, the exact opposite of what occurs in an open marketplace.

A good example of this downward spiral in action is formed by the FDA and pharmaceutical industry in the US. The FDA continues to ratchet up the cost of producing new medical technology to the point at which progress is slowed to a crawl. The short term cost incurred by a politician in blocking advances is far less than that accrued by allowing advances to proceed. The pharmaceutical industry uses the FDA as a weapon to protect itself from progress in the form of competition, disruptive new technologies, and other endeavors that will greatly help health and longevity.

This system of short-termism, chains, and sabotage will eventually destroy the for-profit medical and biotechnology research industry in the US. Short of a revolution, that is the inevitable end state.

With that cheery truth in mind, here's an article from the perspective of infighting between those groups using the FDA as a weapon to protect their profits or livelihoods. That one group is more interested in rapidly developing new technologies than the other is somewhat moot. By engaging with the FDA and regulatory structures, they only add support to the root of all the problems.

Within the next five years, it's quite possible that physicians will come into routine possession of a remarkable set of tools - a brand new way of dealing with the frailty and disabilities of aging. The tool kit is autologous stem cells derived from the patients themselves, amplified in culture, and infused back into the patient according to a precise protocol. It would be such a leap from today's medical diagnostics and treatments; it could only be called revolutionary.

The purpose of employing autologous cells is to prevent rejection of histo-incompatible cells by the patient's immune system. But it's also possible that these new therapies could slip from our grasp, at least in the US. If we're not careful, these therapies could become the exclusive domain of the pharmaceutical industry, as regulated by the Federal Food and Drug Administration (FDA). This could push the availability of this tool kit 15 to 20 years into the future. The opportunity-cost in terms of morbidity and mortality could be catastrophic.

I discussed the consequences of a two decade cost in time due to regulation a little while ago. It isn't pleasant. The sane approach for anyone interested in funding for-profit progress in the near future is probably to perform fundamental research in the US - whilst there are still high quality research communities in the country - and then shift all development and clinical practice overseas to less oppressively regulated regions.

But that's still going to be a fraction of what might have been. Seen from above, we humans are our own worst enemy. If my generation leaves the stage without having witnessed the advent of true rejuvenation through repair-based biotechnology, it will be because too many of us chose not to achieve that goal, preferring instead to wallow in self-destructive systems of governance.

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