Envisaging a World Without the FDA

Issue CCLVIII - August 28, 2010
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Incentives matter in all areas of human endeavor. When people gather to develop and deploy new medicines, for example, they are more incentized by the prospect of personal gains - reputation, profit, feeling good by doing good, and so forth - than by the benefits brought to people they have never met. This is simple, hardwired human behavior. Exceptions are few and far between.

That we instinctively work to improve our own lot first is why progress for all happens so much faster in free, open marketplaces under the rule of law. There, everyone can trade to make themselves better off: specialization and comparative advantage means that trade benefits both sides. Trade is not zero-sum; we grow the whole pie by specializing and trading the results of our work. You go off and work to make the medicine I want, and many people like myself give some our our resources to purchase the end result. Both sides benefit, exchanging - what is for them - lesser value to receive greater value.

There is no open marketplace for medical technology in the developed world, however. Instead, we see a very different set of incentives dominating the state of research and development. 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.

An article that looks at one small part of the destruction caused by the FDA caught my attention, and particularly these snippets:

Since 2005 the FDA has approved 18 new cancer drugs, many of them breakthrough products. But the pipeline contains hundreds more that will never get to market because corporate developers aren't able, or willing, to come up with the money, time, and patients necessary to establish acceptable data.


The clinical trial process now is a three-part, years-long effort that effectively kills off all but a handful of once-promising drugs.


It would have been the first new drug for prostate cancer in 20 years

Twenty years! Just stop a moment and think about how far and fast biotechnology and medical science has moved in the past twenty years. Think about what the far less regulated computing industry has achieved in the same timeframe. We live in the early years of the biotechnology revolution, with something amazing and new demonstrated in laboratories every week. Yet the dominant regulatory body for one of the most advanced regions of the world has managed to stop the clock at 1988 for a major disease, the subject of research in a hundred laboratories worldwide.

This sitation exists in every field of medicine, and all participants labor under the crushing burdens imposed by regulators incentivized to stop progress from happening. The same will be true of the future of longevity medicine, unless we do something about it.

The insanity of this all is quite staggering - that people largely accept and defend the need for regulation that achieves this sort of result, that is. I have heard it said that the failure of libertarianism, of the urge to freedom and personal responsibility, is a failure of imagination on the part of those who have been brought up knowing nothing other than government and regulation on a massive scale. The majority cannot make the leap to see an unregulated marketplace for medical development that works in the same way as the unregulated marketplace for computers - enormous choice, low barriers to innovation, efficiency and low cost, competing review organizations, accountable sellers, rapid progress and responsiveness to customers driven by fierce competition, and so forth.

What is, is, and to propose another way is already an uphill battle regardless of merits. That is also hardwired into the human condition. But the present dismal state of affairs must be changed if we are to see the defeat of degenerative aging in our lifetime - nothing short of a revolution is called for, given just how far in the hole we find ourselves. The technologies needed to repair aging will take only a few decades to develop, and indeed some already exist in prototype, but the present regulatory burden placed upon medical technology will ensure we are all dead and buried, that wondrous potential squandered.

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This TRA feature has been edited in accordance with TRA's Statement of Policy.

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Learn about Mr. Stolyarov's novel, Eden against the Colossus, here.

Read Mr. Stolyarov's comprehensive treatise, A Rational Cosmology, explicating such terms as the universe, matter, space, time, sound, light, life, consciousness, and volition, here.

Read Mr. Stolyarov's four-act play, Implied Consent, a futuristic intellectual drama on the sanctity of human life, here.