Higgs on the FDA

by Don Boudreaux on November 21, 2005

in FDA

Bob Higgs, author of the paper I recommend at the end of this blog-post, wrote the following to me after he read that post.  I publish Bob’s comments with his permission, with emphasis in original:
I think it is very important in discussing this topic not to be diverted in mere speculations about how a market order might deal with quality assurance for health-care products. It is far more telling to insist that the market already supplies this assurance. One can with ease identify, as I have in a few places, any number of currently functioning nongovernmental sources of quality assurance (besides the important tort and reputation factors you noted). Indeed, those who make the bulk of the choices now — doctors, nurses, pharmacists, insurance companies, composers of hospital and other formularies, hospital and other health-care organizations’ administrators — already rely on these sources, not on the FDA. Overwhelming proof that they do so consists, for example, in the enormous volume of off-label prescriptions, indeed in the fact that the recognized "standard of care" often consists of off-label prescription. On this matter, Alex Tabarrok’s 2000 article in The Independent Review is enormously important and powerful, truly irrefutable; the link is here. This is by far the most important article Alex has ever written — an instant classic in this area of analysis (and among the best things ever to appear in TIR, I might add). Currently functioning quality-assurance sources include scientific organizations and their journals, medical organizations and their journals, and private testing organizations, such as ECRI. If you’ve never looked into ECRI, go here and check it out; it’s amazing, and I know for a fact that it is the gold standard for people who purchase medical devices or encounter problems with them. ECRI is not in the business of throwing people into jail and being rewarded by Congress for doing so; it’s in the business of actually helping people make intelligent choices and fix problems that crop up (as they always do).
The FDA is one of the greatest frauds ever perpetrated on the American people. It is a police agency, pure and simple, driven entirely by political motives, yet it constantly harps on, and gains public-relations mileage from, its scientific grounding. We need to keep telling as many people as we can get to listen that the FDA does not do what it claims to do.
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spencer November 23, 2005 at 9:50 am

The FDA does two things.
One sees if the drug actually does what it is claimed to do.
Two, see if the drug has bad side effects.

Because of two, doctors are in a position to experiment with off-label drugs because they are confident it will "do no harm".
Consequently, use of off-label drugs is highly dependent on the FDA approval process. If they did not have that, the off-label use of drugs would be severly limited.

Nicole Tedesco November 26, 2005 at 2:32 pm

If the ECRI is less "politically driven" than the FDA, I wonder how much the Lightening Rod Effect has on that outcome? By creating an agency which becomes the obvious brunt of political influence (the FDA), does that keep the attention away from organizations like the ECRI so that they can remain more independent? If there were no FDA, I wonder how long it would take until political and monetary pressures would drive the ECRI itself to calcification, dysfunction and perhaps even corruption.

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