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It comes down to a basic philosophical difference: centralized or decentralized?

Every single other product we use -- including things like cars/motorbikes, with a direct impact on your health -- we read reviews, ratings, and reports before purchasing. We allow people to set their own risk dial, whether that be a motorbike or a Volvo.

Indeed, the whole point of sites like Metacritic or Amazon's review section is that any particular review could be in error, but the sum total provides signal. Not perfect, but provably better than selecting a few people at random and keeping the product from the market unless they all agree.

And this extends to medical procedures too. Of course I will research hospitals before having that kidney transplant. Cedars Sinai has a good reputation; I don't need 13 years of medicine to know that it's good, anymore than I need to know how to direct a film to appreciate a movie. Because there are many other sources of reputation checks other than government: search engines, your friends, books, newspapers, etc. Good word of mouth about a device or doctor usually reflects technical merit, and when it does not, it is unlikely that a single bureaucrat will uncover that which has fooled the world. Bureaucrats go with public opinion, they do not buck it.

Moreover, every other area of life, we accept that products will suit some and not others. There is no accounting for taste, as the saying goes.

Medicines and treatments show just as much interpersonal variation as nutrients; indeed, many of them are simply refined nutrients. Yet we expect a centralized system to account for something inherently individualized. Little known fact: many arthritics wept when Vioxx was taken off the market, because it worked for them.

Why not let these people have their choice? Cancer patients cannot opt out of the FDA to take experimental drugs (the FDA actually sued to keep it this way!). And sometimes the crazies are actually right and the government is way wrong, like low fat vs. low carb.

The bottom line is that centralization of assessment in a fast-moving, technical area is going to be provably worse than peer review. Make the FDA opt-in rather than mandqtory and let the decentralized network of doctors be the ultimate judge. That's how Europe does it.



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