Aspirin and the Regulation of Medicine
As we discuss the effects of various laws designed to protect us from various and sundry, we often lose track of the real, tangible benefits of liberty that we’re giving up. They’re sometimes hard to see, in the same way the Internet was hard to see in the early 90s. It was here, but most people didn’t know about it. Bad laws could easily have prevented the rise of the web (and the reams of pornography it brought), or free, interconnected email (and the spam it brought). Many people would never have realized they were missing anything.
It’s one of the unfortunate things about limiting freedom: its hard to know what you might have had. There are many medicines that you can not buy in the US because of the FDA, and some which you can only because they predate the FDA. A prime example is aspirin. There’s an interesting article about this in Medical Progress Today:
As a drug discovery researcher, I can tell you something that might sound crazy: many of these older drugs would have a hard time getting approved today. Some of them would never even have made it to the FDA at all.
The best example is aspirin itself. It’s one of the foundation stones of the drug industry, and it’s hard to even guess how many billions of doses of it have been taken over the last hundred years. But if you were somehow able to change history so that aspirin had never been discovered until this year, I can guarantee you that it would have died in the lab. No modern drug development organization would touch it.
(Via Marginal Revolution.)
For another view, see Philip J. Hilts, Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation (2003).
The companies that “discover” drugs experimented on the American public, resulting in the killing of an uncountable number of people. The FDA process may seem burdensome, but it didn’t arise from the ether. It arose from an industry that would lie and cheat in order to convince the public that its products were safe and effective.
Chris,
I made no claims that the FDA process arose from the ether. I’ll add that ether, and the practice of anesthesia which arose from it, is another pre-FDA process.
But is the FDA an optimal regulator when measured by any set of criteria? Does it effectively balance risks and rewards? For example, we can estimate the delay in effective HIV medication, and how many died waiting for it.
The example of aspirin is a perennial favorite of those who disapprove of FDA evaluation of drugs. The people offering that example don’t often offer a counter-example, that of thalidomide. A drug that was used as a sedative in Europe was not available in the US, due to our laws. It turns out that this “harmless” sedative causes very serious birth defects (babies with no arms and legs).
so the knife cuts both ways.
One could even use the example of Vioxx, a drug recently approved and then withdrawn after it was discovered that this “safe, effective” treatment for joint pain causes high blood pressure and strokes.
there are times when the rules actually are effective. And we certainly know that we cannot trust big business to look out for our health and safety.
i think the situation in the world of medicine is more about money and not health. Pharmaceutical companies make such big money that they would never give away their market to foreign enterpreners.