[personal profile] drscott
As part of my exercise program, I occasionally take what's called an ECA Stack - the acronym standing for Ephedrine-Caffeine-Aspirin. Usually these are made with ephedra (the Chinese herb ma-huang), synthesized caffeine, and willow bark (which contains aspirin -- the formulation with actual aspirin is patented and so the manufacturers of ECA stack-equivalents often use the substitute.)

In the amounts I take, none of these things are harmful. Slight increase in heart rate and blood pressure and some thinning of the blood allow for a more effective exercise routine. The effects wear off in a few hours. The labels warn you not to take too many, and to avoid excessive heat or overexercise.

Well, the FDA has just banned ephedrine. The reason it did so is because it has collected reports of 150 deaths and thousands of "incidents" which "related" to use of ephedrine. Three of these were famous athletes who dehydrated their bodies and had other medical problems, but drove themselves relentlessly. This is one of those stories that, if you rely on the media for your knowledge, is presented in the frame of Good Government Stamps Out Bad Business, but if you know more about it, leaves out much of the truth.


Unfortunately it's also a fine example of junk science propaganda techniques used to stampede regulators into removing another small freedom.

Can you say "mission creep?" And "regulatory capture?"

Where the original purpose of the FDA was to punish fraud (mislabelling or adulterated substances for human consumption, false claims of medical efficacy), it has grabbed extra power to regulate all substances which a citizen might wish to ingest. Meanwhile, Big Pharma has cozied up to them as a most excellent barrier to competition. The law which protects supplements from FDA intervention was passed when the FDA was considering actions like banning melatonin -- while Big Pharma was interested in creating a patentable alternative. Junk science meets anti-competitive big business and big media.... and a power-hungry agency.

Even if one accepts the FDA's mission and powers as maximizing the wellness of the people by regulating what they ingest, the FDA's actions are disproportionate to any demonstrable hazard and may even be counter to their supposed goals in that weight loss and improved exercise for millions of people may have vastly greater benefits than a tiny number of adverse reactions. Intense exercise, widely used and accepted fo better health, has killed far more people by raising their blood pressure and heart rates than ephedra. And appropriately targeted regulation of recommended dosages and warning labels would alleviate most of the risks while still allowing people to choose individually.

While we're dumping on the FDA, let's remember their complete silence on the increasing presence of homeopathic patent medicines in the marketplace. Such "medicines" blatantly advertise themselves for ailments like the common cold and flu while every medical scientist (despite some small, crackpot studies) knows they are of no use whatever. (Note: read patent medicine labels VERY closely for tiny "homeopathic" labels or ingredient amounts containing "XXXX.") Why does the FDA tolerate false claims on these "medicines," which sell in the $millions and can present false hope to those who should be seeking medical treatment? Probably because they aren't interested in taking on the pseudoscientific homeopathy cult. And so now we see they intend to start anecdotal anti-supplement cults of their own.

Re: Creeping Loss of Freedom

Date: 2004-01-06 08:04 pm (UTC)
From: [identity profile] excessor.livejournal.com
I'm always taken back when I see how the government operates some times. The tendency has existed for quite some time, and seems to be on the increase, for the government to “save” us from ourselves. The actions you describe seem to be face-saving, in the sense that the FDA has gone to the trouble of banning a substance that might be harmful while letting other products continue to be sold, even though they might be harmful, too. A curious standard.

One of the more popular ideas is that there are proven drugs and then there are treatment options that haven't been discovered yet. That's the wrong distinction: there are drugs that have been scientifically tested, and those that haven't. Period. Many people still believe that wearing a coat will prevent a cold. Or that taking zinc will ameliorate cold symptoms. When the general populace can't act in a way that's responsible, what's a government to do? The government chooses to protect us instead of just saying “Don't do that.”

The FDA's actions were even more suspect when it banned US residents from ordering far cheaper drugs from Canada and the US. While it's not true in all cases, the drugs are often the very same ones we get here, but with a much cheaper price tag. It's easy to blame this administration for this problem, but I think they're more guilty of not acting to fix it. Such policies make us appear even more simple-minded, unsophisticated, and ill-informed. If the idea is to enact policy that is based in science and in service for the country's citizens, we're not doing such a good job.

Other agencies do the same thing; seat belt laws are a good example. Everyone knows you should wear them. I wear one. But why is it a crime to not wear one? If someone decides to not wear one and happens to die in an accident as a result, isn't that just the gene pool asserting itself? It starts off as being an avuncular concern by the government to ensure the continued well-being of its citizens, but it often gets stretched too thinly to include dicta that are nonsensical.

Re: Creeping Loss of Freedom

Date: 2004-01-07 06:46 am (UTC)
From: [identity profile] dr-scott.livejournal.com
The Canada importation thing is a huge Gordian knot mof regulatory mess. The usually-unmentioned problem is that the drug companies have acquiesced in a bizarre system that allows vastly different "official" prices in different countries -- which has meant that countries with government-controlled systems get a bargain, paying just over *marginal* cost in many cases, while the full expense of research and early development is borne by customers in the few uncontrolled markets (mainly the US.)

The FDA has two reasons for opposing importation (and it makes no difference which administration is in power, the FDA is bsically independent of the Executive) -- loss of control (US patients who can order from anywhere gain more freedom to order *anything* from anywhere, which weakens the FDA-controls-doctor-controls-patient system), and worry about completely overturning the current economics of the system.

Some policy wonks suggest opening up importation would in the long run act to equalize prices throughout the world, since the drug companies might well choose to drop US prices and control supply to the "free rider" countries until they say Uncle -- they would be exporting drugs their own people would need. In this view the ban on imports really helps the free-riders keep their discounts.

As for seat belts, you can justify a law forcing you to wear one two ways: first, this society has chosen to guarantee that no one will go without medical care, even if they can't afford it. So an injured person who's uninsured (which is a significant minority of drivers and passengers) costs everyone a great deal. Meanwhile, insurance rates have been set to include the lowered injury rates due to the seatbelt law. So the law actually saves everyone money, as well as reducing injury. And there's also a good argument that unbleted drivers are more likely to lose control in an accident, again negatively impacting others.

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