EP-ology, the study of E PEPidemiology, scientific EPistemology, Ethical and Evidenced-based Policy making.
Readers looking for my more popular blog, about tobacco harm reduction and related subjects, will find it at antiTHRlies.com.
This blog now basically just serves as my home for miscellaneous writings that do not fit there.
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Monthly Archives: December 2010
My mother won a gift certificate for one of those “alternative” health specialty stores (you probably know the type) so picked up a combination of some useful basics (bath supplies are bath supplies) and gag gifts. One item (for which she just collected the brochures – a dozens of pages!) seemed worthy of mention in an epidemiology epistemology blog.
The amusing claim in question is for a far infrared sauna, which is basically a chair, a human-body-sized tent with a head-hole in the top, and some heating elements. It is reported to “remove toxins, reduce body fat, boost metabolism, experience deep relaxation, and slow down aging!” I believe the bit about relaxation. What makes the usual nutty claims interesting, though, is that according to the brochure this is an U.S. Food and Drug Administration approved medical device (they provide a file number and everything), and the the FDA vouches for the claims about far infrared radiation (which is simply low-frequency light that we normally call radiant heat). Keep in mind that this is the same FDA that tried to shut down the e-cigarette market because some manufacturers were allegedly claiming that using e-cigarettes instead of smoking means that someone is no longer smoking (which is the natural language way of saying “it is a smoking cessation aid”).
The sauna manufacturer goes on to offer such gems as:
-far infrared “pulsates the water molecules in the body” (apparently there is a microwave in it, which just does not sound like a good idea at all) and reaches “the depths of the body” – these are the bits they say FDA specifically endorses
-produces 2.3 times as much sweat as other saunas (spontaneous generation of water from the human body!)
-heals diabetic ulcers
-reduces percent body fat by 2 percentage points between “before” and “after” (for a single use? not clear, but since duration is not what stands between this claim and the truth, it probably does not matter)
-removes heavy metals from the body
-you can burn 600-1200 calories per session (I guess they assume you are going to generate the electricity for it by running on a big hamster wheel)
-it is the only sauna that uses “a special technology, i.e., a semi-conductor chip” (because computer-controllers are such an exciting innovation)
-and best of all, it cures hepatitis C
Reading even a little carefully, it is apparent that FDA probably did not endorse most of these claims, though the authors certainly make every effort to imply it. But, at best, FDA (a) approved one or more of these claims to let this glorified toaster oven be classified as a medical device, (b) is content to allow all the other claims to be made, and (c) has not even objected to the implication that they are endorsing most of these claims. Perhaps (b) and (c) are simply the result of inattention: If you spend all your time trying to create a nanny state, after all, how can you be bothered to, say, have a web bot looking for blatantly false health claims being made in your name. But (a), along with the e-cig fiasco, seems to really illustrate what is fundamentally wrong with FDA, how they simply do not understand scientific inference.
Presumably someone ran a few highly artificial experiments (aka clinical trials) and managed to get one of them to show that the sauna had some trivial effect on some Official Medical Condition (presumably because it makes people warm for a while). And, voila, it is an FDA Approved Medical Device. Meanwhile we have all the evidence any real scientist would ever need to prove that e-cigarettes are effective at aiding smoking cessation: Observation 1: Someone who is using e-cigarettes as a substitute for smoking is not smoking. Observation 2: Testimonials and surveys of users show that pretty much 100% of them use e-cigs as a substitute for smoking, most reporting that they had tried to quit smoking using other means and failed. That is all we need to know. Would we know more if we had a clinical trial? No, not really. The artificial situation created in the trial would mean that it would provide far less informative than either of the two above observations.
The problem seems to be that the so-called scientists at FDA (like most people doing epidemiology) are really glorified technicians. They only understand how to plug something into their machine (the clinical trial process). If the machine spits out a result of a certain type then it is declared, say, that anti-smoking drugs are FDA Proven Effective (because under optimized highly artificial conditions they work for a few percent of the population) and the sauna tent is a proven medical device. If it is not possible to jam something into their machine, however, they are incapable of drawing even the most obvious conclusions about it. This includes anything that is primarily a social phenomenon or a matter of consumer economics, such as recreational substance use. They simply have no understanding of what constitute science in such cases.
And finally, an aside. My mom reported that upon going into the “alternative” store and being asked who she was shopping for, she reported that one or more of us was described by “vegetarian”, “vegan”, “green”, “buys organic”. Apparently the proprietor thought that this meant that they could sell us any nutty product on the shelf. Which leads me to ask, with some affrontedness: Why is it that being knowledgeable and scientifically literate enough to be horrified by the way animals are factory farmed and/or to be concerned about habitat destruction and other natural resources — and being willing to act/buy differently in order to reduce one’s contribution to these horrors — translates into “clueless enough about science to believe any nutty health claim so long as it is counter to the mainstream”??? But I suppose, it is not much different from the common assumption, in this country, that if someone is described as “Christian” then they display tribalistic intolerance, favor solving problems with weaponry, oppose helping the poor, and have other characteristics that seem to be the flat-out opposite of what Jesus reportedly taught. Somewhere in there are some interesting thoughts for the Christmas and New Year’s resolution season.
I got too busy and never followed up on my posts about the FDA gunning for drinks that are roughly a combination of Red Bull and alcohol, cut with sickly sweet soda. As you may know, everything has followed the predicted course of action: Cans containing five beers’ worth of sweetened alcohol are still being sold, with some still including various dicey stimulants, but if the kids want a modest amount of caffeine too they will have to spring for another 50 cents worth of coffee.
Another non-solution to media-frenzy pseudo-problem brought to you by the nanny state. Now if only the FDA could do something about kids wanting to rapidly down five beers in the first place the world will be a better place. (Hint: Don’t hold your breath for our health masters to figure out a solution to that one.)
Anyway, the reason I decided to post about this is that I just wanted to thank the FDA for its combination of arbitrariness and wimpiness, in going after cheap caffeine-alcohol combinations that are liked by powerless drunken young people wanting to save a few bucks on their buzz, but mysteriously ignoring the higher end stuff. As usual, nanny statism mostly only hurts the less well off, and not those who like the occasional holiday evening downing Kahlua and Vanilla Silk (or for the fans of the really cloying, Kahlua and Silk Nog).
Perhaps there should be some kind of interlock that prevents blogging under the influence. Oh well.
Happy Xmas or whatever version of the solstice holiday you prefer.
The recent ruling by a Virginia court and writings about it (see this good one by law prof Jason Mazzone in particular) has brought up interesting questions about liberty with regard to commerce, but also health. Background: The new U.S. health care financing law has, at its center, the requirement that everyone buy health insurance from private companies. This sort of addresses a few problems of the insurance market, though not nearly all of them (I have written about that before, but will not go into it because it is not the point today). But because Obama is so easy to roll, there is no “public option” of the government acting as insurer and giving people the opportunity to buy into that program. Thus it is not possible to claim something like “this is a standard government program where you are paying money (call it taxes or not) and getting services, but you have the option of steering your money to a private provider instead”.
Thus, people are being told the must spend money on a particular product from a private merchant, unconditionally. While such conditional requirements are nothing unusual (you must buy liability insurance if you are going to drive a car; you must pay for various services to engage in complex transactions like owning a house), it is not clear if there is any precedent for such an unconditional universal requirement for a rather major expenditure.
Of course, it does really make any difference how things are labeled. This is not actually different from imposing a health care financing tax, outsourcing administration of the service, and offering some program choice. But people do make a big deal about labels. After all, the standard fiction is that the Master Settlement Agreement was a big award paid by tobacco companies when actually it was an extra-legal sales tax on future consumers (smokers). But the press consistently misses this (probably due to naivety) and the rich anti-tobacco organizations that benefit from MSA money, as well as the states who benefit even more, (probably due to self-interested cynicism) never mention that their funding is coming from a sales tax on smokers that is hidden (making it easier to raise taxes even higher and pretend that smokers create net cost for the rest of society when the opposite is true), arguably unconstitutional in most jurisdictions (taxes generally require legislative action, but this was negotiated by a bunch of private lawyers who got very rich from it), and terribly regressive.
The MSA was ugly public policy because those who benefit from it pretend it is something it is not. If the health insurance mandate survives court challenges, however, it will be because it was judged as what it functionally is (a new tax and government service, privately administered) rather than what it pretends to be (a private transaction).
But then the fun really begins. The nanny statists who work to prohibit various choices in the name of protecting people from themselves will have a brand new arena. They will have the precedent of forcing people to buy insurance to protect their health (though really the rule exists to protect the health of the financing system by not letting people with low risk opt out of it), and so will no longer feel constrained to merely prohibit actions they do not like. They will feel empowered to mandate actions they do like.