By Warren Bell, MD (reprinted with author permission) Lost in all this heated discussion of OTC statin use is the whole issue of the appropriate role of drugs as a treatment for what is manifestly a disease of lifestyle in 95% of cases. It is interesting to see that the FDA has, without comment, shifted its ground (unless, of course, it was already there beforehand) to a discussion of drug therapy in an utter therapeutic vacuum -- just what the industry wants it to do! No mention of the relative value of exercise, diet, stress, non- drug biological supplements or dietary augmentation (e.g. garlic), or environmental influences (one scientist proposed that heart attacks in Los Angeles on "bad air days" be called 'lung attacks' instead). In the feeding frenzy around OTC vs Rx availability, we are losing our sense of proportion, and along with it, our humanity. Here's a little more evidence along these lines. The latest issue of Nutrition Action, the newsletter of the Centre for Science in the Public Interest, discusses the safety of supplements. CSPI is a fine organization, founded out of Ralph Nader's many anti-corporate activities, and usually quite enlightened and hard-hitting in its perpective. Yet the CSPI, in this issue, recommends that children and pregnant women avoid taking garlic and soy isoflavones supplements "until more research is done". The article does acknowledge that "most reactions are rare: in some cases they are based on just one or two reports from physicians". But even allowing for the modest difference in supplementary formulation vs food sources, is this not amazing overkill? There are dozens of reports of statins causing severe and even fatal reactions. One member of this class, Bayer's Baycol, is off the market because it was the worst of the lot, but the others all do this to some degree -- it's inherent in their mode of action. They all deplete stores of co-enzyme Q10, which is a critical metabolic element in a wide variety of physiological processes. How many people have turned up in a critical care setting with "garlic-induced fulminant hepatitis", or "soy isoflavone-related dementia"?! How many people end up in the ER with exercise- induced renal failure? (I'm talking about exercise when "used as directed by recognized experts"). How many folks haunt the ICU with "square-dancing-related pulmonary fibrosis"? How about "music- induced hyperkalemia"? We're going nutty, driven by a corporate agenda that wants us to see "a pill for every ill" as the only way to fly. OTC, Rx, coin-operated machines, free give-aways -- industry doesn't care, as long as our first thought, when we feel unwell, is to take a drug. I believe there is a universal rule of biochemistry underlying all this. Molecules (and the behaviours that produce them) that have been around for a few million years, and tested empirically by billions of people without discernible adverse effects beyond highly predictable or nuisance ones (garlic breath, exercise- induced fatigue, music-related procrastination, love-induced foolishness) are likely to safe. Molecules invented a few months, years, or decades ago by a person who's primary goal is to find a patentable substance that is safe enough to make it through a mickey-mouse testing process onto the market where it is likely to produce billions of dollars of profit -- such molecules are unlikely to be safe, and are potential causes of "stealth" reactions that are unpredictable and dangerous. I know there's always exceptions, but I believe the general rule still holds. And we haven't even mentioned the fact of the industrial world siphoning most of the world's resources in order the create the conditions of super-excess of everything that allow "diseases of affluence" to happen in the first place, and also provide the materials for a huge chemical industry to develop around it. And then using force of arms or threat thereof to maintain this obscene imbalance.