Regulating Drugs and Vitamins

Researchers in conventional health science tend not to like nutrient supplements, herbs, and other forms of so-called natural health products. So on a regular basis, some piece of research gets published and publicized that raises alarms about their use. Both the science press and the mainstream media dutifully report the results. Yet people not only continue to use natural health products but have over the past decades increased their use: between 1990 and 2008, the number of people who use some form of natural health product or treatment went from one in fifty to one half.

The latest entry in this parade is an article in the Archives of Internal Medicine titled “Marked Variability of Monacolin Levels in Commercial Red Yeast Rice Products.” It has the scary subtitle “Buyer Beware!” The upshot of the article is that the active ingredient in this widely used natural health product comes in significantly different concentrations depending on brand.

“So what’s the problem?” you ask. “Just read the label, compare how much you get per dollar, and off you go.”

Oh, but you can’t do that. The actual amount of the active ingredient in a tablet or capsule can’t be printed on the label because the FDA has ruled that if the manufacturers do that, they’re in effect selling a drug and would therefore fall under the regulatory requirements for drugs. Right now, red yeast rice is sold as a food.

“Buyer Beware!” is a common cry in these matters. Sometimes baldly stated, sometimes not, the suggestion is always there that the manufacturers of natural health products are scoundrel’s hoodwinking consumers.

But wait! If you’ve been paying attention, you’ll note that the lack of label information isn’t because those manufacturers are unscrupulous rascals that prevent consumers from comparison shopping and letting the market do its magic. It’s because the FDA will throw them into competition with drug companies if the do, forcing them to compete with the biggest of drugs: statins.

The reason for this is that red yeast rice is called a natural statin because the active ingredient, the monacolin of the article’s title, is also known as lovastatin, one of the most commonly prescribed statins on the market. Statins, of course, drive down cholesterol levels under the mistaken theory that cholesterol causes heart attacks. There’s good reason to believe it doesn’t. There’s also good reason to believe that statins cause a lot of health problems. So people rushing to use red yeast rice are making a mistake, not because they’re duped by manufacturers but because they’ve been misled into believing that cholesterol is a problem on the scale of an invasion from Mars. But I digress.

All this worry about natural health product makers is not completely out of place. These are, after all, businesses. Here’s what I learned in economics school: the two rules of business are make money and stay in business. Makers of natural health products are no different than pharmaceutical companies in that regard. Before you think that all vitamin manufacturers are saints and all pharmaceutical companies are the spawn of Satan, I remind you that natural health product manufacturers spend a ton of money on advertising and there are not-for-profit pharmaceutical companies.

Our social arrangement for making sure buyers don’t have to beware is regulation. Government regulators license manufacturers, requiring them to abide by good manufacturing practices and to accurately label their products. That’s true for both natural health products and pharmaceuticals. With those regulations, manufacturers are free to sell whatever they can. What buyers have to beware of is that regulators have set up the rules so no one is harmed or killed.

Some red yeast rice preparations contain a toxin produced by a fungus on the rice stock used to grow the yeast that produces the lovastatin that screws up cholesterol metabolism. The diabetes drug Avandia accounted for 83,000 excess heart attack deaths.

What happens if something goes wrong? Right now, a business can be fined or forced to pull a product from the market or shut down until the problem is corrected or even have they’re license to operate revoked. In addition, victims can sue for damages. Yet things do seem to go wrong fairly regularly.

Whether pharmaceutical or natural health product, how do you get a business to act responsibly to ensure the safety of its customers and citizens generally? Two words: perp walk. I’d like to see the executives at GlaxoSmithKline, the makers of Avandia, convicted of negligent homicide, put into orange jumpsuits, and sent to do hard time. But that can’t happen because the corporation as a legal entity protects corporate officers from the mayhem that is business as usual. Buyer beware!