Friday, December 17, 2004
Herbal supplements flood U.S. with risk, quackery
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Huff lives in Patrick County
and practices rural family medicine.
Why is the herbal section taking over the drugstore? Why is my e-mail in-box full of spam? Why does Smiling Bob do the Cha-Cha across my TV screen?
The answer is DSHEA.
It's not the latest Chinese wonder herb. It's not the active ingredient in Viagra. It's the 10-year-old legislative love child of Sen. Orrin Hatch, R-Utah.
In 1994, after a long day on Capitol Hill, Hatch sneaked the Dietary Supplement Health and Education Act through the Senate on a voice vote. Hailed as a victory for alternative medicine enthusiasts, DSHEA was a slap in the face to the Food and Drug Administration.
In the wake of a series of deaths from a substance called L-tryptophan, the FDA had sought to regulate the herbal industry.
Since then, the supplement market has exploded. Lured by the promise of health, happiness and anatomical superiority, more than half of all Americans now use supplements. You might think we would finally be a country of lean, sexual dynamos with colossal sexual attributes and resistance to infection and cancer.
Sadly, it just isn't so.
You see, the FDA was right, and Hatch has had a little too much kava kava. DSHEA forces the FDA to treat natural supplements like food instead of drugs. As long as makers slap a disclaimer on the box and don't claim to treat a specific medical condition, they can market their products however they please.
As such, a box of cranberry tablets is forbidden to claim that it "prevents bladder infections," but is free to say that it "promotes urinary tract health." (In reality, it does neither.)
Smiling Bob's friends can gape at his crotch as he jumps out of the pool without his shorts, but Enzyte cannot say that its product increases penis size (it doesn't).
It takes a savvy consumer to see through it all. Even the FDA has a hard time. The FDA can step in only after a pattern of problems (deaths, for instance) has occurred. What happens when big business wields a free hand? It gets away with murder.
Take ephedra. This substance comes from an unimpressive shrub that grows all over the world. In basement laboratories across the country, its cousin ephedrine is converted to a widely abused amphetamine. In the human body, ephedra increases heart rate and metabolism much like another natural substance, cocaine.
Nevertheless, ephedra was defined as a natural substance and found its way into scores of supplements. Those supplements were marketed for weight loss and energy boosting. Underground, ephedra was sold as a natural form of "speed" or "ecstasy."
Did the supplement makers have to prove that ephedra was effective? No. Did they have to prove that it was safe? No. Pure? No. The right strength? No. No. No.
Thanks to DSHEA, it took scores of deaths and years of legal wrangling for the FDA to wrench ephedra off the market.
Why did it take so long to get ephedra off the market? The burden of proof fell on the FDA. Unlike the pharmaceutical industry, which has to prove that its drugs are safe and effective before selling them, the supplement industry can just start selling. If it turns out that the supplement is harming or killing people, the FDA has to identify the trend and prove it. The supplement companies don't have to lift a finger.
How about legitimate supplements? St. John's wort lifts depression. Saw Palmetto eases the symptoms of a large prostate. Red rice yeast lowers cholesterol. The proof comes from scientific research.
But if you buy a bottle of any of these supplements, are you getting the same stuff they used in the studies? If so, is it a single molecule, the proper dose, or an overdose? What other substances are mixed in with it?
You may consider these questions far-fetched or alarmist. However, a recent sampling of 11 brands of Echinacea (promoted but never proven as an immune system enhancer) found five with insufficient ingredients and one that was contaminated with lead.
Of 24 ginseng products, eight had no active ingredient at all. Other samplings have uncovered contaminants ranging from pesticides to steroids to Xanax.
Is it safe to mix supplements with medications? What about mixing supplements with other supplements? There are myriad interactions - many serious. However, I find precious few warnings.
Here is what Hatch says in defense of DSHEA (and I paraphrase): Hey, if people overdose on supplements, it's their fault! If supplement makers don't put what they say in their products, they're breaking the law! It's not my fault!
Well, I say it is. When a product line has the clout of the multibillion-dollar supplement industry, and when the products are sold under the premise that they will maintain or improve your health, there darn sure needs to be some serious oversight. Every day, consumers are endangered and defrauded by products that are contaminated, improperly labeled and flat out don't work.
Did I mention that a fifth of all U.S. supplements come from Hatch's home state of Utah?
Well, people are waking up. Last month, under (legitimate) advisement from the American Medical Association, the FDA started talking tough about cracking down on the supplement industry. Sen. Joe Biden, D-Del., spearheaded a law to ban a dangerous class of steroid precursors.
When Tommy Thompson resigned as secretary of Health and Human Services, his parting words characterized DSHEA as a backward law that needs another look from Congress.
Unfortunately, further action will be held back by a number of factors: inadequate funding, the Vioxx controversy, lack of teeth in the original framework of DSHEA and the stranglehold of the natural supplement lobby on Congress.
It's been said that DSHEA affords Third World oversight in a First World country. In many ways, we've returned to the days of snake oil salesmen and patent medicines. So now it's up to you.
Before you buy a supplement, take care to research the product, manufacturer and distributor. Talk to your doctor. Watch for side effects and drug interactions. Above all, do not mistake DSHEA for sound medical judgment.
Some day, Congress will find out the real reason that Bob is smiling.
