Killing Us Softly by Dr Paul Offit Page A

Although they still couldn’t force manufacturers to prove that their products were safe or effective, at least they could make sure the product contained what the label said it contained. What the FDA found was appalling. Of the 450 supplement manufacturers inspected, at least half had significant problems. One, ATF Fitness, substituted ingredients without changing the product label. Others didn’t even have recipes for their products. And some manufactured products in buildings contaminated with rodent feces and urine—in one facility a rodent was found cut in half next to a scoop. “It’s downright scary,” said Daniel Fabricant, head of the FDA’s Division of Dietary Supplement Programs. “At least half of the industry is failing on its face.” Cara Welch, a vice president for the National Products Association, an industry trade group, called the findings “unfortunate.”
    I n 1994, when the Supplement Act passed, sales of dietary supplements were $4 billion a year; by 2007, $28 billion; by 2012, $34 billion. America’s Magical Miracle Medicine Show is back in business.
    E uropean regulation of the supplement industry parallels that in the United States. In Europe, drugs are regulated by the European Agency for the Evaluation of Medicinal Products (EMEA). Like the FDA, the EMEA holds drugs to a high standard of safety and efficacy before licensure. But the EMEA doesn’t regulate vitamins, minerals, dietary supplements, and herbs. Rather, regulation falls to the European Food Safety Authority (EFSA), which has a much lower bar. Lax regulation by the United States and Europe of dietary supplements isn’t the only problem. All countries have to be concerned about the illegal sale of counterfeit vitamins, nutrients, and supplements over the internet.

4
Fifty-One Thousand New Supplements: Which Ones Work?
    There cannot be two kinds of medicine. There is only medicine that has been adequately tested and medicine that has not.
    â€”Marcia Angell, former editor-in-chief of the
New England Journal of Medicine
    H ealth food stores are a wonderland of promise. If people want to burn fat, detoxify livers, shrink prostates, avoid colds, stimulate brains, boost energy, reduce stress, enhance immunity, prevent cancer, extend lives, enliven sex, or eliminate pain, all they have to do is walk in. The question, however, is which products work? And how do we know they work?
    Fortunately, thanks to James Lind, we can figure it out. When Lind climbed aboard the HMS
Salisbury
—intent on finding acure for scurvy—he moved medicine from a faith-based system to an evidence-based system. No longer do we have to
believe
in treatments. Now we can test them to see whether they work. For example, alternative healers recommend ginkgo or rose and orange oils for memory; graviola, astragalus, and cat’s claw for immunity; guarana and
Cordyceps
for energy; chicory root for constipation; lemon balm oil, ashwagandha, eleuthero, Siberian ginseng, and holy basil for stress; sage and black cohosh for menstrual pain; coconut oil and curry powder for Alzheimer’s disease; saw palmetto for prostate health; sandalwood bark to prevent aging; garlic for high cholesterol; peppermint oil for allergies; artichoke extract and green papaya for digestion; echinacea for colds; chondroitin sulfate and glucosamine for joint pain; milk thistle for hepatitis; St. John’s wort for depression; and tongkat ali for sexual potency. Although the size and cost of clinical studies have increased dramatically since the days of James Lind, the claims made by alternative healers are testable—eminently testable.
    W hen pharmaceutical companies make drugs and biologicals, the rules are clear. Company scientists first test the product in animals. If the results are promising, they take the next step, testing it in progressively larger numbers of people. If the results are still promising, they perform a