Killing Us Softly (10 page)

P
erhaps the hearing's most dramatic moment occurred when David Kessler and Orrin Hatch went toe-to-toe—a face-off between a de facto representative of the supplement industry and a doctor who was trying to protect the public. The exchange centered on the FDA's recent seizure of primrose oil due to bogus claims.

H
ATCH
: What safety hazard was the FDA addressing that warranted such intensive use of agency resources and personnel?

K
ESSLER
: Senator, I can read you the claims made for oil of evening primrose. The list starts with cancer.

H
ATCH
: Remember, the issue is safety I am talking about.

K
ESSLER
: My real concern is the types of diseases for which oil of evening primrose is promoted.

H
ATCH
: But my question is: What proof do you have that this substance is unsafe?

K
ESSLER
: This is being promoted for a lot of different diseases, anywhere from hypertension to atopic dermatitis.

H
ATCH
: Safety, Doctor, safety! This is the question! Is an American citizen more likely to die from an adverse reaction to a drug approved by the FDA or a dietary supplement?

K
ESSLER
: Senator, I am amazed. What do you think are
in
pharmaceuticals? Half our pharmaceuticals come from plants. There are chemicals in pharmaceuticals and those chemicals are found naturally.

Kessler was making an argument that had been made for centuries. The source of a chemical doesn't matter; only the chemical matters. And whether it is synthesized by a pharmaceutical company or found in nature, the chemical is the same. And it should be regulated in the same way. Otherwise consumers will think they're getting a guarantee of safety when they're not.

I
n the end, industry money trumped common sense. On May 11, 1994, the Dietary Supplement Health and Education Act became law. The act defined a supplement as “a product intended to supplement the diet that bears or contains one or more of the following ingredients: a vitamin, a mineral, an herb
or other botanical, or an amino acid.” “Breathtaking in its dimensions,” wrote Dan Hurley, “[the act] would end forever the simple legal dichotomy between ‘food' and ‘drug' to create a third, hermaphroditic category that was both yet neither: the dietary supplement. And beyond the usual suspects—vitamins, minerals, herbs, and amino acids—the law would permit manufacturers to define a product as a ‘dietary supplement' merely by saying so, no matter how artificially derived. Put lamb's brain in a drug or food, and prepare to spend millions of dollars and a few years on studies showing that it is safe and effective; put it in a supplement and you're good to go, no evidence necessary.” The
New York Times
called it the “Snake Oil Protection Act.”

O
ne way to judge the effect of the 1975 Proxmire Amendment and the 1994 Dietary Supplement Health and Education Act is to compare two products: vitamins and Vioxx.

On May 20, 1999, the FDA approved Merck's Vioxx for the treatment of pain and arthritis. The drug was an immediate success, grossing $2.5 billion a year.

On November 23, 2000, the
New England Journal of Medicine
published a study comparing Vioxx with the anti-inflammatory drug Naprosyn for the treatment of pain. Merck, which funded the study, wanted to prove that its drug was less likely than Naprosyn to cause intestinal bleeding. It was. But there was a side effect that hadn't been anticipated: patients receiving Vioxx were four times as likely to have a heart attack. The authors of the study argued that because Naprosyn inhibited the aggregation of platelets (a factor in the blockage of the arteries supplying blood to the heart) and Vioxx didn't, Vioxx wasn't
causing heart attacks; it just wasn't preventing them. The FDA didn't buy it, sending a warning letter to Merck's CEO, Ray Gilmartin. The FDA was angry that Merck hadn't adequately warned consumers about the possibility that Vioxx might cause heart attacks. Merck complied. By April 2002, every vial of Vioxx contained a warning label.

Merck had hoped that when Vioxx was compared with something that didn't have an anti-platelet effect, it wouldn't increase the risk of heart attacks. On March 17, 2005, another study was published in the
New England Journal of Medicine
, again supported by Merck; this time Vioxx was compared to a placebo. Investigators found that the risk of heart attacks was lower in the second study (twofold rather than fourfold); and it was a problem only after people had used the drug for at least eighteen months. But the risk was still there. So on September 23, 2004, months before the results of the second study were published, Merck voluntarily withdrew Vioxx from the market. “We are taking this action because we believe it best serves the interests of patients,” said Gilmartin. “Although we believe it would have been possible to continue to market Vioxx with labeling that would incorporate these new data, given the availability of [other] therapies and the questions raised by the data, we concluded that a voluntary withdrawal is the responsible course to take.”

Because the FDA was watching, consumers were well aware of problems caused by Vioxx.

S
o which is more dangerous: Vioxx or vitamins? Indeed, both have dangers. The better question is, why does everybody
know that Vioxx can cause heart disease and nobody knows that megavitamins can cause cancer? The answer is that we have chosen not to know.

Americans are constantly manipulated by public relations campaigns. Sometimes these campaigns champion messages that make our lives better (stop smoking); sometimes they make our lives worse (start smoking). But you have to take your hat off to a campaign that has us not only asking for something that hurts us but screaming for it. Such were the campaigns by the National Health Federation for the Proxmire Amendment and by the National Nutritional Foods Association for the DSHEA. In both cases, the industry manipulated the media, politicians, celebrities, and the public to stoke a multibillion-dollar-a-year industry. And in both cases, the industry forced the FDA to back off so it could make claims about safety and efficacy that weren't true. When Vioxx was found to cause heart attacks, the FDA issued press releases that were immediately picked up by the media. But the FDA doesn't regulate vitamins and supplements, so it can't warn the public when there's a problem. Although the supplement industry skillfully manipulated people into believing that the Supplement Act was about freedom to make health choices, it was really about freeing the supplement industry to offer unsafe choices. If knowledge is power, DSHEA is powerlessness.

T
he vitamin and supplement industry had successfully created a false dichotomy. On one side are natural products: vitamins, minerals, dietary supplements, plants, and herbs. Because they're natural, they're safe. On the other side are drugs.
Because drugs are man-made, they're supposedly more dangerous. However, many drugs are derived from nature, including antibiotics. Furthermore, the notion that natural products aren't dangerous is fanciful. Fava beans (
Vicia faba
) can cause severe anemia; castor beans contain ricin, the most potent neurotoxin known to man; jimsonweed contains hallucinogenic alkaloids; berries from the coyotillo plant (
Karwinskia humboldtiana
) cause paralysis; and the ackee fruit (
Blighia sapida
) causes a severe lowering of blood sugar (“Jamaican vomiting sickness”). Mother Nature can kill you. “Just because something is natural it does not mean that it is good,” write Simon Singh and Edzard Ernst in
Trick or Treatment
, “and just because something is unnatural it does not mean that it is bad. Arsenic, cobra poison, nuclear radiation, earthquakes, and the ebola virus can all be found in nature, whereas vaccines, spectacles, and artificial hips are all man-made.”

The possibility of harm caused by natural products sold in health food stores isn't theoretical. Blue cohosh can cause heart failure; nutmeg can cause hallucinations; comfrey, kava, chaparral,
Crotalaria
,
Senecio
, jin bu huan,
Usnea
lichen, and valerian can cause hepatitis; monkshood and plantain can cause heart arrhythmias; wormwood can cause seizures; stevia leaves can decrease fertility; concentrated green tea extracts can damage the liver; milkweed seed oil and bitter orange (
Citrus aurantium
) can cause heart damage; thujone can cause neurological damage; and concentrated garlic can cause bleeding. Indeed, one of the worst dietary supplement disasters in history occurred in 1992, when about a hundred people developed kidney failure from a “slimming” mixture found to contain the plant aristolochia; at least seventy patients required kidney
transplants or dialysis, and many later developed bladder cancers. In 2008, more than two hundred people—including a four-year-old—were poisoned by massive doses of selenium contained in Total Body Formula and Total Body Mega. The products were supposed to contain 200 micrograms of selenium per serving; instead they contained 40,800 micrograms. Herbal remedies can also cause harm: two infants died from a tea containing pennyroyal and another from a decongestant containing capsaicin. Because the dietary supplement industry is unregulated, only 170 (0.3 percent) of the 51,000 new products brought to market since the 1994 Supplement Act have documented safety tests.

And it's not just the supplements themselves that might be harmful, but what's contaminating them. In 2004, researchers at Harvard Medical School tested Indian (Ayurvedic) remedies obtained from shops near Boston's City Hall. They found that 20 percent contained potentially harmful levels of lead, mercury, and arsenic. Between 1978 and 2004, herbal medicines caused fifty-five cases of severe or fatal heavy-metal poisoning. In late 2009, Kirkman Labs, a supplement manufacturer popular among parents of children with autism, recalled fifteen thousand bottles of zinc because they contained undeclared antimony, a heavy metal.

These problems aren't rare. Between 1983 and 2004, poison-control centers in the United States received 1.3 million reports of adverse reactions to vitamins, minerals, and dietary supplements, of which 175,268 required treatment in hospitals and 139 resulted in death. In 2012, the FDA estimated that approximately 50,000 adverse reactions to supplements occurred every year.

Worst of all: most people don't realize what's happened. A Harris poll found that 68 percent believe that the government requires herbal manufacturers to report side effects, 58 percent believe that the FDA must approve herbal products before sale, and 55 percent believe that manufacturers of vitamins, minerals, and dietary supplements cannot make claims about safety or effectiveness without scientific evidence. All these beliefs couldn't be further from the truth. Serious problems caused by dietary supplements are the industry's dirty little secret. Because of the Supplement Act, they'll remain a secret.

I
n 2007, as problems with the industry continued to mount, FDA regulators were finally granted permission to supervise the way supplements were made. 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.

There cannot be two kinds of medicine. There is only medicine that has been adequately tested and medicine that has not.

—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 a
cure 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.