Killing Us Softly

by Dr Paul Offit

  On June 7, 1991, Henry Waxman introduced the Food, Drug, Cosmetic, and Device Enforcement Amendments, which “authorized any district court to order the recall of a food, drug, device, or cosmetic which is in violation of the [law] if the violation involves fraud or presents a significant risk to human or animal health.” The word most important to Waxman and Kessler—and that most frightened the supplement industry—was fraud. The FDA knew that claims of safety and effectiveness by supplement manufacturers were either unsubstantiated or wrong; it wanted to protect the consumer by making the industry prove it. Otherwise, the American public would continue to be hoodwinked. But Waxman and Kessler had leaned into a left hook. By taking on a wealthy, powerful, politically connected industry, they not only didn’t get what they’d wanted; they got the opposite of what they’d wanted. “Kessler wanted to drive a stake into the heart of the dietary supplement industry,” recalled Peter Barton Hutt. “Instead, he drove it into the heart of the FDA.”

  Rising to meet Waxman’s bill was Gerry Kessler (no relation to David), the founder of one of the nation’s most successful supplement companies, Nature’s Plus. On February 22, 1991, Gerry Kessler asked seventy industry leaders to attend a meeting at his home, near Santa Barbara. Executives had to be impressed by the opulence around them. Called the Circle K Ranch, Kessler’s home boasted a 17,000-square-foot main lodge, a koi pond, tennis courts, swimming pools, visitors’ cabins, a fitness center, and flocks of wandering ostriches and trumpeter swans. The estate’s previous occupant had been Ray Kroc, the owner of McDonald’s.

  Industry insiders sent their wealthiest, most influential representatives to Kessler’s meeting. Present were Allen Skolnick, of Solgar Vitamin and Herb Company, which later sold for half a billion dollars; Milton Bass, Scott Bass, and Martie Whittekin, representing the National Nutritional Foods Association, the health food industry’s lobbying group; Sandy Gooch, founder of Mrs. Gooch’s, the leading natural-food seller in the western United States; and Scott Randolph, from the conglomerate that owned Nature’s Bounty, Rexall Sundown, Puritan’s Pride, and Vitamin World—a group with sales of more than $1 billion a year.

  Gerry Kessler was an aggressive, brilliant, persuasive man. His goal was to convince each company to put up hundreds of thousands of dollars to turn the argument around. Kessler must have known that he couldn’t defeat the FDA by proving his products’ claims. His best chance was to persuade the American public that what the FDA really wanted was to limit their freedom. Let’s appeal to the public’s desire to get the government off their backs, he argued, to buy what they want when they want it. “We’ve got to deal with this now,” warned Kessler. “We’ve got to organize. We have to convince the grass roots, the consumers, to get on the bandwagon and fight.” It was a brilliant marketing strategy. Soon Gerry Kessler would convince millions of Americans that it was in their best interest not to know what they were buying.

  Although science wasn’t on his side, Kessler knew that politics could still win the day. And he knew just the politician to do it. In fact, he didn’t have to look any further than the end of the table during his meeting with industry insiders. Sitting among the CEOs, lobbyists, and lawyers were Patricia Knight and Jack Martin, top aides to Orrin Hatch, the Republican senator from Utah. Knight would soon become Hatch’s chief of staff, Martin an industry lobbyist.

  Orrin Hatch loved the supplement industry. As a young man, he sold vitamins and supplements; as an older one, he took them every day—including saw palmetto, to shrink his prostate. “I really believe in them,” he said. “I use them daily. They make me feel better, as they make millions of Americans feel better. And I hope they give me that little added edge as we work around here.”

  In turn, the supplement industry loved Orrin Hatch. Four of the industry’s top thirty manufacturers—Weider, Nutraceutical Corporation, Nature’s Way, and Nu Skin International—were located in Utah. (It was the only state with its own supplement trade association: the Utah Natural Products Alliance.) At the time of Gerry Kessler’s crusade, Utah benefited from several billion dollars in profits from supplement sales. Hatch’s campaigns also benefited. As Dan Hurley describes in Natural Causes, between 1989 and 1994 Herbalife International gave Hatch $49,250; MetaboLife, $31,500; and Rexall Sundown, Nu Skin International, and Starlight International a total of $88,550. In addition, according to his financial disclosures for 2003, Hatch owned 35,621 shares of Pharmics, a Utah-based nutritional supplement company. In the early 1990s, Hatch’s son Scott began working for lobbying groups representing vitamin and supplement makers. Kevin McGuiness, Hatch’s former chief of staff, was also a lobbyist for the industry.

  With millions of dollars in hand, Gerry Kessler ran a campaign in the 1990s that—like the tobacco campaigns of the 1950s—was a model for how industries could cash in at the expense of the public’s health. First, Kessler convinced supplement manufacturers to send preprinted letters to Congress urging freedom of choice in health products. Second, he turned ten thousand health food stores into political-action centers, convincing employees to offer discounts to their customers if they sent letters to Congress. Third, he recruited celebrities. “Start screaming at Congress and the White House not to let the FDA take our vitamins away,” said actress Sissy Spacek. Other actors, like Mariel Hemingway, Victoria Principal, and James Coburn, appeared at industry trade shows. Fourth, he made it personal, busing supporters to shout down Henry Waxman at public meetings. “They dominated the meetings,” recalled Waxman. “One person after another would harangue me.” One of Waxman’s office windows was pelted with tomatoes.

  Later, Waxman summed up Gerry Kessler’s campaign against his amendment. “It was unlike any other lobbying campaign I’ve ever seen,” he said. “People believed what they were being told because it fed into their view that doctors and pharmaceutical companies wanted to block alternative medicines that could keep people healthy. What they didn’t understand, though, was that this view was manipulated by people who stood to make a lot of money, and did make a lot of money—billions of dollars.”

  In the heat of battle, Gerry Kessler met David Kessler in his office. “Commissioner,” said Gerry, “I don’t know whether you’re for us or against us, but I will be here when you’re gone, and so will this industry. So it would be good if you were for us.” “Is that a threat?” replied David. “No,” said Gerry. “I just hope you’ll be for us.” Gerry Kessler was right. It wasn’t a threat. It was a fact. And what was about to happen would mirror the events of the mid-1970s, when William Proxmire turned an attempt to regulate megavitamins into an amendment that allowed vitamin makers to make even more outrageous claims. Now, with the money, power, and greed of a multibillion-dollar-a-year industry behind him, Gerry Kessler would accomplish the same thing with supplements, minerals, and herbs, allowing manufacturers to avoid FDA oversight and effectively hide critical information. It was called the Dietary Supplement Health and Education Act, a name that fit comfortably into the upside-down world of alternative medicine, where one thing often means another—in this case, an education act that had nothing to do with education. Quite the opposite. Now consumers would have no way of knowing whether what they were buying was safe or effective. It is remarkable, even in retrospect, that consumers not only chose not to know what they were buying; they lobbied for it.

  Although effective, Gerry Kessler’s campaign was amateurish, relying on letter writing and arm-twisting. He needed a lobbyist who had clout, especially with the Democrats. The recommendation that turned the tide came from Bill Richardson, a Democrat from New Mexico, a state with a long-standing interest in alternative medicine. Richardson suggested that Gerry Kessler call Tony Podesta, one of the most influential Democratic lobbyists in Washington and the brother of John Podesta, who would later become Bill Clinton’s chief of staff. Although Edward Kennedy had opposed the Supplement Act, he was indebted to Tony Podesta, who had done much to further Kennedy’s political agenda. Podesta convinced Kennedy to provide a heari
ng for Gerry Kessler’s bill.

  On July 29, 1993, the House hearing for the Dietary Supplement Health and Education Act (DSHEA) was called to order. FDA commissioner David Kessler was one of the first to testify. Standing next to a chart listing serious side effects caused by supplements, he said, “Think about it. Half our prescription drugs are derived from plants, and no one doubts for a minute that drugs can have toxic effects. That is why we insist on rigorous testing to separate out those with unacceptable toxicity. We must not assume that all risk disappears when plants are sold as dietary supplements for therapeutic purposes.”

  Also testifying against the bill was Dorothy Wilson, a victim of the L-tryptophan disaster. In 1989, L-tryptophan, an amino acid sold in health food stores, had caused a neurological condition that affected more than five thousand people and killed twenty-eight. “Mr. Chairman,” said Wilson, who was wheelchair-bound, “before you weaken the statute and make it more difficult for the FDA to do its job, consider how my life was catastrophically and permanently changed. The Dietary Supplement Health and Education Act must not pass. Reject this act because it is the right, courageous, and honorable thing to do.” The Consumers Union, the AARP, the American Cancer Society, the American Heart Association, the American Nurses Association, and the American College of Physicians also opposed the bill.

  In August, while Hatch’s bill was being considered, the campaign against FDA regulation reached a new low, running a nationwide television ad featuring Mel Gibson. It began with white letters on a black background: “Los Angeles, 9:57 p.m.” Police dressed in black clothing, wearing night-vision goggles and carrying rifles burst through a door and run into a bathroom. Mel Gibson’s bathroom. “Hey, guys—guys!” shouts Gibson. “Its only vitamins.” A warning appears: “The federal government is actually considering classifying most vitamins and other supplements as drugs. The FDA has already conducted raids on doctors’ offices and health food stores. Could raids on individuals be next?” As the police handcuff Gibson, he says, “Vitamin C. You know, like in oranges?” Then the take-home message: “Protect your rights to use vitamins and other supplements. Call Congress now.” At the end of Gibson’s commercial, other celebrities join in. Eddie Albert, star of the television sitcom Green Acres, says, “That can actually happen. Don’t let them take your supplements away.” Whoopi Goldberg says it’s “the right of American citizens to have free access to dietary supplements of their choice.” Talk show host Jenny Jones says, “We need to ensure that Congress continues to give consumers the right to make intelligent choices about our health.”

  Perhaps 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.

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

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

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

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

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

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

  HATCH: 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?

  KESSLER: 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.

  In 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.”

  One 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.

  So 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 screami
ng 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.

  The 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.”