Killing Us Softly (9 page)

Schmidt wasn't alone in his opposition. Dr. Sidney Wolfe, representing Ralph Nader's consumer advocacy group, Public
Citizen, said, “This is a drug industry. The difference between large doses of vitamins and over-the-counter [drugs] is nonexistent. Exploitation of genuine concerns people have for their health [by promoting] vitamin pill–popping solutions is no better than … fraud.” Marsha Cohen, an attorney with Consumers Union, made a plea for common sense. Setting eight cantaloupes in front of her, she said, “We can safely rely upon the limited capacity of the human stomach to protect persons from overindulgence in any particular vitamin- or mineral-rich food. For example, you would have to eat eight cantaloupes to take in barely 1,000 milligrams of vitamin C. But just these two little pills, easy to swallow, contain the same amount. … And 1,000 milligrams, it should be recalled, is on the low end of Dr. Pauling's recommended 250 to 10,000 milligrams daily. If the proponents of the legislation before you succeed, one tablet would contain as much vitamin C as all of these cantaloupes—or even twice, thrice or twenty times that amount. And there would be no protective satiety level.” Cohen had pointed to the vitamin industry's Achilles' heel: ingesting large quantities of vitamins was unnatural, the opposite of what manufacturers had been promoting.

Kennedy, Schmidt, Wolfe, and Cohen were supported by the American Association of Retired Persons (AARP), the American Academy of Pediatrics, and the American Society of Clinical Nutrition. It didn't matter. On September 24, 1974, Proxmire's bill passed by a vote of 81 to 10. On April 23, 1976, it became law. “It was the most humiliating defeat in the history of the FDA,” wrote Peter Barton Hutt, the FDA's chief counsel. Dan Hurley, author of
Natural Causes: Death, Lies, and Politics in America's Vitamin and Herbal Supplement Industry,
wrote, “Congress had
made the decision to roll back the government's authority over the sale of foods and drugs for the first time in the twentieth century. So began an unprecedented experiment to test whether the unbridled use of vitamins and other supplements would help or hinder health, with the American public as the guinea pig.”

B
y the early 1990s, the Proxmire Amendment had opened a dangerous door—one that extended well beyond the uncontrolled sale of megavitamins. Henry Waxman, a Democratic congressman from California, and David Kessler, the FDA's newly appointed commissioner, wanted to close it.

Waxman and Kessler were concerned that salespeople in health food stores were advising customers to treat high blood pressure, infections, and cancer with vitamins, supplements, minerals, and herbs. “Unsubstantiated claims are becoming more exaggerated,” said Kessler. “We are back at the turn of the century, when snake oil salesmen could hawk their potions with promises that couldn't be kept. If you walk into a health food store, you have to recognize that we have not approved the safety of these products nor substantiated their claims.”

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.”

R
ising 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.

O
rrin 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.

W
ith 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.

A
lthough 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 hearing 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.

I
n 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.”