Killing Us Softly: The Sense and Nonsense of Alternative Medicine. Dr Offit Paul

before licensure (even though the thalidomide disaster had nothing to do with the drug’s effectiveness); previously licensed drugs could be withdrawn if they were found to be unsafe; manufacturers had to obtain consent from patients before testing experimental drugs; prescription drug advertisements had to include a summary of possible side effects; product labels had to list exact quantities of all ingredients; and manufacturers had to adhere to the code of Good Manufacturing Practices in testing, processing, packaging, and storing drugs. For the first time in history, it appeared that America’s Magical Miracle Medicine Show would be closing its tent.

      Then drug regulation took a giant step backward.

      In 1970, Linus Pauling published his book advising people to take 3,000 milligrams of vitamin C every day, about fifty times the recommended amount. Although the FDA didn’t mind people taking vitamins, Pauling’s advice scared them; no one really knew whether massive doses were safe. In December 1972, the FDA announced its plan to regulate vitamins containing more than 150 percent of the recommended amount; those containing larger quantities would require proof of safety before sale. Vitamin makers saw this as a threat to their $700 million-a-year business. Represented by the National Health Federation (NHF), the industry set out to destroy the bill. In the end, it did far more than that.

      The NHF was (and is) enormously influential. Founded in 1955 and headquartered in Monrovia, California, it consisted of vitamin industry executives and their lobbyists. The list of NHF founders, officers, and board members reads like a who’s who of American quackery:

       Harry Hoxsey, who helped found the NHF, made his fortune selling arsenic, pepsin, potassium iodide, and laxatives to treat cancer before fleeing to Tijuana to escape a fraud conviction.

       Fred Hart, president of the Electronic Medical Foundation and the NHF’s co-founder, distributed electronic devices that he claimed treated hundreds of diseases before a United States district court ordered him to stop.

       Royal Lee, who owned and operated the Vitamin Products Company, served on the board of governors. Lee published a book claiming that polio could be prevented by diet alone, even though a polio vaccine had already been invented. One FDA official said Royal Lee was “probably the largest publisher of unreliable and false nutritional information in the world.”

       Kirkpatrick Dilling, the NHF’s lawyer, was also a lawyer for the Cancer Control Society, a group that promoted questionable cancer cures (which in part explains his interest in representing John and Mary Hofbauer in their attempts to treat their son with laetrile).

       Bruce Halstead, another NHF leader, was convicted of twenty-four counts of fraud for claiming that an herbal tea called ADS treated cancer. ADS, a brownish sludge containing water and bacteria typically found in human feces, sold for $125 to $150 a quart. A Los Angeles County deputy district attorney called Halstead “a crook selling swamp water.” After his license to practice medicine was revoked, Halstead was fined $10,000 and sentenced to four years in prison.

       Victor Earl Irons, vice chairman of NHF’s board of governors, made Vit-Ra-Tox, a vitamin mixture sold door-to-door. Irons’s company created the Vit-Ra-Tox 7-Day Cleansing Program, which included fasting, supplements, herbal laxatives, and a daily enema of strong black coffee. “If every person in this country took two to three home colonics a week,” said Irons, “95 percent of the doctors would have to retire for lack of business.” Irons received a one-year prison sentence for making false claims.

      In addition to lobbying for the unrestricted sale of megavitamins, the NHF also campaigned against pasteurization, vaccination, and fluoridation.

      Although Linus Pauling was a key to blocking the FDA’s attempt to regulate megavitamins, industry executives knew they needed a political insider to win the day—someone who would not only defeat the bill requiring safety studies of megavitamins but free them from FDA regulation entirely. It didn’t take long for the NHF to find its man: Senator William Proxmire, a Democrat from Wisconsin. Proxmire was best known for his Golden Fleece Awards, given to federally funded science programs he considered wasteful. One winner, the Aspen Movie Map project, spawned a technology that enabled soldiers to familiarize themselves quickly with new territory. Although Proxmire later apologized to several award winners, his name became a verb: “to Proxmire” meant to obstruct scientific research for political gain. In 1975, William Proxmire introduced a bill banning the FDA from regulating megavitamins. Bob Dole, William Fulbright, Barry Goldwater, Hubert Humphrey, George McGovern, and Sam Nunn were cosponsors.

      On the morning of August 14, 1974, Senator Edward Kennedy, chair of the Senate Committee on Health, Education, Labor and Pensions, called the meeting to order. “The Food and Drug Administration, in my opinion, has an obvious and important responsibility to protect the American consumer against foods and drugs [that] are potentially harmful,” he said. “It must make certain that Americans are not led to believe that dietary products are therapeutic or in some way beneficial, when in fact they may be worthless and a waste of money.” Proxmire was the first to defend his bill, claiming that the recommended daily allowance for vitamins was far too low: “What the FDA wants to do is to strike the views of its stable of orthodox nutritionists into tablets and bring them down from Mount Sinai where they will be used to regulate the rights of millions of Americans. The real issue is whether the FDA is going to play God.”

      Others rose in support of Proxmire’s bill. Bob Dole, who would later appear in television ads for Viagra, said, “I would like to be on record as absolutely opposing any action by the FDA to regulate the retail sale of vitamin and mineral nutrients. In fact, it’s a little inconceivable to me that such restrictions should ever have been promulgated in the first place.” Milton Bass, a lawyer proficient in the doublespeak of his industry, said, “The Proxmire bill is designed for one purpose. It is designed to permit the customer to buy a safe food product honestly labeled.” Bass failed to explain how defeating legislation requiring proof of safety made products safer.

      Representing the FDA was its commissioner, Dr. Alexander Schmidt. Kennedy asked Schmidt to respond to Proxmire’s contention that vitamins weren’t harmful at any dosage. “Well, the word harm is relative,” said Schmidt. “What is overlooked by a great many people is that while there is not a lot of evidence that very large doses of water-soluble vitamins are harmful, there is not a lot of information that large doses of water-soluble vitamins are safe either.” Absence of evidence, argued Schmidt, wasn’t evidence of absence.

      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.