Killing Us Softly

by Dr Paul Offit

  Samuel Hopkins Adams graduated from Hamilton College before joining the staff of the New York Sun, one of the nation’s most influential newspapers. On October 7, 1905, Adams published the first of a series of articles in Collier’s magazine titled “The Great American Fraud.” Adams wanted Americans to know what they were buying. So he sent samples of patent medicines to chemists, finding that many contained large quantities of alcohol: Paine’s Celery Compound contained 21 percent; Peruna, 28 percent; and Hostetter’s Stomach Bitters, 44 percent. (To put this in perspective, beer contains 4 to 6 percent alcohol, wine 10 to 15 percent, and whiskey 35 to 45 percent.) Patent medicine makers were in the liquor business. They were also in the narcotics business. Adams found that several medicines contained opium, morphine, hashish, and cocaine. These drugs were often given to babies; Winslow’s Soothing Syrup, for example, was loaded with morphine. When Adams asked his maid how she had left her small children alone at night, she replied, “They’re all right. Just one teaspoon of Winslow’s and they lay like dead until morning.” Perhaps the best example of the subterranean narcotics industry was Coca-Cola, introduced in 1886 as an “Intellectual Beverage and Temperance Drink” that offered the virtues of cocaine without the stigma of alcohol.

  By the last installment of “The Great American Fraud,” in February 1906, Samuel Adams had exposed 264 companies and individuals, listed scores of people who had died from dangerous drugs, and shown that many patent medicines had caused diseases rather than treated them. “Every man who trades in this market, whether he pockets the profits of the maker, the purveyor, or the advertiser, takes [his] toll of blood,” wrote Adams. “Here the patent medicine business is its nakedest, most cold-hearted. Relentless greed sets the trap, and death is partner in the enterprise.” More than 500,000 Americans read “The Great American Fraud.”

  With the public up in arms about Adams’s publication, Harvey Wiley felt the time was right. He proposed a federal law to “cover every kind of medicine for external and internal use,” which would require manufacturers to list all ingredients and prohibit them from selling narcotics without a prescription. Wiley’s proposal angered the Proprietary Association of America, lobbyists for the industry. “Such a law,” advised its Committee on Legislation, “would practically destroy the sale of proprietary remedies in the United States.” Industry executives successfully lobbied to kill the bill.

  And that would have been the end of it had it not been for a die-hard socialist who, if anything, wanted less government, not more.

  Upton Sinclair was an unknown journalist who railed against the sins of American capitalism. In the early 1900s, he traveled to Chicago to write a fictional work about the plight of immigrant workers in the meatpacking industry. With The Jungle, Sinclair wanted to inspire his readers; instead he nauseated them. “There would be meat that had tumbled on the floor, in the dirt and sawdust, where the workers had tramped and spit uncounted billions of consumption germs,” wrote Sinclair. “There would be meat stored in great piles in rooms; and the water from leaky roofs would drip over it, and thousands of rats would race about on it. It was too dark in these storage places to see well, but a man could run his hand over these piles of meat and sweep off handfuls of the dried dung of rats. These rats were nuisances, and the packers would put poisoned bread out for them; they would die and then rats, bread and meat would go into the hoppers together.” Sinclair described how employees occasionally slipped into steaming vats, later emerging as Durham’s Pure Leaf Lard. Wanting to hit Americans in their hearts, he hit them in their stomachs. Sales of meat dropped by half. Following publication of The Jungle, Theodore Roosevelt ordered Congress to create legislation guaranteeing clean meat and pure food.

  The bill that President Roosevelt signed into law, the Pure Food and Drug Act of 1906, was a watered-down version of what Harvey Wiley had wanted. If a patent medicine contained alcohol, cocaine, opium, chloroform, or other potentially harmful drugs, manufacturers had to print it on the label. They could still sell narcotics and dangerous drugs; they just had to tell consumers they were doing it. Most important, no statement could be made that was “false or misleading.” Although the law didn’t ask manufacturers to prove that their medicines were safe or effective, it was a start. The federal government now had a hand in regulating the drug industry.

  Enforcement of the Pure Food and Drug Act fell to the USDA’s Bureau of Chemistry. In 1927, the newly minted Food, Drug, and Insecticide Administration took over; three years later, it changed its name to the Food and Drug Administration.

  The next federal law was born of the worst pharmaceutical disaster in United States history. It involved one of the first antibiotics: sulfanilamide. In the early 1930s, six companies made sulfa drugs: Squibb, Merck, Winthrop, Eli Lilly, Parke-Davis, and the S. E. Massengill Company of Bristol, Tennessee. Massengill made it poorly. To make sulfa more palatable for children, Harold Watkins, Massengill’s chief chemist, suspended it in diethylene glycol. The final preparation—called Elixir Sulfanilamide—contained diethylene glycol, sulfanilamide, water, and small amounts of raspberry extract, saccharin, caramel, and amaranth, which gave the drug a deep reddish purple color. Unlike other sulfa preparations, Massengill’s tasted great—perfect for children. The drug, however, was far from perfect, and Massengill knew it. Ten months before marketing the mixture, chemists at Massengill found that a 3 percent solution of diethylene glycol caused fatal kidney failure in rats; Elixir Sulfanilamide contained 72 percent.

  In September 1937, Massengill distributed 240 gallons of its elixir in the United States. Three hundred fifty people drank it and immediately suffered heartburn, nausea, cramps, dizziness, vomiting, diarrhea, and difficulty breathing. Even worse, more than a hundred people died from kidney failure, thirty-four of them young children. Following the tragedy, the president of Massengill said, “My chemists and I deeply regret the fatal results, but there was no error in the manufacture of the product. We have been supplying legitimate professional demand and not once could have foreseen the unlooked-for results. I do not feel there was any responsibility on our part.” Massengill’s president, knowing that his company had acted within the law, wasn’t particularly remorseful. Harold Watkins, the chemist who had formulated the product, was. Soon after the incident he killed himself.

  The Elixir Sulfanilamide disaster led to the next major drug law: the Food, Drug, and Cosmetic Act of 1938. Now the FDA required safety testing before drugs were sold. The newer, stronger law stated that drugs, cosmetics, and therapeutic devices had to be proved safe; manufacturing plants had to be registered and inspected by the FDA every two years; and foods sold across state lines had to be pure and wholesome, safe to eat, and produced under sanitary conditions. Violators could be imprisoned for a year, with longer sentences for second offenses or fraud.

  Although the Food, Drug, and Cosmetic Act of 1938 tightened the reins, manufacturers still didn’t have to prove that their products worked before selling them. It took another tragedy to make that happen.

  On October 1, 1957, Chemie Grünenthal, a West German pharmaceutical company, distributed a sedative called thalidomide. Advertisements claimed that it was safe, even for pregnant women. Within three years, hundreds of women in Europe had delivered babies whose hands and feet were attached directly to their bodies—a disorder called phocomelia (cruelly referred to by the press as “flipper babies”). As many as 24,000 fetuses were damaged by thalidomide; half died before birth. Although Chemie Grünenthal had submitted its drug for licensure in the United States, Dr. Frances Kelsey, an FDA physician, turned it down, believing that the first few reports of phocomelia following the introduction of thalidomide weren’t a coincidence.

  Because of Kelsey, thalidomide was never marketed in the United States. Still, the disaster led to the next important federal drug law: the 1961 Kefauver-Harris Amendment to the Food, Drug, and Cosmetic Act. The amendment included several new regulations: manufacturers now had to show that drugs were not only saf
e but effective 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.

  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.”

  By 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.”