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Falcons defensive tackle Grady Jackson, appealing a four-game suspension from the National Football League (NFL), is suing Balanced Health Products, the maker of StarCaps for "false advertising and unfair business practices."
—Atlanta Journal Constitution (1)
The U.S. Food and Drug Administration (FDA) announced the expansion of the recall of StarCaps-brand dietary supplement. StarCaps is sold in 30-capsule plastic bottles by retail stores nationwide and on the Internet to help "metabolize protein, eliminate bloat, and detoxify your system", as well as to help in weight reduction.
—UPI (2)
More and more products tainted with prescription drugs, including drugs for erectile dysfunction, diabetes, and obesity, are finding their way into the U.S. marketplace. Many are labeled as dietary supplements, however, unfortunately, it is not possible for the FDA to test and identify all tainted products.
—U.S. Food and Drug Administration (3)
"But look here aunt," I said, "It’s a quack medicine. It’s trash." "There’s no law against selling quack medicine that I know of," said my aunt.
—H. G. Wells (4)
THE COKE IN COCA-COLA
If our economy tanked because of subprime mortgages, perhaps the time has come to look at subprime drugs. (I’d call drugs "subprime" if they affect bodily functions without having undergone tests of safety and efficacy by the FDA.) Unfortunately, the $24 billion/year "dietary supplement" industry peddles subprime concoctions that can only be recalled after someone blows a whistle. Case in point: A highly publicized lawsuit filed by the Falcons’ Grady Jackson preceded a manufacturer’s recall of StarCaps slimming capsules and manufacturer recalls of more than 60 other dietary supplements. Among the covert ingredients of these over-the-counter nostrums was bumetanide, a potent diuretic (5)
.
This was not the first time a court in Atlanta has heard accusations of hidden ingredients in a patent medicinal. In 1902, an Atlanta courtroom heard evidence that a medicinal "stimulant," Coca-Cola, was liberally laced with caffeine and undetermined amounts of cocaine. The ensuing uproar over secret components, especially cocaine, in patent medicines led to passage of the Pure Food and Drug Act of 1906, provisions of which still guide the FDA. Follow-up litigation ensured that today’s Coke no longer contains coke (6)
.
The 1902 trial in Atlanta made it clear that Coca-Cola’s claims of medical efficacy were inseparable from its addictive content of caffeine and cocaine. Trans-Atlantic publicity following the trial produced a major work of fiction in England—H. G. Wells’ Tono-Bungay—in which Coca-Cola was recast as the title elixir. Coca-Cola had reached the United Kingdom by 1900, peddled as a medicinal pick-me-up, a "scientific combination of coca leaves and kola nuts" that "cured headaches, calmed the nerves, strengthened the muscles and renewed the vigor of the intellect" (6)
. The Tono-Bungay of Wells’ novel is a stimulating brew of secret ingredients, one of which is so intoxicating that it "Cocks their tails!" (7)
. The elixir is peddled by a snake-oil millionaire, Edward Ponderevo, who sells it "at an unconscionable price by methods that would shame a confidence man" (8)
. The character is a dead ringer for Asa G. Candler, "God’s Capitalist," who began by concocting "Botanic Blood Balm" and went on to build a personal empire in Georgia by making Coca-Cola a household name (9)
. Wells’ narrator, George, is a young lad brought into his uncle’s patent medicine empire, who, after rising to the top of the snake-oil world, admits that the whole packet of tonics and potions, such as Tono-Bungay, was "unmitigated fraud by any honest standard, the giving of nothing coated in advertisements for money" (10)
.
Wells had begun his career writing a textbook of biology but made his own fame and fortune as a man of letters (The Time Machine, The War of the Worlds, etc.). After writing Tono-Bungay, a dark, sci-fi masterpiece worth reading by anyone today, Wells was hailed by William James as the Tolstoy of the English world (11)
. Wells, as a sometime-Fabian socialist, was also a severe critic of laissez-faire and took swipes at Britain’s lack of commercial regulation.
As Tono-Bungay teaches, there was no law against quack medicine at the dawn of the 20th century, either in the United States or in Britain. Yet, by and by, muck-raking novels such as H. G. Wells’ Tono-Bungay and Upton Sinclair’s The Jungle (1906) lit the fires of reform in Edwardian England and Teddy Roosevelt’s America. On both sides of the Atlantic, the Progressive Era saw the pendulum swing to law and order from greed and laissez-faire. But not in Atlanta: Asa Candler, the Coke magnate who led the fight against income taxes, excess profit taxes, and cocaine labels, also "clashed with the progressive trends toward government-imposed standards for the manufacture of his product" and was elected mayor of Atlanta in 1917 (9)
.
PAPAYA, VALERIAN, AND GARLIC
I was reminded of the Coca-Cola trial and Tono-Bungay by news of Grady Jackson’s class-action suit for "false advertising and unfair business practices." The suit was filed not only against the movie star founder of the company, Nikki Haskell, but also against stores that sold these dietary supplements, such as the Vitamin Shoppe and General Nutrition Center (GNC). Money passed hands all around: At $160/month, StarCaps had star appeal: "Kathie Lee Gifford was enthusiastic about them on the ‘Today’ show. Retailers like GNC and the Vitamin Shoppe sold them, no prescription required" (5)
.
Alas, the hefty stars of professional football had followed Hollywood’s over-the-counter advice. Last football season, a half-dozen pros (of the Tennessee Titans, New Orleans Saints, and Minnesota Vikings) also failed their urinary steroid tests and faced four-game suspensions by the NFL. The behemoths blamed StarCaps for lacing its product with bumetanide, a loop diuretic banned by the NFL. Football players know that bumetanide will yield false-positives in urinary steroid tests, and it doesn’t take a physiologist to know that it produces weight loss by the bucket (3
, 5)
.
There is no mention of bumetanide in the disingenuous list of StarCaps ingredients. The capsules are said to contain a "mix of the digestive enzyme in the papaya and the diuretic qualities in the garlic [that] result in weight loss for users. The capsules also include valerian, an herb that is native to Europe and Western Asia. Today it is used often for its properties as an herbal stress reliever, but valerian was used by early herbalists for its diuretic properties as well" (12)
. However, omission of bumetanide isn’t the only flaw in the description of the capsules. StarCaps ads also failed to note that papain is an effective protease that can be absorbed topically, that valerian has proven soporific effects in humans, and that the magnesium salts contained in the capsule affect the gut (13
14
15)
.
The lawsuits filed by the football players caught the attention of the FDA, which since 1994, has had no effective regulatory authority over dietary supplements, unless these nostrums cause harm or are doped with prescription drugs (3)
. Within a month of Jackson’s suit, the manufacturer recalled StarCaps, which was followed by expanded manufacturer recalls of more than 60 other weight-loss supplements found to contain sibutramine (a centrally acting, serotonin-norepinephrine reuptake inhibitor), rimonabant (a cannabinoid receptor antagonist), phenytoin (better known as dilantin), and phenolphthalein (a pH indicator and laxative, banned in the United States as a carcinogen). The manufacturer recalls of those supplements were accompanied by the following FDA advisory:
Many of these products are marketed as dietary supplements. Unfortunately, FDA cannot test and identify all weight loss products on the market that have potentially harmful contaminants in order to assure their safety. Enforcement actions and consumer advisories for unapproved products only cover a small fraction of the potentially hazardous weight loss products marketed to consumers on the Internet and at some retail establishments. (3)
That’s a "small fraction" of those $24 billion spent on dietary supplements in this country in 2007, of which $1.7 billion went for potentially hazardous weight loss products (5)
.
HATCH-HARKIN AND THE REGRESSIVE ERA
Since the New Deal era, when the present FDA took up the regulatory torch of the Pure Food and Drug Act, the agency considered that dietary supplements were simply nutritional items such as vitamins, minerals, and proteins. However, as New Age herbalists, ethnic botanists, and ashram dwellers came of voting age, The Nutrition Labeling and Education Act of 1990 added "herbs, or similar nutritional substances" to the term dietary supplement (16)
. The Internet and word of mouth could now peddle such agents of questionable composition. No tests of safety or toxicity were required. Bad news: A search in PubMed for "dietary supplements/toxicity" reveals 100 such reports since 1990, ranging from the heavy metal contamination of ayurvedic medicines to renal dysfunction following oral creatine supplements (17
, 18)
.
Nevertheless, a huge para-pharmaceutical industry, which soon found friends in the legislature, was spawned. In the final hours of the 103rd Congress, the Dietary Supplement Health and Education Act (DSHEA) of 1994 passed easily, thanks to major bipartisan support. In the Senate, Orrin Hatch (R-UT) and Tom Harkin (D-IA) were its sponsors, and former Congressman Bill Richardson (D-NM) was its sponsor in the House. The legislators were assured that the bill was popular: "Congress has received more mail on this subject than any other issue, including Bosnia, the Gulf War, Somalia, gun control, tax reform, and healthcare reform!" (19)
.
The 1994 DSHEA, also called the Hatch-Harkin act, expanded the meaning of the term "dietary supplements" beyond essential nutrients to include such substances as "ginseng, garlic, fish oils, psyllium, enzymes, glandulars, and mixtures of these." Moreover, the DSHEA assured manufacturers that they could describe the supplement’s effects on "structure or function of the body [or the] well-being achieved by consuming the dietary ingredient" without substantial scientific proof; nor were the supplements required to warn against possible side-effects in the same manner of prescription drugs (19)
.
You don’t need to be a pharmacologist to suspect that almost anything that really affects the structure or function of the human body might have an unwanted side-effect (a.k.a., toxicity). Indeed, a search in PubMed for "herbal drugs/toxic effects" finds such 460 articles since Hatch-Harkin. These range from hepatotoxicity from herbals and weight-loss supplements in the United States (20)
to kidney failure as a result of aristolochia, a Chinese herb used worldwide (21)
. Announcing passage of the 1994 bill, the legislators were proud that "the nutritional supplement industry is an integral part of the economy of the United States" (22)
. It was a statement that could have been found in Tono-Bungay:
Yes, I thought it over—thoroughly enough—Trade rules the world. Wealth rather than trade! The thing was true, and true too was my uncle’s proposition that the quickest way to get wealth is to sell the cheapest thing possible in the dearest bottle (23)
Hatch-Harkin also provided that "unlike health claims, nutritional support statements need not be approved by the FDA before manufacturers make products bearing these statements" (22)
. That’s why you see so many claims for supplements that promote "joint health," "breast health," or "male vigor" rather than more precise claims that would have to be validated by the FDA in following ethical pharmaceuticals. In fact, when Wallace et al. (24)
applied FDA "adverse report standards" to dietary supplements, they found at least 472 adverse events in the period between 1999 and 2003 caused by echinacea, ginseng, garlic, ginkgo biloba, St. John’s wort, and peppermint (sic). They worried that lax "U.S. policy on dietary supplements stands in contrast to the more rigorous approach of the European Union" (24)
. Worse yet, lack of regulation made it possible for manufacturers to spike their herbals with sometimes toxic prescription drugs, such as bumetadine, phenylbutazone, and aminopyrine (3
, 25)
.
It is clear to me that the deregulation of pills and potions containing mixtures of questionable ingredients is another aspect of the general notion that "government is the enemy," an idea that has been as productive in the subprime drug industry as in the subprime mortgage industry. Hatch-Harkin advocates spelled out their reasons for the absence of warning labels on dietary supplements: "Some manufacturers were fearful that putting responsible warning labels on some herbal products might create a situation in which FDA would regulate the product as a drug, since food products do not generally contain warnings" (19)
. That’s almost a summary of the Regressive Era of the last decade and a half.
In Tono-Bungay, the snake-oil millionaire goes bust after having over-extended his empire. His nephew, who survives financial disaster, goes on to fantastic adventures in science and technology. Looking back at the world of patent elixirs, George issues a dark warning against the perils of unregulated commerce:
I did not realize until after the crash how recklessly my uncle had kept his promise of paying a dividend of over eight per cent on the ordinary shares of that hugely over-capitalized enterprise. ... The flags flutter, the crowds cheer, the legislatures meet. Yet it seems to me indeed at times that all this present commercial civilisation is no more than my poor uncle’s career writ large, a swelling, thinning bubble of assurances; that its arithmetic is just as unsound, its dividends as ill-advised, its ultimate aim as vague and forgotten ... (26)
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FOOTNOTES
The opinions expressed in editorials, essays, letters to the editor, and other articles comprising the Up Front section are those of the authors and do not necessarily reflect the opinions of FASEB or its constituent societies. The FASEB Journal welcomes all points of view and many voices. We look forward to hearing these in the form of op-ed pieces and/or letters from its readers addressed to journals{at}faseb.org.
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