Two large studies that were designed to test the value of beta carotene supplements have found them to be completely ineffective in preventing cancer or heart disease. The Physicians' Health Study involved 23,071 doctors randomly assigned to take 50 mg or a placebo every other day. The study ended Dec 31 after 13 years with the finding that there was no benefit.
The Beta Carotene and Retinol Efficacy Trial (CARET) tested both beta carotene (30 mg) and vitamin A (25,000 IU) daily. The 18,534 participants took either beta carotene or vitamin A, both, or a placebo. The beta carotene portion of the study (subjects are still taking vitamin E) was halted 23 months ahead of schedule (1/18/96) when investigators saw that the death rate from heart disease was running 17% higher, and death from lung cancer 28% higher, among the subjects taking supplements.
Such findings were consistent with the Finnish Study reported in 1994. Dr. Richard Klausner, Director of the National Cancer Institute which financed bot h studies said, "With clearly no benefit and even a hint of possible harm, I can see no reason that an individual should take beta carotene." Dr. Charles Hennekins, Director of the Physicians' Health study called the failure of beta carotene to protect from these diseases "the biggest disappointment of my career." Federal officials stated that the idea that a simple supplement capsule might fend off serious diseases has proved "too good to be true!"
Comment: We share Dr. Hennekins' disappointment that an effective preventive practice against cancer and heart disease has not panned out, but because we have tracked both the research and the "antioxidant" promotions by the supplement industry for its entire history, we are not surprised.
In 1986, NCAHF joined with the American Dietetics Association, and others, in the Pills vs. Food campaign in which the message was the same as now emerges from these trials: get your nutrients and various possibly protective elements from food, not pills. The reason is still the same. It is paradoxical that it is the scientific nutrition experts that have been advocating that people rely upon natural sources for good nutrition while the "health foods" promoters have been selling pills. Peter Greenwald, Director of NCI's Division of Cancer Prevention and Control believes that the promotion of dietary supplements for cancer prevention deserves scrutiny. [New York Times, 1/19/96:A16]
Every "antioxidant" is a redox (reduction-oxidation) agent, protecting against free radicals in some circumstances, promoting them in others. On April 12, at the 1995 meeting of the Federation of American Societies for Experimental Biology, five researchers presented data on the pro-oxidant effects of so-called "antioxidants."
Gerber (France) presented a study which suggested that vitamin E may have decreased lipid peroxidation while simultaneously increasing the growth and spread of cancer. Olson (Iowa State U.) discussed how helpful and harmful actions of beta carotene depend upon circumstances and the "mix" of carotenoids in any given food. Herbert (Mt. Sinai School of Medicine) warned that vitamin C supplements taken by 40% of Americans may promote heart disease, cancer and premature aging in the 10%+ of Americans who unknowingly have high body iron. Swartz (Nat'l Institute of Dental Research) discussed work on tumor promotion by "antioxidant" vitamins. Kim (Centers for Disease Control) reported that mortality among Americans who take supplements is identical to those who do not. Their papers are published in the February, 1996 Journal of Nutrition.
A study of 22,748 pregnant women (10/84 to 6/87) yielded 121 infants with birth defects of the cranial neural crest. Women who consumed more than 15,000 IU vitamin A daily were 3.5 times more likely (CI=1.7 to 7.3) to bear babies wit h defects than those who consumed 5,000 IU or less. For vitamin A from supplements alone, women who consumed more than 10,000 IU daily were 4.8 times more likely (CI=2.2 to 10.5) to bear babies with defects than those consuming 5,000 IU or less daily. The increased frequency was concentrated among women who consumed high vitamin A levels before the seventh week of gestation. [Rothman et al. "Teratogenicity of high vitamin A intake," New Engl J Med 1995;333:1369-73.]
Comment: This is not the first time vitamin A supplementation has been associated with birth defects. We published an open letter from Dr. Victor Herbert to FDA's Center For Food Safety Director Sanford Miller in 1986 [Sept-Oct, NCAHF Newsletter] which cited a study in Teratology [1985;33:355-64] with findings nearly identical to the recent report.
There has been a great deal of publicity on the possible value of folic acid in preventing birth defects. The evidence is as strong that vitamin A supplements may cause birth defects. The role of these two vitamins in birth defects provides an excellent opportunity for testing how well health information is disseminated within our free enterprise system. One represents a positive "you can do" message; the other a negative "buyer beware" message. Our guess is that the positive message will be presented to the public more often for both economic and psychological reasons. Positive messages sell products, but negative messages do not.
The psychological reason is more subtle and perverse. Media reporters, and others upon whom the public must rely for health messages, are prone to wishful thinking. It is "as American as apple pie" to believe that we can make our lives better through "good nutrition," and vitamin-taking is commonly confused wit h "good nutrition." A myth fostered by cheerleaders for entrepreneurialism is that promoters are effective health messengers (ie, what's good for vitamin sales is good for America!).
A noteworthy example of commercialism advancing a useful public health message is the promotion of fluoridated toothpastes (primarily Crest) to reduce tooth decay. No general principle can be drawn from this, however. Most health problems are more complex. Each case must be evaluated on its individual merit.
On Nov 20, the U.S. Attorney for the Southern District of Texas, Gaynelle Griffin Jones, charged Stanislaw Burzynski, MD, and the Burzynski Research Institute (BRI) with 75 counts of mail fraud, violations of the Food, Drug & Cosmetic Act (FDAC), and for contempt for failing to obey court orders against FDAC violations in the past.
Like all successful mavericks, Burzynski has a strident lawyer and disciples who attest to his wonderfulness. The "usual suspects" are trotting out their stock charges of persecution (the Galileo ploy of claiming Burzynski is way ahead of his time), paranoia (the grand conspiracy to prevent a cure for cancer), and so forth. One would think that the media has had enough experience in the real world to spot such nonsense, but New York City's WNBC-TV displayed its naivete by airing a claptrap feature dubbed the "truth" about cancer in which the publicists of cancer quackery were presented as credible sources of information.
The claim that Burzynski is a victim of the big drug companies is refuted by the fact that from 1988 to 1994 the BRI grossed $40 million from marketing his "Antineoplastons" and Burzynski and his wife made $5 million personally. It is a curious thing that quackophiles, who are so fond of pointing to the money that is made by the medical establishment, never seem to notice the financial gains of the promoters of quackery.
[For insight into Burzynski's cancer remedy, see Green. "Antineoplastons: an unproved cancer therapy," JAMA, 1992;267:2924-8]
In 1974 the National Health Federation hired John Yiamouyannis, PhD, (JY) for the expressed purpose of discrediting fluoridation. JY initiated the campaign to smear fluoridation by purporting to have found that it causes cancer. His data were proved to be without merit, but served their public relations purpose. In time JY's charges led to a U.S. Senate hearing. Legislators asked the National Toxicology Program (NTP) to test the cancer-causing potential of fluoride. An NTP study of the effects of high doses of fluoride on rats completed in 1991 produced "equivocal" results regarding osteosarcoma (bone cancer).
The New York Department of Health's Department of Occupational Health, and Yale University's Dept of Epidemiology and Public Health, conducted a case-control study in which 130 subjects diagnosed with osteosarcoma between 1978 and 1988 at age 24 or younger were matched with control subjects by gender and year of birth. Total fluoride exposure was based upon interviews wit h subjects and/or their parents. Researchers concluded that fluoride exposure does not increase the risk of osteosarcoma, and may have a protective effect in males. The protective effect may not be directly due to fluoride exposure but to other factors associated with good dental hygiene. B ecause 99% of ingested fluoride is deposited directly into bone, there is a biologic plausibility for a protective effect. [Gelberg. Amer J Publ Hlth. 1995;85:1678-83]
The 1995 California legislature passed a statewide fluoridation mandate requiring every centralized water service with 10,000 or more outlets to fluoridate. Each local jurisdiction must fund its own program. This means that each locale will be discussing the issue. under such circumstances, antifluoridationism can be expected to "rear its ugly head." Early rumblings have already been heard from some communities.
Thus far, it appears that antifluoridationism is stigmatized as screwballism. Even the state legislature seemed to treat it with disdain. Professional antifluoridationist John Yiamouyannis, PhD (JY), is likely to be in considerable demand. JY will be easier to deal with than in the past because his history is laid out by John Hunt et al in the British Dental Journal (1995;179:121-3) in an article entitled "Putting Yiamouyannis into Perspective."
Californians can also expect to hear from John Lee, MD, a Mill Valley family practice physician. Lee authored "Optimal fluoridation" (Western J Med 1975;122:431-6). Lee assessed the fluoride intake of 10 children and found that some got enough to protect them from tooth decay without fluoridation. He argues that fluoridation is no longer needed because of fluoride from other sources including foods processed with fluoridated water. This issue has some validity, but the catch-22 is that discontinuing fluoridation would cut off the food processing source. The degree of fluorosis that can be expected under current conditions is not objectionable.
Although Lee advances a legitimate issue in his article, his other actions indicate that he is a committed, not-to-be-believed antifluoridationist. Lee signed the "Argument against Measure 1" in a 1980 Marin County voter pamphlet that resurrected a laundry list of discredited antifluoridation claims -- which he also presents as valid in oral presentations. Californians are in for a rough time because antis do not have to prove anything--since the issue involves the public water supply, they merely have to create the illusion that a legitimate scientific debate still exists regarding the safety of fluoridation.
Water companies often oppose fluoridation because it means more work (installation, monitoring, supplying and maintenance) for them. The best thing that profluoridation forces have going for them is recent findings that fluoride appears to reduce osteoporosis as well as tooth decay. This means benefits to a broader spectrum of the population.
[For complete information on fluoridation get Fluoridation Facts, American Dental Association 211 East Chicago Ave, Chicago, IL 60611-2678.]
The Centers for Disease Control & Prevention report on the death of one Iowa woman and the hospitalization of another we noted in the May-June issue. The CDCP report included a survey of a nonrandom sample of 24 persons who regularly drank Kombucha tea. Twenty of 21 respondents had obtained their "mushrooms" from friends or relatives, and 15 had given one to their friends. This finding confirms that most quackery is spread by word-of-mouth. Nearly a fourth reported having discarded batches of tea because of concerns about the appearance or taste of the tea, or because of visible mold growth. A randomized survey found that 3.8% (CI=1.4-8.4%) had a household member who had tried the tea.
[JAMA,1996;275:95-6; MMWR 1995;44:892+]
In November, a jury awarded Diane Bailey, 41, a $159,000 malpractice award against Colorado Springs dentist Hal Huggins. Bailey says that she had no dental problems at all when she entered Huggins' office in 1991, but lost many teeth and now has nagging pain as a result of treatment at Huggins' dental practice. Dr. Gino Ortegon, a Huggins employee, removed nine dental amalgams and extracted three endodontically-treated teeth.
Huggins claims that mercury in dental amalgams threatens health and that endodontically-treated teeth are focal points for infection. Both of these notions are unsupported by science and are forms of dental quackery. Bailey was roped into Huggins' nether world of dental hocus-pocus by viewing video-tapes of television newscasts on amalgam--including CBS's 60 Minutes 1991 broadcast--and having read portions of Huggins' book It's All In Your Head: Diseases Caused by Mercury Amalgam Fillings. She said that the positive attitude and beauty of the dental facility convinced her that everything was legitimate.
The state licensing board is investigating Huggins for routinely providing "substandard and unprofessional care" and for performing tests and treatments that are "a sham, illusory and without scientific basis."
[ADA News, 12/4/95] Huggins' troubles were featured in Time magazine [12/11/95, p.71]. Disciplinary action could revoke Huggins' dental license.
A meta-analysis of 23 high quality* studies found that sugar does not affect the behavior or cognitive performance of children. The strong belief of parents may be due to expectancy and common association. However, a small effect of sugar or effects on subsets of children cannot be completely ruled out. [Wolraich et al. "The effect of sugar on behavior or cognition in children," JAMA, 1995;274:1617-21]
*Requirements were: (1) The amount of sugar consumed had to be quantified; (2) use of placebo control; (3) subjects, parents and research staff had to be blinded; (4) statistical reporting that could be used to compute effects.
Comment: In 1983, NCAHF (then the California Council Against Health Fraud) issued a position paper on diet and criminal behavior. During the development of the position paper the task force reviewed the literature on the topic up to that time. Since then, it has followed the research as well. The conclusions have not changed.
It is curious that people continue to believe that sugar causes undesirable behavior. One reason seems to be that the idea is so inculcated into society that it keeps being reinforced. Roseanne Barr often jokes about her "sugar coma." A political cartoonist lampooned a 1994 report that showed that neither sugar nor aspartame had any effect on the behavior and cognitive performance of children. The cartoon showed kids going berserk while gulping down sugary foods with the study's findings being slopped-on. A substantial proportion of elementary school teachers associate the excitement of children at Halloween with the sugar they get trick or treating.
Anti-sugar beliefs are often expressed by people with unrealistic expectations from diet cures. The reasoning is that "bad food" causes, and "good food" cures serious diseases, and that sugar is a major "bad food." Even the U.S. Dietary Guidelines reflected irrational fears about sugar. They recommended that people not eat "too much sugar." The words "too much" intrinsically denote harm by excess. Any food item could have been substituted for "sugar," (ie, too much spinach, broccoli, wheat germ, kelp, bread, vitamin C, etc.). No carbohydrate crosses the gut wall into the blood without becoming a simple sugar.
Tooth decay is the only disease that has been linked to sugar, and even there the research on humans is not very good. It is now known that most carbohydrates can promote decay and the frequency of eating is most important, not specific foods. Consumers have always given sugar bad marks, and giving up sugary foods has long been cited as one of the things people do when they become "health conscious." A small library of books exists which condemns sugar, blaming everything from heart disease to the Kennedy assassination (no kidding) on its effects.
Why is there a negative attitude toward sugar? Anti-sugar attitudes are traceable to the abolitionist movement in 18th Century England. Sugar was the product of slavery and became symbolic of that evil. Puritan notions about pleasure and sinfulness made sweetness itself suspect. Even today most so-called "junk foods" are those that people enjoy. Enjoyment always seems to carry a side load of guilt.
A product sold under the names "Stone," "LoveStone," "Black Stone," and "Rock Hard," and identical to a traditional Chinese medication Chan Su, caused at least two deaths and the need for emergency medical intervention in New York City. The products were sold as topical aphrodisiacs (Chan Su is used as an anesthetic and heart medicine). All patients had measurable levels of digoxin (a glycoside found in Digitalis that affects the heart). Cardioactive steroids derived from toad venom or secretions that cause digoxin-like symptoms were also found. These products were supposed to be applied externally, but were ingested. It was this unintended use that produced these tragic outcomes. [JAMA, 1995:1828-9]
Interviews with caregivers of 101 Alzheimer's patients found that 55% had used at least one "unconventional" remedy; 20% had tried 3 or more. Among those who used such remedies, the leading choices were: vitamins 84%, health foods 27%, herbal medicines 11%, smart pills 9%, and home remedies 7%. Authors note that in addition to the wasted money, many of these remedies expose patients to possible side effects. Patients and caregivers would be better served if they would focus on the proper management of the medical, behavioral, legal, and financial problems associated with the disease. [Coleman J Amer Geria Soc 1995;43:747-50; Editorial: 829-30]
The steroid hormonal drug DHEA has arisen from the crypt it disappeared into following condemnation by the FDA (HHS News 4/9/85). The UCB Wellness Letter (1/96) provides a substantive critique that sounds very much like what was being said more than a decade ago. A new wrinkle is that health food stores are selling a wild yam extract alleged to be DHEA, but this is questionable since the substance doesn't exist in plants (estrogens do, so this may be a case of hormone substitution). The questions about DHEA's safety remain the same; cancer and unwanted side effects. DHEA is being marketed in numerous ways including by multilevel marketing. A few careless physicians are both using it and dispensing it to their patients. NCAHF advises consumers not to use DHEA even with a doctors guidance since so little is known about its long term effects.
The Cooper Aerobics Center (CAC) has demanded that MET-Rx stop using its name. CAC is concerned that "consumers are likely to erroneously believe that MET-Rx is in some way approved, endorsed, licensed or otherwise associated with the Cooper Clinic." [Letter dated 11/3/95]
Larry Katzenstein analyzes the tactics of a Vermont-based environmentalist group, Food & Water (FW), in its campaign against Cabot Creamery for its use of recombinant bovine growth hormone (rBGH). Although the case involves a regional company, the tactics employed can be generalized to food terrorism in general which, Katzenstein says "are right in sync with the Unabomber, whose terror-by-mail rampage -- 16 bombs, 22 people wounded and 3 dead -- is fueled by his hatred of what he calls a corrupt technological and industrial society."
Katzenstein's article is being published and distributed by Cabot's owner, Agri-Mark, and Cabot's employees. Included is insight into Consumers Union's (Katzenstein's former employer) anti-rBG H attitude. This is an important article because it addresses the psychology which is common to the problems of health fraud, misinformation and quackery.
Kentucky dietitians are concerned about attempts by EarthSave, the organization started by John Robbins (author of Diet For A New America [see Sept-Oct, 1991, NCAHF Newsletter for a critique]), to convert school children to a radical, restrictive vegan diet which excludes all animal foods. Carol Chappell and Nancy Tullis of the Kentucky Dietetic Association express their views in an article entitled "School children should not be targeted for vegetarian conversion" which was published in the Voice Tribune on 11/22/95. The authors expose faulty information being advanced by the EarthSave crusade.
Comment: The abuse addressed by Tullis and Chappell recalls a case in which a 34-year-old woman came to her senses and left the Transcendental Meditation cult. She was recruited at the age of 14 following a school assembly at which TM was presented as a science-based method of stress management. School children are very impressionable. EarthSave is based upon ideology with an appeal consistent with the spirit of the times. Even the Disney films such as Fern Gully and Pocohontas exploit our cultural myths of pristine primitivism. Teachers have a responsibility not to let ideologists use the schools as recruiting grounds.
Anthony Robbins, the motivation seminar promoter used by President Clinton (see Jan-Feb, 1995 NCAHF Newsletter) paid $271,000 to settle FTC charges that he misled investors about the profit potential of franchises for his positive thinking seminars. $221,260 of the funds go into an FTC escrow account for refunds. [Orange County Register, May 17, 1995]
The King County (Washington) Council is made up of a number of devotees to naturopathy. The Council is described in a New York Times syndication as "rhapsodizing about garlic pills and the healing power of ginkgo tree extract." One member says that he owes his health to a dietary supplement of enzymes and vitamins. another extols acupuncture. The result is that the Council voted unanimously to establish a natural health clinic funded by taxpayers' money. They hope to use either state or federal money to start the clinic sometime this year. Costs are estimated to be $1-2 million annually. [San Francisco Chronicle, 1/3/96:A4]
Comment: The founding of this clinic by the local political establishment is a scaled-down version of the abuse of political power that led to the NIH Office of Alternative Medicine. There is no doubt that the federal folly helped create a favorable climate for this act.
Robert Park, professor of physics at the University of Maryland, and Ursula Goodenough, Professor biology at Washington University in St. Louis, expressed their dismay with the use of tax dollars to fund "alternative" medicine in an article entitled "Buying Snake Oil With Tax Dollars" (New York Times, 1/3/96). The problem is not that NIH will help people with unusual ideas design research, but that the NIH's good name is being used to elevate magical notions to the level of serious science. NCAHF hopes that more people from the scientific community will openly object to the use of tax money to fund "alternative" medical quackery.