Citing (1) the Finnish intervention study which found that beta carotene increased significantly the incidence of lung cancer in smokers (a population that was expected to benefit); (2) a case-control study of women with cervical dysplasia which found an increased risk for women with a high intake of beta carotene (De Vet, et al. (Internat J Epidem, 1991;20:603-10); (3) the 1993 FDA Conference on Antioxidant Vitamins in Cancer and Cardiovascular Disease where there was agreement that vitamins C, E, and beta carotene were mischaracterized by describing them solely as "antioxidants" because they are actually redox agents that produce free radicals in large amounts; (4) the deception fostered over the years by vitamin promoters that "high potency" products offer greater benefits (ie, the "more is better" myth) causing many people to overdose on supplements; (5) that Healt h Foods Business (8/92) reported that beta carotene was the fifth most popular in supplement sales; (6) that Time magazine (4/6/92) reported that Hoffman La Roche had recently opened a beta carotene processing plant in Freeport, Texas that can produce 350 tons of beta carotene per year; and, (7) that promotions of beta carotene appear to have increased since 1992; NCAHF asked that advertising of "antioxidant" supplements, particularly beta carotene, as conferring health benefits be considered "false and misleading," and that the FTC take appropriate action to stop this assault on the public's health.
Montana's public health agency asked a Utah company to take its popular E'Ola diet drops off the market after receiving reports of allergic reactions, high blood pressure, a stroke and heart attacks. A user in Washington state reportedly displayed severe psychotic reactions associated with the product.
The state considers E'Ola an untested drug while the company claims it is only a food. E'Ola's vice-president, Blaine Rudd, acknowledged that his company had some problems when some distributors claimed that E'Ola had helped diabetics and other medical conditions, and placed such claims in a brochure. The literature has been recalled and rewritten. Blaine also said that the FDA had inspected his plant since the Montana complaint and expressed confidence that the company will be allowed to continue to sell its products. [Great Falls Tribune, 2/26/94]
Comment: According to a computer mail document, E'Ola contains an anti-depressant drug (dimethylaminoethanol); guarana, a potent source of caffeine (marketed on street as Zoom); white willow bark, a source of salicin (aspirin which is synergistic with caffeine); Ma Huang (aka, ephedra which contains an amphetamine-like substance used to make the street drug Speed) licorice root which can act as a potent diuretic that can cause life-threatening potassium depletion. Environmental Nutrition (3/94) newsletter lists seven over-the-counter weight loss products that contain Ma Huang and another 18 with ingredients not proven safe or effective.
The dietary supplement industry is rejoicing over a compromise bill introduced by Orrin Hatch, and passed by the Committee on Labor and Human Resources that exempts it from FDA regulations schedule to go into effect on July 1. Under Hatch's bill health claims would be allowed without FDA approval based upon "the totality of scientific evidence," and must be related to the supplement's ingredients effects on the structure or function of the body.
Hatch wants the burden of proof of safety to be on the FDA instead of manufacturers. This means that people would have to be harmed before regulatory action is taken, which is the "lock the barn after the horse is stolen" situation that existed with drugs before the 1938 Food, Drug & Cosmetic Act replaced the 1906 Pure Food & Drug Act, and with food additives before the 1958 Amendment. This is the situation favored by buccaneer entrepreneurs, but unacceptable in terms of science and consumer protection.
Senator Kennedy says that Hatch's definition would allow prescription drugs from other countries and unapproved drugs from this country to be classified as "dietary supplements." Some revisions are to be worked out by the committee before sending it to the full Senate for a vote. The bill is expected to have a tougher time passing the House. [CNI Nutr Week, 5/13/94]
The June, 1994 Consumer Reports carried the most up-to-date, and accurate presentation on chiropractic available. Among the information provided was the results of a study which found that 60% of American chiropractors either agreed with or were ambivalent about an anti-immunization statement. It is clear from the article that chiropractic is at the same time getting better and worse. This article is must reading for quackbusters.
Santa Fe, New Mexico has more "alternative" than regular health care providers; 1/27 "alternative" compared to 1/200 regulars! [Buckman & Sabbag h Magic or Medicine? Toronto: Key Porter Books, 1993, p.224]
A practitioner who offers breast enlargement by hypnosis has been accused of false advertising by the Kentucky Attorney General. Steve Marek, who operates a counseling service in Lexington, claims that some women suppress their breast growth during puberty. By regressing them back to puberty and asking them to release their repression, theoretically, their breasts may be enlarged. The lawsuit charges that there is no medical evidence to support Marek's claim, and asks $2,000 for each willful violation of the state's Consumer Protection Act. [Courier-Journal (Louisville) 5/27/94]
[Note: NCAHF has received reports of this scam in California and Florida. Kudos to the Ky AG for taking action.]
In 1993, 7,500 health food stores grossed $4.524 billion. Categories of income in millions: vitamins & supplements 1,741.7; herbs 678.6; groceries 488.6; bodycare 352.9; bulk (dried fruit, nuts, seeds, grains) 262.4; refrigerated items (foodservice, meat, poultry, seafood) 217; beverages (not teas) 144.8; books 131.2; frozen foods 108.6; miscellaneous (exercise equipment, pet products) 108.6; produce 54.3; baked goods 54.3. (Health Foods Business, Apr, 1994, p.30)
Comment: Vitamins & supplements plus herbs add up to $2,420,300 which is 53% of total sales. It is clear from these figures that the health food industry has very little to do with food.
A placebo-controlled, double-blind clinical trial which compared 18 different homeopathic remedies with identically prepared placebos (said to be 85% sucrose and 15% lactose impregnated [or not] with a 30C potency 1x10-60) on the duration of diarrhea in 81 Nicaraguan children treatable by oral hydration. Researchers report a significantly better result with the homeopathic remedies than placebos. (Jacobs, et al. Pediatrics, 1994;93:719-25)
Comment: The foregoing represents another study done by homeopathy advocates that begs for credibility. It asks for an explanation of its results to be offered by critics. The NCAHF position paper on homeopathy warns that such studies are uninterpretable unless an independent analysis of the remedies used was done, and their administration policed. In addition, this study tests 18 different remedies, but groups their results. This is a highly irregular way to conduct a clinical trial. Further, it doesn't compare homeopathy with no treatment or standard therapy. NCAHF deems this report uninterpretable and wonders why Pediatrics published it.
Richard Panush, MD, writes about diet and rheumatic disease in the Textbook of Rheumatology (WB Saunders Co, 1994). Dr. Panush answers the question: "Is there a role for diet in the routine therapy of patients with rheumatic diseases?" with a qualified "no." A relationship between diet and rheumatic disease might occur through either (1) altering immune and/or inflammatory responses, or (2) food antigens might provoke symptoms. Panush reviews these possible mechanisms and cites studies which lend support. Findings in studies that have tested patient responses to various dietary factors are of interest in the management of these diseases, but nutrition therapy should be considered experimental at this time.
[Dr. Panush is Chair of the Dept of Medicine, St. Barnabas Medical Center, Livingston, NJ; Professor of Medicine, University of Medicine and Dentistry of NJ, NJ Medical School, Newark; and, Coordinator of the NCAHF Task Force on Questionable Arthritis Remedies.]
General Nutrition, Inc., said to be the largest retailer of nutritional supplements in the USA, has agreed to pay a civil penalty of $2.4 million to settle charges that it violated the terms of two previous FTC orders. [FTC News Notes, 4/25/94]
NCAHF has learned that 42 products were involved in the 1970 and 1989 FTC orders. False claims were made for ergogenic aids (18 products), weight loss (15), baldness (5), diseases (2), and anti-fatigue (2).
Prometheus has published another valuable book written by Jack Raso, MS, RD (edited by Stephen Barrett, MD), "Alternative" Healthcare: A Comprehensive Guide (275 pp) examines the practices and philosophical under-pinnings of more than 200 "alternative" methods and describes the author's personal experiences with 15 of them. Featured are ayurveda, reiki, yoga, macrobiotics, Edgar Cayce remedies, naturopathy, Natural Hygiene, Qigong, six types of "body psychotherapy," and the mystical aspects of chiropractic.
Order from NCAHF Books, P.O. Box 1747, Allentown, PA 18105; Postpaid prices: Members $26.30; nonmembers $29; Canada orders add $1; overseas orders add $2 (U.S. dollars).
On Jan 29, board members of the Nova Scotia Medical Society (NSMS) voted to create a section on Complementary Medicine. The move, the first of its kind in Canada, must be ratified during the society's annual general meeting. The section opens the door to homeopathy, electroacupuncture, chelation therapy, nutrition counseling, herbal therapy and environmental medicine (aka, clinical ecology), and has 17 charter members.
Halifax, NS is home to an Environmental Medicine Clinic test project sponsored by the government. The province paid for Dr. Roy Fox to go to Dallas, Texas to train at the Environmental Health Center there. The Medical Director of the Dallas clinic, Dr. Gerald Ross, reportedly flies to Halifax for 10 days every two months to treat chemically sensitive, allergic and chronic fatigue syndrome patients.
Halifax physician Kempton Hayes is critical. He chaired a provincially-appointed multi-disciplinary committee that screened 86 people who believed they had "environ-mental hypersensitivity" and found that all could be given standard diagnoses ranging from allergic rhinitis to psychiatric disorders. Hayes accuses clinical ecologists of masquerading the placebo effect as science. Ross retorts, "don't knock it before you've tried it." Not all patients get better, but some do, say the clinical ecologists. Many hope that the new section will shed light on the current situation. [Canadian Med Assoc J. 1994;150:1462-5]
Comment: The NSMS Board assumes an enormous burden to prove that allowing "complementary" medicine practitioners to benefit from association with its name was not a betrayal of the public's trust. It should require their cooperation in an independent study of clinical outcomes of patients treated by unproven methods. We can only hope that they are up to the task.
The American Council on Science and Health report Multiple Chemical Sensitivity (2/94) addresses the claims and scientific status of clinical ecology and environmental sensitivity. Order from ACSH, 1995 Broadway-2nd Floor, New York, NY 10023-5860; $3.85.
The NCAHF Task Force on Nutrition Diploma Mills has completed a study of the veracity of nutritionists listed in the yellow-pages (YP) of telephone books. The study expanded and updated one done nearly 10 years ago by the Council. Instead of limiting the evaluation to the information provided in the YP ad, the new study used telephone interviews or familiarity with the practitioners to makes its determinations. Its findings are summarized below:
|"Dieticians"||9% (21 of 231)||3% (7 of 231)||84% (194 of 231)|
|"Nutritionists"||46% (286 of 618)||12% (73 of 618)||40% (245 of 618)|
|"Physicians"||55% (68 of 124)||13% (16 of 124)||32% (40 of 124)|
Data were collected in 64 areas of 32 states, except for physicians (20 of 32 states). A complete report was published in the May/June, 1994 Nutrition Forum. A summary appeared in the June, 1994 Tufts University Diet & Nutrition Letter.
In order to exempt dietary supplements from the consumer protection provisions of the Food, Drug & Cosmetic Act (FDCA), Senator Hatch is saying that FDA "has animus toward supplements" charging that the agency cannot be trusted to give them a fair shake.
This is a kind of "last ditch" strategy used to defend scoundrels by making them appear to be victims of an abuse of power by the police (aka, "They're out to get my client.") In a courtroom the questioning goes: "Tell me officer, why did you stop my client in the first place?" Law officers must have good reason to suspect that some illegal activity has occurred, otherwise, it may construed as an abuse of power.
Having been bullied by King George, the Founding Fathers wrote a substantial amount of protection from abuse by authorities into the Constitution. This is well and good, but can be made into a cover for scoundrels. Hatch can no doubt cite a record of FDA actions against supplement promoters because they have such a terrible history of blatantly disregarding labeling laws, false and misleading health claims, and the marketing of dubious health products. In fact, it was partially the abuses by the dietary supplement industry which made the 1990 Nutrition Labeling and Education Act (NLEA) necessary, and now they seek exemption. The FDA merely wants those who promote products that claim to prevent, alleviate or cure health problems to ALL meet the same standards, a "level playing field."
Hatch is also trying to make it appear that the FDA is siding with drug companies against the health foods industry. In reality, drug companies make up the major portion of the dietary supplement business both as bulk suppliers to the health food industry and as retailers. The Swiss pharmaceutical company, Hoffman-LaRoche is the biggest player, but Lederle (Centrum, Protegra), Squibb (Theragran) and Miles (One-A-Day Plus) are all doing national promotions of vitamins and antioxidants, and drug stores are the main retail outlets.
It is true that the nation's 50,000 drug stores outnumber the 7,500 health food stores, but the latter are more dependent upon supplement sales for their total incomes. Another widespread myth is that vitamins and herbal supplements are not profitable because they cannot be patented. In fact, vitamins are very cheap to produce and require little research and development. Herbal companies do not appear to be spending anything on research and development, nor are doing much on quality control. Profitability has more to do with marketing costs, demand, brand name recognition, and widespread availability than patents.
It has been widely reported that Utah is home to vitamin and herbal supplement industries with $700 million in annual sales, so Hatch is performing his role as Utah's Senator when he tries to gain an advantage for companies in his state, but his mission undermines consumer protection in critical arena of health. His political power and influence has drawn 63 co-sponsors to his bill, but the other Senators must be made to realize that reducing consumer health protection is dangerous business. Ironically, it may be Hatch's own constituents who are at greatest risk of exploitation. Mormon sources writing about the group's susceptibility to quackery mention herbal products specifically [1,2].
Citations: (1) Smith NL "Why are Mormons so susceptible to medical & nutritional quackery? J Coll Aesclep, 12/83, pp.1-15; (2) Bringhurst N. "Medical magic," BYU Today, 2/85, pp.32-6.
The National Association for Chiropractic Medicine (NACM), an organization of reform minded chiropractors that has divorced itself from the unscientific aspects of chiropractic now intends to abandon the chiropractic guild entirely and join a new profession called orthopractic. NACM has established a U.S. chapter of the Orthopractic Manipulation Society of North America (OMSNA), a Canada-based organization made up of science-based manipulation therapy practitioners.
Orthopractic therapy involves restoring a greater range of motion to the joints of the body through gentle and gradual mobilization, or more forceful manipulation. Among other things, orthopractors (1) provide patient education which is aimed at reducing pain and disability and having them become independent of care; (2) specifically reject the chiropractic subluxation theory; (3) do not use x-rays in diagnosis; (4) reject the use of manipulation to treat postural deformities in children (eg, kyphosis, scoliosis, unequal leg lengths), or a list of children's ailments (colic, eczema, learning disorders, infections, asthma, and more); (5) reject spinal manipulations for general health care; (6) support immunization; (7) reject the use of testimonials to promote their services; (8) reject homeopathy; and, (8) advise against sales promotions by chiropractors such as family plans, life-long spinal adjustments, free x-ray exams, and elementary school screening programs for scoliosis.
OMSNA's president is Murray Katz, MD, who is Medical Director of Tiny Tots Medical Center, the largest private practice pediatric clinic in Canada. In 1978, Katz published a report for the New Zealand Commission of Inquiry Into Chiropractic (NZCIIC)*.
Before becoming a physician, Katz had been an investigative journalist. To obtain information that would not be modified to suit a medical investigator, he did not disclose that he was a physician. He interviewed more than 100 chiropractors, attended lectures at the Canadian Memorial Chiropractic College, and registered himself as a chiropractor in order to obtain access to information on the inner workings, and philosophy, of chiropractic.
Although Katz's methods were like those used by government undercover agents, NZCIIC chairman Inglis called them "fraudulent" and "dishonest," words that chiropractic public relations people have used ever since to discredit Katz. A misunderstanding led the NZCIIC to also claim that Katz had falsified his service as a consultant to the Manitoba Health Services Commission on chiropractic, but the Manitoba Commission later confirmed that Katz had served in that capacity. Chiropractic publications are repeating these defamatory words in an attempt to discredit OMSNA, but enthusiasm for orthopractic appears to be very high, and NACM sources believe that they are on the right track to bringing the benefits of manipulative therapy into the main stream of healt h care.
*The NZCIIC report was widely discounted.2,3,4 Only chiropractic public relations people lauded it, but even they have not shown any enthusiasm for its recommendations that chiropractors not be permitted to use the title "doctor" on any sign or publicity material other than in the form of the letters "DC" following their names; not induce any person to believe that a chiropractor should be consulted in the first instance, in preference to a medical practitioner, for any disease or disorder (emphasis ours); or, induce any person to believe that chiropractic treatment will cure or alleviate any organic or visceral disorder5.
Citations: (1) Orthopractic Manipulation Society of North America, pamphlet. (2) Banta, U.S. Congress, OTA, 1980. (3) Jarvis, NZ J Physiother, April, 1980. (4) Parker Med J Aust, 1980;1:103-5. (5) Chiropractic in New Zealand, 1979, p.309.
For information on the OMSUSA, contact: Dr. Ron Slaughter, Nasa-Bay Area Chiropractic Center, 940 Gemini, Suite 101, Houston, TX 77058; 713-486-1675