Congress has taken no action on the legislation promoted by Hatch and Richardson that would have removed nearly all accountability from the dietary supplement industry. Hatch managed to get the Senate to agree to a 120-day extension of his moratorium to prevent the FDA from implementing its new rules, but the House leadership dropped the Richardson version. Hatch hasn't given up. He seems determined to have the dietary supplement industry excused from telling the truth in labeling, but others seem to realize that the industry misrepresented the facts in its disinformation campaign and that the best course of action is to let the FDA implement its new rules and see what happens.
Hatch has shown duplicity by his public challenge for FDA to prove that dietary supplements pose a risk to consumers, while privately trying to get the Administration to squelch the FDA report Unsubstantiated Claims and Documented Health Hazards in the Dietary Supplement Marketplace which identified specific safety problems. On 11/23/93, He, Bill Richardson and Elton Gallegy sent a letter to HHS Secretary Shalala asking that the report be withdrawn, and stating that they were "very serious" about their mission.
Addendum. The FDA has published useful statements and articles on its position on dietary supplements. Two are available from NCAHF: "Dietary supplements: making sure hype doesn't overwhelm science," (FDA Consumer, 11/93) and "Dietary supplements," (FDA Backgrounder, 6/15/93).
A MEDLINE search to obtain documentation supporting the claims of natural-product manufacturers from 1966 to 1992 found that there was no published scientific evidence to support the promotional claims of 42% of the products; 32% had some scientific documentation but were judged to be marketed in a misleading manner; and, 21% were associated with any document-ed human clinical trials.
Evaluated were: Argentinean bull testes, boron, chromium picolinate, clenbuterol, cyclofinil, dibencozide, gamma oryzanol, Menispermum conadense, ornithine/ arginine, plant sterols (diosgenin, smilagenin, hecogenin), saw palmetto berries, yohimbe bark, carnitine, ginseng, guarana root, Gymnema sylvestre, inosine, kola nut, and ma-huang. This useful article contains a table that includes marketing claims, facts and comments which serves as a ready guide. (The Annals of Pharmacotherapy, 1993; 27:607-15).
The American Cancer Society's statement on questionable nutritional therapies for cancer management published in CA-A Cancer Journal for Clinicians (1993;43:309-19) has been republished as an 11-page booklet. Vitamin C, pau d'arco tea, the Gerson diet, Hoxsey herbal therapy, the macrobiotic diet, Manner metabolic therapy, and Kelley metabolic therapy are covered. The booklets are available free from local units of the ACS.
Those who remember those Rexall drug stores will probably be disappointed to learn that the grand old name has been sold to a multilevel marketing firm, Rexall Showcase International (RSI), that sells weight control products, dietary supplements, homeopathic remedies and water filters. According to a RSI brochure, a survey of more than 30,000 households found that 75% recognized the name and that trust in the name was "exceptionally high." The history and current use of the Rexall name is described by Joan Benson in "The Rexall Tradition," Nutrition Forum, 1993;10:41-5 (November-December).
On September 3, the Washington Post described a public demonstration at the National Institutes of Health (NIH) Masur Auditorium at Bethesda of the Chinese healing art of Qi Gong. The Post reported that healer Wang-Pong Cheng punctuated a lecture on the powers of Qi Gong by appearing "to shatter a rock without actually striking it." A NIH physician-scientist hypothesized that Cheng might have "some ability to do this wit h electrophysiological energy." An NIH purchasing agent claimed that Cheng caused "a rush of energy" which relieved the pain in her recent artificial hip replacement by his hand-waving and massage.
The National Capitol Area Skeptics (NCAS) challenged the report by noting that Cheng was actually holding the rock when it broke. It noted that Cheng had tried and failed to break the rock, set it aside, and a half-hour later caught the audience by surprise by picking it up and cracking it (a classical conjurer's method). The critique and an articulate letter by James Randi appeared in Skeptical Eye, (1993;7:(2): 20-1).
Randi says that by permitting such a demonstration on its property, especially in the face of the new NIH Office of Alternative Medicine, NIH had "encouraged the belief of the American public in pseudoscience and quackery." Cheng's appearance had no official NIH endorsement but was presented by a company seeking corporate sponsorship of Qi Gong medicine (Cheng is reported to have conducted classes for NI H employees who wanted to learn more of the art of Qi Gong afterward). Randi expressed alarm over the circus approach to presenting ideas involving healing, and dubbed the event as the "Asian version of the old-fashioned Medicine Show that used to tour the American West selling quack nostrums to the gullible." Randi visited China in 1988 and examined Qi Gong practit-ioners (NCAHF Bulletin Board, March-April, 1991) showing that their "claims were based on outright trickery, simple suggestion, hyperbole or failure to properly observe."
Comment: NCAHF joins Randi in his concerns for the integrity of NIH, and wonders why the media has not shown more interest in the intrusion into NIH by political insiders enamored wit h pseudomedicine.
A report to the University of Colorado Board of Regents by the Academic Relevance Committee regarding the teaching and use of Therapeutic Touch (TT) at the Center for Human Caring which is part of the UC School of Nursing was made public December 16. The report stated that "the scientific basis for Therapeutic Touch has not been validated and that the efforts at this Center to do so have been inadequate."
The committee called for additional outside review of TT, and recommended that if the practice cannot be shown to have a bona fide scientific basis "with academic relevance, then no further course work should be offered under the aegis of the University."
The report is being scored as a victory for reason by skeptics groups in Colorado who fought what appeared to be a losing campaign to have TT judged on its scientific merit for more than two years. The Rocky Mountain Skeptics (RMS) which initiated public criticism of TT was praised by the Board of Regents for exposing the situation at UC. A new organization, the Colorado Skeptics will join RMS in monitoring the situation.
An analysis of 70 brands of calcium supplements found that about 25% of the products exceeded the FDA's "provisional" total tolerable daily intake of lead for children aged 6 years and under. Less than 20% of the supple-ments had "normalized" lead levels comparable to, or lower than, that reported for cow's milk. Grouped as: dolomite, bonemeal, refined and natural source calcium carbonate, and calcium chelates, the bone meal and natural source calcium carbonate samples were highest in lead. Authors recommend that as alternates for children, calcium supplements should deliver concomitant lead dosages no greater than milk. (Am J. Public Health, 1993;83:1155-60)
According to Pediatric Management (Nov. 1993, pp.23-34), "chiropractors tally 20 million pediatric visits a year, and many use those encounters to pro-pound bizarre views on immunization and antibiotics." This figure compares with roughly 87 million visits to pediatricians in 1989.
Most interesting are the marketplace studies presented which reveal what DCs do in their pediatric practices. Canadian pediatrician Murray Katz lists 10 points that DCs use to make inroads with parents drawn from about 100 DCs that he interviewed. Anyone interested in chiropractic marketing tactics will benefit from a careful study of these 10 points which recite a long-standing littany that presents DCs as separate but equal to MDs.
Stephen Barrett, MD, tells how 5 DCs diagnosed a healthy child--all finding what were, in fact, nonexistent problems. Paul Brown, MD, found that 99% of Minnesota DCs treat children and 80% treat ear infections (without antibiotics since DCs cannot employ prescription medicines). Seth Asser, MD notes that DCs are like a child with a hammer in which case "everything he sees looks like a nail!" Katz says chiro-practic is "a treatment in search of a disease." This article is one of the most important patient education pieces we have seen. It is must-reading for everyone concerned about the health and well-being of children.
The May/June, 1992 issue of Natural Foods & Farming magazine carried a detailed "Personal testimony" written by a 32-year-old woman who truly believed that she had been cured of her cancer through the use of nutrition.
Her story recites the type of information people put together to construct the classical scenario of cancer quackery (ie, cancer is out of control, related to dietary deficiencies, and curable by natural nutrition--in which foods are judged mostly by their positive or negative symbolism). She told about how she quit conventional cancer treatment halfway through saving "a ton in doctor's bills." She admitted her ignorance on nutrition and told people to make their own choices, but tesified to a personal triumph over cancer that left little room for any other choice but hers.
The magazine published a follow-up story in the fall of 1993 entitled "Memorial to Maria Haasch Houck"--the heroine had died of cancer! The tribute made only mention of how she inspired hope in others faced with similar circumstances. No caveats of her folly appeared; only tributes to the dear-departed. The pernicious danger of the true-believer is revealed in this article more articulately than any warning we could state. This is a superb educational tool on the unreliability of testimonials and the ways of cancer quackery.
The National Cancer Institute (NCI) has decided not to initiate clinical trials of shark cartilage following a review of selected cases involving use of the substance. NCI held the door open if more data were found to justify such a test. (NIH Observer, Nov-Dec, 1993, p2.)
Reflexology is a type of digital pressure massage that is aimed at stimulating "reflex points" on the ear, hand or foot theorized to correspond with specific areas and organs of the body. Reflexo-logists claim to be able to locate areas of weakness or pathology by testing reflex points, and to be able to relieve physical complaints by stimulating such points.
NCAHF conducted a pilot study in 1981 which found that reflex points did not correspond with self-reported medical conditions within two years of the time. At that time we designed a test of the therapeutic value of reflexology, but did not carry it out.
Now we read of a study, with a design nearly identical to a test that we had planned, which purports to have effectively relieved premenstrual syndrome. In the test, 35 women who complained of premenstrual syndrome (PMS) were randomly assigned to ear, hand and foot reflexology or placebo therapy done on sham reflex points. Subjects kept a daily record on 19 somatic symptoms selected from previous PMS research questionn-aires. The treatment group reported significantly fewer symptoms than the placebo group, and these benefits persisted for 2 months after treatment. The placebo group reported that they thought they were receiving genuine reflexology.
The authors note that it was very difficult to develop a credible placebo control group which may have been the study's flaw. Normally, reflexology is soothing, but the placebo treatment was described as "either overly light or very rough." We believe that the differences could simply have been differences in the quality of the massage being administered. As in applications of sham versus genuine acupuncture, the therapists are likely to vary the quality of the procedure in accordance with their own expectations regarding the study's outcome.
This study supports the value of massage for PMS but does not validate the alleged connection between reflex points and body organs. (Oleson and Flocco, "Randomized controlled study of premenstrual symptoms treated with ear, hand and foot reflexology," Obstetrics & Gynecology, 1993;82:906-11)
A 10-year follow-up study of 34 breast cancer patients enrolled in the Exceptional Cancer Patients (ECaP) program at New Haven, Connecticut (the program highly touted by Bernie Siegel, MD in his books Love, Medicine and Miracles and Love and Healing [Harper & Row, 1986 & 1989 respect-ively]) found no difference in survival time between ECaP patients and 102 controls.
The survival effect of the ECaP program was first evaluated in 1981 and, although inconclusive, suggested a strong, statistically significant beneficial effect on survival. However, this was due largely to a selection bias caused by a failure to match ECaP participants and comparison subjects on the duration of the time-lag between diagnosis and program entry. Analysis of the EcaP patients with 79 matched controls resulted in near-identical survival curves. (Gellert, Maxwell, Siegel, "Survival of breast cancer patients receiving adjunctive psychosocial support therapy: a 10-year follow-up study," J. Clin. Oncology, 1993;11:66-9).
The ECaP program involves individual counseling, patient peer support, family therapy, direction in relaxation, positive mental imagery and meditation aimed at facilitating patient acceptance of their disease, getting patients to exert control in their lives, and building hope.
Popular talk shows such as those of Larry King and Rush Limbaugh promote supplements that claim to increase energy and enhance health. Ira Milner investigated Ginsana, Rejuvex and Trim-Maxx tea and found their claims unwarranted. ("Talk radio doesn't always talk sense when it comes to nutrition ads," Environmental Nutrition, 12/93)
Comment: Talk show hosts, who have great influence on public thinking, aid and abet the dubious supplement industry both by advertising their products and failing to speak out against the destruction of consumer protection law represented by the Hatch-Richard-son bills--or worse, by advancing the health food industry's disinformation campaign against responsible regulation of dietary supplements.
A Buffalo, NY area man, 41-year-old Michael Ricotta, was found guilty of fraud for marketing a "miracle cream" that he claimed would cure various ailments and an electronic device called the REM SuperPro Generator which Ricotta claimed was curing cancer in Mexico. A co-defendant, Pat Ballistra, 40, of Amherst, NY was excused from the trial because of a back ailment, but will be tried later.
Ricotta and Ballistra sold products for a company called Life Energy Resources, Ltd, which went out of business in 1991. Investigation continues into the company which was operated by a former Chautauqua County legislator, Frank Costanzo and his wife Charlene. Ricotta faces 1-3 years in prison. Sentencing is scheduled for Feb 2. (The Buffalo News, 11/20/93)
Note: It is not mentioned in the article, but the REM SuperPro Generator is a Radionics device of the type devised by Raymond Rife (see NCAHF Newsletter, Mar-Apr, 1992, p.3).
On January 13, Minnesota Attorney General Hubert Humphrey III filed a lawsuit against an Owatonna chiro-practor and two others alleging that they have defrauded consumers by using an unlawful and ineffective drug in the treatment of cancer, and for convincing patients not to seek legitimate medical care. Defendants were injecting Chondriana, a substance of unknown qualities, into patients.
At least one patient, who would have had better than a 90% chance of cure, now faces a life expectancy of no more than two years due to having been diverted from proper care. Defendants face for civil penalties up to $25,000 for each violation. The chiropractor involved, Hobart R. Parks, Jr., sits on the State Board of Chiropractic Examiners.
(For more information contact Art Sasse 612-297-1321 or MaryKay Milla 296-2069)
Elsewhere in this issue we report the failure of the EcaP program to improve the survival time of breast cancer patients. Does this condemn psychosocial support programs? We think not. Common sense alone seems to provide reason enough to believe that it is better for cancer patients to be optimistic than pessimistic, to be with supportive others than to be alone, and to be busy trying to do something about one's predicament than to do nothing but worry. However, the theory that psychosocial support programs may improve survival time must be proved.
A widely cited report on the alleged value of psychosocial support in prolonging the lives of cancer patients is the study by Spiegel , which, after 10 years, serendipitously found longer survival among patients who had been enrolled in a psychosocial support program that included: (1) discussions on how to cope with cancer, physical problems including side-effects of therapy, and express feelings; (2) lessons on self-hypnosis for pain and assertiveness with doctors.
The program was directed toward facing and grieving losses, but not to have patients believe that participation would alter the course of their disease. The Spiegel report has taken on mythological proportions in the popular press and among mind-over-matter health care devotees, but as medical oncologist Dr. Wallace Sampson points out, the study was not designed to study survival and suffers from many weaknesses.
Not only was there an imbalance in the number of treatment and control patients, but differences in the proportions of stage I-IV patients. A selection bias appears to have been created by the exclusion from the statistical analysis of 14/50 (28%) patients randomly assigned to the treatment group who were "too weak or too ill to participate." Six of them died before the group sessions began. In contrast, only 6/36 (17%) of the control patients were too ill or died before the program began. Although the difference was not statistically significant, prior exclusion of ill patients from the treatment group could easily have obscured a real difference.
The most important observation is that the difference in the survival time was due to the absence of any long-term survivors in the control group. Although the shape of the treatment group's survival curve is representative of a normal population of breast cancer patients at the time in the same geographic region, the control group's was not.
If the control group had been representative, 32% should have survived between 5 and 10 years . Eighteen of the treatment group lived 5-10 years, whereas none of the control group lived more than 4 years. This is puzzling because 58% of controls were listed as stage I and II patients. The apparent improvement in survival of the treatment group clearly was due to an atypical control group rather than due to the effects of the psychosocial intervention program. The appropriateness of the control group is so basic to the evaluation of any clinical study that the failure to recognize such a defect is hard to understand. The problem may lie in the desire that even many medical people have to believe that we can control serious diseases with our minds (eg, the patient is a "good fighter").
Dr. Sampson also asks whether it can be assumed that the control patients did nothing in terms of psychosocial support? He says, "our patients regularly take advantage of American Cancer Society, hospital-based, and our office-based support groups. Our oncology nurses often spend extra time with patients, as do physicians." It is also unwarranted to conclude that the treatment achieved its goals, and that these persisted for years afterward. To determine the effect of mental attitude on survival it would be more valid to compare people with desirable versus undesirable attitudes as others have done without success [3,4]. A well-designed study  recently reported benefit of psychiatric intervention on survival, but was cautious in its generalizations.
The danger of exaggerating the power of the mind over the biology of cancer is that patients may come to view the feeling good emphasis of psychosocial support as incompatible with the feeling bad side effects of cancer therapies and become uncooperative in their treatment compliance. Responsible programs guard against such, but mind-over-matter quacks cite positive reports as evidence that the mind alone can cure cancer.
Citations: (1) Spiegel, et al. "Effect of psychosocial treatment on survival of patients with metastatic breast cancer," Lancet, 1989;2:888-91; (2) Northern California Cancer Center; (3) Cassileth, et al. "Psychosocial correlates of survival in advanced malignant disease?" New Engl J Med, 1985;312:1551-5; (4) Jamison, et al. "Psychogenic factors in predicting survival of breast cancer patients," J Clin Oncol, 1987;5:768-72.; (5) Fawzy, et al. "Malignant melanoma: effects of an early structured psychiatric intervention, coping, and affective state on recurrence and survival 6 years later," Arch Gen Psychiatry, 1993;50:681-9.