Dr. Stephen Barrett testified on behalf of NCAHF before the House of Representatives Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies on Oct. 18. Barrett reviewed and documented the current deceptive public relations campaign by the health food industry to block the passage of reform legislation that would strengthen consumer protection by increasing the enforcement power of the FDA (and FTC). Barrett stated that after having observed the health food industry for many years that he has come to consider it as "a form of organized crime."
Comment: It has been amazing to have watched over the past ten years how the Congress has identified the nature and extent of the problem of quackery in the nation [1-3] constructed the 1990 Nutrition Labeling & Education Act as a partial remedy, and now how its members are being duped by the very people who are major sources of the original problem.
If the Hatch-Richardson bill is passed, it will represent the greatest setback to consumer protection law since the 1906 Pure Food & Drug Act. Some segments of the media seem to be catching on to the fact that this legislation represents major destruction to consumer rights. We believe that the longer this debate lasts, the better chance there is that the propaganda efforts of the health food industry can be neutralized.
Citations: (1) Heinz Consumer frauds and elderly persons: a growing problem. Special Committee on Aging, U.S. Senate, Wash, DC, April, 1983. (2) Pepper Quackery: A $10 Billion Scandal. U.S. House of Reps, No.98-435, 1984. (3) Louis Harris and Associates. Health, Information and the use of Questionable Treatments; A Study of the American Public. Sept, 1987, Wash, D.C., U.S. Dept of Health and Human Services.
The American Academy of Pediatrics (AAP) has taken the position that it "cannot recommend or support any therapies or treatments for pediatric patients that are not clearly supported by conventional scientific research." AAP Media Alert, 10/18/93
Researchers evaluated five treatment modalities that seemed to work under clinical conditions but whose effects disappeared under controlled clinical trials. Under uncontrolled conditions the procedures all elicited reports of about 70% improvement (40% excellent, 30% good). Physicians as well as patients were fooled by the apparent benefits.
The authors dub these clinical illusions "the power of nonspecific effects in healing." Such are generally dubbed placebo effects (ie, beneficial responses due to the ACT of treatment rather than the treatment itself). The term "nonspecific effects" is good because it corrects the misconception of a single mechanism at work in placebos.
The most common misconception is that the patient must believe in the procedure for the placebo effect to occur. This is not true. Other factors such as operant conditioning (previous experience wit h healing acts), suggestibility, expectation, and many more may be operating. In fact, more than 30 variables are known to affect placebo responses.
This well-conceived study supports the need for double-blind studies, and helps explain why some health professionals fall into quackery. (Roberts, et al. Clinical Psychology Review, 1993;13:375-91)
Comment: Its not enough to say, "Who cares if it is just placebo, so long as it works." The problem is that the treatment may not have worked at all, and we need to know the difference between perception and reality. The reality is that aside from placebo effects, people feel better due to natural cycles in symptoms or normal healing with the passage of time. In some instances, patients have not improved, but clinic-ians following the old adage "seek and ye shall find whether its there or not" have reported illusory improvements based upon their expectations.
The Federal Trade Commission has charged the promoters of Immuno-Plex, an algae-based food supplement, with false claims. Mary Redhead of Yelm, Washington and Thelma Magno of Portland, Oregon have been named as principals of a business called Earthbound. The product has been sold by mail mostly through ads in gay-oriented newspapers--a month's supply going for $195. (FTC News, 10/5/93)
Medical Abstracts points out that it took less than 4 months for the FDA to withdraw temafloxacin from the market, but 4 years to withdraw the guar gum product Calban. Both produced adverse effects including death.
The difference was the presence of a functional reporting system for prescription drugs versus the slowness of reporting of the adverse effects of the over-the-counter products. An FDA survey indicates that 50% of all doctors aren't aware that they should report adverse drug and medical device reactions to the FDA.
The FDA has introduced a program called MedWatch that is designed to speed up and increase adverse-event reporting by doctors, pharmacists, nurses and other health providers. The simpler one-page report form replaces 5 other forms and uses a single address: 5600 Fishers Lane, Rockville, MD 20852-9787; 1-800-FDA- 0178. Since reporting is voluntary, consumers may have to insist that adverse reactions be reported by the provider to whom they complain.
The NIH Office of Alternative Medicine has funded a number of projects that will look into unusual methods of healing. Included among the grants are some real eyebrow- raisers. For instance, Lawrence Kushi will study macrobiotics and cancer. Curiously, Michio Kushi, the investigator's father, is the primary proponent of macrobiotics. A New Mexico physician will investigate intercessory prayer; a New Jersey MD will try Qi Gong (mystical hand waving?) on reflex sympathetic dystrophy; and a California PhD will investigate homeopathy and health.
The grants are being criticized for their use of limited public funding on projects of dubious scientific value while those within mainstream science are denied. In addition to the value to science debate, it is reported that Frank Wiewel and Ralph Moss, both of whom built their notoriety by promoting dubious cancer therapies, have attempted to get Barrie Cassileth, PhD, ousted from the NIH panel because she is a member of the American Cancer Society's national Committee on Questionable Methods of Cancer Management. They charge that the ACS committee's function is to debunk questionable cancer procedures. Cassileth retorts that Moss and Wiewel are "true believers" who are trying to "purify the panel of those who do not blindly accept the value of a product or practice simply because it is termed 'alternative'." (The Chronicle of Higher Education, 9/15/93, pp.A32-3)
Saul Green describes the history, theories, and evidence regarding chelation therapy (CT) for vascular disorders in Nutrition Forum (Sept-Oct). This useful article covers the dubious safety of CT (proponents play down its risks), and rebuts each of four mechanisms of action by promoters to explain how CT supposedly works. The results of past and status of current studies are also presented.
Comment: CT is one of the remedies NCAHF is most often asked about by people considering the procedure as an option to standard care. Dr. Green's article provides the most useful review we have seen on this important topic.
Pathological science encompasses fraud, crankism, and the more subtle wishful science in which true-believers use science to "prove" what they already are certain is true. Wishful scientists gather proof like an attorney, piling up positive data for their case, and while discarding and impugning any data that do not fit the paradigm.
Students of pathological science know that it is nearly impossible to catch a cheat or to find where true believers have distorted the data. The gold standard of science that ultimately uncovers pathological science is the failure of attempts to replicate the studies. The question that must be asked about the NIH grants is who will validate these studies by attempting to reproduce them? Will people with no ideological interest be willing to devote the time and effort to a dubious method that has alleged to have been proved of value by a true believer whose results are just what an outside observer would expect?
Hopefully, there will be competent researchers willing to undertake such tasks, but the chances are slim since good researchers usually have a full agenda and are not inclined to do research in unfamiliar areas. Our fear is that the research will gain NIH's status and be used to promote quackery.
Susan Powter, a spectacle of a woman with a bleached crew-cut and manic activity level, is the latest exercise and health guru attracting media attention. Connie Chung featured Powter on Eye To Eye (10/18). Powter, who is known for her high amplification, mixes her messages to women about taking charge of their lives by doing something drastic about the man who is messing them up, exercising vigorously, and eating a high volume, very low-fat diet. Looking like Twiggy on steroids, she is a screeching dynamo in the style of the Juiceman.
Powter makes her ignorance a virtue by proclaiming that she is not a doctor, nutritionist or dietitian and doesn't wanna-be. She spouts nutrition nonsense about food "chemicals," advocates vegetarian extremism, and other nonsense. Available from NCAHF is The American Dietetic Association's review of Powter's Stop the Insanity program pointing out its positive and negative aspects. SSAE +$1.
Senator Orrin Hatch attempted to justify his legislation that would permit a largely unregulated marketplace for supplement hucksters on CBS Morning News on Oct 19. Hatch charged that the FDA wanted to prevent people from getting beneficial supplements, specifically, folic acid for neural tube defects and vitamin E for heart disease, plus, he alleged that his bill would help reduce national health care costs.
This has no basis. A 1992 study of 10,758 Americans found no longevity benefit and questioned the cost-effectiveness of supplement taking . His complaint that the FDA does not allow health claims for folic acid to prevent neural tube defects does not justify his bill that would create a snake-oil marketplace for supplements.
Hatch's praise of vitamin E reflects recent vitamin-sellers hype, not the established value of vitamin E, and like other vitamin salespeople, he ignores its risks . Incredibily, Hatch is huckstering for the very industry that government studies have revealed is a big part of the nation's multibillion dollar quackery problem. His self-interest is obvious and blatant. Not only does he have a personal financial interest in the industry, but now the health food industry is raising campaign funds for him .
Hatch may not realize that he is ingloriously writing himself into the history of quackery in America.
[Citations:(1) Kim, et al. AJPH, 1993;83:546-50; (2) Roberts. Medical World News, 3/93, p.71; (3) Health Foods Business, 9/93, p.10]
A southern Minnesota dairy farmer, Herbert Saunders, has run into legal difficulties because of claims that his milk cures AIDS, Lyme disease, cancer, diabetes and other ailments. Customers had to first buy a cow at $2,500 and then pay up to $35 a bottle for its milk. Saunders reportedly injects a sample of a patient's blood into the cow's udder; and, theoretically, the cow forms antibodies which become part of its colostrum. This theory is said to have been tested by the Univ. of Minnesota in the 1950s with inconclusive results. Saunders defends his actions with familiar arguments; testimonials, his sincerity, and the hope it offers. (Minneapolis Star Tribune, 9/22/93)
Saul Green, PhD, has come up with another penetrating, insightful critique of so-called "Immunoaugmentative Therapy" (IAT) a dubious cancer treatment created by the late zoologist, Lawrence Burton, PhD, which Victor Herbert, MD, has described as neither "immuno- augmentative" nor "therapy."
Green details the history of its proponent's theory and how it came to be available in the Bahamas as a treatment. Burton's original work was disclaimed by his collaborator. The chemistry of IAT materials does not make sense, and some were found to have HIV contamination. The facts presented not only discredit IAT, but cast great doubt upon its underlying hypothesis that the immune system plays a major role in cancer's etiology.
This article is a splendid piece that will take its place among classical refutations of pathological science and pseudo-medicine. (JAMA, 1993;270:1719-23)
[Saul Green, PhD, is a biochemist who did cancer research at Memorial Sloan-Kettering Cancer Center for 23 years. He consults on scientific methodology and has a special interest in questionable medical procedures. Green is a member of the NCAHF Board of Directors]
The risk/benefit of spinal manipulation therapy (SMT) was analyzed on the basis of 140 case reports by researchers at the Department of Neuroscience, Division of Neurosurgery, University of Illinois College of Medicine at Peoria. Six risk factors (misdiagnosis, failure to recognize the onset or progression of neurological signs and symptoms, improper technique, SMT performed in the presence of contraindications, and manipulation of the cervical spine) are identified.
The review notes that despite flawed designs, SMT demonstrates consistent value for acute low-back pain, and coupled with low risk, is acceptable as a treatment. However, the risk/benefit ratio was judged as unacceptably high for patients with nerve root symptoms or signs associated with prolapsed discs and neck pain. Potential complications and unknown benefits indicate that SMT should not be used for children. (Neurosurgery, 1993;33:73-79)
Multiple chemical sensitivities has been proposed as a new disease in which the victim has adverse reactions when exposed to various substances under ordinary circumstances which do not affect the general population. The hypothesis has generated a cadre of fringe practitioners calling themselves clinical ecologists, a following of patients, and a genre of attorneys and expert witnesses who have managed to hit several industries for some large deep pocket lawsuits.
The media's attention on the environment, the strident claims of environmental activists, and the general concern for the environment taught by schools, public broadcasting, and so forth, have created a psychosocial setting that plays to a kind of mass hysteria one might label environmental anxiety disorder.
This is not meant to poke fun at sufferers whose symptoms are very real, and must be taken seriously. In a report titled "Immuno-logic, psychological, and neuropsycho-logical factors in multiple chemical sensitivity," (Annals Intern Med, 1993;19: 97-103) researchers say that immunologic testing did not differentiate patients with chemical sensitivities from controls, but such patients did exhibit a higher prevalence of current anxiety or depressive disorder (44 v 15%). These disorders did not appear to precede the onset of chemical sensitivity, and 25% of patients showed no current psychological disturbance. 25% of cases (no controls) satisfied criteria for somatization disorder.
Researchers conclude that psychological symptoms, though not causal, are a central component of chemical sensitivity.
Comment: It is interesting that a substantial portion of sufferers do not exhibit psychological disorders. For some insight into what behavioral factors may be at work in such patients see "Allergy-related quackery" (NY State J Med, 1993; 93:100-04) which describes how the power of the imagination, operant conditioning, and practitioner influence can reinforce imaginary sensitivities.
July-August, 1993 we reported that a lawsuit, filed by two UC Berkeley cultologists against the American Psychological Association and the American Sociological Association alleging that several top executives had attempted to destroy their careers through various improper actions, had been settled. We have learned that the case remains unsettled.
Full-page ads that appear to have been torn out of a newspaper (page numbers "D14" and "D15" appear along with the date "Thursday, April 22, 1993," but the top corner where the newspaper's name would appear is cut off) are hawking Prostata, a product that claims to prevent or treat prostate disorders and act as an aphrodisiac.
The product contains zinc and pyridoxine; the herbs: serenoa (aka, saw palmetto and hydrangea extract -- both diuretics)*, panax (aka, ginseng); amino acids: l- alanine and glutamic acid; bee pollen, and silica.
Familiar names and faces dot the ad. "Dr. KW Donsbach" is quoted as reporting on a double-blind study. A mug shot of "Dr." Earl Mindell appears. Also Dr. Hans Kugler (PhD[?]) who's been hawking anti- aging products for years in such publications as the Health Freedom News (ie, the "hang on to your wallet" news).
Prostata, a product of Life Force, Inc, (Cheyenne, WY) is listed in the FDA's publication Unsub-stantiated Claims and Documented Health Hazards in the Dietary Supplement Marketplace, July, 1993, that "demonstrates the pervasiveness of the problem posed by dietary supplements."
*Diuretics can create an illusion of effectiveness by increasing urination frequency or irritation.
In July, 1993, Paul E. Brown, MD, did a phone survey of 100 chiropractic offices in the Minneapolis- St.Paul area. Posing as a parent with a 4-yr-old child with ear problems, he asked five questions to office personnel or available chiros: Do you treat children? (99% yes) Do you treat ear infections? (80% yes) Do you treat allergies? (69% yes) Do you sell vitamin supplements from your office? (78% yes) Do you do applied kinesiology (21% yes)
Some chiros told him that the first cervical vertebra is often out of place and that this affects nerves and blood so that ear problems occur. Others said that dietary practices such as using cow's milk leads to excessive mucous which contributes to the problem.
For further information, contact: Paul Brown, MD, Park Nicollet Medical Center, 14000 Fairview Dr, Burnsville, MN 55337.
The Institute of Food Technologists (IFT) have submitted commentary on the scientific issues raised by HR 1709, Richardson's Dietary Supplement Health and Education Act of 1993 (companion to Sen. Hatch's bill) which provides details as to why supplements should not be permitted to by-pass established FDA procedures for assuring safety and efficacy for health claims. The 12-page document provides information of substance for anyone desiring details on why the Hatch-Richardson legislation should be defeated.
Acting Commissioner Richard Schrader announced on October 27 that the New York City Department of Consumer Affairs was charging seven diet-pill companies with "telling fat lies in magazine and newspaper ads." Among the phone claims were: "the power to block the absorption of calories and the guarantee of effortless weight loss even while continuing to consume a diet rich in fat and calories."
Six of the seven ads were found in national women's magazines, one was in a supplement to the Daily News. The companies and products charged were: - Hanover Labs, Inc. Livingston, NJ (Lipo/trim) - Martrim, Lawrence, KS (Martrim) - Prolab Nutrition, Berlin, CT (Tight and Firm capsules) - Universal, New Brunswick, NJ (Tone 'N Tighten anti- cellulite formula - Body by Jay Fitness Enterprises, Santee, CA (Fat Burning System) - America's Best Nutritionals, Destin, FL (Trim Now) - World Wide Marketing, Hollywood, CA (Nutra Trim 7)
The companies have been directed to contact the department's legal division to answer the charges. They face substantial fines for multiple violations plus the costs of investigation, and will be expected to agree to desist from further violations. Contact persons: Linda Sachs or Pat Cohen at 212-487-4270.
The University of Colorado Board of Regents has announced that it will conduct an inquiry into the teaching of Therapeutic Touch (TT) by its School of Nursing. TT has been under public scrutiny by the Rocky Mountain Skeptics (RMS), a nonprofit group, for the past two years. RMS is concerned about the make-up of the board of inquiry because several TT proponents have been included on the board of inquiry. RMS fears that proponent's influence may dilute or stymie efforts to hold nursing education to a scientific standard in this matter.
The board's findings could establish a landmark in the standards of quality assurance in health care. RMS failed to stop the acceptance of TT course work for continuing nursing education by the Colorado Board of Nursing in 1992, but succeeded in focusing public attention on this dubious practice. For more information contact Bela Scheiber, RMS, Box 7277, Boulder, CO 80306; 303-444-5368