Treatment with freeze-dried lyophilized fetal cells from sheep failed to improve children with Down syndrome. This type of cell therapy is not legally sold in the U.S., but it can be obtained by mail from foreign countries. A study of 190 people with Down syndrome uncovered 21 who had been given cell therapy. Comparisons with a group of untreated patients found no improvement in height, IQ, motor skills, social behavior, language or memory--all of which promoters claim may be helped by cell therapy. (Pediatrics, 85:79, 1990).
An article appearing in the American Druggist (3/90) reveals the impact negative publicity by a consumer group can have on a product. The Viralizer is a device that delivers heat and medication (sort of like a hair dryer with a medicant) to the nose for relief from colds, sinusitis, allergies and sore throat. A critical article appearing in the January, 1989 Consumer Reports condemned the device as having less value than chicken soup. The impact upon sales was devastating and 1988 sales of $2.3 million shrank to $800,000 in 1989. Another example of the impact of negative publicity on dubious medical care is reported by Kentucky physician Walter Stoll in the December, 1989, Townsend Letter for Doctors (a publication directed at maverick physicians). Stoll claims that "black P.R." spread by the state licensing board has caused his income to fall below what he can live on. Stoll presents a graph showing his gross income and how it fell following a negative article in July, 1987. Stoll did not reveal that the article reported the licensing board's decision to issue a complaint for Stoll's "personal drug use and prescribing to an addict" (Lexington Herald Leader, 7/17/87).
The marketplace seems to be experiencing a kind of "patent medicine deja vu." Patent medicines were popular scams in the last century. The NCAHF Task Force on Ergogenic Aids reports that advertisements are again extolling products as "patented," thus conveying the idea that they are effective. Communication with the Attorney for the Assistant Commissioner's Patent Office in Washington, DC, revealed that patent requirements are only that the product's ingredients are distinguishable from other patents on file. No proof of efficacy is necessary; just a reasonable "association between the product ingredients and its claims." Two companies that have used the patent ploy are Advanced Sports Nutrition in its promotion of Maxxon, and The Winning Combination in its advertisements of Oxy-Energizer. Maxxon is a patented formulation of branch-chained amino acids with carnitine and glutamine. Advanced Sports Nutrition does not provide any company research to substantiate its claim of "enhancing skeletal muscle adaptation to exercise training." It merely reiterates theoretical rationale and published research of questionable worth. Oxy-Energizer is patented as a novel hormonal composition, particularly concerned with cortisone or hydrocortisone and certain derivatives thereof. The product's main ergogenic (performance) aid is a blend of potassium, magnesium, and aspartic acid. The company apparently used outdated, poorly controlled studies to claim that aspartic acid can conserve cellular energy, and omitted more recent contradictory research.
Ian Lundman, 11 years old, died of untreated diabetes on May 9, 1989. The boy's mother Kathleen McKown and step-father William McKown, life-long Christian Scientists elected to have Ian treated by Christian Science Practitioner Mario Tosto when he became ill with what appeared to be minor symptoms. The parents and Tosto were charged with manslaughter for failure to properly care for the child. On March 27, Hennepin County (Minnesota) Judge Eugene Farrell dismissed the charges against Tosto, and did the same for the parents on April 2. The reasoning reportedly was the twisted notion commonly seen in such cases that parents who kill their children should be pitied for their great loss. The Judge also indicated that the McKown's conduct did not meet the legal standard required to charge someone for the crime. (Minneapolis Star-Tribune, 3/28/90 & 4/3/90.)
Dr. Stephen Barrett says that society can do a few important things to help lower faith healing's toll:
These recommendations appear in an excellent short review of faith healing under Dr. Barrett's section "Quackwatch" in the ASCH publication Priorities (Spring, 1990).
NCAHF has been informed that the U.S. Department of Education will no longer officially recognize an accreditation agency for naturopathic medical education. We wish we could report that this decision was based upon naturopathy's scientific shortcomings, but the reason appears to have been political. An association of naturopaths whose degrees are of dubious origin have banded together to oppose the formalization of naturopathic education. Of course, it was precisely these diploma mill practitioners that naturopathic reformers wished to put out of their guild. They simply ran into the dilemma of there being a substantial group of practitioners who can also lay claim to the title "naturopathic physician" under present conditions. The maverick group's objection to recognition of the Council on Naturopathic Medical Education apparently did in its approval.
The American Cancer Society has revised and updated its highly informative statements on a number of dubious cancer therapies. NCAHF has the following:
Copies may be obtained free from your local ACS office, or by sending $1 (per reprint) and a business-sized SSAE to the NCAHF Resource Center or Main Office.
Ontario (Canada) Member of Parliament, Margaret Marland, has called for a ban of a self-hypnosis (subliminal) tape that tells sexual-abuse victims that they are paying the price for their own actions in past lives. Barry Konicov, a self-described hypnotist based in Grand Rapids, Michigan, markets the tapes under the Potentials Unlimited, Inc., label. Konicov describes the experience of a woman who was raped by her husband. She found that she had been raped in a past life when she was a plantation slave, and had later killed her rapist. "This woman received no punishment then for killing the overseer; however, in this life, she married the same man, subconsciously, he wanted her to kill him again so that this time she would be punished." Once the woman reached this conclusion, "she forgave herself for her part in the experience." Consumer Affairs Minister Greg Sorbara also finds the tapes offensive, but doesn't know whether he has the power to ban the tape. He prefers to discredit it instead. (Toronto Star and The Globe and Mail, 5/4/90.)
Comment: Although there is no information linking Potentials Unlimited to Scientology, the notion that negative experiences from past lives are transferred to become the basis for hang-ups in this life is central to Scientology's belief system.
In its chiropractic position paper, NCAHF recommended that in order to facilitate reform chiropractic training should be incorporated into regular accredited universities that train scientific health care providers. NCAHF still takes the position that this is an essential need. In the Sept-October, 1989, issue of this newsletter we reported on efforts by Canadian Memorial Chiropractic College to affiliate with the University of Victoria. We realize that this will not be easy to accomplish since there will be resistance from both sides. Sheila Taub, JD, a member of the University of Bridgeport Law School (Connecticut) gives six reasons why her University should not start a chiropractic college in the January 25, 1990 (3:(2):4-5) issue of Forum, the newsletter of the American Association of University Professors. Briefly, the reasons Taub cites are:
Comment: NCAHF would not disagree with any of Taub's points. We only would support a scientifically-founded form of chiropractic, which would probably be centered around caring for functional back disorders ("functional" meaning pain and impaired motion due to physical or psychological stresses, not disease or severe trauma). We see value in manipulative therapy in sports medicine, back care centers, ergonomics, and related areas. We can appreciate the reluctance of a university to incorporate chiropractic into its program. It would have little to gain and would suffer from the stigma for a time. However, we believe that both society and chiropractic could gain a great deal.
FTC FINES PROGRAM-LENGTH COMMERCIALS PROMOTER
The FTC has obtained a consent agreement with Twin Star Productions, Inc., a Texas-based company, to stop making unsubstantiated efficacy claims for its products or services. The company used program-length commercials ("infomercials") to promote a weight-loss product "EuroTrym Diet Patch," a baldness product "Foliplexx," and an impotency product "Y-Bron," in a false, misleading and deceptive manner. Under the terms of the agreement, Twin Star will pay one million dollars, and Jerald H. Steer, Allen R. Singer, Douglas E. Gravink, Peter Claypatch, and Steven L. Singer, all of whom are based in Scottsdale, Arizona, will pay a total of $500,000 in consumer redress over an 18-month period. The investigation was handled by FTC's Seattle Regional Office which is under the direction of Charles A. Harwood. The FTC release stated that this action demonstrates the agency's concern with two important areas: deceptive claims for health products and deceptive program-length commercials. Texas Attorney General Jim Mattox also announced an agreed order against Twin Star and one officer settling similar charges. For information contact Assistant Attorney General of Texas, Craig Jordan at (214) 742-9698. [FTC News Release, April 17, 1990]. (Also see FTC consumer education flyer Program-length TV Commercials, July, 1989).
California's Board of Registered Nursing (CBRN) gives continuing education credit to RNs for attending a seminar on crystal healing. This is the same board that gives credit for nurses to visit the Mexico cancer clinics that dispense therapies which are illegal in its own state. When asked to justify giving nurses credit for studying pseudomedicine, a CBRN representative stated that nursing was an art, not just a science. We knew that, but we also expect nurses to know how to tell the difference between quackery and methods that offer emotional support and comfort.
The Ohio legislature has passed a new child neglect law that defines failure to provide necessary medical care as child neglect that must be reported. A threat of harm to the child's health must also be reported. Christian Science practitioners are included on the list of those who must report children in need of attention. This is a major victory for children's rights in a state that has been badly embarrassed by its past record. C.H.I.L.D. (No.1, 1990) reviews the seven-year struggle by children's rights advocates.
NCAHF does not consider erroneous self-treatment to be quackery. Only the commercialization of remedies that do not meet safety and efficacy standards deserve that label. An unusual example of herbal quackery can be seen in Utah where plant nurseries are selling toxic herbal plants for people's gardens with instruction on how to make tea from them. Included are dangerous plants such as foxglove and comfrey.
James O. Mason, MD, Assistant HHS Secretary, announced on April 26 that a review of the much-publicized (premature) finding that high doses of fluoride had caused bone cancer in rodents has judged the research results to be "equivocal" in male rats, and of "no evidence" in female rats, and both genders of mice. Dr. Mason states that there is no indication of a need to change any Public Health Service policy of continued support for the use of fluorides for the prevention of tooth decay. The terms "equivocal" and "no evidence" are drawn from five descending categories used to evaluate research results: "clear evidence," "some evidence," "equivocal evidence," "no evidence" and "inadequate study." [HHS News Release, 4/26/90; contact person: Jim Brown (202) 245-6867.]
Treating Arthritis: Medicine, Myth and Magic, by Felix Fernandez-Madrid, MD, PhD, is a much needed book that explains the diseases we know collectively as "arthritis," provides readers with the tools they need to protect themselves from quackery, and educates about modern arthritis treatment. The publication lives up to its billing as the "alternative to quackery." It is published by Plenum Press (1989) and costs $22.95 (cloth, 300 pp). Order from the author at: The Center for Rheumatic Diseases, Hutzel Hospital 5-W, 4707 St. Antoine, Detroit, MI 48201; shipping $2.40; Michigan residents add 4% sales tax.
Albuquerque Journal reporter Tamar Stieber, 34, won a Pulitzer prize for stories that linked the dietary supplement L-Tryptophan to EMS. Stieber's stories called national attention to the problem. She faced the threat of a lawsuit and initial skepticism from the medical community when she connected the supplement with the rare blood disorder. Ms. Stieber's publisher described her reporting as "gutsy." She is a graduate of UC Berkeley, and Rockland Community College in New York, and previously worked at two California newspapers in Vallejo and Sonoma. (Albuquerque Journal, 4/13/90.)
The American Council on Science and Health has funded a special report: Quackery and the Elderly written by James A. Lowell, PhD (NCAHF Vice-President) and Alison Lowell, MS. The report describes methods used to sell questionable products and regimens, identifies sources of unreliable health information, suspicious diagnostic tests, therapies, and products aimed at the elderly. This useful report helps to fill a serious need for information in combating quackery aimed at the elderly. This problem has not received the attention it deserves considering the fact that the U.S. Senate determined in 1983 that quackery was number one among ten most harmful consumer frauds directed at the nation's elderly and the U.S. House estimated in 1984 that the elderly alone were wasting $10 billion annually on quackery. The report costs $3; order from: ACSH, 1995 Broadway, 16th Floor, NY 10023-5860.
In 1987, the State of California charged Great Earth International, Inc. and others (including Earl Mindell) with acts of unfair competition in the promotion of a number of products falsely advertised to have therapeutic effects. Included were: vitamin E, Yeasterol, PMS Formula, Lowesterol I, II, III, Elavita Formula DP, Nutrimmune, Interleukin 2, Thymosin, and Rejuveacell. Some of the defendants (not including Mindell) settled for $109,520 without admitting wrongdoing, but promised not to do it anymore (see NCAHF's opinion of consent agreements under "Common Sense, Justice & Quackery," Nov-Dec, 1989 NCAHF Newsletter). [Case No. 528577, Superior Court, Orange County, California.]
What do food allergies, candidiasis hypersensitivity (yeast infection), hypoglycemia, environmental hypersensitivity disorder, TMJ problems, and other maladies that make the sufferer miserable, but seem to defy diagnosis have in common? These are psychiatric disorders that have been with mankind as long as written information has been kept. The ancient Egyptians and Greeks called the problem "wandering of the womb" (hysteria = uterus, hence "hysteria"), in the last century "neurasthenia" was the diagnosis. Donna Stewart, MD, DPsych., FRCP, reviews various psychiatric disorders often misdiagnosed as allergies, sensitivities, and the like, as a preamble to a descriptive study of 50 patients alleged to be suffering from "environmental hypersensitivity disorder" referred for psychiatric assessment between 1985 and 1987 at St. Michael's Hospital in Toronto. Most patients (62%) first suspected their diagnosis based upon popular media reports. Eighteen percent were advised by relatives. Eighty-eight percent had their maladies confirmed by a physician, most of whom practiced "alternative or holistic medicine." Dr. Stewart offers a penetrating, insightful discussion of the personalities of individuals who are most susceptible to these dubious diagnoses. Read the entire report in Psychosomatics, 31:(2):153-158, Spring, 1990.
Consumers and third-party payers should be alert to abuse of thermography as a diagnostic test. Thermography involves taking a picture with a heat sensitive lens that converts infrared energy into a visible picture. Although thermography has legitimate military and industrial uses, its applications to medicine are quite limited. The medically-related limitations of thermography and current abuses are described in two articles in the November, 1989, issue of For The Defense, publication of the Defense Research Institute.
An important decision by the Chancery Court of Jackson County, Mississippi has strengthened efforts against abuses within chiropractic. Long-time readers of this newsletter will recall our report (Jan-Feb, 1989) that the Mississippi State Board of Chiropractic had attempted to thwart peer review by chiropractors working as consultants to insurance companies by imposing difficult requirements and harsh penalties for reviewers. The Board threatened license revocation for any DC who acted as an insurance consultant for the purpose of altering or reducing claim payments. Danny Futch, DC, challenged the Board's policy and obtained a permanent injunction against the rule on March 19, 1990. This very important court decision leaves in-place one of the most effective methods for curbing abuses by DCs. (Case No. 53,389).
The Oregon Workmen's Compensation program paid the state's roughly 1,000 DCs $33 million in 1988. Chiropractic care was 2.5 times more expensive per case than other providers. This finding has shocked Oregon legislators into reforms that will tightly limit the amount of chiropractic care the state will pay for. A plan that seems to be headed for passage would limit the time that a DC may serve as "attending physician" to 30 days. This means that for a DC to continue treatment beyond 30-days would require a prescription by an MD or DO. (The Oregonian, 4/5/90.)
Comment: Oregon DCs appear to be victims of their guild's penchant for over treatment. Chiropractic practice-building seminars mainly teach how to promote long-term care. This is usually predicated on the erroneous founding theory of chiropractic that spinal manipulation will correct "subluxations" and that will lead to normal "nerve flow" which will enhance overall body health. The clinical realities are that the only real benefit of spinal manipulation therapy is that, when it works, it brings more rapid relief to back pain than other methods. It has no long-term advantage. Since its benefit is rapid recovery, the proposal to limit DCs 30-days to perform makes sense.
Oregon has charged 3 chiropractors with theft, and 6 others for overbilling, in civil racketeering lawsuits. The actions came following a 5-month investigation in which the Department of Justice found $357,725 in over-billings. Since creating a Fraud/Investigations Division a year ago, the State has developed 12 cases which ended in judgments or settlements. (Joint News Release, 3/8/90, Oregon Department of Justice & SAIF Corp. Contact: Marla Rae, (503) 370-6002 or Allan deSchweinitz, (503) 373-8005).
The Minnesota Department of Human Rights ruled that two Twin Cities chiropractors acted illegally when they fired three employees after they refused to join the Church of Scientology. The department said that the former employees were exposed to Scientology materials and teachings at work to the point where it became a condition of their employment. Chiropractor Leonard Abel denied the charges saying that he himself is not a Scientologist, but that he only used management technology developed by L. Ron Hubbard, Scientology's founder. Investigator Cindy Greenlaw Benton stated that the practices were so closely related to Scientology that they were indistinguishable. (Minneapolis Star Tribune, 3/30/90).
Note: In the Jan-Feb, 1989 issue of this newsletter we reported on the David Singer Consultants, a Scientology-linked practice management firm that markets itself to chiropractors. Profiled in the American Dental Association News, (2/20/89) was another scientology-linked practice management firm aimed primarily at dentists, Sterling Management.
Rodney Dangerfield is not the only one not getting respect. Rationality and reason aren't doing very well either. What is most shocking is that the source of this disrespect is the U.S. Department of Education (USDE). Elsewhere in this issue you read that the USDE has voted not to continue recognition of an accreditation agency for naturopathic medical education.
During our inquiry into the matter, NCAHF's General Counsel Michael Botts was informed by USDE that scientific validity was not a consideration for recognizing an accreditation agency for schools training health professionals; their legality is all that matters. It further states that a system of health care need only be legal in a single state to qualify. Botts was informed that the USDE would recognize an accreditation agency for schools training astrologists if one were to apply (the example did not appear to be connected with the former First Lady's use of an astrologer, but who knows?). This revelation should shock anyone who believes that accreditation is supposed to mean something in terms of intellectual validity. Astrologists function as mental health counselors. Astrology is based upon a geocentric solar system, disproved notions about planetary influences and other fallacies. It seems incredible that the nation's foremost educational authority demonstrates utter disregard for the scientific method. The nation is in more trouble than anyone previously realized if scientific illiteracy has reached the point where even the bureaucracy no longer esteems the value of science. Menard said: "The development of the scientific method and the construction of the edifice of science are the greatest group achievements of mankind... Science is the only group activity that seems capable at present of indefinite improvement and advancement, because it builds upon a provable base." (Science, Growth and Change. Cambridge: Harvard U. Press, 1971). In terms of health care, science represents reason, rationality and responsible behavior, not elitism. The requirement that health care be safe and effective represents the expectations of consumers, and has been encoded into the U.S. Food, Drug & Cosmetic Act which requires that drugs and devices meet these standards. The FD&C Act controls, to a large degree, the tools of medicine. The history of the law demonstrates that scientific standards can be given the force of law.
Although we realize that schools teaching the arts and theology cannot be expected to meet scientific criteria, those that train health care providers can and should be. We further acknowledge that health care also involves the art of patient care, and have no problem recognizing the limitations of the scientific aspects of health care. No conflict exists between art and science within health care, conflict only emerges when testable procedures claim to be of value without suitable evidence. The present policy of the USDE is the most sinister threat to consumer protection NCAHF has yet uncovered within the Federal bureaucracy. It threatens to undermine the credibility of the accreditation process itself. If exploited by organized pseudosciences, the USDE policy will destroy the protection provided by laws that require health professionals be credentialed by institutions accredited by agencies recognized by the USDE. NCAHF believes that responsible citizens everywhere should demand that scientific standards be required of any agency accrediting a institutions that train people who will provide health services.
The marketplace abounds with self-help psychotherapy books. In 1981, the editor of Contemporary Psychology reported that 150 books arrive in their offices monthly, and that this represented 5% of all books published in America! Most, he says, are written by well-intentioned people, and often are "treatises on pastoral counseling." It is no wonder that the American Psychological Association (APA) felt the need to establish guidelines for evaluating self-help books. The chairman of the APA Task Force, Gerald Rosen, has made the difficult job of developing and refining functional guidelines his pursuit for several years. What has emerged is worthy of attention by all who value maintaining quality in the health marketplace. Paraphrased below are Dr. Rosen's splendid guidelines for reviewers:
These guidelines appeared in Contemporary Psychology, 26:(3):189-191, 1981. An updated report of how self-help treatment books fared when evaluated by these guidelines appeared in the American Psychologist, 42:(1):46-50, 1987. These articles will be of great interest to anyone interested in the enormous problem of the critical, objective evaluation of health books.
Comment: Dr. Rosen's guidelines provide a model for evaluating other types of self-help books (eg, diet, exercise, weight loss). The basic concepts of requiring that: (1) the program upon which the self-help techniques are based have empirical support; (2) a valid basis for self-diagnosis to determine the appropriateness of the plan for the reader be given; and, (3) the book's self-help program itself be tested for safety and efficacy; are fundamental to the principles of science and consumer protection law that NCAHF espouses.
Helen Irlen, a licensed Marriage, Family and Child Counselor from Long Beach, California, theorizes a condition she calls "Scoptic Sensitivity Syndrome" (SSS). She claims that 15% of the general population, and more than 50% of the reading disabled, suffers from SSS as diagnosed with the Irlen Differential Perceptual Schedule (IDPS). Irlen was twice featured on 60 Minutes demonstrating a dramatic improvement in oral reading fluency in children and adults by wearing tinted eyeglass lenses. A brochure published by an Irlen Clinic also claims "great relief," in some cases, for amblyopia, nystagmus and cataracts. Irlen Clinics are opening throughout the USA. A cadre of local screeners is being trained to feed the clinics with patients. Screeners are using direct mailings to schools and professionals claiming a "remarkably simple" cure for reading disability. Screeners charge up to $60 for their services. The total cost of diagnosis and treatment is approximately $565. Yearly follow up visits will add to this cost.
Although the proponents may be sincere in their beliefs, it is my opinion that the aggressive promotion of the Irlen approach is unwarranted based upon current evidence. Computerized searches of the scientific literature have failed to produce studies supporting SSS, although several critical reviews have been published. The psychological literature supports the effects of colors on some aspects of behavior. Flyers, shooters and skiers use yellow lenses to increase contrast, optometrists prescribe pink lenses to control reading glare, and spectrally modified lenses are prescribed to enhance visual performance in selected patients. On the other hand, it has been shown that the eye's autofocus system (accommodation) is blind to color, so tinted glasses should not help a focusing problem.
Testimonials, a clinical study, and several unpublished studies dispensed by the Irlen Institute note some positive effects, but to date, studies have NOT shown that:
SSS seems to be very similar to minimal binocular dysfunction diagnosed by behavioral optometrists. The term scotopic is a misnomer. Scotopic refers to dark adapted vision in which only the rods, which are insensitive to color, are active. Since decoding is a complex cognitive task which transcends vision and involves both auditory skills and higher level functions, it is hard to propose a mechanism for improved oral fluency based on the simple application of colored lenses.
In summary, it is my view that the claims of the Irlen Institute are extraordinary within the historical context of research of learning disabilities and dyslexia. Although their theory is interesting, SSS advocates should develop a broad base of clinical and experimental evidence before commercial promotion can be justified. I believe that parents should evaluate all of the alternatives available to them, including private tutoring, standard assessment and remedial procedures before allocating money, time and energy on any reading enhancement program.
Dr. Worrall is Assistant Clinical Professor, School of Optometry, UC Berkeley; Coordinator, NCAHF Task Force on Vision-Related Misinformation. (References available upon request.)