Omnitrition International, Inc. (OI), a multilevel marketing firm that sells "designer foods" and "nutrients for the brain" is the target of two class action lawsuits in U.S. District Court in San Francisco alleging securities law violations, conspiracy and racketeering.
The actions have been filed by former OI distributors on behalf of 100,000 people who sold the products. The suit alleges that distributors have lost more than $75 million since 1989 because the company overestimated their earnings potential. Omnitrition sells powdered drink mixes and vitamins -- some laced with ephedrine or caffeine -- touted by Durk Pearson and Sandy Shaw who wrote the book Life Extension. Pearson was a frequent guest on the Merv Griffin Show during the 1970s. (Contra Costa Times, 4/16/93)
Dr. Victor Herbert, in collaboration with Simopoulos and Jacobsen, have authored a book, Genetic Nutrition (Macmillan, 1993) that documents the important disease-producing interplay between predisposing genes and lifestyle factors. Genetics have been largely over-looked by the popular press in its enthusiasm to get out information on lifestyle factors and disease.
A national study by the National Center for Chronic Disease Prevention (a part of the national Centers for Disease Control and Prevention) involving more than 11,000 Americans showed that those who took vitamins had the same risk of dying as those who did not. The report appeared in the American Journal of Public Health, 1993;83:546-550). [We'll bet that people won't be seeing this report in the vitamin ads!]
Apparently taking a cue from the public relations value of the NIH Office of Alternative Medicine, Senator Hatch now wants an NI H Office of Dietary Supplements. The NIHODS (odious?) would initiate and coordinate research on dietary supplements and advise the H&HS Secretary on supplement issues. Dietary supplements would include vitamins, minerals, herbs, amino acids, or "another ingredient" (you name it!) for use by man to supplement the diet.
Comment: This incredible suggestion takes the veneration of supplementation to a new high. Not only do the health hucksters want to be exempt from all reasonable regulation, they want their products enshrined in the National Institutes of Health. Senator Hatch, and his co-conspirator in the House of Representatives, New Mexico Congress-man Richardson, are going all-out for the healt h food industry special interest groups, not just to help them fleece the public financially, but to put their health at risk as well. Shame, shame on them.
Adults with unconfirmed food allergies who often complained about foods not usually known to cause allergies may have been influenced by the news media, according to a study reported in the Journal of the American Dietetic Association (January, 1993).
The researchers, from the University of Toronto's Dept. of Nutritional Sciences, say that those with imagined allergies may be at some nutritional risk because the suspected foods were mainly from the vegetable, fruit, and dairy food groups. Many people wit h unusual food allergies had consulted questionable health care providers such as herbalists and naturopaths, or had read popular health books in the lay press.
The problem of what actually constitutes an expert witness in court cases dealing with scientific questions, a problem addressed in Peter Huber's book Galileo's Revenge, has attracted the attention of the U.S. Supreme Court.
The case involves the drug Benedectin (two parents are suing Merrell Dow) and who is qualified to testify as an expert witness. In order to prove harm the court demands scientific evidence. Although animal studies show birth defects from high doses, 30 published studies, one by the Centers for Disease Control and Prevention, have found no problems. A California health worker, Shanna Helen Swan, claims that the epidemiological studies are too weak to find the harm, but that she estimates that the drug can cause limb reduction in 1-in-1000 babies born to mothers using it and 20 to 30 defects per 1000 of defects of all kinds. Her study was presented orally before the Society for Epidemiological Research in 1984, but never published. As a result, two U.S. courts have rejected it as not credible. The U.S. Supreme Court will decide how to judge the quality of an expert's expertise. (Science, 1993;259:588-90)
So-called "smart drugs" are supposed to enhance mental performance. Apparently, some of the people who use them are in some need of increasing their brainpower, at least when it comes to exercising good judgment. Some of the drugs are used to treat people with senile dementia, but there is no evidence that they will make normal people's brains work any better. An article in the April 1993 FDA Consumer provides useful information suitable for a public information or school class handout on this topic of alleged "smart drugs."
The February issue of the New York State Journal of Medicine (vol. 93) is dedicated to health fraud and quackery. A total of 14 articles and commentaries are included.
Four articles are written by NCAHF officials, and several others by NCAHF members. Specific topics covered are AIDS fraud, allergy-related quackery, cancer quackery, questionable nutritional therapies, health foods and supplements for the elderly, sports nutrition fraud, dental quackery, and unproven arthritis remedies. Other articles deal the history and psycho-social dynamics of quackery, and how to combat it.
The New York Times (4/27) reported that a study was done on monkeys in which dental fillings were placed that allegedly led to decreased immunity. According to Drs. John Dodes and Marvin Schissel, the research is highly suspect.
The lead authors, Vimy and Lorscheider, have spent much of their careers trying to prove that dental fillings are dangerous. Their previous research efforts have not been replicated, have been criticized for flawed methodology and inappropriate conclusions, and have been contradicted by the American Dental Association and dental scientists. Their current study is flawed in that monkeys are used as human analogues, but monkeys do not eat fish the major source of human exposure to mercury. Vimy and Lorscheider's previously disproved assertion of the amount of mercury vapor released in the mouth was used as standard, and other of their discredited researc h was used as citations.
According to a brief report in the British Medical Journal(1993;306:951), about two-thirds of family health service authorities, general practice fundholders, and district health authorities see a place for complementary treatments in the National Health Service (the UK's health care system). In general, there was more approval for homeopathy, acupuncture, chiropractic and osteopathy than for aromatherapy and reflexology, the report said. NHS Director, Philip Hunt, stated that the NHS is in favor of offering a range of complementary therapies but that "it is essential that we have credible evidence of their efficiency and effectiveness."
Comment: This survey is interesting, but reveals something other than scientific criteria are being applied. "efficiency and effectiveness" probably means what we in the USA term "cost-effectiveness." This is not the same as clinical effectiveness. For instance, it may be cost-effective to send workers compensation cases of low back pain to chiropractors if their charges are reasonable and they do not over treat.
Self-limiting low back problems will go away in time by themselves. In the meantime the chiropractor may provide temporary relief. Medical care may accomplish the same thing, but at a higher cost. Third party payers have a vested interest in promoting nonscientific care that helps them contain health care costs.
The question is, can complementary medicine be limited to such a benign role, or will its practitioners take advantage of patients by converting them to off-beat health care philosophies which may be hazardous if and when serious illness strikes. We continue to see cancer patients mistreated by true-believing health care providers whose ideologies blind them to reasonable limitations.
The popular athletic performance aids N,N dimethylglycine (DMG) and L-carnitine were reviewed in July-August, 1992 Annals of Pharmacology (26:935-7). DMG is not recommended because of its mutagenic and carcinogenic potential. L-carnitine supplementation may have beneficial properties but insufficient information is available and its use is not recommended until its value is proved.
JAMA (1991;269:2116-21) has a report by an NIH team from the Office of Medical Application of Research that studied 17 cases between 1980-9 in which an insurance company was sued to reimburse a patient for an "unproven or questionable healt h technology" (aka, quack medicine).
Fourteen of the suits were decided in favor of the patient! Six cases are discussed; 2 involving laetrile, 2 immunoaugmentative therapy, and 2 thermography. The circumstances determining how the courts arrived at unscientific decisions fell into three general categories: (1) legal contract interpreted in favor of the insured; (2) reluctance or inability of the court to use published scientific literature; (3) use of adversarial "expert" witnesses with potential conflicts of interest.
To address this situation, the authors urge that: (1) the legal and insurance industries cooperate in improving contract language in a way that would be legally and scientifically appropriate; (2) the courts foster the use of published peer-reviewed scientific material as evidence whenever possible; and, (3) the courts choose their own unbiased expert witnesses to interpret scientific material.
Comment: This is a very significant article because it documents the failure of the courts to uphold science and responsible medicine in health care. It also provides information that ought to be heeded in the design of a national health care program such as is currently underway in Washington. It is encouraging that this was done by an NIH office which could influence the NIH Office of Alternative Medicine.
Americans have been swamped by a barrage of positive publicity promoting the alleged benefits of mind-body related "alternative medicine." The organization behind this propaganda effort is the Fetzer Institute of Kalamazoo, Michigan.
Fetzer describes itself as a "nonprofit educational organization that promotes research into health care methods that utilize the principles of mind-body phenomena." Fetzer supported the New England Journal of Medicine article "Unconventional medicine in the United States" (1/28/93). The article was ill-conceived in that it overstated the popularity of unconventional medicine by defining it too broadly, which seemed to portray a "band-wagon" illusion for unconventional medicine. The main author was Fetzer Institute Fellow David Eisenberg, MD. It only is part of a mosaic being orchestrated by Fetzer.
In February, PBS aired a 5-part series called "Healing and the Mind" narrated by Bill Moyers. The series was funded by the Fetzer Institute and David Eisenberg served as the principal consultant, appearing at-length on camera. Eisenberg is also an advisor to the new NIH Office of Alternative Medicine. An article in USA Today has noted that Eisenberg hopes to create a teaching center "dedicated to the rigid assessment of unconventional therapies." NCAHF's concern is the past history of mind-body devotees who pay lip-service to subjecting their methods to the scientific method, but proceed to the commercial promotion of such procedures while evidence is lacking.
NCAHF also questions what Fetzer means by "mind-body phenomena." Regular medicine has acknowledged the powerful role of the mind on the body for more than a century. The specialties of psychiatry, clinical psychology, behavioral medicine are examples of this. Mind-body conversion illness is well-established in psychosomatic medicine.* And, the phenomena of hypnotically-induced blistering, wart disappearance, stigmata (the spontaneous bleeding resembling the wounds of Christ), psychogenic paralysis, infertility, et cetera, are better documented and more impressive than anything we've seen from within "alternative medicine."
We suspect that what Fetzer is talking about is not the "mind" in terms of psychobiology (ie, brain functioning) but a transcendent metaphysical concept of "mind" (ie, soul or spirit). "Alternative medicine" theories founded upon the existence of a transcendent soul are ayurvedic medicine (prana), Chinese medicine (chi), chiropractic (the Innate), energy medicine (bioelectricity), homeopathy (Vital Force), naturopathy (Vis Medicatrix Naturae), Scientology (Thetan), Therapeutic Touch (prana, again).
Historically, ever since the affront of Darwin's Origin of the Species, there has been an intellectual effort to prove that man was more than simply the highest rung on the evolutionary ladder. Traditionally, efforts to disprove Darwin centered on establishing the existence of a transcendent human soul. Experiments were conducted in which dying people were placed on sensitive scales in an attempt to weigh the soul as it departed the body. What at first seemed to be proof turned out to be the effects of dehydration and/or muscular contractions during rigor mortis.
When photography was new, double-exposures showing deceased people in the same pictures as loved-ones passed for evidence. J.B. Rhine's studies into ESP were prompted by the search for a human soul. More recently, near-death experiences recounted by resuscitated people have been offered as proof of "life after life." Spirit channelers and past-life psychotherapists also work this arena of human curiosity. Eisenberg mentioned on the Bill Moyers PBS show that losing his father at age-4 had dramatically influenced his curiosity about death. One got the feeling from what he said that the loss traumatized him psychologically and now drives him to explore metaphysical propositions.
NCAHF does not object to true scientific research into these alleged phenomena, but we have learned that many who claim to be studying such things are true believers who are merely trying to use the prestige of science to advance their personal ideologies.
*On the positive side, Consumer Reports (2/93) contained "Can your mind heal your body?" which reviewed procedures used in avant garde, mainstream psychiatry/behavioral medicine, said to be largely adapted from Mind-Body Medicine by Consumer Reports Books. Although the article made no mention, the book thanks the Fetzer Institute for cooperating and supporting its planning and development.
During the last part of March proponents of "alternative" medicine reportedly met with representatives of the Clinton Administration to discuss cost-effectiveness. The question of whether or not nonscientific medicine could save health care dollars is likely to yield some surprising answers.
We facetiously stated during the Presidential primaries that Jerry Brown's advocacy of acupuncture and chiropractic could indicate a strategy of lowering the nation's life expectancy to about 68 yrs whic h would save billions in Social Security payments. Shunting cancer, heart disease and AIDS patients off to ineffective therapies would shorten their lives and save money. Further, if the ineffective therapies involved low-technology, the overhead could also be greatly reduced. Best of all, if the procedures were hazardous, such as toxic herbals, colonics that could upset electrolyte balance, spread infectious, or cause septicemia, the demise of terminal patients could be hastened.
This recalls an episode in the first TV series of The Untouchables. One of Capone's henchman stated that a bothersome competitor could be put out of business in a matter of weeks by a nonviolent means. Frank "The Enforcer" Nitty replied that permitting the competitor to continue operating for a few more weeks would cost the Capone organization several hundred thousand dollars. Throwing two bullets on the table Nitty stated, "its a question of economics; two of these only cost 15 cents!"
In fact, one of the most outrageous abuses NCAHF has ever uncovered was a situation where a nurse was referring AIDS patients to a nearby quack clinic on the rationale that their care would be cheaper (dietary supplements instead of AZT) and that they would likely die sooner thus relieving the health care system of their burden. One cannot argue with her economics, but we found the reasoning morally repugnant.
The downside is that quacks are generally quite expert at milking the system. Chances are that they would find wonderfully creative ways to drain the system and cancel out the savings. The instruction manuals gathered from chiropractic practice-building seminars are clear evidence that some nonscientific health care providers work hard at learning how to milk the system. Another problem is that the public expects health care to be safe and effective, the proof for which literally defines the scientific aspects of consumer protection law.
Essiac is a tea made from Indian rhubarb, Sheepshead sorrel, Slippery elm and Burdock root. For more than 60 years it has been promoted as a cure for cancer. Several investigations of the drug have indicated that it has no demonstrable effect on cancer.
The herbal tea is believed to have been originally made by Indians in northern Ontario, Canada. Around the turn of the century, a non-Indian woman claimed that the tea cured her breast cancer. In 1922, the woman is said to have passed the recipe along to Renee Caisse, a public health nurse working in Haileybury, Ontario (Essiac is Caisse spelled backwards). Several years later, Caisse claimed to have cured a relative with terminal cancer using the tea. For some time she operated a clinic in Bracebridge, Ontario, where she dispensed Essiac. The authorities did not interfere with her work because she provided the recipe without charge, and limited it to people who believed their cases were hopeless.
Before her death, Caisse gave the recipe to the Resperin Corporation, which submitted a Preclinical New Drug Submission (PNDS) on Essiac to Health and Welfare Canada. Two hospitals were selected for a clinical trial, but neither were willing to treat a group of cancer patients with Essiac alone. Instead, it was decided to let family practitioners supervise Essiac treatment for terminal cancer patients.
In 1982, 112 physicians were asked to submit case reports. Seventy-four responded with information on 87 cancer patients. Of these, 78 showed no benefit. Investigation of the 9 remaining cases revealed that 2 had died, cancer was progressing in 4, and 3 had stabilized. Of this last group, all had standard treatments which could be expected to have stabilized the disease.
As a result of this review the PNDS was revoked. In 1983, the U.S. National Cancer Institute tested Essiac and found no significant anti-tumor activity.
For these reasons, Health and Welfare Canada does not permit Essiac to be marketed as a drug. However, since the tea has not shown any harmful effects, the agency has historically authorized emergency releases of Essiac on compassionate grounds when desperate cancer patients ask for it. This is the status of Essiac as of March, 1993. (Source: Health Protection Branch, Heal h and Welfare Canada)
The Essiac story resurfaces periodically in the newspapers and on media talk shows. The reason seems to be that it makes a great story. Indian medicine cures (including some made of tobacco!) were the most popular during the time known as the "Golden Age of Quackery" when patent medicines abounded unchecked by consumer protection laws. Medicine showmen also often used the Indian medicine ploy. These stories are enhanced by the testimonials of people whose cancers seem to have been arrested.
The realities are that cancer patients have varying survival times. Any remedy that is used by a large number of patients can be expected to be used by someone who is a long term survivor. It is understandable that they would attribute their good fortune to an unusual remedy (just like when someone turns 100 years-old and is asked to what do they attribute their longevity). We need to understand that such people are not deliberately lying, they simply are letting coincidence pass for good evidence.