Varro Tyler, PhD, a pharmacognosist (expert in medical botany; aka phytomedicine), is one of the most credible writers on the medicinal use of plant substances. In "Should herbal remedies remain in FDA regulatory limbo" (Nutr Forum, Nov-Dec, 1992), Tyler describes the regulation of herbal remedies in the USA and Europe.
Tyler believes FDA should regulate herbal remedies as drugs, but adopt standards that are less stringent than required of new drugs. He says that herbal remedies should be reasonably proven both safe and effective, but that special consideration should be given to their long history of use and scientific and clinical literature which has accumulated in Europe. He describes the German Federal Health Agency's Commission E which has a system to glean data from practitioners, patients, clinical and pharmacological reports. Although not foolproof, the system is worthwhile from a regulatory standpoint.
In the USA, herbal remedies are sold as foods so long as they do not make therapeutic claims on their labels. Without label claims, no legal standards of quality exist or are enforced. As a result, consumers have less than a 50% chance that the herbs are authentic or contain an effective dose. A Canadian study of the herb feverfew found that no commercial product contained even half of the minimum amount of the constituent required for effectiveness. In the absence of labeling standards, health claims are being made in catalogs and books for herbal remedies whic h Tyler describes as "mostly pure hyperbole." Tyler believes that a more reasonable approach by FDA would benefit consumers by insuring standards of quality (identity and dosage) and by requiring accurate information on labels regarding benefits and risks. This would undercut the exaggerated claims now being made by promoters. The article profiles 10 useful herbal remedies.
More than 98% of foods (domestic & imported) either had no detectable pesticides (66.8%) or were below federal limits. Only 0.8% of domestic and 2.3% of imported samples were violative. Copies of the report, Food & Drug Administration Pesticide Program -- Residue Monitoring, may be obtained from Norma Yess, FDA, HFF-420, 200 C St. S.W., Washington, DC 20204.
Note. A useful tool for describing the actual size of residues comes from the book Innumeracy (a term denoting mathematical illiteracy). Using seconds as a standard the book points out that one million seconds = 11.57 days, one billion seconds = 31.69 years, one trillion seconds = 31,688 years. These numerical comparisons can help provide perspective for people trying to make sense of differences between parts per million, billion and trillion commonly used in residue testing and reporting.
A study done in Israel comparing the taste of organically versus conventionally grown plant foods has found no difference that could not be ascribed to degree of ripeness. (Basker D. Amer J Alternative Agri, 1992;7:129-136.) This finding is consistent with other studies done back when the organic craze first hit in the early 1970s. \
Thoracic Outlet Syndrome (TOS; which is characterized by subjective complaints of pain and other abnormal sensations in the neck, shoulder, arm, and hand) is a controversial diagnosis in clinical medicine which continues in spite of increased skepticism in the literature. Researchers examined the 1989 data in Colorado and determined that TOS surgery is heavily influenced by a patient's insurance coverage. The data show that those not covered are rarely diagnosed as having TOS. [Neurology, 1992;42:913-945] \
The cosmetic industry seems to be the last stronghold of alchemy when it touts special ingredients such as turtle oil, shark oil and royal jelly. Close behind these are the vitamins that lace cosmetic products. In obvious attempts to cash in on the public's love affair with vitamin supplements, advertisers tout vitamins to the point to cause one to ask if the products should be eaten. The FDA Consumer reprint "Cosmetic ingredients: understanding the puffery," reveals how little truth is required in cosmetic labeling.
Comment: Puffery is a regulatory euphemism for exaggerations permitted in advertising. The puffery allowed in cosmetic advertising seems to exceed by several magnitudes anything allowed for drugs. The poor regulation of cosmetics seems to reflect a Puritan value that vain people deserve to be cheated.
A lung cancer patient who paid Reno businesswoman, Vera Allison, $2,500 in cash up front for 3-hours of intravenous vitamin C & laetrile therapy dropped dead of cardiac arrest within minutes of finishing the treatment. Allison, who operates the GAM Nutritional Diagnostics Center, is under investigation by a grand jury. Reno police say that a search found no proof that a certified doctor or registered nurse worked at the clinic. (Reno Gazette (NV) 12/29/92)
Comment: This is a sad example of the gambler's fallacy (ie, there is nothing for a terminal patient to lose by trying a questionable therapy) at work.
According to an article in Nature (1992;359:469), the European Parliament has tightened its supervision of homeopathic products to bring them into line with a new system that will permit the free movements of medical products within the European Communities (EC). The action modified last year's controversial directive that would have exempted all products claimed to be homeopathic from the regulations applied to the licensing of rational pharmaceuticals. In Germany, it is reported that there are 22,000 homeopathic products registered using less rigorous criteria compared to 34,000 regular drugs.
Under the new rules, only homeopathic products of very high dilution (1 in 104) will qualify for the proposed simplified registration. The change is not acceptable to the European Federation of Pharmacology Societies which says that the directive lends credibility to homeopathic "medicines." It wants homeopathic products to be called "preparations" to distinguish them from real medicines.
The article notes that the "alternative" medicine lobby is strong in Europe. This is bringing science and pseudomedicine into conflict in the political arena. In Switzerland, the equivalent of US$4.5 million has been set aside to test "alternative" medicine. When EC funding of such projects was challenged by Finland as "unscientific," a compromise was reached and an "unconventional medicine project" was created under the direction of the deputy director of clinical research at Hoffman- LaRoche in Basel.
An evaluation of meditation as a reliever of anxiety or relaxation technique was evaluated by the Committee on Techniques for the Enhancement of Human Performance, a team put together by the National Academy of Sciences/National Research Council. The committee's 13-page report appears in In The Mind's Eye (National Academy Press, 1991).
In its conclusion, the committee reports that "no evidence supports the notion either that meditation reduces arousal any more than does simply resting quietly or that meditation permits a person to better cope with a stressor." The important question is raised about whether or not the beneficial effects of relaxation (such as reductions in blood pressure) continue throughout the rest of a person's daily activities once the meditation period is over. The report also goes into the allegedly paranormal feat of the yogis to remain buried for many hours without suffocating. This is accomplished by minimizing oxygen use through relaxation, a phenomenon achieved by self-confidence in the ability to do so rather than any special feature of meditation.
The report also discusses assertion that Kundalini Yoga can help develop "the soldier saint" in whom is instilled the superhuman desire and ability to excel in the art of warfare. This was deemed unsupported by sound evidence. The NAS report, In the Mind's Eye, focused upon the ability of various psychological self-help phenomena that claim to enhance human performance with a special interest in military applications.
Two cases of acute toxic liver hepatitis, in Texas and California, have been attributed to the ingestion of an herbal nutritional supplement product derived from the leaves of the creosote bush (aka, chaparral). Investigators at the Centers for Disease Control recommend that cases of adverse effects due to herbal products be reported to public health authorities to help track such harms. (MMWR, 1992;41:(43):812-13.)
On November 13, 1992, the U.S. District Court for the Eastern District of Michigan found Edward J. Sopchak to be in contempt of a January, 1990, Decree to stop manufacturing and distributing the unapproved drug Cancell. Sopchak was told that if he violates the injunction again he will face severe penalties, including incarceration.
Sopchak was ordered to cease taking orders and to notify all customers that he can no longer supply the drug. Two colleagues, Diane Petrosky and Bonnie Sue Miller were also warned to cease their violative activities. Sopchak promoted Cancell as a cure for cancer, AIDS, and other serious diseases. He declared that all symptoms of AIDS are gone in 28 days wit h Cancell.
[For more on the "discovery" and contents of Cancell see the NCAHF Newsletter, 1991;14:(2):3 (Mar-Apr).] For more information on the case contact FDA spokespeople: Compliance, John Klemmer, 313-226-6260; Consumer questions, Evelyn DeNike 313-226- 6158.
The New York Times, which in its own advertising prides itself on the reliability of its reporting, ran a front-page story on December 9, 1992 titled, "Pioneer in radiation sees risk even in small doses" by Matthew L. Wald. The study was described as being "independent" and "privately funded."
The American Council on Science & Health investigated and found that the source was an anti-nuclear group funded by court settlements from the Three-Mile Island incident, and that the story had been sent to the newspaper by a Philadelphia lawyer who specializes in environmental litigation.
The CC Pollen Company of Phoenix, Arizona, will pay $200,000 to settle FTC charges that its bee pollen products could cause consumers to lose weight, permanently alleviate allergy symptoms, cure impotence, and reverse the aging process. Promoters also falsely claimed that using their products could not result in allergic reactions. Some of the claims were made in infomercials that were misrepresented to be objective news or documentary programs. (FTC News, 12/30/92)
The D'Youville Nursing Center, a facility of Buffalo, New York's D'Youville College, has been awarded a $200,000 training grant to treat patients using Therapeutic Touch (TT) by the U.S. Dept of Health & Human Services' Division of Nursing. Paul Hageman, director of the center is a graduate of New York University, the main training ground for TT practitioners.
Nursing educators, Vern and Bonnie Bullough, describe the dubious nature of TT. Included are its basic assumptions which transcend science, the poor quality of its research underpinnings, and why some members of the nursing guild have strong reasons to want to believe in the metaphysical aspects of TT. This is an important article for anyone who is concerned about the erosion of the nursing profession by pseudoscience.
[Skeptical Inquirer (Winter, 1993) pp.169- 174]
On March 30, 1992, a Phoenix jury concluded that the Sunrider Corp. had violated Arizona's racketeering laws. Debi Boling, who had become ill, lost large amounts of hair, and had her teet h become discolored was awarded $50,000 damages (tripled to $150,000 under the racketeering law) plus $500,000 punitive damages after proving that she had been injured by a criminal act done with fraudulent intent.
Some ways that this successful multilevel marketing company misrepresents itself is described by Stephen Barrett in "Sunrider and the law," (Priorities, Fall, 1992). Included is an expose of misrepresentations by Tei Fu Chen, a company co-founder. Chen's own father exposed the falsehoods spun in "The Sunrider Story," a yarn which gloried the manner in which Chen supposedly learned how to formulate Sunrider products. Abuses typical of herbal multilevel marketing companies are described in this insightful review.
The New England Journal of Medicine (1993;328:246-52) reports on prevalence of use of unconventional medicine in the U.S. in a study done by researchers at Harvard Medical School and the University of Michigan Institute for Social Research.
The study involved a national random sample of 1,539 English-speaking adults. Although having some usefulness to those interested in health fraud and quackery, the study is greatly limited in its value because it defined unconventional medicine as "medical interventions not taught widely at U.S. medical schools or generally available at U.S. hospitals." Their 16-item list included: relaxation techniques, chiropractic, massage, imagery, spiritual healing, commercial weight loss programs, lifestyle diets, herbal medicine, megavitamin therapy, self-help groups, energy healing, biofeedback, hypnosis, homeopathy, acupuncture, and folk medicine (exercise and prayer were added from open-ended responses).
Many of these cannot be automatically equated with quackery or healt h fraud. Folk medicine, exercise or prayer are not generally regarded to be quackery, the self-help groups included Alcoholics Anonymous which, although not scientific, is not on anyone's quackery list we've seen.
Unfortunately, the media has already used this study to portray nonscientific health care as growing greatly in popularity and acceptance. In fact, this study seems to indicate a smaller increase in the use of nonscientific health care than we would have predicted. Quack remedies such as herbalism, homeopathy, and energy healing were used by only one percent of the sample which is not much different than twenty years ago.
We expect that this study will be misused to portray regular medicine as failing to meeting the country's health care needs because it is too scientific. This will be grist for the mill for nonscientific health care guilds which will be lobbying for inclusion as the Clinton Administration redesigns health care. The evidence shows that health care needs to be more scientific, and the accountability of providers increased.
Among the interesting findings were that individual expenditures for diet supplements at $228/yr, and over-the-counter megavitamins $203/yr (extrapolated to $1.2 billion and $0.8 billion respectively). These figures are considerably higher than the $25 per yr expenditures on questionable health products estimated by Louis Harris in 19871.
Particularly laudable was the recommendation that doctors should begin asking their patients about their use of unconventional therapy whenever they obtain a history. Researchers also encouraged scholarly research and education in the area of unconventional health practices.
We too, hope that this study will increase the awareness of the health care community, academia and public health that the use of nonscientific health products and services is worthy of their attention. Ten years have passed since the U.S. Senate declared that quackery was the #1 harmful consumer fraud problem affecting the elderly2, and 9 years since the Pepper Committee hearings estimated that the elderly wasted $10 billion a year on quackery3. Today we see one of the major engines of quackery, the health food-dietary supplement-herbal remedies industries coalition making major political in-roads in influencing Congress to thwart reform measures which grew out of these government investigations.
Citations: (1) Heinz. Consumer Frauds and Elderly Persons: A Growing Problem, Special Committee on Aging, US Senate, Wash DC, April, 1983. (2) Pepper. Quackery: A $10 Billion Scandal. Subcommittee on Health & Long-Term Care of the Select Committee on Aging, US House of Reps, No.98-435, 1984. (3) Louis Harris & Assoc. Health, Information and the Use of Questionable Treatments: A Study of the American Public. Wash. DC: US Dept HHS, Sept 1987.
In the last issue, we stated that the Hatch bill protecting dietary supplements and herbal remedies from responsible regulation had passed. It turns out that Hatch got much less than he sought. What he got was a one-year moratorium on implementation of the Nutrition Labeling & Education Act of 1990 (NLEA). Health food industry sources describe this as a "reprieve from restrictive NLEA labeling and health claims rules for one year."
The industry is now scrambling to do some heavy-duty lobbying and propagandizing in hopes of passing the Healt h Freedom Act of 1993. Propaganda efforts have already begun. A group calling itself Citizens For Health (CFH), led by health food advocate Alexander Schauss (pretender to diet/juvenile delinquency expertise, and publicist-apologist for Jonathan Wright, MD, whose office was raided by FDA May 6, 1992) held a "black out day" in Las Vegas, Nevada in January. On that day, black paper was put on the labels of every product that CFH claimed would not be available if the big bad FDA had its way.
The point was to make supplement users believe that common vitamins, minerals, and other dietary supplements would no longer be available. This was a classic use of the Big Lie technique. CFH attempted to mislead people by not pointing out that in order for a product to be banned it would have to be guilty of unsubstantiated health claims or contain an excessive dosage. The health food-dietary supplement- herbal remedy industries apparently are incapable of telling the truth on NLEA issues. Apparently the pharmaceutical industry is also against dietary supplement labeling reforms (little wonder since a major portion of marketing abuses involving vitamin-mineral supplements are done by drug companies hawking major brands).
Another example of calculated deception by the health food industry is revealed in the language used in the "legislative strategy" mapped out by the National Nutritional Foods Association (NNFA). In Health Foods Business (12/92, p.12) they state "The NNFA is planning a Congressional Reception in May in an effort to build a positive image of the industry and position the industry as part of the mainstream food chain (emphases ours)."
On the same page HFB reported that Senator Hatch appeared at a meeting of the Utah Natural Products Alliance (composed of 6 Utah-based companies) and urged the industry to mobilize grass roots support by getting customers to write positive letters regarding the Health Freedom Act of 1993. An industry lobbyist advised that the number one priority of the industry should be "to restore credibility."
An industry group calling itself Nutrition Has A Mission (NHAM) has been formed to introduce a proactive bill to Congress, the "Nutrition Advisory Act of 1993" which would mandate that the FDA would have to consult with an advisory committee that would include representatives from the supplement and herbal industries before taking actions regarding those industries.
It seems clear that those who believe that all products which purport to have a direct impact upon preventing, curing, mitigating or alleviating a physical or mental disorder should be required to offer substantive evidence of safety and effectiveness. The requirements proposed by the FDA are reasonable and well- conceived. They merely do what the intent of the NLEA is, improve consumer health information on the nature and usefulness of the health products covered by the law. Only by distorting the trut h can the health foods industry garner support from the general public.
Our fear is that too many media writers will buy the industry's big lies without checking them out. Rest assured, the right wing political press will pump out its paranoid anti- government rhetoric. What about the new administration? Its too early to tell. Mr. Clinton signed a law in 1985 that required dietary supplements aimed at disease to meet drug standards. This has the supplement hucksters worried and the pressure to win over influential Democrats is underway. The right-wing politicos are making deals not to oppose certain legislation in exchange for favoritism for the supplement sellers.
NCAHF urges concerned citizens to make themselves heard on these important consumer issues. Don't let Senator Hatch and the health food industry thwart badly needed consumer protection reforms.