No group of consumers is more susceptible to extravagant claims than the parents of handicapped children. Among the persistent promotions are nutritional supplements containing vitamins, minerals, amino acids, enzymes, hormones, or other substances. Pediatrician, Len Leshin, MD, who has a son with Down syndrome and is a member of the Down Syndrome Medical Interest Group, describes the theories and evidence related to nutritional supplementation that is alleged to improve children with Down syndrome in the July/August, 1998 Nutrition Forum. Some of the theories that underlie the use of certain nutrients although speculative are not so farfetched. An estimated 5,000 children have been placed on such therapies. Anecdotal reports abound, and nothing is more powerful than someone who exclaims that a regimen worked for them. However, the ultimate proof lies in verifiable performance.
As recently as 1997, the Down Syndrome Society cautions that none of the vitamin-related therapies have been shown to be of benefit in a controlled trial. We have followed this topic for more than two decades and Dr. Leshin's article is the best we have seen on the issue.
Deaths among the children of a small Oregon-based, Followers of Christ (FOC), sect have focused attention on that state's law that protects the parents of children who die from medical neglect from prosecution. The matter brings to attention a 1974 federal child-care program that made funding contingent on the state's exempting parents who relied upon faith healing from prosecution for medical neglect. The requirement no longer exists having been removed because of its obvious conflict with the U.S. Constitution's establishment of religion clause. Nevertheless, nine states including Oregon still adhere to the rule. A series of articles in the Oregonian newspaper report that of 78 minors buried over 35years in the private grave yard owned by the sect, 21 probably would have lived with medical care. Actual numbers are not known because of poor recordkeeping and the natural inclination to cover up such activities by those involved. Dr. Larry Lewman, who became Oregon's medical examiner in 1987, reorganized the medical examiner system to require autopsies on all children who die. In 1988, he appointed George Coleman to be his chief deputy in Clackamas County. Coleman has always been concerned about FOC child deaths but could not get the district attorney to take action. In 1997, a new district attorney Terry Gustafson took office. In her first year, three FOC children died without medical care. Deeply concerned, Gustafson extensively researched the law and concluded that parents are protected by religious immunity statutes in Oregon. Efforts at legal reform have run into opposition from both the ACLU, the Christian Science church, and even the Oregon District Attorneys Association. Russell Briggs, a former FOC member, who has lost two sons who very likely would have lived with medical care now publicly campaigns for reforming religious immunity laws. Details of the Oregon situation are presented in the CHILD newsletter (1998, #2). Time magazine reported on the matter in its 8/31/98 issue (pp.68-9). Time cited the Pediatrics study which documented 140 cases of child deaths from religion-motivated medical neglect by CHILD's Rita Swan and NCAHF's Seth Asser, MD (see March-April, 1998 NCAHF Newsletter).
Comment. It is curious that so much attention is given to relatively unimportant issues such as school prayer which is mostly a meaningless ritual and nativity scenes on public property--something that pales in the face of the fact that the words "In God We Trust" appears on money which is a form of public property nobody refuses to own because of these words. The existence of laws that grant special privilege to religious beliefs that, in turn, result in the needless deaths of children is a matter worthy of serious attention. Thirty years of studying the harm done by medical quackery has not uncovered a more persistent threat to the lives of Americans than the religion-motivated medical neglect of children.
The American College of Rheumatology states that it appreciates the current interest in "complementary" and "alternative" therapies and medicine and understands those frustrations and motivations leading to patients' interest in them. The ACR welcomes rigorous scientific evaluation of all hypotheses that might improve our understanding of rheumatic diseases, and supports integration into its treatment repertoire those therapies proven to be safe and effective by proper scientific peer review. It cautions against therapies that are not validated in this way. ACR advises that physicians be informed about "alternative" and "complementary" therapies and should be able to discuss them knowledgeably with patients so that the uncertainty of their diseases and therapies can be reduced. A copy of the complete position statement is available from the resource center.
Needles with blunt tips that move freely inside a copper handle so that the needle appears to have penetrated the skin when it actually has retracted into the handle have been developed at a German university to permit placebo studies of acupuncture. The researchers tested the ability of subjects to know whether or not they had been penetrated, and they could not.
[Lancet, 1998;352:364; also reported in the newscripts portion of Acupuncture, 8/17/98]
The revelation that Mark McGwire takes androstenedione, a drug that is alleged to boost testosteronea has set off a flap. Organized baseball was embarrassed when the media revealed that androstenedione was banned by the National Football League but not by Major League baseball. Baseball has long laid claim to being the national sport (aka national pastime), but football has challenged this assertion for sometime claiming that its vigor, high level of organization, and standards of conduct are more reflective of national values (eg, what sport do you think of when you hear the term "All American"?). Fair play is one of America's most cherished sports-related values. Ergogenicb aids violate the principle of fair play because those who use them seek an unfair advantage via an artificial means. The reason that artificial aids are not allowed in sport is that once the door is opened to such aids the development of performance enhancing techniques is limited only by the human imagination. If ergogenic aids were allowed, technology would soon replace natural human ability. It is acceptable for the military to develop human performance enhancing methods ("all is fair in love and war"), but not athletes. McGwire is 6'5" and 250 lbs of muscle, bone, and viscera with a central nervous system programmed to zero-in upon and send fast-moving baseballs into the heavens. The knowledge that McGwire uses a performance enhancing drug detracts from his achievements in the minds of the public. Some sports reporters have suggested that an asterisk be placed by McGwire's name in the record book if he does break Roger Maris's home run record. Baseball Commissioner Bud Selig and players association executive director Donald Fehr have both decided to take a closer look at their policies.
The realization that the source of McGwire's drug is the "health food" industry is not lost on the public mind either. The so-called health food industry has become the street drug pushers of society. The industry is not about health but about catering to the fantasy-thinking of those who are searching for magical potions. Due to the rampant fraud present in the marketing of dietary supplements no one can say for sure if McGwire's favorite pill really works. Dr. Gary Wadler, author of Drugs And The Athlete, says there are no sound studies in humans to back the claim of increased testosterone production. There is only the data in a 25-year-old East German patent application. David Lightsey, coordinator of NCRHI's Ergogenic Aids Task Force, points out that information written in a patent filing is not reliable. Reports about this matter also made more people aware of the fact that the FDA cannot disallow the sale of this substance even though its safety is in question.
The McGwire case also provides insight into the public's current state of mind regarding appropriate drug use. Americans appear to be growing more accepting of drug use. The success of Starbucks as a place where ambitious yuppies can get stoked for a high performance day is reflective of the fact that people are expected to be more productive if they want to participate in the American dream. Americans also seem to have grown tired of the government's war on drugs. Social Darwinism seems to be on the rise. This is the idea that if people are stupid enough to misuse drugs, let them suffer the consequences. Survival of the fittest includes making choices about drugs. Further, forget about welfare. Those who can't cut it can live in the street and die in the gutter; its their choice! Many young athletes are choosing to emulate McGwire. According to reports from health food stores, sales of androstenedione products are booming.
aTestosterone is the male hormone that causes creatures to behave aggressively without thought to the consequences, eg, billy goats and staggs to butt heads with each other over and over again despite the dizzying effects.
b(Greek, ergon = "work," genic = "producing").
The North American Menopause Society estimates that 16-20% of women who have gone through natural menopause take hormones to reduce symptoms such as hot flashes, night sweats, and vaginal dryness. Side effects include bloating, headaches, resumption of menstrual bleeding, and concern over an increased risk for breast cancer. A few people are claiming that dietary approaches can achieve the same benefits of hormone replacement therapy without the adverse effects named above. The answer, they say, lies in soy. The experience of Asian women provides the basis for their assertions. It is said that only 20% of women in China report hot flashes while 75% of European and North American women do so. (A counter argument is that Asian women are significantly different genetically which also explains their lower incidence of breast cancer, a disease that is related to hormone activity.) Proponents of the soy idea say that when a woman's estrogen is high, the phytoestrogens in soy act as anti-estrogens blocking adverse effects, but when a woman's estrogen is low, they relieve the symptoms of menopause without causing changes in breast or uterine tissue that are seen with hormone replacement therapy. As far as the increased risk of osteoporosis and heart disease seen in post menopausal women, there is no evidence that soy will be a benefit. The UCB Wellness Letter (Sept, 1998) cautions readers to beware of marketers who are eager to claim immediate health benefits from their products, but who do not mention possible adverse side effects. The August issue of Environmental Nutrition provides information on how much soy is needed to reduce symptoms, several herbs that MAY help (including kava which is offered without warning--see "Watch out for kava," May-June, 1998 NCAHF Newsletter), and herbs that are "more hype than help": Dong quai (the main ingredient in Rejuvex), ginseng, licorice root, and wild yam.
David Bricker, 30, a California chiropractor was sentenced to three months in prison, three months in a halfway house, and fined $2,000 for illegally distributing tainted liquids that sickened more than 100 partygoers at a 1996 New Year's Eve "rave" party in Los Angeles expected to draw some 10,000 participants. Bricker intended to market street legal drugs containing kava in the form of cherry, lemon, and orange-flavored liquids (these were labeled "Cherry fX bombs," "Lemon fX Drops," and "Orange fX Rush"). It was Bricker's purpose to establish himself as a source of party drugs by giving out free samples. Unable to obtain kava in time, Bricker substituted an industrial chemical related to gammahydrobutyrate (GHB). Bricker knew that the substance would produce central nervous system toxicity, but hoped that these would be a bridge to the marketing of his kava products in the future. Police and firefighters called to the scene when people got sick seized more than 10,000 vials of Bricker's brews. Bricker's accomplice, Michael Moffett, whose company mislabeled the products pleaded guilty in October, 1997 to misbranding charges. He cooperated with the FDA's Office of Criminal Justice and received a $2,000 fine and two years probation.
[FDA Consumer, July-August, 1998]
Slim America's full-page newspaper ads for Absorbit-ALL, Absorbit-ALL PLUS, and SLIM-Again HCA ran for about a year. A 30-day supply cost $49.95, and 60-day supply cost $89.95. People were encouraged to order by telephone. The Federal Trade Commission charged the Margate, Florida, company with false advertising for claiming that people could achieve substantial weight loss or reduce waist and thigh sizes in a brief period of time without diet or exercise. The company was closed down and a temporary receiver was appointed to take over all funds, documents, properties, and other assets. Unfortunately, most of the $9.5 million netted by the company in one year had already disappeared.
[Healthy Weight Journal, July-August, 1998]
Ernst and Cassileth (Cancer, 1998;83: 777-82) reviewed the literature on the use of nonstandard cancer treatments by cancer patients. They reported on 26 surveys from 13 different countries. The review is useful because it provides a bibliography of studies on this important topic. The authors report that "the average prevalence across all adult studies was 31.4%." This figure was apparently arrived at by simply averaging the percentages reported for each study. This method distorts data when done on studies with varying numbers of subjects. For example, if one study of 100 subjects finds 40% usage, and another study of 1000 subjects finds 20% usage, one cannot say that the average is 30% (ie, 40%+20% divided by 2). Studies with different numbers of subjects must be weighted accordingly (40%+20% divided by 100+1000=20.2%). The total number of adults in the studies was10,482. One study involving 151 patients had to be deleted because it was not possible to discern the actual number of users from the report. This left 10,301, 2,325 (22.6%) of which had used an altcomp therapy. This figure is substantially below that achieved by the method used by the authors. The media has reported the larger number and we can expect to encounter it again and again as others parrot it. Further, do not be surprised if this larger percentage is applied to the USA, and encourages some managed care facility to start offering alt-comp cancer medicine. In fact, only three of the studies were done in the USA (the authors misidentified a Canadian study as done here). The USA studies involved a total of 2,918 patients, 417 (14.2%) of whom used alt-comp therapies.
Few appropriate generalizations can be drawn from a group of studies as diverse as those in the review. It is pretty clear that alt-comp medicine use is significantly greater in European countries. A total of 353/632 (55.9%) patients involved in three Austrian studies, 32% of 101 patients in a German study, and 227/794 (28.5%) of patients in two Swiss studies were impressive. The highest use (64%) was found in Taiwan. Not surprisingly this involved the use of Chinese medications. Alt-comp use in Australia was also quite high, 134/555 (24.1%).
The American Council on Science & Health (ACSH) reviewed 27 health scares that turned out to be unfounded. The incredible aspect of many of these is that the media still reports on many of those on the list as still valid. Why? The reason is hinted at in the opening statement of the report which quotes H.L. Mencken: "The whole aim of practical politics is to keep the populace alarmed (and hence clamorous to be led to safety), by menacing it with an endless series of hobgoblins, all of them imaginary." Included are:
If you still believe that these were legitimate health threats, you aren't necessarily stupid. More likely, you are like Will Rogers who said, "all I know is what I read in the newspapers." Most people simply have never heard the whole story. Here is a chance to do so. Write: ACSH, 1995 Broadway, 2nd Floor, NY, NY 10023-5860; cost: $5.
Essiac is an herbal remedy alleged to prevent and treat cancer. Its name is Caisse spelled backwards. Rene Caisse was a Canadian nurse learned of the Ojibwa Indian herbal mixture from a woman who claimed to have cured herself of breast cancer by using it. Caisse concocted the mixture in her own kitchen for many years and gave it to many people. She claimed many successes, but made no scientific study of the real effects of the compound. Before her death in 1978, Caisse turned the recipe over to the Resperin Corporation which has made millions selling it. A number of agencies have tested the individual herbs (burdock, rhubarb, sheep sorrel, and slippery elm) and the compound and found them to be without value. A study by Canada's Bureau of Human Prescription Drugs of patients who used Essiac under a policy that allows cancer patients to use unproven remedies found nothing that made Essiac appear effective. Lynn McCutcheon provides the details of Essiac's long and twisted history in the July-August Skeptical Inquirer. McCutcheon's article is the best we have seen on this die-hard remedy that has become a modern folk medicine myth.
The Minnesota Board of Medical Practice has barred Dr. Keith Sehnert from treating patients because he failed to live up to a previous disciplinary agreement. Sehnert, 72, had been disciplined in January, 1997 after an audit found that he was diagnosing almost all of his patients with the same ailments, primarily food allergies and candida infections, even though the patients' symptoms differed. He was also cited for making diagnoses without the needed exams or tests. At the time Sehnert agreed to work with a supervising physician and to get board approval for his program for treating obesity and weight loss. He admitted that he had failed to comply. He also told the board that he had retired and had stopped seeing patients.
[Minneapolis Star-Tribune, 7/28/98]
Comment. Sehnert wrote at least two wellness books (Selfcare/Wellcare and Stress/Unstress) and nutrition-related articles that sometimes appeared in chiropractic publications. He wrote the foreword to the book Health Talks by Beth M. Ley that promoted dubious health ideas which was distributed exclusively through the giant health food mail order firm, Swanson Health Products.
One usually associates health fraud and quackery with certain representations about the health benefits of a product. However, health fraud encompasses much more than that. For instance, while representing a product to be beneficial in alleviating feminine cramps when there is no scientific or medical basis for such representation constitutes health fraud. The same can be said about the failure to notify the consumer that a certain product can have adverse health consequences. The result is the same: a consumer is effectively harmed by the purchase of a product. In fact, the harm resulting from the omission of critical facts about the adverse health consequences of a product can exceed the harm resulting about the deliberate misrepresentation of a product's health benefits.
One often finds products sold in drug stores, health food stores, and supermarkets that are not only worthless from a medical and pharmacological standpoint, but also potentially dangerous. For instance, not only is ingesting silver worthless in alleviating the many diseases that it is often claimed to cure, it can cause a graying of the skin to boot.
There are instances where a product is not claimed to have any health benefits at all, but nevertheless causes substantial physical harm to its user. The perfect example is tobacco products. No representation is made about tobacco's health benefits, but I propose that the sale of tobacco without sufficient warnings about its health detriments constitutes health fraud. There are many products that fall into this category. Unfortunately, federal and state authorities usually fail to prosecute such omissions and failures to disclose. For instance, it is only recently that the attorneys general of several states started taking legal action against the tobacco industry, after some fifty years of death and mutilation caused by tobacco products. However, numerous new regulatory schemes are beginning to make difference in this area. Most of the new laws that address this issue are not classified as laws against health fraud, but laws concerning mandatory disclosures about environmentally hazardous products. Examples are the federal and state environmental laws, such as California's Proposition 65 also known as the Safe Drinking Water And Toxic Enforcement Act of 1986.
Proposition 65 is California's voter-enacted law that specifically mandates disclosure of possible adverse health effects of certain chemicals and products. It is a novel law in many respects and has been the subject of much controversy. Proposition 65 requires California to periodically and officially recognize certain chemicals and/or products that can cuse cancer and/or birth defects. A government agency is in charge of reviewing the latest scientific findings regarding certain products and chemicals and determining whether such products and chemicals cause cancer and/or birth defects. Once such a determination is made, the chemical or product in question is officially added to the official list of Chemicals Known to the State of California to Cause Cancer or Reproductive Toxicity. As of today, there are more than five hundred such chemicals and products currently listed. Any manufacturer or distributor of a product which contains any of the listed chemicals is required by law to give California consumers a warning to the effect that this product contains chemical(s) known to the state of California to cause cancer (or reproductive toxicity). If this warning is not given, subject to certain procedural requirements, any person may sue the manufacturer or distributor. The person suing is entitled to personally recover 25% of any penalties which the court assesses against the defendant. The maximum penalty is $2,500 per day. There are several defenses that can be raised. One defense is that the level of the chemical is so low that it cannot cause cancer or birth defect and another is that the manufacturer or distributor employs fewer than ten people. The burden of proving the former is on the defendant.
For instance, if a certain health supplement contains mercury (one of the listed chemicals) and is sold without such a warning in California for one year, it is conceivable that a person could sue the manufacturer and distributor and recover a penalty of $912,500, of which 75% would accrue to California and 25% would go to the person suing. The possibility of such a large penalty is a strong deterrent. Nevertheless, most companies still (and quite literally) get away with murder, simply because consumers are unaware of such laws and do not become more active in enforcing consumer rights. It is important that all of us begin to learn more about our rights as consumers and to start taking charge.
If you are interested in reading more about this topic, pick up a copy of The Safe Shopper's Bible by Steinman & Epstein or go to California's Office of Environmental Health Hazard Assessment on the web (http://www.oehha.org/). If you have any questions or comments, please feel free to contact the author at the Law Offices of Morse Mehrban, 3700 Wilshire Blvd, Suite 480, Los Angeles, CA 90010; tel: 213-382-3183, fax: 3430; e-mail: mehrban@mehrban,com