Be Wary of "Fad" Diagnoses
Stephen Barrett, M.D.
A small percentage of physicians and large percentages of chiropractors, naturopaths and bogus "nutritionists" are labeling patients with diagnoses not recognized by the scientific community. Some of these practitioners apply one or more of these diagnoses to almost every patient they see. The health-food industry profits from this process by selling books promoting these alleged conditions and supplement concoctions claimed to help them. Some "fad" diagnoses have been around for years, while others are recent creations.
Years ago, many people who were tired or nervous were said to have "adrenal insufficiency." The vast majority of these people were not only misdiagnosed but were also treated with adrenal gland extract, a substance that the FDA later banned because it was too weak to treat the actual disease. "Low thyroid" (hypothyroidism) was likewise unjustifiably diagnosed in many cases of fatigue and/or obesity. Today's "fad" diagnoses used to explain various common symptoms are chronic fatigue syndrome, hypoglycemia, food allergies, parasites, "environmental illness," "candidiasis hypersensitivity," "Wilson's Syndrome," "leaky gut syndrome," and "mercury amalgam toxicity." Some products are or have been sold with claims based on cockeyed theories about "oxygen deficiency" and "magnetic deficiency." The first four on this list are legitimate conditions that unscientific practitioners overdiagnose. The rest are figments of pseudoscientific imagination.
Only a small percentage of people troubled by fatigue have chronic fatigue syndrome (CFS). According to criteria developed by the U.S. Centers for Disease Control and Prevention, CFS should never be diagnosed unless fatigue persists or recurs for at least six months and is severe enough to reduce the patient's activity level by more than half. In addition, the fatigue should be accompanied by several other symptoms, such as severe headaches, low-grade fever, joint or muscle pain, general muscle weakness, sleep disturbance, and various psychological symptoms. Consumer Reports has called CFS "a magnet for quacks," and warned that "some practitioners create CFS patients by finding the syndrome in people who clearly don't have it."
Real cases of hypoglycemia exist, but they are rare and should be carefully checked by laboratory testing before the diagnosis is made. The diagnosis should be reserved for patients who get symptoms two to four hours after eating, develop blood glucose levels below 45 mg per 100 ml whenever symptoms occur, and are immediately relieved of symptoms when blood sugar is raised. The glucose tolerance test is not reliable for evaluating most cases of suspected hypoglycemia. Low blood sugar levels without symptoms have no diagnostic significance because they occur commonly in normal individuals fed large amounts of sugar. The only way to reliably diagnose hypoglycemia is to prove that blood sugar is low whenever symptoms occur during the patient's usual living pattern. The most practical way to do this is probably with a home testing device.
Doctors who overdiagnose hypothyroidism often base their diagnosis on "low" temperature readings determined by placing the thermometer under the armpit. This is not a valid test of thyroid function. Proper diagnosis requires blood tests that measure thyroid hormone levels.
Another diagnosis that is popular among supplement promoters is "parasites," which may be "treated" with laxatives and other "intestinal cleansers," colonic irrigation, plant enzymes, dietary measures, and homeopathic remedies. Yet another, "leaky gut syndrome," is described by proponents as a condition in which the intestinal lining becomes irritated and porous so that unwanted food particles, "toxins," bacteria, parasites, and "Candida" enter the bloodstream and result in "a weakened immune system, digestive disorders, and eventually chronic and autoimmune disease." Treatment of this alleged condition can include dietary changes (such as not eating protein and starch at the same meal); "cleansing" with herbal products; "reestablishing good balance" of intestinal bacteria; and supplement concoctions claimed to strengthen and repair the intestinal lining.
Multiple Chemical Sensitivity
"Environmental illness"also referred to as "multiple chemical sensitivity"is based on the notion that when the "total load" of physical and psychological stresses exceeds what a person can tolerate, the immune system goes haywire and hypersensitivity to tiny amounts of common foods and chemicals can trigger a wide range of symptoms. Doctors advocating this notion call themselves "clinical ecologists" or specialists in "environmental medicine." Their treatment approach involves elimination of exposure to foods and environmental substances to which they consider the patient hypersensitive. Extreme restrictions can involve staying at home for months or living in a trailer designed to prevent exposure to airborne pollutants and synthetic substances. In many cases, the patient's life becomes centered around the treatment. The American Academy of Allergy, Asthma and Immunology (AAAAI), the nation's largest professional organization of allergists, has warned: "Although the idea that the environment is responsible for a multitude of health problems is very appealing, to present such ideas as facts, conclusions, or even likely mechanisms without adequate support is poor medical practice." In 1997, the AAAAI reviewed the evidence again and concluded that "a causal connection between environmental chemicals, foods, and/or drugs and the patient's symptoms is speculative and not based on the results of published scientific studies.
Clinical ecologists base their diagnoses primarily on the results of "provocation" and "neutralization" tests, which are performed by having the patient report symptoms that occur within ten minutes after suspected substances are administered under the tongue or injected into the skin. If any symptoms occur, the test is considered positive and lower concentrations are given until a dose is found that "neutralizes" the symptoms. Researchers at the University of California have demonstrated that these procedures are not valid. In a double-blind study, eighteen patients each received three injections of suspected food extracts and nine of normal saline over a three-hour period. The tests were conducted in the offices of clinical ecologists who had been treating them. In nonblinded tests, these patients had consistently reported symptoms when exposed to food extracts and no symptoms when given injections of saline (dilute salt water). But during the experiment, they reported as many symptoms following saline injections as they did after food-extract injections, indicating that their symptoms were nothing more than placebo reactions. "Neutralizing" doses were equally effective whether they were food extracts or saline.
"Candidiasis hypersensitivity" is another bogus diagnosis whose symptoms are said to be multiple and include fatigue, depression, inability to concentrate, hyperactivity, headaches, skin problems (including hives), abdominal pain and bloating, constipation, diarrhea, respiratory symptoms, and problems of the urinary and reproductive organs. The main promoter of "candidiasis hypersensitivity" has been William G. Crook, M.D., of Jackson, Tennessee, who wrote and published The Yeast Connection. According to Crook, "If a careful checkup doesn't reveal the cause for your symptoms, and your medical history [as described in his book] is typical, it's possible or even probable that your health problems are yeast-connected." To correct these alleged problems, he recommends allergenic extracts, antifungal drugs, vitamin and mineral supplements, and diets that avoid refined carbohydrates, processed foods, and (initially) fruits and milk.
The American Academy of Allergy, Asthma and Immunology regards the concept of candidiasis hypersensitivity as "speculative and unproven" and notes that everyone has some of its supposed symptoms from time to time. The academy has warned that some patients who take the inappropriately prescribed antifungal drugs will suffer side effects and that overuse of these drugs could lead to the development of resistant germs that endanger everyone.
Many dubious practitioners claim that food allergies may be responsible for virtually any symptom a person can have. In support of this claim—which is false—they administer various tests purported to identify offending foods. The most notorious such test is cytotoxic testing. This test is performed by observing what happens to a patient's white blood cells when they are placed on microscope slides containing dried food extracts. The test results are then used to explain the patient's symptoms and to design a "personalized diet program" that includes vitamins and minerals—sold by those administering the test. Controlled studies have never shown cytotoxic testing to be reliable, and some studies have found it to be highly unreliable.
Another test claimed to locate "hidden allergies" is the ELISA/ACT, developed by Russell Jaffe, M.D., Ph.D., and performed by Serammune Physicians Lab (SPL), of Reston, Virginia, which Jaffe directs. This test is performed by culturing the patient's lymphocytes and seeing how they react to up to 300 foods, minerals, preservatives, and other environmental substances. After the test is completed, the practitioner (typically a chiropractor) recommends dietary modification and supplements. Although the ELISA/ACT test can assess the levels of certain immune responses, these are not necessarily related to allergy and have nothing whatsoever to do with a person's need for supplements. Moreover, many of the symptoms listed in an SPL brochure are unrelated to allergy and are not appropriately treated with supplement products.
The correct way to assess a suspected food allergy or intolerance is to begin with a careful record of food intake and symptoms over a period of several weeks. If significant symptoms occur, the next step should be to see whether avoiding suspected foods for several weeks prevents possible allergy-related symptoms from recurring. If so, the suspected foods could be reintroduced one at a time to see whether symptoms can be reproduced. However, if the symptoms include hives, vomiting, swollen throat, wheezing, or other difficulty in breathing, continued self-testing could be dangerous, so an allergist should be consulted.
"Wilson's Syndrome" entered the health marketplace in 1990, when E. Denis Wilson, M.D., of Longwood, Florida, coined its name. Its supposed manifestations include fatigue, headaches, PMS, hair loss, irritability, fluid retention, depression, decreased memory, low sex drive, unhealthy nails, easy weight gain, and about sixty other symptoms. However, Wilson claims that his "syndrome" can cause "virtually every symptom known to man." He also claims that it is "the most common of all chronic" ailments and probably takes a greater toll on society than any other medical condition." Wilson claims to have discovered a type of abnormally low thyroid function in which routine blood tests of thyroid are often normal. He states that the condition is "especially brought on by stress" and can persist after the stress has passed. He claims that the main diagnostic sign is a body temperature that averages below 98.6° F (oral), and that the diagnosis is confirmed if the patient responds to treatment with a "special thyroid hormone treatment." (Note: Although "Wilson's Syndrome" is a bogus diagnosis, there is a Wilson's disease, a rare condition caused by a defect in the body's ability to metabolize copper.)
In 1991, a 50-year-old woman died after excessive amounts of thyroid hormone prescribed by Wilson had caused rapid heartbeat that led to a heart attack. According to Wilson, the patient's daughter filed a malpractice suit, which was settled out of court for $250,000. In 1992, the Florida Board of Medicine fined him $10,000, suspended his license for six months, and ordered him to undergo psychological testing. If his license is reinstated, he would also be required to take courses in endocrinology, the scientific method, and medical ethics. As far as I know, Wilson has not resumed practice. However, he still operates the Wilson's Syndrome Foundation, a "900" number "support line" for doctors and patients, and a toll-free number (800-621-7006) for information about his theories and publications. (An article on his Web site states that he thinks he can be more effective by educating the public. The more likely explanation is that if he resumed practice, the state medical board would permanently revoke his license.) In 1998, Richard A. Marschall, N.D., a naturopath licensed in the State of Washington, was disciplined for unprofessional conduct for diagnosing and treating between 75 and 100 patients for Wilson's Syndrome solely via telephone, mail, and/or through the Internet. Wilson claims that "thousands of doctors" have been using his methods, but in 2006, the referral directory on his Web site listed 95 worldwide, most of whom were medical doctors or naturopaths.
A small but vocal group of dentists, physicians, and various other "holistic" advocates claim that amalgam ("silver") fillings are toxic and cause a wide range of health problems including multiple sclerosis, arthritis, headaches, Parkinson's disease, and emotional stress. They recommend that amalgam fillings be replaced with either gold or plastic ones and that vitamin supplements be taken to prevent trouble during and after the process. Scientific testing has shown that the amount of mercury absorbed from fillings is only a tiny fraction of the average daily intake from food and is insignificant. The American Dental Association Council on Ethics, Bylaws and Judicial Affairs considers the unnecessary removal of silver amalgam fillings "improper and unethical." In 1996, the leading antiamalgamist, Hal A. Huggins, D.D.S., of Colorado Springs, Colorado, had his licensed revoked. During the revocation proceedings the administrative law judge concluded: (a) Huggins had diagnosed "mercury toxicity" in all patients who consulted him in his office, even some without mercury fillings; (b) he had also recommended extraction of all teeth that had had root canal therapy; and (3) Huggins's treatments were "a sham, illusory and without scientific basis.
Most practitioners of chelation therapy tell patients that they are suffering toxic effects from mercuty, lead, or other heavy metals. To bolster this claim, specimens of the patient's urine, blood, and/ or hair to a lab that typically reports metal levels as problematic even though they are not. The most common such test is the provoked urine toxic metals test in which a chelating agent is given to the patient to temporarily raise the urine output of the metals so that the reported levels look more abnormal.
Some dentists maintain that facial pain, heart disease, arthritis, and various other health problems are caused by infected "cavitations," within the jaw bones, that are not detectable on x-ray examination or treatable with antibiotics. Calling this condition "cavitational osteopathosis" or "neuralgia-inducing cavitational osteonecrosis (NICO)," advocates claim they can cure the patient by locating and scraping out the affected tissues. They may also remove all root-canal–treated teeth and most of the vital teeth close to the area where they say an infection exists. There is no scientific evidence to support this assertion or the diagnostic and treatment methods based on it. Proponents of this dubious theory have formed the American Academy of Biological Dentistry.
Insurance companies do not knowingly pay for most services associated with the problems described above. For this reason, many practitioners who make fad diagnoses engage in miscoding or "creative" coding in order to make it appear that they are using standard approaches to diagnosis and treatment.
National Council Against Health Fraud president Robert S. Baratz, DDS, MD, PhD has made an astute observation:
Some fad diagnoses seem almost to be interchangeable. Large numbers of people are scammed in the same way for different conditions, by a variety of practitioners and unlicensed personnel. It is as though there is a "menu" of quack treatments that they can choose for a variety of alleged conditions depending on the patient's susceptibility and pocketbook and the practitioner's guile, gall, and greed.
We believe that practitioners who exploit patients in this way should have their licenses revoked and that the inappropriate products they use should be removed from the marketplace.
This article was revised on March 14, 2009.