Chromium (Cr) picolinate continues to be one of the hottest supplementation fads. Two reports, one on effectiveness and the other on safety, constitute bad news for promoters.
Lukaski, et al, tested the effects on strength and body composition of Cr picolinate or Cr chloride against a placebo in young men during strength training. Although strength improved significantly as a result of the program, there was no difference in either treatment or control groups [North Dakota Academy of Science Proceedings. 1994;48:86].
An animal study done under a National Cancer Institute grant by Stearns et al found that Cr picolinate induced chromosome damage in Chinese hamster ovary cells. Researchers concluded "This study raises the question of the safety of chromium picolinate as a human dietary supplement."[FASEB J. 1995;9(3):A451 (3/9)]
FBI Director Louis Freeh told a Senate committee the health fraud costs the health care system $44 billion a year, and the chances that the cheaters will be caught are "minimal." Freeh said that his agents have a backlog of 1,500 cases to investigate.
In order to be taken seriously by the scam artists, Freeh said that the FBI would have to double its present number (249) of agents dedicated to health fraud. Sen. William Cohen (R-Maine) sponsor of legislation to increase penalties for health fraud, stated that yearly losses could be as high as $100 billion.*
Freeh reported that the FBI had recovered only $512 million in fines and seizures in 1994.
[USA Today 3/22/95]
*In 1992 the U.S. General Accounting Office estimated healt h insurance fraud and abuse to be $70 billion--10% of the total cost of care.
An old-time remedy has reappeared--capsicum peppers.
Capsicum was first described by a physician who accompanied Columbus to the West Indies. Capsicum contains an irritating oleoresin, the major component of which is capsaicin (cap-say-sun), a very pungent phenolic chemical that characterizes capsicum peppers (cayenne, red pepper, African chilies, tabasco peppers, paprika and others). Capsaicin is what makes pepper spray work as a self-defensive weapon. Capsaicin's flavor can be detected as low as 1 part in 11 million.
Cayenne pepper has a rich history in folk medicine and quackery. Samuel Thomson, leader of the antiphysician movement of the early 1800s, used it liberally. Nature's Sunshine, a Utah-based multilevel marketing company that NCAHF has strongly criticized (see Jan-Feb, 1990 NCAHF Newsletter) began by selling capsules of cayenne pepper as panaceas.
Cayenne is made to order for quackery. Research has shown that people who experience physiological responses from something they regard as medicine are dependent upon an interpretation by someone they regard as knowledgeable (Mechanic. New Engl J Med 1972;286:1132-40). Ingestion produces a feeling of warmth and fools the body into responding by perspiration and a watering of the eyes and nose. These responses can pass as relief of colds, allergies, arthritis, or other problems.
The power of capsaicin can be felt again upon defecation making it seem useful for hemorrhoids and other lower GI or rectal problems. Topical applications produce an irritating effect which makes the substance useful as a counter-irritant. Compounds are marketed which can be put in socks to warm the feet in cold weather. Tyler warns that these must be handled with care lest one put their capsicum tainted hands on their eyes (Honest Herbal, 1993)
Capsaicin is making its major reappearance as a salve. A number of salves including ArthiCare, Zostrix, Capzacin-P, and Revco's Capsaicin contain 25% capsaicin. Another product, Arthur Itis, is being promoted as a "medical miracle" in newspaper advertising. Despite the fact that Arthur Itis also contains .025% capsaicin, it is selling for 2-6 times the amounts of its competitors.
Capsaicin has the ability to reduce the flare response (redness) of histamine, and reduce pain by depleting substance P, a vasoactive compound involved in the transmission of pain from the periphery to the spinal cord (Lawrence Review of Natural Products, 7/93).
Capsaicin-containing salves are approved by the FDA for pain relief. They are useful for shingles, trigeminal neuralgia, and stump pain following amputation. They will not alter the course of arthritis, but can help relieve its pain.
On May 3, the National Association of Boards of Pharmacy (NABP) passed the following resolution at its annual meeting in Dallas, Texas:
Whereas, there has been an increase in the number of homeopathic products manufactured by U.S. and foreign companies that are available to the American public; and
Whereas, not all of these products are approved by the Homeopathic Pharmacopeia of the United States; and
Whereas, NABP believes that homeopathic products should meet the efficacy standards as determined by the Food and Drug Administration (FDA) and the Homeopathic Pharmacopeial Convention of the United States;
Therefore be it resolved that NABP urge state boards of pharmacy not to recognize as a standard of practice the use of those homeopathic products whic h have not been determined to be safe and effective by the FDA and the Homeopathic Pharmacopeial Convention of the United States.
The NABP is a not-for-profit organization whose members represent 63 boards of pharmacy in the United States, the Virgin Islands, Puerto Rico, the Canadian provinces of Alberta, Britis h Columbia, Manitoba, New Brunswick, Newfoundland, Nova Scotia, Ontario, and Quebec, and the Australian states of Victoria and New South Wales.
The NABP's mission is to: (1) provide for the interstate transfer of pharmaceutical licensure in the U.S. based upon uniform educational and legislative standards; and (2) improve the standards of pharmaceutical education, licensure, and practice by cooperating with those state, national, and international agencies and associations holding similar objectives.
Comment: The NABP has done what the British Pharmacy Conference was unable to do in 1992, namely, pass a resolution that put science and consumer protection above business considerations (see NCAHC Bulletin Board, July-August, 1994). Pharmacists occupy a difficult position between science-based professionalism and the open marketplace. A poll has shown that they are the health professionals most trusted by the public. NCAHF regards what they do as a bellwether of consumer health trends.
Stephen Barrett, MD and pharmacognosist Varro Tyler, PhD teamed up to explain to pharmacists why they should no sell homeopathic remedies in the American Journal of Health System Pharmacists (1995;52:1004-6). They explain that the basis for inclusion of the Homeopathic Pharmacopoeia is not scientific testing but "homeopathic provings" conducted during the late 1800s and early 1900s.
Health Watch Newsletter (May, 1995) says fears that anti-immunization campaigners could wreck attempts to eradicate, or at least minimize diseases, were highlighted recently at the American Association for the Advancement of Science meeting in Atlanta.
Dr. Robert Chen of the Centers for Disease Control & Prevention said that immunization programs are victims of their own success. As a greater proportion of children are immunized, the risk of a disease goes down in relationship to the risks of side-effects of the vaccine. This can lead more and more people to avoid immunization relying upon the immunity of the herd (ie, if 80% of the susceptible population is immunized, the disease is not communicated) for protection. He cited the example of pertussis where the vaccine coverage dropped to the 30% level and the disease reappeared.
Another problem is that the side-effects of immunization are hard to monitor. Thus, any problems that occur within a reasonable time of the immunization are likely to be blamed on the vaccine. [Ed. This is why the Childhood Vaccine Injury Act of 1986 established the National Vaccine Injury Compensation Program for injuries and deat h related to DTP, MMR and polio vaccines as a no-fault program in which injured parties need only show by "preponderance of evidence" that the injury was vaccine-related.]
Anti-immunizers are more active in the UK than the USA at present because here they apparently consider it politically unwise to attack immunization during a time when increased attention is being given to "alternative" medicine. [HealthWatch is published by NCAHF's United Kingdom affiliate.]
A survey of American chiropractors found that one-third agreed that "there is no scientific proof that immunization prevents disease; that vaccinations cause more disease than they prevent; and, that contracting an infectious disease is safer than immunization. Most (81%) feel that immunization should be voluntary, and 46% support an official policy opposing the American Public Healt h Association's policy promoting immunization. [J Manipulat Physiolog Therapeut 1994;17:584-90]
In 1990 the Council of the Faculty of Homeopathy wrote to the Dept of Health in the UK stating its support for conventional vaccination. Other homeopaths have made similar statements acknowledging that they have no evidence that homeopathic treatment produces satisfactory antibody levels. (The Lancet 1994;344:1168)
Comment: It is curious that the most common reason for refusal of childhood vaccination given in a British Medical Asso Journal study (see NCAHF Newsletter Mar-Apr, 1995) was diversion by a homeopath.
The Sept-Oct, 1994 NCAHF Newsletter reported the death of a Texas woman that was associated with use of Nature's Nutrition Formula One manufactured by Alliance USA of Richardson. It was reported that a legal technicality had prevented the Texas Department of Health (THD) from restricting the product despite its apparent dangers. At the time of this writing, the TDH still has not reached the end of its efforts to restrict the sales of products containing more than naturally occurring amounts of ephedrine.
[150 members of Citizens For Health, a lobbying group for the health food industry, attended a TDH hearing on Ma Huang held 4/28/95 and signed a petition against TDH's proposal. CFH is led by Alexander Schauss, "PhD" (unaccredited).]
The Texas Attorney General has taken its own action against Alliance USA and its supplier The Chemins Company of Denver, Colorado, as an unapproved drug and for misbranding, false advertising, and adulteration. The origin action was filed by the AG on 5/12/94. The adulteration charge was added on 1/1/95 after the AG's investigation uncovered the adulteration of Formula One with synthetic ephedrine hydrochloride and synthetic caffeine. Company employees gave sworn statements that they had been directed to conceal the fact that these substances were being added to the product. [Civil Action #3:94cv1002J]
As part of the judgment the defendants must pay $400,000 to cover attorney's fees and investigative costs. The judgment requires the defendants to: 1) warn consumers that Formula One contains ephedrine which may pose a health risk to certain individuals with medical conditions; 2) notify the TDH within 10 days of any adverse reactions reported by consumers; 3) refrain from adulterating Formula One with synthetic ephedrine or caffeine; 4) notify all distributors that products manufactured before 6/1/94 have been recalled.
For more information contact Assistant Attorney General Robert Reyna 214-742-9698; fax 214-939-3930.
A serious condition in children, "failure to thrive" (FTT), can result from elimination diets used to treat food allergies that are both real or imagined.
The authors of a report in the Archives of Pediatric & Adolescent Medicine (1994:148:1150-5) evaluated 700 children referred for food allergies. Eleven children, 4 to 33 months old, were found to have FTT. No cause other that caloric restriction was found. Most parents said their child was allergic to 5 to 10 foods (avg 8.4), yet skin puncture tests failed to detect allergies in seven, and double-blind. placebo-controlled food challenges wit h foods producing positive skin findings yielded responses in only two. The majority of parents who believed their child had a food allergy were apparently mistaken. Some families that persist in potentially harmful feeding practices may be affected by psychological factors that could be addressed by counseling. [Journal Watch 12/5/94, p.93]
Bastyr University, a naturopathic college in Seattle has added several board members who are associated with the natural products industry. Included are Past President of the National Nutritional Foods Association Martie Whittekin, Sandy Gooch founder of Mrs. Gooch's Natural Foods Markets, Michael Murray, ND, Director of Research and Product Development at Enzymatic Therapy, and Jerry Schlesser, ND,DC, President and CEO of IsoChem Corporation. [Natural Health Advocate Winter, 1995 (a publication of Bastyr University as "an update for the natural products industry.")]
Comment: The symbiotic relationship between naturopathic education and the health food industry (natural foods, herbal remedies, dietary supplements, and homeopathic remedies) is scandalous. If drug companies were wielding comparable influence on a medical school there would be a national outcry. It makes naturopathic education appear to be a conspiracy between the health food industry and pseudomedicine.
The over-the-counter (OTC) herbal remedies business is reported to be well over $1.5 billion in current sales with an estimated annual growth rate of 15%. In 1994, $813.8 million of the healt h food store's $4.815 billion in sales (17%) were from herbal remedies. Herbal product vendors benefit from society's romanticized view that equates "natural" with "safe."
Unfortunately, the assumption that natural products are safe is false. It is precisely because herbs are a source of potent drugs that responsible people are concerned about the manner in which herbal remedies are being marketed. Consumers are being denied the most fundamental information and assurances of quality.
By law, drug labels must provide essential information, but herbal remedies are being marketed as "dietary supplements" with little of the type of information needed to enable people to use these remedies properly. The herbal industry blames current regulatory policies for some of these problems. They say that FDA regulations prevent them from supplying drug information because their products are regulated as dietary supplements. Herbal remedies cannot be profitably marketed if they have to meet the full requirements of drug approval.
Reformers argue for herbal remedies to be given special regulatory consideration. The FDA is bound by the law to regulate products that make medical claims as drugs. NCAHF finds the present situation untenable, but believes that there is room for regulatory adaptation without sacrificing consumer protection principles. Recommendations are directed at legislators and regulators, manufacturers and marketers, physicians, and consumers.
To Legislators and Regulators:
Establish a special category of OTC medicines called "Traditional Herbal Remedies" (THRs) regulated as follows:
To Herbal Remedy Product Manufacturers and Marketers.
For a copy of the complete NCAHF Position Paper on OTC Herbal Remedies send $2 and a stamped, self-addressed envelope to P.O. Box 1276, Loma Linda, CA 92354-1276.