Consumer Health Digest #02-25
Your Weekly Update of News and Reviews
June 18, 2002
Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D., and cosponsored by NCAHF and Quackwatch. It summarizes scientific reports; legislative developments; enforcement actions; news reports; Web site evaluations; recommended and nonrecommended books; and other information relevant to consumer protection and consumer decision-making.
PBS broadcast angers chiropractors. Chiropractic's two largest organizations are upset about a program that was broadcast beginning June 4th on Public Broadcasting System stations and can be viewed on the Scientific American Frontiers Web site. The program described how spinal manipulation might be useful for acute low back pain, but it also noted that chiropractic's basic theory is nonsense and that neck manipulation can be dangerous. A detailed analysis of the situation has been posted to the NCAHF Web site.
Bush Administration stalls ephedra ban. HHS Secretary Tommy G. Thompson has announced new efforts to expand scientific research on the safety of ephedrine alkaloids and pursue the illegal marketing of synthetic (non-herbal) ephedrine alkaloid products. HHS has funded the RAND Corporation to conduct a comprehensive review of the existing science on ephedrine alkaloids, particularly those in "dietary supplements." The review, projected for completion in the fall, is expected to help guide further NIH-funded research into ephedrine safety. On June 14, the FDA sent six warning letters to firms unlawfully selling non-herbal ephedrine-containing products over the Internet. These products violate the law because they are not legal dietary supplements and are illegal drugs. The FDA also warned another company for illegally promoting its ephedrine product as an alternative to street drugs. [HHS announces plans to study ephedra; Steps up enforcement of illegal ephedrine marketing. HHS news release, June 14, 2002]
Products containing ephedrine alkaloids (ephedra or ma huang) derived from plants are legal to market as "dietary supplements" provided no blatant drug claims are made for them. Such products are sold as weight-loss, energy, and sports supplements, even though the evidence that they are effective is very slim. This situation exists because the 1994 Dietary Supplement and Health Education Act (DSHEA) included herbals ingredients in the definition of dietary supplements in order to weaken the FDA's ability to regulate herbal products. [Barrett S. How the Dietary Supplement and Health Education Act of 1994 weakened the FDA. Quackwatch, updated May 18, 2002] Thompson's announcement was blasted by critics who charged that enough is already known about ephedrine's dangers to ban it in non-herbal "dietary supplements." DSHEA enables the FDA to ban dangerous ingredients, but implementing the law is so cumbersome that no ban has been enacted despite hundreds of reported adverse events, including many deaths related to ephedra use.
Another study finds supplement labels untrustworthy. Researchers at the Toronto Sunnybrook Regional Cancer Center have found that several brand of supplement and herbal products used for prostate disease did not contain the ingredient amounts stated on their labels. [Feifer AH and others. Analytical accuracy and reliability of commonly used nutritional supplements in prostate disease. American Journal of Urology 168:150-154, 2002] The study found:
- Vitamin E (7 samples) ranged from -41% to +57% of the amount stated on the label.
- Selenium (5 samples) ranged from -19% to +23% of the stated dose
- All vitamin D brands (4 samples) were within 15% of the stated dose.
- Saw palmetto (6 samples) ranged from -97% to +140% of the stated dosage, with 3 containing less than 20%.
- Lycopene brands ranged from -38% and +143%.
- One brand each of vitamin A, vitamin E, selenium, and saw palmetto exhibited 20 to 25% differences from lot to lot of the same brand.
Internet pharmacy faces fines. California state regulators are seeking $88.7 million in fines from a Los Angeles pharmacy and two pharmacists who allegedly filled thousands of prescriptions over the Internet in violation of state law. On May 28, the California Board of Pharmacy charged that Total Remedy & Prescription Center II, Barry Irvin, and William Charles Packer violated a state law prohibiting Internet pharmacies from filling prescriptions without a "good-faith prior medical examination" by a physician licensed in California. The Board said that the defendants had had illegally filled more than 3,500 prescriptions for treating male impotence, hair loss, and weight loss based on customers filling out an online questionnaire, and the prescriptions were written by physicians licensed elsewhere. The defendants have 30 days to appeal the charges. [American Medical News 45(23):27, 2002]
Illegal Internet prescriber receives 51-month prison sentence. Ricky Joe Nelson, M.D., a general surgeon in Oklahoma City, was sentenced to 51 months in prison for prescribing and selling controlled substances without physically examining patients. Evidence at his trial showed that Nelson had prescribed Hydrocodone (a potentially addictive painkiller) and other drugs after patients requested them on the NationPharmacy.com website. Nelson also received a concurrent 51-month sentence for conspiring to launder the proceeds of the scheme by transferring $175,000 to a West Indies bank account in the name of a Bahamian corporation he had formed. The court assessed him $660,000, which included the money in the offshore account. [Internet doctor sentenced to over 4 years in prison. USDOJ news release, May 29, 2002]
NEJM changes its conflict-of-interest guideline. The New England Journal of Medicine has revised a guideline for authors of review articles and editorials so that it now reads: "Because the essence of reviews and editorials is selection and interpretation of the literature, the Journal expects that authors of such articles will not have any significant financial interest in a company (or its competitor) that makes a product discussed in the article." [Drazen J, Curfman G. Financial associations of authors. New England Journal of Medicine 346:1901-1902, 2002. The word "significant"—not included in the previous guideline—refers to (a) annual payment of at least $10,000, (b) "any holding with unlimited profit potential, such as stock, stock options, and patent positions, or (c) major research support or a major proportion of funding from relevant companies received within two years before the article's publication date. The stated rationale for the change is that the former guideline constrained the journal's ability to find authors to provide authoritative review articles. The new guideline is similar to those of other medical journals, including JAMA.
World Chiropractic Alliance criticizes chiropractor suspension. The World Chiropractic Alliance (WCA), which is "dedicated to promoting a subluxation-free world," has criticized New York State licensing authorities for disciplining a chiropractor who allegely promoted unnecessary treatment to symptom-free patients. The practitioner, Frank J. Amato, D.C., of Bellport, N.Y., was found guilty of "unprofessional conduct" and received a 2-month suspension, 2 years of probation, and a $7,000 fine. The licensing board's summary states:
Licensee was found guilty of exerting undue influence on a patient for his own financial gain by placing pressure on the patient to bring family members into the office for examination, evaluation and treatment by him. Respondent was also found guilty of holding a "Patient of the Month" contest in which the patient who recommended the most new patients to the Respondent would win a color television set.
WCA's new position paper states:
Chiropractic care to detect and correct vertebral subluxations offers benefits for all people, including those who do not demonstrate symptoms of a disease or health condition. Therefore, the presence of symptoms and/or a medical diagnosis should not be a factor in determining the need for or appropriateness of chiropractic adjustments, nor should the presence of symptoms be required by any chiropractic board, insurance company or court of law to justify the rendering of chiropractic care to any patient. [Position paper on chiropractic for asymptomatic patients. World Chiropractic Alliance, May 15, 2002]
The paper claims that checking for "subluxations" is analogous to periodic dental and blood-pressure check-ups. However, blood pressure and tooth decay can be objectively demonstrated, but the subluxations to which WCA refers are a figment of chiropractic's collective imagination [Barrett S. Chiropractic's elusive "subluxation." Chirobase, Dec 25, 2001] Amato is appealing the board's action but is unlikley to succeed. Chirobase has additional details.
This page was posted on June 18, 2002.