Consumer Health Digest #03-25
Your Weekly Update of News and Reviews
June 24, 2003
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.
PC-SPES marketers facing criminal charges. The Orange County District Attorney has charged International Medical Research, Inc, of Brea, California (doing business as BotanicLab) and three of its officers with 14 criminal counts relating to the marketing of products that were laced with prescription drug ingredients. [The people of the State of California vs. John Chun Hsiung Chen aka John Chun Hsuing, Xuhui Wang aka Allen Xuhui Wang, Sophie S. Chen aka Sophie S. Fan, and International Medical Research, Inc., dba Botanic Lab. Felony complaint No. 03CF1520, Superior Court of California, Councty of Orange, Central Justice Center, May 8, 2003] The defendants claimed that the products were breakthrough herbal formulas supported by years of research by MD and PhD scientists. PC-SPES was also said to be a centuries-old Chinese remedy that could fight prostate cancer by boosting the immune system. Last year, however, samples of PC-SPES and a similar product (SPES) were found to contain indomethacin (an arthritis drug), warfarin (an anticoagulant), and diethylstilbestrol (DES), a source of estrogen. The DES content may explain why preliminary studies of PC-SPES found some effectiveness against prostate cancer. State health officials asked BotanicLab to recall these products and, shortly afterward, cancer survivors who had used PC SPES filed a class-action lawsuit. In June 2002, the company went out of business, saying it was devastated by the costs of the lawsuit and the recall of the two drugs. That same month, the state health department warned that seven other BotanicLab products (Arthrin, HepaStat, Neutralis, OA Plus, Osporo, Poena, and RA Spes) might be contaminated with prescription-only ingredients.
Medical Letter cautions about "eye" antioxidants. The Medical Letter has cautioned that the results of a widely publicized study has led to overpromotion of antioxidants for preventing and treating age-related macular degeneration, a condition in which retinal deterioration can lead to blindness. In 2001, the researchers reported on what had happened to about 3,600 persons aged 55 to 80 who had been followed for an average of 6.3 years. Patients received either high doses of antioxidants (vitamin C 500 mg, vitamin E 400 IU, beta-carotene 15 mg); 80 mg of zinc oxide; the antioxidants plus zinc; or a placebo. No benefit was found in patients with a relatively small probability of AMD progression. When these patients were excluded from the analysis, the estimated probability of developing advanced AMD was 28% with placebo, 23% with antioxidants alone, 22% with zinc alone, and 20% with both zinc and antioxidants. The authors concluded that patients at high risk for AMD progression "should consider taking a supplement of antioxidants plus zinc such as that used in this study." Age-Related Eye Disease Study Research Group (AREDS). [A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, beta carotene, and zinc for age-related macular degeneration and vision loss: AREDS report no. 8. Archives of Ophthalmology 119:1417-1436, 2001]
Since publication of the report, many dietary supplements have been marketed through the Internet to "promote" and "preserve" healthy vision. The most widely promoted product is Bausch and Lomb's Ocuvite PreserVision, which contains the amounts of beta carotene, vitamin C, vitamin E, and zinc oxide used in the study. However, The Medical Letter has cautioned that (a) the magnitude of the reported effect was "modest"; (b) no data suggest any benefit for people who do not have AMD or who have only mild disease; and (c) the increased death rate from lung cancer in smokers who took beta carotene in other studies is evidence enough that high doses of vitamins and minerals are not necessarily harmless." [Antioxidant vitamins and zinc for macular degeneration. The Medical Letter 45:45-46, 2003]
The FDA has ordered the Vision Group, of North Hampton, New Hampshire, to stop suggesting that its Precision Vision product was effective against AMD. The company had advertised that "eye health research has shown evidence of reduced risks and slowed progression of degenerative eye diseases by maintaining high levels of antioxidants and minerals" and that "those found in this supplement can reduce the risk of age related macular degeneration (the number one cause of blindness in aging persons) and glaucoma." In a warning letter, the agency noted that Precision Vision was misbranded because "its label is false and misleading in that it suggests that the drug is effective for its intended use in the general population, but the only scientific support for the label claim applies to a limited subset of patients with age-related macular degeneration. [Veneziano D. Warning letter to James Parker. May 16, 2003]
New South Wales limits use of whole-body CT scanning. New South Wales Health Minister Morris Iemma has announced strict new conditions and penalties for individuals and companies that offer whole body computerized tomography (CT) scans to healthy people without independent medical advice. As a result, it is now illegal to perform a whole body CT screening on a member of the public:
- Without a written request from an independent medical doctor;
- Unless the person undergoing a whole body scan has the scale of the radiation dose and the health risks involved explained fully to them (including that people under the age of 50 are more at risk of developing cancer as a result of this procedure); and
- Without the written and informed consent of the person undergoing the scan.
Registered owners and licensed operators of CT devices who violate the regulations could face fines of up to $27,500 (for an individual) and $165,000 (for a corporation) and/or up to two years in jail for breaches of the Radiation Control Act 1990. [New penalties to control whole body CT scan. NSWHealth news release, June 8, 2003]
Whole body scans can expose people with up to 500 times more than the standard chest x-ray. About three years ago, the American College of Radiology and American Heart Association concluded that whole-body CT screening for coronary artery disease in people with no symptoms or family history of illness was not justified. The groups also expressed concern that the procedure would result in increased anxiety, unnecessary follow-up examinations, and wasted expense. [American College of Cardiology/American Heart Association expert consensus document on electron-beam computed tomography for the diagnosis and prognosis of coronary artery disease. Journal of the American College of Cardiology 2000;36:326-340, 2000]
Scientology-backed bill arouses concern. The American Psychiatric Association (APA) and five other mental health organizations have warned that the proposed Child Medication Safety Act (HR 1170) could have a "chilling effect on communication between school personnel and parents about students' mental health problems." The bill would prevent teachers and other public school personnel from requiring students to take methylphenidate (Ritalin) or other Schedule II controlled substance as a condition of attending school. The bill would permit school personnel to share observations with parents about a student's academic performance or behavior or "the need for evaluation for special education or related services." However, coalition members, who note that abuses are rare, are concerned that this language might cause teachers not to recommend comprehensive medical assessments when needed. In an interview in Psychiatric News, an official of one of the groups said that the Citizen's Commission for Human Rights (a Church of Scientology affiliate), which opposes all use of psychiatric medication for children, is behind the bill. HR 1170 was inserted as an amendment to the Individuals With Disabilities Education Act reauthorization bill (HR 1350), which passed the House of Representatives last month. [Lehmann C. Bill would regulate ADHD discussions in school. Psychiatric News 38(10):10, 2003]
MSKCC publishes free herbal database. The Memorial Sloan-Kettering Cancer Center has posted a free database with more than 300 entries about herbs, dietary supplements, and "alternative" cancer treatments. The entries contain a clinical summary for each agent and provides details about constituents, adverse effects, interactions, and potential benefits or problems. Both "professional" and consumer versions are provided, but most of the professional information is readily understandable by laypersons.
Sports nutrition companies warned to stop unsubstantiated claims. The FDA has challenged claims that several ephedra-containing products can help people build muscles. In February 2003, the agency warned that claims for five of alleged bodybuilding aids appear to be violate federal rules that structure/function claims made for dietary supplements must be "truthful and not misleading":
- American Bodybuilding (a subsidiary of Optimum Nutrition, Inc), of Florida, was advised to stop claiming that Ripped Force enables maximum endurance, improves reaction time and is for "a ripped, well defined physique," and that Extreme Ripped Force improves reaction time and reduces fatigue. [Baca JR. Warning letter to American Bodybuilding. Feb 28, 2003]
- AST Sports Science, of Golden, Colorado, was advised to stop claiming that EPH 833 would increase strength, dynamic power, energy, and endurance level, build muscle, and was a "muscle building machine"; Dymetadrine Xtreme would increase muscle strength, support lean muscle growth, enable maximum muscle growth, bigger, stronger, more muscular; and Andro Xtreme would produce muscle strength, lean muscle mass, more strength, increasing strength, and "instantaneous surge of strength." [Baca JR. Warning letter to AST Sports Science World Headquarters. Feb 28, 2003]
This page was posted on June 24, 2003.