Consumer Health Digest #05-03
Your Weekly Update of News and Reviews
January 18, 2005
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.
Quackwatch blasts IOM "CAM" Committee report again. Quackwatch has posted further analyses of the report issued by the Institute of Medicine's Committee on Complementary and Alternative Methods. The report is filled with unjustified recommendations for increased research and "integration" of "CAM" methods regardless of whether they have a biologically plausible basis. The report was assembled by a 17-member committee dominated by "CAM" practitioners and ideologues, at least nine of whom have an economic connection with the subject matter. According to Quackwatch's analysis:
- At least five "CAM" Committee have received multiple grants from the NIH Center for Complementary and Alternative Medicine (NCCAM); and one heads a program that received an NIH grant before he became its head. Three others are practitioners.
- At least six either espouse, directly promote, or engage in pseudoscientific practices.
- At least have seven have overstated the value or promise of "CAM" as a whole.
- Knowledgeable "CAM" critics were excluded from participation.
If the "CAM" Committee's research recommendations are carried out, the biggest winner is likely to be the NCCAM, which funded the report and helped ensure that its conclusions were precisely what it wanted. [Barrett S. Institute of Medicine issues irresponsible "CAM" report. Quackwatch Jan 11, 2005] Quackwatch has also posted comments on the background and activities of the individual members. [Barrett S. Some notes on the Institute of Medicine's panel on "complementary and alternative medicine." Quackwatch Jan 15, 2005]
FDA advisors oppose OTC marketing of cholesterol-lowering drug. Two FDA advisory committees have recommended against permitting Merck to market its cholesterol-lowering drug Mevacor (lovastatin) without a prescription. Members from FDA’s Nonprescription Drugs and Endocrinologic & Metabolic Drugs Advisory Committees felt that under current marketing conditions, most patients will be unable to make an appropriate independent assessment about whether or not they would need long-term use of a cholesterol-lowering drug. [Mevacor daily OTC switch rejected based on patient inability to self select. FDAAdvisoryCommittee.com, Jan 14, 2005] In a background document presented to the committees, Charles J. Ganley, M.D., director of the FDA's Division of Over-the-Counter products, stated:
Elevated cholesterol is not associated with symptoms. Before using Mevacor OTC, consumers will be required to make several judgments regarding age, the level of LDL-cholesterol (LDL-C), risk factors for cardiovascular disease and relative contraindications to appropriately select to use the product. . . . Regardless of whether they do this correctly or not, they will also have to make decisions regarding continuation of therapy. . . . There is no positive feedback related to symptomatic improvement. Positive feedback will have to come from a lower LDL-C level, which will require motivation . . . to educate themselves and continue to get cholesterol testing. Unlike other OTC drug products, Mevacor OTC should be a chronic therapy with the duration of use determined by the response to therapy and the development of relative contraindications during use. This clearly puts a burden on users unparalleled by any currently marketed OTC product. Any person choosing to use Mevacor OTC will have to be highly motivated in order to use it according to labeled instructions. [Ganley CJ. Consumer behavior issues related to the marketing of Mevacor OTC. Memo, Dec 13, 2004]
The advisors' position is consistent with FDA enforcement actions that have stopped several supplement manufacturers from marketing red yeast rice products as dietary supplements.
FTC nails Body Wise and Dr. Jesse Stoff. Body Wise International, of Tustin, California has agreed to pay a total of $3.58 million to settle charges that it falsely advertised "AG-Immune," a dietary supplement said to contain “antigen infused dialyzable bovine colostrum/whey extract” or “AI/E-10.” FTC documents state:
- Body Wise hired Jesse A. Stoff, M.D. of Tucson, Arizona to explain the purported benefits of AI/E-10 and endorse products containing AI/E-10.
- In promotional materials and at seminars, Stoff and the company claimed that AG-Immune improved immune system function and could prevent or treat cancer, HIV/AIDS, heart disease, chronic fatigue syndrome, asthma, and other diseases.
- Stoff received a royalty for every bottle sold.
- Body Wise's conduct violated a 1995 FTC consent agreement related to the marketing of an alleged weight-loss product.
Under a stipulated order, Body Wise must pay $2 million to the Federal Trade Commission (FTC) and refrain from making unsubstantiated claims for any health-related product. A second FTC stipulated order prohibits Stoff from making unsubstantiated health claims or misrepresenting the existence or results of tests or studies. The settlement contains a judgment of $358,000 against Dr. Stoff, which is suspended because of his stated inability to pay. (This amount will become due immediately if the court finds that he misrepresented his financial condition to the FTC.) In a separate settlement, Body Wise agreed to pay an additional $1.58 million to the State of California. [Body Wise International to pay over $3.5 million to settle federal and state deceptive advertising charges for “AG-Immune” dietary supplement. FTC news release, Jan 18, 2005]
Chiropractor and two associates accused of massive insurance fraud. Wilmer Dorado Origel, D.C., of Modesto, California and two employees have been arrested on charges that they billed excessively from 1996 through 2004, potentially costing insurers more than $10 million. Origel's associates, Rebecca Marie Benedict of Modesto, and Robin Elaine Barney of Oakdale, were also taken into custody. All three were booked into the San Joaquin County jail and charged with multiple felony counts that included insurance fraud, grand theft, and practicing medicine without certification. Origel’s bail was set at $1 million, while bail for Benedict and Barney was set at $300,000 each. Investigators believe that the defendants conspired to bill workers' compensation and auto insurance carriers for services that were never rendered, not medically necessary, and beyond the scope of their licensed authority to perform. Origel owned and controlled a chain of clinics doing business as Med-1 Medical Center P.C.. and a medical billing company called Unique Healthcare Management Inc. [Modesto chiropractor, two associates nabbed in alleged $10 million workers' compensation scam. California Department of Insurance news release, Jan 6, 2005]
This page was posted on January 18, 2005.