Consumer Health Digest #01-22
Your Weekly Update of News and Reviews
May 28, 2001
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.
Placebo use questioned. The New England Journal of Medicine has published a report challenging the widely held view that the placebo effect is a major factor in the outcome of clinical trials. [Hrobjartsson A, Gotzsche PC. Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment. NEJM 344:1594-1602, 2001] Most placebo-controlled trials compare the active treatment with a placebo, not with no treatment. This design cannot distinguish an effect of placebo from the natural course of the disease, regression to the mean (the tendency for random increases or decreases to be followed by observations closer to the average), or the effects of other factors. Danish scientists who analyzed 114 randomized trials that had a "no-treatment" group in addition to active treatment and placebo groups have concluded:
- Placebos appeared to produce modest benefit in studies of pain and in other studies where the outcome being measured was similarly subjective.
- Some of the reported benefit may be the result of placebos may be the result of patients wishing to please their doctors.
- There is no justifiable placebo use outside of clinical trials.
An accompanying editorial stated that placebo use should be sharply reduced but may still be justified in carefully selected situations where pain relief is needed. [Bailar JC III. The powerful placebo and the Wizard of Oz. NEJM 344:1630-1632, 2001] The study also casts doubt on the widely promoted notion that "alternative methods" may work by stimulating a placebo effect.
Olympic Committee concerned about hormone-boosting "supplements." The Salt Lake City Tribune has reported that Senator Orrin Hatch (R-UT) is being pressed to amend the Dietary Supplement Health and Education Act (DSHEA) of 1994 because some of the Olympic athletes who were caught cheating with steroids last summer blamed mislabeled or adulterated dietary supplements made in Utah as the culprit. The International Olympic Committee (IOC), which prohibits the use of androsterone as well as substances that can boost body hormone levels, subsequently blasted the United States for lax scrutiny of dietary supplements. Hatch told a reporter that (a) he had not considered such products when he sponsored DSHEA; and (b) the FDA has still the authority to ban "imminently dangerous" products and has not properly enforced the law. The article also reported that the supplement industry claims to be Utah's third largest industry, with annual revenues of $2.1 billion. [Smith C. Supplement oversight. Salt Lake City Tribune, May 21 2001.] Meanwhile, Enrico Castellacci, president of the Italian soccer doctors association, warned that some nutritional supplements sold legally in Italy contain the banned steroid nandrolone.
FTC attacks conspiracies to delay generic drugs. The Federal Trade Commission has charged Schering-Plough Corporation, Upsher-Smith Laboratories, and American Home Products Corporation, with making anticompetitive agreements aimed at keeping low-cost generic drugs off the market. The Commission's administrative complaint alleges that Schering, the maker of K-Dur 20, a widely prescribed potassium chloride supplement, illegally paid millions of dollars to induce the others to delay launching their generic versions of the drug beyond any delay they might have agreed to without such payments. The agreements, the FTC said, have cost consumers more than $100 million. [FTC charges Schering-Plough over allegedly anticompetitive agreements with two other drug manufacturers. News release, April 2, 2001] Similar cases involving agreements between Hoechst Marion Roussel (now Aventis) and Andrx Corp. and between Abbott Laboratories and Geneva Pharmaceuticals were settled by consent agreements last year. The agency's enforcement strategy was described in detail at a Congressional hearing on May 24.
Experts support switching three allergy drugs to OTC status. On May 11, the Nonprescription Drugs Advisory Committee and the Pulmonary-Allergy Drugs Advisory Committee held a joint meeting at which they voted 19-4 to support switching three antihistamine products (Allegra, Zyrtec, and Claritin) from prescription-only to over-the-counter status. The manufacturers are opposed to the switch.
Chiropractor warned about Internet claims. The FDA has warned Nutrition Dynamics, of Seguin, Texas, that many claims made for its products are illegal. The company, headed by Winston G. Morrow, D.C., maintains an elaborate site through which it markets more than a thousand products accompanied by a disclaimer such as:
To prevent the vitamins, minerals, herbs, homeopathics, and other dietary supplements reported from referenced sources, or products, from being classified as a "drug" under Section 201(g) of the Federal Food, Drug and Cosmetic Act, we are required to inform you that there is no intention, implied or otherwise that represents or infers that this dietary supplements or products be used in the cure, mitigation, treatment, or prevention of any disease.
The site also states:
All of the information about dietary supplements supplied by Dr. Morrow and Nutrition Dynamics, Inc., in our opinion, has more validity for usage than the products found in the Physician Desk Reference (PDR-the reference for prescription drugs) and their use is considerably safer.
The warning letter, dated March 12, 2001, identifies five products that the company claimed were helpful against a total of more than 50 diseases and conditions, including childhood learning, cancer, epilepsy, and parasites. Morrow undoubtedly hopes that the disclaimer will protect him, even though the site makes thousands of therapeutic claims. But the deciding factor in whether or not a product is classified as a drug is its intended use, which, in this case, is clear from the product descriptions. The site contains the largest number of illegal claims I have ever seen a company make.
HONcode's future is uncertain. The Health on the Net (HON) Foundation, best known for its seal designating that a site adheres to its ethical standards, is facing financial difficulty. Its main source of funding (the Geneva Ministry of Health) does not plan to renew its financial support when the current agreement expires in December.
FBI Internet fraud complaint process. The Federal Bureau of Investigation's Internet Fraud Complaint Center provides a convenient way to alert the agency of suspected criminal or civil violations. This would be a good place to complain against cancer clinics that offer bogus treatments for cancer and other serious diseases and receive advance payments by mail or wire transfer.
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This page was revised on May 29, 2001.