Consumer Health Digest #07-05
Your Weekly Update of News and Reviews
January 30, 2007
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.
DSHEA slightly strengthened. The recently passed federal Dietary Supplement and Nonprescription Drug Consumer Protection Act (S. 3546) will require manufacturers of dietary supplements and nonprescription drugs to notify the FDA about serious adverse events related to their products. Beginning in December 2007, manufacturers must report deaths; life-threatening experiences; inpatient hospitalizations; persistent or significant disability or incapacity; birth defects; or the need for medical intervention to prevent any such problems. Manufacturers will also have to place a telephone number or address on product labels so consumers can contact them. The bill was passed in response to concerns about how difficult it was for the FDA to ban ephedra sales even though thousands of people had adverse effects. Congress reasoned that if notification could be increased, the FDA could do a better job of identifying and dealing with dangerous products. However, public protection is only slightly increased because other parts of DSHEA make it very cumbersome for the FDA to ban dietary supplements and herbs. [Barrett S. How the Dietary Supplement Health and Education Act of 1994 weakened the FDA. Quackwatch, Feb 2, 2007]
Former shark cartilage promoters sued again. The Federal Trade Commission has filed civil contempt charges against Lane Labs, Inc., its president Andrew Lane, and I. William Lane, Ph.D., for violating previous FTC orders requiring them to have adequate scientific evidence to substantiate ad claims. The suit charges that Lane Labs and Andrew Lane falsely claimed that the dietary supplement Fertil Male enhances male fertility and that all three defendants falsely claimed that AdvaCAL (a calcium supplement also sold as AAACa) is superior to other calcium products and equal or superior to prescription drugs used to fight osteoporosis. The previous orders were entered in 2000 to settle FTC charges that they had made unsubstantiated claims that BeneFin and SkinAnswer were effective against cancer. ["Operation Cure.all" nets shark cartilage promoters. FTC news release, June 29, 2000] The FTC now asserts that the defendants cannot substantiate claims that:
- Fertil Male improves male fertility.
- AdvaCAL is more absorbable than other types of calcium.
- AdvaCAL is superior to other calcium or prescription drug products at building bone or increasing bone mineral density.
- AdvaCAL is superior to other calcium products in preventing or reducing the risk of fractures.
The products are sold through the Internet, catalogs, direct mail, infomercials, and in retail stores. The retail cost of a one-month supply of Fertil Male is $34.95. A 25-day supply of AdvaCAL costs $39.95. The FTC is seeking to recover all revenues stemming from the defendants’ order violations. [FTC Files civil contempt action against Lane Labs defendants. FTC news release, Jan 29, 2007]
Many prescription drugs ads are misleading. Opponents argue that direct-to-consumer (DTC) ads mislead consumers and prompt requests for products that are unnecessary or are more expensive than other equally effective drugs or nonpharmacologic treatment options. Proponents counter that such ads educate people about health conditions and available treatments and empower them to become more active participants in their own care. Five researchers who studied DTC television ads for 24 prescription products have reported:
- 82% of the ads made some factual claims, 86% made rational arguments for product use, but nearly all (95%) included emotional appeals.
- Most ads framed their message in terms of losing (58%) and regaining control (85%) over some aspect of life and as engendering social approval (78%).
- 58% of the ads portrayed the product as a medical breakthrough.
- Only about 25% described the causes, risk factors, or prevalence of the conditions for which the drugs might be useful.
- Lifestyle change was never mentioned as an alternative to products, but 19% portrayed it as an adjunct to medication and 18% portrayed it as insufficient for controlling a condition.
The authors concluded:
Despite claims that ads serve an educational purpose, they provide limited information about the causes of a disease or who may be at risk; they show characters that have lost control over their social, emotional, or physical lives without the medication; and they minimize the value of health promotion through lifestyle changes. The ads have limited educational value and may oversell the benefits of drugs in ways that might conflict with promoting population health." [Frosch DLL and others. Creating demand for prescription drugs: A content analysis of television direct-to-consumer advertising. Annals of Family Medicine 5:6-13, 2007]
An accompanying editorial by former FDA Commissioner David A. Kessler, M.D. and a public-relations expert stated:
Patients have always expected simple answers to complex questions, but direct-to-consumer (DTC) advertising has elevated this problem to new heights, because patients in some ways now rely on Madison Avenue as a provider of health information. There is nothing wrong with pharmaceutical companies communicating directly with consumers, but they should adhere to the standards and ethics of medicine, not the standards and ethics of selling soap or some other consumer product that presents minimal risks. . . .
Equally important is the possibility—the likelihood—that consumers who make health decisions based on what they learn from television commercials ultimately take medicines they may not need, spend money on brand medicines that may be no better than alternatives, or avoid healthy behaviors because they falsely think a medicine is all they need. [Kessler DA, Levy DA. Direct-to-consumer advertising: Is it too late to manage the risks? Annals of Family Medicine 5:4-5, 2007]
The full text of both articles is available online free of charge.
This page was posted on February 1, 2007.