Consumer Health Digest #03-26
Your Weekly Update of News and Reviews
July 1, 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.
National Do-Not-Call registry opens. Consumers nationwide can now register online to reduce the number of telemarketing calls they get. After doing this, they must respond to an e-mail confirmation within 72 hours to complete the process. During the first five days days of registration, about 15 million phone numbers were logged into the registry.
The FTC, the FCC, and many states will begin enforcing the "do not call" provisions of the Telemarketing Rules on October 1, 2003 for those who have registered by August 31. However, calls from political organizations, charities, and surveyors are not covered by the National Registry requirements. In addition, companies with which consumers have established a business relationship or have made an inquiry can call for certain periods of time unless directly asked not to do so. After October 1, telemarketers will be required to access the registry every three months and scrub numbers on it from their call lists. Telemarketers who call a number on the list could be fined up to $11,000 per call. Consumers who have been registered for three months can complain at donotcall.gov. Most of the 27 states that have do-not-call lists plan to transfer their information to the National Do Not Call Registry. [National Do Not Call Registry opens. FTC news release, June 27, 2003] The FTC's Media Center has additional information.
New Zealand "CAM" committee report criticized. Quackwatch has posted a line-by-line critique of the 46-page "discussion document" of New Zealand's Ministerial Advisory Committee on Complementary and Alternative Health (MACCAH). MACCAH was established in June 2001 to advise the Minister of Health on matters related to complementary and alternative medicine ("CAM"). Its scope includes "CAM" regulation, consumer information needs, research, efficacy, integration, and the contribution that "CAM" might make towards achieving the goals of the New Zealand Health Strategy. After reviewing the discussion document, Dr. Stephen Barrett concluded:
- The committee appears to be dominated by proponents of irrational "CAM" methods. Knowledgeable critics appear to have had little input and little effect on the report's outcome.
- The discussion document addresses only whether "CAM" methods should be studied, promoted, subsidized, and/or regulated. It fails to identify any circumstances under which "CAM" methods should be criticized, banned, and/or dismissed as worthless.
- The "key tasks" called for the committee to identify priorities for research on "specific complementary and alternative therapies." However, the committee did not discuss research priority or identify a single "CAM" method that should have low priority.
- The "key tasks" called for the committee to "provide advice on whether, and how, specified complementary and alternative health practitioners should be integrated into the mainstream health system." However, the report identified no method that should be excluded.
- The discussion document mentions several recommendations by the White House Commission on Complementary and Alternative Medicine Policy (WHCCAMP) but ignores the WHCCAMP minority report and the detailed criticism to which the majority report was subjected.
- The Ministerial Advisory Committee on Complementary and Alternative Health has produced no useful recommendations and should be replaced by a committee of scientific experts that focuses on consumer protection.
Seasilver operations shut down. On June 27, after the FDA filed a complaint in U.S. District Court in Cleveland, U.S. Marshals seized 63,000 bottles of Seasilver from a warehouse in Parma, Ohio (a Cleveland suburb) that the government charged was being marketed with deceptive claims. On June 18, after the FTC obtained a temporary restraining order (TRO), 132,000 bottles were seized from a Seasilver USA distribution center in San Diego. The combined retail value (at $39.95 per bottle) is said to be $7.9 million. The court-appointed Temporary Receiver has set up a Web site, and Seasilver USA has posted a notice to distributors, which states:
- You must cease any use of the current Seasilver product brochures.
- You must terminate any other marketing activities that are not approved by the company.
- You must terminate any other marketing activities that are not approved by the company.
- You must carefully read the TRO immediately and comply with all applicable provisions.
- The Temporary Receiver is working with the Company and its attorneys to achieve a resolution of these claims by the FTC and FDA so that the Company can resume operations with labeling and marketing materials, which are in compliance with the court order and all government regulations.
Seasilver is said to contain colloidal silver and about 90 other ingredients derived from "whole food matrices." It has been vigorously marketed through multilevel marketing, infomercials, and thousands of Web sites. (It and coral calcium appear to be the Internet's hottest products, with well over 100,000 pages locatable with search engines.) The co-chairman of Seasilver USA's medical advisory board is Daniel G. Clark, M.D., whose Florida medical license was permanently revoked in 1983 for unprofessional practice. Quackwatch has posted a detailed report about Seasilver's history and marketing, as well as transcripts of three of Seasilver USA's misleading infomercials.
Drug found in "dietary supplement" for impotence. The FDA has warned consumers not to buy or use SIGRA, STAMINA Rx and STAMINA Rx for Women, Y-Y, Spontane ES and Uroprin, manufactured by NVE, Inc., in Newton, N.J. and distributed by Hi-Tech in Norcross, Ga. These products, which are being marketed as dietary supplements, actually contain prescription-strength tadalafil, the active ingredient in Cialis, an Eli Lilly product approved in Europe to treat male erectile dysfunction. The products have been sold over-the-counter with claims that they increase stamina, confidence, and performance. Interactions between drugs containing nitrates (such as nitroglycerin) and tadalafil may cause a drastic lowering of blood pressure. [FDA warns consumers against taking the following dietary supplements-SIGRA, STAMINA Rx and STAMINA Rx for Women, Y-Y, Spontane ES and Uroprin. FDA Talk Paper T03-48, June 20, 2003] The marketing of misbranded products greatly increased following passage of the 1994 Dietary Supplement Health and Education Act (DSHEA), which seriously weakens the FDA's ability to protect consumers. The 1994 law was spearheaded by Senator Orrin Hatch, who seems oblivious to the mischief DSHEA encourages.
Neuralyn marketer receives prison sentence. A U.S. district court in Idaho has sentenced Beverly Vigil to 33 months in federal prison and has ordered her to pay back $795,396 to victims of a scheme that used the Internet illegally to promote a bogus cure for spinal cord injuries and other serious illnesses. She has been in jail since her arrest in January 2002 and will receive credit for time already served. Vigil and her ex-husband, Tom Vigil, owned and operated the Alternative Medicine and Biophysics Research Institute in Nampa, and promoted a product they called Neuralyn on their web site. More than 100 patients, most of them paraplegics or quadriplegics, paid up to $10,000 each to come to Nampa or affiliated clinics in Utah and Colorado to be treated with Neuralyn. Prospective patients were falsely told that (a) Neuralyn was 85 to 95% successful and could enable them to move or even walk again by regrowing nerve cells; (b) Tom Vigil was a medical doctor with training in biochemistry, (c) Neuralyn had undergone clinical studies, and (d) a patent application and FDA approval were pending. An "advisory board" of distinguished physicians and scientists consisted mainly of people who had no idea they were on such a board. In addition to conspiracy to commit wire fraud, Beverly Vigil pled guilty to a charge of conspiracy to delivery a misbranded drug in interstate commerce with the intent to defraud.
The Vigils promoted Neuralyn as an all-natural substance made from plants from the Yucatan. In reality, the product contained a topical anesthetic which gave some patients temporary pain relief and led them to believe that they were improving. The Vigils charged $300 to $500 for a vial of Neuralyn for home treatment, claiming that the ingredients, production process, and costs of research and patent applications justified the high price. Beverly Vigil admitted, however, that vials of Neuralyn cost them only $15 apiece. Tom Vigil faces two counts of conspiracy, 18 counts of wire fraud and 8 counts of delivering a misbranded drug into interstate commerce with intent to defraud. He is a fugitive, believed to be in Mexico. California pharmacist David Taylor, who supplied the Neuralyn to the Vigils, pled guilty to conspiracy to deliver a misbranded drug in interstate commerce with intent to defraud. He cooperated with the investigation, was given five years probation, and has paid restitution to the victims.[Woman sentenced for falsely promoting cure for spinal injuries. U.S. Attorney, District of Idaho, news release, June 18, 2003]
FDA warns marketers of "anti-radiation formulas." The FDA has warned two companies to stop claiming that their potassium iodide products would protect against the development of thyroid cancer if nuclear disaster strikes. Both companies falsely claimed that their products were FDA-approved. The warnings went to:
- Joseph Diehl, CEO, Regency Medical Research, Phoenix, Arizona, which marketed KI-Spray through the Web sites www.kispray.com and www.vitamist.com.
- Gary Olen, Chairman, Sportsman's Guide, South St. Paul, Minnesota, which marketed potassium iodide pills through the Web site www.sportsmansguide.com.
This page was posted on July 1, 2003.