Company Touting Unproven Cancer Treatment Agrees to Settle FTC Charges

A Southern California-based company that touted safe and effective "alternative" treatments for cancer has agreed to settle Federal Trade Commission charges. BioPulse International, Inc., BioPulse, Inc., and their principals advertised in print and on the Internet that their therapies - "insulin-induced hypoglycemic sleep therapy" (IHT) and "Acoustic Lightwave Therapy" (ALW) - could effectively treat a wide variety of cancers and other serious diseases. The U.S.-based company offered its purported treatments in a clinic in Tijuana, Mexico. The FTC alleges that the defendants did not have adequate substantiation for the safety and efficacy claims the defendants made for these treatments. As part of the settlement with the Commission, the defendants are permanently barred from misrepresenting the safety of IHT or any similar treatment and from making any unsubstantiated safety or efficacy claims for IHT, ALW, or any dietary supplement, food, drug, device, or any health-related service.

In addition to this settlement, the FTC today is announcing the results of the latest "Operation Cure.All 2002" health claims surf. This surf was conducted as part of an international Internet health surf, led by the Australian Competition and Consumer Commission and participated in by 19 members of the International Marketing Supervision Network (IMSN) - an international network of consumer protection law enforcement agencies. As a result of the surf, the FTC has sent over 280 advisory letters to domestic and foreign sites that were identified as making questionable claims for health-related products or services.

"In any language, health fraud trades on hope," said J. Howard Beales III, Director of the FTC's Bureau of Consumer Protection. "As today's announcements indicate, health fraud is an international issue, and cooperative enforcement across borders is essential to containing it. Consumers who want to learn how to recognize fraudulent, unproved or just plain useless healthcare products and services can learn more at www.ftc.gov/health."

"Surveys have shown that many patients, especially those with chronic and life-threatening conditions like cancer, seek complementary and alternative medical (CAM) practices - to replace conventional treatments or to reduce their side effects, and to extend life or enhance its quality," said Dr. Stephen E. Straus, Director of the National Center for Complementary and Alternative Medicine at the National Institutes of Health. "While we await the outcome of rigorous, NIH-funded studies of these CAM practices, it would be prudent to appreciate that they are not all safe and they do not all work. Patients and doctors should discuss the range of treatment options and develop a plan as to which CAM practices to pursue, and which to put aside altogether."

"FDA is committed to working with the FTC and other consumer protection organizations to combat fraudulent and often dangerous products, whether they are sold on-line or through more traditional outlets," said Dr. Lester M. Crawford, FDA Deputy Commissioner. "The common sense of individual consumers, however, provides an extremely valuable tool in this fight. If you see a so-called 'remedy' touted on the Internet, check with a healthcare practitioner, patient group or other independent medical sources before you buy it. FDA's Web site (www.fda.gov<http://www.fda.gov> ), along with those of the FTC and others, can provide useful tips on avoiding quack health products."

BioPulse

The FTC's complaint names BioPulse International, Inc., BioPulse, Inc., Jonathan Neville, and Loran Swenson. According to the complaint, the defendants marketed two "therapies" to treat numerous serious diseases, including cancer. The first therapy is the so-called "insulin-induced hypoglycemic sleep therapy" (IHT). The IHT therapy involved injecting insulin into cancer patients to "starve" cancer tumors, among other things. Typically, this regimen required insulin injections for up to seven weeks, costing up to $39,900.

The second "therapy" is the so-called "Acoustic Lightwave Therapy" (ALW). ALW was based on the so-called "Rife machine" technology, which allegedly worked by emitting frequencies that purportedly destroyed cells or organisms that caused arthritis, candida yeast, diabetes, flu, headaches, parasites, lyme disease, pneumonia, and some cancers.

The FTC complaint alleges that the defendants lacked substantiation for the IHT and ALW therapies. The complaint also alleges that the defendants made unsubstantiated safety claims for IHT. Under two separate proposed settlements, which require the court's approval, the defendants are barred from misrepresenting the safety of IHT or any similar treatment and from making any unsubstantiated safety or efficacy claims for IHT, ALW, or any dietary supplement, food, drug, device, or any health-related service.

In addition, the proposed settlements would require the defendants to have adequate substantiation for any claims about the health benefits, performance, safety, or efficacy of IHT, ALW, or any covered product or service. The settlements also contain a suspended judgment of $4.3 million, due in full if the defendants are found to have misrepresented their financial situation. Finally, the proposed settlements include standard recordkeeping and reporting requirements to assist the Commission in monitoring the defendants' compliance.

The Commission vote to authorize staff to file the complaint and proposed consent decrees in the BioPulse matter was 5-0. The complaint and proposed consent decrees were filed in the U.S. District Court, Northern District of California, in San Francisco, on July 23, 2002.

NOTE: The consent decrees are for settlement purposes only and do not constitute an admission by the defendants of a law violation. Consent decrees have the force of law when signed by the judge.

Operation Cure.All 2002 Surf

In its continuous efforts to monitor the Internet for questionable health-related products and services, the FTC and over 50 government agencies and non-government organizations conducted the third Operation Cure.All surf. The Operation Cure.All initiative is an ongoing federal and state law enforcement and consumer education campaign launched in June 1999 targeting bogus health claims on the Internet. The latest surf, "Operation Cure.All 2002," was part of an international Internet surf participated in by member countries of the International Marketing Supervision Network (IMSN).

One of the objectives of the surf was to foster international cooperation in tackling consumer problems dealing with cross-border transactions. While the U.S.-sponsored surf focused on Web sites specifically marketing products and therapies for arthritis, cancer, and HIV/AIDS, other IMSN surfing partners also searched for sites promoting questionable products for weight loss and sexual performance enhancements. The international surf identified over 1,400 questionable sites. Countries participating in the international surf include Australia, Austria, Belgium, Canada, Denmark, Ireland, Finland, France, Hungary, Japan, Korea, New Zealand, Norway, Poland, Portugal, Switzerland, Sweden, the United Kingdom, and the United States.

As a result of the Operation Cure.All 2002 surf, the FTC has sent over 200 advisory letters to domestic sites and 80 to foreign sites informing them that they must have scientific support for the claims they make. These Web sites promote dietary supplement products for the (BioPulse/Cure.All2002-07/24/02) treatment of diseases such as arthritis, cancer, and HIV/AIDS. The FTC and the Food and Drug Administration (FDA) will revisit these sites to determine whether they are in compliance with FTC and FDA laws. Appropriate regulatory and law enforcement actions will be initiated as warranted.

Joint Consumer Education Initiative With NIH-ODS

It is difficult to discern good health information from bad on the Internet. "Consumers should know that just because a dietary supplement is widely marketed, it does not necessarily mean that proof of its efficacy or safety has been established," said Dr. Paul Coates, Director, NIH, Office of Dietary Supplements. "While there exists strong evidence for some, there is little or no evidence for others. For example, consider essiac tea. This product has been widely marketed to treat certain cancers; however, there are no clinical trials proving that it is effective for this purpose. In addition, some products might cause serious health risks, such as comfrey and aristolochia. Before using any dietary supplements, consumers should consult reliable sources of information provided by government agencies, independent public health organizations, and academic and research institutions. It is also very important to inform your healthcare professionals about your use of dietary supplements; certain ones could have serious interactions with other medications you might be taking or with treatments you are undergoing."

The FTC, the NIH Office of Dietary Supplements (NIH-ODS), the FDA, and other sister agencies have put together a list of valuable and reliable sources of health information for consumers. The FTC Web site at www.ftc.gov/health provides direct links to these sources of information. Consumers are encouraged to visit these Web sites when searching for health information and ask the following questions before deciding whether to purchase a health-related product or therapy:

• What is in the product; what does this therapy entail?
• What is the evidence that this product/therapy will do whatever the product/therapy purports to do (e.g., counteract the disease or medical condition being treated; relieve symptoms or side effects; lead to better results than conventional treatment)?
• Have results from studies of this product/therapy been published in any peer-reviewed medical journals? Can I have copies of the publications or references to these publications?
• How will I know that the product/therapy is or is not working?
• What is the evidence that the product/therapy is safe? Are there potential side effects? Are there potential interactions with prescription medications?
• What are the training and credentials of the provider?
• Is the provider willing to communicate with my primary care physician and/or my health insurance company?

The FTC and the FDA led the Operation Cure.All 2002 surf, and the Australian Competition and Consumer Commission led the 2002 international Internet health surf. The following agencies and organizations participated in Operation Cure.All 2002: The National Institutes of Health - Office of Dietary Supplements, the National Center for Complementary and Alternative Medicine, and the National Cancer Institute; State Attorney General Offices of Arizona, Arkansas, California, Connecticut, Kansas, Kentucky, Massachusetts, Missouri, Nevada, New Jersey, New Mexico, North Carolina, Ohio, South Dakota, Tennessee, Texas, and Wisconsin; the Health Departments of California, Florida, and Texas; the U.S. Attorney Offices for the Northern, Eastern, and Western Districts of Texas; the Association of Food & Drug Officials; the AIDS Health Fraud Task Force; the American Cancer Society; the Arthritis Foundation; Baylor Medical School; the Better Business Bureau - National Advertising Division of the Council of Better Business Bureaus; Direccion General De Medicamentos Y Technologias Para La Salud, Mexico; the Federation of State Medical Boards; Gloucester County New Jersey Department of Consumer Affairs; Harvard Medical School, Division for Research and Education, Center for Complementary and Integrative Medical Therapies; Health Canada; Competition Bureau, Canada; HealthFinders®, U.S. Department of Health and Human Services; Howard County Maryland, Office of Consumer Affairs; Internet Healthcare Coalition; the Irish Medicines Board; M.D. Anderson Cancer Center; the Mayo Clinic, Complementary and Alternative Medicine Program; Office de la protection du consommateur, Government of Quebec; Province of British Columbia, Ministry of Public Safety and Solicitor General, Consumer Services; Puerto Ricos Justice Department, Office of Monopolistic Affairs; Pediatric AIDS Center at Stony Brook; Secretaria De Dalud, Mexico; the Texas Commission on Alcohol and Drug Abuse; University of Maryland School of Medicine, Complementary Medicine Program; and the Wisconsin Department of Agriculture, Trade and Consumer Protection.

Copies of the complaint and the two proposed consent decrees in the BioPulse matter are available from the FTC's Web site at http://www.ftc.gov and also from the FTC's Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580. The FTC works for the consumer to prevent fraudulent, deceptive and unfair business practices in the marketplace and to provide information to help consumers spot, stop and avoid them. To file a complaint, or to get free information on any of 150 consumer topics, call toll-free, 1-877-FTC-HELP (1-877-382-4357), or use the complaint form at http://www.ftc.gov. The FTC enters Internet, telemarketing, identity theft and other fraud-related complaints into Consumer Sentinel, a secure, online database available to hundreds of civil and criminal law enforcement agencies in the U.S. and abroad.