The 12/7/98 FTC News Notes announced that FTC, FDA, Health Canada, and Mexico's regulatory agency have adopted an international agreement to combat the fraudulent marketing of health related products, services, and devices. This is what has been needed to put an end to Mexico cancer clinics.
[Declaration of the Mexico-USA-Canada Health Fraud Task Force: Joint Strategies to Combat Health Fraud]:
Whereas, health fraud is a critical problem which can induce death or serious injury and which can cause consumers with serious medical problems to delay or discontinue appropriate medical treatment; and, Whereas, health fraud often results in consumers wasting large sums of money on useless, unproved, deceptively advertised and marketed products, treatments and/or devices; and Whereas, cross-border health fraud has become a serious problem, where fraudulent health products and treatments that originate in one country are marketed to residents of another country; and, Whereas, cross-border health fraud is a particular problem for residents living near the Mexico-United States-Canada borders; and Whereas, for the past several years a Mexico-USA-Canada Health Fraud Task Force ("Task Force"), including officials from the U.S. Food and Drug Administration, the Federal Trade Commission's Bureau of Consumer Protection, and members of the National Association of Attorneys General, representing the United States; the Secretaria de Salud and the Procuraduria Federal del Consumidor, representing Mexico; and the Therapeutic Products Program of Health Canada and the Competition Bureau of Industry Canada, has been meeting semi-annually to exchange ideas and information. Now therefore, in order to establish a more formal framework for continuing and broadening such cooperation and to build on the success of the Task Force in identifying and addressing health fraud issues of mutual concern, the member agencies of the Task Force listed below hereby adopt the following joint strategies to combat health fraud:
To the extent compatible with their laws, enforcement policies and other important interests, each agency intends to:
- Share information describing current trends in health fraud and strategies for addressing emerging problems;
- Cooperate in the detection of cross-border health fraud;
- Inform counterpart agencies as soon as practicable of significant investigations and proceedings involving health fraud occurring or originating in the jurisdiction of such agencies;
- Consider counterpart agency requests to investigate domestic activities having harmful cross-border effects;
- Consider coordinating related enforcement activities with counterpart agencies in appropriate cases;
- Undertake to coordinate import surveillance activities and share information that would maximize surveillance efforts;
- Work to develop and disseminate joint consumer and business education messages about health fraud;
- Seek to promote cooperation among federal, state, provincial, and local law enforcement agencies of all three countries, and, as appropriate, seek to include such agencies in cooperative efforts to combat health fraud;
- Develop further strategies to achieve: coordinated compliance and enforcement; joint consumer and business education; trilateral communication and information exchanges; and the building of partnerships to combat health fraud.
This document is prepared in the English, Spanish and French languages, each text being equally authentic. United States of America: Food and Drug Administration, Federal Trade Commission, and Bureau of Consumer Protection. Mexico: Secretaria de Salud; Canada: Health Canada and Therapeutic Products Program of Health Canada.
Prudential HealthCare announced today its newest program designed to provide members discounts on vitamins, minerals and herbal supplements. The Prudential HealthCare Vitamin Advantage-SM Program offers a catalogue for shopping at home. Prudential HealthCare has an agreement with Rexall Sundown, Inc., one of the largest manufacturer of nutritional supplements, to provide its Rexall Managed Care line of products at a discounted cost to the member. Prudential HealthCare is a brand name for the health and dental products and services offered by The Prudential Insurance Company of America, its subsidiaries and affiliates, 56 Livingston Avenue, Roseland, NJ 07068.
Samuel Homola, DC, has produced an incisive guide to chiropractic's history, benefits, and shortcomings. The book covers both positive and negative aspects. Edited by Stephen Barrett, M.D., the 280-page book is thoroughly referenced and indexed. Copies can be purchased from NCAHF Books, PO 1747, Allentown, PA 18105. The cost is $24.30 (Canada 25.80) for NCAHF members and $26.50 (Canada $28.00) for nonmembers.
The February 26 issue of The Medical Letter on Drugs and Therapeutics, the most respected source of drug information for physicians, has concluded: "The chemical content of homeopathic products is often undefined, and some are so, diluted that they are unlikely to contain any of the original material. These products have not been proven effective for any condition. There is no good reason to use them." [1999;41:20-21]
The Science Panel on Interactive Communication and Health has released a consensus statement calling for the need of an evidence-based approach to interactive health communication. The panel proposed a standardized reporting template, which would help those who develop and evaluate health sites on the Internet to provide results to health professionals, purchasers, and consumers. Interactive health communication includes Web sites, Usenet newsgroups. These new media have potential for great benefit--and great harm: The panel's statement cites studies and reports of dangers from electronic health information, for example, wrong or delayed treatment.
Products with misleading claims are rampant on the Internet. Online support groups can disseminate incorrect or inappropriate information. And privacy is not guaranteed in all cases. On the other hand, consumers can become more educated about their conditions. Computer users may remain anonymous when seeking potentially embarrassing information. Support is available from others with similar conditions. The most up-to-date information can be made available immediately.
The panel proposed an Evaluation Reporting Template for Interactive Health Communication (IHC) Applications. A standard approach such as this would help health professionals, consumers, and purchasers in evaluating specific Interactive HealthCommunication Applications and even compare them. It would also help those who develop IHC applications in knowing what the purchasers and users expect. The template is divided into four sections:
The 14-member nonfederal panel had members with expertise in clinical medicine and nursing, public health, media and instructional design, health systems engineering, decision sciences, computer and communication technologies, and health communication. It was convened by the Office of Disease Prevention and Health Promotion, U.S. Department of Health and Human Services.
Comment: The Internet is a marvelous tool for educating consumers. Many more patients have become more knowledgeable about their conditions and their options for treatment and self-care. But it's also an effective means of spreading false and misleading information quickly to a large number of individuals. Time magazine ran an editorial in the Feb. 8, 1999, issue about the proliferation of certain medical myths. It's also given plenty of opportunities for the hucksters to hawk their products and make their claims without fear of interference--until the FTC started cracking down recently. Consumers and physicians need a way to measure the accuracy and effectiveness of the information they're finding in this electronic age. This evidence-based template provides a starting point. Website: www.scipich.org
The March 1999 issue of Consumer Reports magazine contains an article, "Herbal Rx: The Promises and Pitfalls," which examines the issues surrounding herbal supplements. The magazine provides an overview of the situation created in the marketplace since Congress passed the Dietary Supplements Health and Education Act of 1994. A roster of 18 herbal supplements gives information on their purported benefits, evidence of effectiveness, and side effects. The magazine recommends that Congress re-examine the Dietary Supplement Health and Education Act of 1994, which caused the "free-for-all" now in the marketplace. The editors also suggest that consumers who want to try supplements learn as much as possible and to report any ill effects to their doctor and the FDA's MedWatch monitoring program.
The Medical Letter reports that JAMA published a review article looking at 18 trials of saw palmetto products and their effect on prostate enlargement, or benign prostatic hyperplasia. The condition is generally associated with age and results in decreased urinary flow and increased urinary frequency. Saw palmetto is an herbal supplement made from extracts of the berries from the saw palmetto, a dwarf palm tree found in the southeastern United States. The FDA has not approved saw palmetto for any use. Proscar,or finasteride, as well as several alpha-adrenergic blockers, have FDA approval for the treatment of prostatic enlargement.
The JAMA article (TJ Wilt et al, JAMA, 280:1604, 1998) found that the saw palmetto products improved urinary tract symptoms and urinary flow about the same as finasteride. The Medical Letter concludes that though saw palmetto may decrease the symptoms of prostatic enlargement, "published data are limited and the composition of the extracts has not been standardized."
[The Medical Letter, vol. 41 (issue 1046) 2/12/99].
A Wisconsin judge ordered a woman pushing phony cancer cures to pay a $50,000 fine and refund money to her customers. Shelvie Rettmann, 62, had been accused of claiming to cure cancer with machines not approved by the FDA. Rettman has also been charged in Minnesota with theft by swindle and practicing medicine without a license. Her trial is scheduled for April. Minnesota Attorney General Hubert Humphrey III was quoted in the Minneapolis Star-Tribune saying this is "a case of health quackery at its worst." Her alleged crimes include selling more than $7,000 worth of useless treatments to a man with pancreatic and liver cancer.
[Minneapolis Star-Tribune, Feb. 16, 1999]
The HeartBar, a "medical food," is being test marketed in Sacramento from December to March. The bar contains four grams of L-arginine, an amino acid that increases the body's production of nitric oxide, a blood vessel dilator, plus ingredients such as Vitamins C, E, B6 and B12.
Consumers don't need a prescription for the bar, although the wrapper contains a warning to use under the supervision of a physician. The bars cost $1.95 each and are sold in pharmacies. They were developed by Dr. John Cooke of Stanford University Medical Hospital after 10 years of research, according to The Sacramento Bee. He was quoted saying that studies show heart disease patients who consumed two bars a day for two weeks had vessels dilated to the size of those of healthy persons.
The article quoted physicians both pro and con and profiled a 78-year-old patient who said, "It's like a whole new life." But one cardiologist pointed out the need for long-term studies and the concern that nitric oxide could possibly stimulate the development of heart disease in some cases.
[The Sacramento Bee, Jan 28, 1999] Website: www.cookiepharma.com
Ayurvedic physician and best-selling author Deepak Chopra got a plug in the Los Angeles Times when the paper's Weekend Escapes column targeted The Chopra Center for Well Being. Reporter Susan Spano described the center as "part day spa, part holistic retreat, with a full roster of therapies (consultations, yoga, guided meditation sessions, massages, facials and wraps) inspired by the 5,000-year-old Indian health and spiritual practice known as ayurveda, which views body, mind and spirit as one." Spano took the budget- conscious route, signing up for a day-long "Balance" program on Saturday. She ran a tab of $475.55 for her weekend escape, which included $335 for the center's fee and $11.95 for a Chopra tape. She waxed poetic over the bliss she experienced, complete with sightings of Chopra and a whale heading to Baja for the winter.
[Los Angeles Times, Jan. 24, 1999]
A board-certified psychiatrist in Nyack, NY has been sued by a patient he diagnosed as a hypochondriac for using a bogus medical device. The civil lawsuit, filed in state Superior Court in Paterson [NJ], says that Keith Bachman was seen by Dr. Michael Schachter and then given "electro-dermal testing." The machine, called a Vegatest, is supposed to diagnose problems through an electric probe pressed against the skin. A numerical readout on the machine's gauge reveals where the problems are. Bachman was shown to have food allergies, an impacted molar, and dyspepsia. The article quoted several experts who call such machines a sham, and a FDA spokesperson confirmed that many of these machines are legal because they were grandfathered under a 1976 federal statute forbidding bogus medical devices.
The Federal Trade Commission (FTC) put the brakes on efforts by the American College for the Advancement of Medicine (ACAM) to push chelation therapy as a safe and nonsurgical treatment for atherosclerosis. Chelation therapy uses a chemical to bond with metals in the bloodstream and draw them out. It's approved by the FDA for treating conditions caused by heavy metals in the blood such as lead poisoning but has not been scientifically proven as effective for atherosclerosis. The ACAM, a California group of physicians and other practitioners who promote chelation, agreed to stop distributing a seven-page brochure on chelation therapy, which had also appeared on their website. As part of the agreement, the organization did not have to acknowledge guilt or wrongdoing. ACAM's president said the material didn't even constitute advertising and that the FTC action revealed the agency's bias toward traditional medicine. He denied the material contained inaccuracies.
Stephen Barrett, MD, board chair of Quackwatch Inc., applauded the FTC's action. The government agency, which oversees the advertising of nonprescription drugs, has taken an aggressive stance on the claims made by health products in the last two years. He said the agency has filed more "false advertising" claims in the last two years than during the 1980s. The FTC issued 1,200 warnings after an international health claim Internet "surf day" Nov. 10, 1998 when numerous agencies surfed the Internet and assessed Web sites. Email the FTC to send complaints or comments about health claims on the Internet.
Comment: Here's one effective way for the government to stop some of these rascals from getting the word out. Although it's impossible for the FTC to crack down on everyone advertising products with misleading or false claims, such actions may encourage other companies and practitioners to think twice before they push their products. It's also heartening to see the efforts in policing the Internet, which has become a haven for quacks promoting everything.
A prize-winning series of articles on integrative and alternative medicine and multilevel marketing of Mannatech (a multi-level marketing organization) was published in the Oakland Press, Pontiac, Michigan. Staff Writer Denise Jenkin; Phone: 248 745 4637.
Looking on the Internet for scientific literature on dietary supplements? Click on http:/www.nal.usda.gov/fnic/IBIDS/overview.html for the International Bibliographic Information on Dietary Supplements (IBIDS). The database currently contains more than 250,000 scientific citations and abstracts on vitamins, minerals and botanicals. It is produced by the Office of Dietary Supplements (ODS) at the National Institutes of Health and will be maintained through an interagency partnership with the Food and Nutrition Information Center, National Agricultural Library, U.S. Department of Agriculture.
"Does homeopathy work?" according to the authors of an article in Chemist Druggist. This critical look at the effectiveness of homeopathy was undertaken by the Department of Complementary Medicine, established in 1993 at the University of Exeter. The authors stressed the need for assessing complementary medicine critically, asking three main questions: Is the treatment effective? Safe? Can it save money? About 100 trials of homeopathy have been published, but because single trials are rarely conclusive and certainly not convincing, the authors examined recent systematic reviews.
The largest, by Linde, published in The Lancet in 1997 (350:834-43), concluded that the results of 89 randomized or placebo-controlled, clinical trials of homeopathy could not be due to the placebo effect. However, Linde's meta-analysis included methodologically flawed studies and studies of material dilutions and of nonclassical homeopathy. Once these were eliminated, five trials were left to analyze with a total sample size of 587.
Results: Two trials showed a significantly positive result of homeopathy over placebo, two showed placebo over homeopathy, and one had no difference. The authors then looked at studies for treating the same condition and though they found "some evidence that homeopathic treatment can reduce the duration of post-operative ileus" the"poor quality" of the studies must be taken into consideration. They found the published evidence did not support homeopathic remedies as more effective than placebo when it came to relieving delayed onset muscle soreness. They also looked at all the trials using the same remedy: Arnica montana, chosen because the most data existed. Yet those data did not show Arnica montana more effective than placebo.
Comment: The lack of published evidence supporting the safety and effectiveness of homeopathy has failed to deter the public's love affair with this form of treatment. The authors in Chemist Druggist conclude the need for additional research. As they put it, "Not attempting to answer conclusively the question of whether today's widespread use of homeopathy does more good than harm, therefore, means not acting in the best interest of our patients."
The federal government has requested Medicare beneficiaries to report billing errors, overcharges, and other evidence of fraud by their physicians and hospitals. "Senior citizens are our first line of defense in the battle against Medicare fraud," Donna Shalala, secretary of Health and Human Services, was quoted as saying in The New York Times. The government is even offering rewards of up to $1,000. The campaign's theme is "Who pays? You pay!" Improper Medicare payments have been estimated at $12.6 billion but no figures are available as to how much is due to intentional fraud. The American Medical Association complained to Medicare officials that the campaign is using "inflammatory language" and risks creating an adversarial relationship between patient and doctor. Doctors quoted in the article don't like the government's tactics to use patients for policing Medicare. A Louisiana physician said, "The government is, in effect, asking patients to turn in their doctors." According to the article, more than 8,500 health care providers were excluded from Medicare after practicing fraud or professional misconduct in the last four years. There were 326 criminal convictions for health care fraud last year, compared to 140 in 1994. Medicare fraud hot line: 1-800-447-8477.
[The New York Times, Feb. 24, 1999]
The Dec 7, 1998 issue of Chemical and Engineering News [02/12/99] takes an in-depth look at the controversy surrounding the establishment of the Office of Alternative Medicine, which has blossomed into the National Center for Complementary and Alternative Medicine (NCCAM) with a budget of $50 million and plans to emphasize clinical trials.
Morristown, NJ, Feb 12 (PRNewswire.) All herbal supplements are not created equal--sometimes even within the same bottle. But thanks to the entry of major pharmaceutical companies like Bayer Corporation into the herbal supplements market, consumers can be assured that the supplements they take are standardized with the same amount of the herb's ingredient or marker from bottle to bottle and pill to pill. Bayer was the first major over-the-counter pharmaceutical company to offer herbal Products in the United States. "Large pharmaceutical companies are accustomed to complying with rigorous standards, and they also have the financial power to back up their products with quality assurance testing," said Dr. Robert Kay, an herbal consultant for Bayer's line of herbal supplements, One-A-Day(R) Specialized Blends. To produce One-A-Day Specialized Blends a five-step process is used to ensure a standardized and pure product.
Further, the name on that label should be as important to consumers as the list of ingredients, according to One-A-Day spokesperson Dr. Judith S. Stern, co-director of the University of California-Davis Center for Complementary and Alternative Medicine. "When it comes to using herbal preparations, quality is of the utmost importance," said Dr. Stern. "That is why I recommend buying herbs from a brand that you know and trust." Dr. Stern's advice rings true for many Americans, according to a 1997 Gallup poll on herbal remedies. It showed that, while 41 percent of people are unsure about herbal remedies, still, more than two-thirds of that group said they would try an herbal if it was from a brand they know and trust. Stern's other tips for choosing herbal preparations include:
Dr. Kay agrees, adding, "The bottom line is that I'd be more confident about what's in the bottle, if I knew and trusted the name on the outside." Many companies start off with the same herbal extracts and materials, the end result is not always the same, according to Dr. Kay. "There's an art to making a botanical supplement -- and not all companies are creating masterpieces. If you give an artist and a novice the same materials, what you get from each will be vastly different." One-A-Day Specialized Blends address eight major health benefits and include the following products:
One-A-Day Specialized Blends are a product of the Bayer Corporation Consumer Care Division based in Morris Township, NJ. Headquartered in Pittsburgh, Bayer Corporation is a research-based company with major businesses in health care and life sciences, chemicals and imaging technologies. Bayer Corporation is a member of the worldwide Bayer Group, a $32.4 billion chemical and pharmaceutical company based in Leverkusen, Germany.
Comment: With big insurance companies and large pharmaceutical corporations now in the herbal business, what remains to be done are good clinical trials so we know that both safety and efficacy are proven. How far away from that goal are we? Having trusted researchers as consultants an spokespersons adds a new dimension. Let me hear from our members. I am sure some of you will have something to say. -- John H. Renner M.D.