"Miracle cures, once thought to have been laughed out of existence, have found a new medium [on the Internet]," says Jodie Bernstein, director of the Federal Trade Commission's Bureau of Consumer Protection, in an FTC press release. The FTC launched the campaign, Operation Cure-All, which uses the Internet as both a law enforcement tool to stop bogus claims and a communication tool to provide consumers with reliable health information. The FTC announced the campaign at a press conference June 24, 1999 during which Bernstein discussed the settlement agreements with four companies charged with making unsubstantiated health claims for products advertised on the Internet. Bernstein also said that two Health Claim Surf Days, conducted by the FTC in 1997 and 1998, identified approximately 800 websites and Usenet newsgroups with questionable content, and 28% of those sites removed their claims or websites after receiving e-mail messages from the FTC. Consumers must be provided with reliable resources so that they can use the Internet to find the support and health care information they need," Bernstein said. Health and medical content is the sixth most commonly accessed type of information on the Internet. Two new FTC Consumer Alerts, Fraudulent Health Claims: Don't Be Fooled and Virtual Treatments Can Be Real-World Deceptions are now available. Two websites were discussed: www.healthfinder.gov is the federal gateway for reliable information and www.fda.gov is the FDA's website for accurate information. Bernstein also offered tips for evaluating health claims. [Federal Trade Commission press release, June 24, 1999]
Modern Healthcare reports that the American Hospital Association (AHA) has found a way to help member hospitals take advantage of money-making alternative treatments. The AHA has formed a partnership with University Hospital and Medical Center, home of the University Center for Complementary and Alternative Medicine in Stony Brook, and part of the State University of New York at Stony Brook, to share education and information about incorporating alternative treatments into standard care. The move is in response to patient demand, according to AHA's chief operating officer Jonathan Lord, MD, but he was also quoted as saying alternative therapies can be a potential source of new revenues and give hospitals a competitive edge. Patients pay for most alternative treatments out of pocket, and JAMA (Nov. 16, 1998, p. 16) estimated that Americans spent more than $21 billion on visits to alternative practitioners in 1997. [Modern Healthcare, 9/27/1999]
Carefirst Blue Cross Blue Shield has become one of the first insurers in the nation to discount alternative therapies in response to customers. Acupuncture, chiropractic, massage therapy, fitness centers, personal trainers and yoga classes are among the alternative therapies included in the discount program. Members will receive a 15 to 25 percent discount. Although members don't need a referral from their primary care physician, they will need to see alternative practitioners who have been screened to meet training, licensure and experience requirements by Consensus Health Corp, based in Emeryville, California. Carefirst has 2.5 million members in northern Virginia, the District of Columbia, Maryland and southern Delaware. It is a not-for-profit health care company. [US Newswire, 9/21/1999]
In "The Juice Plus+ 'miracle'; Can powdered, encapsuled foods save your health?" Nutrition Forum 1999;16:41+) Stephen Barrett, MD, does a splendid job of exposing the realities behind the multilevel marketed product Juice Plus+. The products claim to confer the benefits attributed to the whole foods from which juice supplements are derived. Further, they promote nonsense about the value of enzymes in foods. Barrett also points to the invalidity of selling points made by Richard DuBois, MD, a board certified internist who is huckstering for Juice Plus+. The bottom line is that obtaining one's veges the Juice Plus+ way would be enormously expensive, and one would be buying degraded foodstuffs.
In a side-bar, Barrett debunks the claims of super salesman Jay Kordich, aka "The Juiceman." Misinformation similar to those above apply to Kordich's promotions, but spectacular claims about the ability of juicing to "flush the body of toxins," "energize," or alleviate serious diseases take nonsense to a higher level.
Baltimore cardiologist Stephen Gottlieb decided to conduct a study of Coenzyme Q10 after discovering that about a third of his congestive heart failure patients were taking the nutritional supplement, which is also known as CoQ10 or ubiquinone. Fifty congestive heart failure patients enrolled in the six-month study. The Baltimore Sun reported that CoQ10 made no difference in how much patients could exercise and how much blood their hearts could pump. Any feelings of well-being probably stemmed from the placebo effect. Patients felt better because they believed they would. Gottlieb, who is director of the cardiac care unit at the University of Maryland Medical Center, presented his study at a national heart-failure conference in San Francisco. Magazines and internet sites have touted CoQ10 as a treatment not only for congestive heart disease, but for angina, chronic fatigue, high blood pressure and high cholesterol as well. The Baltimore Sun quoted a pharmacist who said that the supplement has been available for 20 years, but its popularity has increased dramatically in the last 5 years. [The Baltimore Sun, 9/27/1999]
Just as some prescription medicines can be dangerous if taken before surgery, so can some commonly used herbs. Ginkgo biloba, garlic, ginger and ginseng are anticoagulants; they keep the blood from forming clots and could cause excessive blood loss during surgery. The anti-depressant St. John's wort and relaxant kava-kava can extend the sedative effective of anesthesia.
Yet 17 percent of presurgical patients report that they take at least one herbal medicine, according to a survey of 979 patients conducted by anesthesiologist Dr. Charles McLeskey. He presented his findings to the American Society of Anesthesiologists in Dallas, according to the Associated Press. [The Associated Press, 10/15/1999]
The Brown County Democrat (10/6/99) reports that Feb 2, 2000 has been set as the trial date for Hulda Regehr Clark, who was charged with practicing medicine without a license in Brown County, Indiana in 1993. The charges stem from an undercover investigation by the Indiana Attorney General's Office and the state Department of Health. Clark, who has a PhD, but not an MD, says she has discovered parasites that cause cancer and AIDS and claims she can use herbs and an electronic device to cure these diseases. Clark was arrested Sept 20 by the FBI in California, according to the San Diego Union (10/5/99). That article calls her a miracle worker to the patients who say she cured them at her Tijuana clinic using unconventional treatments. Clark is the author of three self-published books: The Cure for All Cancers, The Cure for HIV and AIDS, and The Cure for All Diseases. She has pled not guilty to the charges. Her cronies and supporters are organizing to defend her. Readers can view Clark's claims on the Internet at: firstname.lastname@example.org or email@example.com
NCRHI has collected a pile of those slick, four-color flyers put out by Gero Vita Laboratories of Toronto, Canada. People send them to us because they are so quackish. Like us, most seem to wonder how such blatant, exaggerated claims can continue to be distributed by the U.S. Postal Service. Well, at least the FDA has taken some action. In March, 1999, the FDA banned the importation of all Gero Vita products marketed with claims that they can prevent or treat disease. Unfortunately, the action is not likely to have an effect because all Gero Vita has to do is have such products shipped from within the USA to outwit the importation ban.
In 1998, James Rosenfield, a lecturer and writer on marketing and direct marketing, wrote a stinging critique of Gero Vita promotions that appeared in Direct Marketing magazine (Oct, 1998)--reprinted in Swift 1998; 2(3&4):16-18
Skip the Web when it comes to filling your prescriptions online. It may sound convenient but it could cost your wallet and even endanger your health, according to an article in HealthSCOUT. Researchers at the University of Pennsylvania reported their findings in the October 1999 Annals of Internal Medicine. Study co-author Bernard S. Bloom from the University of Pennsylvania Medical School told HealthSCOUT that the cost of getting prescription medications over the Internet was substantially more expensive, because the drugs are generally priced higher, the physicians visit over the Web is higher (sometimes the source for the prescription), and shipping costs are added on. There are also risk factors because you don't know if you're getting the right dosage or the right drug or whether your Web doctor is a genuine physician. You're also at greater risk for drug interactions. And the FDA is concerned that drugs could be contaminated. The American Medical Association has formally adopted the position that writing a prescription based only on an online visit fails to meet the appropriate medical standard of care. In an accompanying editorial, the FDA agrees with the AMA. States are following suit--more than a dozen don't allow such practices. Note: Websites for major chains are in a different category; they require a copy of the prescription or a call from the patient's doctor. [HealthSCOUT, 10/1/1999]
According to a 9/27/99 press release by the American Chiropractic Association, the House of Representatives approved the Veterans Millennium Health Care Act HR 2116, which could potentially result in full integration of chiropractic care in the VA health care system. The release also credits joint lobbying efforts by the American Chiropractic Association and the Association of Chiropractic Colleges for the House's approval.
The National Center for Complementary and Alternative Medicine (NCCAM) (part of the National Institutes of Health), has awarded five Specialized Center Research Grants to advance complementary and alternative medicine research in aging, arthritis, craniofacial disorders, neurological disorders, women's health and cardiovascular disease in African Americans. Five-year grants, each totaling approximately $7.5 million, were awarded. [Department of Health and Human Services press release, 10/4/1999]
The National Institutes of Health, through the Office of Dietary Supplements in collaboration with NCCAM, has announced funding to establish the first Dietary Supplements Research Centers with an emphasis on botanicals. These awards of approximately $1.5 million a year for five years were made to the University of California at Los Angeles and to the University of Illinois at Chicago. The UCLA center, directed by Dr. David Heber, will look at yeast fermented rice for cholesterol reduction, green tea extract and soy for inhibition of tumor growth, and do research on St. John's wort as well as assess levels of bioactive compounds in several botanicals available as dietary supplements. The UIC center, directed by Dr. Norman Farnsworth, will focus on 10 herbal supplements with implications for women's health. That center will also support research training in pharmacognosy (the study of natural products, primarily plants) and provide information to consumers, including the establishment of an interactive website. [NIH press release, 10/6/1999]
Jasmuheen, author of the book, Living on Light, claims on her website that her physical nourishment has come solely from liquid Light since mid-1993. She refers to this as Pranic Nourishment. Her newsletter, The ELRAANIS Voice which is the voice for MAPS-The Movement of an Awakened Positive Society is also available online.
According to the British Medical Journal, some deans' letters, which accompany applications for residency, may put a positive spin on the budding physician's record. Researchers found more than a third of the 500 letters they looked at -- and compared to actual records from the medical schools -- failed to mention relevant negative information such as failing an exam. [British Medical Journal, 10/16/1999]
Dr. Dean Edell reported on the results of a study looking at melatonin's effect on jet lag. Touted as a cure for jet lag and insomnia, melatonin is a hormone made by the body but is also sold as a food supplement and has been extremely popular. The study, in the American Journal of Psychiatry (1999;156:1392-1396), compared various dosages of melatonin with placebo on a group of Norwegian physicians flying back to Norway after five days in the US. The melatonin made no difference on the symptoms of jet lag. Dr. Edell also reports that melatonin fails to help sleep problems in younger adults but may help the elderly who suffer from lower levels of the hormone. One concern, however, is taking too much because most supplements contain 3 to 5 milligrams, around 10 to 15 times more than what the body makes. [Dr. Dean Edell, TV report, 9/21/1999]
In New Zealand, legislature-mandated changes in accident and injury insurance may be dangerous to patients, say physicians. Injured patients can now receive immediate treatment from a range of treatment providers that include chiropractors, acupuncturists and physiotherapists -- any provider who can show competency to treat. But health care providers need to be able to diagnose the underlying condition properly, New Zealand Medical Association chairwoman Pippa MacKay is quoted saying.The NZMA is collecting cases in which these practitioners failed to diagnose the condition and improper treatment was provided. [from www.press.co.nz]
Harold Shipman, a 53-year-old GP in Great Britain, was charged with 15 counts of murder, according to the British Medical Journal. He allegedly killed 15 women, most of whom were widows, between the ages of 49 and 81 from 1995 to 1998. He was also charged with forging the will for one of his victims. BMJ called the investigation one of the biggest murder inquiries in Europe. Police looked into the deaths of more than 100 of Shipman's former patients and exhumed a number of bodies. Shipman has denied the charges. [British Medical Journal, Oct 9, 1999]
Lawrence Perry, 46, an "herbalist" who operates the General Health Care Facility for Preventive and Alternative Medicine in Columbus, North Carolina, has been charged with manslaughter in the October 21 death of 8-year-old Helena Rose Kolitwenzew. Perry is alleged to have urged the child's mother to use herbs rather than insulin for the treatment of diabetes. [Times-News (Hendersonville, NC), 11/14/1999]
Illinois Attorney General Jim Ryan sued an Aurora medical clinic that has been promising to cure patients with devastating diseases. Ryan charged Life Care Systems, GenSys, Inc (Life Care's associated lab) Stephen Wechter and John Peterson with violating the Illinois Consumer Fraud and Deceptive Business Practices Act by telling consumers that they had sound medical evidence that they had found the cure to such diseases as multiple sclerosis, lupus, and Lou Gehrig's Disease, rheumatoid arthritis, Alzheimer's Disease, and other degenerative disorders. Consumers were told that a bacteria known as spirochete, found in water, caused their diseases and that only GenSys lab had the technology to detect it. Life Care Systems employed doctors to prescribe various antibiotics that the defendants claimed would cure the disorders based upon blood tests provided by the GenSys lab. At least one patient was told not to inform her regular physician that she was being treated by Life Care. When Ryan's Health Care Bureau served an administrative subpoena on the defendants asking for substantiation of their claims, no evidence was provided that they had a cure or had helped any patients recover. The AG had received 18 consumer complaints against the defendants regarding various unfair billing practices. [From Press Release, 11/17/99]
Richard Panush, MD, of the Department of Medicine at St. Barnabas Medical Center at Livingston, NJ, served as guest editor for the Rheumatic Disease Clinics of North America's issue of "Complementary and Alternative Therapies for Rheumatic Diseases I," 1999;25(4):789-994. Dr. Panush approaches the topic from many perspectives, but is true to science in his open-minded, yet skeptical approach, and with an emphasis upon the need for evidence and responsible behavior on the part of health care providers. Part one deals with the epidemiology of CAM practices, presents the nature of quackery from the NCAHF perspective (by William Jarvis, PhD), talking with patients about CAM, a patient's perspective on why he would want to use CAM, and physician viewpoints both for and against recommending CAM. Part two deals with therapies: placebos; antibiotics; spa therapy; topical agents; venoms, copper and zinc; trace elements; and, diets, dietary supplements, and nutritional therapies. Rheumatic Disease Clinics of North America is published quarterly by the WB Saunders Company of Philadelphia.
Herbal marketers argue that the deregulation of herbal remedies was necessitated by the high cost of moving an herbal remedy product through the FDA drug approval process. The Pharmaceutical Marketing Association (PMA) is the source of the data that claims it cost $231 million to develop a drug in 1990. According to the PMA, the cost had grown from $54 million in 1976 to $87 million in 1982, and $125 million in 1987--all were total costs evenly divided into direct and indirect costs.1 Robert Temple, MD, of the FDA's Office of Drug Evaluation and Research rejected the view that drug trials are too expensive, and has said that the drug industry uses high figures to show how expensive it is for them to stay in business.2 To my knowledge, there has been no independent confirmation of these cost estimates. I do know that creative accounting procedures can be used to run up costs to meet political needs. For instance, when the railroads wanted to get rid of passenger trains they inflated operating costs by charging bridge and building maintenance to the passenger trains even though all trains used the facilities. How many of the high costs attributed to new drug development are for new buildings, CEO bonuses, special conferences, or whatever, can only be known by highly placed insiders.
Insight on the real costs of drug development, that can be used for comparison, recently became known to me in a report on the Orphan Drug program. An Orphan Drug is a category of products developed to treat an "orphan disease," ie, one that affects fewer than 200,000 persons in the USA. Pharmaceutical firms have little incentive to develop new drugs for orphan diseases because the potential market value is unlikely to make the investment profitable. Congress passed the Orphan Drug Act in 1983 which provided incentives such as: (1) seven years exclusive marketing rights; (2) research grants; (3) assistance with protocol design to assure conformity to regulatory requirements; (4) tax credits for 50% of clinical trial costs. The Orphan Products Grant Program funds $11.5 million annually. Researchers may receive up to $200,000 a year for a maximum of 3 years for clinical trials on the safety and efficacy of orphan products. From 1983-1998, a total of $115 million has been awarded and has funded 384 grant studies. During that same period, the FDA approved 182 orphan products.3
Comparisons are always fraught with difficulties, but it seems clear from the foregoing data that the cost of developing orphan drug products is far below the amount claimed by the PMA, and that the claim that it would cost $200 million to prove the clinical value of an herbal remedy is without foundation. In the first place, the cost of proving the value of herbal remedies would be far less than new drugs because botanicals already exist and much is known about the pharmacological substances they contain. Such products primarily need to be tested for safety and efficacy, they do not have the costs of initial discovery. The reality is that the herbal remedy product industry is a multi-billion dollar business that could easily afford to test its products if the law required it to do so.
It is generally acknowledged that the tough regulatory standards of the USA have resulted in a superior pharmaceutical industry. Every parent, teacher and coach knows that one gets the kind of behavior that one rewards. The reality that lax standards stifles incentive to research and progress is supported by the fact that chiropractic has not made a single contribution to the body of knowledge used by healthcare worldwide because lawmakers have never required it to meet scientific standards of conduct.
Mainstream pharmaceutical companies are now cashing in on the bonanza created by the 1994 dietary supplements law, and some are making as much money on dubious herbal remedies as their legitimate medicines. Mainstream drug companies were probably frustrated by the double-standard created by a law that allows herbal remedies unfair advantage over standard medications. It is easy to understand the logic of "if you can't lick 'em, join 'em," but a downside to such an approach is it undermines the concept that legitimate drug companies are primarily committed to scientific altruism. Company leaders would do well to recall an old caveat: "When you lie down with dogs, you will arise with fleas." Standard companies should stand up for evidence-based products and demand scientific standards for everyone in the medicine-product industry.