Consumer Health Digest #05-08
Your Weekly Update of News and Reviews
February 22, 2005
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.
Medicare carrier attacks chelation fraud. The CIGNA HealthCare Medicare Administration, which processes Medicare claims for Idaho, North Carolina, and Tennessee, has concluded that many claim submissions for chelation therapy have been inappropriate. This conclusion was documented by a study of 40 claims which found that, in many cases, "heavy metal toxicity" was inappropriately diagnosed and no need for chelation was documented. This finding is not surprising because many chelation therapists tell patients they are toxic when they are not. On November 24, 2004—to guide providers and claims reviewers—the company published a "Progressive Correction Action Review" which included the following points:
- Chelation therapy for treatment of arteriosclerosis is not covered by Medicare.
- The screening of symptom-free individuals for heavy metal toxicity is not a Medicare-covered benefit.
- Services related to and leading up to non-covered services are not covered under Medicare. For example, if the chelation therapy is not covered, associated evaluation/management services, infusion codes, and laboratory tests are not payable.
- History of past exposure and nonspecific symptoms and findings in the presence of elevated heavy metal levels in and by themselves do not constitute heavy metal toxicity. An effort corresponding to the standard of practice must be made to corroborate a cause-effect relationship and to establish the diagnosis. . . .
- The decision to initiate chelation therapy cannot be based solely on specific blood or urine levels but depends on the "whole picture," which includes the constellation and severity of clinical symptoms and findings.
- The "gold standard" for evaluating acute heavy metal toxicity is the blood level. Although measuring the excretion of heavy metals in the urine after provocation with edetate calcium disodium may demonstrate an increased body burden with previous high-level exposures, this only indicates previous exposure, not past or current poisoning.
- Treatment with chelating agents may have significant adverse effects. The rationale for initiating and continuing therapy must be solid, in keeping with the standard of practice, evidence based, and well documented in the medical record.
Connecticut chelationist restricted. Robban A. Sica, M.D., who operates the Center for the Healing Arts in Orange, Connecticut, has settled charges related to her care of about about 40 patients. In 2003, she was charged with improperly using chelation therapy to treat cardiovascular disease, failing to obtain adequate consent for such treatment, and failing to properly manage many of these patients whom she said were suffering from heavy metal toxicity. The case has been settled with a consent agreement that she will: (a) serve a year of probation, (b) stop using DMPS as a chelating agent, (c) stop using a provoked test to diagnose heavy metal toxicity, (d) use a patient consent form which states that chelation therapy has not been scientifically substantiated, and (e) have her practice monitored by an independent consultant. Quackwatch has additional information about Sica's activities.
Court upholds acupuncturist's license revocation for cancer fraud. The Rhode Island Superior Court has upheld the Rhode Island Department of Health (DOH)'s disciplinary action against Long V. Mai. In 2001, the DOH permanently revoked Mai's acupuncture license for engaging in “dishonorable, unethical and unprofessional conduct which may deceive, defraud and harm the public." Documents in the case indicate that Mai had stated that he could cure cancer and other serious diseases and had sold herbal products at exorbitant prices. The Superior Court's ruling states:
The Court finds that the DOH had overwhelming evidence to conclude that the Appellant preyed upon vulnerable individuals in times of personal crisis. He made numerous empty promises to extort disproportionate sums of money for the services he provided. To add insult to injury, he published advertisements that contained reproductions of his State-issued license to practice acupuncture to lend credence to this disgusting operation. As such the record evidence demonstrates the necessity of the penalty to protect the public from potential harm at the hands of Dr. Mai. Therefore, the Court not only refuses to disturb the decisions and orders of the DOH but, rather, wholly endorses the penalty imposed on Dr. Mai.
The DOH Web site indicates that Mai is the only Rhode Island acupuncturist whom the board has disciplined since the state's acupuncture licensing law went into effect in 1991. Another Rhode Island law enables some unlicensed persons to offer health care, but the DOH refused to permit Mai to practice Chinese herbal medicine. The appeals court's decision is posted on Casewatch.
FTC nails Paul Harvey advertiser. Hi-Health Supermart Corporation (Hi-Health) and its owner, Simon Chalpin, have settled Federal Trade Commission charges that they made unsubstantiated advertising claims that their "Premier Formula for Ocular Nutrition-Optim3" can restore vision lost from age-related macular degeneration and eliminate "floaters" (small specks that move in the field of vision). The proposed consent agreement bans the respondents from making unsubstantiated claims that the product or any similar supplement product: (a) restores vision lost from macular degeneration, or (b) eliminates floaters. It also requires payment of $450,000 to the FTC. The FTC complaint states that from January 2002 to June 2004, the respondents advertised Ocular Nutrition primarily through testimonials and other statements read on the Paul Harvey News & Comment radio show. [Seller of "Ocular Nutrition" Dietary Supplement That Purports to Treat Eye Diseases Settles FTC Charges and Pays $450,000. FTC news release, Feb 15, 2005] Hi-Health's Web site features a "Wellness Education Center" that contains hundred of articles about dietary supplements, homeopathic products, herbal products, and "health concerns." Much of this information is misleading.
Former laetrile peddler disciplined again. The Medical Board of California has publicly reprimanded James R. Privitera, Jr., M.D., for "failing to perform an adequate history and physical of a patient before commencing treatment, and for failing to maintain adequate and accurate records of the care and treatment provided to that patient." The patient was a 71-year-old woman who in 1999 had complained of a headache while in Privitera's waiting room. According to the Medical Board's complaint, Privitera (a) prescribed 20,000 units of heparin (an anticoagulant) to be placed under the woman's tongue, (b) examined a blood sample with a dark-field microscope, (c) concluded that the blood specimen showed too much tendency to clot, and (d) prescribed another 20,000 units of heparin to be given under the patient's skin. Soon afterward, the patient became lightheaded, vomited, and passed out. She was rushed to a hospital. where it was noted that she was comatose and bleeding from several places. She died a few hours later, apparently as a result of a massive hemorrhage inside her head. In 2003, the Medical Board charged that Privitera had (a) failed to properly evaluate the woman's headache, (b) had no documented rationale for administering heparin, and (c) had administered an overdose. The case was settled with a stipulation under which Privitera agreed to be reprimanded, pay $5,000 in costs, and take courses in prescribing and medical recordkeeping.
In 1975, Privitera was convicted of conspiring to prescribe and distribute laetrile and was sentenced to six months in prison. (Laetrile is a bogus cancer remedy.) In 1980, after the appeals process ended, he served 55 days in jail but was released after being pardoned by California Governor Jerry Brown. Then, because Privitera had been prescribing unapproved substances for the treatment of cancer, the California Board of Medical Quality Assurance suspended his medical license for four months and placed him on ten years' probation under board supervision. During the probationary period, Privitera was "prohibited from making any representation that he is able to cure cancer through nutrition." During the probationary period, he began marketing darkfield microscope equipment for performing "live cell analysis," a blood test that aberrant practitioners use for recommending dietary supplements. Privitera improperly states that live cell analysis can be used to diagnose "clot malfunction," which he claims is an underlying cause of many diseases. Quackwatch has additional information about his activities.
This page was posted on February 22, 2005.