Consumer Health Digest #03-29
Your Weekly Update of News and Reviews
July 22, 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.
Seasilver agrees to temporary injunction. Defendants in the FTC's Seasilver case have agreed to a temporary injunction under which they are banned from making unsubstantiated claims about the product. They also must recall previously distributed sales materials and to accompany future product distributions with the following notice:
Previously, Seasilver has claimed that its product can cure cancer, diabetes, and a host of other serious diseases and conditions, and that it results in significant and permanent weight loss without dieting. No clinical studies support these claims. In fact, medical experts state that these claims are highly implausible and likely false. If you are under a physician's care, it is very important that you not discontinue or reduce any prescription medication without consulting your physician.
In addition, at one time Seasilver claimed that its product provided the health benefits of natural cranberries, although it contained no natural cranberry. Rather Seasilver contained artificial cranberry flavoring [Stipulated preliminary injunction with asset freeze and other equitable relief. Federal Trade Commission v. Seasilver USA Inc, et al. United States District Court, District of Nevada. CV-S-03-0676-RLH(LRL), July 15, 2003..
Seasilver is an expensive, irrationally formulated supplement product that has been marketed with a long list of false and misleading claims. The FTC action, combined with product seizures by the FDA, shut down Seasilver USA's business temporarily. If the company is able to recover, there will still be no logical reason to use the product. Quackwatch has additional information.
Aetna issues new quackery-related guidelines. Aetna has issued several clinical policy bulletins explaining why it does not cover various questionable procedures:
- Cavitat ultrasonography for neuralgia inducing cavitational osteonecrosis: "The Cavitat Ultrasonograph, an ultrasonograph bone densitometer that has primarily been used to detect neuralgia inducing cavitational osteonecrosis in the jaw bones. The Cavitat Ultrasonograph is considered experimental and investigational." CPG #0642, March 18, 2003. [Neuralgia inducing cavitational osteonecrosis (NICO) is a bogus diagnosis.]
- Spinal Imaging—videofluoroscopy, cineradiography, x-ray digitization and computer analysis of the spine. "Spinal videofluoroscopy and spinal cineradiography . . . are considered experimental and investigational. . . .Digitization of spinal X-rays, and computerized measurements with graphical analysis of joint position and spinal curvature . . . have not been shown to improve patient outcomes and therefore are considered experimental and investigational." CPG #0631, March 18, 2003.
- Spinal ultrasound: "Diagnostic spinal ultrasound for the evaluation of the spine and paraspinal tissues for evaluation of neuromusculoskeletal conditions. . . is considered experimental and investigational." CPG #0628, April 22, 2003.
- Eye movement desensitization and reprocessing (EMDR) therapy: "EMDR therapy for the treatment of post-traumatic stress disorder or other psychiatric and behavioral disorders including phobias, eating disorders, and panic and anxiety disorders . . . effectiveness has not been established." CPG #0583, May 13, 2003.
- Salivary hormone tests for menopause and anti-aging: "Tests of estrogen, progesterone, testosterone, melatonin or DHEA for the screening, diagnosis, or monitoring of menopause or diseases related to aging because these tests have not been proven to be valid for this purpose." CPG #0608, May 13, 2003.
Chiropractor's license may be revoked for dubious practices. In January 2003, the Wisconsin Chiropractic Examining Board revoked the license of Harold J. Dykema, D.C, based on his use of a Toftness Sensometer and three other dubious approaches (neural organization technique, neuro emotional technique, and live cell analysis) in treating a woman who consulted him on the board's behalf. The administrative law judge who evaluated the case for the board concluded:
The evaluative and treatment modalities utilized by Dr. Dykema in this case run the gamut from questionable to absurd. With the possible exception of Neuro Emotional Technique, there is satisfactory evidence that the techniques utilized are useless and, as a trained health care professional, Dr. Dykema should know that they are useless. . . .
If his treatment of [the undercover investigator] is a manifestation of underlying incompetence, retraining would probably not be of value. If he is aware that he provides ineffective care, then his rehabilitation is beyond the powers of this board to effect. Consequently, it is concluded that the objectives of deterring other licensees from engaging in similar misconduct and protecting the public militate for revocation of Dr. Dykema's license.
Dykema is appealing the revocation and has been allowed by the Court to continue practicing pending judicial review. On July 15, the Court reversed one of four charges against Dykema and remanded the case back to the board for a "less severe disciplinary action." The board's decision has been posted to Chirobase. The status of the appeal can be followed by searching the Wisconsin Circuit Court Accesssite for Harold Dykema and clicking the "Court Records" button when the record of the case appears.
Laetrile promoter jailed. A federal jury in Brooklyn has found Jason Vale guilty of criminal contempt for which he is likely to be sentenced to prison. In 1999, a federal court judge ordered Vale to pay $631,585 to America Online for misusing its services to send out more than 20 million unsolicited e-mail messages promoting apricot pits and laetrile tablets as a cure for cancer. Most of his business was conducted under the name ""Christian Brothers." In 2000, acting on a complaint by the FDA, a federal district court judge ordered Vale to stop selling these products. Although Vale signed a consent decree, he continued his sales activity through a network of Internet sites, toll-free telephone numbers, and shell companies. According to federal prosecutors, Vale's supporters distributed leaflets to jurors throughout the trial that advised them to ignore the government's evidence and "vote their conscience." After Vale admitted that he knew those responsible for the leaflets, the judge said he couldn't trust him and ordered him held without bail. [Masters NC. Jurors convict salesman of promoting apricot seed as cancer cure. CNSNews.com, July 22, 2003] Sentencing is scheduled for December 19. Quackwatch has additional background information.
Bogus homeopathic smallpox product stopped. Bill Gray, M.D., a leading homeopath has been ordered to stop marketing a homeopathic product that he falsely claimed would offer protection approximately equal to that of smallpox vaccine. On April 2, the FDA sent Gray a warning letter stating that it was illegal to introduce biological products into interstate commerce without a special license and FDA approval. Gray's Smallpox Information Central Web site is no longer online. HomeoWatch has additional information about Gray' activities.
FDA attacks "anti-radiation pills." The FDA has warned The Sportsman's Guide, of St. Paul, Minnesota, to stop marketing potassium iodide tablets with claims that they can protect the thyroid from radiation damage in the event of an emergency. The company has also claimed that its pills were FDA-approved for this purpose. [Becoat WC. Warning letter to Gary Olen, May 29, 2003]
Rhode Island warns of lead in herbal product. The Rhode Island Department of Health has warned the public not to use Litargirio (pronounced "lee-tar-heario"), a yellow or peach-colored powder manufactured in the Dominican Republic and sold in shops that cater to the Hispanic population. The powder, used as a traditional remedy, contains nearly 80% lead, which can cause neurological damage in children. The warning was triggered by a case of lead poisoning in a child who had used Litargirio as an antiperspirant/deodorant. The product is also used for treating fungus on the feet and for burns. Rhode Island Department of Health. HEALTH Warns RI residents about use of "Litargirio"; traditional remedy contains dangerous levels of lead. News release, June 30, 2003]
This page was posted on July 22, 2003.