Consumer Health Digest #15-13
Your Weekly Update of News and Reviews
March 29, 2015
Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D., with help from William M. London, Ed.D., M.P.H. 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.
FDA will reexamine its homeopathic product regulation. The U.S. Food and Drug Administration (FDA) has scheduled a public hearing to discuss the homeopathic marketplace and the regulation of homeopathic products. The 1938 Federal Food, Drug, and Cosmetic Act permits all substances included in the Homeopathic Pharmacopeia of the United States to be marketed as drugs, but the FDA has not held homeopathic products to the same standards as other drugs. The FDA is seeking participants for the hearing and written comments from all interested parties. The hearing is scheduled for April 20 and 21 from 9 AM to 4 PM at the FDA's White Oak Campus in Silver Spring, Maryland. Registration is free and available on a first-come, first-served basis. Registration to attend or provide oral testimony must be done by April 13th. Comments can also be submitted online. The hearing will be viewable on the Internet, and a transcript will eventually be available. The Federal Register has complete details.
Note: The March 15th issue of Consumer Health Digest contained the wrong link to the Australian Government's National Health and Research Council's 40-page information paper titled Evidence on the effectiveness of homeopathy for treating health conditions. The report is relevant to the FDA proceedings because it concludes, essentially, that homeopathic treatment is worthless.
Another "biological" dentist in trouble. Washington's Dental Quality Assurance Commission (DQAC) has charged Runar D. Johnson, D.D.S. with unprofessional conduct related to his credentials, his infection control procedures, and his care of three patients. The DQAC's statement of charges alleges that he (a) represented himself as naturopath although he is not licensed as a naturopathic physician in the state of Washington, (b) administered tests and treatments that are outside the appropriate scope of dentistry, (c) failed to keep adequate records, and (d) did not meet infection control standards. Johnson's Web site states that he "offers an alternative to traditional dentistry" and that he recently "graduated from The School of Integrative Biologic Dental Medicine as a Board Certified Naturopathic Physician." (This school is not accredited by an agency recognized by the U.S. Secretary of Education.) Johnson has also lectured at "biological dentistry" conferences. In 2001, Johnson signed an agreed order under which he was reprimanded and fined $10,000 for failing to cooperate with a board investigation of his orthodontic treatment of a patient. He was also ordered to take additional training, pass a jurisprudence examination, and have his current and future orthodontic cases reviewed by an orthodontic consultant. The order notes that he had (a) failed to submit requested documents, (b) tried to intimidate the patient into withdrawing the complaint, (c) failed to create and maintain appropriate records, (d) failed to perform necessary procedures, and (e) failed to refer the patient to an orthodontist when the patient's condition had worsened.
Gonzalez cancer claims examined. Retired surgeon Peter J. Moran and a colleague have reviewed One Man Alone: An Investigation of Nutrition, Cancer, and William Donald Kelley, in which the book's author, Nicholas Gonzalez, M.D., evaluates Kelley's "metabolic" treatment of 50 patients. Gonzalez, who has provided similar treatment since 1987, typically prescribes coffee enemas, dietary strategies, and up to 150 pills a day for his patients. The review notes that to provide credible evidence of a possible cure, cases should demonstrate three things:
- There should be a firm diagnosis of an invasive cancer of a type that has predictable behavior. This usually requires biopsy evidence, but some diagnoses can be reliably based on imaging and/or laboratory tests.
- All signs of cancer disappear with the use of the treatment being assessed, with that treatment alone, and within a time frame consistent with a causal relationship.
- The patient stays cancer-free long enough to conclude that a cure has occurred or the tumor is unlikely to recur.
Moran's review states that none of Gonzalez's cases satisfied these criteria. At least 41 had been treated with surgery, radiation, and/or chemotherapy that could have been responsible for the length of their survival. The rest lacked biopsy evidence and/or had cancers that typically have long survival times. Gonzalez also claims that the famous cancer researcher Dr. Robert Good regarded his work favorably. However, letters from Dr. Good indicate that this was not true.
This page was posted on March 29, 2015.