Consumer Health Digest #11-42
Your Weekly Update of News and Reviews
December 8, 2011
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.
Cochrane reviews undercut chiropractic hype. A recent Cochrane Collaboration review examined the effect of spinal manipulation plus other modalities on low-back pain. The other modalities were heat and cold therapy, electrotherapy, mechanical devices, exercise, nutritional advice, orthotics, lifestyle modification, and patient education. The reviewers concluded that although combined chiropractic interventions slightly improved pain and disability in the short term and pain in the medium term for acute and subacute low-back pain, "there is currently no evidence to support or refute that combined chiropractic interventions provide a clinically meaningful advantage over other treatments for pain or disability in people with low-back pain." [Walker BF and others. Combined chiropractic interventions for low-back pain. Cochrane Database of Systematic Reviews 2010, Issue 4. Article. No. CD005427] A subsequent review drew similar conclusions for chronic low-back pain. [Rubinstein SM and others. Spinal manipulation for chronic low back pain. Cochrane Database of Systematic Reviews 2011, Issue 2. Article. No. CD008112]
Burzynski facing more regulatory action. The Texas Medical Board has charged Stanislaw Burzynski, M.D. with (a) failure to meet standard of care, (b) negligence, (c) lack of diligence, (d) lack of informed consent, (e) unprofessional conduct, and (f) non-therapeutic prescribing. The charges are related to his management of two cancer patients. According to the complaint:
- He treated a woman with breast cancer with a combination of five immunotherapy drugs that are not FDA-approved for treating breast cancer and that the combination plus a chemotherapy agent caused the woman to have unwarranted side effects.
- He treated a neuroblastoma patient with a drug that lacks FDA approval for that cancer and continued it for an 11-month period even though the cancer kept growing.
Burzynski has achieved notoriety by claiming that substances he calls "antineoplastons" can cure cancers by normalizing cancer cells. He and his supporters also claim that he has been unfairly targeted by regulatory agencies.
This is the second time Burzynski has faced board action. In 1994, he was placed on 10-years' probation for violating state and federal laws by treating AIDS and cancer patients with antineoplastons. He subsequently worked out a unique arrangement under which he could conduct clinical trials, but knowledgeable observers have challenged the validity of the trials.
In 2009, the FDA notified the Burzynski Research Institute's institutional review board that its oversight of Burzynski's research was seriously deficient. The Science-Based Medicine Blog contains additional information about Burzynski's activities.
"Homeopathic HCG" products targeted. The FDA and FTC have warned six companies that it is illegal to market over-the counter HCG products that are labeled as "homeopathic" for weight loss. [FDA, FTC act to remove "homeopathic" HCG weight loss products from the market. Joint action is first step in halting sale of the products. FDA news release, Dec 6, 2011] The targeted companies are:
- Theoriginalhcgdrops.com (New York City)
- Nutri Fusion Systems, Inc (Sandy Utah)
- Hcg-miracleweightloss.com (Orofino, Idaho)
- Natural Medical Supply, LLC d/b/a HCG Complete Diet (American Fork, Utah)
- HCG Platinum, LLC (Bluffdale, Utah)
- HCG Diet Direct, LLC (Tucson, Arizona)
Human chorionic gonadotropin (HCG), a hormone produced by the human placenta and found in the urine of pregnant women, is FDA-approved as an injectable prescription drug for the treatment of some cases of female infertility and other medical conditions. No HCG drug products are approved for weight loss. The products have been marketed online and in retail outlets as oral drops, pellets, and sprays. Their labeling states that each should be taken in conjunction with a very low calorie diet. However, there is no scientific evidence HCG increases weight loss beyond that resulting from the caloric restriction. Very-low-calorie diets can trigger gallstone formation, electrolyte imbalance, and abnormal heart rhythms.
Ephedra products seized. At the FDA's request, U.S. Marshals have seized raw materials containing ephedrine alkaloids imported by Infinity Marketing Group, Inc. The action, which took place in Rancho Dominguez, California, removed more than $70,000 worth of these potentially dangerous dietary supplement ingredients from the market. The warrant authorized the seizure of more than 4,000 pounds of raw material—Cissus quadrangularis and Cassia angustifolia extracts—that contained alkaloids. Ephedrine alkaloids are adrenaline-like stimulants that can have potentially dangerous effects. Prior to 2004, ephedra products were extensively promoted for aiding weight control and boosting sports performance and energy, but after their use was linked to heart attacks, strokes, and other serious adverse effects, ephedrine alkaloids were banned as a dietary supplement ingredient. FDA's chemical analysis confirmed their presence in the shipment, even though the shipping drum labels did not disclose them. [U.S. Marshals seize products containing banned ephedrine for dietary supplements: Potentially dangerous products banned for use in supplements in 2004. FDA news release, Dec 6, 2011]
This page was posted on December 8, 2011.