Consumer Health Digest #15-16
Your Weekly Update of News and Reviews
April 19, 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.
Prominent critic suggests how to regulate homeopathic products. Stephen Barrett, M.D., who has closely tracked the homeopathic marketplace since the 1980s, has submitted a detailed comment to the FDA about homeopathic regulation. Last month the agency announced that it would hold a hearing on April 20 and 21 and invited public comments through its docket portal. 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. Since 1990, the vast majority of homeopathic products sold in the United States were nonprescription (OTC) products subject to the provisions of Compliance Policy Guide CPG 7132.15. This document states that homeopathic products can be marketed OTC for the treatment of "self-limiting disease conditions amenable to self-diagnosis (of symptoms)," but it does not require proof that any product be demonstrated as effective by scientific standards. CPG 7132.15, protects sellers by telling them that if they do not claim to prevent or cure serious diseases, the FDA will leave them alone. However, because homeopathic products are ineffective, it fails to protect consumers. After tracing its history, Dr. Barrett recommends the following.
- It is neither necessary nor possible to establish rules through which claims for ineffective products can be safely made. CPG 7312.15 should be scrapped.
- The distinction between OTC and prescription homeopathics should be abandoned because it serves no purpose.
- Because a complete ban of homeopathic products is probably not politically feasible, the FDA should limit their marketing to single-ingredient products that strictly comply with the Homeopathic Pharmacopeia.
- No health claims should be permitted for homeopathic products unless they are approved through the FDA's standard drug approval process.
- Products that combine a homeopathic ingredient with any other ingredient (homeopathic or not) should be considered new drugs that require premarket approval.
- Lacking approval, the only information that should be permitted in labeling or advertising is the monograph (chemical) name, the dilution, and that fact that the product is homeopathic.
- The FDA should advise consumers not to buy homeopathic products.
- The FDA should give high priority to ridding the marketplace of "electrodermal screening" devices that are used to misdiagnose disease and sell products.
More than 800 comments have been filed so far.
Site started to combat robocalls. This week, Dr. Barrett also launched Robocall Watch with the hope of organizing an international network of people who can campaign against the nuisance of unwanted mass-produced calls. The site's activities will include identifying and reporting scams; reporting relevant news; urging regulatory agencies to do more; persuading telephone companies to enable robocall blocking; urging legislators to tighten the laws; helping law enforcement agencies; and archiving enforcement actions. Robocall Watch's most important activity will be its Robocall Discussion List, which will enable concerned people to share experiences and strategies. Although the site will be "under construction" for several more weeks, it is accepting sign-ups for the discussion list.
Columbia's medical school urged to fire Dr. Oz. Ten physicians have jointly asked Columbia's College of Physicians and Surgeons to remove Mehmet Oz, M.D. from the faculty because of his unethical conduct as host of "The Dr. Oz Show." The letter, sent to Dean of the Faculties of Health Sciences and Medicine, states:
Dr. Oz has repeatedly shown disdain for science and for evidence-based medicine, as well as baseless and relentless opposition to the genetic engineering of food crops. Worst of all, he has manifested an egregious lack of integrity by promoting quack treatments and cures in the interest of personal financial gain. Thus, Dr. Oz is guilty of either outrageous conflicts of interest or flawed judgments about what constitutes appropriate medical treatments, or both. Whatever the nature of his pathology, members of the public are being misled and endangered, which makes Dr. Oz's presence on the faculty of a prestigious medical institution unacceptable.
This page was posted on April 17, 2015.