Consumer Health Digest #15-38
Your Weekly Update of News and Reviews
September 27, 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.
FTC holds homeopathy workshop. On September 21, the U.S. Federal Trade Commission held a 4 -hour workshop on homeopathic advertising. The topics included: (a) changes in the homeopathic market, its advertising, and what consumers know, (b) scientific research that tested whether homeopathic products are effective, (c) the effects of recent class actions against homeopathic product companies, (d) how Section 5 of the FTC Act should be applied to advertising claims for homeopathic products, and (e) public policy concerns about the current regulation of homeopathic products. The speaker list and a Webcast of the proceedings are available online. (Click "Event Speakers" to display the speaker list.)
The U.S. Food and Drug Administration is also reviewing its homeopathic policies. During the public comment period, the FTC staff noted that the FDA's homeopathic Compliance Policy Guide CPG 7132.15, which does not require proof of effectiveness, clashes with FTC laws that require that advertising be truthful and based on reliable scientific evidence. The FTC staff's 99-page report also noted (based on the FTC's own research) that a significant percentage of consumers do not understand the nature of homeopathic products or how they are regulated. Dr. Stephen Barrett has asked both agencies not to permit product labels or advertising to include any health or safety claims—including any implied by product names—that have not been approved through the FDA's standard drug approval process. [FDA submission] [FTC submission] Homeopathic labeling regulations in Canada and the United Kingdom are similar to those of the FDA, but the British Advertising Standards Authority has been tougher on advertising claims.
JAMA editorial suggests that discussions of "conflicts of interest" have been simplistic. JAMA has published an editorial suggesting that "conflicts of interest" related to drug research and promotion are far more complex than they might seem. The authors state:
- The term "conflict of interest" is pejorative, confrontational, and improperly implies that there has been inappropriate behavior. A better term would be confluence of interest, which considers that the potential for bias can extend to departments, research institutes, universities, and nonprofit funders (such as the National Institutes of Health and foundations), as well as to journals that might generate advertising revenue from sponsors.
- Although disclosures have focused on financial gain, in academia, the prospect of fame may be more seductive than fortune.
- Safeguards can be deployed to counter all of the potential problems.
Source: Cappola AR, FitzGerald GA. Confluence, not conflict of interest: Name change necessary. JAMA, Sept 24, 2015. The full article can be read online free of charge.
Chelation leader facing criminal charges. Cardiologist Roy G. Heilbron, M.D., who has co-chaired chelation workshops for the American Academy for Advancement in Medicine, has been charged with health care fraud and wire fraud that involved submitting false and fraudulent claims to Medicare, Blue Cross Blue Shield, and other health insurers in 2010 and 2011. The indictment alleges that he:
- Performed and billed for a wide array of unnecessary tests on every new patient and submitted false diagnoses with the billing claims to justify the tests to the insurance plans
- Inserted false symptoms, observations, and diagnoses into patients' medical charts to provide written support for the tests he ordered or performed
- Inserted photocopied clinical notes, diagnostic test results, and ultrasound images in patients' medical charts to create a written record of procedures that were either not performed or that had not been sufficiently documented to support the billing
- Submitted the photocopied notes, results, and images to the insurance plans when the plans requested documentation to support the claims submitted
- Submitted claims to health plans for procedures that were never performed
- Submitted claims for procedures performed on two consecutive dates to increase the amount paid for services that were actually rendered together on one single date
- Misused billing codes and modifiers in order to increase his rate of reimbursement
This page was posted on September 27, 2015.