Consumer Health Digest #16-38
Your Weekly Update of News and Reviews
October 16, 2016
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/USDA to examine "organic" perceptions. The Federal Trade Commission and U.S. Department of Agriculture have scheduled a roundtable discussion of consumer perceptions of "organic" claims for non-agricultural products. The event, which will be held on October 20th at the FTC Constitution Center offices, 400 7th St. SW, Washington, DC, will run from 9 am to 1:30 pm. The discussions will include (a) consumer misconceptions of claims, (b) potential approaches to improving claims to prevent deception, and (c) broader regulatory approaches. The event is free and open to the public and will be webcast live. Registration will open at 7:45 am. Pre-registration is not required. [FTC, USDA Issue agenda for roundtable on consumer perceptions of "organic" claims. FTC news release, Sept 30, 2016]
NC newspaper blasts anti-fluoridation letter. The Wilkes Journal-Patriot newspaper has performed a great public service by indicating that anti-fluoridation claims published in a letter to the editor were unfounded. Although it published a letter containing false claims, the editors followed it with statements that fluoridation was safe and effective. In communities where fluoridation is being considered, opponents typically flood the local media with their views. Editors generally feel that their letter columns should be an open forum. Editors who wish to protect their readers from misleading statements about public health can follow these letters with reassurance, but few bother to do so.
FDA shuts down compounding lab. A federal judge has issued an order prohibiting Paul W. Franck of Ocala, Florida from manufacturing, holding, and distributing sterile drug products until he complies with federal laws and regulations. [Federal judge enters order of permanent injunction against Paul W. Franck. FDA news release, April 29, 2016] During the past 20 years, Franck has owned and operated many compounding pharmacies, including Franck's Lab Inc., d/b/a Franck's Compounding Lab, and Franck's Lab Inc., d/b/a Trinity Care Solutions. An FDA press release stated:
- Franck manufactured drugs that were adulterated because they contained filthy, putrid, or decomposed substances; were prepared, packed or held under unsanitary conditions; and fell below the quality and/or purity standards they purported to possess.
- In 2009, 21 polo ponies died after receiving a drug product compounded by Franck's Compounding Lab that contained 100 times the amount of selenium that should have been administered.
- In 2012, contaminated ophthalmic drugs compounded by Franck's Compounding Lab were linked to at least 47 cases of eye infections, including at least 39 cases of temporary or permanent vision loss.
- In 2014, Trinity Care Solutions recalled all sterile drugs and ceased compounding operations after the FDA's inspection revealed violations that could compromise drug sterility. These violations included the presence of dead spiders, beetles, ants, wasps and cockroaches in the ceiling panel directly above the area where employees prepare for sterile processing; lack of sufficient physical barriers to prevent the introduction of contamination from nearby construction into the clean room; and failure to adequately clean and sanitize sterile compounding areas.
Earlier this year, the FDA warned that although compounding can serve a valuable purpose for some patients, consumers need to be aware that compounded medications are not FDA-approved and have not been verified for quality, safety, and effectiveness. [The special risks of pharmacy compounding. FDA Consumer Update, Feb 2, 2016] The FDA's index of compounding inspections, recalls, and other actions lists actions taken against more than 300 compounders during the past eight years.
BBC uncovers illegal cancer product sale. BBC-TV investigators have reported that GcMAF, an unlicensed and unproven treatment for cancer, is being sold illegally in a health food store in the United Kingdom. [Cancer 'cure' GcMAF being sold illegally in health food shop. BBC Web site, Oct 15, 2016] The product, which is an injectable made from blood, sells for £600 a month. The investigators interviewed both the seller and a supplier (Amanda Mary Jewell) said to be loacted in Mexico. Cancer Research UK's comprehensive report recommends against using GcMAF.
Correction: Last issue's article about a chiropractic advertising scheme marketed during the 1960s and 1970s linked to the ads but should have linked to an article about the scheme.
This page was revised on October 18, 2016.