Consumer Health Digest #07-18
Your Weekly Update of News and Reviews
May 1, 2007
Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D., and cosponsored by NCAHF and Quackwatch. 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.
Compounding pharmacy implicated in three deaths. Three recent deaths have been attributed to intravenous injections that contained toxic amounts of colchicine prepared by ApothéCure Inc., a compounding pharmacy based in Dallas, Texas. The colchicine, which was mislabeled, contained 4 milligrams per milliliter, rather than the 0.5 milligrams per milliliter stated on its labels. A single injection could be fatal. ApothéCure said that an employee had made a weighing error. Geoffrey Wiss, M.D., told authorities that either he or a partner at the Center for Integrative Medicine, which employed medical doctors and naturopaths, supplied the colchicine to the three patients who died. The drug, sometimes used in small doses to treat gout, was used to treat back and neck pain, which is not an FDA-approved use. [Korn P. Bad medicine led to three deaths: Texas firm that supplied fatal drug to Portland clinic escaped FDA oversight. Portland Tribune, April 27, 2007] As a result of the deaths, the center has been permanently closed. The Oregon Poison Center has warned the state' naturopaths about colchicine use. [Medication safety alert: Colchicine use. Oregon Poison Center, April 2007] ApothéCure is not licensed with Oregon's pharmacy board, as required for any pharmacy sending drugs into the state. [Dworkin A. Badly made medicine ends with three dead: Overdose: A pharmacy not licensed in Oregon mixed a special blend of a deadly drug too strong. The Oregonian, April 28, 2007] At least five state and federal agencies are investigating the deaths.
ApothéCure is a leading supplier of drugs to offbeat practitioners. In 2004, after three patients experienced adverse effects, the Pennsylvania Department of Health issued a health advisory about the use of intravenous phosphatidylcholine manufactured by ApothéCure. Intravenous phosphatidylcholine has no approved medical use. [Adverse reactions to intravenous phosphatidylcholine infusion. Pennsylvania Department of Health Health Alert #15, Aug 6, 2004]
Many observers believe that compounding pharmacists and manufacturers are inadequately regulated. [Bouts BA. The misuse of compounding by pharmacists. Quackwatch, Nov 26, 2005]
Illegal "homeopathic" marketer fined. Barbara Brewitt, Ph.D. has been fined $415,000 for falsely claiming to be a medical doctor and illegally manufacturing and selling homeopathic "healthy aging" drugs through her Seattle-based company Biomed Comm, Inc. The health law judge's order concluded:
- Brewitt and Biomed Comm were not licensed to manufacture or sell drugs.
- Over a 5-year period, Brewitt falsely represented herself as a medical doctor more than 20 times to a Seattle-based pharmacy in order to obtain Norditropin, a growth hormone drug used in Biomed Comm's manufacturing process.
- Brewitt's products were promoted for treating Alzheimer’s disease, autism, cancer, menopausal symptoms, attention deficit hyperactivity disorder (ADHD), and HIV/AIDS and about 50 other conditions. Many callers to her company were advised about what to take for their conditions.
- Inspections of her manufacturing facility revealed multiple law violations. On one occasion, Brewitt hid materials in her car that she did not want the inspector to see.
Concluding that Brewitt had "systematically avoided compliance with laws regulating the manufacture and sale of drugs," the judge ordered the maximum $1000-per-day penalty for (a) 315 days of unlicensed drug sales, (b) 37 days of unlicensed manufacturing, and (c) 63 days of unlicensed practice of medicine.
In a parallel action, another health law judge denied Biomed Comm's application for a license to manufacture drugs and prohibited it from reapplying for a 10-year period. The judge's order concluded that Brewer had engaged in dishonesty, misrepresentation, and unprofessional conduct.
The Department of Health's investigation was triggered by a complaint from a former employee who stated that Brewitt herself mixed many of the products in her own kitchen as she chanted over a crystal bowl. The department obtained a temporary restraining order in February 2006.
New search engine for searching scientific journals. The University of Virginia School of Medicine's Department of Public Health Sciences have developed a free tool for more efficient searching of the MEDLINE database of biomedical articles. The National Library of Medicines PubMed site posts its results in chronological order. In contrast, Relemed "weights" the frequency and relationship of searched-for words and posts its results in order of most probable relevance. [Siadaty MS and others. Relemed: Sentence-level search engine with relevance score for the MEDLINE database of biomedical articles. MC Medical Informatics and Decision Making 7:1 doi:10.1186/1472-6947-7-1, 2007]
This page was posted on May 2, 2007.