Consumer Health Digest #13-45
Your Weekly Update of News and Reviews
November 28, 2013
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.
FDA orders genetic testing service to stop marketing. The FDA has issued a warning letter ordering 23andMe, Inc. to stop marketing its saliva collection kit and Personal Genome Service. The letter noted:
- The company's Web site offers health reports on 254 diseases and conditions, including categories such as "carrier status," "health risks," and "drug response," and specifically as a "first step in prevention" that enables users to "take steps toward mitigating serious diseases" such as diabetes, coronary heart disease, and breast cancer.
- Most of the intended uses for PGS listed on the website are medical device uses that require premarket approval or a special classification.
- The FDA is particularly concerned about assessments of breast-cancer risk and drug response tendencies that, if inaccurately reported, could have severe consequences.
- Despite numerous meetings and conferences with the FDA during the past four years, the company has failed to validate challenged claims or take appropriate remedial action to correct the problems that have been pointed out.
The company's name is derived from the fact that normal human cell nuclei contain 23 pairs of chromosomes. One of its stated goals is to "revolutionize health care." In November, in a CBS-TV interview, company president Anne Wojcicki glibly claimed that testing would lead to better medical decision-making by making it possible to determine in advance whether particular treatments will work for a particular individual. However, as noted by Dr. Steven Novella: (a) the company has not performed the due diligence required to make sure its tests are valid and reliable and (b) even if the tests were 100% accurate, the information has considerable potential for harm as well as for good, and (c) and the net effect of using the test is presently unknown. The CBS report stated that the company was founded in 2006 and had 475,000 customers. The saliva test costs $99.
Mother of dead boy arrested for avoiding medical care. Tamara Lovett, of Calgary, Canada, whose 7-year-old son Ryan died last March from a medically treatable streptococcal infection, has been charged with criminal negligence and failure to provide the necessaries of life. Press reports state that Lorett had never taken him to a doctor, had a belief system in homeopathy, and had used "holistic remedies" to treat the infection even though Ryan was bedridden for ten days and looked very ill. [Schmidt C. Calgary mother arrested in death of young son. CTV News, Nov 22, 2013]
Another chelationist disciplined. Ronald R. Wempen, M.D., who operated the Environmental Medical Center of Orange County, has had his medical license revoked. In 2009, the Medical Board of California charged Wempen with gross and repeated negligence, failure to maintain adequate and accurate records, and failure to release medical records on request. The charges were based on his management of a woman who died in 2010 after taking Captomer (DMSA), a chelating drug that Wempen had prescribed without adequately investigating whether it was appropriate and whether she could tolerate it. After the woman died, Wempen told an insurance company that her records had been lost; yet he subsequently sent a copy to the medical board. The charges were settled in 2013 with an agreement under which Wempen surrendered his license. In 1998, Wempen was charged with gross and repeated negligence in connection with his management of a female patient. Board documents indicate that he failed to take an adequate history, failed to perform an adequate physical examination, treated the woman for several conditions without evidence that she had them, failed to investigate when lab tests showed that the woman showed signs of intestinal bleeding, and failed to maintain adequate records. Wempen settled the charges by signing a consent agreement under which he was ordered to pay $8,000 for administrative costs, serve on probation for five years, undergo an assessment of his medical skills, and complete 40 more hours per year of continuing medical education courses than were required for license renewal.
Dr. Stephen Barrett has compiled a database of disciplinary actions that state licensing boards have taken against practitioners who have administered chelation therapy for inappropriate reasons. In some cases, the action was based on misuse of chelation itself. In other cases, the complaint against the physician had other grounds or was based on conduct that would be regarded as improper regardless of whether chelation was involved. The database currently includes more than 100 medical and osteopathic physicians.
This page was posted on December 1, 2013.