[*quote*]
Subject: [chd] Consumer Health Digest #13-45, November 28, 2013
From: "Stephen Barrett, M.D." <sbinfo@quackwatch.org>
Date: Sun, December 1, 2013 20:37
Consumer Health Digest #13-45
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. 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.
###
Continuing request for help from Dr. Barrett
###
In June 2010, Doctor's Data, Inc. sued Dr. Barrett because it didn't like what what
he wrote about them on Quackwatch and in this newsletter. The events leading up to
the suit are described at
http://www.quackwatch.org/14Legal/dd_suit.html In
November, 2011, about half of the allegations were dismissed, but discovery was
permitted for more than a year. The rest of the suit will be ripe for dismissal by
the end of this year, but the proceedings have cost hundreds of thousands of
dollars. Contributions to the defense fund can be made by mail or through
http://www.quackwatch.org/00AboutQuackwatch/donations.html###
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=================================
Stephen Barrett, M.D.
Consumer Advocate
Chatham Crossing, Suite 107/208
11312 U.S. 15 501 North
Chapel Hill, NC 27517
Telephone: (919) 533-6009
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Editor, Consumer Health Digest
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See:
http://www.quackwatch.org/00AboutQuackwatch/donations.html[*/quote*]
