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Consumer Health Digest #11-01
January 6, 2011
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.
###
Wakefield paper declared fraudulent.The British Medical Journal (BMJ) has accused Dr. Andrew Wakefield of
fraud. In 1998, The Lancet published a paper -- spearheaded by
Wakefield -- which suggested that the measles-mumps-rubella (MMR)
vaccine might be linked to autism. The paper didn't declare that
cause-and-effect had been demonstrated, but at the press conference
announcing its publication, Wakefield attacked the triple vaccine;
and he has continued to do so ever since. Last year, The Lancet
retracted Wakefield's paper
http://www.autism-watch.org/news/lancet.shtml and the British
Medical Council concluded that Wakefield acted dishonestly and
irresponsibly and struck him from its register (the equivalent of
license revocation in the United States).
http://www.casewatch.org/foreign/wakefield/sanction.shtmlThe BMJ plans to publish three articles by Brian Deer, the
investigative reporter who uncovered Wakefield's misconduct. In an
accompanying blog, Deer summarized his findings this way:
"The British Medical Journal has begun a series that will bare the
MMR scandal in detail never published before. Drawing on interviews,
documents, and properly obtained data collected during seven years of
inquiries, we show how one man, former gastroenterology researcher
Andrew Wakefield, was able to manufacture the appearance of a
purported medical syndrome, whilst not only in receipt of large sums
of money, but also scheming businesses that promised him more. His
was a fraud, moreover, of more than academic vanity. It unleashed
fear, parental guilt, costly government intervention, and outbreaks
of infectious disease." [Deer B. Piltdown medicine: The missing link
between MMR and autism. BMJ Group Blogs, Jan 6, 2011]
http://blogs.bmj.com/bmj/2011/01/06/brian-deer-piltdown-medicine-the-missing-link-between-mmr-and-autism/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+bmj/blogs+(Latest+BMJ+blogs)&q=w_bmj_podblogThe first of Deer's three articles details how he examined the
medical records and interviewed the parents of the 12 children used
in Wakefield's study and found that all of the cases reported in the
1998 Lancet paper were misrepresented. [Deer B. How the case against
the MMR vaccine was fixed. BMJ 342:c5347, 2011]
http://www.bmj.com/content/342/bmj.c5347In an accompanying editorial, three of the BMJ's top editors wrote:
"The Lancet paper has of course been retracted, but for far narrower
misconduct than is now apparent. The retraction statement cites the
GMC's findings that the patients were not consecutively referred and
the study did not have ethical approval, leaving the door open for
those who want to continue to believe that the science, flawed though
it always was, still stands. We hope that declaring the paper a fraud
will close that door for good." [Godlee F and others. Wakefield's
article linking MMR vaccine and autism was fraudulent: Clear evidence
of falsification should now close the door on this damaging vaccine
scare. BMJ 342:c7452, 2011]
http://www.bmj.com/content/342/bmj.c7452.full###
DAN! doc threatened with debarment.The FDA has asked Amy K. Holmes, M.D. to show cause why she should
not be disqualified as a clinical investigator. Referring to a
clinical trial in which she was repeatedly inspected, the agency
stated:
"Based on our evaluation of information obtained by the Agency, we
believe that you have repeatedly or deliberately submitted false
information to the sponsor or FDA in required reports, and repeatedly
or deliberately violated regulations governing the proper conduct of
clinical studies involving investigational products."
The name of the trial is redacted, but it appears to have been a
study of an antibiotic for severe skin infections.
http://www.clinicaltrials.gov/ct2/show/NCT00671580?term= The company overseeing the research appears to have been Gulf Coast
Associates of Baton Rouge, Louisiana. In 2008, laboratories directed by
Holmes and by Gulf Coast Research's president David Deshotels had their
CLIA certifications revoked for "condition level noncompliance." Holmes's
lab (Stat Lab I, Inc.) lost its Medicare approval for at least two
years
http://www.casewatch.org/fdawarning/debar/holmes/lab_appeal.pdf, and Gulf Coast's lab lost both Medicare and Medicaid approval.
Holmes, who appears to have retired from active practice, is one of a
small network of doctors who claim that autism is is caused by heavy
metal toxicity and should be treated by chelation therapy and other
"biomedical" approaches. This approach, referred to as the "DAN!
protocol," has no legitimate scientific support.
###
Dannon Company settles FTC charges.The Dannon Company, Inc. has agreed to stop making unsubstantiated
claims about its Activia yogurt and DanActive dairy drink, which
contain potentially beneficial bacteria known as probiotics. [Dannon
agrees to drop exaggerated health claims for Activia yogurt and
DanActive dairy drink. FTC news release, Dec 15, 2010]
http://www.ftc.gov/opa/2010/12/dannon.shtm Under the settlement:
**Dannon is prohibited from claiming that any yogurt, dairy drink, or
probiotic food or drink reduces the likelihood of getting a cold or
the flu, unless the claim is approved by the FDA.
**Dannon may not claim that any other yogurt, dairy drink, or
probiotic food or drink will relieve temporary irregularity or help
with slow intestinal transit time unless the claim is substantiated
by at least two well-designed human clinical studies.
**Dannon may not make any other claims about health benefits,
performance, or efficacy of any yogurt, dairy drink, or probiotic
food or drink, unless the claims are true and backed by competent and
reliable scientific evidence.The FTC worked in close coordination with 39 state attorneys general,
who are simultaneously announcing the resolution of their own
inquiries into Dannon's advertising of DanActive and Activia. Dannon
has agreed to pay the states $21 million to resolve these
investigations. Dannon has also settled a class-action suit by
agreeing to create a $35 million fund to reimburse consumers for up
to $100 for products purchased.
http://www.casewatch.org/civil/dannon/settlement.pdf###
Request for help from Dr. Stephen Barrett
In June, Doctor's Data filed suit against Dr. Barrett because it
didn't like 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 Contributions to his
defense fund can be made by mail or through
http://www.quackwatch.org/00AboutQuackwatch/donations.html###
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--
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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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