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Consumer Health Digest #07-35
September 11, 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. Donations to help support this
newsletter can be made conveniently through
PayPal or Amazon via
http://www.quackwatch.org/00AboutQuackwatch/donations.html###
Two reports blast non-surgical spinal decompression therapy.
Two major reviews have concluded that spinal
"decompression" performed by motorized traction
devices has not been proven safe or effective for
treating back pain.
**One report concluded, "Currently available
evidence is too limited in quality and quantity
to allow for the formulation of evidence-based
conclusions regarding the efficacy of
decompression therapy as a therapy for chronic
back pain when compared with other non-surgical
treatment options." [Daniel DM. Non-surgical
spinal decompression therapy: Does the scientific
literature support efficacy claims made in the
advertising media? Chiropractic & Osteopathy
15:7, May 18, 2007]
http://www.chirobase.org/06DD/vaxd/c&o.html**The other report said, "Considering the
cost-benefit relationship, many better researched
and less expensive treatment options are
available to the clinician." [Tiller MJ and
others. Decompression therapy for the treatment
of lumbosacral pain. Agency for Health Care
Research and Quality, April 26, 2007]
http://www.chirobase.org/06DD/vaxd/ahrq.pdfNon-surgical spinal decompression therapy uses a
motorized traction device to stretch the lower
back. The devices are two-part tables in which
the upper part is fixed to the table frame and
the lower part slides back and forth to provide
intermittent traction. The patient is anchored to
the lower part by a pelvic harness. The devices
can provide relief in some cases of back pain but
are widely promoted with unsubstantiated claims
that they can correct degenerated and herniated
discs without surgery. In clearing the first such
device (VAX-D), the FDA set limits on what the
manufacturer could claim. Individual providers,
provider associations, and the manufacturers have
exceeded these limits. Anesthesia & Pain Coder's
Pink Sheet, Dec 2005] Besides the VAX-D, the
devices include the Decompression Reduction
Stabilization (DRS) System, Accu-Spina System,
DRX-3000, DRX9000, SpineMED Decompression Table,
and Lordex Traction Unit. Billings in the United
States have been estimated to exceed $100 million
per year. [Vogenitz W. Miscoding advice causes
financial troubles, liabilities for unsuspecting
anesthesia, pain offices Anesthesia & Pain
Coder's Pink Sheet, Dec 2005]
http://www.ucg.com/specialreport/ For additional
information, see
http://www.chirobase.org/06DD/vaxd/vaxd.html###
Oregon Attorney General curbs DRX9000 marketing.
The Oregon Department of Justice (DOJ) has
announced that Axiom Worldwide and its owner
Benjamin A. Altadonna signed agreements to settle
charges that the company had made deceptive
claims in the marketing package it provided to
buyers of the device.
**DOJ lawyers found deceptive claims throughout
the advertising package including statements that
the DRX 9000 had an 86% success rate for the
treatment of degenerative disc disease, disc
herniations, sciatica and post-surgical pain; in
fact, the companies did not possess competent and
reliable evidence to substantiate the claim.
**The companies stated that the FDA had approved
the devices and substantiated their claims of
effectiveness. DOJ found the device had merely
been cleared as similar to preexisting devices.
**Axiom also falsely claimed that the DRX9000 was
a scientific and medical breakthrough that
resulted from NASA discoveries when, in fact,
NASA discoveries had no relationship with the
device.
The settlement agreement calls for payment of
$75,000 and prohibits Axiom from misrepresenting
scientific studies and patient testimonies. [AG
stops out-of-state companies from using "junk
science" to promote chiropractic devices: Oregon
chiropractors disseminated deceptive
advertisements. Oregon Department of Justice news
release, June 29, 2007]
http://www.devicewatch.org/reg/axiom.shtmlFlorida newspapers have reported that in March
the FBI raided Axiom's headquarters. [Zayas A.
FBI agents search offices of medical equipment
maker. St. Petersburg Times, March 9, 2007]
http://www.sptimes.com/2007/03/09/Hillsborough/FBI_agents_search_off.shtml Shortly afterward, in an unrelated case, a
Florida federal court judge ordered Axiom to stop
claiming that its device was based on NASA
discoveries or is FDA-approved. [Order. North
American Medical Corporation et al v. Axiom
Worldwide, Inc. Civil case No. 1:06-CV-1678-JTC,
U.S. District Court for the Northern District of
Georgia, March 29, 2007]
http://www.casewatch.org/civil/axiom/injunction.pdf###
FTC stops phony weight-loss patch marketers.
Transdermal Products International Marketing
Corporation and William H. Newbauer have been
banned from selling weight-loss patches in the
future and will pay $180,000 to settle FTC
charges that advertising claims for their
weight-loss patches were false and
unsubstantiated. They are also prohibited from
making false or unsubstantiated claims about any
alleged weight-loss product in the future. The
products were sold under several brand names
(LePatch, Revo Patch, Svelt Patch, and Z Patch)
and in an unmarked version that retailers could
sell under their own brand names. The advertising
made false or unsubstantiated claims that the
products caused weight loss and that their main
ingredient, sea kelp (Fucus vesiculosus), had
been approved by the FDA for that purpose.
[Weight-loss patch manufacturer banned from
selling weight-loss patches, Will pay $180,000.
FTC news release, Aug 20, 2007]
http://www.ftc.gov/opa/2007/08/transdermal.shtm###
Chiropractic publisher sentenced for investment fraud.
Richard E. Busch, Jr., 64, a nonpracticing
chiropractor, has been sentenced to serve five
months in federal custody and five months of home
detention. He was indicted in January 2003 and
was a fugitive until his capture in March 2007.
The indictment charged that Busch, James Michael
Hanks, R. Stephen Bowden, Brian Burgdorf, and
Jacques Latourette conspired to sell unregistered
securities through an investment fund known as
"the Millennium Fund." [Richard Busch back in the
public eye. Dynamic Chiropractic May 21, 2007]
http://www.chiroweb.com/archives/25/11/18.html Busch pled guilty to one count of conspiracy to
sell an unregistered security. Hanks, Bowden, and
Burgdorf had previously pled guilty and were
sentenced to home detention, payment of
restitution, and probation terms. The defendants
were jointly ordered to pay $5,611,959 in
restitution to nine victims. Latourette remains a
fugitive. Busch founded and published The
American Chiropractor, a popular magazine
distributed free of charge to chiropractors
throughout the United States. A chiropractic
newspaper has reported that Busch left the United
States in 1993 after several states issued
cease-and-desist orders against an unlicensed
malpractice insurance company for which Busch
served as president. [Who's minding the CARE
store? Managing director of malpractice insurance
co. arrested: President out of country. Dynamic
Chiropractic Jan 14, 1994]
http://www.chiroweb.com/archives/12/02/03.html###
Dubious Mexican clinic open again.Tijuana-based Hospital Santa Monica appears to be
back in business. The clinic's founder and
director,
Kurt W. Donsbach, is an unlicensed
chiropractor with a long history of illegal
activity. Last year, in response to massive
publicity about the death there of Coretta Scott
King (widow of former civil rights leader Martin
Luther King), the Mexican Government ordered
Hospital Santa Monica to shut down. This week the
San Diego Union-Tribune reported:
**The hospital reopened at the same location with
no name displayed outside but with the name
"Centro de Atención Integral" on a health
department certificate displayed inside. The
hospital's Web site still identifies it as
"Hospital Santa Monica."
**Mexican officials said the facility is not
authorized to treat serious diseases or to offer
"alternative" treatments.
**Several patients and patient family members at
the clinic said that Donsbach represented that he
ran the clinic.
**During a 2006 deposition, Donsbach said that he
had sold the clinic in 2002 to a former employee
and that went there to "visit the sick" and pray
for them but was not compensated for these
visits. However, during another deposition, his
office manager said Donsbach received a
percentage of revenue from the American patients.
**A suit by a former patient who alleged that
Donsbach had duped him was settled under
confidential terms. [Crabtree P, Cearley A. Baja
clinic shut down for unorthodox care reopens:
Embattled founder's role open to question. San
Diego Tribune, Sept 9, 2007]
http://www.signonsandiego.com/news/health/20070909-9999-1n9donsbach.html###
Other issues of the Digest are accessible through
http://www.ncahf.org/digest06/index.html. For
information about the National Council Against
Health Fraud, see
http://www.ncahf.org/about/mission.html. If you
enjoy the newsletter, please recommend it to your
friends.
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Stephen Barrett, M.D.
Board Chairman, Quackwatch, Inc.
Chatham Crossing, Suite 107/208
11312 U.S. 15 501 North
Chapel Hill, NC 27517
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[Donsbach hervorgehoben, ama]
