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FDA Urged to Curb Bogus "Energy Medicine" DevicesIn January 2008, Washington Attorney General Rob McKenna and state Department of Health Secretary Mary Selecky sent the below letter asking the FDA to block the sale and distribution of unproven and dangerous "energy medicine" devices. An FDA official replied that the agency has increased its surveillance of Internet promotion and advertising.
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Rob McKenna
ATTORNEY GENERAL OF WASHINGTON
1125 Washington Street SE - PO Box 40100 - Olympia WA 98504-0100
December 20, 2007
Timothy Ulatowski
Compliance Director
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Room 244 Gaither Road
Rockville, Maryland 20850
RE: "Energy Medicine" Medical Devices
Dear Mr. Ulatowski:
We were encouraged by your recently announced commitment to block the
import of the EPFX, and to investigate its manufacturer, distributors and
operators. We believe your response to the Seattle Times series that
exposed the dangers of the EPFX was appropriate and commendable.
While the Seattle Times series presented an in-depth look at the dangers
of one "energy medicine" device, it also alluded to the existence of
dozens of other devices that are equally dangerous. We encourage you to
expand your import block and investigation to those other devices.
In 2003, the state of Washington sued Pacific Health Center for, among
other things, its use of an "electrodermal testing" device, the Omega
Accubase C-29a. Investigations by our agencies and the Attorney General's
Office lawsuit confirm our belief that targeting a singular device does
not deter or immobilize the overall industry.
This particular "energy medicine" device was purported to determine the
presence of various conditions, including arthritis, immune deficiencies,
high cholesterol and hypertension. It was also purported to be able to
determine the proper remedy for these conditions.
The Attorney General's Office lawsuit claimed that the efficacy of the
device - which had been used on more than 5,000 people who each paid
approximately $500 - had not been adequately substantiated. The suit also
claimed that the operators of the device were practicing medicine,
acupuncture and naturopathy without proper licensure. The State ultimately
dropped its substantiation claims voluntarily when the court decided that
the defendants were engaging in unlicensed practices. The defendants are
no longer doing business in Washington, but continue to operate from
locations in Oregon and Idaho.
In the course of investigating and litigating the case, we learned an
enormous amount about the "energy medicine" field. Our research of
the device used by Pacific Health Center uncovered an entire industry
devoted to the sale, distribution and use of various unproven devices.
These devices were advertised widely on the Internet, sold by several
manufacturers, and used in clinics across the country. We found no
research that scientifically substantiated their effectiveness, not even
one study that relied on the double-blinded clinical trials that are the
scientific "gold standard" for proving the truth of medical claims. And
yet, they were and are used widely for a variety of purposes including
diagnosing and treating human and animal diseases, determining food
sensitivities and allergies, and finding tooth decay. The amount of money
spent by unwary consumers is enormous, and the risk that these consumers
are foregoing traditional treatment in favor of "snake oil" cures is
frightening.
We request that the FDA consider not just the EPFX as the target of your
investigation, but to include all of the unproven and dangerous medical
devices that are currently being sold and used the U.S. market.
In a recent review of Internet websites touting these devices, the
Attorney General's Office was able to find the following numerous examples
that are indistinguishable in their ineffectuality from the
EPFX:
NES, E-Lybra, LSA Biofeedback, QXCI/SCIO, Life System, CoRe, Oberon, Mars,
Quantec, Metascan, Etascan, SCENAR, ACUSEN,
Interx:
VEGA, Prognos, Biomeridian, Rife, Bicom, BioPuslar, Mitosan Therapy,
Bodyscan, Zappers, F-Scan, Q2, Syncrometer, Magnagraph, Merid, NES,
Acusense, Listen, EQ4, Orion, Explorer, Computron, Elision, Interro,
Interactive Query System, MORA, Matrix Physique System, Propylene, Punts
III and Vitel.
This list is not exhaustive, and there are even more devices on the
market.
The sale and use of untested medical devices is a national problem. States
can chip away at it through actions under their consumer protection and
medical licensing statutes, but the FDA is the most effective regulator in
this area. We encourage you to ban the manufacture, distribution and use
of these dangerous devices, to step up enforcement against those who are
taking consumers' money and risking their health, and to generalize your
approach to include more than just one device. We pledge to work with you
in this endeavor and are happy to share our thoughts, research and the
testimony of the experts we have consulted.
Sincerely,
ROB MCKENNA
Washington State Attorney General
MARY SELECKY
Secretary, Washington State Department of Health
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