FDA Urged to Curb Bogus “Energy Medicine” Devices


April 2, 2008

In 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.


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

This page was posted on April 2, 2008.