This is of great concern to anyone involved in any way with any type of electromedical device that is not FDA approved. You may recall the Seattle Times series on the EPFX and Bill Nelson. Here is the next step. Note the long list of energy devices to be banned. Device manufacturers and vendors may wish to be especially careful about making claims for their devices.
FDA Urged to Curb Bogus "Energy Medicine" Devices 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 http://www.devicewatch.org/eav/fda_reply.pdf 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
