A bit of old school investigative reporting by the Seattle Times has led the FDA, and even Congress, to look into companies selling two fake medical devices that apparently promise to cure everything from AIDS to colon cancer. Because the FDA allows the sale of these things as “stress-relief tools,” the companies are not banned outright from marketing their products without a scrupulous regulatory process. The current investigations by the FDA and U.S. House Energy and Commerce subcommittee, is looking into promises made by companies marketing the devices in question.
From The Seattle Times:
The report detailed victims of a growing and largely unregulated field called “energy medicine” – alternative therapies based on the belief that the body has energy fields that can be manipulated to improve health.
One device, the EPFX, is manufactured by William Nelson, a federal fugitive in Budapest, Hungary. The desktop machine purports to diagnose and cure diseases from cancer to AIDS. Nelson rakes in millions of dollars monthly by selling the machines and other products through his company, Eclosion.
In the past week, dozens of EPFX distributors and operators stripped their Web sites of any illegal claims, such as that it can diagnose or cure disease, according to a review by reporters.
The largest distributor of the EPFX, The Quantum Alliance of Calgary, Alberta, removed from its Web site a November newsletter that outlined how to use the machine for blood and stem-cell analysis, facelifts and lip enlargement.
The FDA recently revoked Nelson’s registration, which will prevent the EPFX devices from entering the country. Further action is expected involving an estimated 10,000 devices already shipped into the U.S, FDA officials said.
Legally, the device can be sold as a stress-relief tool, according to the FDA.
Congress is investigating the EPFX as well as the PAP-IMI, a 260-pound electromagnetic pulsing machine, manufactured in Greece, that has been linked to injuries and death. The machine, invented by Panos Pappas, is banned for use in the U.S. but The Times found treatments offered in clinics in at least five states.
More at The Seattle Times…
The Times’ Original Report: Miracle Machines: The 21st-century snake oil …
House Committee on Energy and Commerce press release: Dingell, Stupak Investigating Institutional Review Boards, Questionable Medical Devices