Web sites stripped of medical-device claims

As news spread of two federal investigations into dubious medical devices used throughout the Northwest, distributors and operators have purged their Web sites of the fraudulent claims that are under scrutiny.

Two investigations, one by the U.S. Food and Drug Administration, the other by a U.S. House Energy and Commerce subcommittee, are focusing on two machines detailed in a recent Seattle Times investigation.

The three-day series revealed how manufacturers and practitioners profit from treating people with unproven or fraudulent machines, some of them potentially dangerous, others illegal.

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.

Rep. John Dingell, chairman of the Committee on Energy and Commerce, and Rep. Bart Stupak, chairman of the Oversight and Investigations Subcommittee, both Michigan Democrats, are leading the investigation.

Makers of both devices appear to have exploited a regulatory hole that lets them bypass FDA oversight by hiring private companies of medical professionals called institutional review boards, or IRBs.

In a Dec. 13 letter, the subcommittee gave the FDA two weeks to supply any information it had about the EPFX and the PAP-IMI.

The subcommittee is looking into two private IRB companies that had authorized the PAP-IMI for use on patients. The subcommittee sent letters demanding records from Biomedical Research Institute of America in San Diego and Texas Applied Biomedical Services in Houston.

"It appears that the protections for research volunteers are not only being ignored, but are being manipulated for marketing purposes," Stupak said. "American consumers deserve to be treated better than guinea pigs."

Michael J. Berens: 206-464-2288 or mberens@seattletimes.com; Christine Willmsen: 206-464-3261 or cwillmsen@seattletimes.com.