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US: FDA bans import of unproven machine

Trying to shut down a federal fugitive’s medical-device empire, the US Food and Drug Administration is blocking the import of the machine he claims can cure diseases such as cancer and AIDS.

The desktop device, called the EPFX, is manufactured in Hungary by William Nelson, who fled the US in 1996 after he was indicted on felony fraud charges related to his invention. FDA compliance director Timothy Ulatowski, who oversees medical-device regulation, said the action is the first step in a sweeping investigation of Nelson, his distributors and EPFX operators. „This is pure, blatant fraud. The claims are baloney,” Ulatowski said. „These people prey in many cases on consumers who are desperate in seeking cures for very serious diseases.”

The FDA said it took action as a result of a recent Seattle Times investigation that uncovered a global network of manufacturers who sell unproven devices and practitioners who exploit unsuspecting patients. Also in response, a congressional subcommittee is investigating how these manufacturers have taken advantage of federal loopholes to profit from the machines. And last week, the Washington State Chiropractic Association asked a state board that governs chiropractors to ban the EPFX. The Times series revealed how manufacturers and operators used unproven devices — some illegal, some dangerous — to misdiagnose diseases, divert critically ill people from life-saving care, and drain their bank accounts. Many operators dupe patients by posing as highly trained health-care professionals through the use of deceptive credentials and degrees from unaccredited institutions. These victims are casualties in the growing field called „energy medicine” — alternative therapies based on the belief that the body has energy fields that can be manipulated to improve health. Thousands of these unproven medical devices were found in venues across the country from health-care clinics in Florida to an 866-bed hospital in Missouri.

The FDA and state regulators failed to confiscate or warn the public about a dangerous device, the PAP-IMI, a 260-pound electromagnetic pulsing machine linked to patient injuries and death. The devices, made in Greece by math professor Panos Pappas, were smuggled into the US as seed germinators. They remain in use today in at least five states, including Washington. The FDA will take action against the PAP-IMI, Ulatowski said, but he wouldn’t give details. „I don’t want to tip my hand to those who might benefit,” he said. „They may evade action.” (full article)