State urges FDA to ban unproven medical devices

Washington state officials are urging the U.S. Food and Drug Administration to ban numerous unproven and dangerous medical devices, saying their sale and use is "a national problem."

Attorney General Rob McKenna and Department of Health Secretary Mary Selecky have called for the FDA to take industrywide action, after a Seattle Times investigation highlighted problems with unproven "energy medicine" devices.

"They're all variations on the same type of snake oil," McKenna said Thursday. "It doesn't make sense to go after one or even a few machines because they are fake, and not go after the same kinds of devices that sell under different names or made by different manufacturers."

The Times' series, "Miracle Machines," revealed how manufacturers and operators used unproven devices — some illegal, some dangerous — to misdiagnose diseases, divert critically ill people from lifesaving care and drain their bank accounts.

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. These devices can be as small as a television remote control or as large as a steamer trunk.

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 to booths at the Puyallup Fair.

"The sale and use of untested medical devices is a national problem," McKenna and Selecky wrote in a Dec. 20 letter to the FDA. "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."

The FDA is reviewing the state's request, according to spokeswoman Karen Riley.

The series highlighted several machines, including a desktop device, called the EPFX, manufactured in Hungary by William Nelson, a federal fugitive. The machine purports to diagnose and cure diseases, from cancer to AIDS.

The FDA 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 U.S. as seed germinators. They remain in use today in at least five states, including Washington.

Since the series, the FDA has revoked Nelson's manufacturing registration, which prohibits him from importing the device into the country.

McKenna is encouraged by the FDA's commitment to block the import of the EPFX, but said the agency needs to do more.

"They're going to have to take an industrywide approach to this field of energy medicine or else they will play a perpetual game of regulatory 'whack a mole,' " he said. "One pops its head up and you knock it out, but you turn around and another one pops up. So you have to take out the whole field. You can't just go after individual purveyors and expect to have long-term results."

In a check of the Internet, the Attorney General's Office found numerous manufacturers and practitioners making unsubstantiated claims about energy devices. McKenna and Selecky listed more than two dozen machines they want the FDA to ban, including those detailed in The Times series such as the EPFX, LIFE System, Inergetix-CoRe System, Orion and Vantage.

"Attacking the problem state by state is a cumbersome and much slower means of solving the problem," he said. "This is a case that clearly calls out for federal action."

Christine Willmsen: 206-464-3261

or cwillmsen@seattletimes.com.