Ban Unproven 'Energy Medicine' Devices, Washington State Officials Tell FDAJan 4, 2008 | Parker Waichman LLP
Unproven medical devices have injured many people in the United States, yet the Food & Drug Administration (FDA) has not moved aggressively to protect consumers from these unsafe – and often illegal – devices. Now, officials from the state of Washington have formally asked the FDA to ban numerous unproven and dangerous medical devices that are being used with increasing frequency.
Recently, The Seattle Times newspaper published a series of articles highlighting the problems of unproven medical devices. The Seattle Times investigation focused on devices that are used in a field called "energy medicine" — alternative therapies based on the belief that the body has energy fields that can be manipulated to improve health. The Seattle Times found thousands of these unproven medical devices across the country in healthcare clinics, hospitals and even at carnivals. Operators of such energy medicine devices often uses them to purposely misdiagnose diseases to that they can divert critically ill people from lifesaving care and drain their bank accounts with their own phony treatments.
The Seattle Times investigation detailed several such questionable medical devices. These included 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. Since The Seattle Times series appeared, the FDA has revoked Nelson's manufacturing registration, which prohibits him from importing the device into the country.
According to the paper, the FDA also 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.
Obviously, much more needs to be done to keep sick people safe from these phony medical devices. To that end, Washington’s Attorney General Rob McKenna and Department of Health Secretary Mary Selecky have called for the FDA to take industrywide action. "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."
According to the Attorney General’s office, a check of the Internet 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 Seattle Times series such as the EPFX, LIFE System, Inergetix-CoRe System, Orion and Vantage. "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."