FDA to Go After Dangerous Fake Medical DeviceFeb 1, 2008 | Parker Waichman LLP
Fake medical devices have finally gotten the attention of federal regulators. In a collaborative move with foreign governments, the Food and Drug Administration (FDA) is taking steps to stop manufacturers who import fraudulent, and often, dangerous medical devices into the United States, FDA commissioner Dr. Andrew von Eschenbach testified Tuesday. Thousands of such devices have been shipped to the U.S. and have found their way into the health-care system based on false claims that these machines diagnose and cure disease, including cancer. "We need to stop this at the source," von Eschenbach told the House Energy and Commerce subcommittee, which oversees the FDA.
The FDA commissioner was responding to questions about a 2007 Seattle Times series entitled, “Miracle Machines,” which revealed how manufacturers and operators use unproven devices—some illegal and some, often, dangerous—to misdiagnose diseases, divert critically ill patients from legitimate care, and divest people of their savings. While the FDA has offices overseas to inspect devices, they are so behind that some foreign-device manufacturers have gone nearly 30 years without having been reviewed, according to Marcia Crosse, director of health care for the Government Accountability Office. During the hearing, other witnesses portrayed the FDA as overburdened, understaffed, and unable to protect the public from everything from food to drugs to devices.
Following the Times series, the FDA and the subcommittee initiated investigations into several devices, including a desktop computer machine called the QXCI or EPFX manufactured in Hungary by federal fugitive William Nelson, who claimed the device could diagnose and cure disease. Nelson and dozens of distributors and operatives work in 22 countries and claim to have sold 17,000 devices worldwide, with most sales in the U.S. According to federal court records, Nelson fled the U.S. in 1996 due to felony fraud charges.
Subcommittee members requested von Eschenbach look into extraditing Nelson to the U.S. Meanwhile, the FDA issued an import alert for new shipments of Nelson’s devices. Regarding the U.S., "We will stop this at the border," von Eschenbach--a physician who has seen patients victimized by false promises—testified. FDA officials are hoping to work with Hungarian authorities to examine Nelson's huge manufacturing and distribution operations.
The device is part of the growing alternative medicine field called “energy medicine” in which therapies are employed based on manipulating the body’s energy fields. This device and others like it administer frequencies or electromagnetic pulses to the body that are alleged to have therapeutic benefits.
Representative Jay Inslee (Democrat-Bainbridge Island) a subcommittee member who requested the investigation, said he is "horrified" that not only are thousands of these fake and dangerous devices making their way into the U.S. health-care system, but that untold hundreds of unlicensed health care workers are marketing illegal treatments. Islee hopes to expand the congressional hearings to include an investigation into why the FDA and state regulators failed to confiscate and warn the public about another illegal device, the PAP-IMI, a 260-pound electromagnetic pulsing machine linked to injuries and death. The Times reported last year that PAP-IMI owners manipulated federal regulations to operate PAP-IMIs in clinical studies.