The Food and Drug Administration (FDA) will team with foreign governments to crack down on manufacturers who import fraudulent medical devices...
The Food and Drug Administration (FDA) will team with foreign governments to crack down on manufacturers who import fraudulent medical devices into this country, FDA commissioner Dr. Andrew von Eschenbach testified Tuesday.
Thousands of the devices have been shipped to the United States based on false claims of diagnosing and curing disease, including cancer.
“We need to stop this at the source,” von Eschenbach told the a House Energy and Commerce subcommittee, which oversees the FDA.
His comments came in response to questions about a Seattle Times series, Miracle Machines, which revealed last year how manufacturers and operators used unproven devices — some illegal, some dangerous — to misdiagnose diseases, divert critically ill people from lifesaving care, and drain their savings.
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The FDA has offices overseas to inspect devices, but the backlog is so great that some foreign-device manufacturers have gone 27 years without review, according to testimony by Marcia Crosse, director of health care for the Government Accountability Office.
During the congressional hearing, other witnesses painted a bleak picture of the FDA as overburdened, understaffed and unable to fully safeguard the public involving all areas of responsibility, from food to drugs to devices.
However, as a result of the Times series, the FDA and the subcommittee launched dual investigations into several devices, including a desktop computer machine called the QXCI or EPFX.
The QXCI is manufactured in Hungary by federal fugitive William Nelson, who fled the U.S. in 1996 over felony fraud charges, according to federal court records. Nelson and dozens of distributors and operatives have claimed that the device can diagnose and cure disease.
Subcommittee members asked von Eschenbach to investigate whether Nelson can be extradited to the U.S. Meanwhile, the FDA has issued an import alert for new shipments of QXCI devices.
“We will stop this at the border,” von Eschenbach testified. As a doctor, he said he has witnessed patients who were victimized by false promises.
Additionally, FDA officials hope to work with Hungarian authorities to examine Nelson’s manufacturing and distribution empire, which stretches into 22 countries.
Nelson claims to have sold 17,000 devices worldwide, with the bulk of sales in the U.S. More have been sold in the Pacific Northwest than any place nationally, company records show.
Many patients have become 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. The QXCI and other machines shower patients with frequencies or electromagnetic pulses that purportedly have therapeutic benefits.
Rep. Jay Inslee, D-Bainbridge Island, a subcommittee member who requested the medical-device investigation, said he is “horrified” that thousands of dubious and dangerous devices have slipped into the U.S. health-care system, and that hundreds of unlicensed health-care operatives are blatantly marketing illegal treatments.
He hopes to broaden the congressional hearings to explore why the FDA and state regulators failed to confiscate or warn the public about another fraudulent and illegal device, the PAP-IMI, a 260-pound electromagnetic pulsing machine linked to patient injuries and death. The Times reported last year that PAP-IMI owners took advantage of federal regulations that let them operate on an honor system in clinical studies.
“We’re just peeling back the first layer of the onion,” Inslee said.
Rep. Bart Stupak, subcommittee chairman, and Rep. John Dingell, chairman of the full committee and a subcommittee member, said more oversight hearings will be held this year, possibly as soon as late March. Both are Michigan Democrats.