Spread of illegal devices causes alarm

U.S. Rep. Jay Inslee on Tuesday called for a congressional investigation into medical-device manufacturers and operators who use unproven "energy medicine" machines to exploit patients.

"I fear these may be the tip of the iceberg when it comes to deadly scams aimed at vulnerable Americans who are sick and holding out hope for a cure to what ails them," Inslee, D-Bainbridge Island, said in a letter.

Inslee said his request was in reaction to this week's Seattle Times investigation, "Miracle Machines." The three-day series revealed how manufacturers and practitioners profit from treating people with the unproven machines, some of them potentially dangerous, others illegal. They have used these devices to misdiagnose diseases and divert critically ill people from life-saving care, while also draining their bank accounts.

Many operators avoided detection by taking advantage of a lack of federal oversight of clinical studies, The Times found.

"Energy medicine" is a collection of alternative therapies based on the belief that the body has energy fields that can be manipulated to improve health.

The U.S. Food and Drug Administration said Tuesday that it is investigating two of the machines detailed in the series.

One machine is the PAP-IMI, which the FDA has linked to patient injuries and death. The agency never warned the public about its dangers.

Although the FDA in 2005 prohibited use of the machine, The Times found PAP-IMIs in use in at least five states, including Washington.

Many of the bulky machines, made in Athens, Greece, were illegally imported into the U.S. as agricultural seed germinators.

The other device under FDA inquiry is the EPFX, manufactured in Budapest by William Nelson, a federal fugitive charged with felony health-care fraud.

The shoe-box-size EPFX has been illegally marketed as a diagnostic and healing machine, The Times found. About 10,000 of the machines have been sold in the U.S. — more of them in the Pacific Northwest than in any other region, according to distributors.

Washington Department of Health officials said they are reviewing The Times' findings and may open investigations.

State health officials disclosed Tuesday that cases of illegal practice of medicine in Washington, especially by those using energy-medicine machines, have more than doubled since 2005.

"Unlicensed practice is growing very fast and it's become a big concern," Assistant Secretary Laurie Jinkins said. The department has opened 573 investigations in the past two years, she said. Complaints from the public led to nearly all of them.

Also Tuesday, the Washington State Chiropractic Association asked state regulators to ban the EPFX from use by the state's 2,100 chiropractors. The proposed ban will be discussed at a Dec. 6 meeting of the Chiropractic Quality Assurance Commission, which regulates the profession.

Inslee is a member of an Energy and Commerce subcommittee that has oversight of the FDA, which regulates medical devices.

In a letter to members of the subcommittee, Inslee said Congress should determine whether the FDA has adequate resources to oversee the institutional review boards (IRBs) that govern clinical studies for devices.

Inslee wants the FDA to prevent "IRB shopping," in which a device maker can hire a private overseer for a study. The FDA does not track all such studies.

"Americans with serious or life-threatening illnesses should have the option of turning to alternative or experimental therapies," Inslee wrote. "We must ensure that the FDA has procedures to weed out cases of snake-oil peddlers who recklessly risk the safety and lives of patients."

He said more federal regulation may be needed to govern the growing use of unproven medical devices. "What's so disturbing is the industrial-scale abuse," he said.

The FDA doesn't know how many or which devices are under clinical study.

Rep. Bart Stupak, D-Mich., chairman of the subcommittee, will determine whether an investigation will take place.

State health-department officials said they were unaware that unlicensed operators had grown so bold as to offer therapies at public places like the Puyallup Fair.

Jinkins asked the public to send the department any complaints about the practice of unlicensed medicine.

The state does not have an investigative unit that looks into all such complaints. They are distributed among different licensing boards. A case of someone posing as a medical doctor, for instance, would be handled by investigators assigned to the Medical Quality Assurance Commission.

In most cases, violators agree to stop illegally practicing medicine. Increasingly, however, the state has had to go to court to obtain cease-and-desist orders.

Since 2005, the state has obtained 87 orders, a sixfold increase over the previous two-year period.

Michael J. Berens: 206-464-2288 or mberens@seattletimes.com; Christine Willmsen: 206-464-3261 or cwillmsen@seattletimes.com