Risky devices found in Issaquah, Bellevue

For anyone going to the tiny yellow building in Issaquah last year to get treatments from the PAP-IMI machine, a warning sign attached to the device was hardly reassuring: "Attention. Do not let device and probe overheat. Allow cooling. Check probe frequently for insulation defects."

The bulky energy-medicine machine — prohibited for use in the U.S. — was owned by Regan Golob, a former chiropractor. His office was tucked in the woods on the campus of a Montessori school his wife runs.

He said his machine was used on professional and high-school athletes to treat pulled muscles and sprains as well as on a patient from Eastern Washington who was hoping to stop her cancer from spreading.

"I don't advertise," he said. "It's a touchy thing, because it's not FDA approved."

In 2005, the U.S. Food and Drug Administration, which regulates medical devices, prohibited the PAP-IMI from being used, saying it poses a significant risk.

That didn't deter Golob.

When interviewed by The Times last year, Golob was offering 10 PAP-IMI treatments for $400. Employees of the Montessori school were treated for free.

He also had surrendered his Washington chiropractor's license, which listed him as Patric R. Golob. He was being investigated by the state Department of Health for a violation not connected to his use of the PAP-IMI.

He said he bought the PAP-IMI several years ago for $53,000 from Bio-Energy Services in Los Angeles, the national distributor.

"People came out of the woodwork," he said. "I was just kind of experimenting with people."

His PAP-IMI displayed a counter indicating 794 hours of use, or more than 1,500 sessions. Golob said no one using his PAP-IMI has been harmed.

Contacted last week, Golob said he no longer lets people use the device. He said he doesn't have an office on campus. Nor is the PAP-IMI there, he said.

Golob said many of his clients had been referred by his friend, Barbara Setters, who ran the PAP-IMI Pain Relief Clinic in a Bellevue medical building a few blocks from Overlake Hospital Medical Center — until state health officials shut her down in 2005.

Setters, who has no medical training, formed Abundant Health Services and began using the device in May 2003 as part of a PAP-IMI pain study run by Bio-Energy Services in Los Angeles. She treated people with the machine, charging $60 for a half-hour session.

"We didn't know if we could make money with this — there was never a guarantee," Setters said in an interview.

"The hope was that it would be wonderful and [help] people with pain."

Seattle physician Kinne McCabe, a friend, was the principal investigator for the Bellevue pain study, meaning he had to protect the safety of patients and report any adverse events to an institutional review board, which had approved the study.

But McCabe did not work at the clinic or examine patients, and instead came in about once a month to review files, state records show. By the time he signed off on the files, some patients had already completed all treatment.

"I obviously felt that what we were doing was safe," McCabe told The Times.

During part of the study, McCabe was under a two-year probation issued by the state medical-licensing board. He had left a patient unmonitored in a sauna for about two hours at a West Seattle alternative clinic.

The woman suffered heat stroke, had a heart attack and developed neurological problems, state records show.

After getting a complaint about Setters' pain clinic, a Department of Health investigator went undercover to the clinic in April 2004.

Gayle Crowley said the office resembled a hotel lobby, with a reception counter, nice furniture and plants, but no exam rooms.

Crowley filled out paperwork and her blood pressure was taken. Then an employee, Cindy Yonck, used the PAP-IMI's probe, a long hose with a loop at the end, to send electromagnetic pulses to the investigator's head, shoulders and back.

Crowley was told the probe could overheat. Yonck "kept coming over with what she called a cooling-down pad ... like a pot holder."

Within days, Crowley returned to the clinic and told Setters that she and her three employees appeared to be violating state law by practicing medicine without a license, and warned them to stop.

Setters started crying, saying she had invested $125,000 in the business, Crowley recalled.

In 2005, Setters, Yonck and two other employees signed an order with the state, agreeing not to practice medicine. The state fined each of them $250. Setters said she doesn't own a PAP-IMI anymore. She would not say where it is.

The Times questioned state health regulators last year about McCabe's role in the Bellevue clinic.

As a result, the state Medical Quality Assurance Commission investigated, and last month charged that McCabe failed to ensure patient safety and supervise a clinic staffed by unlicensed practitioners.

The case is pending.

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