What does "FDA registered" mean? Not much The FDA registers manufacturers of energy-medicine devices — not the products. Many manufacturers submit basic...
In the late 1980s, an out-of-work math instructor in Colorado built an electronic device he claimed could diagnose and destroy disease — everything from allergies to cancer — by firing radio frequencies into the body.
But the U.S. Food and Drug Administration, which regulates medical devices, ordered William Nelson to quit selling his machine and making false claims. Nelson refused, and he was indicted on felony fraud charges. He fled the country, never to return.
That should have been the unremarkable end of another peddler of medical miracles.
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Today, Nelson, 56, orchestrates one of America’s boldest health-care frauds from a century-old building in Budapest, Hungary. Protected by barred gates, surveillance cameras and guards, he rakes in tens of millions of dollars selling a machine used to exploit the vulnerable and desperately ill.
This device is called the EPFX. In the U.S. alone, Nelson has sold more than 10,000 of them. More have been sold in the Northwest than in any other region, company officials said.
Nelson built his business by recruiting a sales force of physicians, chiropractors, nurses and thousands of unlicensed providers, from homemakers to retirees, drawn by the promise of easy money.
Nelson is just one profiteer, with one device.
A Seattle Times investigation has uncovered a global network of manufacturers who sell unproven devices, and practitioners who prey on unsuspecting patients.
Capitalizing on weak government oversight, they have used these devices — some illegal, others potentially dangerous — to drain patients’ bank accounts, misdiagnose diseases, and divert critically ill people from life-saving care.
These victims are 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. Energy devices range from handheld machines the size of television remotes to behemoth machines that weigh hundreds of pounds, with costs ranging from $1,200 to $55,000.
Many manufacturers and operators do follow FDA rules and disclose that treatments are unproven.
But The Times’ investigation, based on government records and more than 200 interviews, found thousands who skirt the law. Among its findings:
• FDA officials do not know how many energy-medicine devices exist, where they are used and even whether they are safe. Ten years ago, Congress reduced medical-device oversight. Ever since, most energy-device manufacturers who register with the FDA submit little more than basic contact information.
• Federal and state regulators failed to warn the public about a dangerous energy device, the PAP-IMI, which is linked to patient injuries and death. Nor did they confiscate all of the devices, which pulse the body with strong electromagnetic waves. They had been smuggled into the country as seed germinators. The PAP-IMI remains in use today in at least five states, including Washington.
• Many energy-medicine operators dupe the public by posing as highly trained health-care professionals through the use of deceptive credentials and unaccredited degrees. Some of the largest and seemingly independent credentialing organizations are in fact controlled by two men who run competing mail-order operations.
FDA spokeswoman Karen Riley said the agency is looking into the EPFX, based on The Times’ findings.
Medical charlatans have used energy devices in this country for more than a century.
In the past decade, the machines exploded into the mainstream, fueled by the Internet, which quickly and cheaply reached prospective buyers and patients.
Today, dozens of energy-device manufacturers present flashy Web sites with video testimonials and fake science.
“The message itself has stayed the same for centuries: ‘This is the cure that I discovered and it’s backed with testimonials from lots of people snatched from the grave by using it,’ ” said James Whorton, professor of medical history at the University of Washington’s School of Medicine.
The National Institutes of Health says research in the area of energy medicine may hold promise, but so far none of the devices, or their treatments, has been scientifically validated.
“Undoubtedly, there’s a lot of quackery,” Whorton said. “They will tell you what you want to hear. The average person isn’t educated or trained to be able to evaluate these therapies critically.”
Couple’s final hope
In a clinic in Tulsa, Okla., JoAnn Burggraf, 58, sat in an oversized armchair as she was hooked up to an EPFX.
Clinic owner Sigrid Myers, who was trained on the device in Seattle, wrapped black straps containing electrodes around Burggraf’s forehead, wrists and ankles. The straps were connected to the shoe-box-sized EPFX, which plugged into a desktop computer.
Myers used the EPFX to scan and analyze Burggraf’s body. Burggraf watched as the monitor displayed bright-colored graphics representing parts of her body that Myers said were unhealthy.
Then, Myers recounted, she set the EPFX to “zap mode” and transmitted imperceptible, low-level frequencies through the electrodes and into Burggraf’s body.
She and her husband, Jerry Burggraf, owned a successful cleaning and restoration company in Tulsa. He developed leukemia and underwent chemotherapy. In 2004, he began EPFX treatments, hoping to stop the disease.
He died in March 2005 at age 59.
Her husband endured painful side effects from the chemotherapy. After that, she distrusted doctors.
She started EPFX sessions, at $60 an hour, seeking relief from pain in her joints and legs.
“I begged her to go to the hospital,” her son, Bryan Burggraf, 37, said. “Mom told me this device would make her well.”
But her pain grew worse, becoming so intense that she frequently blacked out. In October 2005, Bryan finally convinced his mother that she needed to go to a hospital immediately. She was so weak and sick, with inflamed, open sores on her legs, that she eventually had to be transported by helicopter.
She died within hours of admission. Tests showed that her body had been devastated by undiagnosed leukemia.
Her son said doctors speculated that his parents were exposed to now-banned solvents used in their restoration business.
“I’m outraged that this fraudulent device is still out there,” Burggraf said. “If my mom had gone to the hospital earlier there may have been hope. If nothing else, she would not have died in incredible pain.”
Myers, a massage therapist, has no formal medical training or college degree. But on the wall of her home clinic were half a dozen framed certificates that bestowed her with health-care titles and credentials such as “naturopathic doctor.”
“We’re not supposed to say it, legally, but it can zap away disease,” she told a reporter who visited the clinic. Asked why the EPFX did not cure JoAnn Burggraf, Myers tearfully explained: “I had just a few days of training. I really didn’t know what I was doing.”
Now she says she’s more experienced.
Myers continues to treat patients in her home office with a newer EPFX. She persuaded an elderly patient to buy the machine for her, which cost $12,000. In exchange, Myers said, she didn’t charge the woman for EPFX sessions to treat her heart disease.
That patient died, too.
Last year, at an international EPFX conference in Budapest, William Nelson bounded to a stage in front of a cheering crowd of several hundred — operators of the machine or those hoping to buy one. They rose to their feet and applauded.
He explained how he had used the EPFX to cure cancer and AIDS.
“It helps that I’m a genius,” he told them.
But nothing is what it appears with Nelson, including his appearance. On stage, he wore a white dress, heels and heavy makeup.
“Judge the teaching, not the teacher,” he told the crowd in a soothing baritone. Nelson is a polished performer — funny, confident, commanding the tools of a natural-born salesman.
Later, under his stage name Desiré Dubounet, he sang rock songs at his lounge, Club Bohemian Alibi.
This is the Nelson that few patients ever learn about.
From his restored, five-story building in downtown Budapest, Nelson operates the main EPFX business, Eclosion, and lives with his fifth wife and 8-year-old son. He has a personal staff of about a dozen, including a cook, hairdresser, nanny, security guards and chauffeurs.
From his movie production studio, he has created films that portray him as the crusader of alternative medicine and the FDA as the corrupt villain.
He said he has sold 17,000 EPFX devices worldwide. They now cost $19,900 each.
Nelson makes extraordinary claims about his life. He said he worked as a contractor for NASA, helping to save the troubled Apollo 13 mission as a teenager. He boasts that he was an alternate member of the 1968 U.S. Olympic gymnastics team. He says he has eight doctorates, including degrees in medicine and law. See a PDF of his Curriculum Vitae here.
None of it checks out. NASA has no record of his employment; he was not an Olympic athlete. And his “degrees” came from unaccredited schools and mail-order businesses.
In truth, at age 33, Nelson was a part-time mathematics instructor at Youngstown State University in Ohio, according to school records.
As an avid “Star Trek” fan and father of an autistic son, Nelson became obsessed with creating a space-age device that melded modern mathematics with alternative therapies to heal the body.
In 1984, he moved his family to Colorado, where he started to sell his homemade medical device, called the Electro-Physio-Feedback-Xrroid System, or the EPFX.
Nelson registered his company with the FDA in 1989 as a maker of biofeedback machines, meaning he could sell them only as stress-relieving tools. By law, he could not claim the devices diagnosed or treated disease.
But Nelson did it anyway. In 1992, the agency ordered him to stop making false claims, then later ordered a recall of the EPFX. But Nelson continued to sell it as a healing machine.
He was indicted on nine counts of felony fraud in 1996 and fled the U.S. See a PDF of Nelson’s court docket here.
Eclosion remains registered with the FDA.
Today, Nelson’s sales empire reaches across 32 countries with dozens of distributors, brokers and trainers in the U.S. Top sellers can get hefty commissions, tropical cruises and BMW sedans.
Emma Robinson, a regional manager for the Pacific Northwest, earned one of the BMWs. She said she pulls in about $7,000 a week through sales commissions and by treating patients at her clinic, Quantum Pacific Wellness Center, in Wilderville, Ore.
Nelson and his distributors saturate the Internet with glitzy Web sites packed with animation, music, videos, even operators available to answer questions.
EPFX sales have exploded, fueled by aggressive marketing including such pitchmen as a physician for pop star Britney Spears and a chiropractor for cyclist Lance Armstrong.
As Nelson tells his audiences: Conventional doctors speed patients through appointments with treatments that focus only on symptoms, not on the root causes of ailments. The EPFX treats the whole body, and it does it without surgery or drugs.
Practitioners encourage patients to talk with them about any health problem. EPFX treatments typically last an hour. Afterward, a substantial number of patients will report that they feel better.
Energy-device operators benefit from the placebo effect, a psychological phenomenon in which patients report improvement that cannot be linked scientifically to treatment, studies show. People feel better through the power of suggestion or because they believe they are expected to feel improvement, experts say.
The EPFX is made up of circuit boards and other computer components that run software full of colorful graphics of the body. During a typical EPFX treatment, a patient may watch as a computer screen displays an animation of the interior of an artery blocked by white blobs, representing cholesterol. Then the blobs shrink and disappear.
Tens of thousands have found Nelson’s pitch persuasive. “Traditional doctors don’t want you to use the EPFX,” he says. “They will tell you it’s a fraud. That’s because they are scared. I have discovered something that will put them out of business. And they don’t want you to have it.”
His fervor is shared by Emma Robinson’s husband, John, also an EPFX regional sales manager. He says the device can do most anything.
“It’s the closest thing to God I know.”
In 1997, Congress passed the Food and Drug Administration Modernization Act, which made it cheaper and quicker to bring a device to market.
Consequently, the number of energy-device makers has increased to 462, up 45 percent in the past decade, according to a Times analysis.
The act also exempted many manufacturers of low-risk devices from submitting proof that the machines worked and were safe.
The agency places them on the honor system when it comes to classifying their devices. As a result, a popular strategy for some manufacturers is to list their devices as biofeedback machines. Legally, they can only be used to relieve stress.
But The Times found dozens of biofeedback machines that are marketed to the public with wild claims. Some examples:
• Practitioners using the LIFE System, distributed by Energetic Medicine Research Ltd., offer patients a “full diagnostic and treatment system.” They claim the devices can assess the health of organs and “clear health blocks,” from allergies to dental problems.
• Hippocampus-Brt Ltd., a Hungarian company registered with the FDA, declares that its Mobile Cell-Com can treat allergies through short “therapy sessions,” strengthen the body’s immune system and relieve inflammatory ailments.
• California-based Inergetix Inc. sells the Inergetix-CoRe System that can “scan and balance the organs and systems of the body.”
Additionally, health improvements are shown on a computer screen “as they occur.”
Installed in a hospital
Three years ago, EPFX operators scored one of their biggest coups: They managed to get two devices inside a U.S. hospital — St. John’s Hospital, an 866-bed facility in Springfield, Mo.
Nelson markets this as proof that mainstream medicine embraces the EPFX.
On Friday, hospital administrators launched an investigation into how the EPFX machines got approved. They learned about their presence from The Times.
Faith Nelson, a registered nurse who works in the department where the devices are used, is also a regional sales manager for the EPFX, records show. (She is no relation to William Nelson.)
In addition, Susan Blackard, a hospital vice president who oversees that department, conducts training sessions for EPFX operators worldwide, records show.
Blackard, who is also a registered nurse, trained several hundred people at a conference last year in Budapest.
Neither woman returned calls for comment.
St. John’s spokeswoman Cora Scott said the hospital is reviewing the employees’ relationship to Nelson and the EPFX sales network.
The hospital is owned by the Sisters of Mercy Health System. Officials there said the two EPFX devices were used only for stress relief.
One operator cut off,
Washington state regulators first learned about the EPFX in April 2004 when a Puyallup physician filed a complaint that an unlicensed health-care practitioner in Tacoma was using one.
State investigator John Kozar checked out the complaint, interviewing Janet Zibell, who used the EPFX at her spa.
At the same time, Kozar learned that other EPFX operators across the state were using it. In May 2004, Kozar wrote to his superiors: “This device is being used by unlicensed people to treat and diagnose patients with illnesses.”
Zibell told state investigators that she used the EPFX only as a biofeedback machine to help relieve stress, according to state records. In Washington and all states, no license is required to perform biofeedback.
To show investigators how she used the device, Zibell conducted an EPFX session at Department of Health headquarters in Olympia. Zibell connected the EPFX to state investigator Carol Neva. During the demonstration, Zibell said the device detected a parasitic worm in Neva’s colon so she “zapped a worm” with the device’s electrical frequencies.
That was enough for investigators. Zibell was issued a cease-and-desist order. She agreed not to use the EPFX to diagnose or treat illness. The Health Department stopped there, closing the case. It did not look into the other EPFX operators Kozar warned about, records show.
In Oregon, regulators took a far different approach.
The Oregon Board of Chiropractic Examiners earlier this year barred chiropractors from using the EPFX. “This device is complete hocus-pocus,” the board’s executive director, Dave McTeague, said. “There is no rational explanation as to how it works.”
Karen McBeth’s losses
Seattle cancer patient Karen McBeth, 59, had no trouble finding an EPFX operator. A retired employee with state Juvenile Rehabilitation Administration, McBeth had squamous-cell carcinoma that mushroomed into terminal bone cancer. She underwent chemotherapy. By early 2005, she was in so much pain that she could barely walk.
Desperate for a cure, she looked for an alternative and through friends learned of BioScience, a health-care clinic in Port Orchard that offered EPFX treatments. BioScience was run by Robert and Marie Erdmann, and their daughter, Ann Riner. None of them had a state health-care license. McBeth was skeptical at first. But she did some Internet research and learned the device manufacturer was registered with the FDA and that dozens of physicians and chiropractors touted the device.
She began twice-weekly treatments. She was even persuaded to buy a machine for use at home, and spent $17,000 from her retirement savings.
“She was led to believe that treatment would cure her cancer,” said her husband, Al Bergstein.
By the summer, she began to doubt whether the device was effective. She died Sept. 3, 2005.
Bergstein said the device offered a false hope that consumed his wife and robbed the family of precious remaining time with her.
A retired Microsoft manager, Bergstein looked at the source code in the EPFX’s software. It appeared to generate results randomly.
“It’s a complete fraud,” he said.
Marie Erdmann, 64, who now manages the clinic since the death of her husband last year, defended the EPFX. “It’s where medicine will go, but it will take a long time,” she predicted.
A cure for everything
The world’s largest EPFX distributor, The Quantum Alliance, is headquartered in Calgary, Alberta. It also operates its largest North American training center in Victoria, B.C., not far from Seattle.
Ken Wilkinson, chief executive officer, said the company does not market the EPFX as a diagnostic or healing machine.
However, dozens of such claims are found in the company’s brochures and newsletters. For example, one brochure, used by a Washington practitioner this year, claimed that the EPFX can test for toxins, bacteria, viruses, allergens, parasites and disease.
In addition, The Quantum Alliance distributed a training video, narrated by Nelson, that claimed the EPFX can repair injured tissue and accelerate healing.
Wilkinson said the company no longer uses these materials. The EPFX is marketed only as a stress-relief tool, he said.
But a training newsletter, published last month by The Quantum Alliance, provided step-by-step instructions on how to use the EPFX to enlarge lips or cheeks and treat dental problems.
Company President Brian Thompson said the EPFX has “helped thousands of people.” He couldn’t explain what the device does or how it works. “We just sell them,” Thompson said.
Hundreds of other brokers and practitioners sell the device as well, earning up to $2,500 in commissions per sale. Dozens of their Web sites tout testimonials of miraculous healings and declare that the EPFX can provide hundreds of therapies.
One of its strangest features is found on top of the EPFX: a 5-inch silver plate. Nelson claims the device can detect problems in the body by analyzing hair, saliva or blood placed on the plate. The device then fires healing frequencies to patients — even if they’re hundreds of miles away.
A taunt to regulators
The EPFX was a big draw at this year’s Western Washington Fair in Puyallup. Bart Keough, owner of The Healing Circle Counseling in Eatonville, Pierce County, ran a booth where more than 400 people were treated. They were charged $20 for a half-hour session.
Keough calls himself a “certified biofeedback specialist,” a certification he earned from a mail-order training program. He said he has to be careful about how to describe the EPFX to avoid hassles with the FDA.
“We’re told not to tell anyone that it heals anything,” he said.
But a 4-foot-long banner that draped his booth listed dozens of “Therapies” the EPFX could provide. Keough admitted the EPFX contains many therapies that go beyond what the FDA allows. “I don’t know how Bill Nelson gets by with it,” he said.
In Budapest, Nelson doesn’t worry about the FDA. In the past year, he established companies that are bringing in new products and devices into the United States.
He also has produced a music video in which he sings in front of a giant image of FDA headquarters. Nelson’s song ends with a taunt to the regulators: “You ain’t seen nothing yet.”
Staff reporter Sonia Krishnan and researchers David Turim and Gene Balk contributed to this report.