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Thursday, March 7, 2019

Electronic Medical Devices

     In the late 1980s, a fellow named William Charles Nelson (born June 19, 1951) built an electronic device he claimed could diagnose and destroy disease by firing radio frequencies into the body. 
     At age 33, Nelson was a part-time mathematics instructor at Youngstown State University in Ohio.  He was a Star Trek fan with an autistic son and became obsessed with creating a space-age device that combined modern mathematics with alternative therapies. 
     In 1984, he moved to Colorado where he started to sell his homemade medical device. He 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 he did it anyway. 
     The device, the Electro Physiological Feedback Xrroid was claimed to be a remarkable invention...it could zap everything from allergies to AIDS to cancer. It was known as EPFX or, alternately, as Quantum Xrroid Consciousness Interface (QXCI). 
     The device claimed to balance bio-energetic forces, something that the scientific community does not recognize as real. The device mainly reflected skin resistance (how easily low-voltage electric currents from the device pass through the skin), which is not related to the body's health. 
     Some people chose to use Nelson’s invention instead of seeking or continuing conventional medical care and some died as a result. In one documented case, undiagnosed and untreated leukemia resulted in the death of a patient. 
     The device used so-called energy medicine and claimed to read the body’s reactivity to various frequencies and then send back other frequencies to make changes in the body. The machine is made up of circuit boards and 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. 
     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. As a result, more than 10,000 of the devices sold in the United States alone.
     In 1992 the Food and Drug Adminstration, which regulates medical devices, asked that Nelson stop claiming that the EPFX could diagnose or cure diseases and stop selling them.  He didn’t and in 1996 was indicted on nine counts of felony fraud. You would think that would be the end of it, but it wasn’t. Wilson fled the United States to Hungary where he continues to operate and is also involved in, among other things, homeopathic medicine.  Imports of the devices to the US are banned.
     Wilson lives in Budapest with his fifth wife and their children and has a personal staff that includes a cook, hairdresser, nanny, security guards and chauffeurs. He is also now a woman known as Desire Dubounet. 
     With all the charisma of a televangelist, at the international EPFX conferences in Budapest, Nelson bounds onto a stage in front of a cheering crowd wearing a dress, heels and a lot of makeup. The crowd is made up of several hundred including machine owners and people hoping to buy one.  The crowd jumps to their feet and applaud as he explains how he is a genius and uses the EPFX to cure cancer and AIDS.  It works...he claims to gave sold 17,000 EPFX devices worldwide at a cost of $19,900 each. If my calculator is working correctly, that's over 338 million dollars.
     He also claims to have worked as a contractor for NASA while a teenager and he helped save the Apollo 13 mission. He claims to have been an alternate member of the 1968 U.S. Olympic gymnastics team. He has eight doctorates, including degrees in medicine and law, listed on his credentials. None of it is true except for the degree claim, but they are from unaccredited schools and mail-order degrees.
     After the conference he appears at his lounge, Club Bohemian Alibi, where he sings rock songs. Like modern televangelists, he also has a movie production studio where he creates films that portray him as the crusader of alternative medicine and the FDA as a corrupt villain. 
     See Desire’ Dubounet, the man who left America to find freedom who is no longer a man for complete details.

     Today in the U.S. there is a growing field called energy medicine that is supposed to offer alternative therapies based on the belief that the body has energy fields that can be manipulated to improve health. 
     Devices range from handheld machines the size of a television remote to huge machines that weigh hundreds of pounds with costs ranging from $1,200 to $55,000. Many manufacturers and operators follow FDA rules and disclose that treatments are unproven. 
     Today you can see former basketball great Shaquille O'Neal appearing in TV commercials claiming you can turn off pain using an Icy Hot Smart Relief gizmo.
     The devices uses TENS Therapy and is designed for back, hip, knee and shoulder pain. It costs $29.99 and includes one reusable electrode pad. A electrode refill pack, including a replacement battery, costs an additional $14.99, and should last about a month. 
     TENS stands for Transcutaneous Electrical Nerve Stimulation and the gadgets are actually quite popular. They attach to your skin with sticky electrodes and send a low level of electricity through the skin to where you're feeling pain.
     Some doctors say that TENS devices can actually help patients reduce the amount of pain-relieving medications they need to use, including opioids. Icy Hot claims the device uses the same technology used by doctors, relieves painful muscles and joints, has 63 intensity levels and is prescription strength.  It’s good for sore aching muscles and relief of chronic pain associated with arthritis. 
     There is also another popular device called Quell. It cost $300. The manufacturer says their device is five times as powerful as cheaper TENS devices out there. 
     Do these things work? Many patients say they do, but it’s also claimed it’s because of the placebo effect, a psychological phenomenon in which patients report improvement that cannot be linked scientifically to treatment. People feel better through the power of suggestion or because they believe they are expected to feel improvement. 
     Blame the FDA. In 1997, Congress passed the Food and Drug Administration Modernization Act, which made it cheaper and quicker to bring a device to market which lead to an explosion of energy-device on the market. The act also exempted many manufacturers of low-risk devices from submitting proof their machines worked and were safe. 
     The new law placed manufacturers on the honor system when it comes to classifying their devices. A lot of manufactures simply claim their products are for biofeedback and legally can be used only relieve stress. 
     But, many biofeedback machines are marketed with wild claims ranging from offering full diagnostic and treatment systems, assess the health of organs and clear health blocks, to relieving allergies and dental problems. Devices are also claimed to be able to strengthen the body’s immune system and relieve inflammatory ailments and health improvements are shown on a computer screen as they occur. 
     In one interesting case St. John’s Hospital in Springfield, Missouri actually bought two of Nelson’s machines. Hospital administrators learned about the purchase from a newspaper and launched an investigation into how the EPFX machines got approved. It turned out that a registered nurse who worked in the department where the devices were used was also a regional sales manager for the EPFX. In addition, a hospital vice president who oversaw the department conducted training sessions for EPFX operators worldwide. Hospital officials there said the devices were used only for stress relief and the case was closed. 
     St. John's Hospital, run by the Sisters of Saint Mary in St. Louis, was reorganized and renamed in 2012 and in 2015 had to repay the Federal Government millions for fraudulent billing activity.  Here's another juicy story involving the repayment of 34 million dollars in fraud. 

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