The source of this article is the Arizona Daily Star: http://tinyurl.com/b9ylu Magnetic treatment clinic draws controversy By Carla McClain ARIZONA DAILY STAR A new and controversial Tucson clinic that promises hope for people suffering from incurable and often untreatable medical problems has triggered widespread skepticism throughout the local medical community and may face the scrutiny of federal health authorities. Among the devastating ailments that the clinic - known as the Advanced Magnetic Research Institute - claims success in treating are brain and spinal cord injury, Alzheimer's and Parkinson's diseases, heart and liver failure, multiple sclerosis, muscular dystrophy, cerebral palsy, autism and even the ravages of a stroke. Open just two weeks, the AMRI clinic uses an experimental device to deliver powerful electromagnetic currents that operators say can heal, repair or regenerate the damaged body part, to cure or at least improve symptoms of these disorders. The physician supervising the Tucson AMRI said he took the position after trying the therapy himself - on a damaged thigh muscle that hobbled him - and found it successful at restoring his mobility. "I know it works, and I know it's safe," said Dr. Joseph McCready, citing an analysis of results at similar clinics around the country showing a 70 percent success rate - either curing or significantly easing injury or disease. But the clinics' unproven claims, and the high cost of the therapy, have caught the attention of the U.S. Food and Drug Administration. "This device is not approved or cleared by the FDA," said Julie Zawisza, with the agency's Office of Compliance. "That means it cannot be marketed or promoted or advertised as if it has clinical utility. And that is the case even if the device is under clinical study." FDA regulations also prohibit charging fees to make a profit from such a device. Operators can charge only enough to recover the cost of providing the therapy, Zawisza said. A for-profit enterprise, AMRI charges $45 an hour for its 10,000-pound electromagnetic field device, the "magnetic molecular energizer." With recommendations of at least 100 to 200 hours of treatment, that means thousands of dollars per patient - not covered by insurance. "The exorbitant amounts being charged for this do raise a red flag at the FDA, as do what appear to be claims of relief for these diseases," Zawisza said. Although the use of magnets for healing is considered an unproven and experimental alternative therapy, it certainly is nothing new, with reports dating back 3,000 years. Ancient Greeks and Egyptians reported improved well-being when they lay on magnetized rocks - lodestones - after strenuous work. Today, several pro athletes, including tennis star Lindsay Davenport, say magnets have helped relieve pain and heal injuries. Most people who try it use small static magnets, placed on the ailing area. Although reports of relief are numerous, actual scientific studies are few and have conflicting results. "Scientific research so far does not firmly support a conclusion that magnets of any type can relieve pain," states the National Institutes of Health on the subject. And no studies have shown any effectiveness against chronic disease. That includes the more powerful electromagnetic technology used at AMRI, which generates magnetic fields via electric currents. That type of magnet therapy is approved and used for one medical purpose only - to heal resistant bone fractures, according to the NIH. That's why, despite its claims of success with a myriad of difficult medical conditions, all patients undergoing this therapy at the local clinic must sign a consent form stating that they understand it's under research and may not provide a cure. "This is still considered experimental, so every treatment we do will be submitted to the FDA," said McCready, a respected longtime Tucson ophthalmologist who came out of retirement to be chief clinical investigator for the local AMRI. The Tucson clinic is the newest of seven such offices opened in North America in the last six years - six in the United States, and the founding clinic in Canada. All are run by doctors. Most charge $50 to $60 per hour. Collectively, the AMRI clinics have treated some 1,300 patients - including about 35 in Tucson - for all kinds of conditions, and are reporting 75 percent showed "some degree of improvement," 12 percent had "minimal improvement," and 13 percent showed "no change." However, in February, the FDA sent a warning letter to the AMRI clinic in Hanover, Pa., about "objectionable conditions" and "serious violations" found in an FDA inspection. Specifically, investigators cited the clinic for failing to present alternative treatments to patients, and any risks in therapy. The clinic also failed to perform patient medical tests required before therapy, and found several patients who were never seen by a physician, as required. If such deficiencies, and the lack of scientific trial, eventually doom FDA approval of AMRI therapy, McCready said that will not affect the demand for it, noting some clinics are booked more than a year in advance. Despite its popularity, local doctors are highly skeptical. Just the gamut of disorders the clinic claims to assist makes "you lose trust," said Dr. Kutaiba Tabbaa, director of the University of Arizona Pain Clinic. "This must be Jesus inside that machine," he said. Even doctors who embrace alternative treatments along with mainstream medicine remain wary. McCready approached Dr. Andrew Weil, internationally known founder of the integrative medicine movement, based at UA, to consider referring patients to AMRI. He declined. "We are familiar with what is called pulsed electromagnetic field therapy, and we've seen only marginal results with it," said Dr. Brian Becker, head of science and ethics at Weil's integrative medicine program. "They say it's safe and non- invasive, but no one knows what physical effects might result from hundreds of hours of exposure to this energy. We'll know in 20 years. To be completely safe, something has to be completely inert, and this is not." But such concerns did not discourage Tucsonan David Reilly, 61, from trying the clinic last week, a day after he heard of it. For six years, he's struggled with a deteriorating and severely painful knee joint, requiring narcotics to control the pain. Two years ago, he was told he needed a total knee replacement - an option he rejected. But after his first four hours under the AMRI electromagnet Wednesday - which involves simply lying on a bed, watching TV, reading or sleeping - he called the treatment "100 percent successful." "By morning, I was so excited, I rode my bicycle, I climbed a ladder - these are things I couldn't do without a great deal of difficulty," Reilly said. "The swelling is way down; the mobility is way up. I know I'm going to be able to forgo the narcotics now, and that's exciting." Reilly can afford to continue therapy for at least 200 hours, at which point he expects the damaged cartilage will be repaired. "All I can say is people who close their eyes to this, who pooh-pooh it, well, that's unfortunate," he said. If Reilly completes his 200 hours, he's looking at a $9,000 bill. McCready does not apologize. He said it cost $500,000 to open the clinic, which has four magnetic molecular energizers, costing $100,000 each. "What is the money if you can significantly improve nerve damage from diabetes, or disability from cerebral palsy or Parkinson's? Or if you can avoid a complication from surgery?" he asked. "Money is not a deterrent to a lot of people who have these problems." ? Contact reporter Carla McClain at 806-7754 or at [log in to unmask] ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn