Electromagnetic Devices Offer Alternative Treatments for Life-Threatening Illnesses
By Paul J. Rosch, M.D., F.A.C.P.
President, The American Institute of Stress
Clinical Professor of Medicine and Psychiatry, New York Medical College
Obtaining FDA Approval for Innovative Therapies
Medical device manufacturers have long complained about the difficulty in obtaining FDA approval for their products because of very delayed or no response to inquiries.
This is a particular problem for cancer patients who must travel abroad to receive therapies that are not available here in the United States. In response to mounting criticisms, the FDA Modernization Act of 1997 was passed to address these and other concerns. It mandated that correspondence would be answered in timely fashion as well as other revisions to ensure the timely availability of safe and effective new products.
One of these was a "globalization and harmonization" provision stipulating that devices approved by regulatory agencies abroad requiring strict proof of safety and efficacy should be made available here, provided that post marketing surveillance was instituted to guarantee safety.
The FDA was also directed to establish policies for the "compassionate use" of these and other investigational approaches through a licensed physician while they underwent regulatory view. Although these provisions went into effect in 2002, they have not been implemented.
I am one of five individuals selected to testify before a Congressional Oversight Committee investigating this and have five or ten minutes to explain my qualifications and provide examples of devices and approaches proven worthwhile elsewhere in the world that should be approved here in the United States.
By coincidence, I have just finished editing a 52-chapter book, "Bioelectromagnetic Medicine," to be published later this year by Marcel Dekker. Although it includes several devices that should be mentioned, I intend to focus on two cancer therapies I am personally familiar with for the following reasons.
The FDA's responsibility is to protect the public by monitoring such things as the safety of foods and pharmaceuticals as well as medical devices. However, it must establish priorities because of limited resources, especially with respect to personnel with expertise in the evaluation of electromagnetic field therapies. There are some that are authentic and have been thoroughly investigated by reputable researchers.
Unfortunately, these are drowned out by others being promoted by well-meaning but misguided zealots as well as entrepreneurs and charlatans who make extravagant and unsupported claims for their worthless wares. Alleged remarkable results are usually based on lavish testimonials, occasionally by paid celebrities, and it is likely that any legitimate benefits are placebo effects.
This is especially true because double blind studies designed to exclude this for drugs may be impossible to perform with some devices. As a result, it can be difficult to separate the wheat from the chaff.
In addition, there is a growing wariness of the possible harmful effects of electromagnetic fields emanating from high power lines and cell phones. The FDA should not be criticized for exercising extreme caution in approving devices whose adverse effects decades later are unknown. I have tried to address this in "Bioelectromagnetic Medicine" by limiting contributions to those that are evidence-based and supported by citations in peer-reviewed publications.
While there is no guarantee that this resolves the long-term safety issue, this is of much less concern to cancer patients in contrast to children or adolescents.
Electromagnetic Devices for Treating Cancer
Björn Nordenström, M.D., Ph.D. has impeccable credentials. He was formerly chairman of the Department of Radiology at Karolinska Hospital and chairman of the selection committee that picks the Nobel Laureate for Physiology of Medicine. He is famous for having developed the "skinny needle" technique for biopsies used by most surgeons and interventional radiologists around the world.
About four decades ago, he became intrigued by the observation that he could occasionally see what appeared to be a halo around malignancies on routine chest X-rays that was not present with benign tumors. He collected a series of these and showed them to colleagues who had also noted this but assumed they were artifacts.
His subsequent detailed animal experiments revealed that the reason was malignant tumors had different electrical characteristics from surrounding normal tissue. He found that correcting this by inserting his skinny needles into these two areas and using them as electrodes to supply weak DC current caused these malignancies to disappear.
The procedure is painless and takes only a few hours. At our 1998 Congress, he showed two patients with inoperable pulmonary metastases from cancer of the ovary and breast that were well with no evidence of tumor 10 and 12 years later. As noted in "Bioelectromagnetic Medicine," one is now in her 90s and in good health more than 20 years after one treatment.
Others have now replicated these results and a chapter from Chinese Physicians reports on satisfactory results in over 9,000 patients with these and other malignancies. Another chapter deals with Nordenström's description of an "electrical circulatory system" and its relationship to ancient Oriental concepts of Qi, yin and yang.
In award-winning writer Gary Taubes' Discover magazine cover story, he noted that some authorities compared this as being as important as William Harvey's explanation of how blood circulates in the body and described it as "the most profound biomedical discovery of the century."
Demetrio Sodi Pallares is a respected Mexican cardiologist and the author of 20 texts including a dozen on the electrocardiogram. He became internationally famous decades ago for his glucose-insulin-potassium "polarizing solution" that dramatically improved survival following a heart attack.
It was based on his observation that this increased the production of ATP, the source of energy for all cellular functions. He subsequently found that the application of a pulsed magnetic field enhanced this effect in injured cells and that combining these treatments provided amazing benefits in other disorders. He has shown at our Congresses how he has been able to actually reverse advanced metastatic disease and terminal cardiomyopathy.
Patients whose life expectancy was a few weeks or months were leading normal lives with no evidence of their disease two or three years later. In "Bioelectromagnetic Medicine" he included patients with pancreatic cancer, which is almost always fatal within a year of detection, who are well three years later and the reasons why his treatment works are explained.
Why should cancer patients have to travel abroad for these proven life saving therapies?
Electromagnetic Medicine and Osteoarthritis
Many suspect that powerful pharmaceutical interests have been able to exert their influence over the FDA and other regulatory agencies to prevent anything that threatens their huge profits. Another chapter in "Bioelectromagnetic Medicine" describes an electromagnetic device for the treatment of osteoarthritis currently administered in 18 countries at over 500 sites including University affiliated clinics and The American Hospital in Paris.
This non-invasive and painless therapy, consisting of treatment for one hour daily over 10 days is reimbursed by fiscal intermediaries and often governmental agencies that are the equivalent of Medicare because of its proven long-term cost effectiveness and superior safety record compared to drugs.
This is important since the latest statistics indicate that osteoarthritis now affects one in three U.S. adults (70 million), up 63 percent from the 1997 estimate of one in five. Current medications are not always effective and can be dangerous.
In 1993, of 140,000 hospital admissions for osteoarthritis, 25,000 deaths were directly attributed to high dosage or prolonged use of NSAIDs.
While Cox-2 inhibitors were touted to be safer, this has now been questioned and one has been linked to a higher incidence of coronary events and they are no more effective than drugs a fraction of their cost. Since their introduction in 1999, combined sales of Vioxx and Celebrex have exceeded $6 billion annually due to aggressive advertising, which also drives up their price.
In 2000, Merck spent $161 million on advertising for Vioxx, more than Pepsico spent on Pepsi and Anheuser-Busch spent on Budweiser. And if you don't think that advertising and samples bring in big bucks, consider this. One study found that in treating patients with hypertension, over 90 percent of physicians actually dispensed a sample that differed from their preferred drug choice! It's not likely that these drug giants and others will tolerate anything that threatens their huge profits.
Dr. Paul J. Rosch is the president of the American Institute of Stress and clinical professor of medicine at New York Medical College and has written extensively about relationships between stress and cancer over the past 25 years. He is also a member of the contributing editors board at Mercola.com. In addition to the research noted above, additional chapters in "Bioelectromagnetic Medicine" are devoted to cancer as well as depression, anxiety, insomnia, tinnitus, migraine, multiple sclerosis, obesity, epilepsy, herniated disc, Parkinson's disease, urinary incontinence, macular degeneration, cardiac and brain lesions. These cutting edge "energy medicine" approaches are much safer than drugs and surgical procedures, considerably less costly and, in many instances, more effective. "Bioelectromagnetic Medicine" will be published by Marcel Dekker, Inc. later this year.