This is a proposal to fill a significant gap in the testing of therapeutic methodologies. There is a need for an independent laboratory to evaluate new and promising methods that are coming into widespread use but that are not well regulated or tested by existing institutions. What is being proposed is the equivalent of the Underwriters Laboratory specializing in the evaluation of new medical devices and techniques. The UL label is the trusted source across the globe for product compliance and public safety. The proposed laboratory would provide a similar service for medical technologies, and will play a key role in the future of medicine and in improving public health by revealing which approaches are safe and effective, and identifying long term effects.

This is an opportunity for anyone interested making a major contribution to medical science while furthering their own knowledge and understanding of health and medicine. A key issue that has been raised again and again throughout the history of medicine is the conflict between beneficial short-term solutions and longer-term effects. Nowhere has this been more apparent than in the use of antibiotics and pain medications. For example, it is well known that antibiotics are becoming impotent, as bacteria mutate into resistant strains that pose a very serious threat to public health in the event of an epidemic. Alternative approaches to microbial toxicity are urgently needed. And the side effects of Cox-2 type drugs such as Vioxx and Celebrex has left many patients without a viable pain medication. Alternatives to purely pharmacological approaches have become high priority.

Historical background

Luigi Galvani (1737-1798), Italian physician and anatomy professor in Bologna is credited with the discovery of "animal electricity." Not long after this discovery, physicians began experimenting with the application of electricity and magnetism for the treatment of disease. By 1900, a wide variety of devices were in widespread use in the USA and Europe. Some of these devices appear to have been successful, as judged by their extensive use by large numbers of physicians. It has been estimated that by 1884, there were 10,000 physicians in the USA using electricity every day for therapeutic purposes. Toward the end of the 19th century, interesting and sometimes humorous devices were introduced for public consumption, and were purported to cure every malaise or malady known to mankind. Many of these gadgets were pure quackery, and produced no documented effects. Some are listed in the 1902 Sears Roebuck Catalog: electric battery plasters, an electric ring for rheumatism, electric insoles, and electric liniments. While it can be stated that there was no careful scientific documentation of the value of any of these devices, it must be acknowledged that this era preceded the development of rigorous scientific testing of any medical interventions.

It was during the early years of the 20th century that the 1895 discovery of X-rays, by Wilhelm Conrad Röntgen, was leading to new ways of visualizing the human body and detecting diseases. As with other kinds of radiation, the X-ray eventually proved to be a double-edged sword: while it was extremely valuable as a diagnostic tool, excessive use of X-rays can cause gene mutations leading to leukemia and other cancers.

The Pure Food and Drug Act of 1906 and the Flexner Report of 1910 sought to put medical education and treatments on a more scientific footing. Soon all electrical and other energy therapies were declared scientifically unsupportable and therefore illegal. However, in retrospect, we can see that "scientifically unsupportable" simply meant that no scientific studies had been done on these devices. Discarding all of these energetic approaches definitely set the stage for the age of pharmaceutical medicine, which became the dominant medical paradigm of the 20th century.

During the half century beginning in 1906, very little basic research was done on the healing properties of energies such as light and electricity. Medical research was primarily focused on the development of new drugs. The discovery of penicillin was a major advance and saved millions of lives. Penicillin also created an illusion that captivated the public's perception of medical advancement: sooner or later a pill would be discovered for every disease. At the same time, academic research on electrophysiology became increasingly important, particularly in the field of neuroscience. Efforts were made to understand the basis for important clinical electrical measurements such as the electrocardiogram and electroencephalogram. Occasionally inventors developed healing devices based on electricity or magnetism or light, but it was difficult to reintroduce the topic of energy healing into modern biomedical science without encountering an inordinate amount of skepticism due to the prior history. Regulatory bodies, particularly the FDA, discouraged the use of various forms of energy in general medicine and it has taken nearly a century for energy devices to begin to be restored to widespread use.

Turning points

A turning point came in the 1950's when distinguished orthopedic surgeons in New York rediscovered the use of electricity and magnetism as treatments for a serious medical problem called non-union of fracture. Electrical stimulation had actually been the method of choice in the mid 1800's (Lente RW, 1859. Cases of un-united fracture treated by electricity. New York Journal of Medicine 5:317) but was discontinued along with all other electrotherapies following the Flexner report of 1910. Eventually it was discovered that one could "jump-start" healing in a bone that had failed to heal for as long as 40 years. After extensive clinical trials, under excessively stringent FDA supervision, pulsing electromagnetic field therapy became an accepted and widely-used procedure for treating non-union of fracture. Much credit is due C.A.L. Bassett and his colleagues at Columbia University, College of Physicians and Surgeons for their persistence in overcoming daunting regulatory hurdles, entrenched skepticism, and a stifling academic atmosphere to bring this technology into mainstream medicine.

A few years later, Norm Shealey, M.D. introduced the TENS unit for treatment of pain. Again, after a lengthy and difficult interaction with the FDA, the TENS unit was recognized as safe and effective, and there are now more than 100 different FDA approved devices in this category, with some 250,000 TENS units prescribed annually in the United States alone. Like Bassett, Shealey deserves much credit for persisting with the regulatory process, for his work has had a huge impact in pain management and has reduced the suffering of a very large patient population.

In recent decades, the public has been introduced to a variety of "energy therapies" that seem to provide inexpensive and non-invasive relief from a wide variety of musculo-skeletal and other pain-related issues. A key step has been the gradual acceptance of acupuncture, following  the 1971 trip to China by Secretary of State Henry A. Kissinger. An accompanying journalist from the New York Times, James Reston had an emergency operation for appendicitis. Reston was administered acupuncture to relieve pain after the operation. Announcements in the news caught the public's imagination (Now, Let Me Tell You About My Appendectomy in Peking...). Newspaper and magazine articles followed, and acupuncture practitioners came out of the woodwork to let people try the technique for relieving pain and many other maladies. In 1996, after reviewing the clinical data on acupuncture, the FDA approved the acupuncture needle as a medical device. Today a large number of physicians have actually learned acupuncture and use it every day in their medical practices. For example, the American Academy of Medical Acupuncture has approximately 1800 members.

In the meantime, a variety of additional energy therapies have become popular, including those listed below:

• Acupuncture
• Alexander
• Aura balancing
• Biodynamics
• Body Talk
• Bowen
• Chiropractic
• Consegrity
• Cranial-sacral
• Feldenkrais
• Healing touch
• Holographic Repatterning
• Homeopathy
• Massage
• Osteopathy
• Praunic Healing
• Polarity therapy
• Reiki
• Rolfing/Structural Integration
• Therapeutic touch
• Yoga
• Zero Balancing

In recent years, a number of new energy devices such as low level laser therapy and microcurrent have begun to make their way through the regulatory process and achieve FDA approval. Because of a century of research into electrophysiology and biophysics, it is much easier to research these methods and to determine how they affect living systems. Consequently, a wide range of energy therapy devices are in various stages of the approval process.

The Vioxx affair

These developments have come at a time when the pharmacological approach to pain relief is coming under increasing legislative focus due to extensive side-effects. A turning point was the Vioxx affair, which revealed various serious side effects from the use of very popular pain control medications. Many patients who have been using and depending on pain medications were left without a good alternative, as various pain-killers in the Cox-2 family (Vioxx, Celebrex, Bextra and certain antidepressants) were found similarly beset with serious side effects: heart attack and stroke.

Congressional hearings on the Vioxx affair led to the realization by the public and by Congress that the FDA has been compromised by misuse of scientific information in the approval process used to justify new pharmacological treatments. It has been stated that, "By far, the Vioxx debacle is the most serious public health failure to occur since the FDA took on the authority for safety oversight of medical products in 1938" (FDA Shields Drug Companies from Lawsuits).

FDA was roundly criticized for failing to take adequate action to address safety concerns. It has become apparent that the FDA is unable to adequately protect the public from unsafe drugs. Vioxx, Celebrex, and SSRI's (Selective serotonin reuptake inhibitors) are just three examples of how the FDA failed to quickly respond to numerous warning signals, putting millions of Americans at-risk. The FDA also approved the modern advertising practices of drug companies, who mass market their products by telling people to tell their doctors what drugs they want to take, not the other way around. In this way, tens of millions of patients have bypassed the advice of their physicians. Unfortunately, the FDA is unable to meet the enormous safety issues created by this new approach to drug marketing.

The problem with the FDA approval process, revealed by the way pain medications and other drugs have been dealt with, is that it is not geared to concerns about long-term effects and safety in general. For a drug or device to be approved by the FDA, it is only necessary to prove that it is safe and effective in two short-term clinical trails. Behind the scenes, dozens of unsuccessful trials may be conducted until a way is found to produce the desired statistical outcome. Longer term effects are not taken under consideration. At the same time, the FDA has come under fire from Congress for its reluctance to approve non-pharmacological approaches to medicine. This is an enormous issue in medical care in general, and this document introduces a solution to the problem.

A proposal

What is needed for all medical interventions is a means of independent testing, entirely insulated from vested interests. Such testing must take into consideration the long-term effects of any intervention that seems promising. Such testing needs to be open to all forms of medical treatment, not just those focused on pharmaceuticals. No such means exists at the present time.

The proposed organization must have complete financial independence from organizations and individuals who develop new types of medical technologies. It must have an atmosphere of academic freedom, in which critical scientific information can be independently developed and evaluated and freely debated. It must have access to all techniques that can be used to research the effects of medical technologies on organisms, including cell cultures, animal testing, and human clinical trials. Like Underwriters Laboratories, the proposed organization must have unimpeachable integrity, so that it becomes the trusted source across the globe for information on medical effectiveness and safety. Medical crises of our times, such as the rise of antibiotic-resistant bacteria and the breakdown in pain medications show that the need for such an institution is real and timely.

If you are interested in working with Dr. Oschman on this idea please contact him at Nature's Own Research Association