Politics in Healing By Daniel Haley
Chapter 9: The Miracle Of Electromedicine
“We’d have had regeneration 15-20 years ago if it hadn’t been for the government! Nobody knew how the salamander regenerated its limbs until Dr. Becker came along”, exclaimed Ruth Harvey. A private researcher in alternative medicine, it was she who first put me onto the story of Dr. William F. Koch. (Chapter 3) Ruth was referring to Dr. Robert O. Becker, a world-renowned orthopedic surgeon and pioneering scientist in electromedicine – the kind of person who wants to know what makes living things “alive”.
From 1958 to 1980, Dr. Becker was chief of orthopedic research at the Veterans Administration (VA) Hospital in Syracuse, NY. During those years, he published 150 papers in medical journals and was twice nominated for the Nobel Prize. Unfortunately, even in electromedicine, political decisions intruded and hampered his research. Almost all of his funds came from the VA. In 1980, all funds were cut off because of Department of Defense (DoD) irritation over Becker’s warnings of danger from unlimited exposure to electromagnetic (EM) fields. Friends in Washington had told him that opposition to his VA funding was coming from the DoD; their people were saying, ‘How do we shut this guy up?’” However, cutting off his funds did not shut up Bob Becker. Retiring to the foothills of the Adirondacks, he wrote The Body Electric (1985) and Cross Currents (1990). The first is a fascinating and highly readable description of his electromedical discoveries. All of them had been published in technical language in medical journals, but in Body Electric, assisted by writer Gary Selden, Becker presents them in laymen’s language. In Cross Currents, Becker contrasts the marvelous promise of electromedicine with the perils of electromagnetic pollution – the potential dangers of careless and indiscriminate exposure to electromagnetic (EM) fields.
In the late 19th century, Sears & Roebuck listed in their catalog an “electric corset” for alleviation of arthritis pain. It sold well, which usually doesn’t happen when things don’t work. Many doctors used electrical treatments of one sort or another but there was no underlying theory of why they worked. The field of biochemistry, on the other hand, was constantly producing new discoveries. As the 20th Century dawned, there was a growing sense that the human body was a chemical creation, that “life was just an array of chemical reactions” (Body Electric), and that “modern” medicine, then, must be chemical in nature. This understanding laid the foundations for the great pharmaceutical companies, which deal in chemical drugs, some excellent, some dangerous. The acceptance of chemicals as the basis of medical treatment has become so ingrained that a cousin’s reaction may be typical. As I was explaining the Rife device, he interrupted me to say, “It never occurred to me that medicine could be other than a drug.” This perception of the taken-for-granted chemical nature of medicine was set off by the Flexner report of 1910, a study commissioned by the Rockefeller and Carnegie Foundations to bring medicine up to date. The study’s director, Abraham Flexner, decreed that there was no scientific basis for electromedicine, which then gradually vanished. In the 1930’s, Dr. Morris Fishbein warned in his JAMA editorials against the quackery of electromedicine. Electric corsets disappeared from the Sears catalog. That was the end of the first wave of electromedical research.
By the 1940’s, the accepted scientific paradigm limited the effect of EM currents or fields on living organisms to electroshock and thermal effects – for instance electric blankets – or the electric chair. That was where things stood until Dr. Robert Becker came along. He is regarded as the creator of the field known as Bioelectromagnetics, in which he showed the profound biological effects of very minute electric currents and very low strength electromagnetic fields on living tissues. The rebirth of electromedicine as a recognized and respected field of medical study is largely due to his work.
Even in college, Robert Becker was fascinated by the salamander’s ability to regenerate lost limbs. As an orthopedic surgeon, he had done enough amputations and dreamed of discovering how to replicate this feat in humans.
It has long been known that a “current of injury” exists at any wound, human or animal, and even in plants where a stem or branch is removed. The conventional view was that this current was simply ions (electric particles) leaking from dying cells, and that the current would eventually taper off and disappear. Becker didn’t believe this, and suspected that the current of injury was somehow related to regeneration – in those animals capable of that feat. Curiously, nobody had ever bothered to measure how long this current lasted. As his first research project in 1958, Becker proposed to do just that. He would make such measurements in salamanders, which regenerate, and in frogs, which don’t, and compare the currents in regenerating and non-regenerating limbs.
At that time, Becker was in charge of orthopedic surgery at the VA Hospital in Syracuse, which was closely associated with the State University of NY Medical School. Two months after he presented his proposal, he was summoned to a special meeting in the hospital director’s office of the committee that governed research at the two institutions. As Becker tells it in Body Electric, “Now that was really strange. The director almost never paid any attention to the research program. Besides, his office was big enough to hold a barbeque in. It was a barbeque, all right, and I was the one being grilled”. The committee chair came right to the point, “We have a very grave basic concern over your proposal. This notion that electricity has anything to do with living things was totally discredited some time ago. It has absolutely no validity, and the new scientific evidence you’re citing is worthless. The whole idea was based on its appeal to quacks and the gullible public. I will not stand idly by and see this medical school associated with such a charlatanistic, unscientific project”.
Becker replied that “I was sorry if it flew in the face of dogma”, but that ”I didn’t intend to withdraw the proposal, so they would have to act upon it” (ibid). After the meeting, one of the committee members took Becker aside to give him some kindly advice. “Go back to school and get your PhD, Becker. Then you’ll learn all this stuff is nonsense” (ibid).
Two days later, Dr. Robert Becker got a break; the committee referred his proposal to Professor Chester Yntema, who had studied the regrowth of ears in salamanders. Yntema approved his project, observing, however, “I don’t believe for one minute that it will work, but I think you should do it anyway. We need to encourage young researchers”.
That was how Robert Becker’s historic research got started. His first step was to measure current at the tip of the limbs of each of his 14 frogs and 14 salamanders, finding a negative charge of 8-10 millivolts in each. The experiment didn’t take long to produce results. After anesthetizing the animals, Becker amputated the right forelegs of each of the animals. He noticed that the polarity at the stumps reversed to positive right after the injury. By the second day, the current climbed to 20 millivolts in both species. The salamanders’ current dropped rapidly, however, vanishing to zero on the third day. Becker was almost ready to drop the project. Meanwhile, the frogs were holding at the original 20 millivolts, so at least their current of injury hadn’t vanished. Then, between the sixth and the tenth days, the salamanders’ electric potential returned, changed back to negative, and climbed to a peak of 30 millivolts (negative). At that point, blastemas formed. A blastema is a little ball of primitive or undifferentiated cells able to “differentiate” into all the various cells needed to reconstitute the missing limb. The blastema always forms at the stump of an animal about to regenerate a missing limb. The frogs’ positive voltage began to decline as their stumps healed over (not regenerating), and the salamanders began to regrow their missing forelegs. When the frogs’ wounds had completely healed, and the salamanders’ limbs had completely regrown, both again measured the original 10 millivolts (negative).
In his very first experiment, Robert Becker thus had the excitement of seeing something nobody had ever seen before. He had proved beyond question that the current of injury was not due to dying cells, which were long gone by the time the salamanders’ electric charge had changed to negative. Moreover, the opposite polarities displayed by frogs and salamanders indicated a profound difference in the electrical properties of the two species. The negative potential seemed to bring forth the all-important blastema, without which regeneration did not happen.
Then Becker decided to apply negative current – which he’d seen the salamanders use to such good effect – to the stumps of frogs after amputating a foreleg. He dreamed of being the first to produce regrowth in a normally non-regenerating animal. Writes Becker in Body Electric, “The frogs were less interested in my glory. They had to hold still for up to half an hour with electrodes attached. They refused, so I anesthetized them each day, which they tolerated poorly. Within a week, my Nobel Prize had turned into a collection of dead frogs.”
Writing up his research results, Becker submitted it to the Journal of Bone and Joint Surgery, the most prestigious orthopedic journal in the world, and hit paydirt – his study was accepted. He was launched and recognized as a pioneer in the vanguard of electromedical research.
Becker isn’t the sort of person to give up easily and persisted in trying to help frogs regenerate limbs. He succeeded in causing some regrowth, but wasn’t the first to do so. As a young anatomy professor at Smith College in the 1940’s, Dr. S. Meryl Rose had achieved partial regeneration in frogs, the first time anybody had achieved that in an animal normally lacking in that capability. After the publication of Becker’s research, he got a call from Dr. Rose and then a visit. Dr. Becker’s wife, Lillian, remembered him; she’d studied at Smith and it turned out she’d helped treat the frogs he used in his experiment.
When Robert Becker began his reevaluation of the place of electricity in biology, he discovered an important ally in Albert Szent Gyorgy, the Nobel Laureate who discovered Vitamin C. Szent Gyorgy pointed out that when experimenters broke living things down into their constituent parts, somewhere along the line, life slipped through their fingers and they found themselves working with dead matter. “It looks as if some basic fact of life were still missing,” and for that missing part, Szent Gyorgy proposed electricity. He pointed out that the molecular structure of many parts of the cell was regular enough to support superconduction. That manner of movement of electrons, fundamental to computers and solid-state electronics, occurs only in materials having an orderly molecular structure, such as crystals. Semiconductors can carry only small currents, but can carry them over long distances. Becker notes in Body Electric that when the discoverer of Vitamin C proposed this concept in Introduction to Submolecular Biology in 1960, it was seen as “evidence of his advancing age”.
With Szent Gyorgy’s suggestion in mind, Becker writes, “I put together a working hypothesis. I postulated a primitive… information system closely related to the nerves but not necessarily located in the nerve fibers themselves. I theorized that this system used semiconducting direct currents and that, either alone or in concert with the nerve impulse system, it regulated growth, healing, and perhaps other basic processes.”
In research, it pays to know the right question to ask. Having figured out the question, it took Becker a few years, but he did prove the existence in all living animals of a direct current system that operates in the perineural cells along the nerve cells. The perineural cells constitute more than one half the bulk of the brain and accompany even the smallest nerve fibers. Therefore, this system, with its semiconducting ability to transport small amounts of current, permeates the entire body – The Body Electric.
Becker found that this system controls growth and healing and, in the salamanders, regeneration. The current of injury, then, is a local expression of this DC system.
His breakthrough in understanding the semiconducting properties of the body was a staggering discovery, of Nobel Prize magnitude.
Fundamental to electricity is the fact that where there is a flow of electrons, there is a magnetic field. Becker writes in Cross Currents, “In the early 1960’s, I predicted that the flow of this DC current in the brain would produce a magnetic field that could be observed at a distance outside of the head if one had a magnetometer of sufficient sensitivity. When I made this statement at a scientific meeting, there was considerable laughter from the audience. I was told that such a device would never be made, and that even if such a magnetic field could be measured, its strength would be so small that it would be of no physiological consequence whatsoever.” A few advances in solid-state physics and electronics eventually permitted the development of the device Becker predicted; the superconducting quantum interference detector, or SQUID. And the SQUID easily reads the brain’s magnetic field as far as several feet from the head in what is called a magnetoencephalogram, or MEG.
In the 1960’s, Dr. Becker also predicted that living organisms could be influenced by external electromagnetic fields as the fields interacted with the DC currents he had discovered to be flowing within the organisms. Conducting research in mental hospitals, Becker found that right after disturbances in the Earth’s magnetic field caused by sunspots – magnetic storms on the sun – admissions rose and patients’ behavior was more agitated.
In order to cause regeneration, Becker knew that he had to figure out how to induce a blastema, and to do that, he needed primitive or dedifferentiated cells. These are the cells in an embryo that eventually differentiate or specialize into skin or bones or eyes, etc. In conventional science, it was accepted as fact that once a cell has differentiated, it can never retrace its steps back to its embryonic stage and de-differentiate, with the exception of bone marrow cells. This is why regeneration in humans can happen in fracture healing, where bone marrow cells are available.
Becker was surprised to find when he studied fracture healing in frogs that it was not bone marrow cells which dedifferentiated, but red blood cells. This was a surprise, since such cells are a long way from bone marrow cells. It turned out that frog red blood cells have a nucleus which contains DNA, which can be reactivated to direct the cell to return to its primitive state. Human red blood cells, on the other hand, contain no nucleus and no DNA to re-program. Therefore, red blood cells could not serve humans as raw material to be dedifferentiated into primitive or “stem” cells to produce the blastema needed for regeneration. Since there would not be enough bone marrow cells to serve this purpose, Dr. Becker came to the reluctant conclusion that regeneration in humans – his El Dorado – probably was impossible.
However, Robert Becker did succeed in dedifferentiating frog red blood cells. This had never been done before and was considered impossible. He achieved this by exposing the cells to just one-half billionth of an ampere of current. After four hours of exposure to this current, all red blood cells in the experiment had reactivated their DNA and had become unspecified in form – they had dedifferentiated. What happened indicated the reactivation of the DNA, since the process continued even after the current was totally shut down. The process only worked with frogs’ red blood cells, not with their white cells. The experiment was filmed on electron photomicrographs, pictures taken through an electron microscope. Charlie Beckman, a member of Becker’s research team, had helped develop the electron microscope, and his presence contributed to Becker’s credibility. Even so, when Becker presented the pictures at the NY Academy of Sciences, seeing wasn’t believing. Many people stated that they didn’t believe what they had seen, for everyone knew that cells can’t be dedifferentiated.
After four years of such research, Dr. Becker turned his attention to seeing if the electric currents he had been observing could be used to accelerate human bone healing. He demonstrated that non-union fractures – bone fractures that won’t heal – could be stimulated to do so with small DC currents, or with low-strength slowly-pulsing EM fields. In 1970, having deciphered the electrical control mechanisms governing fracture healing, Becker wrote a major article on the research and published it in Clinical Orthopedics and Related Research. He found it the most satisfying of his publications, since this was his first work that led directly to a technique that helped patients. Electrical stimulation of bone healing was quickly accepted by clinical medicine and was soon put to wide use.
Getting grants from the Veterans Administration proved almost as difficult as doing the research. To look for other support, Becker submitted a proposal to the Department of the Army. Suggesting that DC currents might stimulate wound healing, and that the Army’s business often produced a lot of wounds, he figured there might be interest. There was, but not what he expected. First, his grant proposal was quickly turned down. Then about a month later, he got a call from a prominent orthopedic surgeon who had served on the Army’s committee that had turned him down. The surgeon told Becker, “I have a grant from the Army to study the possibility that direct currents might stimulate wound healing, and I wonder if you might have any suggestions as to the best approach to use.” No-nonsense Bob Becker quickly told his caller what to do with his grant.
There was another offer which Becker declined. With only minor amounts of research funds, he was publishing more than all his supervisors combined. One of them came to him one day with “an offer you can’t refuse” – all the VA funds he could ask for, so long as the supervisor’s name was added to all Becker’s publications. Becker found out more about the politics in research than he wanted to.
During his orthopedic research, Dr. Becker discovered something of conceivably great value to a lot of people, something that has never been followed up. Becker explains in Body Electric, that “bone is composed of collagen, the main structural material of the entire body, and apatite, a crystalline material that’s mainly calcium phosphate”. Both materials turned out to be semiconductors. Becker and his assistants found something else in bone they had not been aware of – copper. He found that the electrical forces of copper hold the apatite crystals and the collagen together just as wooden pegs hold old chairs together. Writes Becker, “Unfortunately for victims of osteoporosis, the copper peg discovery still hasn’t been followed up, even though it was published in 1970. Regenerative growth was our primary target, so I reluctantly dropped osteoporosis.”
Another of Dr. Becker’s experiments would be of interest to anyone who recalls the unpleasant grogginess of coming out from under anesthesia. Studying the effects of magnetic fields on salamanders, Dr. Becker placed a salamander between the poles of an electromagnet and gradually increased the magnetic field. Delta brain waves (which characterize anesthesia) appeared at 2,000 gauss. At 3,000 gauss, the animal was motionless and completely unresponsive to stimuli. Then as he decreased the strength of the magnetic field, “normal EEG patterns returned suddenly and the salamander regained consciousness within seconds.” Becker also tried anesthetizing the salamanders with direct current. It worked, but a half hour after the current was shut off, the animals remained groggy and unresponsive, just as after chemical anesthesia. Electromagnetic anesthesia seemed to Becker as “the best possible…allowing prompt recovery with no side effects”. Becker tried to follow this up but got no takers at the VA. Proposing “to get a bigger electromagnet to try the method on larger animals and eventually humans, we never even got a reply.”
In the Lazarus Heart chapter of Body Electric, Robert Becker describes one of his most incredible experiments. Studying red blood cells from salamanders, the animals were so small that the only practical way to extract blood was to cut the hearts in two and throw away the carcasses. One day his assistant, Sharon Chapin, asked “What would happen if I sewed these three up?” Becker assured her that they would be dead within minutes, since it was known that no animal’s heart could repair major wounds. A few days later, Sharon brought the three salamanders back, looking perfectly healthy. Astounded, Becker anesthetized the miraculous creatures and dissected them. Their hearts showed no signs of having been damaged and were perfectly normal. Becker found that the salamanders’ hearts regrew to normal in four hours after being mutilated, showing no sign of injury. Red blood cells formed a blastema within one-half hour of the injury, occupying the entire space where the missing part of the heart had been. After 2-3 hours, most of the blastema cells redifferentiated into heart muscle. After 4 hours, the heart was normal in appearance and was pumping blood. Becker wrote a report on this for Nature magazine but “even toned down”, he writes in Body Electric, “it sounded like science fiction”. “This is ideal healing”, he summarized. “Spilled blood closes a wound at the body’s center and replaces the missing part in a few hours. You can’t get much more efficient than that.”
After President Nixon went to China in 1970, interest in acupuncture surged. Dr. Becker secured a grant from the National Institutes of Health (NIH) to see if acupuncture worked electrically. He confirmed that thesis, finding less resistance and greater conductivity over the acupuncture points. Becker’s research showed that the acupuncture meridians were conductors of current, the points being gateways to the body’s electrical system. Just as he was going to start the next phase of his study, the NIH cancelled the grant.
Dr. Becker found that the shock of spinal cord injuries produced a prolonged positive charge. This seemed to be the main roadblock to spinal cord repair, since a negative charge is the current of regeneration. But, Becker speculates, it should be possible to cancel that positive polarity and replace it with a growth-stimulating negative charge by using a proper electric current. With sufficient funds, Becker believes he could achieve spinal cord regeneration. As far as he knows, no one has ever brought his work to the attention of America’s most famous spinal cord injury victim, Christopher Reeves.
As his research progressed, Robert Becker became more and more aware that human beings, and indeed all living creatures in the plant and animal kingdoms, exist within an electromagnetic system and that we all are basically electromagnetic in nature – in effect, we all live in electric bodies. This keen awareness of the body’s EM qualities and how little it took to affect them made him ever more concerned over the global smog of EM pollution that has come to exist world-wide.
In Cross Currents, Dr. Becker spells out some of the potential perils of certain frequencies. He describes a Swedish test of rats exposed to the EM frequencies from standard TV sets. The sets were placed about 12 inches above the animals for four hours a day. “Male rats were exposed for thirty-five to fifty days and then examined. Testicular weights were found to be significantly reduced.” Prolonged exposure to unshielded TV electromagnetic frequencies is unique to the second half of the 20th century. One can only wonder if there is a connection between the Swedish study and the sharp drop in human male sperm count that has been observed in all parts of the world.
Here’s another example of the sort of thing that concerns Becker. In the 1970’s, a machine to monitor fetal heartbeats was developed which is not passive but invasive; it sends out an electromagnetic (EM) signal to the fetus. A study was done in 1989 which compared babies monitored by the device with those monitored the old-fashioned way, by ear. Over a period of 18 months, babies monitored by the EM device had a much higher rate of cerebral palsy than babies monitored by ear. This study is like an alarm signal going off.
Becker notes that 40% of children born in the 1990’s are exposed to significant EM fields equal to what rats were exposed to in a study done by the NYS Department of Health; the rats later developed learning disabilities.
Current conventional concepts about cancer assume that cancer cells can never dedifferentiate and revert to normal cells. Such thinking holds that once a cancer cell, always a cancer cell, so therefore the only thing to do is to try to remove it with surgery or to kill it by radiation or chemotherapy. Becker’s research, on the other hand, points to a different understanding; possibly a cancer cell is stuck in a state of incomplete dedifferentiation. It has already dedifferentiated back far enough to pick up the ability of the primitive cell to proliferate rapidly. It has not gone far enough to become a normal primitive cell, which by nature will specialize or differentiate into a cell of whatever organ it is part of.
Recent discoveries suggest that a cell may become cancerous because of a genetic alteration (the wrong genetic sequence being expressed) caused by – whatever. Dedifferentiation unravels the cell’s malignant genetic program, permitting it to be reprogrammed as a normal cell. Becker believes that cancer cells would revert to normal if they could be fully dedifferentiated.
The possible link between regeneration and cancer occurred to a young researcher at the National Cancer Institute (NCI). One month after he submitted his proposal to his superiors with a request for funding, he was forced out of NCI.
In the 19th century, it was known that silver had antibacterial qualities; it is said that the early pioneers would put a silver dollar in a quart of milk to keep it from going sour while crossing the prairies. The knowledge of silver’s value goes back even further. In the Middle Ages, doctors would advise putting a silver spoon in a child’s mouth to protect against the plague. Since only the rich had silver spoons, this may have been the origin of the saying “born with a silver spoon in the mouth”.
Dr. Becker rediscovered silver. By this time, he knew that he could turn on growth with negative current or turn it off with positive current. If he applied negative current, he could stimulate growth of a bone, but would it also stimulate growth of bacteria?
In preliminary lab tests, he had seen that silver electrodes, “when made electrically positive, would kill all types of bacteria, apparently because of positive silver ions driven into the culture by the applied voltage. This was an exciting discovery, because no single antibiotic worked against all types of bacteria.” And this was accomplished with voltages harmless to human cells.
A big problem with his silver electrodes, however, was that their effects were too local, extending only 1 inch from the electrode. Needing something larger, like a screen made of silver, Dr. Becker stumbled onto a nylon cloth impregnated with silver ions. Since silver is highly conductive, direct current could be delivered all over the cloth.
Becker soon had a challenging case for trying the silver nylon cloth. His patient, John, had suffered a badly broken leg in a snowmobile accident. The bone had become infected – osteomyelitis, an even worse nightmare for an orthopedic surgeon than a non-union fracture, and that was present too. A cavity in John’s leg was infected by five different kinds of bacteria. Becker explained to John his plan to use the silver nylon first with positive current to control the bacteria and later to use the negative current to try to heal the bone. Cleaning out the wound during the operation, Becker packed a large piece of silver nylon into the excavation, which ran almost from John’s knee to his ankle. He then connected a battery to the silver nylon, which thus served as an electrode adapted to the shape of the wound. By the end of two weeks, all five kinds of bacteria had disappeared. The first problem was solved, and this represented the conquest of osteomyelitis. Taking an X-ray, Becker found that there had been some bone growth – all the pieces were stuck together. He kept using the positive electrodes and at the end of one month found that the non-union fracture was practically healed and by two months, the patient was walking on the leg. How could this be? The current used was positive and should have killed the bacteria but not have helped with the healing. The mystery was soon solved.
During one of his osteomyelitis treatments with silver nylon, while checking a culture of material from a patient’s wound, Robert Becker found something completely unexpected and serendipitous. It could never have been predicted, and it reopened his old dream of human regeneration. Faced with the fact that he couldn’t regenerate without cells that could be dedifferentiated, which were hard to come by in humans, Becker had sadly concluded that human regeneration was impossible. Now, inspecting the culture, he found dedifferentiated, primitive, human cells. Quickly jumping on this lead, he combined the electrically-generated silver ions he had used in the wound with fibroblasts, a common human cell type found throughout the body. Incredulously, he saw that he soon had a petri dish full of dedifferentiated cells. Until then, it was accepted that once cells differentiate, or specialize, that was the end of the line and there was no way back to square one. But Becker had found a way to dedifferentiate human cells, which even he had thought to be impossible. This could mean the elimination of the main obstacle to regeneration in humans, the lack of cells which could be dedifferentiated.
Furthermore, Becker realized that the silver electrode technique could be used to dedifferentiate large quantities of a patient’s cells to their primitive state to be stored for use in an emergency when tissue healing is necessary, such as after an operation. It is for just such a purpose that companies have been set up to store stem (primitive) cells from the umbilical cords of newborn children.
On June 1, 2000, National Public Radio announced some interesting research on stem cells and pointed out that if only we knew how to produce stem cells in mass, it would revolutionize medicine. But we do know how to do this, for a dedifferentiated cell can do anything a stem cell can do. Dr. Bob Becker published the above research in the late 1970’s, but nobody paid any attention. It’s time somebody did, because the NPR announcer was right; it would indeed revolutionize medicine.
Dr. Becker patented his silver electrode technique, pointing out in the patent that silver is not toxic or harmful to tissues, is not cytotoxic, not carcinogenic, not mutagenic (doesn’t change genes), but is a destroyer of bacteria and fungi, and is a dedifferentiating agent. In this process, Becker explains that the work is done by silver ions which bind right at the site being treated. They do not get into the bloodstream, and therefore cannot cause argyria, a graying of the skin which occasionally has happened to people taking a lot of colloidal silver.
He also found an application to cancer. When he used a positive charge delivered through silver electrodes to cancer cells in his lab, cell division (mitosis) stopped completely. While growing tissue is negatively charged, cancer is the most negative of all. This was not the result of the positive current but of the silver ions being released from the electrodes. If the electrodes used are made of any material other than silver, the electric voltage and current will cause cancer cells to increase their rate of mitosis, or growth.
Electricity in cancer has a long history. In 1880, the British medical journal Lancet published a letter from a doctor telling of a patient whose cancer of the chin gradually vanished over two weeks after he was struck by lightning. Also in the 1880’s, Dr. Apostoli, a French surgeon, reported reversing tumors by passing between 100 and 250 milliamperes of positive polarity direct current through an electrode inserted into the tumor. Learning of Apostoli’s work, Dr. Frederick Martin, who later founded the American College of Surgeons, published several papers confirming Apostoli’s work. In a more recent application of this method, Swedish Dr. Björn Nordenström (who invented needle biopsies) has reversed tumors with 10 volts of positive DC delivered through stainless steel electrodes placed directly into tumors.
Dr Becker has observed that anything over 1.1 volts creates electrolysis in the body, i.e., the splitting of water into hydrogen and oxygen. In Cross Currents, Becker states, “In biological tissues, this produces gases such as hydrogen, that are extremely toxic to the cells. Hydrogen immediately turns into hydrochloric acid, which dissolves cells. Since Nordenström used 10 times the current that causes electrolysis, Becker assumes that Nordenström’s results, as well as those of Apostoli and Martin, have come from electrolysis, and not from any biologically significant electrical current or polarity.
Since Becker has seen both negative and positive currents stimulate tumor growth, he is concerned that this method could result in the stimulation of other tumors in the area. This phenomenon did occur in some of Nordenström’s cases, Becker observes. However, Becker points out, the targeted tumors were destroyed, so even if the method achieved cell destruction by hydrochloric acid created by electrolysis, it works and is useful.
Before his lab closed, Dr. Becker demonstrated the dedifferentiation of one type of cancer cells by placing them in a petri dish with silver electrodes delivering positive direct current and releasing silver ions. Such a method goes right to the heart of what a cancer cell is, a once normal cell that went astray. It reverses the cancer cell back to a primitive cell, which then redifferentiates as a normal cell of whatever organ it is part of. Becker later used the method to reverse two skin cancers. Becker states in Cross Currents, “While we do not have firm evidence at this time, what probably happens is that the silver ion is shaped so as to connect with some receptor site on the surface of the cancer cell membrane”.
What a lead to leave hanging! But that is just what happened, because this research occurred just before the Veterans Administration cut off his funding on January 1, 1980.
The cause was politics at its worst. His research having shown the sensitivity of human cells to the most miniscule amounts of current, Dr. Becker began to realize that human health may be affected by the incredible electromagnetic smog of the second half of the 20th century. He was asked to serve on a special environmental committee to advise the U.S. Navy on Project Sanguine. This was a plan conceived by the Department of Defense at the height of the Cold War to permit communications with nuclear submarines submerged to a depth of 120 feet. The system involved creating signals of 45-70 hertz from an enormous antenna to be buried under a large part of northern Wisconsin. Meeting in Washington, the committee learned of research where 9 out of 10 human volunteers exposed for just one day to the magnetic field component of the Sanguine signals showed a significant increase in serum triglycerides. A rise in triglycerides is part of the body’s response to stress. The system was shelved, but the Navy never released the impact statement.
Returning to New York State, Dr. Becker learned of a plan to construct ten ultra-high frequency (765 KV) transmission lines across the state. The potentially harmful Sanguine frequencies were similar to those of the proposed power lines. He wrote to the NYS Public Service Commission (PSC) and informed them that the Navy had substantial evidence of possible harm to the population in the vicinity of the proposed lines, and told them the name of the person to call. A few weeks later, a man from the PSC called Becker to say that the Naval officer whose name Becker had given him had said that there was no such thing as Project Sanguine, that there was no such committee, and that he’d never heard of Becker, who had not been there. “That’s funny”, Becker replied. “I just got the minutes of the Project Sanguine committee meeting from the Office of Naval Research in this morning’s mail”. When Becker assured the PSC man that he could see the minutes, since they were not classified, the man said “I’ll be over tomorrow”. After reading the minutes of the meeting that never happened of the Navy committee that wasn’t supposed to exist, the PSC set up public hearings on the proposed lines. Becker and others testified. When information on Project Sanguine came out, Wisconsin’s Senator Gaylord Nelson was furious with the Navy over its proposed experiment on his constituents. After the hearings, the PSC adopted Becker’s recommendations for a 5-year moratorium on the proposed lines, and for a 5-year, $5,000,000 study of possible hazards, with costs assessed to the utilities proposing the lines. As final fallout, the PSC required a wider right-of-way for the lines.
On the national level, no one paid much attention to Dr. Becker’s warnings about possible dangers to human cells from frequencies carried by high tension lines, except behind the scenes. Meanwhile, other voices were raised. New Yorker staff writer Paul Brodeur wrote The Zapping of America in 1977. In Electromagnetic Man (1989), British researcher Cyril Smith, PhD, described how, after a major power line was constructed right over the main street of Fishpond, a tiny hamlet in Dorset, England, most of the villagers became ill in one way or another. There were numerous cases of cancer and also mental disturbances. Having moved to Fishpond, Smith also became sick, which precipitated his research into EM frequencies and his book.
On December 14, 1990, the Atlanta Journal reported that when the Environmental Protection Agency (EPA) did a study that linked EM fields to leukemia and brain cancer in children, White House aides in the Bush Administration delayed release of the report, concerned that the public “might misinterpret the report’s conclusions”. An earlier version of the EPA study had proposed to classify EM fields as “Class B” carcinogens (meaning probable sources of human cancer). This proposal was removed upon “revision”.
In July 1997, the New England Journal of Medicine published a study done by the National Cancer Institute (NCI) claiming that there was no evidence that powerline EM fields increased the risks of childhood leukemia. However, an article in the Oct-Nov 1997 issue of Nexus magazine pointed out that the researchers dismissed as a “statistical fluke” a 24% increase in leukemia risk for children exposed to especially high magnetic fields. The NCI researchers dismissed this fact by setting a 2 milligauss level as a cut-off point for their calculations. Nexus asked Dr. Ross Adey, one of the most respected bioelectromagnetics researchers in the U.S., to comment. Dr. Adey pointed out that if the NCI had taken a 3 milligauss level as their cut-off, the conclusions would have been exactly the opposite, i.e., that there is a significant risk of childhood leukemia.
Finally, in early 1999, a committee set up within the National Institutes of Health (NIH) issued a report acknowledging that, yes, there is a statistically significant relationship between children with leukemia and exposure to EM fields. Becker again was vindicated.
Becker points out that, “We’ve filled the electromagnetic spectrum with all manner of frequencies which have never before existed on the planet, frequencies with which humans and other species have never before coexisted.”
After his PSC testimony, Becker noticed increasing resistance to renewing the VA grants which were funding his research. Finally, all grants ceased and his lab closed on January 1, 1980. It was the only one in the world doing any research in regeneration.
Ruth Harvey was right; had Dr.Becker’s funding continued, he probably would have shown how to regenerate limbs. With all the significance this could hold for so many U.S. veterans, it was ironic that it was the Veterans Administration that cut off his funds. And he probably would have demonstrated practical ways to cause cancer cells to “dedifferentiate” and revert to normal. As noted earlier, in retirement, Becker refused to “shut up” and wrote Body Electric. In it, he writes, “I wanted the public to know that science isn’t run the way they read about it in the newspaper… As research is presently funded and evaluated, we’re learning more and more about less and less, and science is becoming our enemy instead of our friend”.
During the twelve years his lab was operating, Dr. Robert Becker and his staff discovered:
the secrets of how the salamander regenerates its limbs;
a DC control system existing in all animals, travelling in semiconducting currents through the perineural cells along the nerves, controlling growth and healing;
techniques for electrical stimulation of bone healing including healing non-union fractures;
the effects of low frequency electromagnetic (EM) fields on human cells;
how to dedifferentiate frogs’ red blood cells – something known to be impossible;
how to dedifferentiate human fibroblast cells- something known to be impossible;
how to dedifferentiate some cancer cells – something known to be impossible;
aspects of the electrical nature of the acupuncture system;
the quantity of voltage which causes electrolysis in the body;
how to cure osteomyelitis – infected bone;
a clue to the cause of osteoporosis, thus to a cure.
All these discoveries were published in medical journals, and many are Nobel Prize material. Why Dr. Becker has not been awarded the Nobel Prize is as great a mystery as was the way the salamander regenerates his limbs – until Becker figured it out.
One more sad story, the reader might think, but after so many stories of what might have been or should have been, this one proceeds on a happier note.
Over the years, Ruth Harvey has often said, “I pray that someone will fund Dr. Becker, so that he can continue with his brilliant work”.
Ruth has demonstrated the power of prayer in this case. When she and her husband put their Montana home up for sale, Bruce Kania came to take a look. A partial amputee, he had devised a plastic pad to place between stump and prosthesis, which he was marketing and selling like hotcakes. In gratitude for his new-found success, he told Ruth, he had a deep desire to help someone’s research. Meanwhile, he was looking for some material to place on the pad to prevent infections. Ruth immediately thought of Becker’s silver nylon, loaned him her copy of Body Electric, and put him in touch with Dr. Becker. As an amputee, Bruce had to be interested in someone who was researching regeneration. He went to visit Becker and made arrangements, within his means, to fund the continuation of Becker’s research, which had just about ground to a halt by that time. So this story isn’t over yet. Once more the prospect is alive that this should-be Nobel Laureate will have the opportunity to show the world the science of human regeneration.
Dr. Robert Becker inaugurated the scientific discipline now called Bioelectromagnetics. Its basic tenets, the electrical properties of all living things, were denied as quackery when he first came along. However, the wonders of electromedicine were greeted with about the same enthusiasm as Official Medicine greeted Rife in the earlier part of the century. But there was a younger generation coming on, and younger generations are often not too impressed by orthodoxy.
As a young woman, Ruth Harvey once had a dream that someday she would be working with electrical machines used in healing. And so it was that when I first met her in 1982, she was demonstrating and distributing a remarkable device called the Alpha-Stim 2000. This was the brainchild of Dr. Daniel L. Kirsch, PhD in neurobiology, and produced by Electromedical Products International Inc. (EPII), a company he founded in 1981. Kirsch started studying acupuncture at age 13, and later studied other health disciplines such as chiropractic and naturopathy. He acquired quite a bit of clinical experience, too, serving as Director of the Center for Pain and Stress-Related Disorders at Columbia Presbyterian Medical Center in New York. He also studied electronics and took a great interest in Eastern European work in electromedicine, particularly something then called “electrosleep”. Examining the existing devices, he decided he could do a better job and founded EPII. Moving to the Los Angeles area, he found time to serve as Clinical Director of the Electro-Acutherapy Medical Group in Laguna Beach, California, the Sports Medicine Group in Santa Monica, and wrote the curriculum for a graduate degree program in electromedicine at City University, Los Angeles.
Dr. Kirsch’s Alpha-Stim 2000 was loosely classified as TENS (transcutaneous electrical nerve stimulation) but had its own unique twist. While TENS units suppress pain by overriding body electricity with stronger currents, Kirsch’s device used microcurrents similar to the body’s own electricity, the ones Becker found to be normal to the body. Acupuncture holds that illness results from alterations or blockages in the body’s flow of energy. The Alpha-Stim 2000 was able to measure the body’s normal current, determine to what extent it was altered at the site of a problem, and supply the appropriate microcurrent wave form to restore the normal flow of bioelectricity, thus healing the underlying cause of the problem. An ordinary TENS unit is designed to provide current strong enough to override a pain signal. While connected, such a unit will relieve pain, but the pain often returns when the unit is turned off. Kirsch’s version usually resolved pain permanently by eliminating electrical blockage, or by restoring the normal flow of current to the problem area. The Alpha-Stim also had a way to administer its microcurrents through earclips in a variable square wave form designed by Dr. Daniel Kirsch so that it would not “entrain” brain waves; if the wave were repetitious instead of variable, the brain would get used to it and ignore it. His variable wave form thus would interrupt the chaotic brain waves which characterize stress, inducing or permitting them to return to a normal, harmonious pattern. This use of earclip electrodes is known as cranial electrotherapy stimulation, or CES, not invented or discovered by Kirsch, but improved on by him. Several other manufacturers were producing devices of this sort, all stimulated by the electrosleep research of Eastern Europe, where electromedicine is considered more “mainstream”.
Learning of this interesting device, my late mother and I decided to acquire one around 1982. By then she was in an advanced state of arteriosclerosis and all too often exhausted by anxiety. When Bob Kirsch, Dan’s father, drove to my mother’s home in northern New York State to deliver the machine, she was in bed in just such a state. Observing her, Bob Kirsch said to himself, “This is going to be a challenge”. After confirming that a doctor had prescribed the device (in conformance with FDA regulations), he unpacked the device and placed the earclips on my mother. As she dozed off, he sat down in the kitchen to talk with Ordetta Sharpe, her housekeeper. About 45 minutes later, my mother awoke and came out to the kitchen, refreshed, relaxed, even effervescent, as she was when at her best. Bob Kirsch could not believe how much better she was, nor could she herself. The Alpha-Stim’s microcurrents had done their magic, melting away her stress and revitalizing her.
In the winter 1985 issue of the American Journal of Electromedicine, the organ of the National Institute of Electromedical Information, Ruth Harvey published an article on remarkable results she had observed while working with the Alpha-Stim 2000:
Sister Louise Hentzen had been a nun for fifty years. For thirty-five of those years, she suffered excruciating pain as a result of the amputation of her right leg. She could not tolerate analgesics because of severe allergies, yet she remained stoic… When I met Sister Louise, she was sitting on an examining table in one of the best pain clinics in the midwest. Her doctor, a prominent neurosurgeon, had asked me to see if I could ease her pain. In less than five minutes, her pain was gone! Only once before had she known this kind of relief. A week before, her doctor had treated her with acupuncture, leaving the needles in for twenty minutes. The present treatment, however, took only five minutes and no needles were used. This is typical of the results we see with electromedicine.
When Ruth Harvey demonstrated the Alpha-Stim at a convention in Madison, Wisconsin, she wrote in her article that “a lady wondered if the instrument could help her hearing. Although the Alpha-Stim 2000 had FDA clearance only for the relief of pain, I treated her on a point where acupuncture had been known to help. The following day, the lady excitedly informed us that her hearing had returned to normal.”
In Body Electric, Dr. Robert Becker wrote; “There’s reason to believe that gifted healers generate supportive electromagnetic effects which they convey to their patients.” When he wrote that, he was not aware that Ruth Harvey had measured just such a capability with a close friend, the late English healer Rose Gladden. Before Rose started to perform a healing, Ruth took a microcurrent measurement with the Alpha-Stim on a place on the patient’s body. Then Rose placed her hands on that area of the patient. After she had finished her healing, Ruth took another measurement on the same spot. The original reading had increased by 75%.
Blanche Hanks, a therapist using the Alpha-Stim 2000 while working under Lyle Brooks, MD, a family practice physician in Edmond, Oklahoma, told Ruth of a remarkable case, which Ruth included in her article:
Elbert Jones…first came to our office as a stroke patient… He had no use of his left side…couldn’t move his arm at all and could only barely drag his left leg. He couldn’t walk unassisted. When I first saw Mr. Jones, I placed two electrodes at the base of his brain and two at the sacral area of his spine… His improvement was phenomenal. With each treatment, we watched him gain more and more use of his limbs. With two treatments a week, his activity increased to mild exercises and swimming, and in three months, he was playing racketball at the ‘Y’ with much younger men. Then in late February, 1983, he suffered another stroke affecting the same side and leaving him just as disabled as before. When he was able to leave the hospital, we started treating him again and had the same phenomenal results. He can now walk two miles a day, but no longer plays racketball – doctor’s orders!
William Bauer, MD, MS, while an assistant professor at Case Western University School of Medicine and Chief of Otolaryngology at the VA Medical Center in Cleveland, Ohio, acquired an Alpha-Stim 2000 and found electromedical treatments effective in relieving tinnitus and even multiple sclerosis. Bauer wrote a paper entitled “Neuroelectric Medicine” which was published in the Journal of Bioelectricity in 1983. He described the biological mechanisms involved…not only for pain relief but the mechanisms by which the body is healed when stimulated with the appropriate electric currents. Bauer presented this paper at the First Symposium of the International Society for Bioelectricity in Boston on October 1, 1983, at which both Dr. Robert Becker and Dr. Björn Nordenström were present.
Explaining to Ruth Harvey his theories as to why Alpha-Stim works, Dr. Bauer said “There is evidence that there is a balancing process going on. Cells that are performing at sub-optimal levels are stimulated to ’turn on’ and produce what they’re supposed to produce, probably through DNA, which is stimulated through the cell membrane. I believe that normal cells simply resonate with the electrical impulses we send in because they’re already doing their job. But diseased cells will take up this energy and literally be turned on. The thing that’s nice is that you can’t damage anything where you’re treating since you’re only bringing things back into balance, up to the optimal level, which is normal.”
However effective, Dan Kirsch’s Alpha-Stim 2000 cost $5,850 and was not selling all that well. To keep his company alive, he needed something that could be marketed in larger volumes. Going back to the drawing board, he designed a miniaturized Alpha-Stim. Getting it into production was another matter. Being brilliant in electromedicine wasn’t enough; he needed to be a good entrepreneur as well. His adventures with venture capitalists were incredible and sometimes traumatic. At one point, he felt certain he could write a best seller on his experiences; then the profits from that might permit him to afford to return to electromedicine. There was a bad period when he was at a complete standstill and almost went through the floorboards. But he persisted, obtained the capital he needed, and launched a miniature Alpha-Stim in 1989. It sold well, and a few years later, he came up with his present version, the handsomely-designed “Alpha-Stim 100”. By this time, his work had been noticed by Michael Hutchinson, who wrote a chapter on it in Mega Brain. He was written up twice in the Los Angeles Times, in Kathy Keaton’s Omni magazine, in USA Today, the Denver Post, the Seattle Post-Intelligencer, Saturday Evening Post, Houston Chronicle, and Rolling Stone Magazine as well as in publications in South America, Australia, Japan, and Europe.
No larger than a cellular telephone, the Alpha-Stim 100 delivers microcurrents of the type and strength compatible with normal bioelectricity either through earclips or two electrodes, which can be self-adhesive or in the form of hand-held probes. Thus microcurrents can be steadily delivered to a sprain or strain. One of Dan Kirsch’s most treasured pieces of promotion is a TV clip of the Dallas Cowboys’ famed running back Emmitt Smith wearing an Alpha-Stim 100 at half-time. Since then, many if not most major professional sports teams use Alpha-Stim technology.
Just like its predecessor, the Alpha-Stim 100 cuts through stress like a hot knife cuts through butter, and I would not leave home without it.
Dr. Robert Becker has long been concerned that in the excitement over electromedicine, people might use currents that are too strong, which might do harm. He remembers hearing Dr. Dan Kirsch state at a conference in the 1970’s that “some people think that if a certain current is good, more is better, and that’s not true!” When I brought up Dan Kirsch’s name, Becker said “He’s the only one that’s doing it right; the rest are using too much juice”.
As Kirsch’s cranial electrotherapy stimulation (CES) device gained momentum, there was the ever-present FDA, not paying a lot of attention at first, but always there. FDA could not conceive that medicine could be other than a pharmaceutical; for pain, you’d take a drug; for stress, you’d take another drug; what did microcurrents have to do with it? The FDA understood drugs, and a great many FDA higher-ups (some estimates say as many as 65% of FDA employees) upon finishing their FDA careers, go off to high-paying jobs in the pharmaceutical industry – if they have not made waves while at FDA. By the early 1990’s, FDA regulation of medical devices had become more and more complex, approaching that for drugs. It was not intended to be that way.
The late Dr. Andrew Bassett, an early pioneer with Dr. Becker in using microcurrents for bone healing, served on a committee to plan the law (passed in 1976) governing regulation of medical devices. Bassett felt the law was good, but the problem was in getting the FDA to obey it. The law’s intent was quite clear; medical devices should not be regulated like drugs. And devices which were “substantially equivalent” to devices on the market before the law was passed should be “grandfathered” and allowed on the market with no undue fuss. Electrosleep had inspired Dan Kirsch’s original work. While he clearly had designed a better technology, there had been several such devices on the market. Thus getting grandfathered with the FDA as substantially equivalent to one of those devices should not have been a problem. The law requires that the FDA should grant such “510(K)” approvals in 90 days; for Kirsch’s Alpha-Stim, it took 22 months. When approval was granted, FDA declared he could not market it for anxiety, depression, and insomnia – which were its main purposes. Kirsch hired a lawyer, something he was to do a great deal of in the years ahead. The lawyer wrote FDA pointing out that it was out of step with its own law, and that his client intended to go ahead and market his product if he didn’t hear from the FDA. The FDA made no comment, so Kirsch proceeded to market.
In 1978, FDA set up a panel of experts to study CES. The panel recommended that CES be accepted for treatment of anxiety and addictions. The reference to addiction brings up one of the most interesting of CES products, a device invented by Dr. Margaret “Meg” Patterson of the United Kingdom. Her device was successful in enabling several famous British rock stars, such as Pete Townsend of The Who, to escape from heroin addiction. With all the problems in the U.S. over drugs, why has Dr. Meg Patterson’s device not caught on? Why is it not standard issue in drug rehab centers? Treatment with her device would cost a small fraction of conventional treatments. Furthermore, the results would be more permanent since they would correct the bioelectric disturbances in the brain which characterize addiction.
As Kirsch was trying to survive the FDA, serious researchers were beginning to take notice, and he was happy to loan his CES devices for a large variety of studies. An early one looked at the effect of CES microcurrents on learning abilities. College students with no typing experience had Alpha-Stims hooked up to their earlobes. Some were turned on and some were not. Microcurrents in the CES device were set so low that they could not be felt, so students did not know whether they were receiving microcurrents or not. When the results were in, it was clear that those whose devices had been activated had learned significantly more quickly than those whose devices were not on. Also, a group of stenography students who had failed their test as much as four times passed on the fifth attempt when using Alpha-Stims.
Stress could be considered as a condition in which normal, harmonious, coherent brain waves become incoherent and chaotic, reflecting the distressed state of an anxious person. Dr. Michael Heffernan conducted a study that graphically illustrated the above; two pictures of brain waves, one of a distressed person before an Alpha-Stim treatment and one after, with the previously spiked waves smoothing out (see page 300).
This first chart shows a typical pain patient’s brainwaves averaged over two minutes. This is an abnormal frequency pattern.
This second chart was taken from the same patient after 10 minutes of Alpha-Stim use. It shows beneficial smoothing of the brainwaves to a normal pattern. ( NOTE: EEG = Electroencephalogram)
In 1992, tumultuous riots and fires in Los Angeles kept Dan Kirsch and his wife Tracey from getting to their office. For a few days, they didn’t even know if they still had an office. Reluctantly deciding to leave the West Coast, the small city of Mineral Wells, Texas, came to their attention at an industrial relocation exposition. Once a booming resort, Mineral Wells might as well have changed its name after 1947, when the FDA appeared and shut down their wells, their main business, on a labeling pretext. The 14-story, 400-room Baker Hotel still stands, closed, in downtown Mineral Wells as an elegant reminder of the pre-FDA era. It is with considerable frustration that the people of Mineral Wells realize that in Europe, doctors prescribe and government health insurance pays for “taking the waters”. Before 1947, people used to take the waters in Mineral Wells, coming from all over the U.S. by the trainloads.
The Kirsches decided that Mineral Wells met their criteria and moved Electromedical Products there in 1994. Happily and comfortably resettled, Dan and Tracey Kirsch, now the company president, would have liked nothing better than to concentrate on building their business in a pleasant small city near the Dallas-Fort Worth Metroplex. Tracey even became the chairperson of the local chamber of commerce. However, how long could they stay there? Increasing pressure from the FDA made them seriously consider relocating to Europe. On one of several scouting trips, a European industrial development official welcomed them with open arms and told them, “We love the FDA. They send us some of your most technologically-advanced companies, which can’t stand their excessive regulation”. Kirsch learned from the Medical Device Manufacturers Association (MDMA) that 24% of the American medical device industry had relocated to Europe. These were companies like Kirsch’s EPII, on the cutting edge of the technological breakthroughs in which the U.S. excels, the high-tech companies which epitomize and symbolize the U.S. competitive advantage in the world.
During the 1980’s and early 1990’s, Dr. Kirsch was one of six or seven FDA-registered manufacturers in the CES field. This was to change in a very dramatic way.
One day in August, 1995, Dan Kirsch called me and said “the FDA is trying to put me out of business”. Aware of the earlier pressures that had led him to contemplate moving to Europe, I asked, “what have they done now?” While the FDA was directed by law not to try to regulate devices like drugs, they were proceeding to do just that. Part of the regulatory process requires the preparation of a Pre-Marketing Approval or PMA before a new product is placed on the market. Preparing a PMA is a monstrous process, requiring the history of all scientific research on all similar products, a history of the marketing of the product, and all other relevant information. PMA’s are not that common; the FDA only gets about 40 per year, i.e., 40 new products. However, there are 12,000 or more “510(K)” applications for product updates; the comparison indicates how FDA requirements for exhaustive paperwork stifle the introduction of anything new. What the FDA had done, Dan Kirsch explained, was to publish a proposed regulation requiring all manufacturers of CES devices to prepare a PMA within 90 days or go off the market. In his case, this would be a pre-marketing approval not for a new product to go on the market, like a new drug, but so that a product which had already been on the market for 16 years could stay on the market. Consulting several experts, Kirsch learned that to hire someone to prepare the PMA would cost about $250,000 and take at least one to two years or more, at least four times the time allowed. Not having the time or money to hire anyone, he set out to do the job himself.
Apparently assuming that nobody could possibly prepare a PMA in 90 days, the FDA entered in their computer that Electromedical Products International Inc., was “out of business”. EPII products were manufactured in Asia, so this meant that when they arrived at Customs in Los Angeles, it would take Tracey Kirsch two to four weeks to clear a shipment. On one occasion, she threatened to call their congressman, who had already given public support to EPII against the FDA. FDA released the shipment the same day.
Having noticed an increasing volume of static from FDA over the previous couple of years, the Kirsches had had the good sense to seek the help of their congressman, Charles Stenholm (D-TX), who took a keen interest in their situation, as did Congressman Joe Barton (R-TX), chair of the committee which oversees the FDA. So when real trouble came, the Kirsches had some friends in Washington.
On Halloween Day, 1995, Dan Kirsch was literally working around the clock in a desperate attempt to finish the PMA and thus stay in business, the business he’d spent most of his life building. On that day, the FDA decided to stage an inspection, which lasted three days. In came two inspectors from the FDA Dallas office, led by an agent of the Texas Department of Health (TDH), who was acting jointly as an FDA inspector (the two agencies work closely together). It was a memorable inspection.
Very much on their guard, the Kirsches had arranged for Jonathan Emord, their Washington attorney, very experienced in FDA matters, to participate by telephone in any FDA visit. Dennis Rudder, the FDA/TDH chief inspector, strenuously objected but finally agreed to the attorney’s participation. On several occasions, Emord had to point out that Rudder’s questioning was outside of his authority, such as, “where are your bank accounts?” Emord reminded Rudder that EPII’s finances were not the business of the FDA. There was a reason for the FDA’s question. When the FDA decides to target a firm, they have a disturbing pattern of seizing and freezing its bank accounts, leaving such a firm unable to fight back.
All these matters were on Tracey Kirsch’s mind as she tried to find out what the FDA group really wanted. They said they were there to investigate a complaint, but refused to provide the nature of the complaint, which they are required to do. She had earlier informed the Mineral Wells Daily Index of the FDA visit, and the newspaper had sent reporter Charles McClure to see if there was a story. There was, and he was soon to become a big part of it. Seeing himself being photographed, Rudder demanded to know “Who is THAT?” Informed that it was the press, there to cover the public business of a government agency doing its regulating, Rudder and his agents stormed out of the office, refusing to talk in the presence of the press. He returned sometime later, saying that his superior, whom he refused to identify to Attorney Emord, had said it was all right for the press to be there. However, on his way back in, Rudder told reporter McClure, “Don’t you photograph ME!” and lunged at him, pushing the reporter back into some file cabinets. Meanwhile, McClure snapped a picture of Rudder and his thumb coming at the camera. The picture appeared on the front page of the Index the next day, November 1, 1995. The entire proceedings were videotaped by EPII, much to the distress of the FDA agents. Attorney Emord had to tell them sharply that EPII was entirely within its rights to videotape and audiotape the inspection. When the dust finally settled, the FDA inspectors asked a few minor questions which were quickly answered. The “complaint”, a legally defined term indicating that someone had been injured, turned out to be nothing more than a competitor complaining that EPII was marketing devices for CES applications – not exactly a secret.
The Freedom of Information Act, passed in the wake of an earlier time of government excesses, enables any citizen to demand any government documents that are not classified. Hiring a firm specialized in this area, Dan Kirsch asked for every document on EPII in the FDA files. When the file finally arrived after the FDA had stonewalled for two years, the Kirsches saw how close they had come to a raid. After the inspection, the Dallas FDA office had recommended stern measures against EPII and had drafted a severe warning letter to be sent, threatening seizures, injunctions and civil penalties. However, FDA headquarters in Washington, aware that Congressmen Barton and Stenholm took an interest in EPII, overruled the Dallas FDA office.
Dealing with the FDA, Dan and Tracey Kirsch found, was not for the faint-hearted.
As the rumpus of the inspection was going on, Dan Kirsch was in his back office feverishly working to finish the PMA, which he did with five days to spare. The FDA wanted the PMA in six copies, which he had his attorneys hand deliver. Each copy weighed 18 pounds and six ounces.
The next move for the FDA upon receiving a PMA would be to “file” it for review. The Office of Device Evaluation (ODE) in the FDA’s Center for Devices and Radiological Health (CDRH) informed Dr. Kirsch that it would not “file” the document he had spent 85 days and nights preparing. It outright refused to review his work, meaning that he would be out of business after all; if they didn’t accept it, he was done.
The only preliminary review given the PMA at ODE was by a mechanical engineer, a woman who repeatedly demonstrated that she knew nothing of electromedicine, of electricity, of medicine, of behavioral sciences or of stress and anxiety. At their first meeting, she asked questions making it very evident that she had not read the document at all. Given FDA hostility, Dr. Kirsch informed those attending the FDA meeting that his company would almost certainly have to move to Europe. That being the case, Kirsch told the mechanical engineer, “please hold onto those six copies of my PMA, since I can probably use part of the documents in Europe.” A few weeks later, the engineer called Tracey Kirsch, asking for six more copies, since the previous ones had been destroyed. Since FDA was supposed to retain them on microfiche, Mrs. Kirsch told her to get them from that.
Given the FDA’s attitude, Attorney Emord agreed to do whatever the Kirsches wanted, but he was not optimistic. EPII then hired a different lawyer, Larry Pilot, a former FDA counsel, and an expert on the FDA devices law. When Pilot saw how arbitrary and capricious FDA’s treatment of EPII and its PMA was becoming, he filed suit against the FDA. He demanded that the FDA obey its own laws and that a review of Kirsch’s PMA be carried out by independent persons qualified to do so, as the law requires. FDA produced an electrical engineer to pronounce on the relationship between anxiety and depression; EPII and Pilot maintained that electrical engineers, while important, are not qualified to render medical or psychiatric opinions. FDA even had a government dentist say that although CES research shows that CES will help anxiety in dentistry, she could not see any need for that. Dan Kirsch wondered if she had ever been to a dentist herself.
Finally, FDA agreed to “file” the PMA, but sent EPII a “major deficiency” letter. In a manner designed to create a problem rather than settle one, the letter asked questions, but said that if the questions were answered, FDA would restart the clock of review of the PMA upon receipt of the answers. This was calculated to mean that EPII would thus have missed the 90-day deadline for submitting the PMA. Then it would have to stop marketing, and thus be out of business in the U.S. – just as FDA had entered into its computers months earlier. FDA suggested that EPII devote itself to full-time research, but gave no suggestions as to how to pay for the research if the company had no cash flow.
The legal battle had its ups and downs; Pilot won some stages for EPII and lost some. At one point, it seemed the cause was lost. But then came a surprise.
On January 28, 1997, the FDA announced that it would completely withdraw its proposed regulation of August 1995 requiring CES manufacturers to file a PMA. Dan Kirsch had won; he had beaten City Hall. But as Tracey Kirsch commented, “The FDA is a lot bigger than City Hall”.
Commercially, all the commotion had produced an unexpected effect; EPII was the last man standing. All the other CES manufacturers had folded when faced with FDA’s demand for the PMA.
In March 1999, Dr. Dan Kirsch attended the 10th International Congress on Stress in Montreux, Switzerland, to give a paper entitled “Cranial Electrical Stimulation: An overview of its application for the treatment of pain, anxiety, insomnia, depression, and other stress-related disorders”. A senior FDA official was there, also to give a talk, and he knew who Dan Kirsch was. He told Kirsch, “It was really unnecessary that you were put through all that, for after all, the treatment is harmless.” He added that, “The FDA should not bother companies with a 20-year marketing history.” The FDA man was absolutely right, for the bottom line is: if something is harmless, why do we need the FDA protecting us from it?
In the late 1990’s, ABC’s 20/20 literally accused the FDA of being responsible for killing people with excessive red tape, and for giving the impression of being more interested in paperwork than scientific fact. In a show devoted to the over-regulation of medical devices, ABC told of FDA’s refusal to approve “Breastpad”, a very simple lubricated pad with an established 20-year history intended to aid women in self-examination for breast tumors. The manufacturers won quick approval in Japan, Europe, and Canada. But after 1,200 pages of documentation and $2,000,000 spent over nine years on attempting to obtain approval, FDA classified this simple pad as “high risk”, like pacemakers. In another case, 20/20 told how the FDA had gone after defibrillators, a device the American Heart Association calls “the most important treatment for cardiac arrest”. FDA forced some defibrillator manufacturers to shut down because of insufficient paperwork; ABC estimated that this may have cost 1,000 lives. Originally introduced at the end of the 18th century, defibrillators were denounced by religious leaders at the time, since they considered that reviving people from the dead had to be the work of the devil. It took a lawsuit to get the FDA off of defibrillators. ABC also told how FDA barred the use of heart pumps, standard equipment on ambulances in Europe and Japan, since the patient had not given informed consent for their use. The FDA did not volunteer how a patient with no heartbeat could give informed consent. ABC estimated that this resulted in another 20 lives lost each day because of FDA regulations.
From the first, the Alpha-Stim has been considered a Class III device, meaning significant risk, and thus requiring a doctor’s prescription. For years, the FDA also considered acupuncture needles as Class III devices, “significantly risky, dangerous devices”. Finally, at an August 1996 meeting, the head of FDA’s Office of Device Evaluation openly granted that there was no safety issue with EPII’s CES device. Since the PMA flap, EPII has applied to FDA for reclassification of CES to Class II or Class I (harmless). It would seem that Dr. Kirsch put the safety issue to rest once and for all in 1997 by completing the rigorous examination to secure registration of the Alpha-Stim 100 CES device by the Underwriters Laboratories (UL), a good way to handle safety questions for any electromedical device. The Alpha-Stim also passed the strict safety requirements to market in Europe having earned their CE Mark of Approval.
Part of the PMA asked about the efficacy of CES devices. In answer, Dr. Kirsch pointed to seventeen independent scientific studies maintaining that Alpha-Stim technology is effective in reducing anxiety and related symptoms. Kirsch further notes that his PMA application contained 155 CES studies, 28 of them double-blinded, and 20 experimental animal studies. He also notes that in 1995, the Harvard School of Public Health published a thorough statistical review of selected CES research in the Journal of Nervous and Mental Diseases confirming the modality as an effective treatment for anxiety. Kirsch published a summary of all the CES studies listed in his PMA in 1999 in a book entitled The Science Behind Cranial Electrotherapy Stimulation.
Despite the dubiousness of the FDA, cranial electrotherapy stimulation (CES) is regarded as an important anti-stress treatment in most of the world. Following the Gulf War, Kuwait, which knows something about stress, invited Dr. Kirsch to come teach their doctors, and treat Kuwaiti veterans suffering from stress and anxiety. The VA never offered such help to U.S. veterans.
Kirsch notes that it has been estimated that stress is the cause, or at least a contributing cause, in 75% to 80% of all diseases. “If that is indeed the case”, says Kirsch, “then I believe that CES and the Alpha-Stim can make a big contribution to preventing such things as cardiovascular disease and stroke, thus reducing healthcare costs.”
Studies by Official Medicine often tend to confuse the issue. The National Institute of Drug Abuse, part of the NIH, carried out a study to see if use of CES devices could help people cut down on smoking, or stop completely. The Institute pronounced that they were ineffective. However, the study was set up to fail; it used far too little current to treat addicted persons, only 10% of the current necessary to achieve results. In the next two chapters, similar tests that were set up to fail will be described, carried out by another branch of the NIH, the National Cancer Institute, only those cost lives. In a way, cheating by Official Medicine is the greatest of compliments, showing that a therapy is being taken seriously.
The sky seems the limit for what electromedicine can accomplish. Consider one of the most dreaded calamities that can befall anyone – a stroke. Ruth Harvey reported on someone whose paralysis was reversed twice with electromedicine. Dan Kirsch heard of another such case, not an old man but a young girl, only 25. As a medical student, she had had a stroke at age 20 and hadn’t walked or been able to move one arm in five years. She got hold of an Alpha-Stim, used the earclips, but other than resting her, it didn’t help her main problem; she couldn’t walk. Then someone told her that when the clips are placed on the earlobes, microcurrents are sent through the lower part of the brain, which controls the emotions and automatic functions of the heart and lungs. But if the clips are placed on the top of the ear, they send microcurrents to the cerebral cortex. Three days later, she reported that she had just gone for a slow one-mile walk and could rotate her arm at the elbow after using the earclips on the top of her ears.
Apologists for Official Medicine would aerily dismiss such stories as mere anecdotes. To be sure, two cases do not make a double blind study, but what anecdotes! Strokes are still among the costliest illnesses in the U.S., and among the most numerous. Surely these anecdotes are a signpost, an incredible lead, pointing to a solution for a dreaded problem.
The stroke reversals point a tantalizing finger to the vastness of the electromedical potential, whose limits we do not yet know. Chinese acupuncture charts show numerous points on the scalp; our medicine has no notion that anything can be accomplished through electrical stimulation of such points. Many years ago, Ruth Harvey was using the Alpha-Stim 2000 on a woman who had had a disc operation on her back. A nerve was cut that should not have been, and the woman dragged her right leg. Knowing that the left side of the brain governs the right side of the body, and studying a scalp acupuncture chart in a book Dan Kirsch wrote in 1978, she looked for the area of the brain governing the leg. The Alpha-Stim 2000 could measure bioelectricity, and when she found the point, it registered dead – no electricity at all. She treated the point until the machine indicated that normal electric flow had been restored. Within a half hour, feeling returned to the woman’s leg. Two other therapists, using an Alpha-Stim on the scalp of Parkinsons patients, saw tremors come to an abrupt halt.
These are indications of a dramatic therapy, something that works quickly, the sort of things Americans like. Dr. Bill Bauer saw improvement in MS patients after treatments on the tops of the ears and on the scalp. Conventional medicine has nothing for these conditions – strokes, Parkinsons, MS. Does the list stop there? Could CES treatments help epileptics? Or Alzheimers? Nobody knows. Dr. Kirsch and other manufacturers should be free to tell the truth about what electromedicine can do, based on facts, and doctors should be free to use such harmless therapies (there has never been any report of any harm coming from a CES device). Until then, the poor unfortunates suffering from such diseases will continue in their adversity and be told “there’s no drug for this”.
Were we as a society organized to greet medical breakthroughs as eagerly as we do computer breakthroughs, our health costs would plummet.
With Dan Kirsch having enough trouble with the FDA just over claims for effectiveness in stress and anxiety, the last thing he wants is to do is to open Pandora’s box and talk about these other CES capabilities. For the FDA, that would be making claims, even though he would simply be telling the truth and announcing interesting scientific events that happened. Dr. Kirsch has had to put a great deal of resources and attention just into surviving. Someday, as a neurobiologist also trained in acupuncture, homeopathy, chiropractic, and naturopathy, perhaps he will have the freedom and resources to organize research in other CES capabilities. Such research will have to be done abroad, far from the FDA – unless things change.
Already well situated in Europe, Kirsch’s next focus is China, where a young doctor, who also earned a PhD in electrophysiology from the University of Arizona, is interested in Kirsch’s work. Together, they plan to open an electromedical treatment center based on Alpha-Stim therapy. There, Chinese stroke victims, or Parkinson’s patients, will be able to receive Alpha-Stim treatments. Meanwhile, news of the very existence of such treatments is censored from American stroke victims by the FDA.
For continuing CES research, it would be nice to have the capabilities of the earlier Alpha-Stim 2000, which is out of production. When it measured low electricity at certain points, you treated until the reading came to normal. Kirsch would love to produce a modernized version of the old 2000, but there is just one problem; money. He’s still paying the legal bills he ran up to sue the FDA to stay in business. He feels that it would cost about $5,000,000 to reengineer the 2000 and bring it up to the latest in computerization. While good, his business does not generate that kind of cash. Ruth Harvey has declared a new prayer objective: funds to produce a new 2000. With her demonstrated track record, it may happen.
After a lecture, someone asked Dr. Kirsch to present a “best case”. Kirsch referred to one written up in the October 1998 American Journal of Pain Management about a U.S. government official named Wilson Hulley who has global reflex sympathetic dystrophy (RSD), one of the very worst pain-related illnesses. Usually this is just in one limb, Kirsch explained, but Hulley had it throughout his entire body. He was in such extraordinary pain that he felt tempted to commit suicide. Using nothing more than the Alpha-Stim’s earclips applied to his earlobes, Hulley’s pain was reduced significantly during his very first treatment. After 18 months of Alpha-Stim, his pain was further reduced sufficiently to allow him to continue his activities as an executive for President Clinton’s Committee on Employment of People with Disabilities. He again can work 30-40 hours a week, is completely off morphine, and has reduced his need for other drugs.
On a perfect summer day in June 1999, at a restaurant in Alexandria Bay, NY, overlooking Boldt Castle and the Thousand Islands, Robert Becker and Daniel Kirsch and their wives finally met. They had paid their dues as pioneers, blazing hard trails, and immediately became friends. Kirsch gave Becker an Alpha-Stim and they laid plans for close collaboration.
After some months of experience with his patients, Becker commented, “In the majority of cases when you’re dealing with a pain syndrome where you can’t locate the source, what we call neurogenic pain, the Alpha-Stim does a pretty decent job, although not in every case. In pain, as a substitute for pharmaceuticals, it has considerable value.”
CES is a field that would not have happened without the pioneering efforts of Dr. Robert O. Becker and Dr. Daniel L. Kirsch. Looking at the unfulfilled potential of electromedicine is kind of like a walk on the wild side – It can stop pain, dissolve stress, accelerate learning, raise I.Q.’s, reverse stroke damage of long standing, stop Parkinsons tremors, regrow bones, regenerate flesh, even dedifferentiate cancer cells. Future Science, we could call it, except that it already exists. Dealing with the basic forces of life, the secrets of the body’s currents, frequencies and resonances, electromedicine is surely the medicine of the new millennium. We will hear much more of it, for it will save many lives, much suffering, and fortunes in healthcare costs – if the government will just get out of the way.