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Thread: Pulsed Electromagnetic Fields (PEMF) in treating SCI

  1. #1
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    Pulsed Electromagnetic Fields (PEMF) in treating SCI

    Interesting recent article by James Kelley on Funding and SCI research!!

    I do not agree with James Kelley on the Stem Cell Research issue, but do find parts of his article insightful regarding funding and what scientist choose to research,..........and the reporting on that research.

    Tuesday, April 11, 2006


    On Sep. 15,1985, America's most prominent spinal cord injury (SCI) researcher, Dr. Wise Young, Ph.D. (current Director of Rutgers Center for Collaborative Neuroscience — named America's leading SCI researcher by Time Magazine) wrote to the U.S. Food and Drug Administration regarding his use of pulsed electromagnetic fields (PEMF) in treating acutely injured cats:
    "The eventual percentage of cats receiving PEMF at four hours after injury that recovered the ability to walk at four months after spinal cord injury is 78 percent (7/9), compared with zero percent of the sham-treated injured controls."

    On Sep. 28, 2000 I wrote to Dr. Young on his Internet forum, inquiring into his PEMF research of the eighties. I made this request without mentioning that I had the document quoted above, plus additional PEMF documents of Young's. His reply stunned me:
    "In cats, we did not see a significant improvement in walking when we applied PEMF after injury."

    In my opinion, Young's claim that seven of nine animals "recovered the ability to walk" after SCI represented a "significant improvement," especially since none of the "sham" treated animals recovered.
    There followed several days of discussions. The error was mine, Dr. Young explained, for misunderstanding his denials. However, try as I might, I could not reconcile his explanations of 2000 with his data from the 1980's.

    Eventually Young admitted that he dropped this very promising and practical line of research in part due to the lack of support from America's National Institute of Health (NIH):
    "I was also influenced by the fact that we were unable to get funding for these studies from NIH or other sources. At the NIH and other funding agencies, there was and continues to be deep skepticism about the potential effects of electromagnetic fields on regeneration."

    PEMF may or may not have positive effects on regeneration. However, the results of the studies in question concerned functional outcome after acute SCI. Clinical evidence indicates that PEMF, if properly used, improves regional blood flow. Reduced blood flow due to vasospasms, inflammation, and edema contributes to massive secondary tissue damage during acute SCI.
    The NIH did have a clinical plan for acute SCI — the use of an anti-inflammatory steroid called methylprednisolone (MP). In his letter to the FDA Young compared his PEMF results to similar tests using MP:
    "No pharmacological treatment that we have tested to date, including naloxone and methylprednisolone (both of which are in double blind randomized clinical trial in 12 spinal centers around the country), has exhibited this degree of effectiveness in similar animal studies."

    Young detailed this comparison in a 1984 presentation to the American Association of Neurological Surgeons:
    "In a separate series, we evaluated for five months the neurophysiological and motor recovery of twenty-seven cats, in three groups: (1) injured controls, (2) injured and PEMF treated, (3) injured and treated with a 30 mg/kg methylprednisolone (MP) IV 45 minutes after injury. Fifty percent of the PEMF treated cats walked independently just four months after injury, compared with one of the untreated cats and one of the MP cats. PEMF cats had significantly larger mean somatosensory evoked potentials and vestibulospinal response amplitudes than MP-treated or control cats."

    The NIH chose to ignore Young's impressive PEMF findings. Instead, they expanded their clinical testing of MP from twelve to sixteen trauma centers, spending an additional eleven years conducting the trials. Over the past decade dozens of articles in medical journals have questioned whether the use of MP for SCI does any good, while suggesting it places the patient at serious risks.

    I was not disturbed though that the NIH refusal to consider Young's data may have caused the abandonment of an effective treatment for acute SCI. Although this may have been true, experimental treatments that work in animals often fail in humans.

    My concern stemmed from the refusal of the NIH to objectively consider the scrupulous data of a respected scientist regarding a catastrophic medical condition, instead choosing to proceed with (and expand) a preferred project that head-to-head tests indicated was inferior.

    Since 2000, multiple articles from Germany, Sweden, Italy, the U.K, Canada, Turkey, and the U.S. question the worth and safety of MP for acute SCI. Researchers in the U.K. report: "The evidence produced by this systematic review does not support the use of high dose methylprednisolone in acute spinal cord injury to improve neurological recovery. A deleterious effect on early mortality and morbidity cannot be excluded by this evidence."


    Canadian researchers claim that methyprednisolone use for acute SCI may block positive effects of other treatments. Italian researchers agree.
    "These findings demonstrate that the non-selective and enduring effects of immunosuppressive therapy with methylprednisolone not only fail to improve neurological outcomes, but can also block the beneficial actions of selective therapies such as the anti-CD11d mAb."

    Yet, for over a decade this treatment received preferential treatment by America's NIH, while evidence of the superiority of other treatments was ignored or dismissed. On his Internet forum, Dr. Young revealed the importance of NIH research prioritization: "Many scientists will go to great lengths to get funding from the NIH and other organizations, including changing their experiments and even [their] fields to get funding. NIH has had a great influence on science in the United States for this reason."
    http://theseoultimes.com/ST/?url=/ST...d.php?idx=3217

    Based upon my own prior literature search on methyl prednisolone I too have expressed my own skepticism previously on Care Cure:
    http://carecure.org/forum/showthread...hylprdnisolone

    "There’s far too much unthinking respect given to authority,” Molly Ivins explained; “What you need is sustained outrage.”
    Kerr, Keirstead, McDonald, Stice and Jun Yan courageously work on ESCR to Cure SCI.

    Divisiveness comes from not following Christopher Reeve's ESCR lead.
    Young does ASCR.
    [I]I do not tear down CRPA, I ONLY make peopl

  2. #2

    I dont agree

    With much of anything James Kelley has to say.

  3. #3
    Faye, you weren't around when James Kelly and Wise hashed this out ad nauseum on Spinewire and then Cando about 6-8 years ago.

    His allegations were completely without merit and thoroughly dismantled.
    Last edited by antiquity; 04-12-2006 at 03:32 AM.

  4. #4
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    Quote Originally Posted by antiquity
    Faye, you weren't around when James Kelly and Wise hashed this out ad nauseum on Spinewire and then Cando about 6-8 years ago.

    His allegations were completely without merit and thoroughly dismantled.
    That may be true, but disregarding the personalities and politics of the matter is this statement true?
    However, the results of the studies in question concerned functional outcome after acute SCI. Clinical evidence indicates that PEMF, if properly used, improves regional blood flow. Reduced blood flow due to vasospasms, inflammation, and edema contributes to massive secondary tissue damage during acute SCI.
    If so a valuable tool for use in acute spinal cord injuries may be overlooked.

  5. #5

  6. #6
    Quote Originally Posted by IanTPoulter
    That may be true, but disregarding the personalities and politics of the matter is this statement true?

    If so a valuable tool for use in acute spinal cord injuries may be overlooked.
    Ian,

    I find it so strange that Jim Kelly continues to bring this subject up. He must be running out of things to write about. You will note that he cites me in his writing but, whenever I have disagreed with his interpretation of what I said, he attacks me for abandoning PEMF in favor of methylprednisolone. It is bizarre.

    Let me give you the background. In 1983-1985, I was a young scientist who became interested in a PEMF device made by Diapulse. The company lent two machines to my laboratory, one that emitted the pulsed radiofrequency and the other that looked like it emitted the pulsed radiofrequency. They did not provide funding for the project and I was doing the studies without funding.

    In preliminary experiments, we treated cats shortly after spinal cord contusion and observed their walking recovery. About half of the cats showed better (or perhaps more rapid) recovery of function but half did not. I did not understand why this was so. In the meantime, Diapulse was on the verge of losing their FDA approval and asked if I would write a letter to the FDA on their behalf. I did so, along with various abstracts and summaries of work I had done.

    Diapulse retained their FDA approval but was still limping along without sufficient funds to support any research. I wrote several grants to try to get funding and was unsuccessful. In the meantime, I tried to repeat the experiments and was not able to get the same results. So, in the late 1980's, after having spent more than 5 years trying, I gave up on the experiments. I encouraged the company to use the Diapulse machine to treat pressure sores and helped them make the contacts for the trial. It seemed to accelerate healing of the sores, by the way, and has been published.

    In the meantime, a British surgeon by the name of Wilson published a paper saying that Diapulse increased peripheral nerve regeneration. I encourage these studies but had no resources to go forward with my own studies. The company came to me over and over again for nearly a decade and I helped them at every opportunity. I even treated several chronic spinal cord injury patients with the device in the 1980's and did not observe any improvements. The company eventually slipped into oblivion in the 1990's. My friend in the company died. I had all but forgotten about Diapulse when Jim Kelly brought up the documents in the late 1990's and accused me of conspiring to hide a promising therapy for spinal cord injury.

    We had many long and tedious discussions on the subject on spinewire. At the time, I even encouraged Jim Kelly to try the device on himself if he thought that it was so promising. I don't know whether he did. In any case, to my knowledge, he is still paralyzed. Eventually, Jim Kelly went (in my opinion) off the deep end in the late 1990's and started to attack stem cell research. He was embraced by the pro-life groups and testified in front of Congress and the White House, and even in New Jersey against the stem cell legislation. I don't think that he has done anything to support spinal cord injury research but has used his spinal cord injury to say that stem cell research should not be allowed, that it was going to steal funds from spinal cord injury research.

    Jim Kelly seems to believe that I am responsible for all spinal cord injury therapies and that I conspired to hide this promising therapy. It is not true. In fact, I had done my very best to promote this therapy in the 1980's and it failed for the lack of data. Diapulse never provided any funding for my research and I never was able to get grant funding for the research. By the way, there are thousands of therapies that are like this, therapies that seem to have some promise at the beginning and have bit the dust. In my opinion, there are much more promising therapies than PEMF and one simply has to prioritize.

    By the way, the efficacy and safety of methylprednisolone for acute spinal cord injury have been demonstrated in four large randomized clinical trials. Hundreds of animal studies have shown the beneficial effects of the drug. Because the drug went out of patent in 1987, there was no interest by the company (Upjohn at the time, bought by Pharmacia, and then Pharmacia was bought be Pfizer) to push for registration of the drug for spinal cord injury. There is a growing movement to stop use of methylprednisolone in the U.S. and Canada. In my opinion, this movement has no basis in clinical data.

    In the early 1980's, I had shown that high-dose methylprednisolone, given early after injury (within hours) and for only a short period of time, can improve neurological recovery in cats. We subsequently did the phase 1 safety trial at Bellevue Hospital (because nobody had ever given such high doses of methylprednisolone to patients before) and then convinced the NIH to fund a double-blind randomized clinical trial of the drug in spinal cord injury. We carried out the National Acute Spinal Cord Injury Study (NASCIS) that was published in the New England Journal of Medicine in 1990, reporting the first effective acute neuroprotective therapy for spinal cord injury. In a subsequent trial, we showed that a 48-hour course of methylprednisolone was more effective than a 24-hour couse when the drug was started 3-8 hours after injury, but if the drug was started within 3 hours, the 24- and 48-hour course had the same effect (published in the Journal of the American Medical Association). These two trials studied nearly 1000 patients and two other randomized clinical trials have essentially supported these results.

    High-dose methylprednisolone is now being used for many conditions besides spinal cord injury, including multiple sclerosis, transverse myelitis, systemic lupus, tumors, and other causes of damage to the spinal cord. If its use is limited to 24 hours, it appears to be very safe. The NASCIS dose of methylprednisolone has now been given to hundreds of thousands, perhaps millions of people, in the past 20 years. I am saddened that doctors would be taking so much time to attack methylprednisolone while they themselves have provided no evidence for a better treatment for acute spinal cord injury. As I have said many times, if they truly do not think that methylprednisolone works, it is the perfect placeo control.

    I would be very pleased indeed if somebody were to find a drug or treatment that is better than methylprednisolone for acute spinal cord injury. I am deeply saddened that a drug that I tested in 1979 is still the standard and only therapy for acute spinal cord injury. In 1995, I decided to switch directions on my research and focus on chronic spinal cord injury and initiating clinical trials for chronic spinal cord injury.

    Wise.
    Last edited by Wise Young; 04-12-2006 at 09:43 AM.

  7. #7
    Quote Originally Posted by IanTPoulter
    That may be true, but disregarding the personalities and politics of the matter is this statement true?

    If so a valuable tool for use in acute spinal cord injuries may be overlooked.
    No Ian and that's my point. Dr. Young carried out some of the first PEMF studies. The reason he discontinued the research was not due to the NIH as Kelly asserts, he applies quotes out of context, those are not the responses Wise gave to the questions he posed, but because Wise was not able to duplicate the results. However, PEMF has been shown to be useful in wound repair.
    Last edited by antiquity; 04-12-2006 at 09:35 AM.

  8. #8
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    Doc, Please dont misunderstand me, I am not doubting the efficiacy of methylprednisolone which I know from researching this site and reading first hand accounts has undoubtedly helped many people. Your motives are unquestionably altruistic. I am aware of some of the history behind the accusations thus I clarified my question to exclude the politics of the matter. However my daughter was not given MP primarily because she had internal bleeding at the time of her accident. I have noticed by talking to many people in the Rehab centre that most were not in the position to be able to be given MP. i.e. too late after accident or other medical complications.
    I am not suggesting by any means that PEMF would be a superior alternative to MP however in cases where MP cannot be given I believe an alternative needs to be found. In my daughters case, the Doctors had nothing else and did question if MP would have worked anyway (not my opinion). IMO not enough research is going into alternatives such as PEMF and administration of anti inflammatory antioxidants in acute SCI.
    Please do not think I am attempting to attack or question your motives or research.

  9. #9
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    Quote Originally Posted by antiquity
    No Ian and that's my point. Dr. Young carried out some of the first PEMF studies. The reason he discontinued the research was not due to the NIH as Kelly asserts, he applies quotes out of context, those are not the responses Wise gave to the questions he posed, but because Wise was not able to duplicate the results. However, PEMF has been shown to be useful in wound repair.
    My understanding is Dr Young used the Diapulse machine only in his research which operates on specific frequencies. There are a number of other PEMF machines now available which use different settings. There has been advances in PEMF therapy since then I believe. And just to clarify, I am not seeking to promote Kellys arguement.

  10. #10
    Ian,

    I hope that I was not giving the impression that I thought you were attacking me. To tell you the truth, I would like to see PEMF adequately tested. The problem is priorities. Since there seems to be interest, let me discuss PEMF and particularly the Diapulse machine.

    Electromagnetic fields have been used for nearly a century for many conditions. If one uses radiofrequency electromagnetic fields, it is possible to heat tissues up. In fact, almost every hospital and sports training facility use to have diathermy machines that are intended to heat muscles. In the beginning, people thought that the improved blood flow was due solely to the heating. There is no question that heating tissues will increase blood flow.

    Pulsed diathermy, which is what the Diapulse machine provides, does not heat up the tissues. By reducing the "duty cycle" of the on pulse, it delivers the peak energy to the tissue without heating the tissue. The device was designed in the 1970's and looked like something out of Star Trek, with a large circular head and a red light that indicated when it was on. If you pass your hand through the field, some people can feel the slightly prickly sensation that occurs when you pass a hand through an electromagnetic field, but it is otherwise difficult to tell that the field is on.

    We attempted to measure the blood flow in the spinal cord (by the way, methylprednisolone dramatically increases the blood flow in the spinal cord) due to PEMF. It was difficult because the electrical fields interfered with the measurements that we were trying to make. I was using a method called hydrogen clearance and electrodes to measure the levels of hydrogen in the tissue as a tracer of blood flow. In any case, we treated cats shortly after a contusion injury for about an hour and then daily for a week (if my memory serves me correctly). We then graded recovery of walking in the cats for 6 weeks. Several of the cats treated with Diapulse had better walking than the control cats that were treated with a machine that did not deliver any power. In a subsequent and larger study, I was unable to confirm these results.

    The real question is who should be funding the Diapulse studies. The answer is of course Diapulse. After all, it was their machine and they would make a great deal of profit if the machine had been shown to be effective for acute spinal cord injury. I had hoped that Diapulse would be able to make sufficient revenues from sales of the Diapulse machine for treatment of pressure sores to be able to fund spinal cord injury studies. There are many more patients with pressure sores than acute spinal cord injury and they could have sold a machine to every rehabilitation hospital in the world. But, despite the positive clinical trial results, they never were able to market the device. They were unable to attract any venture capital funding, or at least funding on conditions that the company was willing to accept. In the end, the Diapulse machine bit the dust. As I pointed out below, there are thousands of therapeutic approaches that have had the same ignominious end.

    I am sorry to hear that your daughter did not get methylprednisolone. This was in Australia or UK? Both of these countries have had a difficult time accepting methylprednisolone. Because it is a glucocorticoid, many doctors have a mindset against the drug because they have all experienced patients who have suffered the side effects of prolonged glucocorticoid therapies. When I first started giving 30 mg/kg of methylprednisolone to patients, my colleagues were telling me that it would blow holes into the stomachs and melt the joints of the patients. Our protocol calls for giving 10 grams of the drug intravenously to people during the first 24 hours after spinal cord injury. As you can imagine, it was nerve-wracking giving the drug to our first few patients in 1981. We treated 30 consecutive patients that came into Bellevue with the high dose drug. Nobody suffered any untoward complications and 17 of them walked out of the hospital. This was of course an uncontrolled trial and we had both complete and incomplete patients.

    One of the first patients that received methylprednisolone was Carey Erickson, a well-known dancer and choreographer in New York City. He was nearly "complete". He had only a patch of sensation on his left leg and was completely paralyzed below the C4/5 injury site. I monitored his somatosensory evoked potentials weekly for nearly 3 months. He eventually recovered to the point that you could not tell that he had spinal cord injury. Four years after his injury, he walked into my office and told me that he was depressed. I said to him that there are many people who would dearly love to have recovered as much as he has and Carey told me that while he may look normal, as a dancer, he knows that he really has only 30-40% of the motor control that he had before injury. Carey eventually worked for me 6 years as my patient liaison during the NASCIS trials. We had probably the lowest refusal on informed consents in the trial because of Carey. Carey died in the early 1990's from AIDS and I was told that before he died, he started to lose neurological function in reverse order of what he had recoverd from his spinal cord injury. He was a good friend.

    Anyway, all this ancient history. In the move from NYU Medical Center to Rutgers, I had put all my papers into storage. Nearly 20 years of my files and early work are there and I don't have the time to pull any of it out. Locked up in those files is a lot of primary source information on the early development of the spinal cord injury field. It is interesting that when Jim Kelly showed up with the letter that I wrote to the FDA in 1984, I did not have a copy of it and could not even remember what I had said 15 years earlier. It would be interesting to write a history of those years, that I call the "Dark Ages" of spinal cord injury. It was lonely being a spinal cord injury scientist in those days. Nobody thought that any therapy would have any effect on spinal cord injury once it had occurred. I still remember trying to convince my colleagues to try methylprednisolone and one of my best friends said to me that I was crazy, that the injured spinal cord is like a stepped on strawberry and nothing could be done to restore it. Can you imagine trying to get an NIH grant for PEMF in those days? It was not a good time or place to do so.

    Wise.


    Quote Originally Posted by IanTPoulter
    Doc, Please dont misunderstand me, I am not doubting the efficiacy of methylprednisolone which I know from researching this site and reading first hand accounts has undoubtedly helped many people. Your motives are unquestionably altruistic. I am aware of some of the history behind the accusations thus I clarified my question to exclude the politics of the matter. However my daughter was not given MP primarily because she had internal bleeding at the time of her accident. I have noticed by talking to many people in the Rehab centre that most were not in the position to be able to be given MP. i.e. too late after accident or other medical complications.
    I am not suggesting by any means that PEMF would be a superior alternative to MP however in cases where MP cannot be given I believe an alternative needs to be found. In my daughters case, the Doctors had nothing else and did question if MP would have worked anyway (not my opinion). IMO not enough research is going into alternatives such as PEMF and administration of anti inflammatory antioxidants in acute SCI.
    Please do not think I am attempting to attack or question your motives or research.
    Last edited by Wise Young; 04-12-2006 at 10:43 AM.

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