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Thread: To Wait or Not to Wait: Overseas’ Stem Cell Treatments

  1. #21
    Faye, maybe you can send that info. over to Dr. Green at the Miami Project. Doubt if he'd be persuaded against its use tho since researchers of his caliber base their judgements on hard data rather than the spite fueled ramblings of non-scientists but hey, guess it's worth a try.

    By the way, I should point out that methylprednisolone has been used to treat hundreds of thousands of people, not only for spinal cord injury but for many other conditions. It is routinely used to treat millions of people with multiple sclerosis flareups and for tumor compression of the spinal cord. If any of the problems that are being said to be associated with methylprednisolone were true, we would be seeing a huge flareup of muscle atrophy and other problems associated with its use. The amount of data supporting the safety of methylprednisolone is very substantial.

  2. #22
    Faye was previously banned and has now reinvented herself as Jaycee, continuing her (lack of) style. Is this going to be tolerated? It's time to ban/ block the IP address.

  3. #23
    Faye,
    All the naysayers of the recommended IV dosing of MSSP are trying other inflammation controls on paraylyzed dogs. The newage oral and supposed better steroids are causing problems beyond belief. More dogs are going into surgery with no pain perception thus less recovery. More dogs are still ambulatory albeit very
    guarded, painful movement and being given oral and injected doses of dex..and other antiinflammatories..they end up paralyzed within a day or so. Many with NO pain perception left. NO bladder. No bowel control.

    This I find it inhumane to do the testing of their theories on dogs not in a clinical trial. Their theories are untested yet they make these statements.

    And the practicing vets think they should follow untested advice. You want this in human medicine also?

    I'm sorry Faye but thru our data of real living animals the MP blasting..that is what we call it..if we are lucky enough to get to the vet in the timeframe the dog goes into surgery with pain perception and if the surgery doesn't cause subsequent problems the dog comes out of surgery with pain perception in their little hindpaws. And those dogs ultimately do regain leg use. Often accompanied by B&B.

    Dogs that are treated conservatively and with the newage dosing and meds. have a much lower percentage of recovery. All the while messing with their digestive systems. Which even blasting has to be accompanied by some antacid dosing..also the smaller dose/longer term steroid use causes Cushing's and other problems that these naysayers don't include in
    their statements.
    Life isn't about getting thru the storm but learning to dance in the rain.

  4. #24
    Eric S., it is clear that the myriad of other expert MD opinions as reproduced by me here on CC are not welcomed, as they contradict the singletary Bracken et al. findings in the NASCIS studies.
    The Bracken et al findings have been impossible to replicate by anyone else.

    The ChasB signature is quite interesting,..... is he for or against censorship?
    www.stemblog.net

    Cure Paralysis Now

    www.StepNow.org

    How can they not see? In part, they’ve been blinded. In part, it meets their needs to close their eyes. by Andrew Smookler.

  5. #25
    Honestly, jaycee I'm not really interested in the whole mp arguement. i would want the stuff if i were injuried again..

    my problem is with the process itself. Dr. Wise you truly believe the clinical trial process is as effective and efficient as it could or should be? I dont believe so. Someone who claimed to be a former fda officer posted my sentiments perfectly saying the system is cumbersome and unefficient. In my opinion those claims are blatantly obvious....

    I believe after safety is assured a clinical trial is pointless. if the procedure doesn't work it will be abandoned by doctors anyway.
    Last edited by Eric.S; 09-28-2007 at 07:40 PM.

  6. #26
    Quote Originally Posted by Jaycee
    My words are VERY familiar indeed, as the consensus is that Methylprednisolone is unproven, despite its aura of legitimacy:
    Faye,

    Do you read what you post?

    29. Faden AT, Jacobs TP, Holaday JW: Thyrotropin-releasing hormone improves recovery after spinal trauma in cats. N Eng J Med 1981;305:1063-1067.

    30. Rucker NC, Lumb WV, Scott RJ: Combined pharmacologic and surgical treatments acute spinal cord trauma. Am J Vet Res 1981;42:1138-1142.

    31. Hedeman IS, Sil R: Studies in experimental spinal cord trauma. Part 2: Comparison of treatment with steroids, low molecular weight dextran, and catecholamine blockade. J Neurosurg 1974;40:44-51.

    32. Eidelberg E, Staten B, Watkins CJ, Smith JS: Treatment of experimental spinal cord injury in ferrets. Surg Neurol 1976;6:243-246.
    Reference 29 cited steroids, but not methylprednisone. References 30, 31, and 32 are unavailable and their titles don't say which steroids they used, but it is unlikely they tested methylprednisolone. These studies were also done in the mid 70s to early 80s, well before NASCIS II began.

    The portion you bolded mentioned that steroids, generally speaking, did not prove efficacious.

    Faye, if you want to prove that the methylprednisolone regime is ineffective, find studies that show that methylprednisolone show no benefit if started within 8 hours.

    From the abstract in reference 5:

    In NASCIS II, the placebo group treated before 8 hours did poorly, not only when compared with the methylprednisolone group treated before 8 hours...
    The argument in reference 5 says that patients treated with placebo after eight hours also faired better than those who receive placebo within 8 hours.

    If the after 8 hour placebo group showed equal efficacy to the methylprednisolone group treated within 8 hours, the author would have noted it as part of his argument.

    You have multiple degrees (must be 10 or 20 by now), so you should know how to provide a rational argument.

    You say don't trust one doctor, but I prefer Mulder's approach -- trust no one. If you want to present a published article as an argument, check the sources instead of trusting them blindly and using them to mislead people.

    When you can produce the articles that can actually defend your stance, come back and post them. Until then, please don't waste our time.

    Feel free to post, but don't: 1) attack members or 2) continue to post blatant lies.

    Steven
    Last edited by Steven Edwards; 09-28-2007 at 05:52 PM.
    ...it's worse than we thought. it turns out the people at the white house are not secret muslims, they're nerds.

  7. #27

    Unhappy

    quote:

    It is entirely possible that, given appropriate financial support, many of the complex problems of SCI one day will be solved. Until that day arrives, it is import-ant to urge the federal government to provide broad-based support for basic science research so the fundamental questions about how and why the CNS acts the way it does can be answered. A cure or new treatments are possible only if scientists receive the support necessary to con-tinue their work in this important area.



    Spinal Cord Injury Treatment and Cure Research
    http://www.spinalcord.org/news.php?d...e=94&list=1179

  8. #28
    You have to do clinical trials to show something doesn't work? what an expensive red tape nightmare we live in. It would have been impossible for a polo vaccine to ever occure in this environment, they would have still been looking for funding and for trials to began.

  9. #29
    Consider the following:
    • The National Acute Spinal Cord Injury Studies (NASCIS) were funded by National Institutes of Health after extensive and rigorous peer review. NASCIS 2 was the first randomized placebo-controlled multicenter trial carried out in spinal cord injury. Fourteen of the leading spinal cord injury centers in the United States participated in the trial. NASCIS 2 studied 487 patients and NASCIS 3 studied about 500 patients.
    • The studies were published in the most prestigious and rigorously peer-reviewed journals in the United States. NASCIS 2 was published in the New England Journal of Medicine, arguably the top-ranked clinical journal in the United States. NASCIS 3 was published in the Journal of the American Medical Association. It underwent detailed and critical peer review in both cases.
    • The data used to criticize the NASCIS trials are mostly retrospective, non-randomized trial. By the way, of the studies that are usually cited to oppose the NASCIS trial, only one was a randomized trial. The study was done in France, involving 100 patients randomized to methylprednisolone, nimodipine (a calcium channel blocker, and placebo control. That subjects were not stratified according the treatment severity or treatment timing.
    • Critics who claimed that the study was based on post-hoc analyses are wrong. The planned a priori hypotheses of both clinical trials, implicit in the design of the trial, were that treatment timing and injury severity may affect the response to treatment. That is why the patients were stratified according to timing of treatment after injury and divided into those with "complete" and "incomplete" spinal cord injury.
    • The suggestion that such stratification is not rigorous or inappropriate is wrong. It is entirely appropriate to assess treatment timing in a clinical trial. In fact, our trial demonstrated that early treatment is more effective than late treatment. The median time of treatment was 8 hours in NASCIS 2 and there was a significant difference between patients treated within 8 hours and those treated between 8 and 24 hours.
    • It is also important to assess treatment effects on complete and incomplete spinal cord injuries separately. This is because we know that these two conditions have dramatically different prognoses for recovery. As it turns out, methylprednisolone had significant beneficial effects of motor, touch, and pinprick (pain) sensory recovery in both complete and incomplete patients.
    • The study showed *no* significant complication from the 24-hour course of methylprednisolone. It is possible that there may be some complications that we did not look for. However, our study ruled out any difference in mortality, urinary tract infections, wound infections, aseptic necrosis of joints, and 10 other potential complications of steroids.
    • The "NASCIS dose" of methylprednisolone has now been used in millions of patients world-wide not only for spinal cord injury but for many other conditions. When SARS hit China, Hong Kong doctors discovered that high-dose methylprednisolone markedly reduced mortality and used it extensively in many patients. High-dose methylprednisolone is used to treat flare-ups of multiple sclerosis, transplanted organ rejection, graft versus host disease, acute transverse myelitis, and many other diseases. While methylprednisolone is well-known to have numerous side-effects if given over long periods of time, a 24-hour course of the drug has relatively few or no significant side-effects.
    • In 2002, Hurlbert and Moulton conducted a survey of 60 Canadian doctors and found that the NASCIS III dosing regimen in the most commonly prescribed medication for spinal cord injury in Canada, that about two thirds of surgeons used the treatment. Note that Hurlbert is a strong critic of methylprednisolone and clearly showed his bias when he commented that "the vast majority of spine surgeons in Canada either do not prescribe methylprednisolone for acute SCI or do so for what might be considered the wrong reasons." By the way, it should be noted that spinal surgeons are not the ones who normally prescribe methylprednisolone in Canada. In my experience, the drug is almost always given by the emergency room doctors before the spine surgeon even appears on the scene.
    • In 2006, Eck, et al. surveyed 305 US spine surgeons concerning their use of methylprednisolone for acute spinal cord injury. Fourteen (4.6%) used steroids only if initiated before their consult... presumably these would not use the drug if not initiated before they got to the patient. 262 of the surgeons (85.9%) would initiate the treatment if it were within the accepted 8 hour timeframe, 20 (6.6%) did not use steroids at all, and 9 (3.0%) used a different protocol. They concluded that a majority (90.5%) of responding surgeons used the steroid protocol.
    • In summary, methylprednisolone improves neurological recovery (albeit modestly by 20%). The 24-hour course has few or no significant complications. The treatment is the only one that has been shown to be effective. The studies opposing the results of the NASCIS 2 and 3 studies are weak, mostly retrospective, poorly designed, and not convincing. The arguments against methyprednisolone use are not only weak but irrational. A large majority of doctors continue to use the treatment in the United States and Canada.

    • Hurlbert RJ and Moulton R (2002). Why do you prescribe methylprednisolone for acute spinal cord injury? A Canadian perspective and a position statement. Can J Neurol Sci. 29: 236-9. Department of Clinical Neurosciences, Foothills Hospital and Medical Centre, Calgary, AB, Canada. OBJECTIVE: To determine the practice patterns for methylprednisolone administration for patients with acute spinal cord injury (SCI) within the spinal surgery community across Canada, and the reasons behind these patterns. METHODS: Canadian neurological and orthopedic spine surgeons were surveyed at their respective annual meetings with a questionnaire asking seven questions with respect to their practice standards. RESULTS: Sixty surgeons completed the survey representing approximately two-thirds of surgeons treating acute SCI within Canada. The NASCIS III dosing regimen is the most commonly prescribed steroid protocol. However, one-quarter of surgeons do not administer steroids at all. Of those who administer methylprednisolone, most do so because of peer pressure or out of fear of litigation. CONCLUSIONS: The vast majority of spine surgeons in Canada either do not prescribe methylprednisolone for acute SCI, or do so for what might be considered the wrong reasons. These results demonstrate the need for an evidence-based practice guideline. The Canadian Spine Society and the Canadian Neurosurgical Society fully endorse the recommendations of the steroid task force (see preceding paper).
    • Eck JC, Nachtigall D, Humphreys SC and Hodges SD (2006). Questionnaire survey of spine surgeons on the use of methylprednisolone for acute spinal cord injury. Spine. 31: E250-3. Department of Orthopaedic Surgery, Memorial Hospital, York, PA 17403, USA. jason-laurie@suscom.net. STUDY DESIGN: A questionnaire survey. OBJECTIVE: Estimate the use and justification of the steroid protocol for spinal cord injury (SCI) patients. SUMMARY OF BACKGROUND DATA: There remains significant debate over clinical benefits and potential complications of the steroid protocol for SCI patients. METHODS: A survey was sent to spine surgeons requesting information on 1) specialization, 2) trauma center affiliation, 3) use of steroid protocol, 4) justification of using steroid protocol, and 5) SCI volume. RESULTS: Responses were received from 305 surgeons. Fourteen (4.6%) surgeons used steroids only if initiated before their consult, 262 (85.9%) would initiate if within the accepted 8-hour timeframe, 20 (6.6%) did not use steroids at all, and 9 (3.0%) used a different protocol. Justification for steroids use: 65 improved recovery, 64 institutional protocol, 110 medicolegal reasons, and 26 did not personally initiate steroids. Eighteen surgeons listed both clinical benefit and institutional protocol, and 22 others listed both institutional protocol and medicolegal reasons. CONCLUSIONS: The majority (90.5%) of responding surgeons used the steroid protocol; however, only 24.1% used the steroid protocol due to a belief in improved clinical outcomes.

    Last edited by Wise Young; 09-28-2007 at 08:18 PM.

  10. #30
    Quote Originally Posted by Eric.S
    You have to do clinical trials to show something doesn't work? what an expensive red tape nightmare we live in. It would have been impossible for a polo vaccine to ever occure in this environment, they would have still been looking for funding and for trials to began.
    Eric, absolutely. One of the most important functions of a clinical trial is to show that things don't work. The problem with most of the so-called clinical trials that are going on overseas is that the investigators have a conflict of interest (they are receiving money for the treatment) and are very unlikely to say that it does not work. They will continue to use a therapy even one that does not work, as long they continue to be paid.

    Clinical trials that demonstrate that treatments don't work are essential for progress in the field. That is the only way that use of unsafe and ineffective therapies can be stopped. Otherwise, people's time and money (and bodies) continue to be wasted on such therapies.

    Wise.

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