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Thread: ISCoS Meeting 2009 - Florence

  1. #21
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    Quote Originally Posted by Duran View Post
    Leif,

    this is amazing... so that I wouldn't have to be forced to travel for the therapy to the United States of America after all?!

    Do you happen to know when (in which year) this would become a reality for common mortal like me?

    Joe
    Hi Joe,
    As for you’re questions here I wouldn’t know much and I don’t think I am the right person to answer you’re questions. Wise might if he see you’re questions. All I can say is that the different professionals working on SCI recovery over here are very positive and want to collaborate; meetings has already been held to disuses plans, legal and funding issues etc. I think if I recall correctly that the SCINetUSA will issue approval papers to the US FDA in 2010, thus the professionals over here as well want to start the necessary processes as soon as possible for this clinical trial multi-center study.

    Quote Originally Posted by Leo
    I could come to Norway for a treatment and do family history research.
    Anytime Leo
    Quote Originally Posted by Leo
    Corinne great courage on speaking out and I must say you look hot.
    She was very beautiful indeed (Paolo, keep you’re hands for yourself).
    Last edited by Leif; 10-27-2009 at 12:43 PM.

  2. #22
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    I also happened to speak whit some peoples from ESCIF while there in Florence, and in fact they was also very positive about the upcoming planned clinical trials, they even wanted to make neurobiology and regenerating of SCI as their main topic for the next years ESCIF meeting, which is great. I also spoke to peoples from Denmark while there, they was also positive, also spoke whit a neurosurgeon from the Karolinska Institute in Sweden, she was also positive about what’s going on now. I talked whit many others as well and the general attitude seems very positive.

  3. #23
    Thank you, Leif, for all the kind words describing my talk at ISCOS 2009 in Firenze. It was a unique and auspicious time to have virtually all the heads of major centers for spinal cord injury care and rehabilitation of Europe and the United States congregated in the beautiful city of Florence. In addition, we were very lucky to have Leif and Corinne there. Paolo Cipola (by the way pronounced Chipola) and Patricia Morton, with the generous support of Wings for Life and Vieri Failli, organized a wonderful dinner-meeting and "Open House" for the spinal cord injury community on Thursday, October 22, 2009 that lasted well past midnight.

    I think that it might be useful to describe what was going through my mind when I gave the talk about ISCOS. I must be have been feeling feisty from the previous night's Open House, where I made many "amici del cuore" (friends of the heart... yes, Amiy Graziano is teaching me Italian and I am practicing to impress her), but I was fired up when I went in front of the audience at ISCOS. Sergio Aito (the organizer of the meeting) had assigned me the task of reviewing drug therapy clinical trials for spinal cord injury. I told Paolo not to expect too much because I would be talking about mostly drug therapies. They had assigned the task of speaking about cell transplants to my friend Alain Privat from Montpelier, France. Paolo told me to do it the Italian way, i.e. talk about what you want to talk about.

    Sergio Aito, the head of the top rehabilitation unit in Firenze and organizer of the ISCOS meeting, introduced the speakers. John Steeves from University of British Columbia in Vancouver was the first speaker, I was second, and Alain Privat was third. We were each supposed to talk for 30 minutes. John Steeves gave a talk about spinal cord injury clinical trials, what we must do in order to show that a therapy is eligible for trial, what the trial must do to demonstrate efficacy, and the importance of outcome measures, stratification, and controls.

    Then it was my turn. Let me give a little background first. The day before, I had visited a clinic in Firenze, run by Dr. Arcangeli. This man has been running a private clinic in Firenze since 2001. In fact, when I searched CareCure for his name, I came up with the following from 2002 by Curt Leatherbee topic. In any case, this man has a very intensive rehabilitation program (6 hours a day, five days a week) aimed at exercising people with spinal cord injury. He told me that he got his inspiration from the Russians who had very intensive physical training programs. Around 2005, he hooked up with Carlos Lima and started to do rehabilitation of Italian patients who had gone to Lisbon. Arcangeli was shunned by many rehabilitation groups in Italy.

    Buoyed by the very strong emotions from families and people with spinal cord injury that I felt at the Open House in the Hotel Grand Adriatico on the evening of October 22, the memory that many of the families told me that European doctors are pessimistic that anything could help them, and previous day being told that Dr. Arcangeli was being shunned by other rehabilitation doctors, I decided to come out of my corner in the boxing ring swinging as hard as I can. Because my assignment was to talk about drug therapies of spinal cord injury, I focused on methylprednisolone, since that was the first drug to be shown to have beneficial effects on spinal cord injury and I was involved with those trials.

    The National Acute Spinal Cord Injury Study (NASCIS) were three double-blind randomized multicenter trials, involving over 1300 patients studied at 14 of the leading spinal cord injury centers in the United States, funded by the National Institutes of Health and published in the New England Journal of Medicine, the Journal of the American Medical Association, and the Journal of Neurosurgery. I pointed out that the detractors of methylprednisolone are wrong when they claimed that the trials engaged in "post-hoc analyses" when we stratified the treatment groups by the time of treatment and severity of injury. If people think that we got the trials funded three times by NIH and published in the best journals in the field using post-hoc analyses, they are mistaken.

    More important, if people truly believed that methylprednisolone was ineffective, it would be the ideal control against which to compare a new treatment against. This year is the 30th anniversary (1979) of when I did the animal experiments showing that very high-dose methyprednisolone is effective for acute spinal cord. I said that I would be very happy (I should have used the word ecstatic) if anybody had shown a treatment that is better than methylprednisolone. It is a shame that in 30 years, we have not come out with a better treatment than methylprednisolone for acute spinal cord injury. This reflects the paucity of clinical trials and failure of our field.

    Alain Privat did come up privately to me after the talk to point out that I did not mention his trial (that was carried out in France) of Gacylidine, a trial which did not show beneificial effects on spinal cord injury. I apologized profusely to Alain for not mentioning that study. It was a randomized placebo-controlled trial. Because a majority of emergency rooms in France are not using methylprednisolone, they were able to carry out this trial against a placebo control. Alain said that they were fortunate in France to be doing such a study without methylprednisolone. While I believe that Alain is a very good scientist and cares for people with spinal cord injury, I disagree with his opinion. If doctors chose to use placebo rather than methylprednisolone because they thought methylprednisolone is effective, then this would be unethical deprivation of people of a possibly effective drug. If the trial had shown that gacyclidine was more effective than methylprednisolone, I would have gladly congratulated Alain Privat and embraced the drug for acute spinal cord injury.

    During the talk, I emphasized that we need more clinical trials to provide evidence that of safety and efficacy of therapies for spinal cord injury. I did not say what was on the tip of my tongue, that doctors who rely on unsubstantiated and non-evidence based dogmas concerning spinal cord injury are as bad as the doctors who are treating patients with treatments that have not been tested in formal controlled clinical trial, such as Hongyun Huang and Geeta Shroff. But, I think that the message got across. The attacks on methylprednisolone over the past decade have not been based on evidence. Almost all the arguments against methylprednisolone had been based on retrospective, non-randomized, and inadequately powered studies. If we are to achieve progress in the field, we need to do the clinical trials.

    I went ahead to talk about other various drug trials that had been carried out and then described our own trials of lithium, a drug that has long been used to treat manic depression but has been reported by several independent groups to stimulate regeneration in the spinal cords of animals. I summarized the published data regarding lithium, how it stimulates umbilical cord blood mononuclear cells to proliferate and produce growth factors, and how the ChinaSCINet and the SCINetUSA will be testing umbilical cord blood and lithium combination treatments in clinical trials in China and the U.S. I pointed out that a negative result would be as important as a positive result, that many people around the world are giving umbilical cord blood to people without evidence.

    I showed a few pictures of American doctors visiting China, described the trials, and summarized what we hoped to achieve with the trials. I ended the talk with a pictures of the ChinaSCINet investigators and a picture of John Ditunno, Suzanne Poon, Li Jianjun, and myself in Beijing, pointing out that the monies for the trials in China were raised by the Hong Kong SCI Fund headed by Suzanne and that many people, including John Ditunno and Li Jian Jun, participated in the training of the doctors in China to do the trials.

    In my opinion, I overdid it. Nobody likes to be accused of being pessimistic or unscientific. I did both to doctors in the audience. I am sure that many people probably resented what I said and I apologize to them. Doctors are entitled to their opinion and their skepticism about clinical trial results. I do not, for a minute, think that doctors must accept the results of clinical trials. On the other hand, I do believe that they must come up with data before they can say that the therapy should not be used. Evidence-based medicine requires evidence. If they want evidence, the best would be a clinical trial that shows that another therapy is better than methylprednisolone in a straight randomized comparison. The fact that such evidence is not available is saddening but I should not bash people over the head over this.

    On the other hand, a number of people came up to me afterwards, wanting to be part of the ChinaSCINet and SCINetUSA trials. In particular, a pediatric surgeon from Rome thought this was a trial that his hospital, a Catholic hospital, would be glad to support. As Leif described, Norway is very interested in participating. I spoke to people at Stanford and the Karolinska and will be sending them material about the clinical trial. But, most important of all, our own Corrinne spoke up at the end of the questions and answers period. She gave an impassioned speech about how the meeting must including more spinal cord injury research and therapies aimed at restoring function to people. I think that she had a huge impression on the group and I believe that this group should go to the next ISCOS meeting in Delhi, India and keep everybody eyes on the goal and that is improving the lives of people with spinal cord injury.

    Sorry for this long rambling post.

    Wise.
    Last edited by Wise Young; 10-27-2009 at 06:39 PM.

  4. #24
    Senior Member Kratos's Avatar
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    your long posts is what keeps me alive dr.Young.
    http://www.facebook.com/ivicamaotze.rod

  5. #25
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    Again, great talk Wise.
    Quote Originally Posted by Wise Young View Post
    I spoke to people at Stanford and the Karolinska and will be sending them material about the clinical trial.
    Ahh, Stanford and Karolinska, this is very good if this is the same person I’m thinking of (Spinalis?). If so, I also had a good talk to this person from Sweden at the gala dinner on Friday, told him about Norway now also wanted to participate in these trials. Hope the Swedes also could be in, -it would have been super great if Karolinska would be interested.

  6. #26
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    Quote Originally Posted by Leif View Post
    Hi Joe,
    As for you’re questions here I wouldn’t know much and I don’t think I am the right person to answer you’re questions. Wise might if he see you’re questions. All I can say is that the different professionals working on SCI recovery over here are very positive and want to collaborate; meetings has already been held to disuses plans, legal and funding issues etc. I think if I recall correctly that the SCINetUSA will issue approval papers to the US FDA in 2010, thus the professionals over here as well want to start the necessary processes as soon as possible for this clinical trial multi-center study.
    Thank you, Leif. I suspect no dates have not been named so far. By the way, choosing the Karolinska Institute wouldn't be to the detriment of the cause...

    I spoke to people at Stanford and the Karolinska and will be sending them material about the clinical trial.
    Wise, it seems that you are about to establish something like a "EuropeSCINet" around here...

  7. #27
    Congrats on an excellent meeting!

    SCINetITA/SCINetEU/SCINetNOR sound great

  8. #28
    Quote Originally Posted by Leif View Post
    Again, great talk Wise.
    Ahh, Stanford and Karolinska, this is very good if this is the same person I’m thinking of (Spinalis?). If so, I also had a good talk to this person from Sweden at the gala dinner on Friday, told him about Norway now also wanted to participate in these trials. Hope the Swedes also could be in, -it would have been super great if Karolinska would be interested.
    You got a hold on any danes? - I'd looove to help out

  9. #29
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    Quote Originally Posted by Jim View Post
    Congrats on an excellent meeting!

    SCINetITA/SCINetEU/SCINetNOR sound great
    Great Jim, but how about this…

    How about SCINetWorld, to make it a l’ill simple, I mean.

    And hey! Maybe those Abba songs posted of mine previously wouldn’t be too silly, now, if Karolinska would join… hmmm?

    Funding should not be an issue… There’s always a plan by anything…



    Money, we fix, minor.

  10. #30
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    Quote Originally Posted by topperf View Post
    You got a hold on any danes? - I'd looove to help out
    Info sendt.

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