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ISCoS Meeting 2009 - Florence

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    #31
    Originally posted by topperf View Post
    You got a hold on any danes? - I'd looove to help out
    Friend. Have the Danish National Rigshospitalet with the two great SCI units in Denmark, in on this.

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      #32
      Originally posted by Leif View Post
      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.
      I had a few e-mails exchange with people in the ESCIF board last january. I asked them why they do not have sci research in their priorities etc. I was told they would have kept in consideration what I said.

      I can't belive it yet, but it seams things can change, we just need to keep pressure in the right direction
      In God we trust; all others bring data. - Edwards Deming

      Comment


        #33
        Originally posted by Wise Young View Post
        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.
        Wise,

        I am convinced that you couldn't do any better than you did.

        Of course when you speak to a non homogeneous audience you can’t use words that fits perfectly for every single person. So the compromise you look for is to use the language that gets the best outcome you can ask for – for the given situation. I think that a moderate aggressiveness sometimes was needed to be effective. Then the intervention of Corinne I think made many people understand why you have been so passionate i.e. you reflected what people with SCI feel and ask for.

        Thank You!!

        Paolo
        In God we trust; all others bring data. - Edwards Deming

        Comment


          #34
          Here is Corinne intervention, we were able to get to speak when the chair Dr. Sergio Aito started to say the session was over, I said no and Corinne started to talk


          http://www.youtube.com/watch?v=Gn20n4beIGo
          Last edited by paolocipolla; 29 Oct 2009, 1:34 PM. Reason: Change the link
          In God we trust; all others bring data. - Edwards Deming

          Comment


            #35
            Originally posted by Leif View Post
            This is a picture from Munich to Florence. It shows heavy peaks and a lot of trouble as the tectonic geological formations shows here in the picture. It is the Alps off course, shown by a view from an airplane I was in. Difficult to cross one might ask? Well, imagine how difficult the crossing must have been just some short human historical time ago. The east-west Alps as for crossing the north south or vice versa was always a huge task for humans, in fact also in a short perspective of time. So, what did humans do, regardless their objectives, they found ways trough this barrier in communication breach, they said a few rocks will not hamper us, they said screw the Alps screwing. Then they moved on, and today we even have machines flying over it while enjoying services from nice peoples in planes or having a short half an hour nap and then we are where we want to be at our destination...? Spinal cord injurie research could be compared to this, the task might seam huge, but if we all push we might soon find our valley trough the obstacles of our Alps. I personally believe in this. Wise and others too. Dr. Wise and others has flown over the Alps.

            This is a great pecture Leif, wow! Thanks for sharing the pictures with us, and keep ip the good work. cure is coming!

            your friend,manouli

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              #36
              Originally posted by paolocipolla View Post
              I can't belive it yet, but it seams things can change, we just need to keep pressure in the right direction
              It is Ok'eied.

              Comment


                #37
                Originally posted by paolocipolla View Post
                Here is Corinne intervention, we were able to get to speak when the chair Dr. Sergio Aito started to say the session was over, I said no and Corinne started to talk

                http://www.youtube.com/watch?v=e3xyebKs2o0

                Like always Paolo, but Sergio Aito and all can go to bed if they don't follow on this, regardless...

                Comment


                  #38
                  Originally posted by paolocipolla View Post
                  Here is Corinne intervention, we were able to get to speak when the chair Dr. Sergio Aito started to say the session was over, I said no and Corinne started to talk

                  http://www.youtube.com/watch?v=e3xyebKs2o0
                  I cried now. And that happens very seldom. Thanks all.

                  Comment


                    #39
                    Originally posted by Leif View Post
                    I cried now. And that happens very seldom. Thanks all.
                    I have to admit that I almost did a few times too, but I remainded to myself that a man like me sholud never cry just in time to keep my tears
                    In God we trust; all others bring data. - Edwards Deming

                    Comment


                      #40
                      Agree, we are very strong, any could test us. I posted on facebook the link you gave because it was so special. Paolo buddy, me and you help Corinne for all. We don't easely back up/off.

                      Comment


                        #41
                        Hey Guys,

                        they pulled the video or that's what message i got?
                        http://justadollarplease.org/

                        2010 SCINet Clinical Trial Support Squad Member

                        "You kids and your cures, why back when I was injured they gave us a wheelchair and that's the way it was and we liked it!" Grumpy Old Man

                        .."i used to be able to goof around so much because i knew Superman had my back. now all i've got is his example -- and that's gonna have to be enough."

                        Comment


                          #42
                          Here is the video again, sorry I had to work a little on it

                          http://www.youtube.com/watch?v=Gn20n4beIGo
                          In God we trust; all others bring data. - Edwards Deming

                          Comment


                            #43
                            Thanks Paolo,

                            And WOW.......Corinne

                            you rock seems inadequate

                            thank you again
                            http://justadollarplease.org/

                            2010 SCINet Clinical Trial Support Squad Member

                            "You kids and your cures, why back when I was injured they gave us a wheelchair and that's the way it was and we liked it!" Grumpy Old Man

                            .."i used to be able to goof around so much because i knew Superman had my back. now all i've got is his example -- and that's gonna have to be enough."

                            Comment


                              #44
                              Originally posted by Duran View Post
                              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...



                              Wise, it seems that you are about to establish something like a "EuropeSCINet" around here...
                              hi everybody,
                              EuropeSCInET would indeed be fantastic. It will take more than a simple speech to achieve it but work done so far and during the conference by fellow angel Leif (in Angel category, the smoothest of all ;-), Paollo and others is paving the way! it's fantastic that Wise Young clearly said that it was necessary to switch to action. Obviously we all need to take care and get the scientific and professional community with us.
                              Also, a European (EU or Europe at large) fund might not be a bad idea? so far the only body existing on european level is a spinalcordinjury federation or something like that, whose main focus seems to be again the ''pipi - caca - bobo - crac/crac''. NB: this is a patterned concept I invented in Florence. must admit French people will be at an advantage to understand this unique and smart concept. if you need a translation, pls let me know ;-) although it will not lead you much further on the way to recovery!!
                              Seriously, we do also need to check how to get support and funding from the EU itself. As discussed with Paollo, living not too far from Brussel, i would not mind playing a role in that.
                              www.endparalysis.org!

                              Comment


                                #45
                                paolocipolla

                                Originally posted by paolocipolla View Post
                                Here is the video again, sorry I had to work a little on it

                                http://www.youtube.com/watch?v=Gn20n4beIGo
                                paolocipoll

                                the problem i found with the youtube video was when the lady spoke i did not hard the reply can you or any one else past on a youtube video of what the doctors has to say
                                AS I SIT HERE IN MY CHAIR . I LOOK OUT UPON THE GROUND .I WONDER WILL I EVER GET UP AND WALK A ROUND ??


                                http://justadollarplease.org

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