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Thread: I want combo trials, and now!!

  1. #191
    Quote Originally Posted by paolocipolla View Post
    All we need is a therepy that provide functional return in people with chronic SCI (basicly complete a phase II with success).
    We have to focus on the way to make that happen asap. Then evrithing will happen without the need to fight anymore.

    SCINetUSA is a great option, but it seems to me people don't belive in it enough to make it work soon enough, so I wonder if there is enother option to start from.

    Norway? Leif, Norway or Noway??

    Paolo
    Paolo,

    There is enthusiastic support of SCINetUSA in many states. For example, I recently came back from a fundraiser held in Austin (TX) by the Lone Star Foundation. The excitement and the interest in getting clinical trials going is not only palpable but manifested by significant donations that will support the trial at Brackenridge.

    I have only recently begun to realize that the pessimism and even nihilism expressed by some CareCure members on the Cure Forum are not representative of the spinal cord injury community in the United States. On the other hand, we are facing something that is even more difficult to overcome, i.e. skepticism.

    Many people, particularly those who have been injured for a long time, have seen many potential "cures" come and go. Many have put their hope into certain procedures, only to be disappointed. I don't blame people, particularly those who have gone and paid for unproven therapies, for hesitating to involve themselves again.

    Most people initially think that I am just pushing for umbilical cord blood cell transplants and lithium. They are accustomed to other doctors or scientists advocating a particular therapy. When they realize that I am not advocating a particular therapy but rather I am pushing for a systematic clinical trial approach to ascertaining whether a therapy works or does not work, they are not sure that they want to donate.

    People want therapies but they don't believe in the clinical trial approach. After all, if something works, then all the proof that one needs is to put it into somebody and see whether or not it works. Why does one have to do randomized clinical trials? Some of my best friends and supporters have asked me that question in earnest.

    We all know people who have recovered this or that function even long time after injury. I can take any treatment and apply it to a population of chronic spinal injured people and find some of them, even as many as half of them, recover some function and reporting that they have benefitted from the therapy. If a therapy works, it must get more improvement of function than a placebo control.

    To obtain convincing data that the therapy being tested actually works, we have to do double-blind randomized controlled trials where neither the doctors nor subjects know which therapy they are receiving. The therapy must be standardized and extensively tested for safety. The doctors must be trained to assess the subjects in the same way.

    There is the problem of money and advocacy of the therapy. No matter how pure the doctors' motives, taking money for unproven treatments corrupts. Even though the doctors may believe that they are objective, they cannot be objective when their operations and institution depends on the income from the unproven therapy.

    This is particularly true when the so-called trials are not blinded. Doctors are not objective when they have invested substantial time and their careers into a therapy. They often see improvements where there may be none. Believe me, I have seen this in my students and fellows. They want so badly for the rats to walk that I insist that studies in my laboratory be double-blinded.

    Neither the doctor nor the subject can be objective about the therapy. That is why double-blinding (of both the doctor and subject) is necessary. Also, people running the clinical trials must work very hard to keep distance between themselves and the therapies being tested, to avoid any potential conflict of interest, and to not oversell the therapies.

    Many people here who have known me for a long time can probably see the struggles that I am having not to slip into an advocacy mode concerning the umbilical cord blood and lithium therapy. As the head of clinical trials testing these therapies, I must refrain from too much enthusiasm and always present a balanced picture.

    Likewise, I am very careful to avoid all conflicts of interest concerning the therapy that the clinical trials are testing. I do not receive any payment from companies providing therapies for the trials. For example, I do not get consulting fees or any other compensation and own no stock in Stemcyte, the company that is providing the umbilical cord blood cells for our trial. Whether the trial succeeds or fails, I will not be financially enriched or impoverished.

    We have also been careful to segregate fundraising from the clinical trials. For example, the fundraising arm (HKSCIFund) is separated from the actual running of the clinical trials in ChinaSCINet. This way, there would not be undue influence from donors. We of course listen to the donors and try to implement what they want but there is no quid pro quo.

    Finally, I want to comment that while things may seem to be moving slowly in ChinaSCINet, they are actually moving much faster than industry trials and especially considering our small budget. We are recruiting subjects for the phase 2 trials in Hong Kong and I hope that we will have 20 subjects soon. In the meantime, we are working very hard optimizing the shipping and testing of the cells. We are also awaiting for word from the Chinese government for permission to start the trial in Kunming. I hope that we will receive such permission in May. There is no problem with shortage of subjects in China. In the meantime, I am heading to Norway at the end of May to discuss the possibility of clinical trials there but I must emphasize that Norway may want to test their own therapies and not become a mirror of ChinaSCINet or SCINetUSA. I would do everything that I can to help them.

    Wise.

  2. #192
    Senior Member
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    Quote Originally Posted by Wise Young View Post
    Paolo,

    There is enthusiastic support of SCINetUSA in many states. For example, I recently came back from a fundraiser held in Austin (TX) by the Lone Star Foundation. The excitement and the interest in getting clinical trials going is not only palpable but manifested by significant donations that will support the trial at Brackenridge.

    I have only recently begun to realize that the pessimism and even nihilism expressed by some CareCure members on the Cure Forum are not representative of the spinal cord injury community in the United States. On the other hand, we are facing something that is even more difficult to overcome, i.e. skepticism.

    Many people, particularly those who have been injured for a long time, have seen many potential "cures" come and go. Many have put their hope into certain procedures, only to be disappointed. I don't blame people, particularly those who have gone and paid for unproven therapies, for hesitating to involve themselves again.

    Most people initially think that I am just pushing for umbilical cord blood cell transplants and lithium. They are accustomed to other doctors or scientists advocating a particular therapy. When they realize that I am not advocating a particular therapy but rather I am pushing for a systematic clinical trial approach to ascertaining whether a therapy works or does not work, they are not sure that they want to donate.

    People want therapies but they don't believe in the clinical trial approach. After all, if something works, then all the proof that one needs is to put it into somebody and see whether or not it works. Why does one have to do randomized clinical trials? Some of my best friends and supporters have asked me that question in earnest.

    We all know people who have recovered this or that function even long time after injury. I can take any treatment and apply it to a population of chronic spinal injured people and find some of them, even as many as half of them, recover some function and reporting that they have benefitted from the therapy. If a therapy works, it must get more improvement of function than a placebo control.

    To obtain convincing data that the therapy being tested actually works, we have to do double-blind randomized controlled trials where neither the doctors nor subjects know which therapy they are receiving. The therapy must be standardized and extensively tested for safety. The doctors must be trained to assess the subjects in the same way.

    There is the problem of money and advocacy of the therapy. No matter how pure the doctors' motives, taking money for unproven treatments corrupts. Even though the doctors may believe that they are objective, they cannot be objective when their operations and institution depends on the income from the unproven therapy.

    This is particularly true when the so-called trials are not blinded. Doctors are not objective when they have invested substantial time and their careers into a therapy. They often see improvements where there may be none. Believe me, I have seen this in my students and fellows. They want so badly for the rats to walk that I insist that studies in my laboratory be double-blinded.

    Neither the doctor nor the subject can be objective about the therapy. That is why double-blinding (of both the doctor and subject) is necessary. Also, people running the clinical trials must work very hard to keep distance between themselves and the therapies being tested, to avoid any potential conflict of interest, and to not oversell the therapies.

    Many people here who have known me for a long time can probably see the struggles that I am having not to slip into an advocacy mode concerning the umbilical cord blood and lithium therapy. As the head of clinical trials testing these therapies, I must refrain from too much enthusiasm and always present a balanced picture.

    Likewise, I am very careful to avoid all conflicts of interest concerning the therapy that the clinical trials are testing. I do not receive any payment from companies providing therapies for the trials. For example, I do not get consulting fees or any other compensation and own no stock in Stemcyte, the company that is providing the umbilical cord blood cells for our trial. Whether the trial succeeds or fails, I will not be financially enriched or impoverished.

    We have also been careful to segregate fundraising from the clinical trials. For example, the fundraising arm (HKSCIFund) is separated from the actual running of the clinical trials in ChinaSCINet. This way, there would not be undue influence from donors. We of course listen to the donors and try to implement what they want but there is no quid pro quo.

    Finally, I want to comment that while things may seem to be moving slowly in ChinaSCINet, they are actually moving much faster than industry trials and especially considering our small budget. We are recruiting subjects for the phase 2 trials in Hong Kong and I hope that we will have 20 subjects soon. In the meantime, we are working very hard optimizing the shipping and testing of the cells. We are also awaiting for word from the Chinese government for permission to start the trial in Kunming. I hope that we will receive such permission in May. There is no problem with shortage of subjects in China. In the meantime, I am heading to Norway at the end of May to discuss the possibility of clinical trials there but I must emphasize that Norway may want to test their own therapies and not become a mirror of ChinaSCINet or SCINetUSA. I would do everything that I can to help them.

    Wise.
    Are there any more members who think the CC membership should try to find common ground and do something to promote a cure?

  3. #193
    Quote Originally Posted by rdf View Post
    Thanks for filling out your profile. What I have bolded in your quote is so very true. There are over 36K CC members, and one would think to gather just a small percentage together to act wouldn't be difficult. But it seems to be very difficult.
    I agree. Raising a half million really isn't that difficult, people just need to feel compelled and motivated. I posted an example here. If only half our membership made a one time donation of 25.00, we will have raised 450,000.00.

    Perhaps a mandatory, one time membership fee could be considered.

  4. #194
    Quote Originally Posted by swh2007 View Post
    Are there any more members who think the CC membership should try to find common ground and do something to promote a cure?
    I do and I have since Spinewire days. This lather gets whipped up every few years. Sometimes something comes of it, usually not, though.

    I donate $ because I can.

  5. #195
    Senior Member lynnifer's Avatar
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    Windsor ON Canada
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    Quote Originally Posted by swh2007 View Post
    Are there any more members who think the CC membership should try to find common ground and do something to promote a cure?
    I would like to see something global.

    It seems we have so many researchers, resources in Canada, the US, Australia, UK and other places ... it would be nice if they could collaborate.

    That won't happen though. Wouldn't want my call centre to 'collaborate' with another so some of us lose our jobs. The conundrum then.
    I think over again my small adventures,
    My fears,
    Those small ones that seemed so big,
    For all the vital things
    I had to get and to reach;
    And yet there is only one great thing,
    The only thing,
    To live to see the great day that dawns
    And the light that fills the world.

    Anonymous (Inuit, 19th century)


    T-11 Flaccid Paraplegic due to TM July 1985 @ age 12

  6. #196
    Perhaps a mandatory, one time membership fee could be considered.[/QUOTE]

    Very good idea.

  7. #197
    Senior Member Leo's Avatar
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    Location
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    In poker terms, I've been all in for a while and will remain all in.

    The SCINetUSA will establish the infrastructure for trying many types of waiting treatments.

    number one priority imo

    we need to build the enthusiasm for it
    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."

  8. #198
    Senior Member rdf's Avatar
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    I don't think it'd work. The membership would probably drop dramatically.

    Maybe have a 'paid member' option, for extra content vs. normal member. Without becoming a paid member, you can't access the Cure and Member forums. Just an idea.
    Quote Originally Posted by antiquity
    Perhaps a mandatory, one time membership fee could be considered.
    Quote Originally Posted by kivi66
    Very good idea.
    Please donate a dollar a day at http://justadollarplease.org.
    Copy and paste this message to the bottom of your signature.

    Thanks!

  9. #199
    Senior Member
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    Norway
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    I do not care 'bouth amateurs, but I tell ya, I can fix things.

    If some nead funding for efforts for cure efforts, I will fix.

    If the US and Europe is in, I can guarante money for all efforts!

    No problems.
    Last edited by Leif; 05-01-2010 at 08:20 PM.

  10. #200
    Senior Member
    Join Date
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    Norway
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    Quote Originally Posted by lynnifer View Post
    I would like to see something global.

    It seems we have so many researchers, resources in Canada, the US, Australia, UK and other places ... it would be nice if they could collaborate.

    That won't happen though. Wouldn't want my call centre to 'collaborate' with another so some of us lose our jobs. The conundrum then.
    Global, do then.

    cc neads to put cure ppl first! Not lazy butt moderators.

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