Announcement

Collapse
No announcement yet.

ChinaSCINet Update

Collapse
This is a sticky topic.
X
X
 
  • Filter
  • Time
  • Show
Clear All
new posts

    Originally posted by Wise Young View Post
    As I said, I have not yet decided. Wise.
    Couldn't releasing or not releasing information impact the ability of you or others to raise funds for the trials?

    Comment


      Originally posted by ay2012 View Post
      Was your mind changed because of the backlash/questioning that came when you provided the last personal observations? The fact that you keep us in the loop and the access you give of yourself to our questions and concerns is, as you note, not common....but its also a reason, among others, why so many throw our support behind your work.
      ay2012, I simply have not decided.

      Let me review what happened. I had earlier provided general comments about the results when I announced that we will go ahead to do Phase III trials because our phase I/II trials indicate that the therapy is safe and some patients have shown improved locomotor function. This was greeted with great interest by many people and disbelief by some people, who went as far as to suggest that I am providing confusing information in order to raise more money for the trials.

      Last month, I was giving a talk to other scientists in the New Bedford workshop about the obstacles and lessons we have learned from clinical trials. I pointed out two interesting findings in our trial, i.e. that we are seeing white matter regrowth in some patients and that improved locomotor function can occur without significant changes in motor and sensory scores. This led to a spirited discussion that I hope helped the community understand some of the mechanisms of recovery from regeneration.

      I have stated many times that I will not provide detailed trial data and that people would have to wait until publication for such data. In addition, I also said many times that I did not believe that even the 6-month data would be sufficient to show that umbilical cord blood cell transplants is effective or not. Despite my repeated assertions that it is too early to say anything definitive about efficacy of umbilical cord blood transplants, many people have been jumping to unwarranted conclusions that umbilical cord blood mononuclear cell transplants are not effective.

      Some people have dismissed the therapy because people are not walking at 6-12 weeks. So, clearly, releasing the 6-month data can lead to misconceptions by the community. At the present, I am unsure that the benefits of releasing the 6-month data are sufficient to counter the misconceptions.

      Lyerly, are you suggesting that people would stop supporting the trial if the information suggests that the treatment seem to be ineffective at 6 months? Or, if the results seem positive, people would give more money? If so, that would be a terrible shame for the following reasons:
      1. The 6-month outcomes are still too early to say whether the treatment is or is not effective.
      2. "Negative" results are as important as "positive" results.
      3. People should be supporting the trials regardless of the results.



      Wise.
      Last edited by Wise Young; 20 Dec 2012, 7:58 PM.

      Comment


        Lyerly, are you suggesting that people would stop supporting the trial if the information suggests that the treatment seem to be ineffective at 6 months? Or, if the results seem positive, people would give more money? If so, that would be a terrible shame for the following reasons:
        1. The 6-month outcomes are still too early to say whether the treatment is or is not effective.
        2. "Negative" results are as important as "positive" results.
        3. People should be supporting the trials regardless of the results.



        Wise.[/QUOTE]

        I was thinking that positive results would lead to increased donations with possibly positive press. I think it would be easier to gain support for something that is known to potentially have significant and maybe even visible improvement.

        I think it would be easier to convince people to donate to something they have expectations for as opposed to just donating to research in general.

        Comment


          Lyerly,

          In my opinion, people should support clinical trials. Their support should not depend on whether the trials are trending positive or negative. They should not be fair-weather friends who support trials only when they think that it is showing positive results and drop their support when the trials are not showing positive results. Negative results are important also.

          Lest somebody think that I am suggesting that our trial results are negative, let me say that I am sufficiently optimistic that the trials will show positive results to have committed to doing a phase III trial in 2013. By the way, if anybody thinks that I am willing to spend the next several years working my butt off and raising millions of dollars to do clinical trials on a therapy that I don't believe will work, they are absolutely wrong.

          I am undecided about whether and how to present the 6-month data on CareCure. For example, if I say that patients are walking, people will demand that I present videos. If I showed videos of walking patients, I will likely be severely criticized for presenting anecdotal data to raise money for the trials, which would be true. If I presented the detailed data and the analyses, it may jeopardize publication of the data in a good journal. It is not an easy decision.

          Wise.


          Originally posted by Lyerly View Post
          Originally posted by Wise Young
          Lyerly, are you suggesting that people would stop supporting the trial if the information suggests that the treatment seem to be ineffective at 6 months? Or, if the results seem positive, people would give more money? If so, that would be a terrible shame for the following reasons:
          1. The 6-month outcomes are still too early to say whether the treatment is or is not effective.
          2. "Negative" results are as important as "positive" results.
          3. People should be supporting the trials regardless of the results.

          Wise.
          I was thinking that positive results would lead to increased donations with possibly positive press. I think it would be easier to gain support for something that is known to potentially have significant and maybe even visible improvement.

          I think it would be easier to convince people to donate to something they have expectations for as opposed to just donating to research in general.
          Last edited by Wise Young; 20 Dec 2012, 9:55 PM.

          Comment


            Wise:
            Please hold on to the data and keep it from this site. Publication is much too important to worry about what some on this forum will think or wonder. That is all that they have is time to wait for the publication. If you detail that info here you will be bombarded with question and what if's that will take your time away from the goal.

            Comment


              Seems like a no-brainer. You need millions in funding which would be much more contingent on a well received article in a peer-reviewed journal than presenting any form of the results to people who either see your dedication and will support you regardless of if you present the data or people who for some reason have a personal grudge against you and will find fault with whatever you post.

              As a researcher you are in a very unusual position in that you have a large website related to your work. if people can google and see even partial results of your trials they may see no point in publishing them in their journal.

              Originally posted by Wise Young View Post
              Lyerly,

              In my opinion, people should support clinical trials. Their support should not depend on whether the trials are trending positive or negative. They should not be fair-weather friends who support trials only when they think that it is showing positive results and drop their support when the trials are not showing positive results. Negative results are important also.

              Lest somebody think that I am suggesting that our trial results are negative, let me say that I am sufficiently optimistic that the trials will show positive results to have committed to doing a phase III trial in 2013. By the way, if anybody thinks that I am willing to spend the next several years working my butt off and raising millions of dollars to do clinical trials on a therapy that I don't believe will work, they are absolutely wrong.

              I am undecided about whether and how to present the 6-month data on CareCure. For example, if I say that patients are walking, people will demand that I present videos. If I showed videos of walking patients, I will likely be severely criticized for presenting anecdotal data to raise money for the trials, which would be true. If I presented the detailed data and the analyses, it may jeopardize publication of the data in a good journal. It is not an easy decision.

              Wise.

              Comment


                I know that if I was raising money for something that has a good chance that will benefit me or even a proven or documented chance that it would be easier. It gives the donor something to see that there investment lead towards and would make them more comfortable and generous knowing the chances of improvement are high as opposed to just giving in general.

                Originally posted by Wise Young View Post
                Lyerly,

                In my opinion, people should support clinical trials. Their support should not depend on whether the trials are trending positive or negative. They should not be fair-weather friends who support trials only when they think that it is showing positive results and drop their support when the trials are not showing positive results. Negative results are important also.

                Lest somebody think that I am suggesting that our trial results are negative, let me say that I am sufficiently optimistic that the trials will show positive results to have committed to doing a phase III trial in 2013. By the way, if anybody thinks that I am willing to spend the next several years working my butt off and raising millions of dollars to do clinical trials on a therapy that I don't believe will work, they are absolutely wrong.

                I am undecided about whether and how to present the 6-month data on CareCure. For example, if I say that patients are walking, people will demand that I present videos. If I showed videos of walking patients, I will likely be severely criticized for presenting anecdotal data to raise money for the trials, which would be true. If I presented the detailed data and the analyses, it may jeopardize publication of the data in a good journal. It is not an easy decision.

                Wise.

                Comment


                  While people should support clinical trials in general, good results or bad, this is probably an idealistic viewpoint relative to how people react. Then, the question becomes, where will the majority of the funding come from moving forward? If from outside institutions, agencies, corporations (as I would assume) then, as some above have suggested, if telling us anything jeopardizes the chances of publishing, forget about us. If the risk is not too much, and a lot of the funding will end up coming from Justadollarplease then perhaps it's beneficial to keep the community engaged with updated information. Sorry, but I'm an economist by trade and we always look at incentives!

                  Comment


                    I think the issue here is that Wise is trying to help us out by keeping us informed of the trial's progress, not for the purpose of soliciting funding as some suggest, but because he understands the position we're in, how it helps us get by each day knowing that we're a step (or push) closer. But some on this site, who are not from the medical profession (and obviously don't understand the protocols and procedures of scientific reporting), feel that it's their role to peer reveiw his work and question his integrity for the sake of self gratification, rather than ask geniune questions to improve our understanding, and this does nothing but waste his time (and our's as we have to plough through all of the rubbish lately to find the real info). I totaly understand where Wise is coming from regarding this. As a sceintist I would do the same if I was in a similar position with my work.

                    Clayton
                    Last edited by Geoman; 21 Dec 2012, 5:15 AM. Reason: forgot to sign my name!
                    "Wheelie Wanna Walk!"

                    Comment


                      Definitely agree with the above and would like to point out that I'm not suggesting that Wise is reporting or not reporting for funds; he's explicitly stated that he is not doing this and feels uneasy at the prospect. I was just pointing out that, regardless of how he feels, people in the community are likely to react by supporting a "front-runner". Although this isn't how science truly works, in the absence of understanding everything in these trials and in the subsequent papers people will likely feel that those with the "best" results are doing the "best" work. It's the publication bias and it's present in all fields....

                      Comment


                        Originally posted by ay2012 View Post
                        Definitely agree with the above and would like to point out that I'm not suggesting that Wise is reporting or not reporting for funds; he's explicitly stated that he is not doing this and feels uneasy at the prospect. I was just pointing out that, regardless of how he feels, people in the community are likely to react by supporting a "front-runner". Although this isn't how science truly works, in the absence of understanding everything in these trials and in the subsequent papers people will likely feel that those with the "best" results are doing the "best" work. It's the publication bias and it's present in all fields....
                        Agreed.
                        "Wheelie Wanna Walk!"

                        Comment


                          Originally posted by Geoman View Post
                          I think the issue here is that Wise is trying to help us out by keeping us informed of the trial's progress, not for the purpose of soliciting funding as some suggest, but because he understands the position we're in, how it helps us get by each day knowing that we're a step (or push) closer. But some on this site, who are not from the medical profession (and obviously don't understand the protocols and procedures of scientific reporting), feel that it's their role to peer reveiw his work and question his integrity for the sake of self gratification, rather than ask geniune questions to improve our understanding, and this does nothing but waste his time (and our's as we have to plough through all of the rubbish lately to find the real info). I totaly understand where Wise is coming from regarding this. As a sceintist I would do the same if I was in a similar position with my work.

                          Clayton
                          I totally agree with the above. Had a feeling that these wanabees and so called BS meters were going to ruin things for us.
                          "Talk without the support of action means nothing..."
                          ― DaShanne Stokes

                          ***Unite(D) to Fight Paralyses***

                          Comment


                            Two important quotes from Wise are reproduced below.

                            “Last month, I was giving a talk to other scientists in the New Bedford workshop about the obstacles and lessons we have learned from clinical trials. I pointed out two interesting findings in our trial, i.e. that we are seeing white matter regrowth in some patients and that improved locomotor function can occur without significant changes in motor and sensory scores. This led to a spirited discussion that I hope helped the community understand some of the mechanisms of recovery from regeneration”.

                            “What I believe we are seeing in our trial now is regeneration. Long fiber tracts are regrowing long distances in the spinal cords and they appear to be making some synaptic connections with distal motor structures at 6-18 months after umbilical cord blood transplants. At least in initial stages, subjects are showing improved walking without much change in motor and sensory scores.”

                            These purported findings, especially the report of long distance regeneration (and now with evidence of synaptic connections) in a chronically injured human, could be extremely important to the spinal cord injury field. It is also important to point out that when one makes extremely bold statements about ones research or clinical trial findings at a conference (ie., the New Bedford Workshop) that is being widely disseminated via the web, that the information is now in the public domain and is deserving, indeed, crying out for answers to critical questions. I’ve watched the New Bedford video twice and I have lots of questions that I wish had been asked by those in your audience. I also believe that public disclosure of scientific findings here at Care Cure should be subject to the same level of scrutiny. I think both Paolo and I share this viewpoint, not because we wish to assault anybody, but because we are passionate about getting to the truth about what may or may not be a viable strategy to improve the lives of people with chronic SCI.

                            Because of the unprecedented nature of Wise’s claims, I’d really like him to present what he believes to be the solid and convincing evidence that functional regeneration has occurred in his patients.

                            Here are just a few of the myriad of questions:

                            What is your evidence in vitro that umbilical cord cells are preferred surfaces for axonal regeneration? I have not seen this presented. If they are not good surfaces for growth in vitro how can they form a growth bridge in vivo?

                            When axons truly regenerate in animal models they always take meandering trajectories. Indeed, this characteristic is a hallmark of acceptable evidence for regeneration. Yet, in your presentation you suggest that axon regeneration in humans occurs in tight, rectilinear bundles. Why would the human be different than all other animal species?

                            You state that you see “white matter regrowth”. I have never heard of regeneration being described this way before. As stated above, axons always wander around as they regenerate and they completely lack myelin. Indeed, lack of myelin is another hallmark of true regeneration. Are you also suggesting that regenerating axons in your patients become re-myelinated? What is your evidence for this?

                            You mention in your presentation that you saw no correlation between patients with purported regeneration and functional recovery. Yet you now suggest that you see evidence for synaptic reformation and imply that such recovery is correlated with regeneration. Could you explain the change in interpretation? Could you present your evidence that new synapses have formed? It seems impossible to conclude this solely from DTI data.

                            You describe a patient in whom you saw a long “regenerated” bundle of axons that totally degenerated and then remarkably regenerated again. What is your convincing evidence for this spectacularly amazing finding?

                            You mention repeatedly here at Care Cure that regenerating axons in your chronic patients is occurring at 1MM per day and, therefore, is going to take a long time for the axons to reach their targets. What is your evidence that in your patients the axons are continuing to elongate and at a given rate? Also, related to this, why do you suggest that axons have to grow all the way to their motor neuron targets before you might get functional recovery? All of us in the regeneration/SCI field appreciate that in animal models, axons can link up with distant targets via interneuronal connections. Why couldn’t that happen in humans?

                            What is your evidence that the long strands of whatever they might be that pass through and beyond the lesion in your DTI images (those that were not especially visible in your presentation) are truly axonal and not something else? Might it be possible that such strands of tissue were at one time spared bundles of axons that may have degenerated (and had become DTI invisible) but then became intensely gliotic (DTI visible)? I think Dr. Tansey was getting at this with his question. In other words what is your evidence that there are, in fact, viable axons in these newly formed structures if, indeed, they are really newly formed? With only simple snapshots of these bundles at one timepoint and a claim that they were not there at an earlier stage, I suggest that one is hard pressed to conclude the remarkable conclusion that white matter “regrowth” is occurring. I am not an expert on all of the caveats that revolve around DTI imaging but I know they exist and it might be a good thing to discuss this.

                            I think that showing that the distal tip of the bundle continues to elongate weekly would be your most compelling evidence, using DTI only, for ongoing regeneration. It would also surely be nice if you could show convincing long distance regeneration using these same strategies in an animal model of long chronic cord injury. Given that this has never before been shown in an animal model you can surely understand why one might be legitimately skeptical and why your claims are so profound.

                            Comment


                              jsilver and paolo should really change the focus of their questions. On want side you claim what you seek is knowledge, yet when I read your questions all I see is cynicism, meaning you care more about proving that there is not gonna be a cure within our life time than actually leaving anything positive to us.

                              I don't see anything wrong with what Wise have said so far. All the data needed to make an accurate statement is not yet ready. Wise IMO express what seems to be happening and what that could lead to. If it not, understanding why not is gonna help future researches.

                              It had been said before, but all this labeled "doubts" are starting to become annoying for some of us. You may or may not know more than us, but I swear I don't see anything positive with the way some of you rise questions. Actually feels like a POS attitude towards our situation and people on the research field who tries to help

                              Comment


                                To be fair, none of us know enough about the science to determine how fair or unfair Dr. Silver's questions are. Let Dr. Young respond...and it would likely be helpful for a "third-party" scientist to post some comments on these issues, so as to deescalate the emotions, help the community understand, and allow everyone to find some common ground. Good questions should be encouraged.... Unless we're all content to just sit on the sidelines while these things are discussed...

                                Comment

                                Working...
                                X