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    #46
    Originally posted by canuck View Post
    Don't you think the attitude of us chronics that there "is nothing in it for me" is a bit of a kick in the teeth to anybody with a acute injury who happens to read it? Any progress that helps is a win win, it shouldn't be a us vs them.
    Acutes only have to wait two weeks to become chronic.

    Comment


      #47
      just because I am apathetic toward gerons trial doesn't mean that one thinks it is "us v.s them "..... Where do you get that?
      "That's not smog! It's SMUG!! " - randy marsh, southpark

      "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


      2010 SCINet Clinical Trial Support Squad Member
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        #48
        http://reason.com/blog/2011/11/16/wh...d-no-profits-m

        What's So Hard to Understand? - No Profits Means No Medicines
        Ronald Bailey | November 16, 2011
        Yesterday, the biotech company Geron announced that it was halting its stem cell research and stopping its Phase 1 trial in which stem cells were used to treat broken spinal cords. It was a business decision based on the company's evaluation of the commercial prospects of the treatment. One comment particularly struck me in the Washington Post's reporting on the company's announcement:
        “I’m disgusted. It makes me sick,” said Daniel Heumann, who is on the board of the Christopher and Dana Reeve Foundation. “To get people’s hopes up and then do this for financial reasons is despicable. They’re treating us like lab rats.”
        WTF! First, Geron's announcement is a disappointment to be sure, but just how does Mr. Heumann expect a company to continue to operate if it runs out of money? Does he think a bankrupt company will be able to provide treatments? And, of course, the participants in the Phase 1 treatment trial are treated like lab rats because that's what they are. In Phase 1 trials:
        Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
        There's nothing about benefit to the patient in a Phase 1 trial. If a patient happens to benefit, then that's just great. Whatever one might say about government funding of biomedical research, the plain fact is that the National Institutes of Health has never brought a treatment to market. Profit-making companies do that.
        Last edited by GRAMMY; 17 Nov 2011, 3:31 AM.
        http://spinalcordresearchandadvocacy.wordpress.com/

        Comment


          #49
          Originally posted by GRAMMY View Post
          http://reason.com/blog/2011/11/16/wh...d-no-profits-m

          What's So Hard to Understand? - No Profits Means No Medicines
          Ronald Bailey | November 16, 2011
          Yesterday, the biotech company Geron announced that it was halting its stem cell research and stopping its Phase 1 trial in which stem cells were used to treat broken spinal cords. It was a business decision based on the company's evaluation of the commercial prospects of the treatment. One comment particularly struck me in the Washington Post's reporting on the company's announcement:
          “I’m disgusted. It makes me sick,” said Daniel Heumann, who is on the board of the Christopher and Dana Reeve Foundation. “To get people’s hopes up and then do this for financial reasons is despicable. They’re treating us like lab rats.”
          WTF! First, Geron's announcement is a disappointment to be sure, but just how does Mr. Heumann expect a company to continue to operate if it runs out of money? Does he think a bankrupt company will be able to provide treatments? And, of course, the participants in the Phase 1 treatment trial are treated like lab rats because that's what they are. In Phase 1 trials:
          Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
          There's nothing about benefit to the patient in a Phase 1 trial. If a patient happens to benefit, then that's just great. Whatever one might say about government funding of biomedical research, the plain fact is that the National Institutes of Health has never brought a treatment to market. Profit-making companies do that.
          I am surprised by Danny here. Correct info on the possible benefit (modest) of the OPC1 therapy have been available since the beginning. I learned about this therapy shortly after my SCI and it was clear to me since the begining that just some acute SCI might have had some benefit.
          Danny should be upset about the fact that there is a marginal focus on chronic SCI, not about Geron stopping the trial.

          Is Danny still in the CDRF board? If yes I would suggets him to resign.

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

          Comment


            #50
            Originally posted by paolocipolla View Post
            I am surprised by Danny here. Correct info on the possible benefit (modest) of the OPC1 therapy have been available since the beginning. I learned about this therapy shortly after my SCI and it was clear to me since the begining that just some acute SCI might have had some benefit.
            Danny should be upset about the fact that there is a marginal focus on chronic SCI, not about Geron stopping the trial.

            Is Danny still in the CDRF board? If yes I would suggets him to resign.

            Paolo
            @Paolo, I was also surprised that Geron got a punch in the nose from CDRF. There will probably be many more biotech companies in the future that will be attempting various cells for spinal cord injury. We've talked before that it costs a huge amount of money for any company to take a product to clinical trial for testing. A clinical trial for acutes was probably tough with tight timing and locations, let alone the regulatory climate...at least they attempted to test a cell type on acute injuries with the hope they could help with SCI. We're all disappointed, but the cash burn was enormous and couldn't be sustained. If Christopher Reeve were alive today, I highly doubt he'd be punching Geron in the nose in the Washington Post like that for trying to test their cells and all the work that had gone into lab research and passing through the FDA regulations. I also thought it was a bit odd....??? Any SCI therapy has to go through FDA and clinical trials in order to be used by the public..."lab rats" ??????
            http://spinalcordresearchandadvocacy.wordpress.com/

            Comment


              #51
              Is this new?

              http://clinicaltrials.gov/ct2/show/N...%2F2011&rank=1

              Is this an example of one door closing while another opens?

              Comment


                #52
                I can understand his comments, it's all just so frusterating.
                "Life is about how you
                respond to not only the
                challenges you're dealt but
                the challenges you seek...If
                you have no goals, no
                mountains to climb, your
                soul dies".~Liz Fordred

                Comment


                  #53
                  Terribly frustrating! But, comments like that wouldn't help sway young biotechs to enter the field and work on SCI. They'll do a double take and enter safer fields like cancer, HIV, etc...(which many already do)

                  I just don't see cancer, HIV, ALS, SMA organizations making statements in the Washington Post like that when one of their promising biotechs aren't successful in a clinical trial treatment or they go totally under and out of business.

                  Why would the general public want to donate to CDRF if SCI folks feel like lab rats when all the proposed treatments absolutely have to go through one of these clinical trials? It makes the general public think we don't want any clinical trials because we'll feel like lab rats. I was saddened by that kind of comment. Will that help donations for research or future trials? Seriously???? With a one star financial rating at CharityNavigator, I don't think I'd be making statements like that! Whew!
                  Last edited by GRAMMY; 17 Nov 2011, 11:24 PM.
                  http://spinalcordresearchandadvocacy.wordpress.com/

                  Comment


                    #54
                    Originally posted by Curt Leatherbee View Post
                    I can understand his comments, it's all just so frusterating.
                    Did you think that GRN OPC1 was directly going to help us get out of w/c?

                    I am disappointed that they stopped the trial, but I don't think it is a big deal for us.

                    Let's not forget they got the FDA approval and they did 4 people. That's a big positive deal IMO.

                    Hans Keirstead, for example, has the way open for his next trial with hESC derived cells thanks to Geron.

                    It seems to me Denny is missing that. If he were just "one of us with SCI" it could be OK, but if he is a member of the CDRF board, that's not ok IMO.

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

                    Comment


                      #55
                      http://sciencedude.ocregister.com/20...-trial/159883/

                      Geron Corp. shuts down world’s first stem-cell trial

                      A culture of human embryonic stem cells. Photo courtesy UC Irvine.

                      Geron Corp. is shutting down the world’s first patient trial of a treatment involving human embryonic stem cells, citing lack of funding and economic difficulties.
                      The company’s decision leaves a doubtful future for clinical trials of the spinal-cord injury treatment, developed by researchers at UC Irvine.
                      Hans Keirstead, who developed the treatment along with UCI researcher Gabriel Nistor, said he is exploring alternative funding to continue the trials.
                      Neither was involved in Geron’s clinical trial.
                      UC Irvine stem-cell researcher Hans Keirstead. Register photo by Leonard Ortiz.

                      Geron recently reported that patients had completed the first year of a safety trial of the treatment with no adverse effects.
                      But with a potential pool of only about 6,000 patients per year, the trial could not acquire enough funding to continue, Keirstead said Wednesday.
                      “In a nutshell, the small market size could not support the cost of development,” Keirstead said. “That is a fear that the spinal cord community has had for years, and now it clearly manifests itself.”
                      Geron said it also is laying off 66 full-time employees.
                      The treatment is for acute spinal cord injuries, less than 14 days old. Neural cells derived from human embryonic stem cells are injected into the site of the injury.
                      The trial underway so far was only to check the safety of the procedure; a trial to measure its effectiveness was expected to follow.
                      Geron announced in October that patients involved in the trial experienced no ill effects from the treatment itself, although there were a few “mild” adverse reactions to a drug used to suppress the immune system.
                      And one of the patients, Timothy Atchison of Alabama, came forward to report that he had experienced sensation in his legs after the treatment, although his statement was not scientifically verified.
                      The treatment has the potential to reverse paralysis from such injuries, and has succeeded in doing so in laboratory rats.
                      “I’m really disheartened for the patients,” Keirstead said. “All I ever wanted to do was develop treatments for spinal cord injuries and other diseases. This is a serious blow to the treatment.”
                      Still, he said he was optimistic that alternative funding could be found and the trials could go forward.
                      “I don’t think this is the end of the road for this trial,” he said. “I think it’s a hurdle rather than a barrier. We’ll get over it.”
                      Moving the treatment beyond the United States could increase the number of potential patients and reduce costs, he said.
                      “I predict this will move offshore,” he said.
                      Last edited by GRAMMY; 17 Nov 2011, 11:28 PM.
                      http://spinalcordresearchandadvocacy.wordpress.com/

                      Comment


                        #56
                        Hope :

                        1. confident desire: a feeling that something desirable is likely to happen
                        "The research offers hope to sufferers."


                        2. likelihood of success: a chance that something desirable will happen or be possible
                        "There's not much hope that things will improve."


                        3. wish or desire: something that somebody wants to have or do or wants to happen or be true
                        "My hope is that she will change her mind."


                        4. source of success: somebody or something that seems likely to bring success or relief
                        "We have to do this, it's our only hope."


                        5. trust: a feeling of trust
                        Last edited by jhope; 26 Nov 2011, 2:56 PM.
                        Han: "We are all ready to win, just as we are born knowing only life. It is defeat that you must learn to prepare for"

                        Comment


                          #57
                          Originally posted by GRAMMY View Post
                          http://sciencedude.ocregister.com/20...-trial/159883/

                          Geron Corp. shuts down world’s first stem-cell trial

                          A culture of human embryonic stem cells. Photo courtesy UC Irvine.

                          Geron Corp. is shutting down the world’s first patient trial of a treatment involving human embryonic stem cells, citing lack of funding and economic difficulties.
                          The company’s decision leaves a doubtful future for clinical trials of the spinal-cord injury treatment, developed by researchers at UC Irvine.
                          Hans Keirstead, who developed the treatment along with UCI researcher Gabriel Nistor, said he is exploring alternative funding to continue the trials.
                          Neither was involved in Geron’s clinical trial.
                          UC Irvine stem-cell researcher Hans Keirstead. Register photo by Leonard Ortiz.
                          bbm

                          Bless this guy for perservering in spite of the setback! Where the heck is Bill Gates when we need him??!

                          Comment


                            #58
                            Originally posted by KYLady View Post
                            Where the heck is Bill Gates when we need him??!
                            He is vaccinating children in impoverished 3rd world countries against TB and malaria, mostly

                            Comment


                              #59
                              Originally posted by paolocipolla View Post
                              Did you think that GRN OPC1 was directly going to help us get out of w/c?

                              I am disappointed that they stopped the trial, but I don't think it is a big deal for us.

                              Let's not forget they got the FDA approval and they did 4 people. That's a big positive deal IMO.

                              Hans Keirstead, for example, has the way open for his next trial with hESC derived cells thanks to Geron.

                              It seems to me Denny is missing that. If he were just "one of us with SCI" it could be OK, but if he is a member of the CDRF board, that's not ok IMO.

                              Paolo
                              Paolo: A 5th individual was implanted at Stanford 2 days after the Genron announcement. The individual had entered an agreement with Genron prior to their shutting down the trial.

                              It is impt for people to note that Genron is continuing to study the 5 people involved.
                              Every day I wake up is a good one

                              Comment


                                #60
                                Originally posted by cheesecake View Post
                                Paolo: A 5th individual was implanted at Stanford 2 days after the Genron announcement. The individual had entered an agreement with Genron prior to their shutting down the trial.

                                It is impt for people to note that Genron is continuing to study the 5 people involved.
                                Sure it is great that a 5th individual has been implanted, that will add statiatical strenght to the outcome data.
                                I have also stated in a previous post that I believe we have to thank Geron for what they did. Even if the 5 patients treated do not recover but "just" don't show side effects it would still be a great progress IMO.

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

                                Comment

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