Announcement

Collapse
No announcement yet.

Where Are the Cures?

Collapse
X
 
  • Filter
  • Time
  • Show
Clear All
new posts

  • #16
    It is so frustrating to read this thread because it feels as if people are rediscovering the wheel. Let me re-iterate some information that I have been posting for the last few years.
    1. There is currently little or no federal funding for spinal cord injury clinical trials and it has been this way for the past 6 years.
    2. NIH does fund clinical trials for cancer, AIDS, cardiac, and other conditions, but not for spinal cord injury.
    3. Several companies and foundations are raising money for clinical trials but the economic climate is not good for fundraising;
    4. Some scientists are calling for clinical trials to test therapies that they have discovered but few have ever organized a clinical trial.
    5. Clinicians do clinical trials. They unfortunately are so busy that they seldom have the time to organize or even participate in clinical trials.
    6. Most companies that are thinking of doing clinical trials in spinal cord injury do not have the experience nor funding to do such trials.


    Let me give some good news to counter all this negativity. First, the upcoming Congress hopefully will pass the Christopher and Dana Reeve Paralysis Act (CDRPA), which should target some funding at NIH to spinal cord injury clinical trials. Many members of this community have worked very hard during the past 4 years to make this happen and we should be proud. Second, clinicians are interested in doing spinal cord injury clinical trial and have been traveling to China and organizing their own clinical trial networks. This is good. Third, there are many therapies to test in clinical trial. We didn't have as many therapies before. Fourth, several big companies are getting involved in spinal cord injury clinical trials, including Novartis, Biogen, Pfizer, and others. If Acorda gets Fampridine approved, it will be the first company to have gotten a chronic spinal cord injury approved to to make money from it, a fact that will attract more companies to the field.

    We need to push as hard as we can to get the CDRPA passed with as much funding as possible and encourage clinicians to participate in clinical trials for all the exciting new therapies. We can sit and moan in our soup or work hard to do something with what we have.

    Wise.

    Comment


    • #17
      why not take those promising therapies offshore and apply them to people now?

      Comment


      • #18
        Originally posted by Wise Young View Post
        It is so frustrating to read this thread because it feels as if people are rediscovering the wheel. Let me re-iterate some information that I have been posting for the last few years.
        1. There is currently little or no federal funding for spinal cord injury clinical trials and it has been this way for the past 6 years.
        2. NIH does fund clinical trials for cancer, AIDS, cardiac, and other conditions, but not for spinal cord injury.
        3. Several companies and foundations are raising money for clinical trials but the economic climate is not good for fundraising;
        4. Some scientists are calling for clinical trials to test therapies that they have discovered but few have ever organized a clinical trial.
        5. Clinicians do clinical trials. They unfortunately are so busy that they seldom have the time to organize or even participate in clinical trials.
        6. Most companies that are thinking of doing clinical trials in spinal cord injury do not have the experience nor funding to do such trials.

        Let me give some good news to counter all this negativity. First, the upcoming Congress hopefully will pass the Christopher and Dana Reeve Paralysis Act (CDRPA), which should target some funding at NIH to spinal cord injury clinical trials. Many members of this community have worked very hard during the past 4 years to make this happen and we should be proud. Second, clinicians are interested in doing spinal cord injury clinical trial and have been traveling to China and organizing their own clinical trial networks. This is good. Third, there are many therapies to test in clinical trial. We didn't have as many therapies before. Fourth, several big companies are getting involved in spinal cord injury clinical trials, including Novartis, Biogen, Pfizer, and others. If Acorda gets Fampridine approved, it will be the first company to have gotten a chronic spinal cord injury approved to to make money from it, a fact that will attract more companies to the field.

        We need to push as hard as we can to get the CDRPA passed with as much funding as possible and encourage clinicians to participate in clinical trials for all the exciting new therapies. We can sit and moan in our soup or work hard to do something with what we have.

        Wise.
        I have a question. Suppose one were to try and organize a donation drive or even a perminent donation apparatus, where would be the best place to direct the funds? Cancer has the American Cancer Soiety, and the Komen foundation, ect..., but do we (SCI) have a similar organization (big name, easily recognizable) for such funding administration? If not, Why?

        Another question is; How can we convince people who are unfamilisr with SCI to put up funds? I would like to have something in the works that holds true promise of becoming a reality to use as an example of what is possible. Simply asking for money to sponser "research" without specifics, is likely going to be fruitless. Also, to suggest to most people to donate to any kind of stem cell research is risky, as it may alienate potential donators away from any funding our way due to the controversy surrounding this topic. The bottom line is, until science gives us something that laymen can actually grasp as a "cure" or "fix", our hopes of generating any substantial funding is bleak.

        I believe there are many potential industries that would like to lay claim to the funding for a specific cause, but most would be unwilling to do so unless there research dollars follow a steady influx of press. imagine if we could tap into the construction industry to make SCI research thier own "pet" cause. Specially colored hard hats (perhaps safety Orange), tape measures, safety vests, ect... Soon everyone would begin to associate that color with SCI and the quest for the cure. Every highway job would have thousands of people noticing these colors. I believe that is why breast cancer has been so successful at attracting doners...it's news worthy. Business', while generous, must still seek the wisest way to spend those dollars. And the best "bang for thier buck" is often breast cancer research. Just watch the news or read the paper for a myriad of products and t-shirts in pink. This is the critical element that is missing in SCI funding. It's about time we consider this as part of the future of our cause.

        Do we agree? or, am I just talkong into the wind?

        Comment


        • #19
          Originally posted by Eric.S View Post
          why not take those promising therapies offshore and apply them to people now?
          Eric,

          I want to dispel the notion that it is easy to move U.S. therapies offshore and apply them to people. I have been running clinical trials in China for several years now and things are neither easier nor faster here. In fact, there are a lot more Chinese regulations restricting U.S. drugs and products here in China than one has to deal with in the United States. It is easier to do clinical trials on U.S. products in the U.S. than it is to do the trials in China. For example, China does not allow phase 1 trials of any new drug or cells from the U.S. in China.

          Wise.

          Comment


          • #20
            Originally posted by Wise Young View Post
            Eric,

            I want to dispel the notion that it is easy to move U.S. therapies offshore and apply them to people. I have been running clinical trials in China for several years now and things are neither easier nor faster here. In fact, there are a lot more Chinese regulations restricting U.S. drugs and products here in China than one has to deal with in the United States. It is easier to do clinical trials on U.S. products in the U.S. than it is to do the trials in China. For example, China does not allow phase 1 trials of any new drug or cells from the U.S. in China.

            Wise.
            WOW! It's too bad they aren't as strict with things like food or
            pollution.

            I'm surprised to hear that though, with so many people going to Huang
            for stem cell treatments.

            Comment


            • #21
              Originally posted by Buck_Nastier View Post
              WOW! It's too bad they aren't as strict with things like food or
              pollution.

              I'm surprised to hear that though, with so many people going to Huang
              for stem cell treatments.
              Buck,

              The contaminated milk issue forced a lot of regulations in China. By the way, there are many rules but the government has trouble enforcing all of them, China is a monstrously huge country. Part of the problem is that things are unpredictable and it takes a long time to get anything new going. In fact, I am thinking of doing some of our ChinaSCINet trials first in the U.S. even though it is more expensive.

              Let me give an example. It would be very difficult, for example, to test embryonic stem cells in China. First, the rules say that no overseas product can be tested in China unless it has already gone through phase 1 testing. In other words, they don't want Chinese people to be used as guinea pigs to test drugs or treatments that are considered too dangerous or unethical to be tested on Americans. Second, in China, they don't have to respond to your application to test a new drug or cell transplant in clinical trial. In the U.S., when you apply to the FDA, they must respond in 90 days by law. Third, if the product is made in China, you have to inspect and make sure that things are done properly and everything is properly documented.

              Wise.

              Comment


              • #22
                Originally posted by Wise Young View Post
                Buck,

                The contaminated milk issue forced a lot of regulations in China. By the way, there are many rules but the government has trouble enforcing all of them, China is a monstrously huge country. Part of the problem is that things are unpredictable and it takes a long time to get anything new going. In fact, I am thinking of doing some of our ChinaSCINet trials first in the U.S. even though it is more expensive.

                Let me give an example. It would be very difficult, for example, to test embryonic stem cells in China. First, the rules say that no overseas product can be tested in China unless it has already gone through phase 1 testing. In other words, they don't want Chinese people to be used as guinea pigs to test drugs or treatments that are considered too dangerous or unethical to be tested on Americans. Second, in China, they don't have to respond to your application to test a new drug or cell transplant in clinical trial. In the U.S., when you apply to the FDA, they must respond in 90 days by law. Third, if the product is made in China, you have to inspect and make sure that things are done properly and everything is properly documented.

                Wise.
                You've explained much of that in the past. It certainly sounds
                complicated.

                Third, if the product is made in China, you have to inspect and make sure that things are done properly and everything is properly documented.
                Yeah, scan those cells for traces of lead. LAWL!

                Comment


                • #23
                  Originally posted by Wise Young View Post
                  Eric,

                  I want to dispel the notion that it is easy to move U.S. therapies offshore and apply them to people. I have been running clinical trials in China for several years now and things are neither easier nor faster here. In fact, there are a lot more Chinese regulations restricting U.S. drugs and products here in China than one has to deal with in the United States. It is easier to do clinical trials on U.S. products in the U.S. than it is to do the trials in China. For example, China does not allow phase 1 trials of any new drug or cells from the U.S. in China.

                  Wise.
                  then why use china. why not some where with less restrictions. why keep banging your head against a wall of regulations and costly redundant restrictions. thats always been my arguement. why not just help people in the most direct cheapest way possible.

                  Comment


                  • #24
                    Originally posted by Eric.S View Post
                    then why use china. why not some where with less restrictions. why keep banging your head against a wall of regulations and costly redundant restrictions. thats always been my arguement. why not just help people in the most direct cheapest way possible.
                    Eric, because I want to help the people of China. Wise.

                    Comment


                    • #25
                      wise makes a point. why due premature tests in some third world country on the poor and leave them possibly worse off. then leave them with no followup care. i am desperate but still can't live with that.
                      PS my family is Chinese and they donate yo charities in China.
                      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


                      • #26
                        Originally posted by jhope View Post
                        wise makes a point. why due premature tests in some third world country on the poor and leave them possibly worse off. then leave them with no followup care. i am desperate but still can't live with that.
                        PS my family is Chinese and they donate yo charities in China.
                        then don't operate on the poor, operate on willing participants who fully understand the consiquences. theres plenty willing gueina pigs just no willing researchers. I'm open to the idea if I truly believe a therapy will work or atleast is relatively safe.

                        Comment


                        • #27
                          Posted long article on this subject at
                          /forum/showthread.php?t=111745

                          Comment


                          • #28
                            I agree, just because you do the trials somewhere else does not necessarily mean your operating on the poor, or a certain race of people. Just because you want to help Chinese people doesn't mean you have to do it there. I think the point was, if its not able to get approved here, then go somewhere that will approve trials. For instance, if Dr. Davies stuff is proven to work without a doubt, but for some ridiculous reason the U.S didn't want to approve it, and lets say the U.N. says hey we can make money off of it so come here, why not do it there? It wouldn't make sense to say no, I'm not going to do it there because I want to help Americans! That's kind of messed up. If your a scientist supposedly wanting to help folks and you can, who cares where you do it. You act as if people won't travel for treatment. How many people travel out of they're own country just for these fake ole stem cell treatments. Now imagine if there's something real to go get done, people will go, no matter where it is. I don't mean to sound rude because that's not what I'm aiming for. It's just an opinion.

                            Comment


                            • #29
                              Originally posted by Han Solo View Post
                              I agree, just because you do the trials somewhere else does not necessarily mean your operating on the poor, or a certain race of people. Just because you want to help Chinese people doesn't mean you have to do it there. I think the point was, if its not able to get approved here, then go somewhere that will approve trials. For instance, if Dr. Davies stuff is proven to work without a doubt, but for some ridiculous reason the U.S didn't want to approve it, and lets say the U.N. says hey we can make money off of it so come here, why not do it there? It wouldn't make sense to say no, I'm not going to do it there because I want to help Americans! That's kind of messed up. If your a scientist supposedly wanting to help folks and you can, who cares where you do it. You act as if people won't travel for treatment. How many people travel out of they're own country just for these fake ole stem cell treatments. Now imagine if there's something real to go get done, people will go, no matter where it is. I don't mean to sound rude because that's not what I'm aiming for. It's just an opinion.
                              I am with you why don't the Doctor's come out and tell us all exactly what thay have got For must time's thay talk in riddle's etc etc
                              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

                              Comment


                              • #30
                                Originally posted by Wise Young View Post
                                Eric, because I want to help the people of China. Wise.
                                "Our goal is to move promising therapies, including those based on stem cells, from the laboratory into clinical trial as quickly as possible," Young [once] said.

                                I must admit, I thought the prime reason you were futzing around in China was because it was the gateway to getting "laboratory into clinical trial as quickly as possible." I agree with the sentiment expressed: why on earth would doing research anywhere exclude people from anywhere else if viable therapies were developed? What are we missing?

                                f
                                ight

                                Comment

                                Working...
                                X