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Next decade offers promise for treatment of spinal cord injuries

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    Originally posted by Wise Young View Post
    Eric,

    If the trial is double-blind, nobody knows what the results are until the trial is "unblinded". Many investigators will not allow any of the trial results to get out until the study has been peer-reviewed. I would urge you not to trust "leaked" data. Most often, it is inaccurate. More important, it has not been reviewed by experts and therefore not trustworthy.

    Wise.
    What about Dr. Hongyun Huang? He must have the facilities and
    permission to offer stem cell therapies (that don't seem to work).
    I'm not challenging your method, but why is it that he's able to
    offer what he does without as much difficulty as other doctors
    in the stem cell field?

    Comment


      buck,
      you hit the nail on the head.why dont domestic research facilities assist overseas clinics in providing better therapies than the snake oil they are currently being accused of selling?

      Comment


        Originally posted by jim sampson View Post
        DA,
        for the x prize to work you have to win the lottery first,otherwise i agree completely.
        not necessary. if we as a community stop giving money to the system and start using it to fill kate's pot. just redirect the money we would give to the pot. the guy in canada raised $25 million. what a great start to the pot, as an example. why can't we raise the money.
        the nfl can put a few million in the pot. Beaumont is the birth place of exxon-mobile, i would hit them up. can't we cc find enough donors to make the pot sweet?

        Comment


          Originally posted by eks View Post
          No, actually I would think he started smoking crack. Just sayin.
          No you wouldn't because he'd just use different terminology and you wouldn't even recognize its the same thing... not different than when politicians change positions, they just re-phrase and people fall in line..

          If Dr. young Announced on here he was putting together a "open participation pre-clinical procedure" you really believe there would be back lash from this board, please. He could say its just a small test to see if a procedure is worth taking to trial. you'd eat it up.
          Last edited by Eric.S; 6 Apr 2010, 10:12 PM.

          Comment


            Originally posted by DA View Post
            maybe a gunman is forcing him to read... lets give him the benefit of the doubt.
            I read your posts purely for entertainment DA, the same reason I sometimes watch that drama-queen, Glen Beck

            If you have a better way, then actually DO SOMETHING to change the system. Giving Dr Young grief for working within the guidelines of the US System is doing nothing. You have 32,000 posts on CareCure. You could have had a huge impact if you had used that time and energy in a productive manner. Attacking the people who have dedicated their lives to making your life better is pathetic. Sure you should debate with him, but often times you are out of line and disrespectful.

            Instead of pissing, moaning, and bashing those on the front lines, do something yourself.

            Eric, aka, drama queen jr, see above message to drama queen sr.

            Comment


              Originally posted by DA View Post
              not necessary. if we as a community stop giving money to the system and start using it to fill kate's pot. just redirect the money we would give to the pot. the guy in canada raised $25 million. what a great start to the pot, as an example. why can't we raise the money.
              the nfl can put a few million in the pot. Beaumont is the birth place of exxon-mobile, i would hit them up. can't we cc find enough donors to make the pot sweet?

              DA I bet you can do excellent job to collect money for the cure. Think of something to be involve in money collecting. You have a great authority power for something like this, and even you can make politician to donate too. Come on organize something. I'll be behind you. Help Dr. Young to get money. I know you can help A LOT! PLEASSSSSSSSSSSSSSSSS!

              Comment


                Originally posted by Jim View Post
                I read your posts purely for entertainment DA, the same reason I sometimes watch that drama-queen, Glen Beck

                If you have a better way, then actually DO SOMETHING to change the system. Giving Dr Young grief for working within the guidelines of the US System is doing nothing. You have 32,000 posts on CareCure. You could have had a huge impact if you had used that time and energy in a productive manner. Attacking the people who have dedicated their lives to making your life better is pathetic. Sure you should debate with him, but often times you are out of line and disrespectful.

                Instead of pissing, moaning, and bashing those on the front lines, do something yourself.

                Eric, aka, drama queen jr, see above message to drama queen sr.
                i have not been disrespectful to dr young. what you want is for me to be a smiling
                hopping bob to everything dr young say. i could have a field day on all the things
                dr young said the last +12 years that turned out to be wrong. and he knows it. im sure
                he can find 1 or 2 things when i was wrong. dr young and you take any criticism of this bad system personally. thats not my fault. get over it. the system stinks. i am not biting the hand that feeds me because that hand is empty. in my 24 years of sci that hand never had
                anything in it. NOTHING. NOT A DAMN THING. But let me guess, 5 more years right?
                or 5 more years of excuses. maybe you should start memorizing them since you are now dr young's nanny.

                Comment


                  Originally posted by manouli View Post
                  DA I bet you can do excellent job to collect money for the cure. Think of something to be involve in money collecting. You have a great authority power for something like this, and even you can make politician to donate too. Come on organize something. I'll be behind you. Help Dr. Young to get money. I know you can help A LOT! PLEASSSSSSSSSSSSSSSSS!
                  i think this forum could raise a lot of money. but not for the current system. i can not support that effort and i get the feeling many here is also frustrated by the thought of
                  pouring money into a bad system. a system that takes but never gives back.

                  Comment


                    Originally posted by Buck_Nastier View Post
                    What about Dr. Hongyun Huang? He must have the facilities and
                    permission to offer stem cell therapies (that don't seem to work).
                    I'm not challenging your method, but why is it that he's able to
                    offer what he does without as much difficulty as other doctors
                    in the stem cell field?
                    Buck,

                    Hongyun Huang is a good man and a very passionate doctor. I know him because he trained with me for nearly three years and learned how to grow olfactory ensheathing glia in New Jersey. He unfortunately did not do the necessary studies to convince the world that the treatment is effective. The treatment also has limited effect, mostly sensory improvement, possibly because the cells are not immune-matched and are rejected after a period of time.

                    In China, fetal cell transplants are allowed as a treatment for some conditions. Hongyun Huang has taken advantage of that loophole to transplant cells from aborted fetuses. I don't know how long this will continue because there are lots of changes in regulation in China and there is much uncertainty concerning what the Ministry of Health will permit or not permit as they implement new regulations concerning cell transplants.

                    Please also understand that the cells that he is transplanting are olfactory ensheathing glial cells and astrocytes. Although he has recently been trying to transplant neural stem cells isolated from the olfactory bulbs, the cells that he has been transplanting are not stem cells. Although he has been trying, he does not yet have the facilities or the personnel to do genetic manipualtions to produce new cell, including the IPS (induced pluripotent stem) cells and the newly discovered INS (induced neural stem) cells. However, there are many very well funded laboratories in China that are now making such cells and I would not be surprised at all if he collaborates with them to initiate trials. Hongyun Huang has more experience with transplanting cells into the spinal cord than any other doctor in the world.

                    I am not sure what you are referring to as "my method". By my method, are you referring to the clinical trial method? If so, let me assure you that it is not *my* method. It is the method accepted by the world, by all the countries in Europe, America, China, Taiwan, and Japan. Randomized controlled trials are the world-wide standard by which *all* new treatments are assessed and approved. The fact that it is not being done with olfactory ensheathing glia means that it will not be accepted in the rest of the world.

                    Wise.

                    Comment


                      Originally posted by DA View Post
                      i think this forum could raise a lot of money. but not for the current system. i can not support that effort and i get the feeling many here is also frustrated by the thought of
                      pouring money into a bad system. a system that takes but never gives back.
                      Don't be funny DA, -you have done zero, you are doing zero and you will continue to do zero. Blaming all that lazyness on a system is laughable. I have seen ppl like you before, we used to fire them. And you talk about contacting Exxon-Mobile? Even funnier, -they would laugh so hard they probably never have done before.
                      Last edited by Leif; 7 Apr 2010, 6:46 AM.

                      Comment


                        dr wise

                        Originally posted by Wise Young View Post
                        Skeaman,

                        Your question is not rude but it shocks and frustrates me. Do you truly think that these groups are not doing clinical trials because they don't know any better and I have not shared information with them? I don't mean to be condescending but your question forces me to say things that I didn't think need to be said.

                        These groups are not doing clinical trials for three reasons. First, they are charging money for their treatments. They can't ask patients to be randomized to a placebo control group when the patients are paying for a therapy. Second, these groups are making money hand over fist. For example, according to a post from one of their representatives here on CareCure last year, Beike is treating 2 patients with spinal cord injury per day, charging $20,000 and more per case. They are making over $20 million per year. They don't want to do anything that will jeopardize this profit. Third, some of the groups believe that it is impossible or unethical to do clinical trials. They are wrong. ChinaSCINet will prove that they are wrong and that it is possible to do randomized, ethical, and rigorous clinical trials in places like China and India.

                        The above illustrates why GCP (Good Clinical Practice) regulations forbid doctors to charge patients for clinical trials. When patients pay, they don't want to be randomized. If they are not randomized, nobody will believe that the treatment is due to the treatment or for some other reason. Even the most ethical doctor will succumb to the pressures of money and patients asking them to try therapies. So, for example, I have many doctor friends who are being bombarded by requests from their patients to treat them with this or that transplant. Some have done so, charging the patient to cover the cost of the therapy. One thing leads to another. Soon, they become dependent on the income from the treatment. They convince themselves that the treatment is working. And so it goes.

                        GCP regulations are enforced as law in Europe. They are not yet enforced as law in the United States. China has adopted GCP standards that are even stricter than those in Europe but they left a few loopholes. Thus, many unproven therapies that have not been approved by the SFDA (particularly cell transplant therapies) are being practiced as accepted therapies. For example, the use of umbilical cord blood stem cells to treat spinal cord injury is treated as "off-label" use of treatments that have been approved for other indications (leukemia, etc.). Likewise, fetal cell transplants are allowed for some indications in China and the law is sufficiently vague that some doctors are able to use fetal cells to treat spinal cord injury. But, the government in China is beginning to enforce GCP and it is already stricter than in the United States.

                        There will always be countries that will not regulate medical practice to the same extent at the United States and Europe. As long as there are gullible and ignorant people, there will be a market for for unscrupulous doctors who are selling snake oil and worse to them. The more desperate the condition, the more gullible people are, even when they are very knowledgeable. For example, I have very smart friends who have ALS pay exorbitant sums for therapies that they know are very unlikely to help them and yet they are eager to grasp at any straw.

                        Clinical trials provide impartial and objective information concerning therapies. Clinical trials should be carried out by impartial investigators who have "no skin" in the deal. For example, it is often not the best idea for the inventor of a therapy to be the one to test the therapy. It is the reason why it is often important for a therapy to be supported by two or more third party investigators before it is accepted for clinical trials. It is the reason why I am so careful always to emphasize that the ChinaSCINet trials may show that umbilical cord blood mononuclear cells and lithium do not work. If the treatment does not work, we will say so.

                        Wise.
                        i did not main to frustrate you in any way .
                        but the government must come down hard on this they are as much to blame if not this will keep going on .why do you think they left the loopholes in it. would it be to run with the fox's and hunt with the hounds meaning people with money and looking for a cure will still come and spend money
                        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


                          Originally posted by skeaman View Post
                          i did not main to frustrate you in any way .
                          but the government must come down hard on this they are as much to blame if not this will keep going on .why do you think they left the loopholes in it. would it be to run with the fox's and hunt with the hounds meaning people with money and looking for a cure will still come and spend money
                          Skeaman,

                          Far be it for me to defend or attack the practices in China, I can only say that what they do is relevant to the Chinese and not relevant to the United States. They are struggling to impose a high standard of science and GCP on a country that has not had either for centuries. It is hard to know what will happen. It has been surprising to me that the Chinese government has embraced the western standards of clinical practice and science more than the United States has. Even the US FDA does not require all the institutions and chairmen of departments to take tough examinations before they can do clinical trials.

                          Much medical practice in the United States is not evidence-based. In fact, the U.S. FDA really came into its current form only in the 1970's during the Nixon administration, after the thalidomide crisis. All the drugs that were being used in the United States before 1971, for example, were grandfathered into an approved pharmacopiea that still exists today. By the way, that is why compounding pharmacies can make fampridine on prescription for people with spinal cord injury.

                          The drive for evidence-based medicine really began in the early 1970's. It has taken over to the extent that no new drug can be approved without having gone through phase 1, 2, and 3 trials that have been pre-negotiated with the FDA as fulfilling the standards that has been set for showing safety and efficacy. Cell transplantation is still in limbo, both in the United States and China. The FDA is likely to announce their policy on cell transplants. The Chinese are already setting up for their new policy by requiring all hospitals that transplant cells to be approved and to have their protocols approved.

                          In the coming year or two, comprehensive cell transplant policy will soon be announced by both China and the United States. At that time, a lot of the cell transplant therapies that doctors are doing in China will probably be shut down until rigorous clinical trial evidence becomes available to show safety and efficacy. China is actually ahead of the US FDA in this area, in part because they are a much more authoritarian government and they don't hesitate to impose regulations on all the doctors whereas the FDA is sensitive to politics and they do not want to antagonize the doctors.

                          Wise.

                          Comment


                            Originally posted by Leif View Post
                            Don't be funny DA, -you have done zero, you are doing zero and you will continue to do zero. Blaming all that lazyness on a system is laughable. I have seen ppl like you before, we used to fire them. And you talk about contacting Exxon-Mobile? Even funnier, -they would laugh so hard they probably never have done before.
                            then look down at your paralyzed body and keep laughing.

                            Comment


                              Originally posted by DA View Post
                              then look down at your paralyzed body and keep laughing.
                              You missunderstands it all. I don't work hard for this for myself, I do it most of all for people which can't work hard for it themselves, I also do it for confused dodging people like you.

                              Comment


                                Ok, lets get back to the thread topic- Next decade offers promise for treatment of spinal cord injuries.

                                Clinical trials have finally begun. This is a huge "step" forward very exciting!

                                Comment

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