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Thread: A fervent wish for the coming year

  1. #41
    I'm a big fan of DA's but I don't agree that it's the researchers who are to blame.

    Wise has pointed out that it's the surgeon's who aren't aware of the progress and don't turn up to conferences, so maybe blame could be apportioned there.

    And it seems the cost and regulations etc make a clinical trial a difficult step even if researchers have done their jobs properly.

    It's governments and medical institutions and other SCI people who need educating that a cure is possible and imminent - and will save the country millions of dollars.

  2. #42
    Senior Member DA's Avatar
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    dr young...i said their success is not the point. they gave the finger to the system and found a way to try. why cant we do the same?
    dr young...usa medical system unfairly looks down at overseas research as inferior. therefore if everything is done, still nothing will be changed here. we need usa ppl overwseas to convince prejustice usa system.


    chris...their is plenty of blame to go around. we, the sci community, is the biggest at fault. but not much we can do until we relize how naive and stupid we are.

    yes clincians have their fingers in theirs ears and eyes closed tight screaming "lalala i dont believe progress in sci research lalala i can't hear you lalala ah lalala"
    its because they aren't the ones paralyzed and careless about those who are. therefore why so many of you put your faith in ppl such as these?

  3. #43
    There are of course clinicians who have their fingers in their ears and who have not paid much attention to the research in the field. On the other hand, there are clinicians who really want to get clinical trials going. If a clinician today wants to transplant cells into the spinal cord, that clinician must really jump through the hoops. Where would he/she get the cells? Will the cells be approved by the FDA for the clinical trial? Who will pay for the surgery and other costs, which may be as much as $20,000 per patient or more? Are there patients who are willing? These are not trivial questions.

    I personally know of more than a few trials that have died on the vine, for the lack of materials, funding, and patients. People like Harry Goldsmith can tell you how hard it is to start a clinical trial, to raise money for the trials, to go out on the limb. On the other hand, it can be done. It takes a lot of work. Methylprednisolone and 4-aminopyridine are two examples. You probably don't want to hear about all the war stories. Doing a clinical trial is not just a matter of plopping a bunch of cells into somebody's spinal cord.

    So, what does it take to get treatments into clinical trials?

    First, we need data. It takes a lot of data to get a clinical trial going. There will always be naysayers and skeptics. There is tremendous competition for clinical trial funds, not just from NIH but even within companies. A company like Novartis, for example, has hundreds of projects competing vigorously for clinical trial funding. Any doubt or problem will be used as an excuse to push another project forward.

    Second, we must make the materials accessible. There is a lot of talk about stem cells and other transplants. The problem is that clinicians do not currently have access to such cells. NIH tried to propose a way of making embryonic stem cells available for this purpose but this has been shot down. One of the major obstacles to getting OEG trials in the U.S. is the source of the cells. It was one of the reasons why I was so excited about the possibility of nasal mucosa transplants because it is an available source of cells.

    Third, we need a clinical trial infrastructure. The main reason why Gleevec could move forward so rapidly is because there is a very well-organized clinical trial infrastructure for cancer. The National Cancer Institute, for example, funds several hundred cancer centers in the United States that are always looking for and trying new therapies. That is one of the reasons why they were able to gather so much data since 1999. We don't have such an infrastructure right now for spinal cord injury.

    Fourth, we need to have industry participation in treatment development. At the present, the only company that is investing substantially into spinal cord injury clinical trials is Acorda Therapeutics. While there are some big pharma companies that are showing interest, they have not yet invested significantly into such trials. Without that investment, things will be slow in the U.S.

    Blaming scientists or clinicians for a situation that they cannot change is not the answer. More than anybody else here, I think that I understand that we will not be getting "gazillions" of dollars necessary to jumpstart spinal cord injury clinical trials. So, we must do what we can. These include encouraging better clinical trials overseas. A clinical trial that is poorly run and documented may be worse than no clinical trial. We must make sure that cells are available for transplantation. For example, if there was a national stem cell bank that can provide stem cells or specific progenitor cells, this would solve the problem of sources of cells. If we had a OEG cell bank that would be available to doctors, it will allow the trials to move quickly. Finally, we need to identify a cohort of clinicians who are ready and willing to do clinical trials. By the way, NIH will be doing this by convening the clinical and scientific leadership of the field for a pow-wow on how to move therapies more quickly to clinical trials.

    Wise.

  4. #44
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    Does Dr. Huang have a good clinical trial infrastructure? Can we not use his/Dr. Lima's data?

    If a patient could supply:
    -the proper source for cells(ESC, OEG, or otherwise)
    -a location outside of the U.S. to avoid the FDA hoopjumping
    -all of the funding needed for the procedure and care(no cost to you)
    -a legal document releasing you of any liability in case something went wrong

    Would you do it??

  5. #45
    Senior Member DA's Avatar
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    dr young you dont get it. your fours answers are from "the book". if we continue doing things by "the book", we will drag this cure out for 20 years.
    please throw that damn book out your window.


    i think your questions are very trivial.
    Where would he/she get the cells?
    "the nose, all should remember these are trials, not proven cures."

    Will the cells be approved by the FDA for the clinical trial?
    "why would the fda not approve oec? or oec combined with copaxone?
    i think safety was proven long ago"

    Who will pay for the surgery and other costs, which may be as much as $20,000 per patient or more? Are there patients who are willing?
    "the patient can pay. we want it bad enough to pay. have not already several members of the forum paided $30,000 for a less promising procedure. if you told me today, get 20k, i will get it and pay for it. do a poll dr young, see how many would pay 20k."

  6. #46
    Originally posted by cjo33:

    Does Dr. Huang have a good clinical trial infrastructure? Can we not use his/Dr. Lima's data?
    Dr. Huang does not have a good clinical trial structure although he has access to many patients. For example, it was a real struggle for him to set up the system for producing the cells and his current approach would probably not pass muster in the U.S. with regard to regulation of GLP (Good Laboratory Practices) and GMP (Good Manufacturing Practices). He doesn't have a good system for bring the patients back for followup. Yes, we can use their data but only if it is properly documented. That is one of the reasons why we have been working closely with him to ensure that he gets as much help as possible to achieve a convincing study.

    If a patient could supply:
    -the proper source for cells(ESC, OEG, or otherwise)
    Where would a patient get such cells in the United States?

    -a location outside of the U.S. to avoid the FDA hoopjumping
    There is nothing to stop you or anybody from going overseas to do this right now. However, it has not happened. Perhaps we should consider the reasons why. First, most of the overseas clinics do not have funding or access to the technology or know-how to do anything that is more complicated than isolating cells from fetuses. Second, if it is overseas, it means that the technology would not be available to a majority of the half million people in the United States who could not afford to have such therapies. I believe that we must try to do it here in the U.S. as well. We must work with the overseas clinics to get the clinical trials going, to make sure that they are working well, and to learn what we can so that the treatments can be migrated back to the U.S.

    -all of the funding needed for the procedure and care(no cost to you)
    What if somebody does not have the money?

    -a legal document releasing you of any liability in case something went wrong


    Would you do it??

    I am assuming that you are referring to me personally. The answer is no because I don't think that there are any therapies right now that has been proven to work in humans. That is what clinical trials are for.

  7. #47
    DA,

    Although I respect you very much, I don't think that you understand my point. More than anybody else, I have supported clinical trials overseas. Many of the clinicians who are doing clinical trials around the world trained here. That does not mean that we must stop trying here in the U.S. What you are advocating is abandoning the system in the U.S. That is ultimately not the solution. We must continue working on getting a path for therapies in the United States.

    Wise.

  8. #48
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    You answered precisely the way I figured you would regarding Dr. Huang regarding his clinical trial infrastructure. But let me ask you this, is he helping people regain some of what was lost due to SCI?

    As for my hypothetical question, I feel you tackled that the way clinicians are tackling the SCI cure - sidestepping. I asked if a patient could supply the proper cells and you asked where I could get them. When talking about funding, you asked what if somebody does not have the money? I was merely posing a question based on the existence of those conditions, not the means by which they were obtained.

    My first post in this topic dealt with resposibility and science. SCI treatments will not be perfect for a long time, but people are benefitting from current treatments, even if they don't have a good clinical trial infrastructure. Is it responsible for scientist/researchers/clinicians to drag their feet with clinical trials when they could be helping people today? DA was right on when talking about the "book" and how it needs to be thrown out. Yes, clinical trials are important, but not more important than people. Do you care more about following proper scientific procedure or helping people now? Yes, those are different because I don't want to sit in a chair and be totally dependent on others for the next 10 years while science works out a cure for those not yet injured.

  9. #49
    Senior Member DA's Avatar
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    -all of the funding needed for the procedure and care(no cost to you)
    What if somebody does not have the money?

    dr young this is not about me, myself, and I. i don't want to be cured while others are denied. this is about getting a stubborned finger in the ear usa with all its technology and resources to get off its butt. dr lima work has gone ignored here in the usa. why? because he is not american and the clinical breakthrough didn't occurr at a usa facility. had his work been done miami, hahaha yeah right, or a major usa center;craig, tirr, etc.. ABC, CBS, CNN, PBS,NBC, BBC, FOX, BET, XXX, OXY, ESPN, weatherchannel, and even pat robertson would have covered the event. the news would have forced the issues you feel is needed like money. you know how the american system works, use it.
    celebrities do wild stunts for attention, politicans make outrages statements, why can sci researchers do the same with research. im sure you can get 6 ppl from the forum to pay their own cost.


    Would you do it??

    I am assuming that you are referring to me personally. The answer is no because I don't think that there are any therapies right now that has been proven to work in humans. That is what clinical trials are for.

    dr young at current pace, you will never know. money and other problems you mentioned was an issue 3 years ago, its an issue today, its hard to imagine it wont be in the future.

  10. #50
    cjo, I am not sure how to respond. I guess that we disagree about what scientists and clinicians should do.

    I am troubled by your suggestion that clinical trials are not necessary. Clinical trials are essential for showing that a therapy is safe and works. When clinical trials are not carried out, therapies often languish for years without being adopted by other clinicians. Carl Kao and Harry Goldsmith have applied their therapies without rigorous clinical trials for 20 years without convincing other clinicians to apply their therapeutic approaches. Likewise, the Tijuana group has been implanting shark embryos into people with spinal cord injury without clinical trial. Is this the way that you think it should be done?

    In my opinion, the most important responsibility of scientists and clinicians is to prove that their therapy is safe and effective, to convince other clinicians that the therapy is effective. It is not enough to apply the therapy to people. For example, when I met him, Dr. Shaocheng Zhang who operated on Satish (see posting) told me that he has done peripheral nerve bridges on several hundred patients. Other doctors are not yet practicing what he is doing.

    Failure to disseminate the therapy deprives many people of potentially effective therapy. Without rendering a judgement on whether Carl Kao's surgical approach, shark embryo transplants, Zhang's peripheral nerve bridging, and fetal OEG transplants are effective, let me point out that all the efforts of these individual clinicians are but a drop in the bucket. Dr. Huang, even if he were to operate on two people per day, five days a week, for the next 10 years, he will be able to treat only 6000 patients. Rigorous clinical trials are essential for this reason.

    Wise.

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