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Thread: What can you do about a cure now?

  1. #1

    What can you do about a cure now?

    Quote Originally Posted by Eric.S
    well doctor then for me hope must be gone because from the looks of things my life will remain unchanged by either the charlatans or the beauarcy.

    You speak a lot about the MS community compared to the SCI. Does this suggest some sort of flaw or innate bad attitude in the sci community? If this does exist what is your opinion why?

    Eric,

    I am afraid that we are hijacking the topic and so put my answer in this topic.

    Wise.

    -----

    Eric,

    I have been doing spinal cord injury research for 30 years. The first half of my career was spent on developing treatments for acute spinal cord injury and the last half has been on regenerating the spinal cord. When I first started in the field, doctors and scientists were very pessimistic. Most of my time and effort was spent trying to convince them that something can work. The second half has been different. The 1990's was the decade of the spinal cord. Scientists became convinced that the spinal cord can regenerate. Doctors are not yet convinced but most of them are not in touch with the latest research in the area. However, people in the spinal cord injury community heard about the therapies, particularly stem cell therapies.

    In the past decade, since 1997, many clinics, such as those in Mexico, China, Bahamas, Portugal, and India began advertising stem cell therapies for spinal cord injury. They charge about US$20,000-$30,000 for unproven therapy. People flocked to these clinics, often not knowing what they are getting. These places do not publish their work. Some do not even bother to get followup studies on the patients. Many have invented some kind of repeat procedure in order to get the patients to come back to the hospital and so that they can charge more for the therapies. When asked to provide details about the treatment, these places are reluctant to provide the information. These are pathognomonic signs of a scam.

    In the meantime, many legitimate and scientifically based therapies are being developed by scientists. Dozens of therapies have been shown to regenerate the spinal cord in rats. Some of these therapies were beginning to go into clinical trial in the late 1990's. The attack on 9/11/2001 unfortuantely diverted the attention of the United States. Since 2001, funding sources for spinal cord injury clinical trials dried up in the United States. Industry was not willing to invest because they thought that spinal cord injury is a small market. Christopher Reeve did a great job building up the private fund-raising for spinal cord injury research but his untimely death left us with very big shoes to fill. The main source of spinal cord injury funding is the NIH and they have been cutting back funding of research, for example NIH spinal cord injury research funding declined from $84 million in 2005 to $64 million in 2006.

    Instead of joining forces and pressing our government and industry to invest in spinal cord injury clinical trials, many people in the spinal cord injury simply gave up. Some decided to go overseas for their therapies. You have read about many of those on these forums. However, some decided to lobby for research. In 2005, several hundred people went to the first rally in Washington DC to press Congress to fund the Christopher Reeve Paralysis Act. We have subsequently gone two more times but I want to point out that this was really the first major effort by the spinal cord injury community to push for spinal cord injury research funding by the government. While there have been many successful efforts lobbying the govenrment for ADA, rehabilitation, veteran administration, and home care issues, lobbying for spinal cord injury research and particularly clinical trials is a relatively new phenomenon.

    Many, like yourself, blamed the problem on the FDA. In my opinion, the FDA is not the culprit. They apply the same standards to spinal cord injury therapies as to all other diseases, including AIDS, MS, Parkinson's disease, Alzheimer's disease, depression, etc. The FDA sets tough safety and efficacy standards but this is what the American public wants. Do you remember the COX-2 inhibitor Vioxx scandal. This was one of the best drugs for arthritis and joint pain. Then, it turned out that people who received prolonged (many months) high-dose Vioxx had a slightly higher risk of strokes and heart attacks. There was enormous public pressure on the FDA to force Merck to withdraw Vioxx. Merck voluntarily withdrew the drug.

    The American public wants to eat their cake and have it, too. There is no such thing as complete safety and miraculous efficacy, and yet people seem to expect complete safety and miraculous efficacy at the same time. During the AIDS crisis, the FDA tried to come up with some compromises to the long bench-to-bedside gap. They invented a category of approval called “compassionate use” for situations where there are no other effective therapies. Spinal cord injury would fall under this category if any company or doctor ever wanted to get more rapid approval of a therapy. For example, the alternating current electrical stimulation device tested in Purdue was just approved on a compassionate use basis after a phase 1 trial. So, there are ways to move therapies faster through the bureaucracy. The problem is that very few clinical trials are going on in the United States. The government is not funding clinical trials. The industry is not funding clinical trials. Foundations are not funding clinical trials. Is it any wonder that we don't have few spinal cord injury clinical trials in the United States? The solution is to get clinical trials going in the United States.

    What does it take to get clinical trials going in the United States? First, we must convince the government to fund clinical trial networks. Such networks reduce the cost of clinical trials and encourage industry to invest in spinal cord injury trials. Note that the government has long funded clinical trial networks for many conditions, including cancer, multiple sclerosis, and even for traumatic brain injury. It has never funded a spinal cord injury clinical trial network. The Christopher and Dana Reeve Paralysis Act is asking for modest funding for such a network. Second, the community has to help recruit and educate the doctors. Wait, you say... how come that is the responsibility of the community? It is because nobody will do it for you. Doctors are always behind on the latest research. After leaving medical school, they just don't have the time to keep up with the latest research. It is up to the community to recruit them and teach them. Third, people need to help fundraise for spinal cord injury research. Most people don't realize how much their neighbors, friends, relatives, and many people they don't know care about curing spinal cord injury. It is a shame that we can't raise more than $15 million per year for spinal cord injury research in the United States. We should be able to raise $250 million per year. That would go a long ways towards cure.

    You are probably thinking that all this will take a long time and how will it help you. I agree. It will take time. But, if we keep postponing getting the cure movement started, it will never happen. I believe that we would have had the cure by now, if the spinal cord injury cure movement had really gotten underway twenty years ago. There were people at that time who tried, i.e. the American Paralysis Association. However, they were never able to attract more than a small fraction of the spinal cord injury community. I have heard every excuse why the cure movement has not yet happened. These excuses range from we are too small (AIDS movement was way smaller than we are when they started) to nobody cares and there is no money (these are simply not true). But, in reality, we don't have the cure today because the spinal cord injury community has never truly believed that there would be a cure, never took the time to understand the science behind the cure, and kept on thinking that somebody else would do it for them.

    I started Spinewire in 1997 (the precursor to CareCure) in order to provide information to the spinal cord injury community about themselves and their condition, so that they can advocate effectively for the cure. I believe that the community must lead this effort. The community must understand what is necessary to make the cure happen. No cure has ever occurred without the community. The polio vaccine occurred with the support of the March of Dimes and FDR. Note that the community were parents of children frightened of polio, not the people with polio. So, although the vaccine prevented polio, it unfortunately did nothing for the millions of people who were disabled by polio. The world trumpeted the cure of polio and all those people disabled from polio were forgotten. Some of the strong anti-cure sentiments in today's disability community still emanate from memory of that abandonment. If you take the time to read the disability literature leading up to the ADA, you will see how anti-cure people were. Many people in disability don't want cure. They want societal support of people with disability.

    Some of us have been working hard on ways to start small cure efforts around the world until the United States gets its act together. So, for example, I have spent the past three years organizing the ChinaSCINet which hopefully will be able to test combination therapies for spinal cord injury rigorously and efficiently. I believe that there will be clinical trials involving stem cells in California and New Jersey (as well as other states) by 2008. These state-funded approaches are necessary because the federal government has just dropped the ball. Finally, a number of companies are beginning to understand that spinal cord injury may be the gateway to the central nervous system and that if they can get their regenerative drug approved for spinal cord, it will be easier to get that drug approved for brain injury and stroke. Several large and deep-pocketed drug companies, including Pfizer, Novartis, Johnson & Johnson, Boston Life Science, and Biogen are beginning to invest in clinical trials. Several small companies, such as Acorda Therapeutics, Geron, and others are planning or doing clinical trials.

    What can you do now? I recommend the following:
    1. Take the time to understand spinal cord injury and the various treatments. I am here to answer questions and there are many people here with a great deal of experience. You need to understand things well-enough to make rationale decisions concerning clinical trials that will be coming.
    2. Participate in lobbying your government to fund more spinal cord injury research and clinical trials. This can be in the form of letters or telephone calls. It is a long-term effort but it has to start.
    3. You must prepare your body for clinical trial. This includes rebuilding your bone and muscle, getting your cardiovascular system up, and weaning down on any unnecessary drugs that you are taking. This will increase the probability that you will respond to whatever therapy.
    4. Become educated and earn money. You probably think that I am kidding. I am not. Many studies have shown that the highest correlation with recovery from spinal cord injury is education and wealth.

    I hope that the above helps.

    Wise.
    Last edited by Wise Young; 05-21-2007 at 12:20 AM.

  2. #2
    Banned adi chicago's Avatar
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    i wont die until i will be ab again.i hope and i will never loose faith.
    help us please.
    • Dum spiro, spero.
      • Translation: "As long as I breathe, I hope."

  3. #3
    Senior Member CapnGimp's Avatar
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    Thank you VERY much for this post. It has cleared up many questions for myself and probably many others..

  4. #4
    Dr Wise

    Congartulations!
    Is the best of your posts!

  5. #5
    Quote Originally Posted by CapnGimp
    Thank you VERY much for this post. It has cleared up many questions for myself and probably many others..
    Thanks. I edited it a bit... I wrote the message all in one swhoosh and then realize that I don't really mean some of it. Particularly, I changed the section about what people can do about getting the clinical trials going. Wise.

  6. #6
    Senior Member lynnifer's Avatar
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    How can you compare SCI to MS? With MS, there's a window of opportunity to slow progression into disability especially with the ABC drugs ... people can live in remission for their whole lives.

    SCI does not have that luxury.

    One stops MS from going forward, one tries to pull back with SCI - with no luck, so far.

    I never thought I'd see the day where I said this ... but Dr Young may very well live out the rest of his life without seeing reversal of paralysis.
    Roses are red. Tacos are enjoyable. Don't blame immigrants, because you're unemployable.

    T-11 Flaccid Paraplegic due to TM July 1985 @ age 12

  7. #7
    Quote Originally Posted by lynnifer
    How can you compare SCI to MS? With MS, there's a window of opportunity to slow progression into disability especially with the ABC drugs ... people can live in remission for their whole lives.

    SCI does not have that luxury.

    One stops MS from going forward, one tries to pull back with SCI - with no luck, so far.

    I never thought I'd see the day where I said this ... but Dr Young may very well live out the rest of his life without seeing reversal of paralysis.
    Lynnifer,

    I am not sure what prompted you to say what you just said. I was saying that the MS community has been a lot of more successful in funding clinical trials than we have in spinal cord injury. Have I suggested that spinal cord injury research take a back seat to MS? On the contrary, I am suggesting that SCI community should be as successful in funding clinical trials as the MS community.

    You probably know disabled people with MS. People with MS face a double problem. They not only need to find treatments to stop progression; they need to find therapies to restore function. For obvious reasons, much of MS research has focused on stopping progression. They have been successful with the inteferons and now with tysabri. About 80% of people with MS can now stay in remission for decades or longer. By the way, these advances were rather recent, starting only in 1999. Before that time, it was a veil of tears and most people with MS expected at least one or two relapses a year. In the coming years, I believe that all autoimmune diseases such as MS will be treated with bone marrow stem cell replacements (probably with umbilical cord blood).

    Just like people with spinal cord injury, people with MS will need regenerative and remyelinative therapies to restore function. I am hopeful that we will soon have the first FDA approved therapy that improves function in MSL: Fampridine SR. MS is not just a demyelinating condition. Much evidence indicates that MS kills axons and therefore regeneration is also needed. MS clinical trials are beginning to come in line with those of SCI. It is important to remember also that MS has brain involvement and all the complications of spinal cord injury, including bladder, neuropathic pain, spasticity, and dysautonomia. It is a form of combined brain and spinal cord injury.

    The problem for spinal cord injury is and continues to be the lack of clinical trial funding in the United States. People need to understand how difficult it is to start a clinical trial in the United States. First, you have to raise millions of dollars. Second, you have to convince and train clinicians to do the clinical trial. Third, you have to make sure that the cells or the treatment is clinical grade and available. Fourth, then you have to get the FDA to approve the trial. Most clinical trials preparations fail before they get to the FDA stage.

    Having a spinal cord injury clinical trial network will ease the burden of the first two problems. The cost of the trial will be much less and the speed of getting a therapy into trial is much faster if such a network were available. You don't have to raise as much money and the clknicians will be all set up to do the trial. You still have to make sure that there is a company that has the therapy ready to go. The FDA approval part is a cinch from that point on.

    Let me comment a little about the FDA. Now that I have experience with both, I must say that the U.S. FDA is easier to deal with than the sFDA in China. By law, the U.S. FDA has to respond within 90 days or else an application for clinical trial is automatically approved. In China, the sFDA does not have to respond to your application and typically take 9 months or longer to respond. In China, they have a very tought job. They have to approve not only tens of thoussands of western drugs but also tens of thousands of Chinese herbal medicines.

    My point was the the FDA is not the culprit. We need clinical trials.

    Wise.
    Last edited by Wise Young; 05-21-2007 at 04:49 AM.

  8. #8
    Hi Wise,

    You wrote:

    Quote Originally Posted by Wise
    Many studies have shown that the highest correlation with recovery from spinal cord injury is education and wealth.
    Except for the words "Many studies have shown" what in the world do you mean by the above statement? I've been a T-5 "complete" paraplegic for 27 years and have the exact same motor and sensory function that I had when they scraped me off the side of the road back in '79. Which is none below my chest. Except for the "normal" (and luckily in my case only nominal) burning sensation in my buttocks, knees and feet.

    Are you saying that if I were better educated and perhaps had a well paying job or if I started a successful business and became wealthy that I'd have had a better "recovery" today? Or if I were born into wealth? I don't believe that for a New York second. Perhaps if I were an ASIA B, C, or D etc. and still had some spinal cord connection left and was able to afford special physical therapy with those new gait and vibratory contraptions etc. or could afford a personal trainer experienced in SCI physical therapy I might gain an iota of recovery. But those magical mechanical devices weren't around 27 years ago and being an ASIA A wouldn't have helped me anyway.

    The only thing that has changed in my life over the past 27 years, physically speaking, is that I now have neuropathic pain in my abdomen and I'm developing pressure sores on my hips. And if I spend anymore time in this damn wheelchair than I do the edema in my feet will prohibit me from wearing any footwear at all. Unless I buy size 14 sneakers for my size 10 & 1/2 feet and I leave the laces untied! And I've already had 2 pressure sores on the bottoms of my feet that I healed myself... personal transportation and treatment at a wound care center is only for the wealthy. I guess because I'm poor and Medicare doesn't pay for the above "luxuries" that I wrote about and I can't afford special hand-crafted $500 shoes that my chances of recovery are less than someone who has the "same" injury but is formally educated and wealthy?

    Doesn't sound quite like the Dr. Wise Young that I "know".

    Bob.
    "Be kind, for everyone you meet is fighting a great battle." - Philo of Alexandria

  9. #9
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    Dr. Young,
    Thank you for these words. I agree totally, organization and money is truly what are going to make the difference in the time frame. There seems to be numerous organizations and foundation doing good things for SCI and of course there is the Christopher and Dana Reeve Foundation but everything seems disjointed to me. We, as a community, need to sharpen our focus and fine tune our message. The biggest question for me is after the clinical trial network is put in place, God willing, how do we as a community decide where we dedicate collected research money? Let us say a group raised 10 million dollars and we want to put this into clincal trials, how do we do this?
    Do we need our own review board? How do we establish criteria? How do we decide where we are going to get the biggest and fastest bang for out buck?


    Chuck

  10. #10
    Dr. Wise,
    In 1962 a cure seemed a much simpler thing to do.
    Paralysis 101. Polio.

    There wasn't all the electronic information that contradicts itself over and over again.

    We spent months into years having corrective surgeries, recovering from corrective surgeries and rehabilitating. WHEN in the recovery stage you know what we did? WE READ. Everything and anything we could get our hands on in anyway possible.

    Many of those books while in hospital came off the shelves of the medical providers. WE actually learned what happened to us. And actually genuinely believed it could easily be rectified.

    YES, we were wrong. BIGTIME.
    BUT how is it a disease that affected one set of cells primarily..ONE set..be so very difficult for all the educated and wealthy of the most educated and wealthy country in the world to fix?

    Science and scientists also abandoned US.
    WHY? How many plug nickels will you be granted to study a cure for a disease that has been CURED?


    We would have gladly been guinea pigs for transplantations of anterior horn cells obtained from a monkey or a goat.

    I would even have bought the damn goat for them.
    Just to see if maybe it would work.

    It's not 1962 anymore..there is PLENTY of money and PLENTY of education..which your right is vital and necessary. BUT something is missing some intrinsic value.
    Life isn't about getting thru the storm but learning to dance in the rain.

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