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A glimmer of hope.
Forum: Amyotrophic Lateral Sclerosis Forum  
  • A glimmer of hope.   RRR Educational SilverFox   3y  6,730  
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    SilverFox
    Date: 12/17/2011 3:00:19 PM   ( 3y ago )   Hits:   6730

    Over the past six months I have been working with a group of terminally ill people. I was asked to provide some help when a drug, currently in Phase II clinical trials, provided not only a stop of the progression of this disease, but some people were actually regaining function that they had previously lost as a result of the disease.

    The drug is NP001. It is made from a chemical that many may be familiar with, sodium chlorite.

    The problem with a drug trial is that they exclude people from the trial. Efforts were made to broaden the acceptance criteria, some progress was made, but still many were left out of the trial. While the main reason was that they lived in an area that was outside the trial locations, another reason was the progression of the disease in their bodies.

    NP001 is administered via IV injection. I explained that there is more than one way to get chlorite into the body and that while it is not as efficient as IV injection, drinking a solution of chlorite will result in some chlorite getting into the blood stream.

    A group of these people suffering from this disease decided to run an experiment on themselves. Efforts have been made to get the medical community involved and these have not been totally successful, so far. They have provided support in the form of check ups and blood work designed to monitor for any adverse effects of participating in the experiment, but ethics and legal ramifications prevent them from getting too involved with this.

    A research neurologist was kind enough to explain to me that anecdotal evidence over a period of days to weeks is usually thought of as being the result of the placebo effect. However, anecdotal evidence that continues to show positive results with the same people over a period of months to years is much harder to dismiss as placebo. Testing done that supports the positive effect also helps. I was also informed that when the results are spectacular the general bias is to question the original diagnosis.

    This experiment is coming up on six months now. The positive benefits seem to be holding on, so I think there is now a glimmer of hope.

    Keep in mind that the group involved in this experiment is small. There are about 35 people that are openly vocal about it, and about that number again that are quietly participating. Also, not everyone is showing improvement.

    Not knowing a lot about this disease I asked the group this question.

    Chlorite is a free radical oxidizer. It does nothing to rebuild the body. What are you going to do to rebuild your bodies after the progression of this disease is slowed down or stopped?

    The answer I received was............. Well, the question was not answered.

    I asked again.

    This time I was informed that nothing had ever been successful in stopping the progression of this disease, so this question had never come up.

    During this holiday time it is very exciting to see this glimmer of hope permeate the group, and to see some of their focus change to how to rebuild the body.

    The changes are not drastic, but incremental. No one has jumped out of a wheel chair and started running down the street. However, to someone who has lost function in their hands or arms or legs, suddenly having some function restored and seeing this restored function continue over time is remarkable.

    On May 2 1939 Lou Gehrig benched himself after playing 2130 consecutive baseball games with the NY Yankees. His health had deteriorated to the point where he was no longer able to play well. Addressing the crowd before a July 4 1939 game, Lou Gehrig told people that he was the "Luckiest Man on the Face of the Earth." Two years later on June 2 1941 Lou Gehrig died of amyotrophic lateral sclerosis.

    ALS is the illness that the people involved with this experiment are suffering from.

    This glimmer of hope started with the drug trial that lead to the oral experiment. The purpose of the experiment is to help people live long enough to be able to use the drug. There appears to be a willingness of the FDA to speed things along, but the process will most likely take a few years and people who are diagnosed with ALS have an average expected life span of three years. I don't think the FDA can speed things along that fast.

    In loose side to side comparisons it appears that the drug is far more effective. The oral solution helps and seems to be able to halt or radically slow down the progression of ALS, but the results from the drug trial seem to be better.

    Six months is not a year, but it is more than a day or a week. Making assumptions on the outcome of a clinical trial in the middle of the trial is not the best thing to do. Extrapolating from the observations of a small group of people is also not the best thing to do. Still, I think there is a glimmer of hope.

    Chlorite is not a cure for ALS, but it does seem to provide something that people suffering from ALS have in very limited supply - additional time.

    If you know of someone that is has ALS, I invite you to cautiously share this glimmer of hope and have them watch the progress of the NP001 trial.

    Tom
     
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