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Thread: Millions of Americans Living With Paralysis Provided Hope with the Introduction of the Christopher Reeve Paralysis Act of 2003

  1. #21
    Senior Member DA's Avatar
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    instructors 700 level college classes never gave us so few pages in so much time 6 months.
    i dont get it dr young. sounds to me like more cow milking.


    animal use? i thought this was a human trial network. more cows and more milking. animal trials mean more waste of time because after the animal trial the excuse will be "what works in animals may not work in humans".
    THEREFORE MORE RESEARCH IS NEEDED.

    i can go on about your whole post but its obvious we are in a no win situation. the speed bumps are getting bigger and the system refuses to go around them.

  2. #22
    Senior Member mattcorregan's Avatar
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    DA,
    If only you knew how uninformed you were, you would be shocked and embarrassed at your comments.

    Where to start..... Dr. Young has over 20 years of experience in the field of SCI research. He is very familiar with the process of moving a drug candidate through research and development and on into phase 1, 2, and 3 clinical trials. That process is easy to say in a sentence, but takes years to accomplish with the coordination of literally thousands of people. Initially, research is conducted in an academic lab, state or federal agency (i.e. NIH) or in a company's lab that is funded by their own research pipeline. If the drug candidate shows promise, it can then possibly be picked up by a large pharmaceutical company, or a startup company can be developed around the new drug candidate, or a whole host of other possibilities. This process alone can take 5 to 10 years or more.

    Then the development phase begins. Now we are in the FDA regulatory compliance world!! And it only gets worse with each successive step. You have to work in the industry to understand the massive amount of work required to develop a drug candidate and manufacture product for clinical trials. The safety, efficacy, and integrity of the candidate needs to be determined. In order to do this, other things must happen first. Assays, processes, equipment, and infrastructure of the facilities need to be validated. Raw materials must be approved and tracked. Personnel need to be trained. Each of these things are performed by entire departments of people. All activities must be strenuously documented, signed and approved. Then characterization of the candidate can begin, stability studies initiated and hopefully introduction of the candidate into animals for safety studies (phase 1). Then things move on into phase 2, phase 3 and into approval in a similar fashion, but the FDA noose tightens a little more, and of course safety in humans and efficacy must be shown.

    Why all these "speedbumps"? Companies don't want to harm people, be litigated against, and flush all their hard work down the toilet and and piss off their investors(if their public). Also, the FDA requires it. I could continue on but I'll spare you, I think you get the idea. I share your frustration at the tedious process, i'm a C-5 incomplete quad who would give my left nut--hell, both my nuts-- for a cure, but the "system" is a necessary evil and all we can do is stay as involved as possible.
    Matt

  3. #23
    Mattc

    hey, don't give both your nuts - you might want them when there's a cure

  4. #24
    Senior Member Leo's Avatar
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    Ok! Back to the intent of this post we need to contact our legislators, get them to sign on and make it to the news conferance!
    WHEN: Wednesday, May 7, 2003 2:30 p.m.

    Answer me this at WHERE: what's TBA stand for?

  5. #25
    Senior Member DA's Avatar
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    mattc...thank you i now see the light.



    mattc go research other diseases and ailments then you will see the differences and how others find short cuts while sci field find long cuts. let me give you a few examples. 4 years ago they used stem cells for sci. the stem cells didnt work(long story short). now, they refuse to use oeg because they think the stem cells are working now. who cares, figure it out later, start the trials. cancer drugs go to trials with 1% of the data needed for sci. another is 4-ap. mattc name 1 other drug that has been safe and effective as 4-ap but still not approved in 14 years? just 1 mattc. 1. one. una. eechi.

  6. #26
    Senior Member Max's Avatar
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    Christopher Reeve Paralysis Foundation Awards Almost $2M in Individual Research Awards

    [This message was edited by Jeff on 05-01-03 at 02:18 PM.]

  7. #27
    "Answer me this at WHERE: what's TBA stand for?"

    To Be Announced.

    -Steven

  8. #28
    wait...I'm really confused here. Procedures using stem cells are being used for a specific population of blind people with excellent results. This is happening today, before a widespread clinical trial has even started! The NY Times article says that there are a couple hundred of these procedures done anually.
    Unless the NY Times dabbles in science fiction, where were the 10 years of approvals, then to get FDA certified..which is another 10 years at best! This is cutting edge technology being used, so these therapies have not been through a 10 year grinder!
    I just guess blind folks are an exception to the endless red tape Mattc listed. This proof of the relative speed undertaken in these therapies has not even begun phase 1, 2, and 3 clinical trials yet and there are people being treated Goddamnit!
    You cannot argue that sci, being the exception, needs the 10 years to initiate phase 1 trials when the mentioned above has sailed through.

  9. #29
    I have heard that it will be next Wednesday afternoon and I will be there! It is in the Rayburn building.

    Has everyone seen the online chat with CR on the 9th regarding this Bill? If not I can post the chat time and link if people are interested.

    "Don't worry about the world coming to an end today.
    It's already tomorrow in Australia!"----- Charles Schultz


  10. #30
    Senior Member DA's Avatar
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    bent it happens all the time. i have posted many examples of this double standard.

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