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Thread: Want a Cure?

  1. #21
    Quote Originally Posted by lynnifer View Post
    Worse neuro pain. Tumours. One death can shelve a potential therapy for decades (4-ap). The do no harm clause.
    True but if that happens the treatment was obviously not safe and ineffective anyways so those decades could be put to better use on a more effective treatment.

  2. #22
    Acorda Therapeutics canceled the Fampridine-SR (a.k.a. 4-AP) Phase 3 SCI clinical trials because they were losing money.
    Two serious adverse events that were judged potentially related to treatment and led to discontinuation were anxiety in one subject and a seizure in another subject that was observed during an occurrence of sepsis associated with a urinary tract infection. No deaths occurred during the study. One death was reported for a subject five weeks after the last on-drug study visit. This death occurred outside of the protocol time window for reporting adverse reactions and the cause of death is not known at this time.
    The test of success is not what you do when you are on top. Success is how high you bounce when you hit the bottom
    --General George Patton

    Complex problems need to be solved collectively.
    ––Paul Nussbaum
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  3. #23
    And the larger inescapable consequences, the very reason why biotech's and many big Pharma abandoned the neurological field like the plague last decade and stopped investing in treatments and therapies...

    They expect a return on their investment and cannot finance one risky venture after another when millions are at stake or something goes wrong in the human trials. They're risk adverse, but luckily Ampyra pulled it out for Acorda in the MS population. Acorda now has nothing listed in the pipeline for SCI at all even though that was the premise for the company being founded in the first place. http://www.acorda.com/products/pipeline.

    It takes time to perfect a drug or therapy and run assay's to make a therapy the best it can be. It has to be able to cut the muster when submitted to the FDA. That's why good basic research and proper injury models are so terribly critical in the labs in the first place. It's become more difficult and more expensive as time goes on. The only way to know is by utilizing basic research strategies in the lab with ongoing in vivo testing in rats, larger mammals and good outcome measures built into the human trials. We can no longer expect Pharma to throw their investor/shareholders money at SCI with little promise. They simply do not part with it very well. Their successes are being much more calculated than previous years and everything is scrutinized to the maximum before a dollar is invested.

    Presentation: John Reddington PhD, DVM, Chief Operating Officer of Cambridge Biomedical. John discusses recent regulation changes by the FDA for LDT's in the future.
    Last edited by GRAMMY; 01-02-2015 at 10:06 PM.

  4. #24
    Doesn't the government fund research? Doesn't the government fund the NIH? Corporations have no conscience, only profit and loss statements. The purpose of the government is to solve problems that small groups or individuals cannot. God help us if we have to depend on corporate America.

  5. #25
    I'm beginning to think the government should step in to promote R&D spending in the bio-science industry more. Especially for low population diseases such as SCI's. If there were special tax breaks or low interest government sponsored loans available for companies, big & small; to research, develop, & deliver treatments I think industry and investors might be more favorable to get the ball rolling again in our direction.

    It's all about waging a dollar on the stick in front of a buisnessman's glasses. Companies, no matter how humanitarian they are, need to make a profit, bottom line and the bigger return on investment the more interested they become. This is why so much technology has progressed in the pain, cardiac, and diabetic fields, larger populations with long term complications to treat.

    Thoughts?

  6. #26
    Senior Member lynnifer's Avatar
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    Regarding Acorda, I was going way back before they even picked up on 4-ap. I believe there was a trial in Switzerland and a woman had a fatal brain seizure. That was the end of that for well over a decade.
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