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Some of the Dirty Secrets: Hurdles for SCI Cures

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    #16
    The guy has no disease, I assume, so he can afford to joke about it..........

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      #17
      Originally posted by Wise Young View Post
      I am disappointed.

      Juan Enriquez paints an exceedingly negative picture of the pharmaceutical industry and even makes a joke out of it. These problems of the pharmaceutical industry are well known. There is no question that the system is not working well. The industry itself has said that they cannot continue the way they are going. There are too many people grousing and few people actually doing something about it.

      By the way, the examples that he gives are exaggerations, unusual, and not normative. He gives thalidomide and table salt as examples of how fear of negative side-effects paralyzes the regulatory agencies, increases costs, and kills people. Both examples are misleading because FDA has approved thalidomide for several conditions and table salt has obviously not been banned by the FDA.

      The FDA is not the monster agency that he paints it to be. It is an agency that has been given the charge of protecting people but by people who expect all medicines to be safe and always look for scapegoats when things go wrong. Decisions made at the FDA are made by experts in the field. To change the FDA, we must change the experts. It is the culture in which we live. It is obvious. If the goal of FDA is to assure total safety, then most of the drugs will not be or will take a long time to approve.

      The problem for spinal cord injury is not the FDA. It is the lack of commitment by our community, our government, our industry, and our doctors to do clinical trials to determine whether therapies are safe and effective. If a therapy is not safe or is not effective, we need to know and avoid that therapy. If is has side-effects but also some benefits, we need to know. If it works and is safe, that would be great but we can't always be lucky.

      In my opinion, Congress should commission a study of the FDA to find out which of its regulations are most costly and slow down approvals the most without increasing the safety or efficacy of the treatments that it is considering. [In the same way, I believe that Congress should commission a similar study to determine which regulations of Transportation Security Administration are effective and actually prevent terrorist activities]. The regulations that don't work should be jettisoned.

      On the other hand, I have generally found the FDA to be full of reasonable and hardworking people who are honestly trying to protect the public and get drugs tested as efficiently and as rigorously as possible. For every horror story that one hears about a drug taking years to get approved, there are probably dozens of drugs that were found to be unsafe or ineffective and consequently were stopped for the lack of evidence.

      Wise.

      Wise,
      did you apply to the FDA to do the clinical trial in Austin?

      Paolo
      In God we trust; all others bring data. - Edwards Deming

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        #18
        Originally posted by paolocipolla View Post
        Wise,
        did you apply to the FDA to do the clinical trial in Austin?

        Paolo
        Soon. We are still waiting for the safety data to be completed from the ChinaSCINet trials.

        Wise.

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          #19
          Originally posted by Wise Young View Post
          Soon. We are still waiting for the safety data to be completed from the ChinaSCINet trials.

          Wise.

          Do you know approximately how long that will take?
          "That's not smog! It's SMUG!! " - randy marsh, southpark

          "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


          2010 SCINet Clinical Trial Support Squad Member
          Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature

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            #20
            Originally posted by lunasicc42 View Post
            Do you know approximately how long that will take?
            We were hoping to have the phase 2 trial in Kunming and Hong Kong completed by Christmas but we are only three-quarters through. Due to Christmas and the Chinese New Year, we probably won't be able to do any patients between now and February. We will restart the trial in February and hopefully will complete recruiting all the patients by March. We then have to wait for the 6 week followup for all the safety data. So, we probably won't be able to submit the IND to FDA until April 2012.

            Wise.

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              #21
              pr y a t'il des nouvelles recrues a hong-kong a par les 8 opérais

              merci

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                #22
                Originally posted by Wise Young View Post
                Soon. We are still waiting for the safety data to be completed from the ChinaSCINet trials.

                Wise.
                Why the FDA require you the safety data form ChinaSCINet?

                Isn't there enough studies about UCB and Lithium for the FDA to approve the trial?
                If that is the case then the FDA is the problem in this case or I am missing something?

                Paolo
                Last edited by paolocipolla; 15 Dec 2011, 8:45 PM.
                In God we trust; all others bring data. - Edwards Deming

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