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    • #18207
      Richard
      Participant

      Biogen indicated; if they provide the drug to patients who are not involved in clinical research, the research conducted on subjects randomized to receive placebo treatment is unfair.

       

      https://topic.echemi.com/a/bojian-refuses-sympathetic-use-of-experimental-als-drugs_145528.html

       

      Is Biogen correct in their thinking?

       

      Richard

       

       

    • #18220
      Richard
      Participant

      Their decision is like putting a stumbling block before the blind.

       

    • #18230

      I blogged about it on padiracinnovation.org but Tofersen is not a drug targeting ALS, it is targeting a subset of people having SOD1 ALS. So the people who may benefit from it are less than 2% of ALS cases.
      It’s already extremely difficult to find enough pALS that meet all requirements, finding people meeting rare conditions makes conducting clinical trials even more complex. I suppose that if Biogen provides Tofersen under compassionate use, they could stop their clinical trial today as pALS who progress will quit the trial. No one will gain if this happens.

    • #18231
      Richard
      Participant

      Thanks for the info.  No simple solutions.

       

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