Parkinson’s News Forums Forums Parkinson’s Research Potential Parkinson’s Therapy Evaluated for Safety in Trial

  • adrian-hobden

    Member
    April 29, 2019 at 2:07 pm

    I don’t think a researcher should ever use the word ‘safe’ to describe a compound being tested in a Phase 1/2 trial. Indeed, the FDA looks very unfavorably on a company using this word. The FDA makes the decision whether an experimental compound is ‘safe enough to be approved’. ‘Generally well tolerated’ suggests some side effects so how can they decide the compound is ‘safe’? As far as the compound is concerned, it is obviously desirable to treat the symptoms of PD but the holy grail has to be slowing or even stopping disease progression. I think efforts in that direction should be the focus of this forum.

  • Deleted User

    Deleted User
    April 29, 2019 at 7:34 pm

    Thank you Adrian for your comments.  I agree, there are way too many drugs with side effects that are supposed to ease our symptoms.  I too wish more focus was put on stopping or slowing progression, but then again, Big Pharma would probably  lose their revenue stream.

  • adrian-hobden

    Member
    April 30, 2019 at 5:11 pm

    Jean, Big Pharma have everything to gain from finding a drug to slow or stop progression. Patients would not be treated with the drug until they had started to shown symptoms and, therefore, received a diagnosis of PD. In those circumstances, patients would receive both the drug for symptomatic relief and the drug to stop further progression. Latest research in the area of progression points to the brain’s innate immune system as being responsible. The best analogy would be to an auto-immune disease of the brain but by a mechanism quite distinct from the adaptive immune system outside of the brain. This insight comes partially from research on the role of LRRK2 in microglia and astrocytes. You may be aware that an inherited dominant mutation in LRRK2 accounts for 3-4% PD.

  • Deleted User

    Deleted User
    April 30, 2019 at 5:14 pm

    Thank you Adrian for your clarification. I just hate taking drugs LOL

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