Last year we were desperate to get my Father into a liver
Last year we were desperate to get my Father into a liver cancer trial. (Liver cancer is always fatal.) He was accepted into a study using inter-lesional injections and one of the things we were told was that if he responded favorably, he could get additional injections if necessary until his situation resolved, one way or the other. I agree that sounds somewhat illogical since it would seem to indicate that the study parameters were somehow open-ended. (i.e. The injections might have decreased the tumor burden but not illiminate it, thus necessitating continuing injections for the rest of his life. Such an outcome would still be a huge improvement over the current standard of care but how could they report the results so that they could advance to later stage trials?) Unfortunately my Father fell and hit his head. By the time he recovered from the brain bleed his cancer had grown to the point that he was no longer eligible for the trial. We lost him a couple of months later.
I can only assume that such eventualities were somehow covered in the original study parameters. And I certainly hope that anyone who was being helped by Kevetrin is still able to continue taking it. The fact that those who were accepted into the Kevetrin trial at lower doses were allowed to continue in the trial and participate at higher doses if they wished, gives me hope that the study parameters did not call for cutting them off cold turkey.
"Without getting a direct answer from the company one can only make an assumption. Mine currently, be it right or wrong, is that drugs used in a STUDY that have not yet been FDA approved cannot be given LEGALLY to anyone outside an authorized study. That even includes participants in a now close PHASE trial that have and could benefit from continued use of a developmental drug. That may seem a bit harsh but laws and regulations are in place to protect us even if at times they do not. This is of course an OPINION as I am not up on FDA regulations. Am hoping I am missing something." - NotRichYet2
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