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Fisher Man

08/21/18 11:36 PM

#46000 RE: SAMNOTSAMUEL #45999

Thanks, that's helpful! If we put ourselves in the shoes of a patient who is going through informed consent, and imagine if we had the disease......and we knew that current choices for treatment were abysmal, and there was a new treatment that reportedly worked better...which arm would we want to be enrolled in?

Then imagine that if we enrolled, and were randomized to the other arm, the one we were not hopeful for......without hope for crossover. Would you enroll? I wouldn't, nor would I recommend it to my patients...I would recommend, and have, to travel abroad and pay for the treatment we already know is superior, even if it has not been "approved" by the FDA.

Therefore, enrollment suffers, and the company dies a slow death of shell games and lack of capitalization, even though approval for any use opens off label use for other cancers metastatic to the liver. I employ off label use of medications every single day...