<<From Scher's letter on DNDN panel - "More important, and perhaps underappreciated during the discussion, is the recognition that the “placebo” used in this trial, a portion of the leukopheresis product that is cultured without the immunizing antigen and reinfused, may not be inert and in itself contributed to a relative worsening of survival for the control group in this tri"
I actually posted a question with regards to a possible negative placebo effect a while back before the meeting. Surprising it took so long to rear its head up. Still interested in the science and rationale behind placebo selection for different selection.>>
One of my biggest pet peeves was DNDN not releasing the final three-year placebo arm breakdown for the 9901 or 9902A trials between the placebo crossovers and the placebo non-crossovers. In the Sept 2003 interim data release, for the patients who had either completed three years after randomization or had died, the median survival for the placebo crossovers was 23.9 months, and the placebo non-crossovers 19.3 months. Based on this information and the final 76% rate of crossovers in the placebo arm, I believe that the median survival difference may have widened for the final tally in October 2004, as the final median survival for the entire placebo arm was 21.4 months.
I just don't understand why these numbers were not part of DNDN's package. They are pretty convincing to me.
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