October '02 | briefing | mail | don't say this | flakers' jargon | flaker creativity | articles | other places | archives | send mail | ed dewke | legal stuff | order | search | 2001 Ed Dewke

Recent Developments with Raptiva
from Linda D.

Have you seen any news articles regarding "Raptiva"?  There was one in the Los Angeles Times stating they anticipate year end application submission for FDA approval.   I was in a trial on this one, it was helpful — lessened lesions but did not clear, however reduced pain and discomfort to a bearable level.  The article went on to say that Johnson & Johnson and Amgen are seeking to market Remicade and Enbrel for psoriasis treatment.  Hope so - if Remicade is approved for P then maybe the cost will decrease. –Linda D.


Ed’s Response:  A news item no doubt derived from the same source as newspaper articles that appeared in mid-September is posted now at the National Psoriasis Foundation web site —  (http://www.psoriasis.org/raptiva-sept02.htm).  

In short, Genentech and XOMA posted findings from another Phase III trial of Raptiva.  Evidently the FDA requested this additional trial because the efalizumab (formerly aka Xanelim, now aka Raptiva) used by the two involved companies had some slight differences.  This study, as the previous Phase III trial, indicated that 75% more of the patients treated with Raptiva experienced improvement of their P than did an equivalent number of patients treated with a placebo. 

One of the things I learned at NPF 2002 in Orlando in August is that the formal expression of these statistics is not easily interpreted by laypersons such as myself.  I left confused about how to understand percentages expressed in FDA-required study findings.  I am disgusted by the scientific and governmental community that perpetuates this ambiguity.  (What is it they say about “statistics lying”?)  When I find a concise understandable explanation of how to interpret the expression of  percentages in these findings, I will gladly share it here.  In the meantime, I’m inclined to think of many of these researchers — and the professional employees of the Food and Drug Administration — as snake oil salesmen wearing fashionable scrubs. If I sound irked, it’s because I am.  But certainly not at you, Linda. -Ed

This Month's Mail | Archives