To: Richard Huth who wrote (1397 ) 10/13/1998 9:03:00 AM From: NeuroInvestment Read Replies (1) | Respond to of 1491
FWIW, I was sufficiently concerned by what I feel was the excessively gloomy slant taken by BioCentury (a publication that I respect and enjoy greatly) that I contacted David Flores and Ilan Zipkin (the publisher and writer respectively). Regarding the points abstracted here from the article: 1)the article implied that previous PhII studies were equally appealing, only to collapse in PhIII. In fact, the studies tended to be smaller and not as well constructed (e.g. the Cambridge Neuroscience Cerestat PhII involved 38 pts, no control group, no statistical analysis possible...the first Cortech PhII involved 20 pts in a single hospital in Africa...). By comparison the PARS study was much more rigorously constructed and carried out; the results thus deserve more credence than those earlier studies. 2)the comment by Mr. Huth suggests that one less placebo death would have left the drug group with more deaths--not true, it was 5/3. I would agree that the small n, and the infrequent incidence of death, makes this a highly unstable measure in this study. 3) The BioCentury article quoted the press release regarding 'no difference in the highest outcome groups', which referred to the lack of difference between drug and placebo when it comes to the proportion falling into the good outcome and mild disability categories, the two GOS categories lumped together. It made no mention of the three month figures, the 6 month 45-37% contrast for the highest 'good outcome' category, nor did it mention the 38-13% contrast for the severely injured subgroup. To me, it seemed a selective reporting of results that was excessively negative. After all, the PARS release mentioned the lack of contrast using the two category criterion only to avoid appearing excessively positive. Big Pharma suitors will not be swayed by the tenor of the BioCentury article, so ultimately it matters little. But it was unfortunate that even a normally astute observer of the biotech scene could end up viewing this study through a skeptical lens so darkened by the legacy of other companies failures, failures from which Pharmos tried very hard to learn and improve in the design of this trial. NeuroInvestment (www.neuroinv.com)