Fred Levine: 360,000 pages of data were submitted to the FDA from Imcl about the Irinotecan/Erbitux combination treatment trial in alleged irinotecan subjects and the only claim was "tumor shrinkage", not saving lives. Even that goal was not proven. FDA rejection of application means NOT PROVEN efficacy.
The clinical presentations are as honest as the company presenting it, AND the best is presented, the full data is not, the public TRUST that the presenters are honest. The FDA has a big hand on all aspects of the trials.
AND your 5 out of 18 who remitted completely (part of the combination or solo trial?) does not mean survival, it could be so or not, it is not prove.
Survival is measure usually at 5 years, less for terminally ill subjects. To investigate a cancer drug like Erbitux takes many years. The FDA allows that shorter trials are accepted EVEN the ones with lack of concurrent placebo control subjects and blind assignments like the Erbitux trial was, it is a measure to help save lives until further proofs are confirmed later during marketing phase. But, Imcl abused it to hype and dump stock, at best to irresponsibly mismanage the trial.
You can not have it both ways, Imcl is great, Erbitux works, Sam is astute, Saltz is prestigious and brilliant but when the whole combination produces a mismanaged trial that DO NOT provides the evidece of efficacy THEN the Fda is the problem. |
