It is becoming increasing obvious that Wall Street and others are trying to bring political pressure to bear upon the FDA by spinning an FDA decision in favor of Dendreon's (NASDAQ:DNDN) Provenge as a compromise in their ability to review future drugs. I do not buy this argument one bit.
Provenge is a very unique situation: compelling survival potential, very low side-effect profile, no reasonable treatment alternatives, and a treatment population with an extremely poor prognosis for survival. How many treatments that come before the FDA fall within this category? Frankly, if they choose to view FDA support of treatments with a 39 in 40 chance of being effective in prolonging the lives of patients without any reasonable treatment options and poor prognosis for survival, then I believe most will agree that such a compromise within the FDA is long overdue.
The bottom line in this decision boils down to whether it will do more harm to patients to offer this treatment now and find out later that it less effective than originally thought, or offer it a few years from now after confirming that it is effective. Since Provenge does not limit additional treatment options such as chemo and has an extremely low side-effect profile, my personal view is that there is zero harm in offering it now. But, to withhold treatment for years only to confirm that Provenge is effective WILL result in tens of thousands of lives cut short because this treatment option was not available for patient consideration.
However, if this argument is not compelling enough, the catalyst a Provenge approval will represent within the industry towards pursing and financing new paradigms in cancer treatment cannot and should not be ignored. This decision is bigger than Provenge and bigger than Dr. von Eschenbach. I truly believe Dr. von Eschenbach knows this and is willing to accept the future consequences of his decision, even if in the 1 in 40 chance (1 in 40 chance according to the FDA statistician in the Provenge briefing documents that Provenge's success is due to chance) Provenge proves to be less than promised in the future, because in the end he can accomplish more towards his goal of curing/controlling cancer by 2015 at this moment in time, with this decision on Provenge, than perhaps any opportunity he will ever have.