It's been a just a day since Dendreon announced that the interim analysis of its Provenge anti-prostate cancer candidate showed some -- but not enough -- improvement in sufferers, and already the drug's army of web activists is heaping abuse on those who suggest that possibly, just possibly, this drug isn't going to get approved by the FDA.
Dendreon said the drug lowered the death rate in its 500-person study by 20 percent -- not bad, except that the FDA wanted to see a 22 percent reduction in order to end the study early and put the drug on the fast-track for approval. As it is, Dendreon must take the study to its full term, and those results won't be due until 2009. Back story here.
In the meantime, three things have happened:
- The stock has gone up -- so lots of people clearly think Dendreon is going to pull this one off.
- Analysts have sounded words of caution.
- The community of web activists who follow Provenge with religious zeal have taken to the bulletin boards to chastise anyone who dares ask questions about this drug.
Not as good as it could have been, nor as bad as it could have been. -- Paul Latta of McAdams Wright Ragen.
We maintain our view that any meaningful survival advantage of Provenge treatment would become apparent only upon final analysis ... We assume a 50-50 likelihood that the trial may demonstrate a survival benefit upon final analysis. -- Joel Sendek of Lazard Capital Markets.Those seem like the reasonable, cautiously optimistic comments of people who know how hard it is to get a drug approved by the FDA, and that even very promising drugs turn out to have hidden trapdoors that can kill off their chances at the last minute.
But not to the pro-Provenge crowd. Unlike most other drugs, Provenge has taken on the aura of a cause for some. Those folks have taken to the net to pour boiling oil on anyone who dares criticize Provenge. Here's what they're saying in reaction to yesterday's news:
APPROVE Provenge NOW and save 83 men per day from a horrible death! DO THE RIGHT THING, APPROVE PROVENGE NOW!!! May God Bless all those who fight to right this terrible wrong.Matt Herper at Forbes dared to suggest that with only 500 patients in the trial, perhaps it was not large enough to provide the kind of statistical robustness that will pass muster at the FDA. Big mistake, Matt! Check out what people wrote on his comment boards:
your report was far from neutral. There appeared to be a deliberate effort to put a negative tone to the interim result.
Since such patients will likely die in a short period of time, treatment options, even if unproven, are often desired by such patients. This is understandable, because at such a severe stage of illness, such as prostate cancer, possible extension of their lives with comfort is worth it to them, regardless of lack of evidence of proof of whatever treatment that may be advantageous to them regarding these issues.
Mr. Herper: One can only conclude you are short DNDN, or represent the interests of those who would want to thwart a therapy that gives hope to prostate cancer sufferers - that would be the chemo establishment.That's nothing compared to the time a few months ago when Herper suggested that the interim analysis itself might not be all that useful. (Note, he turned out to be right.) Here's what the Provengistas said then:
You need to start thinking what is best for the Men who are DYING instead of Manipulating the Market. What will you say about ALL the MEN that have DIED after this is approved?Some of them have even decided that Provenge works regardless of the evidence. Here's what one person wrote after Joe Tartakoff of the Seattle PI suggested that Dendreon's Q2 conference call was a non-news event:
Your article is much like your writing ability.....its garbage!
ALL I CAN SAY 2 ANYBODY THAT BELIEVES THE IMPACT DATA TRAIL WILL FAIL IS U ARE A COMPLETE IDOT!!(Spelling in the original.) And this is in a trial to which the company itself is blinded ...