Replies to post #4467 on Dendreon Corp fka DNDNQ

[SaulK]

Copied from Ivillage:

Here's a copy of the letter I just emailed to the editor and copied to Stein:
To the Editor--
It's great you are covering the FDA's refusal to approve Provenge, the first of its kind immunotherapy vaccine for late stage prostate cancer. It is the last hope for many men dying of this widespread disease and has been shown in two phase III trials to meaningfully extend lives with practically no side effects--unlike Taxotere, the only other approved treatment, which half of men reject because of its harsh side effect profile (which can include death).

I only wish your article were more on the lines of an investigative piece, and did not read like the "balanced" he-said, she-said journalism that sadly passes for good reporting in most other papers.

The fact is the FDA expert panel voted unanimously that Provenge is safe--a vote of 17-0--and 13-4 that there is substantial evidence of its efficacy.

It is also a fact that two of the dissenting voters, Drs. Scher and Hussain, were on the panel pursuant to conflict of interest waivers because they both conduct research for companies with products competing with Provenge (including Taxotere--mentioned above). In fact barely two months after Provenge's rejection by the FDA, Novacea, a company with a different competing treatment for prostate cancer whose lead investigator is Dr. Scher, announced a multimillion dollar partnership with Schering-Plough, to seek approval for and market the competing drug. Dr. Scher was very quiet about this obvious conflict--which one would have expected would disqualify him from making recommendations about Provenge--as he instead actively lobbied against Provenge. Novacea's share price doubled on the news. Dr. Scher's conflict of interest waiver on file with the FDA discloses ownership of significant shares of Novacea.

In light of these facts your readers may have had somewhat less sympathy for the poor doctor, harassed by dying men who wanted Provenge.

It is also unfair to dredge up the Vioxx and Avandia controversies in a discussion of the delay of Provenge approval. First, as above, the panel voted unanimously that Provenge is safe--which included the votes of Drs. Scher and Hussain. Second, standards of safety are very different--and should be--for drugs that are intended as treatments of last resort for terminal illnesses and those that are intended for chronic ailments in the general public.

Men who are dying should be allowed to make their own choices regarding whether they wish to risk any known side effects of a drug that has been shown to extend lives. In fact Provenge's only known side effects are mild flu like symptoms for a couple of days.

The FDA statisticians testified that there was only a 1 in 40 chance that the trial results showing Provenge's effectiveness resulted from random chance. A 97.5% chance of effectiveness seems like a pretty good risk to take for dying men. How exactly is the FDA serving these men's interests by denying them this chance to live?

I hope you will follow up with a more in depth piece.

Saul Kerpelman