I'll be out of the office for an extra-long holiday weekend, so I'm emptying out the blog inbox before I go.
Nick Stavriotis sent an email to clarify his previous incomplete statementregarding the FDA's "overrule" of the Dendreon Provenge advisory committee recommendation:
"...my words should have said 'refusal to follow an overwhelming AC recommendation for approval of a drug for an end-stage disease is unprecedented.' And it is; and that was what I meant re.the terminal illness reference. The record is quite clear on this, and the FDA move to overrule is, in fact, unprecedented. Apologies for any confusion…but there should be no confusion that this move by the FDA demands, begs the question: Why overrule your panel now? The FDA has never overruled an overwhelming AC recommendation for approval of a drug for an end-stage disease...making the FDA's action 'unprecedented.'"
And, of course, his isn't the last word on the FDA and Provenge. Bill Stroud says:
"I am one of those whose life might be extended by Provenge. I have just turned 65 and I have advanced prostate cancer that has spread to my bones. Chemotherapy will be tried, but it is not likely to do much good. Death from the spreading cancer, and not a particularly pleasant death, is inevitable. I am willing, even eager, to try Provenge, even if the FDA suspects that it would not be good for my heath. I think of myself as a drowning person, still hoping someone will throw me a lifeline. I see the FDA as a man standing nearby on a boat holding a lifeline, but hesitating to throw is because he's wondering, 'What if the rope breaks?'"
And Lori Gluth who I quoted in the mailbag post last week sentanother communication including the disclosure that she has made a "relatively small monetary investment" in DNDN. Gluth says the Seattle biotech and its developmental drugs "has become a passion. When I first was involved with DNDN the story sounded great from an investment perspective: a new cancer treatment that will revolutionize cancer treatment. How many families suffer the pain of losing someone far too early because treatments that may help them are not accessible?"
Well, this week at at Lance Armstrong's LivestrongPresidential Cancer Forum in Iowa many of the candidates who showed up endorsed the idea of improving access to promising experimental oncology drugs. For example, Senator Clinton said, "I think we have to balance speed and safety. I think we've got to give people informed consent, but let more people make this decision for themselves."
And my report last week on the seniors sex survey and how it spells opportunity for big pharma generated an email filled with WTMI (way too much information) from a W. Kindig, but here's a reprintable excerpt that gets to his point that he doesn't like any of the erectile dysfunction drugs because of their side effects.
First on Pfizer's Viagra:
"The extreme flushing, the bright blue vision and the feeling of the worse hangover imaginable was enough for me."
And then on the other two from Lilly and GlaxoSmithKline,Schering-Plough and Bayer:
"I tried Cialis and Levitra and hoped that the side effects would diminish with repeated use but that didn’t happen. So I’m in that large group who has tried the product and will never use it again, at least, until the side effects, particularly the 'hangover effect', is largely eliminated."
And while we're on the topic of impotence pills. An unidentified woman wrote to say she's a fan of the new "Viva Viagra" spots I blogged about recently. She didn't say if she works for Pfizer or the agency that made the commercial:
"The "Viva Viagra" ad is one of the most effective (from a woman's point of view) sponsored by this type of pharmaceutical. It isn't sleazy or suggestive or dismayingly clinical. It looks like a bunch of really good ole boys who are genuinely interested in getting home to their spouses or partners. I especially like the line "she's my one desire." Fidelity is rarely touted these days, and I appreciate it, even if I wasn't all that keen about the early advertising. (Who are all those decent-looking if ordinary forty-plus men?)"
Dear Anonymous: I have no idea. Actors, I suppose, who will now be able to put the national "Viva Viagra" commercial on their resumes and will forever be the target of taunts and ribbing that they sang about Viagra on national TV.
Questions? Comments? Pharma@cnbc.com