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iwfal

04/02/12 10:16 AM

#139590 RE: DewDiligence #139586

Median values ought to be banned from all serious discussions of biostatistics, including those occurring at FDA advisory panels. From a mathematical standpoint, medians have no more inherent worthiness than any other arbitrary cross-section of the K-M curves.



Couldn't agree more. Interestingly, Merck (the rida sponsor) tried exactly that approach in their pre-briefing material to the AC - they graphically pointed out all the other decile-ians. Obviously it didn't work.

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DewDiligence

06/24/12 6:42 PM

#144391 RE: DewDiligence #139586

Rob Waters, Forbes’ new medical columnist, doesn’t think much of Provenge, evidently:

http://www.forbes.com/sites/robwaters/2012/06/22/medical-radiation-and-cancer-patients-take-the-risk-in-game-of-russian-roulette/

We all want scientists to create new therapies that can save lives and improve the prospects and lifespan of cancer patients. I’ve written about the potential of antibody-drug conjugates including Genentech’s T-DM1 and Seattle Genetics’ Adcetris.

But I worry about the hype. The military metaphors and often-breathless enthusiasm that greets so many new high-tech therapies remind me of the global arms race and the exorbitant cost of developing and building increasingly sophisticated weapons. In both cases, enormous amounts of money are spent developing powerful technology to tackle problems, while prevention is all but ignored. The result in the world of biotech are therapies like Dendreon’s Provenge, a complex, high-tech treatment that extend the lives of prostate cancer patients by four months at a cost of $93,000. Small wonder Provenge is fighting to gain traction with doctors, patients, payers and investors.

As so often happens in writings about biotech, Waters cites the median survival benefit rather than something more meaningful such as the hazard ratio.

The main body of the article is about the cumulative radiation risk from CT scans.