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Biotech / Medical : ZymoGenetics ZGEN -- Ignore unavailable to you. Want to Upgrade?

To: rkrw who wrote (184)	8/20/2009 12:14:45 PM
From: Steve Lokness	Read Replies (2) \| Respond to of 210

Read the release a little closer, they say "can" lead to death. It's not 25 deaths. Oh I know that - and I don't think it is likely there was many. Maybe even only one? But with more awareness they will be looking at this more carefully. I agree it is likely to be pulled .......now ......... but these stories have a way of growing if there is any truth to the problem.

To: rkrw who wrote (184)	8/22/2009 11:32:57 AM
From: Clarksterh	Respond to of 210

Read the release a little closer, they say "can" lead to death. It's not 25 deaths. Agreed. But my guess is that that is from studying substantially less than 1 percent of all surgeries in the US. (the studies, and there are several, typically are of the form of one institution for a fixed duration - because of the difficulty in ensuring all post surgery bleeding problems are tested for Factor V antibody problems). My guess, based upon the rate of issues seen in some of these studies, is somewhere between 10 and 100 people die every year from this. It's not an epidemic. But neither is it completely inconsequential (the FDA has acted on death rates this low before). I think its unlikely the fda will pull bovine thrombin from the market. Agreed. But they might put out an alert and change the black box. I need to read the referenced paper (again? I don't remember if I read it in its entirety the first time). If it does some epidemiological calculations with meat I think the probability of serious FDA response goes up substantially - essentially Zymo is calling the FDA on the carpet about the fact that they have their head in the sand wrt the routine ingoring of the black box label. That's why i say it's a marketing ploy, I'd suggest it is more than that - depending upon how the FDA responds it may also kick start some lawsuits. Which would likely have a huge effect on market share. they need an angle to make up for their price premium They did not have a price premium if the hospital was willing to sign a contract. That might change, but the contractual plans explicitly made sure the hospital didn't lose money on the switch.