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

To: Pancho Villa who wrote (1124)	3/31/1998 4:13:00 PM
From: WeirdPro Randy	Read Replies (2) \| Respond to of 1359

<<Three questions: <<Does the study decrease potential liability for the patients that may show damage from the version that was marketed?>> It will make it much more difficult to prove causality of damage...legally makes it a more difficult issue to bring to trial. <<Given the troublesome history of the initial approval, what are the chances the FDA ever approesl for the sustained release version.>> This study released today has nothing to do with looking to market the sustained release version of Redux. Anyway, neither AHP or IPIC would be looking try. <<I wonder what other experts will have to say about these results.>> The experts have largely been laughing at the Mayo clinic "study", this is the first true double-blinded study on this issue. I would think they are going to put great faith in this study compared to anything else available currently. <<And, who paid for this study? Seems to me that if AHP/IPIC paid there is a built in bias to soften possible valve anormality reading from the electro regardless of the group.>> AHP paid for it......and from beginning to end, nobody including the patients, knew what they had been given during this study. Hey!...that's 4 questions.

To: Pancho Villa who wrote (1124)	3/31/1998 4:31:00 PM
From: Thomas C. White	Read Replies (1) \| Respond to of 1359

Just a quick comment -- I rather doubt that on something likely to be subjected to this level of scrutiny, with a study conducted by one of the more prestigious authorities in this area, that you will find anyone softpedaling the results. It would be too difficult because of the enormous attention. Probably what I would speculate is that Wyeth Ayerst may have had a pretty good idea that the results would not be as extreme as some people have made them out to be (keeping in mind that there is a large body of "standard" Redux users in Europe etc. and probably a good deal of information available to them), so they were not too uncomfortable about commissioning the study.