tag:blogger.com,1999:blog-36762711.post8395796009709828386..comments2023-11-03T06:14:58.449-04:00Comments on Drug and Device Law: Adverse Event Report Cheat SheetRachel B. Weilhttp://www.blogger.com/profile/02251124525069607080noreply@blogger.comBlogger2125tag:blogger.com,1999:blog-36762711.post-46964724559460107382010-09-07T08:25:34.848-04:002010-09-07T08:25:34.848-04:00Many scientific breakthroughs may be suggested ini...Many scientific breakthroughs may be suggested initiallly by anecdotal evidence, but they're not accepted as proven until the anecdotal reports are confirmed by scientifically valid experiments producing statistically significant results.<br /><br />That's precisely what these cases are all about. AERs may be signals - provide notice - but that's all. When offered as purportedly proving causation, they should not be accepted into evidence in a court of law.<br /><br />Complaints are under-reported, and thus subject to all sorts of biases that preclude causative analysis. Reports as required by the FDA are also required where there's no reason to believe that a causal link exists. The FDA itself admits that.<br /><br />I think you've got the venue under the wrong post. What is "this" that reps are supposedly trained not to do? Promote off-label? Relatively few of the cases are even about that. They're about suing reps whether or not they did anything at all to get a tactical advantage.Bexishttps://www.blogger.com/profile/12984303395998821374noreply@blogger.comtag:blogger.com,1999:blog-36762711.post-257354836054611562010-09-04T10:25:21.582-04:002010-09-04T10:25:21.582-04:00It's amusing to see a lawyer hide behind scien...It's amusing to see a lawyer hide behind science when many scientific breakthroughs are based on anecdotal and/or uncontrolled observations. Let's face it. Complaints of any kind are UNDERREPORTED. Doctors do ignore AEs. Yes, if patients are told what they experience is an AE, reports will go up. DUH! If 25% of a population of 200k+ on a drug experiences an AE while the rest not on the drug don't that's a clue something should be looked at. <br /><br />All I see here is whining about venue because the sales rep is being sued. Yes they should be sued. All reps are trained not to do this and they know better. Yes the company will pay if the suit is lost. BUT if the rep is banned from the industry maybe some of the lies will stop.Anonymousnoreply@blogger.com