tag:blogger.com,1999:blog-5883634615775822475.post8181401035743860710..comments2024-03-18T09:00:31.992-04:00Comments on Doctor Grumpy in the House: Say That Again?Grumpy, M.D.http://www.blogger.com/profile/09858110332436246760noreply@blogger.comBlogger14125tag:blogger.com,1999:blog-5883634615775822475.post-41694760137744158392009-07-18T01:45:47.486-04:002009-07-18T01:45:47.486-04:00The guy who wrote the report attempted to write in...The guy who wrote the report attempted to write in the style of Orwell's <i>1984</i>?Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5883634615775822475.post-13272360852029730692009-07-07T19:54:51.278-04:002009-07-07T19:54:51.278-04:00I was never any good at that stuff where they had ...I was never any good at that stuff where they had a null hypothesis and you had to figure out whether to accept or reject it.gingerbnoreply@blogger.comtag:blogger.com,1999:blog-5883634615775822475.post-47699214599919249092009-07-06T09:26:41.024-04:002009-07-06T09:26:41.024-04:00let's just say that the makers of product M co...let's just say that the makers of product M conducted several pain studies with M, placebo and oxycodone, all in the same study. and they set the studies up to show superiority over placebo, and non-inferiority to oxyC. as other comments, non-inferiority is a complex statistical measure of "about as good as..."<br /><br />What they really want is to claim that their crummy little drug is "about as good as" the big dogs. They figure that statement is worth big dollars. <br /><br />Then they went to the FDA and begged and pleaded to be allowed to put both results (eg; vs placebo and vs oxyC) in the prescribing information sheet, but the FDA said "no, you can only put in the superiority over placebo but not the non-inferiority findings."<br /><br />Now the makers of M are stuck. They really want to tell you that M is as good as oxyC, but legally they can't. They want to go back to FDA and beg and plead some more to get the good statement. <br /><br />So now they're conducting a survey to test various ways of phrasing the message, in the hopes of finding a message that is strong enough to resonate with docs and yet may still be bland enough to pass FDA muster.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5883634615775822475.post-42396200783553689122009-07-05T11:23:11.301-04:002009-07-05T11:23:11.301-04:00wtf/goddamn/*carlface*wtf/goddamn/*carlface*xtinehttps://www.blogger.com/profile/12960024706010157642noreply@blogger.comtag:blogger.com,1999:blog-5883634615775822475.post-57714703827247443742009-07-04T23:23:05.446-04:002009-07-04T23:23:05.446-04:00That kinda reads like the 1040 tax return instruct...That kinda reads like the 1040 tax return instructions. I dont get it.Anonymoushttps://www.blogger.com/profile/07083141849691624128noreply@blogger.comtag:blogger.com,1999:blog-5883634615775822475.post-76418809011321168642009-07-04T20:08:03.565-04:002009-07-04T20:08:03.565-04:00The study sought to find whether there was a diffe...The study sought to find whether there was a difference between oxycodone and Product M. The statement you provide is statistician speak. The flowering endorsement (and big boobs) will come from the drug rep.<br />But the fact that oxycodone is a pretty good drug means that this one might be, too. Differences will be in side effect profiles, ease of use, and CO$T.Steph the Pharmacistnoreply@blogger.comtag:blogger.com,1999:blog-5883634615775822475.post-21356818953738028632009-07-04T12:35:32.622-04:002009-07-04T12:35:32.622-04:00that is a double negative, which cancels each othe...that is a double negative, which cancels each other out. it actually says product M is inferior at both pain relief and non-pain relief. which makes no sense. But it does clearly state that product M is inferior at pain relief.xxxhttps://www.blogger.com/profile/05142207859664468166noreply@blogger.comtag:blogger.com,1999:blog-5883634615775822475.post-52486857047684924032009-07-04T11:13:10.514-04:002009-07-04T11:13:10.514-04:00omg... I wonder why they didn't say non-supe...omg... I wonder why they didn't say non-superior?Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5883634615775822475.post-70419828101614709132009-07-04T04:11:51.193-04:002009-07-04T04:11:51.193-04:00What is 'non-relief of pain'??
'Here ...What is 'non-relief of pain'??<br /><br />'Here you go Mrs Patient, have a prescription for some pills that won't stop it hurting in the slightest'.Food Addicthttps://www.blogger.com/profile/16413887520614296421noreply@blogger.comtag:blogger.com,1999:blog-5883634615775822475.post-89066542875735890512009-07-03T23:55:21.809-04:002009-07-03T23:55:21.809-04:00I read that before and I interpret that to be that...I read that before and I interpret that to be that M is no better and no worse than oxycodone. I wouldn't exactly call it a warm endorsement. Its like calling somebody "not ugly". But I'll bet its very costly.pharmacy chickhttp://pharmacychick.blogpharm.comnoreply@blogger.comtag:blogger.com,1999:blog-5883634615775822475.post-45103970955232283872009-07-03T23:14:32.486-04:002009-07-03T23:14:32.486-04:00Well, ya gotta have a heck of a lot of date to pro...Well, ya gotta have a heck of a lot of date to prove non-inferiority to me with numbers. But, I'd hazard the guess that they company is attempting to suggest that the side-effect profile may be a deal-breaker.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5883634615775822475.post-24704824297494910372009-07-03T23:07:18.711-04:002009-07-03T23:07:18.711-04:00Product M = Oxycodone....Product M = Oxycodone....08armydochttps://www.blogger.com/profile/08822263660673470153noreply@blogger.comtag:blogger.com,1999:blog-5883634615775822475.post-20192610757249235092009-07-03T19:26:33.948-04:002009-07-03T19:26:33.948-04:00Nucynta maybe? From here forward it's just me-...Nucynta maybe? From here forward it's just me-too drugs and reformulations of the same shit. You gotta watch those sneaky reps.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5883634615775822475.post-61243118279212705302009-07-03T12:58:08.473-04:002009-07-03T12:58:08.473-04:00From reading many Science, APL (Applied Physics Le...From reading many Science, APL (Applied Physics Letters), PRL (Physical Review Letters), etc. for my dissertation this statistician appears to be trying to say that Product M is about as good as Oxycododne but in as complicated a way as to make M more sound better then it is. There is also the possibility that product M is Opana.Anonymousnoreply@blogger.com