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<p>[QUOTE="Anonymous, post: 3021626"]The sad fact of the matter is that COX2s are highly effective in a pre- & post-operative setting. You get non-narcotic pain relief without the bleeding issues that prevent the use of non-selective NSAIDs in these patients. In fact, a pharmacy director at a hospital that was involved in the paracoxib surgical trials (the injectable form of Bextra) intimated to me that it was dificult to keep the study blinded because the response of the paracoxib patients was so robust (and resulted in little to no post-operative morphine use).</p><p><br /></p><p>What killed paracoxib were the inane CABG trials (attempting to answer a question that no rationale surgeon would have asked). Even in those trials, if you look at when the CV events/mortalities occured, there were actually more events on placebo as a number of the events in the paracoxib arm occured before they were administered active drug. Add to this the timing of when this information was coming out (shortly after Merck pulled Vioxx off the market, which was a huge mistake, IMHO, as it's still safer than all other non-selective NSAIDs when considering all-cause morbidity/mortality), and Bextra was doomed. Sad, because it was the best drug in the class. Yes, it didn't have the pain indication that Celebrex had, but the data was there, the FDA was just being the inefficient government bureaucracy that it is in wanting still more data (above and beyond what it took to get Celebrex the same indication).</p><p><br /></p><p>Around this same time the Federal Government and various state Attorney's General (and the trial bar) realized that they could use labeling as a weapon with which to extort huge sums of money from Big Pharma. Those of you who think the GOP is a friend of Big Pharma might want to consider that this happened during the W administration, proving that government bureaucrats of all political stripes care far more about money than they do any of their alleged special interest groups. Just take a look at the fines that have come down the pike over the past few years, most notably the $2.3 BILLION we're forking over for basically promoting Bextra for something it was highly effective at (treating pain). Don't think Bextra worked for pain? Why do people take NSAIDs in the first place? Inflammation? No, folks, ... it's PAIN. Just don't say it out loud if it's not in your label, or the FDA will fine you millions, perhaps billions of dollars.</p><p><br /></p><p>Unless of course you are a government provider of health care, an HMO, or a PBM, who have all seen fit over the past couple of decades of instituting off-label protocols for hundreds of meds.</p><p><br /></p><p>Funny how that works...[/QUOTE]</p><p><br /></p>
[QUOTE="Anonymous, post: 3021626"]The sad fact of the matter is that COX2s are highly effective in a pre- & post-operative setting. You get non-narcotic pain relief without the bleeding issues that prevent the use of non-selective NSAIDs in these patients. In fact, a pharmacy director at a hospital that was involved in the paracoxib surgical trials (the injectable form of Bextra) intimated to me that it was dificult to keep the study blinded because the response of the paracoxib patients was so robust (and resulted in little to no post-operative morphine use). What killed paracoxib were the inane CABG trials (attempting to answer a question that no rationale surgeon would have asked). Even in those trials, if you look at when the CV events/mortalities occured, there were actually more events on placebo as a number of the events in the paracoxib arm occured before they were administered active drug. Add to this the timing of when this information was coming out (shortly after Merck pulled Vioxx off the market, which was a huge mistake, IMHO, as it's still safer than all other non-selective NSAIDs when considering all-cause morbidity/mortality), and Bextra was doomed. Sad, because it was the best drug in the class. Yes, it didn't have the pain indication that Celebrex had, but the data was there, the FDA was just being the inefficient government bureaucracy that it is in wanting still more data (above and beyond what it took to get Celebrex the same indication). Around this same time the Federal Government and various state Attorney's General (and the trial bar) realized that they could use labeling as a weapon with which to extort huge sums of money from Big Pharma. Those of you who think the GOP is a friend of Big Pharma might want to consider that this happened during the W administration, proving that government bureaucrats of all political stripes care far more about money than they do any of their alleged special interest groups. Just take a look at the fines that have come down the pike over the past few years, most notably the $2.3 BILLION we're forking over for basically promoting Bextra for something it was highly effective at (treating pain). Don't think Bextra worked for pain? Why do people take NSAIDs in the first place? Inflammation? No, folks, ... it's PAIN. Just don't say it out loud if it's not in your label, or the FDA will fine you millions, perhaps billions of dollars. Unless of course you are a government provider of health care, an HMO, or a PBM, who have all seen fit over the past couple of decades of instituting off-label protocols for hundreds of meds. Funny how that works...[/QUOTE]
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Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
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Pharma/Biotech Companies
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Pfizer
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MARY HOLLOWAY CONVICTED
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Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
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>
Pharma/Biotech Companies
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Pfizer
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MARY HOLLOWAY CONVICTED
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