Comments on: Vytorin Trial Misses Goal & Shows Cancer Risk http://www.pharmalot.com/2008/07/vytorin-trial-misses-goal-and-shows-cancer-risk/ News, Comment and Conversation Fri, 10 Feb 2012 20:59:25 +0000 http://wordpress.org/?v=2.6.2 By: Unsupported Opinion http://www.pharmalot.com/2008/07/vytorin-trial-misses-goal-and-shows-cancer-risk/#comment-371272 Unsupported Opinion Thu, 04 Sep 2008 20:22:26 +0000 http://www.pharmalot.com/?p=14731#comment-371272 It is my understanding that some scientists believe that high levels of cholesterol serve to block the development of cancer. If that is true it might stand to reason that a drug, such as vytorin, that radically reduces cholesterol levels, may give rise to the development of cancer by reducing the blocking agent. Admittedly, this is pure speculation, but it may be worthy of scientific inquiry. It is my understanding that some scientists believe that high levels of cholesterol serve to block the development of cancer. If that is true it might stand to reason that a drug, such as vytorin, that radically reduces cholesterol levels, may give rise to the development of cancer by reducing the blocking agent. Admittedly, this is pure speculation, but it may be worthy of scientific inquiry.

]]> By: Piper http://www.pharmalot.com/2008/07/vytorin-trial-misses-goal-and-shows-cancer-risk/#comment-368203 Piper Wed, 30 Jul 2008 21:56:19 +0000 http://www.pharmalot.com/?p=14731#comment-368203 Regarding the pediatrics question - both Zetia and Vytorin were approved for pediatric use last month.... Regarding the pediatrics question - both Zetia and Vytorin were approved for pediatric use last month….

]]> By: Ron Kavanagh http://www.pharmalot.com/2008/07/vytorin-trial-misses-goal-and-shows-cancer-risk/#comment-367376 Ron Kavanagh Tue, 22 Jul 2008 00:18:06 +0000 http://www.pharmalot.com/?p=14731#comment-367376 In contrast to what Dr. Peto says I do not believe that inducing cancer is a 'bizarre hypothesis'. In fact I believe that there may be a biologically plausible mechanism that also may underlie those aspects of FDA's critical path initiative and personalized medicine being used for treating or preventing cancer. The problem is that the possible mechanism can cut both ways and is one of the problems with using biomarkers for many drugs. Another problem is that it may be a factor with other drugs or drug classes. (N.B. people with many forms of severe mental illness have high comorbidity of diabetes, lipid disorders, and cardiovascular disease, yet low incidences of cancer.) Having said that either statistical variability, population size or differences in patient populations (e.g. genetics) might also underlie differences between trials. Big Pharma Guy makes a valid point and is the first thing I would look at, what is the net effect. Unfortunately based on what Bad News says, prima facies it appears that the net effect is not to Schering's advantage. I hope that subgroup analysis is performed. In addition an examination of genetics, drug metabolites, and their effects on various receptors that might be involved, as well as possible drug interactions are also looked into. This is what FDA calls a signal for a serious risk. Ron Kavanagh In contrast to what Dr. Peto says I do not believe that inducing cancer is a ‘bizarre hypothesis’. In fact I believe that there may be a biologically plausible mechanism that also may underlie those aspects of FDA’s critical path initiative and personalized medicine being used for treating or preventing cancer. The problem is that the possible mechanism can cut both ways and is one of the problems with using biomarkers for many drugs. Another problem is that it may be a factor with other drugs or drug classes. (N.B. people with many forms of severe mental illness have high comorbidity of diabetes, lipid disorders, and cardiovascular disease, yet low incidences of cancer.) Having said that either statistical variability, population size or differences in patient populations (e.g. genetics) might also underlie differences between trials.

Big Pharma Guy makes a valid point and is the first thing I would look at, what is the net effect. Unfortunately based on what Bad News says, prima facies it appears that the net effect is not to Schering’s advantage.

I hope that subgroup analysis is performed. In addition an examination of genetics, drug metabolites, and their effects on various receptors that might be involved, as well as possible drug interactions are also looked into.

This is what FDA calls a signal for a serious risk.

Ron Kavanagh

]]> By: Lisa Van S http://www.pharmalot.com/2008/07/vytorin-trial-misses-goal-and-shows-cancer-risk/#comment-367375 Lisa Van S Tue, 22 Jul 2008 00:17:34 +0000 http://www.pharmalot.com/?p=14731#comment-367375 Geee, This surprises' folks!!!! Geee, This surprises’ folks!!!!

]]> By: Insider http://www.pharmalot.com/2008/07/vytorin-trial-misses-goal-and-shows-cancer-risk/#comment-367365 Insider Mon, 21 Jul 2008 22:31:01 +0000 http://www.pharmalot.com/?p=14731#comment-367365 I wonder if SP will apply for a pediatrics licence? I wonder if SP will apply for a pediatrics licence?

]]> By: Justice in MI http://www.pharmalot.com/2008/07/vytorin-trial-misses-goal-and-shows-cancer-risk/#comment-367360 Justice in MI Mon, 21 Jul 2008 21:33:14 +0000 http://www.pharmalot.com/?p=14731#comment-367360 Does anyone now see a pt. population for which Vytorin would make sense, even as third line, _at this time_? Does anyone now see a pt. population for which Vytorin would make sense, even as third line, _at this time_?

]]> By: Day Trader http://www.pharmalot.com/2008/07/vytorin-trial-misses-goal-and-shows-cancer-risk/#comment-367355 Day Trader Mon, 21 Jul 2008 20:44:12 +0000 http://www.pharmalot.com/?p=14731#comment-367355 Cancer concerns came up with pravastatin some time ago and no causal relationship was ever determined. Considering that the other Vytorin trials aren't showing increased incidence of cancer, it's reasonable to conclude that the cancer rates were not drug related. As for the other data, the drug lowers cholesterol as it is indicated to do and prevented heart attacks in a sick population. This does not spell disaster for MSP but it gives their competitors something to distract physicians with... Remember, lipitor showed no benefit over placebo in post-menopausal women's CIMT nor did it show any benefit over placebo in aortic stenosis. No-one ever speaks to these concerns about Pfizer's blockbuster medication... Bias against Merck, perhaps? Cancer concerns came up with pravastatin some time ago and no causal relationship was ever determined. Considering that the other Vytorin trials aren’t showing increased incidence of cancer, it’s reasonable to conclude that the cancer rates were not drug related. As for the other data, the drug lowers cholesterol as it is indicated to do and prevented heart attacks in a sick population. This does not spell disaster for MSP but it gives their competitors something to distract physicians with… Remember, lipitor showed no benefit over placebo in post-menopausal women’s CIMT nor did it show any benefit over placebo in aortic stenosis. No-one ever speaks to these concerns about Pfizer’s blockbuster medication… Bias against Merck, perhaps?

]]> By: Bad News http://www.pharmalot.com/2008/07/vytorin-trial-misses-goal-and-shows-cancer-risk/#comment-367348 Bad News Mon, 21 Jul 2008 19:36:08 +0000 http://www.pharmalot.com/?p=14731#comment-367348 Cancer man! We're talking cancer man! Cancer incidence was up 43%. Cancer deaths were up 69%. CV events down 22%. if you look at all the numbers in the trial for overall benefit/risk, less than 12 patients did better with Vytorin in an almost 1900 patient trial in which patients were foillowed for four years. Bad, really bad! Cancer man! We’re talking cancer man! Cancer incidence was up 43%. Cancer deaths were up 69%. CV events down 22%. if you look at all the numbers in the trial for overall benefit/risk, less than 12 patients did better with Vytorin in an almost 1900 patient trial in which patients were foillowed for four years. Bad, really bad!

]]> By: Reality Bites http://www.pharmalot.com/2008/07/vytorin-trial-misses-goal-and-shows-cancer-risk/#comment-367345 Reality Bites Mon, 21 Jul 2008 19:22:23 +0000 http://www.pharmalot.com/?p=14731#comment-367345 One word for Merck and Schering-Plough - disasterous! One word for Merck and Schering-Plough - disasterous!

]]> By: LeftPharma http://www.pharmalot.com/2008/07/vytorin-trial-misses-goal-and-shows-cancer-risk/#comment-367343 LeftPharma Mon, 21 Jul 2008 19:08:33 +0000 http://www.pharmalot.com/?p=14731#comment-367343 “Vytorin was significantly better than placebo in reducing atherosclerotic events, defined as non-fatal heart attacks, need for coronary artery bypass surgery or artery-clearing procedures, hospitalization due to chest pain and strokes.” Don't we have a far more cost effective class that accomplishes this? Hint: One example is the half of Vytorin that's not ezetimibe. “Vytorin was significantly better than placebo in reducing atherosclerotic events, defined as non-fatal heart attacks, need for coronary artery bypass surgery or artery-clearing procedures, hospitalization due to chest pain and strokes.”

Don’t we have a far more cost effective class that accomplishes this?

Hint: One example is the half of Vytorin that’s not ezetimibe.

]]>