Comments on: A Key Vytorin Memo Was Misleading And Inaccurate http://www.pharmalot.com/2008/04/a-key-vytorin-memo-is-misleading-and-inaccurate/ News, Comment and Conversation Sun, 21 Mar 2010 21:28:28 +0000 http://wordpress.org/?v=2.6.2 By: Concerned http://www.pharmalot.com/2008/04/a-key-vytorin-memo-is-misleading-and-inaccurate/#comment-285713 Concerned Tue, 15 Apr 2008 16:42:13 +0000 http://www.pharmalot.com/2008/04/a-key-vytorin-memo-is-misleading-and-inaccurate/#comment-285713 With all of this information emerging, I wonder how long it will take before the whole truth comes out? Perhaps never! Even if the people involved are called to DC to testify, is there any way to obtain the real story? This seems to be a very tangled web with so many involved parties, each party having its' own concerns and agenda. I don't think I've ever seen such a mess and it seems to get worse and worse with each passing week. I think that Big pharma is headed for a lot more trouble. It appears that they won't even be able to count on the Republican presidential candidate to support them. Big trouble! With all of this information emerging, I wonder how long it will take before the whole truth comes out? Perhaps never! Even if the people involved are called to DC to testify, is there any way to obtain the real story? This seems to be a very tangled web with so many involved parties, each party having its’ own concerns and agenda. I don’t think I’ve ever seen such a mess and it seems to get worse and worse with each passing week. I think that Big pharma is headed for a lot more trouble. It appears that they won’t even be able to count on the Republican presidential candidate to support them. Big trouble!

]]> By: FBP MD http://www.pharmalot.com/2008/04/a-key-vytorin-memo-is-misleading-and-inaccurate/#comment-277322 FBP MD Sun, 13 Apr 2008 14:01:00 +0000 http://www.pharmalot.com/2008/04/a-key-vytorin-memo-is-misleading-and-inaccurate/#comment-277322 What a mess! Such a shame. I really believe that ezetimibe does lower cholesterol in addition to a stain and has the potential to impact cardiovascualr events, but the ENHANCE trial was a disaster. The way that SP and Merck handled the whole thing has been awful and has made everything much, much worse for them that it would have been if they would have come clean earlier. They just couldn't do it because they feared for their profits! What a mess! Such a shame. I really believe that ezetimibe does lower cholesterol in addition to a stain and has the potential to impact cardiovascualr events, but the ENHANCE trial was a disaster. The way that SP and Merck handled the whole thing has been awful and has made everything much, much worse for them that it would have been if they would have come clean earlier. They just couldn’t do it because they feared for their profits!

]]> By: Alex H. http://www.pharmalot.com/2008/04/a-key-vytorin-memo-is-misleading-and-inaccurate/#comment-277060 Alex H. Sun, 13 Apr 2008 12:18:44 +0000 http://www.pharmalot.com/2008/04/a-key-vytorin-memo-is-misleading-and-inaccurate/#comment-277060 What if Kastelein was obsessed by an idee fixe & could not let the ASAP and RADIANCE 1 failures to show additional intima-medial reduction go? He persuades Big Pharma to lay down big money on his white whale ENHANCE trial but the results do not come through as he feels they must. (Another Hwang Woo-Suk scenario - so near & yet so far? so close but no cigar?) Then Merck & S-P move in & majorly bungle what is already a debacle, to the frustration of JK, who is convinced he can still rescue the study & save face, if perhaps through a data fishing expedition, but wants the data massaging under his control, which by now it's too late for? What if Kastelein was obsessed by an idee fixe & could not let the ASAP and RADIANCE 1 failures to show additional intima-medial reduction go? He persuades Big Pharma to lay down big money on his white whale ENHANCE trial but the results do not come through as he feels they must. (Another Hwang Woo-Suk scenario - so near & yet so far? so close but no cigar?) Then Merck & S-P move in & majorly bungle what is already a debacle, to the frustration of JK, who is convinced he can still rescue the study & save face, if perhaps through a data fishing expedition, but wants the data massaging under his control, which by now it’s too late for?

]]> By: sharlott http://www.pharmalot.com/2008/04/a-key-vytorin-memo-is-misleading-and-inaccurate/#comment-274561 sharlott Sat, 12 Apr 2008 04:17:13 +0000 http://www.pharmalot.com/2008/04/a-key-vytorin-memo-is-misleading-and-inaccurate/#comment-274561 Amazing!! John Kastelein was the lead investigator for ASAP - and then RADIANCE 1 - which was an extension of ASAP showing no additional intimal-medial reduction. Knowing that one could not achieve intimi-media regresseion after patients had been aggressivewly treated with statins, he conducted the Enhance trial - which he knew would show no additional intimal media thickness regression. At the end of the day it is the patients that suffer - either from heart attarl of stoke! Shame on you Dr. Nissen - and shame on you ACC! Amazing!! John Kastelein was the lead investigator for ASAP - and then RADIANCE 1 - which was an extension of ASAP showing no additional intimal-medial reduction. Knowing that one could not achieve intimi-media regresseion after patients had been aggressivewly treated with statins, he conducted the Enhance trial - which he knew would show no additional intimal media thickness regression. At the end of the day it is the patients that suffer - either from heart attarl of stoke! Shame on you Dr. Nissen - and shame on you ACC!

]]> By: rainnn http://www.pharmalot.com/2008/04/a-key-vytorin-memo-is-misleading-and-inaccurate/#comment-274295 rainnn Sat, 12 Apr 2008 01:53:54 +0000 http://www.pharmalot.com/2008/04/a-key-vytorin-memo-is-misleading-and-inaccurate/#comment-274295 I have made easy-view images of the actual FDA letter, telling Merck and Schering-Plough, that it thinks the Vytorin promotional materials "would be misleading". Hard to overstate the effect that is likely to have -- revisions to all ads to indicate, in essence, that there is no evidence that Vytorin does any job a generic doesn't already do -- or do, better. Wow. See the link in my name for the images. I have made easy-view images of the actual FDA letter, telling Merck and Schering-Plough, that it thinks the Vytorin promotional materials “would be misleading”.

Hard to overstate the effect that is likely to have — revisions to all ads to indicate, in essence, that there is no evidence that Vytorin does any job a generic doesn’t already do — or do, better.

Wow.

See the link in my name for the images.

]]> By: Justice in Michigan http://www.pharmalot.com/2008/04/a-key-vytorin-memo-is-misleading-and-inaccurate/#comment-274186 Justice in Michigan Sat, 12 Apr 2008 00:12:41 +0000 http://www.pharmalot.com/2008/04/a-key-vytorin-memo-is-misleading-and-inaccurate/#comment-274186 Perhaps relevant. At one point, as Strony is attempting to reassure Stein about the minutes, he writes: "These minutes are intended for the FDA ard are not subject to public access." Perhaps relevant. At one point, as Strony is attempting to reassure Stein about the minutes, he writes:

“These minutes are intended for the FDA ard are not subject to public access.”

]]> By: Justice in Michigan http://www.pharmalot.com/2008/04/a-key-vytorin-memo-is-misleading-and-inaccurate/#comment-274163 Justice in Michigan Fri, 11 Apr 2008 23:56:46 +0000 http://www.pharmalot.com/2008/04/a-key-vytorin-memo-is-misleading-and-inaccurate/#comment-274163 Why didn't anyone learn from Nixon that it's the cover-up for which you always get hung? This also bring us back to Bob Temple as recently cited in a thread here; that, as far as he knew, none of this carotid endpoint stuff mattered anyway. Once again, we see that it sure as heck mattered to MSP. And, if one thing is certain, it is that Bog Temple is no dummy. What, then, would he be? Why didn’t anyone learn from Nixon that it’s the cover-up for which you always get hung?

This also bring us back to Bob Temple as recently cited in a thread here; that, as far as he knew, none of this carotid endpoint stuff mattered anyway.

Once again, we see that it sure as heck mattered to MSP. And, if one thing is certain, it is that Bog Temple is no dummy.

What, then, would he be?

]]> By: Thom http://www.pharmalot.com/2008/04/a-key-vytorin-memo-is-misleading-and-inaccurate/#comment-273921 Thom Fri, 11 Apr 2008 21:03:24 +0000 http://www.pharmalot.com/2008/04/a-key-vytorin-memo-is-misleading-and-inaccurate/#comment-273921 Let's see how long it takes Schering-Plough to argue that the memo is "out of context." Let’s see how long it takes Schering-Plough to argue that the memo is “out of context.”

]]> By: FBPP http://www.pharmalot.com/2008/04/a-key-vytorin-memo-is-misleading-and-inaccurate/#comment-273887 FBPP Fri, 11 Apr 2008 20:42:44 +0000 http://www.pharmalot.com/2008/04/a-key-vytorin-memo-is-misleading-and-inaccurate/#comment-273887 If you look through the entire document, it is incredibly revealing! I wonder what else the feds have already discovered? It's a good thing for Schering-Plough that this news broke late on a Friday afternoon as the markets were closing for the week. Monday could be a wild ride! If you look through the entire document, it is incredibly revealing! I wonder what else the feds have already discovered? It’s a good thing for Schering-Plough that this news broke late on a Friday afternoon as the markets were closing for the week. Monday could be a wild ride!

]]> By: Laurie http://www.pharmalot.com/2008/04/a-key-vytorin-memo-is-misleading-and-inaccurate/#comment-273881 Laurie Fri, 11 Apr 2008 20:37:58 +0000 http://www.pharmalot.com/2008/04/a-key-vytorin-memo-is-misleading-and-inaccurate/#comment-273881 Wow....pretty revealing about the level of misrepresentation of the meeting in the minutes Wow….pretty revealing about the level of misrepresentation of the meeting in the minutes

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