Comments on: Vytorin Fallout: DTC Ads, Dear Doc Letters And… http://www.pharmalot.com/2008/04/vytorin-fallout-dtc-ads-dear-doc-letters-and/ News, Comment and Conversation Fri, 10 Feb 2012 22:26:41 +0000 http://wordpress.org/?v=2.6.2 By: Jack2 http://www.pharmalot.com/2008/04/vytorin-fallout-dtc-ads-dear-doc-letters-and/#comment-239740 Jack2 Tue, 01 Apr 2008 14:54:44 +0000 http://www.pharmalot.com/2008/04/vytorin-fallout-dtc-ads-dear-doc-letters-and/#comment-239740 This study didn't even look at "clinical event reduction." It examined plaque build-up, as a sort-of theoretical bridge between LDL and heart-attacks. It takes a long time to get a drug approved, and all during the approval process a company's buring patent life. I don't have any problem with the FDA approving drugs based on well-established biomarkers. If you actually force the industry to show important clinical changes for some drugs in some theraputic areas pre-approval (like heart-attack reduction), then you really reduce the incentive to innovate. However, a company has a responsibility to disclose their trial results in a reasonable amount of time. That's where SP and Merck messed up. This study didn’t even look at “clinical event reduction.” It examined plaque build-up, as a sort-of theoretical bridge between LDL and heart-attacks.

It takes a long time to get a drug approved, and all during the approval process a company’s buring patent life. I don’t have any problem with the FDA approving drugs based on well-established biomarkers. If you actually force the industry to show important clinical changes for some drugs in some theraputic areas pre-approval (like heart-attack reduction), then you really reduce the incentive to innovate.

However, a company has a responsibility to disclose their trial results in a reasonable amount of time. That’s where SP and Merck messed up.

]]> By: Vince http://www.pharmalot.com/2008/04/vytorin-fallout-dtc-ads-dear-doc-letters-and/#comment-239690 Vince Tue, 01 Apr 2008 14:15:58 +0000 http://www.pharmalot.com/2008/04/vytorin-fallout-dtc-ads-dear-doc-letters-and/#comment-239690 The focus on lowering LDL easy to sell ;as opposed to clinical event reduction is what allows this to occur The focus on lowering LDL easy to sell ;as opposed to clinical event reduction is what allows this to occur

]]> By: Jack Friday http://www.pharmalot.com/2008/04/vytorin-fallout-dtc-ads-dear-doc-letters-and/#comment-239604 Jack Friday Tue, 01 Apr 2008 12:51:42 +0000 http://www.pharmalot.com/2008/04/vytorin-fallout-dtc-ads-dear-doc-letters-and/#comment-239604 Busted! Busted!

]]> By: Jack2 http://www.pharmalot.com/2008/04/vytorin-fallout-dtc-ads-dear-doc-letters-and/#comment-239596 Jack2 Tue, 01 Apr 2008 12:45:30 +0000 http://www.pharmalot.com/2008/04/vytorin-fallout-dtc-ads-dear-doc-letters-and/#comment-239596 This does seem bad. Drugs have risks and benefits. In this case SP and Merck took a long time, too long a time, to fess up to the whole story on the benefits (or lack thereof). It's behavior like this that drags the whole industry down. This does seem bad.

Drugs have risks and benefits. In this case SP and Merck took a long time, too long a time, to fess up to the whole story on the benefits (or lack thereof). It’s behavior like this that drags the whole industry down.

]]> By: Doc http://www.pharmalot.com/2008/04/vytorin-fallout-dtc-ads-dear-doc-letters-and/#comment-239589 Doc Tue, 01 Apr 2008 12:39:34 +0000 http://www.pharmalot.com/2008/04/vytorin-fallout-dtc-ads-dear-doc-letters-and/#comment-239589 Khanna's outrage is miniscule compared to the outrage that every physician should have in regard to the way Merck and Schering tried to 'manage' their way out of a less than significant drug trial. Who would believe anything these people have to say at this point? Khanna’s outrage is miniscule compared to the outrage that every physician should have in regard to the way Merck and Schering tried to ‘manage’ their way out of a less than significant drug trial. Who would believe anything these people have to say at this point?

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