Comments on: Has Vytorin Created New FDA Approval Hurdles? http://www.pharmalot.com/2008/04/has-vytorin-created-new-fda-approval-hurdles/ News, Comment and Conversation Fri, 10 Feb 2012 22:24:10 +0000 http://wordpress.org/?v=2.6.2 By: John Osborne, MD, PhD http://www.pharmalot.com/2008/04/has-vytorin-created-new-fda-approval-hurdles/#comment-322002 John Osborne, MD, PhD Tue, 29 Apr 2008 21:39:44 +0000 http://www.pharmalot.com/?p=13341#comment-322002 Dear riv: With a TC of 480 (and I suspect it's not with an HDL of 200!), i'd be happy to do a free Cardiac CTA on you to see if you really don't have coronary artery disease! John Osborne, MD, PhD State of the Heart Cardiology Dear riv:

With a TC of 480 (and I suspect it’s not with an HDL of 200!), i’d be happy to do a free Cardiac CTA on you to see if you really don’t have coronary artery disease!

John Osborne, MD, PhD
State of the Heart Cardiology

]]> By: riv http://www.pharmalot.com/2008/04/has-vytorin-created-new-fda-approval-hurdles/#comment-319935 riv Mon, 28 Apr 2008 21:54:08 +0000 http://www.pharmalot.com/?p=13341#comment-319935 "her" ??? I have a TC of 480. No cardiovascular disease. What is FH anyway but some artificial ceiling over which pharma decides we have a deficit of statins. www.spacedoc.net “her” ???

I have a TC of 480. No cardiovascular disease. What is FH anyway but some artificial ceiling over which pharma decides we have a deficit of statins.

http://www.spacedoc.net

]]> By: Justice in Michigan http://www.pharmalot.com/2008/04/has-vytorin-created-new-fda-approval-hurdles/#comment-319867 Justice in Michigan Mon, 28 Apr 2008 20:59:57 +0000 http://www.pharmalot.com/?p=13341#comment-319867 I wouldn't agree with the opening part of Riv's post, but I would add neuropathies to her list. I have personal experience with that one, confirmed by neurologist on retrial. It certainly appears to be rare, but, in the best summary I've found, each of the statins is associated with hundreds of confirmed cases that are not explicable in other ways (pts. not diabetic, etc.) I wouldn’t agree with the opening part of Riv’s post, but I would add neuropathies to her list. I have personal experience with that one, confirmed by neurologist on retrial. It certainly appears to be rare, but, in the best summary I’ve found, each of the statins is associated with hundreds of confirmed cases that are not explicable in other ways (pts. not diabetic, etc.)

]]> By: riv http://www.pharmalot.com/2008/04/has-vytorin-created-new-fda-approval-hurdles/#comment-319721 riv Mon, 28 Apr 2008 18:24:10 +0000 http://www.pharmalot.com/?p=13341#comment-319721 People who have heterozygous do not need to be on meds. Lowering cholesterol doesn't do anything for mortality rates. Why take cholesterol lowering drugs when the only proven benefit is to pharma? There is risk of rhabdomyolysis, myopathy, myositis, transient global amnesia, aphasia, memory loss, language loss, strokes, pancreatic disease including pancreatic cancer, ALS and Parkinson's syndrome. (Syndrome: the weasel word pharma is now using for the thousands of the latter two cases showing up). People who have heterozygous do not need to be on meds.
Lowering cholesterol doesn’t do anything for mortality rates. Why take cholesterol lowering drugs when the only proven benefit is to pharma? There is risk of rhabdomyolysis, myopathy, myositis, transient global amnesia, aphasia, memory loss, language loss, strokes, pancreatic disease including pancreatic cancer, ALS and Parkinson’s syndrome. (Syndrome: the weasel word pharma is now using for the thousands of the latter two cases showing up).

]]> By: Common Sense http://www.pharmalot.com/2008/04/has-vytorin-created-new-fda-approval-hurdles/#comment-319662 Common Sense Mon, 28 Apr 2008 17:18:15 +0000 http://www.pharmalot.com/?p=13341#comment-319662 Hi MKM, Thanks for the clarification. When I first heard about this item, I was surprised. can you imagine a clinical outcomes trial in HoFH? Talk about difficult. How about impossible? I agree that the plan sounds sensible given your points. Hi MKM,

Thanks for the clarification. When I first heard about this item, I was surprised. can you imagine a clinical outcomes trial in HoFH? Talk about difficult. How about impossible? I agree that the plan sounds sensible given your points.

]]> By: www.worldpharmanews.net http://www.pharmalot.com/2008/04/has-vytorin-created-new-fda-approval-hurdles/#comment-319644 www.worldpharmanews.net Mon, 28 Apr 2008 16:59:02 +0000 http://www.pharmalot.com/?p=13341#comment-319644 <strong>Pharmalot » Has Vytorin Created New FDA Approval Hurdles?...</strong> Given the concerns over how widely marketed Vytorin and Zetia were over the past few years, the FDA response to Genzyme and Isis raises an interesting thought - whether the agency is no longer willing to approve new drugs for wide use based solely on t... Pharmalot » Has Vytorin Created New FDA Approval Hurdles?…

Given the concerns over how widely marketed Vytorin and Zetia were over the past few years, the FDA response to Genzyme and Isis raises an interesting thought - whether the agency is no longer willing to approve new drugs for wide use based solely on t…

]]> By: MKM http://www.pharmalot.com/2008/04/has-vytorin-created-new-fda-approval-hurdles/#comment-319637 MKM Mon, 28 Apr 2008 16:49:38 +0000 http://www.pharmalot.com/?p=13341#comment-319637 response to Common Sense: The FDA is allowing accelerated approval for homozygous FH (hoFH) based on LDL-lowering. HoFH occurs in 1 out of a million people. The outcomes trial is to support full approval for hoFH and for other indications (heterozygous FH (heFH) and other high-risk individuals with high cholesterol). People with hoFH generally need to be treated with LDL apheresis. However, people with heFH (1/500 people) can usually be managed with medication. I think the FDA is being sensible here, because the long-term effects of antisense drugs are not known. This is a first-in-class drug, and there are other treatments available. response to Common Sense:

The FDA is allowing accelerated approval for homozygous FH (hoFH) based on LDL-lowering. HoFH occurs in 1 out of a million people. The outcomes trial is to support full approval for hoFH and for other indications (heterozygous FH (heFH) and other high-risk individuals with high cholesterol).

People with hoFH generally need to be treated with LDL apheresis. However, people with heFH (1/500 people) can usually be managed with medication.

I think the FDA is being sensible here, because the long-term effects of antisense drugs are not known. This is a first-in-class drug, and there are other treatments available.

]]> By: Response to Paul http://www.pharmalot.com/2008/04/has-vytorin-created-new-fda-approval-hurdles/#comment-319619 Response to Paul Mon, 28 Apr 2008 16:24:15 +0000 http://www.pharmalot.com/?p=13341#comment-319619 ENHANCE wasn't a small trial that MSP tried, but designed as a definitive trial intended for a regulatory submission requesting approval for a new indication for reducing the progression of atherosclerosis. Additionally, thickening of carotid IMT is associated with increased risk for CV events. It is a failed trial. The big fallour from ENHANCE appears to have been created by the companies themselves as they delayed releasing results until almost 2 years after the study completed. In addition, it seems that several top individuals make have taken advantage by selling large blocks of stock. This doesn't please anybody, particulalry other shareholders! ENHANCE wasn’t a small trial that MSP tried, but designed as a definitive trial intended for a regulatory submission requesting approval for a new indication for reducing the progression of atherosclerosis. Additionally, thickening of carotid IMT is associated with increased risk for CV events. It is a failed trial.

The big fallour from ENHANCE appears to have been created by the companies themselves as they delayed releasing results until almost 2 years after the study completed. In addition, it seems that several top individuals make have taken advantage by selling large blocks of stock. This doesn’t please anybody, particulalry other shareholders!

]]> By: Vince http://www.pharmalot.com/2008/04/has-vytorin-created-new-fda-approval-hurdles/#comment-319609 Vince Mon, 28 Apr 2008 16:16:25 +0000 http://www.pharmalot.com/?p=13341#comment-319609 The point of this study is that it showed no improvement in the surrogate endpoint and in fact the changed noted in the study pointed in the wrong direction. This combination could in fact decrease or increase events.The fact that previous drugs used to reduce LDL in fact did not reduce mortality must in fact be considered. If the LDL hypothesis is indeed correct. than why did this data not support it? The point of this study is that it showed no improvement in the surrogate endpoint and in fact the changed noted in the study pointed in the wrong direction. This combination could in fact decrease or increase events.The fact that previous drugs used to reduce LDL in fact did not reduce mortality must in fact be considered. If the LDL hypothesis is indeed correct. than why did this data not support it?

]]> By: Paul http://www.pharmalot.com/2008/04/has-vytorin-created-new-fda-approval-hurdles/#comment-319597 Paul Mon, 28 Apr 2008 15:58:28 +0000 http://www.pharmalot.com/?p=13341#comment-319597 Just to be clear, unless I completely missed it, there were no "later safety" issues found with Zetia or Vytorin as a result of the Enhance study. What happened is that they tried a small trial on something that in itself is a surrogate endpoint (people don't die of carotid intimate narrowing, it's only an indicator). The trial didn't work for who knows what reasons, but the product still works for what was indicated and the safety is the same as before. Just to be clear, unless I completely missed it, there were no “later safety” issues found with Zetia or Vytorin as a result of the Enhance study. What happened is that they tried a small trial on something that in itself is a surrogate endpoint (people don’t die of carotid intimate narrowing, it’s only an indicator). The trial didn’t work for who knows what reasons, but the product still works for what was indicated and the safety is the same as before.

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