Comments on: The Vytorin Limbo: How Low Can You Go? http://www.pharmalot.com/2009/11/the-vytorin-limbo-how-low-can-you-go/ News, Comment and Conversation Fri, 10 Feb 2012 18:44:07 +0000 http://wordpress.org/?v=2.6.2 By: Anonymous http://www.pharmalot.com/2009/11/the-vytorin-limbo-how-low-can-you-go/#comment-447374 Anonymous Wed, 25 Nov 2009 19:48:47 +0000 http://www.pharmalot.com/?p=20099#comment-447374 It is interesting that all of the articles published around Zetia fail to mention that Zetia did show regression in the Sub-analysis of the SANDS trial, another CIMT trial which funded by the NIH. Also, in the METEOR trial, 40mg of Crestor could only show "slowing of progression", but in the ASTEROID trial, 40mg of Crestor was able to show regression of the coronary artery. There is more going on with atherosclerosis than what can be shown in an CIMT study, hence it is only a surrogate endpoint, not to mention that the ARBITER study was skewed in Niaspan's favor. It is interesting that all of the articles published around Zetia fail to mention that Zetia did show regression in the Sub-analysis of the SANDS trial, another CIMT trial which funded by the NIH. Also, in the METEOR trial, 40mg of Crestor could only show “slowing of progression”, but in the ASTEROID trial, 40mg of Crestor was able to show regression of the coronary artery. There is more going on with atherosclerosis than what can be shown in an CIMT study, hence it is only a surrogate endpoint, not to mention that the ARBITER study was skewed in Niaspan’s favor.

]]> By: patrons99 http://www.pharmalot.com/2009/11/the-vytorin-limbo-how-low-can-you-go/#comment-447369 patrons99 Wed, 25 Nov 2009 19:04:11 +0000 http://www.pharmalot.com/?p=20099#comment-447369 The mainstream theory of atherogenesis should be reexamined. An alternative theory is the hemorheologic-hemodynamic theory of atherogenesis. This theory holds that atherosclerosis is a disease of stasis of blood, which promotes the organization of a thrombus into an atherosclerotic plaque. Why not undertake head to head, double blind, placebo controlled studies comparing statins (the present standard of care) with active control arms that might include molecular entities (both new and old) which alter the hemorheologic and hemodynamic properties of blood? It's time to validate the hemorheologic-hemodynamic theory of atherogenesis. The mainstream theory of atherogenesis should be reexamined. An alternative theory is the hemorheologic-hemodynamic theory of atherogenesis. This theory holds that atherosclerosis is a disease of stasis of blood, which promotes the organization of a thrombus into an atherosclerotic plaque. Why not undertake head to head, double blind, placebo controlled studies comparing statins (the present standard of care) with active control arms that might include molecular entities (both new and old) which alter the hemorheologic and hemodynamic properties of blood? It’s time to validate the hemorheologic-hemodynamic theory of atherogenesis.

]]> By: riv http://www.pharmalot.com/2009/11/the-vytorin-limbo-how-low-can-you-go/#comment-447350 riv Wed, 25 Nov 2009 17:27:12 +0000 http://www.pharmalot.com/?p=20099#comment-447350 BP Watch thanks for the phrase "benefit to the patient". We know prescribing physicians were offered financial benefit. And Ed, correct me if I am wrong, but didn't the NEJM article say that ezetimibe *increased* carotid intima-media thickness? How Ezetimibe (Zetia) was tested: (CHERYL CORNACCHIA The (Montreal) Gazette Tuesday, February 24, 2004): ‘When a company contacted Colin Rose and offered to pay him $6,000 to refer patients to a drug study, they had the wrong doctor. Rose, a cardiologist at the Montreal General Hospital, not only said no, but he passed the written offer to the College des Medecins du Quebec, suggesting it investigate the ethics of paying doctors to refer patients. ‘ "I’m about the last one on Earth they should have contacted," Rose said yesterday. It turns out that the physicians’ college doesn’t investigate those kinds of cases, but the doctor is no less upset by the offer to send patients to the study, which was sponsored by Merck Frosst. Rose, who is also an assistant professor of medicine at McGill University, is outspoken about what he sees as an increasingly cozy relationship between doctors and drug companies. He says it undermines doctors’ will to suggest alternatives like lifestyle changes instead of prescription drugs. The hypercholesterolemia and coronary heart disease study to which Rose referred is being conducted by the Clinical Research Consultant Group at the Seaforth Medical Building on Cte des Neiges Rd. The group’s letter to Rose, dated Nov. 18, 2003, detailed how he would receive an honorarium of $6,000 if he referred at least one patient being treated for high cholesterol and heart disease. He would have been required to perform a physical exam of the patients at the beginning and end of the study and write the initial prescription. ‘ Nurses employed by the group would do the rest - seeing patients throughout the 12-week study. The study is evaluating the cholesterol-lowering efficacy of a 10-milligram dose of a drug called Ezetimibe when given with a 10-milligram or 20-milligram dose of Atorvastatin, another cholesterol-lowering drug. Both drugs are approved for use in Canada. Rose later received an e-mail from Bernice Pynn, the lead researcher of the drug study, saying ‘at this time there is no discussion of publication’ of the study results. Pynn, a biochemist, was unavailable for comment yesterday. However, an assistant at the clinical research group confirmed the multisite study is sponsored by Merck Frosst. So far, she said, 15 patients are enrolled in Montreal. Vincent Lamoureux, a spokesperson for Merck Frosst in Kirkland, said doctors are sometimes compensated for their time. However, he said, he was unfamiliar with the study Rose cited, even though ‘there definitely seems to be a link to some of what we do.’ Copyright 2004 Montreal Gazette BP Watch thanks for the phrase “benefit to the patient”. We know prescribing physicians were offered financial benefit.

And Ed, correct me if I am wrong, but didn’t the NEJM article say that ezetimibe *increased* carotid intima-media thickness?

How Ezetimibe (Zetia) was tested:

(CHERYL CORNACCHIA The (Montreal) Gazette Tuesday, February 24, 2004):

‘When a company contacted Colin Rose and offered to pay him $6,000 to refer patients to a drug study, they had the wrong doctor. Rose, a cardiologist at the Montreal General Hospital, not only said no, but he passed the written offer to the College des Medecins du Quebec, suggesting it investigate the ethics of paying doctors to refer patients. ‘

“I’m about the last one on Earth they should have contacted,” Rose said yesterday. It turns out that the physicians’ college doesn’t investigate those kinds of cases, but the doctor is no less upset by the offer to send patients to the study, which was sponsored by Merck Frosst. Rose, who is also an assistant professor of medicine at McGill University, is outspoken about what he sees as an increasingly cozy relationship between doctors and drug companies. He says it undermines doctors’ will to suggest alternatives like lifestyle changes instead of prescription drugs.

The hypercholesterolemia and coronary heart disease study to which Rose referred is being conducted by the Clinical Research Consultant Group at the Seaforth Medical Building on Cte des Neiges Rd. The group’s letter to Rose, dated Nov. 18, 2003, detailed how he would receive an honorarium of $6,000 if he referred at least one patient being treated for high cholesterol and heart disease. He would have been required to perform a physical exam of the patients at the beginning and end of the study and write the initial prescription. ‘

Nurses employed by the group would do the rest - seeing patients throughout the 12-week study. The study is evaluating the cholesterol-lowering efficacy of a 10-milligram dose of a drug called Ezetimibe when given with a 10-milligram or 20-milligram dose of Atorvastatin, another cholesterol-lowering drug. Both drugs are approved for use in Canada.

Rose later received an e-mail from Bernice Pynn, the lead researcher of the drug study, saying ‘at this time there is no discussion of publication’ of the study results. Pynn, a biochemist, was unavailable for comment yesterday. However, an assistant at the clinical research group confirmed the multisite study is sponsored by Merck Frosst. So far, she said, 15 patients are enrolled in Montreal. Vincent Lamoureux, a spokesperson for Merck Frosst in Kirkland, said doctors are sometimes compensated for their time. However, he said, he was unfamiliar with the study Rose cited, even though ‘there definitely seems to be a link to some of what we do.’

Copyright 2004 Montreal Gazette

]]> By: BP Watch http://www.pharmalot.com/2009/11/the-vytorin-limbo-how-low-can-you-go/#comment-447326 BP Watch Wed, 25 Nov 2009 14:55:20 +0000 http://www.pharmalot.com/?p=20099#comment-447326 It's absolutley amazing to me that over 150,000 doctors gave over 150,000 prescriptions to ove 150,000 patients given the absolute lack of evidence that Zetia provides any type of benefit to the patient other than getting them to a better LDL-C number! It’s absolutley amazing to me that over 150,000 doctors gave over 150,000 prescriptions to ove 150,000 patients given the absolute lack of evidence that Zetia provides any type of benefit to the patient other than getting them to a better LDL-C number!

]]> By: Former SP http://www.pharmalot.com/2009/11/the-vytorin-limbo-how-low-can-you-go/#comment-447325 Former SP Wed, 25 Nov 2009 14:51:50 +0000 http://www.pharmalot.com/?p=20099#comment-447325 You reap what you sow! You made your bed and now you've got to sleep in it! And any other phrases describing justice.... You reap what you sow!

You made your bed and now you’ve got to sleep in it!

And any other phrases describing justice….

]]> By: Anonymous http://www.pharmalot.com/2009/11/the-vytorin-limbo-how-low-can-you-go/#comment-447177 Anonymous Tue, 24 Nov 2009 22:42:15 +0000 http://www.pharmalot.com/?p=20099#comment-447177 All the way to the floor? All the way to the floor?

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