Comments on: Vytorin Follow-Up Trial Delayed ‘Til 2012 http://www.pharmalot.com/2008/03/vytorin-follow-up-trial-delayed-til-2012/ News, Comment and Conversation Fri, 10 Feb 2012 19:46:45 +0000 http://wordpress.org/?v=2.6.2 By: HorusCat http://www.pharmalot.com/2008/03/vytorin-follow-up-trial-delayed-til-2012/#comment-236012 HorusCat Sun, 30 Mar 2008 17:41:22 +0000 http://www.pharmalot.com/2008/03/vytorin-follow-up-trial-delayed-til-2012/#comment-236012 Doc, We also need to overhaul the clinical trial process. The FDA's requirements sometimes lead to useless data and restrictive PI information. The emphasis on placebo controls versus showing efficacy over established treatments is one area that needs to be addressed. Further--granting a guaranteed patent life after a drug is actually brought to market would allow the FDA to require studies showing actual clinical benefit. These studies often take years to perform, and companies have nothing to gain and much to lose by completing those studies before a product comes to market. As it is, a company develops its trials to give the FDA what it needs to approve the drug. People who actually know what they're doing need to help revamp the structure of trials so that they actually provide useful information. Doc,

We also need to overhaul the clinical trial process. The FDA’s requirements sometimes lead to useless data and restrictive PI information. The emphasis on placebo controls versus showing efficacy over established treatments is one area that needs to be addressed.

Further–granting a guaranteed patent life after a drug is actually brought to market would allow the FDA to require studies showing actual clinical benefit. These studies often take years to perform, and companies have nothing to gain and much to lose by completing those studies before a product comes to market.

As it is, a company develops its trials to give the FDA what it needs to approve the drug. People who actually know what they’re doing need to help revamp the structure of trials so that they actually provide useful information.

]]> By: HorusCat http://www.pharmalot.com/2008/03/vytorin-follow-up-trial-delayed-til-2012/#comment-236007 HorusCat Sun, 30 Mar 2008 17:36:53 +0000 http://www.pharmalot.com/2008/03/vytorin-follow-up-trial-delayed-til-2012/#comment-236007 Doc, I aree that pharma has gone berserk...but I think the media plays up the missteps and makes us look worse than we are. I'd rather put checks and balances in place with private pharma than give government a major role in deciding which diseases do and do not merit funding... Look at the AIDS debacle...a disease which is 100% avoidable and we are throwing billions at it because of a vociferous political minority got the government involved. Malaria kills millions in Africa...but it is AIDS getting all the attention, when the AIDS "epidemic" in Africa could be halted with monogamy. Doc,
I aree that pharma has gone berserk…but I think the media plays up the missteps and makes us look worse than we are. I’d rather put checks and balances in place with private pharma than give government a major role in deciding which diseases do and do not merit funding…

Look at the AIDS debacle…a disease which is 100% avoidable and we are throwing billions at it because of a vociferous political minority got the government involved. Malaria kills millions in Africa…but it is AIDS getting all the attention, when the AIDS “epidemic” in Africa could be halted with monogamy.

]]> By: Doc http://www.pharmalot.com/2008/03/vytorin-follow-up-trial-delayed-til-2012/#comment-235919 Doc Sun, 30 Mar 2008 16:28:45 +0000 http://www.pharmalot.com/2008/03/vytorin-follow-up-trial-delayed-til-2012/#comment-235919 HC, Private industry is great, private pharma industry gone bad is not great. I've been in it too long and seen too much greed, so admitidly I'm biased. HC,
Private industry is great, private pharma industry gone bad is not great. I’ve been in it too long and seen too much greed, so admitidly I’m biased.

]]> By: HorusCat http://www.pharmalot.com/2008/03/vytorin-follow-up-trial-delayed-til-2012/#comment-235835 HorusCat Sun, 30 Mar 2008 15:35:38 +0000 http://www.pharmalot.com/2008/03/vytorin-follow-up-trial-delayed-til-2012/#comment-235835 Doc, By all means lets empower the government to run even more of our lives. They do so well in the areas they already control. Doc,
By all means lets empower the government to run even more of our lives. They do so well in the areas they already control.

]]> By: Doc http://www.pharmalot.com/2008/03/vytorin-follow-up-trial-delayed-til-2012/#comment-235800 Doc Sun, 30 Mar 2008 15:15:50 +0000 http://www.pharmalot.com/2008/03/vytorin-follow-up-trial-delayed-til-2012/#comment-235800 These trials are twisted, extended, end points changed, analyzed by shills too frequently. How about a fund all pharma pays into for NIH to decide what needs to be studied and run the trials. Enhance should be a wakeup call to even the biggest defenders of pharma. These trials are twisted, extended, end points changed, analyzed by shills too frequently. How about a fund all pharma pays into for NIH to decide what needs to be studied and run the trials. Enhance should be a wakeup call to even the biggest defenders of pharma.

]]> By: HorusCat http://www.pharmalot.com/2008/03/vytorin-follow-up-trial-delayed-til-2012/#comment-234811 HorusCat Sun, 30 Mar 2008 02:10:58 +0000 http://www.pharmalot.com/2008/03/vytorin-follow-up-trial-delayed-til-2012/#comment-234811 Vince, If they do prolong the trial like that, it will the drive the reps to a homicidal fury at management. I used to sell Lipitor, and it killed us, just KILLED US, that we didn't have any morbidity and mortality data for so long. Docs, cardiologists especially, didn't just want lowering, they wanted endpoint data. I am long out of the CV field, but I suspect the Vytorin reps are hearing "Show me the data!" Not only that, but without endpoint data, they may have a hard time justifying preferential formulary placement, especially after atorva goes off-patent. Vince,
If they do prolong the trial like that, it will the drive the reps to a homicidal fury at management. I used to sell Lipitor, and it killed us, just KILLED US, that we didn’t have any morbidity and mortality data for so long. Docs, cardiologists especially, didn’t just want lowering, they wanted endpoint data. I am long out of the CV field, but I suspect the Vytorin reps are hearing “Show me the data!” Not only that, but without endpoint data, they may have a hard time justifying preferential formulary placement, especially after atorva goes off-patent.

]]> By: Vince http://www.pharmalot.com/2008/03/vytorin-follow-up-trial-delayed-til-2012/#comment-234803 Vince Sun, 30 Mar 2008 02:07:39 +0000 http://www.pharmalot.com/2008/03/vytorin-follow-up-trial-delayed-til-2012/#comment-234803 They may well keep this trail going until the patent has expired . Enhance showed no benefit and if this is repeated here then the relationship of LDL to CVD will bear a closer look but only after the proper time period. They may well keep this trail going until the patent has expired . Enhance showed no benefit and if this is repeated here then the relationship of LDL to CVD will bear a closer look but only after the proper time period.

]]> By: Ed Silverman http://www.pharmalot.com/2008/03/vytorin-follow-up-trial-delayed-til-2012/#comment-234254 Ed Silverman Sat, 29 Mar 2008 19:49:20 +0000 http://www.pharmalot.com/2008/03/vytorin-follow-up-trial-delayed-til-2012/#comment-234254 Hi MKM, Thanks. I modified the language. Sometimes, the effort to keep things simple either oversimplifies or clouds the picture. Hope this makes more sense now. ed Hi MKM,

Thanks. I modified the language. Sometimes, the effort to keep things simple either oversimplifies or clouds the picture. Hope this makes more sense now.

ed

]]> By: MKM http://www.pharmalot.com/2008/03/vytorin-follow-up-trial-delayed-til-2012/#comment-234229 MKM Sat, 29 Mar 2008 19:36:34 +0000 http://www.pharmalot.com/2008/03/vytorin-follow-up-trial-delayed-til-2012/#comment-234229 Ed, Patients with heterozygous familial hypercholesterolemia do not necessarily have heart disease. That have very high LDL, which is a risk factor for heart disease. ENHANCE looked at carotid intima-media thickness, not carotid artery plaque. Marilyn Ed,

Patients with heterozygous familial hypercholesterolemia do not necessarily have heart disease. That have very high LDL, which is a risk factor for heart disease.

ENHANCE looked at carotid intima-media thickness, not carotid artery plaque.

Marilyn

]]> By: Ed Silverman http://www.pharmalot.com/2008/03/vytorin-follow-up-trial-delayed-til-2012/#comment-234170 Ed Silverman Sat, 29 Mar 2008 19:00:01 +0000 http://www.pharmalot.com/2008/03/vytorin-follow-up-trial-delayed-til-2012/#comment-234170 Hi John, There are different Internet sites listing 2013 and 2014, in fact. I asked the Schering-Plough spokesman and he says 2017. I then asked him to clarify the discrepancy between his response and what I'd seen on the Internet. He has not yet replied. There are different patents involved, as you know. I am also waiting to hear from an industry analyst. If the info provided me needs to be clarified, for whatever reason, I will do so. Hope this helps, ed Hi John,

There are different Internet sites listing 2013 and 2014, in fact. I asked the Schering-Plough spokesman and he says 2017. I then asked him to clarify the discrepancy between his response and what I’d seen on the Internet. He has not yet replied. There are different patents involved, as you know. I am also waiting to hear from an industry analyst. If the info provided me needs to be clarified, for whatever reason, I will do so.

Hope this helps,
ed

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