Comments on: Forget The FDA, Get Acomplia In Mexico http://www.pharmalot.com/2007/06/forget-the-fda-get-acomplia-in-mexico/ News, Comment and Conversation Fri, 10 Feb 2012 18:53:13 +0000 http://wordpress.org/?v=2.6.2 By: Sal Giorgianni. Pharm.D http://www.pharmalot.com/2007/06/forget-the-fda-get-acomplia-in-mexico/#comment-4887 Sal Giorgianni. Pharm.D Tue, 12 Jun 2007 00:08:49 +0000 http://www.pharmalot.com/2007/06/forget-the-fda-get-acomplia-in-mexico/#comment-4887 I was responsible for external relations and worked in part on image management for Viagra for over a decade before retiring from Pfizer recently. I can tell you that the American public's appetite for drugs of this type is insatiable. (pun intended). The best thing FDA can do is approve it with the proviso that post-marketing surveillance studies are done by clinicians in practice. This will cost Sanofi-Aventis big time but it is the way of the future and might as well start here. The current risk adverse climate at FDA is going to stall a lot of products from getting on the market. While the American public may not miss not having access to a better treatment for hypertension they will miss not having access to something like this. To not approve it will, in my estimation, create one of the biggest black-markets around with untold adverse public health consequences. I was responsible for external relations and worked in part on image management for Viagra for over a decade before retiring from Pfizer recently. I can tell you that the American public’s appetite for drugs of this type is insatiable. (pun intended). The best thing FDA can do is approve it with the proviso that post-marketing surveillance studies are done by clinicians in practice. This will cost Sanofi-Aventis big time but it is the way of the future and might as well start here. The current risk adverse climate at FDA is going to stall a lot of products from getting on the market. While the American public may not miss not having access to a better treatment for hypertension they will miss not having access to something like this. To not approve it will, in my estimation, create one of the biggest black-markets around with untold adverse public health consequences.

]]> By: B man http://www.pharmalot.com/2007/06/forget-the-fda-get-acomplia-in-mexico/#comment-4714 B man Mon, 11 Jun 2007 20:05:22 +0000 http://www.pharmalot.com/2007/06/forget-the-fda-get-acomplia-in-mexico/#comment-4714 Forget about Motezuma's revenge! Attack of the Zimulti is now available at a taco stand pharmacy near Texas. After spending $117 for a month, you'll definitely lose 3-4 pounds but then you'll be depressed about it and will need an SSRI to complete the suicide mission when you go across the border to buy it. Forget about Motezuma’s revenge! Attack of the Zimulti is now available at a taco stand pharmacy near Texas. After spending $117 for a month, you’ll definitely lose 3-4 pounds but then you’ll be depressed about it and will need an SSRI to complete the suicide mission when you go across the border to buy it.

]]> By: Dr. No http://www.pharmalot.com/2007/06/forget-the-fda-get-acomplia-in-mexico/#comment-4706 Dr. No Mon, 11 Jun 2007 19:16:17 +0000 http://www.pharmalot.com/2007/06/forget-the-fda-get-acomplia-in-mexico/#comment-4706 I guess Big Pharma will not have an issue with this type of reimportation, bring forward no safety concerns regarding drugs from other markets, nor curtail the drugs available to the Mexican population due to the sudden whooping demand wildly exceding the logical demand locally. I guess Big Pharma will not have an issue with this type of reimportation, bring forward no safety concerns regarding drugs from other markets, nor curtail the drugs available to the Mexican population due to the sudden whooping demand wildly exceding the logical demand locally.

]]> By: Dr. Remulac http://www.pharmalot.com/2007/06/forget-the-fda-get-acomplia-in-mexico/#comment-4703 Dr. Remulac Mon, 11 Jun 2007 17:48:01 +0000 http://www.pharmalot.com/2007/06/forget-the-fda-get-acomplia-in-mexico/#comment-4703 OK, where's Nissen now?? From the Zimulti NDA submission; relative risk of psych event versus placebo: Anxiety - 152% greater with Zimulti Depression or any mood disorder - 87% higher with Zimulti Any psych disorder - 61% higher with Zimulti Suicidal ideation - 72% higher with Zimulti Suicide attempt/self-injury/suicidal ideation in ongoing trials - 99% higher with Zimulti European postmarketing reported case rate for depression/suicidal ideation is 12.2 cases/10,000 pts treated. Why is Nissen silent on Zimulti? He waxed poetic over a 43-61% excess risk of CV events with Avandia. Look here, and judge for yourself: http://clinicaltrials.gov/ct/show/NCT00124332?order=25 Yes, that's right. Sanofi-Aventis placed a multi-million dollar IVUS trial on rimonabant with the Cleveland Clinic and good Dr.Nissen OK, where’s Nissen now??

From the Zimulti NDA submission; relative risk of psych event versus placebo:
Anxiety - 152% greater with Zimulti
Depression or any mood disorder - 87% higher with Zimulti
Any psych disorder - 61% higher with Zimulti
Suicidal ideation - 72% higher with Zimulti
Suicide attempt/self-injury/suicidal ideation in ongoing trials - 99% higher with Zimulti
European postmarketing reported case rate for depression/suicidal ideation is 12.2 cases/10,000 pts treated.

Why is Nissen silent on Zimulti? He waxed poetic over a 43-61% excess risk of CV events with Avandia. Look here, and judge for yourself: http://clinicaltrials.gov/ct/show/NCT00124332?order=25

Yes, that’s right. Sanofi-Aventis placed a multi-million dollar IVUS trial on rimonabant with the Cleveland Clinic and good Dr.Nissen

]]> By: Arlene Teck http://www.pharmalot.com/2007/06/forget-the-fda-get-acomplia-in-mexico/#comment-4700 Arlene Teck Mon, 11 Jun 2007 17:34:43 +0000 http://www.pharmalot.com/2007/06/forget-the-fda-get-acomplia-in-mexico/#comment-4700 Yes, and in 1998 Viagra® was approved for sale in the USA before it was approved in Japan. And thousands of Japanese men stormed the beaches of Hawaii on so-called "Viagra Tours." Yes, and in 1998 Viagra® was approved for sale in the USA before it was approved in Japan. And thousands of Japanese men stormed the beaches of Hawaii on so-called “Viagra Tours.”

]]> By: Dr. Remulac http://www.pharmalot.com/2007/06/forget-the-fda-get-acomplia-in-mexico/#comment-4558 Dr. Remulac Mon, 11 Jun 2007 16:33:39 +0000 http://www.pharmalot.com/2007/06/forget-the-fda-get-acomplia-in-mexico/#comment-4558 I just reviewed Sanofi-Aventis's NDA submission. Given today's risk-averse climate at the FDA and among the general public, I am guessing that ultimately it will be decided that the risk-benefit ratio is unacceptable for Zimulti and it will not be considered for approval until completion of their CV outcomes and CV imaging trials. Benefit on weight loss of about 10 pounds or so over placebo will not be considered enough to overcome the clear psychiatric risk of this drug. If the CV outcomes/imaging trials demonstrate fewer events/less atherosclerosis over placebo, then this may be considered enough benefit that outweighs the psych risk - but only if the current psych risk holds steady in these trials (if it increases over previous rates, forget about it). They have no chance of getting any labeling for glucose control (especially since there are effective alternatives already available), and likewise no hope of labeling for lipids. I just reviewed Sanofi-Aventis’s NDA submission. Given today’s risk-averse climate at the FDA and among the general public, I am guessing that ultimately it will be decided that the risk-benefit ratio is unacceptable for Zimulti and it will not be considered for approval until completion of their CV outcomes and CV imaging trials. Benefit on weight loss of about 10 pounds or so over placebo will not be considered enough to overcome the clear psychiatric risk of this drug. If the CV outcomes/imaging trials demonstrate fewer events/less atherosclerosis over placebo, then this may be considered enough benefit that outweighs the psych risk - but only if the current psych risk holds steady in these trials (if it increases over previous rates, forget about it). They have no chance of getting any labeling for glucose control (especially since there are effective alternatives already available), and likewise no hope of labeling for lipids.

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