Comments on: Was The FDA Given A Secret Vytorin Report? http://www.pharmalot.com/2008/09/was-the-fda-given-a-secret-vytorin-report/ News, Comment and Conversation Fri, 10 Feb 2012 19:50:25 +0000 http://wordpress.org/?v=2.6.2 By: quit smoking withdrawl http://www.pharmalot.com/2008/09/was-the-fda-given-a-secret-vytorin-report/#comment-408801 quit smoking withdrawl Sun, 07 Jun 2009 16:20:59 +0000 http://www.pharmalot.com/?p=15264#comment-408801 Have spent ages looking for sites like this, yours is the best I have seen today! Well done! Google blog search has you pretty well indexed it seems! you have some and informative stuff here! are you on twitter? Have spent ages looking for sites like this, yours is the best I have seen today! Well done!
Google blog search has you pretty well indexed it seems! you have some and informative stuff here! are you on twitter?

]]> By: Piper http://www.pharmalot.com/2008/09/was-the-fda-given-a-secret-vytorin-report/#comment-371670 Piper Mon, 08 Sep 2008 19:44:24 +0000 http://www.pharmalot.com/?p=15264#comment-371670 How about this reality: it is not biologically plausible that ezetimibe caused or promoted the cancer growth in SEAS. Does it block plant sterols? Sure, in the genetically unique individuals with sitosterolemia. But those poor folks would die if it didn't. For the rest of the hypercholesterolemia patient population, it doesn't HAVE TO block plant sterols. Why? Cholesterol is the sterol synthesized and utilized by mammals. Mammalian cells cannot use plant sterols, which possess an additional carbon group, thereby preventing their efficient absorption in the human intestines. In sitosterolemia, patients have defective cellular machinery that cannot differentiate between plant and animal sterols - these patients go on to accumulate large amounts of plant sterols in their tissues and die of coronary heart disease at an early age. As for Dr. Bradford, which the NY Times cited for his work with plant sterols, his first two trials were done in vitro, such that the obvious intestinal barriers were removed. The third trial, in hamsters, clarified that the beneficial effects of phytosterols were not observed with FREE plant sterols and stanols (hmm, I wonder why). The logic behind Nissen and Fleming's theory for ezetimibe's carcinogenic properties is just the wishful thinking of two spotlight loving cardiologists that apparently want to be oncologists. Should you not believe me, feel free to look it up in your old college Biochemistry book; or better yet, look it up in Cell, Science, the ASNS...... On an obvious side note, cancer is a mutation. Skin cells, prostate cells, stomach cells all take time to mutate (Those were the three areas where Vytorin outweighed the placebo in SEAS). Lung cancer is the deadliest of all cancers (has the lowest survival rate). The incidence of lung cancer was higher in the meta-analysis of IMPROVE-IT and SHARP and subsequently, so was the death rate. Lung cancer doesn't develop overnight, but it will kill you in no time. Is that ezetimibe's fault? People get lung cancer years after they quit smoking....who is to blame then? If you were diagnosed with cancer, where would you turn for help - your cardiologist?? the NYT?? No. An oncologist, maybe an epidemiologist, but not the other guys. Anyone that can turn a cholesterol absorbing drug into the equivalent of asbestos, while ignoring the fundamental basics of biology and oncology, shouldn't be quoted over and over again like the god of all things good in health care. How about this reality: it is not biologically plausible that ezetimibe caused or promoted the cancer growth in SEAS. Does it block plant sterols? Sure, in the genetically unique individuals with sitosterolemia. But those poor folks would die if it didn’t. For the rest of the hypercholesterolemia patient population, it doesn’t HAVE TO block plant sterols. Why? Cholesterol is the sterol synthesized and utilized by mammals. Mammalian cells cannot use plant sterols, which possess an additional carbon group, thereby preventing their efficient absorption in the human intestines. In sitosterolemia, patients have defective cellular machinery that cannot differentiate between plant and animal sterols - these patients go on to accumulate large amounts of plant sterols in their tissues and die of coronary heart disease at an early age.
As for Dr. Bradford, which the NY Times cited for his work with plant sterols, his first two trials were done in vitro, such that the obvious intestinal barriers were removed. The third trial, in hamsters, clarified that the beneficial effects of phytosterols were not observed with FREE plant sterols and stanols (hmm, I wonder why). The logic behind Nissen and Fleming’s theory for ezetimibe’s carcinogenic properties is just the wishful thinking of two spotlight loving cardiologists that apparently want to be oncologists. Should you not believe me, feel free to look it up in your old college Biochemistry book; or better yet, look it up in Cell, Science, the ASNS……
On an obvious side note, cancer is a mutation. Skin cells, prostate cells, stomach cells all take time to mutate (Those were the three areas where Vytorin outweighed the placebo in SEAS). Lung cancer is the deadliest of all cancers (has the lowest survival rate). The incidence of lung cancer was higher in the meta-analysis of IMPROVE-IT and SHARP and subsequently, so was the death rate. Lung cancer doesn’t develop overnight, but it will kill you in no time. Is that ezetimibe’s fault? People get lung cancer years after they quit smoking….who is to blame then? If you were diagnosed with cancer, where would you turn for help - your cardiologist?? the NYT?? No. An oncologist, maybe an epidemiologist, but not the other guys. Anyone that can turn a cholesterol absorbing drug into the equivalent of asbestos, while ignoring the fundamental basics of biology and oncology, shouldn’t be quoted over and over again like the god of all things good in health care.

]]> By: Chris http://www.pharmalot.com/2008/09/was-the-fda-given-a-secret-vytorin-report/#comment-371183 Chris Thu, 04 Sep 2008 01:47:46 +0000 http://www.pharmalot.com/?p=15264#comment-371183 LILLI - What exactly are you proposing? Taking all drugs with side effects off the market? By firing all pharma management? How would you suggest we 'repair the problems'? Many people benefit with these drugs, typically some have side effects. LILLI -
What exactly are you proposing? Taking all drugs with side effects off the market? By firing all pharma management? How would you suggest we ‘repair the problems’? Many people benefit with these drugs, typically some have side effects.

]]> By: LILLI http://www.pharmalot.com/2008/09/was-the-fda-given-a-secret-vytorin-report/#comment-371145 LILLI Wed, 03 Sep 2008 21:50:20 +0000 http://www.pharmalot.com/?p=15264#comment-371145 I really do not know th purpose of Pharmalot! As a child I learned that when problems occur we worked at fixing the problems---not just discussing. America's health care management system is corrupt. One day we are told this medication will help us, a Month or years later we are informed that the medication caused serious problems, yet our elected and appointed officials do not repair the problems and allow the general public to endure serious illness that has cause many unnecessary fatalities. I really do not know th purpose of Pharmalot! As a child I learned that when problems
occur we worked at fixing the problems—not just discussing. America’s health care
management system is corrupt. One day we are told this medication will help us, a Month
or years later we are informed that the medication caused serious problems, yet our
elected and appointed officials do not repair the problems and allow the general public to
endure serious illness that has cause many unnecessary fatalities.

]]> By: SP 2 http://www.pharmalot.com/2008/09/was-the-fda-given-a-secret-vytorin-report/#comment-371078 SP 2 Wed, 03 Sep 2008 15:59:38 +0000 http://www.pharmalot.com/?p=15264#comment-371078 Probably. Virtually nothing with SP is completely up-front and complete - spin rules! Probably. Virtually nothing with SP is completely up-front and complete - spin rules!

]]> By: Condor http://www.pharmalot.com/2008/09/was-the-fda-given-a-secret-vytorin-report/#comment-370958 Condor Tue, 02 Sep 2008 21:47:25 +0000 http://www.pharmalot.com/?p=15264#comment-370958 As a service to the readership -- I've set today's Congressional letter, in full text, right here: http://shearlingsplowed.blogspot.com/2008/09/ed-silverman-on-secret-seas-report-to.html Cheers! As a service to the readership — I’ve set today’s Congressional letter, in full text, right here:

http://shearlingsplowed.blogspot.com/2008/09/ed-silverman-on-secret-seas-report-to.html

Cheers!

]]> By: Condor http://www.pharmalot.com/2008/09/was-the-fda-given-a-secret-vytorin-report/#comment-370948 Condor Tue, 02 Sep 2008 20:35:34 +0000 http://www.pharmalot.com/?p=15264#comment-370948 Again, Ed is all over it -- like white on rice! Piper -- I guess you ARE confused. Five pages can't possibly be a "complete report" or a "full assessment". See -- here's how it works: these Congressional Committees share jurisdiction with the FDA over the pharma industry. The sooner CEO Fred Hassan accepts that reality, the better for Schering's long term interests. This sort of obstinence/sand-bagging will not play well in the new Administration's view of Schering. Again, Ed is all over it — like white on rice!

Piper — I guess you ARE confused. Five pages can’t possibly be a “complete report” or a “full assessment”.

See — here’s how it works: these Congressional Committees share jurisdiction with the FDA over the pharma industry.

The sooner CEO Fred Hassan accepts that reality, the better for Schering’s long term interests.

This sort of obstinence/sand-bagging will not play well in the new Administration’s view of Schering.

]]> By: Dan A. http://www.pharmalot.com/2008/09/was-the-fda-given-a-secret-vytorin-report/#comment-370944 Dan A. Tue, 02 Sep 2008 20:12:35 +0000 http://www.pharmalot.com/?p=15264#comment-370944 Is anyone really suprised about this allgation? Is anyone really suprised about this allgation?

]]> By: Piper http://www.pharmalot.com/2008/09/was-the-fda-given-a-secret-vytorin-report/#comment-370943 Piper Tue, 02 Sep 2008 20:04:59 +0000 http://www.pharmalot.com/?p=15264#comment-370943 I'm confused. No wait, Stupak and Dingell are confused. Because I understood back in July that the Oxford analysis was done. Or so I assumed, based on the rather lengthy PowerPoint presentation they had posted on their website. So what exactly were Stupak and Dingell expecting? MSP didn't run SEAS (they funded $$$) and they didn't run the cancer analysis. They also didn't write (ghost or otherwise) the NEJM articles/analyses published today, which showed the same unfavorable conclusions we saw a month and a half ago. I think Sir Peto was correct in saying Dingell's committee action amounts to "harassment". It seems they have lost all objectivity at this point....if they ever had any. I’m confused. No wait, Stupak and Dingell are confused. Because I understood back in July that the Oxford analysis was done. Or so I assumed, based on the rather lengthy PowerPoint presentation they had posted on their website. So what exactly were Stupak and Dingell expecting? MSP didn’t run SEAS (they funded $$$) and they didn’t run the cancer analysis. They also didn’t write (ghost or otherwise) the NEJM articles/analyses published today, which showed the same unfavorable conclusions we saw a month and a half ago. I think Sir Peto was correct in saying Dingell’s committee action amounts to “harassment”. It seems they have lost all objectivity at this point….if they ever had any.

]]> By: Dan A. http://www.pharmalot.com/2008/09/was-the-fda-given-a-secret-vytorin-report/#comment-370936 Dan A. Tue, 02 Sep 2008 19:43:27 +0000 http://www.pharmalot.com/?p=15264#comment-370936 Would anyone be suprised if the FDA was given a secret Vytorin report? Would anyone be suprised if the FDA was given a secret Vytorin report?

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