Lipitor's Cashmere Study

Results shed a ray of light on what may have been inherently wrong with ENHANCE. Cashmere shows Lipitor 80 didn't slow progression of plaque over 12 months - contradiction of what previous Lipitor studies show! Use of the CIMT technique for measuring arterial thickening is being scrutinized...and ENHANCE is back in the news. This time, critics aren't dismissing Vytorin/Zetia -- they're dismissing CIMT!


http://money.cnn.com/news/newsfeeds/...9_FORTUNE5.htm

Originally Posted by Anonymous

Results shed a ray of light on what may have been inherently wrong with ENHANCE. Cashmere shows Lipitor 80 didn't slow progression of plaque over 12 months - contradiction of what previous Lipitor studies show! Use of the CIMT technique for measuring arterial thickening is being scrutinized...and ENHANCE is back in the news. This time, critics aren't dismissing Vytorin/Zetia -- they're dismissing CIMT!


http://money.cnn.com/news/newsfeeds/...9_FORTUNE5.htm

thanks

This is great. Only hope it doesn't get buried in the holiday - what makes news on the day before a long holiday these days besides the outrageous gas prices? A 'good' journalist (is there such a thing anymore?) would dig this up again on Monday and get things stirring with an over-sensationalized headline similar to the ones they ran after ENHANCE was published. Millions of people in the US take Lipitor - which translates to millions of papers sold, programs watched, links clicked, etc. Let's just hope it strikes up some good intellectual conversation (rather than fueling more bitterness against the Pharma industry) - and let's hope our docs can take the info from CASHMERE in combination with the info we've given them over the past few months about ENHANCE, and apply their own deductive reasoning...if so, Zetia and Vytorin will bounce back! It's already started to happen - It's only a matter of time before it's back to GROWING share instead of fighting to keep it. Hold tight my friends, "we're on our way back home......."

Originally Posted by Anonymous

Results shed a ray of light on what may have been inherently wrong with ENHANCE. Cashmere shows Lipitor 80 didn't slow progression of plaque over 12 months - contradiction of what previous Lipitor studies show! Use of the CIMT technique for measuring arterial thickening is being scrutinized...and ENHANCE is back in the news. This time, critics aren't dismissing Vytorin/Zetia -- they're dismissing CIMT!


http://money.cnn.com/news/newsfeeds/...9_FORTUNE5.htm

I am all for vigorous scientific debate -- but to paint CASHMERE as vindicating Vytorin is simply wishful-thinking.

Correct me if I am wrong, but Vytorin has no "outcomes data" in its favor. Lipitor plainly does -- tons of it.

So a small study on Lipitor comes out inconclusively -- and the measurement is suspect. That is all fair.

It is a horse of a completely different color, though, to suggest that this means Vytorin is in any way on a par with Lipitor -- as to outcomes.

Vytorin simply has no data to back that claim. None.

Lipitor now has one smaller inconclusive study, to add to its several larger favorable outcomes studies. Doesn't that say it all? It is what I will now go publish -- <A href ="http://shearlingsplowed.blogspot.com">in a few moments</a>:



Have a safe Fourth, one and all!

Originally Posted by Anonymous

This is great. Only hope it doesn't get buried in the holiday - what makes news on the day before a long holiday these days besides the outrageous gas prices? A 'good' journalist (is there such a thing anymore?) would dig this up again on Monday and get things stirring with an over-sensationalized headline similar to the ones they ran after ENHANCE was published. Millions of people in the US take Lipitor - which translates to millions of papers sold, programs watched, links clicked, etc. Let's just hope it strikes up some good intellectual conversation (rather than fueling more bitterness against the Pharma industry) - and let's hope our docs can take the info from CASHMERE in combination with the info we've given them over the past few months about ENHANCE, and apply their own deductive reasoning...if so, Zetia and Vytorin will bounce back! It's already started to happen - It's only a matter of time before it's back to GROWING share instead of fighting to keep it. Hold tight my friends, "we're on our way back home......."

My take?

W I S H F U L

T H I N K I N G.

While I wait for mine to clear the Kindly Moderators -- here is a link to a more fleshed-out version of my take:

http://shearlingsplowed.blogspot.com...ssen-then.html

I believe the OP is simply stating what the Cashmere study suggests: that CIMT imaging data may not be an accurate source of determining thickening of the arterial wall. The fact that previous Lipitor studies have shown OUTCOMES DATA actually support this point! And, DONCOR, the fact that such studies proving OUTCOMES were proved using means other than the CIMT support this even further.

What is in question now, CONROD, is not whether LDL lowering is the ultimate source of reducing cardiac events, but whether we've been studying such a risk factor correctly all along.

If, in fact, CASHMERE proves ANYTHING, DORCON, it is that we still have much work to do in determining how we evaluate the efficacy of drugs like Lipitor, Crestor, Zocor, and Vytorin. I have not at all suggested that CASHMERE will "vindicate" Vytorin, Zetia, or Enhance. All I offer is the current suggestion is that CASHMERE makes obvious: that CIMT isn't enough to determine long term results. It is almost impossible to read CASHMERE without having ENHANCE come to mind. In scientific thought, this is one of the best types of outcomes you could get: a debate in how we are performing our scientific research.

ROCOND, I'm sad for you. I've read your posts on this forum. I've read your blog. I have agreed with you on some posts, even. Your blog even made me laugh at times. You a very talented (and witty) writer.

Please tell me, DROONC, what is your motivation? What has the drug industry done to you that has made you so bitter? Why Schering? Why now? Surely, you could have reaped the benefits of compiling your collection of SP data long ago - you seem to be no stranger to the insides and outs of the SP organization. This may deem you a traitor in some circles.

What disturbs me most, CORNDO, is that you insist on posting such 'sensational' items to your blogspot. I suppose you like it when people panic? It's sick. Sadistic. What most right-wingers would call leftist. And what most liberals would call absolutey fucked up. Who exactly is your audience DOCNOR?

It leads me to believe, NORDOC, that to parallel your literary talent, you also take pride in something very very awful, yet, until now, private. What you write about is your only outlet to the world going on outside your own. Inside your soul you know there is something evil. Inside your home you are reminded by it....that's why you are always posting. You've got nothing else.

Except the girl tied up in the basement...you should let her go.




ACC Statement on ENHANCE Trial


January 15, 2008

The ENHANCE (Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia) trial results were released by Merck and Schering-Plough Pharmaceuticals on January 14, 2008. The results of the trial show no benefit from the combination of ezetimibe (Zetia) and simvastatin (sold together as Vytorin) over simvastatin alone in terms of affecting the rate of atherosclerosis progression.

The study involved 720 patients with heterozygous familial hypercholesterolemia and showed no significant difference in the primary endpoint between patients treated with ezetimibe and simvastatin versus patients treated with simvastatin alone over a two-year period. The study was designed to prove that Vytorin could slow the growth of plaque in carotid arteries supplying the brain more than simvastatin alone. Media reports indicate that the results of the trial show no benefit from the combination of ezetimibe (Zetia) and simvastatin (sold together as Vytorin) over simvastatin alone.

The American College of Cardiology recommends that major clinical decisions not be made on the basis of the ENHANCE study alone.

According to the American College of Cardiology (ACC), this study deserves serious thought and follow-up. The overall incidence rates of cardiac events were nearly identical between both treatment groups, and both medicines were generally well tolerated. There should no be reason for patients to panic. The difference in IMT changes between the simvastatin group and the Vytorin group was 0.006 mm vs. 0.011 mm.

Health care professionals should speak to their concerned patients using this drug. The ACC is also releasing a public statement explaining that this is not an urgent situation and patients should never stop taking any prescribed medications without first discussing the issue with their health care professional. Further research will be needed in this area to provide conclusive evidence about which lipid lowering strategy is preferred (statin alone vs. statin plus ezetimibe).

Furthermore, the ACC notes that this trial is an imaging study and not a clinical-outcome study. Conclusions should not be made until the three large clinical-outcome trials are presented within the next two to three years. The ACC recommends that Zetia remain a reasonable option for patients who are currently on a high dose statin but have not reached their goal. The ACC also notes that Zetia is a reasonable option for patients who cannot tolerate statins or can only tolerate a low dose statin.

http://www.theheart.org/article/876565.do

You wrote: ". . . .This may deem you a traitor in some circles. . . ."

Perfect. Except, of course, to be considered a traitor, I must've sworn allegiance to some fiefdom, or flag, first. I've never made any such oath.

". . . .'tis by the sweat of my brow, the strength of my back, the ring of my steel, and the flash of my cannons, alone*. . . ."

I owe no debts, nor do I hold any "markers", of debts owed to me. I simply follow the facts -- wherever they lead.

More seriously, though -- for a moment, at least -- you ought to get some professional help about your "girl tied up in the basement" delusions -- to write something like that, in reference to someone you don't know in the least -- do not even have passing familiarity with -- might well-suggest that your grip on reality is fragile, at best. Ever considered old-Sandoz's Clozaril?

Ah -- "good luck with all that", just the same.

~~~~~~~~~~

* POTC III -- "At Worlds' End"

Ha! Thought you might pick up on the Silence of the Lambs reference. Guess not.

Happy 4th of July.
Enjoy your freedom today, Buffalo Bill!

Here's a link to the study results:

http://www.clinicalstudyresults.org/...udy_2902_0.pdf

This study was underpowered and was conducted in a fairly low risk population: postmenopausal women, average age 57, with no history of coronary artery disease who had LDL between 130 and 190. The study only lasted one year, and there was a high discontinuation rate. There were no deaths and only one heart attack during the study.

Although the results are somewhat surprising, I would describe them as inconclusive. We have outcomes data for Lipitor, but not a lot of data that indicates a large benefit for primary prevention in low risk women. There were only 400 women in the study to begin with, and 41% of the Lipitor group and 30% of the placebo group discontinued treatment.

The bottom line for ezetimibe is that we don't have outcomes data and ENHANCE is some evidence, the best we have at the moment. Given the uncertainty about whether ezetimibe has any benefit, the recommendation to go with statins first, and other medications like niacin and resins second, makes a lot of sense. I don't see how CASHMERE changes any of that.

Merck and Schering-Plough have only themselves to blame for not starting outcomes studies earlier. I don't feel sorry for them.

Originally Posted by Anonymous

This is great. Only hope it doesn't get buried in the holiday - what makes news on the day before a long holiday these days besides the outrageous gas prices? A 'good' journalist (is there such a thing anymore?) would dig this up again on Monday and get things stirring with an over-sensationalized headline similar to the ones they ran after ENHANCE was published. Millions of people in the US take Lipitor - which translates to millions of papers sold, programs watched, links clicked, etc. Let's just hope it strikes up some good intellectual conversation (rather than fueling more bitterness against the Pharma industry) - and let's hope our docs can take the info from CASHMERE in combination with the info we've given them over the past few months about ENHANCE, and apply their own deductive reasoning...if so, Zetia and Vytorin will bounce back! It's already started to happen - It's only a matter of time before it's back to GROWING share instead of fighting to keep it. Hold tight my friends, "we're on our way back home......."

I hope you're right! I like the optimism!!

I think we could all use some positive thought. Thanks for sharing this...

No reply from Buffalo Bill? guess it's rubbing the lotion on its skin so it doesn't get the hose again

Originally Posted by Anonymous

Here's a link to the study results:

http://www.clinicalstudyresults.org/...udy_2902_0.pdf

This study was underpowered and was conducted in a fairly low risk population: postmenopausal women, average age 57, with no history of coronary artery disease who had LDL between 130 and 190. The study only lasted one year, and there was a high discontinuation rate. There were no deaths and only one heart attack during the study.

Although the results are somewhat surprising, I would describe them as inconclusive. We have outcomes data for Lipitor, but not a lot of data that indicates a large benefit for primary prevention in low risk women. There were only 400 women in the study to begin with, and 41% of the Lipitor group and 30% of the placebo group discontinued treatment.

The bottom line for ezetimibe is that we don't have outcomes data and ENHANCE is some evidence, the best we have at the moment. Given the uncertainty about whether ezetimibe has any benefit, the recommendation to go with statins first, and other medications like niacin and resins second, makes a lot of sense. I don't see how CASHMERE changes any of that.

Merck and Schering-Plough have only themselves to blame for not starting outcomes studies earlier. I don't feel sorry for them.

Someone just asked about Buffalo Bill's answer -- I incorporate the above, en todo, as my answer.

". . . .'tis by the sweat of my brow, the strength of my back, the ring of my steel, and the flash of my cannons, alone*. . . ."

I owe no debts, nor do I hold any "markers", of debts owed to me. I simply follow the facts -- wherever they lead.

Cheers!

Originally Posted by The Condor

I am all for vigorous scientific debate -- but to paint CASHMERE as vindicating Vytorin is simply wishful-thinking.

Correct me if I am wrong, but Vytorin has no "outcomes data" in its favor. Lipitor plainly does -- tons of it.

So a small study on Lipitor comes out inconclusively -- and the measurement is suspect. That is all fair.

It is a horse of a completely different color, though, to suggest that this means Vytorin is in any way on a par with Lipitor -- as to outcomes.

Vytorin simply has no data to back that claim. None.

Lipitor now has one smaller inconclusive study, to add to its several larger favorable outcomes studies. Doesn't that say it all? It is what I will now go publish -- <A href ="http://shearlingsplowed.blogspot.com">in a few moments</a>:



Have a safe Fourth, one and all!

And once again, Rainn-Condor finds a way to interpret everything in the worst possible sense for SP.

Look, a lot of people are beginning to realize that the ENHANCE flap was overdone, and the effect on the company (and therefore the rank and file) has been disproportionate. Even Greeley has moved on to other windmills.

Most of the action with SP lately has been tied directly to the will of the market as a whole, and not at all reflective of shareholder response to the kind of minutia you constantly harp on.

In other words, the more you scream and shout, the more spiteful you sound. And yes, your target audience is catching onto that.

Originally Posted by Anonymous

And once again, Rainn-Condor finds a way to interpret everything in the worst possible sense for SP.

Look, a lot of people are beginning to realize that the ENHANCE flap was overdone, and the effect on the company (and therefore the rank and file) has been disproportionate. Even Greeley has moved on to other windmills.

Most of the action with SP lately has been tied directly to the will of the market as a whole, and not at all reflective of shareholder response to the kind of minutia you constantly harp on.

In other words, the more you scream and shout, the more spiteful you sound. And yes, your target audience is catching onto that.

As in Senator Chuck Grassley. . . . but hey, it's your barbeque, Cyrus (the "Virus"), and it tastes real good. . . .

Now you wrote something about "my target audience" -- what was it? Oh, yes -- this: ". . .And yes, your target audience is catching onto that. . . ."

I am genuinely curious, here -- how would YOU define MY "target audience"?

So, who is my target audience? I'd really like to read your perspective.

Do tell.

this guy is so creepy

Originally Posted by The Condor

As in Senator Chuck Grassley. . . . but hey, it's your barbeque, Cyrus (the "Virus"), and it tastes real good. . . .

Now you wrote something about "my target audience" -- what was it? Oh, yes -- this: ". . .And yes, your target audience is catching onto that. . . ."

I am genuinely curious, here -- how would YOU define MY "target audience"?

So, who is my target audience? I'd really like to read your perspective.

Do tell.

Can't speak for the poster, but I'd say it was anyone unfortunate enough to be caught near the street corner where you usually scream and rave about the coming apocalypse and people who talk in the movie theater.

You don't find it interesting how many people withdrew from the Lipitor treatment group because of adverse events?? Say it with me condor.....mialga. You can thank the half-life of Lipitor for that one. But what's more amazing is how many patients complain to their doctors about mialga when taking Lipitor and they are told to just deal with it because they will get that from every statin. Bull shit! I can think of a lot of family members that were finally switched from Lipitor to Vytorin and guess what,, the muscle pains went away. Condor, until you have a father, mother, etc. with CHD and can't walk because of what Lipitor does to his muscles, stick to stock quotes.

Originally Posted by The Condor

Someone just asked about Buffalo Bill's answer -- I incorporate the above, en todo, as my answer.

". . . .'tis by the sweat of my brow, the strength of my back, the ring of my steel, and the flash of my cannons, alone*. . . ."

I owe no debts, nor do I hold any "markers", of debts owed to me. I simply follow the facts -- wherever they lead.

Cheers!

Let's take the initiative and email the study to all those reporters and news stations...so that the CASHMERE trial gets the same coverage as the ENHANCE trial did...it's up to us...or will we continue to take it because our corporate Marketing departments are a joke compared to Pfizer and Astrazeneca?

Originally Posted by Anonymous

You don't find it interesting how many people withdrew from the Lipitor treatment group because of adverse events??. . . . [Emotional appeal ommitted -- as irrelevant.]

Actually, I find it even more interesting that ABOUT THE SAME number withdrew from the "placebo" therapy. That "kinda' dings" your mialgia mantra, no?

But don't let any actual FACTS invade your "spin" here, skipper.

BTW I also find it interesting that it covered only a low-risk group -- older women.

Again, feel free to spin all day on this. . . .

Cheers!

Originally Posted by The Condor

Actually, I find it even more interesting that ABOUT THE SAME number withdrew from the "placebo" therapy. That "kinda' dings" your mialgia mantra, no?

But don't let any actual FACTS invade your "spin" here, skipper.

BTW I also find it interesting that it covered only a low-risk group -- older women.

Again, feel free to spin all day on this. . . .

Cheers!

Sayeth the Condor: "What? Information and facts that dispute my naysaying? They must be dismissed! And emotional appeals only matter when I use them to justify my crusade, damn it!"

High risk patients? Old women with no history of M.I.,LDL's of only 130-190?? Didn't we test against hererozygous patients with baseline LDL's of 330? Oh, what about that little IDEAL study where Lipitor was no different in reducing cardiovascular death or mortallitiy than pravachol?? Are you serious. Oh wait, it was also higher dose Lipitor vs a lower dose of $4 prava and still no difference in saving lives. You can quote lipitor's P.Is all you want but don't forget that the 3 studies listed in there all say the same thing, no difference in cardiovascular death or overall mortallity. So how is Lipitor saving more lives??

In regards to the AEs in the Cashmere study I don't see many dropping out in the placebo arm for myalgias.

Originally Posted by The Condor

Actually, I find it even more interesting that ABOUT THE SAME number withdrew from the "placebo" therapy. That "kinda' dings" your mialgia mantra, no?

But don't let any actual FACTS invade your "spin" here, skipper.

BTW I also find it interesting that it covered only a low-risk group -- older women.

Again, feel free to spin all day on this. . . .

Cheers!

Originally Posted by Anonymous

. . . .Oh, what about that little IDEAL study where Lipitor was no different in reducing cardiovascular death or mortallitiy than pravachol?? Are you serious. Oh wait, it was also higher dose Lipitor vs a lower dose of $4 prava and still no difference in saving lives. You can quote lipitor's P.Is all you want but don't forget that the 3 studies listed in there all say the same thing, no difference in cardiovascular death or overall mortallity. So how is Lipitor saving more lives??

In regards to the AEs in the Cashmere study I don't see many dropping out in the placebo arm for myalgias.

I am not defending Lipitor. Don't get it twisted, commander.

And I thought you wanted to talk about CASHMERE -- not three other studies -- none of which vindicate Zetia or Vytorin. But as I say -- it's your barebque! -- go nuts!

Finally, my point on the palcebo arm was that an equal number dropped from the placebo arm. That's all -- no cause suggested; just a fact.

I am aware of no finding that all treatment arm drop-outs were related to adverse events. In fact, I am under the impression that such data was NOT retained. Or, am I mistaken -- are you admitting to possessing a set of the actual, original, raw Cashmere study data?

That would be theft, BTW -- a felony.

Cheers!

Originally Posted by Anonymous

Sayeth the Condor: "What? Information and facts that dispute my naysaying? They must be dismissed! And emotional appeals only matter when I use them to justify my crusade, damn it!"

Quoting the study abstract now (thus far it has only appeared in a non-peer-reviewed journal, BTW):

In the treatment arm, 24 people discontinued due adverse events; 39 people for OTHER reasons.

In the placebo arm, 20 people discontinued due to adverse events; 24 for OTHER reasons.

See the middle of page 4 of this PDF:

http://www.pharmalot.com/wp-content/...mere-study.pdf


Those are facts. They track my summary, almost verbatim.

Cheers, sport!

Backtracking a little now huh? Is this what you do when you are faced with someone with more facts than you. This probabaly goes all the way back to your childhood though. You get your ass kicked at school, girls don't like you, but when you are at home playing with your stuffed animals you talk all tough "I'm going to kick your butt bear. You don't know who you are messing with" then you wake up to mom's PB&J and start groundhawg day all over again. Really, get a life, a hobby, geesh even a girl, but if you want to be credible on here you need to be a little more fair ballanced. Let's start by admitting the Cashmere study results are 10 times worse than enhance

Originally Posted by The Condor

I am not defending Lipitor. Don't get it twisted, commander.

And I thought you wanted to talk about CASHMERE -- not three other studies -- none of which vindicate Zetia or Vytorin. But as I say -- it's your barebque! -- go nuts!

Finally, my point on the palcebo arm was that an equal number dropped from the placebo arm. That's all -- no cause suggested; just a fact.

I am aware of no finding that all treatment arm drop-outs were related to adverse events. In fact, I am under the impression that such data was NOT retained. Or, am I mistaken -- are you admitting to possessing a set of the actual, original, raw Cashmere study data?

That would be theft, BTW -- a felony.

Cheers!

Originally Posted by Anonymous

. . . .Is this what you do when you are faced with someone with more facts than you. [Non-sequiturs ommitted.]. . . .Let's start by admitting the Cashmere study results are 10 times worse than enhance. . . .

Here is the abstract link (again):

http://www.pharmalot.com/wp-content/...mere-study.pdf

That puts the lie to your statement about having "more facts" than me.

You have yet to post ONE sentence from the actual study, or the actual abstract.

Don't get it twisted, junior.

Please explain how CASHMERE is "ten times worse" for Lipitor than ENHANCE is for Zetia/Vytorin. Please do so, using small words -- and short sentences, for I must be dense -- do explain how a drug (Lipitor) with actual OUTCOMES studies in its favor -- the TIMI-22 study (which found that Lipitor reduces CV events and death) is in worse shape than one with NONE (Vytorin/Zetia). Or perhaps you'd like to read the 4S study with simvastatin, it is indicated to reduce total mortality.

BTW, CV event reduction is also in the FDA approved ad-copy for Lipitor.

Now, what does the FDA approved ad-copy for Zetia/Vytorin say? RIGHT -- IN BOLDED OUTSIZED TYPE, ON THE IRST PAGE, HERE:

"Unlike some statins, ZETIA has not been shown to prevent heart disease or heart attacks."

LINK:

http://www.zetia.com/ezetimibe/zetia/consumer/index.jsp

AND HERE:

"VYTORIN has not been shown to reduce heart attacks or strokes more than Zocor alone."

LINK:

http://www.vytorin.com/ezetimibe_sim...umer/index.jsp

Did you catch that? "UNLIKE SOME STATINS. . ." -- sure you did.

If you do choose to respond, please provide FACTS next time -- not spin.

It looks like I ruffled your cunt hairs a little. How do you have this much free time when you are sucking phizer's cock all day?

Ok, why is the cashmere study worse? It was vs a sugar pill and didn't prove to be any bette at slowing progression or providing any regression. How can you deny that?

I also want to give a comparison. When blood pressure meds came out they had outcome studies to prove that lowering HBP reduced events and prolonged life. Numerous new BP meds have been released in the past 5 years without outcome studies, and docs quickly started using them because the new meds were more effective and safer at getting their patients to their goal. Why is Vytorin vs Lipitor any different? Every study has already proved that lowereing LDL reduces events. Lower is better! Why would a company spend millions to prove what's already been proven?

Originally Posted by The Condor

Here is the abstract link (again):

http://www.pharmalot.com/wp-content/...mere-study.pdf

That puts the lie to your statement about having "more facts" than me.

You have yet to post ONE sentence from the actual study, or the actual abstract.

Don't get it twisted, junior.

Please explain how CASHMERE is "ten times worse" for Lipitor than ENHANCE is for Zetia/Vytorin. Please do so, using small words -- and short sentences, for I must be dense -- do explain how a drug (Lipitor) with actual OUTCOMES studies in its favor -- the TIMI-22 study (which found that Lipitor reduces CV events and death) is in worse shape than one with NONE (Vytorin/Zetia). Or perhaps you'd like to read the 4S study with simvastatin, it is indicated to reduce total mortality.

BTW, CV event reduction is also in the FDA approved ad-copy for Lipitor.

Now, what does the FDA approved ad-copy for Zetia/Vytorin say? RIGHT -- IN BOLDED OUTSIZED TYPE, ON THE IRST PAGE, HERE:

"Unlike some statins, ZETIA has not been shown to prevent heart disease or heart attacks."

LINK:

http://www.zetia.com/ezetimibe/zetia/consumer/index.jsp

AND HERE:

"VYTORIN has not been shown to reduce heart attacks or strokes more than Zocor alone."

LINK:

http://www.vytorin.com/ezetimibe_sim...umer/index.jsp

Did you catch that? "UNLIKE SOME STATINS. . ." -- sure you did.

If you do choose to respond, please provide FACTS next time -- not spin.

It looks like I ruffled your cu-t hairs a little. How do you have this much free time when you are sucking phizer's co-k all day?

Ok, why is the cashmere study worse? It was vs a sugar pill and didn't prove to be any bette at slowing progression or providing any regression. How can you deny that?

I also want to give a comparison. When blood pressure meds came out they had outcome studies to prove that lowering HBP reduced events and prolonged life. Numerous new BP meds have been released in the past 5 years without outcome studies, and docs quickly started using them because the new meds were more effective and safer at getting their patients to their goal. Why is Vytorin vs Lipitor any different? Every study has already proved that lowereing LDL reduces events. Lower is better! Why would a company spend millions to prove what's already been proven?

Originally Posted by The Condor

Here is the abstract link (again):

http://www.pharmalot.com/wp-content/...mere-study.pdf

That puts the lie to your statement about having "more facts" than me.

You have yet to post ONE sentence from the actual study, or the actual abstract.

Don't get it twisted, junior.

Please explain how CASHMERE is "ten times worse" for Lipitor than ENHANCE is for Zetia/Vytorin. Please do so, using small words -- and short sentences, for I must be dense -- do explain how a drug (Lipitor) with actual OUTCOMES studies in its favor -- the TIMI-22 study (which found that Lipitor reduces CV events and death) is in worse shape than one with NONE (Vytorin/Zetia). Or perhaps you'd like to read the 4S study with simvastatin, it is indicated to reduce total mortality.

BTW, CV event reduction is also in the FDA approved ad-copy for Lipitor.

Now, what does the FDA approved ad-copy for Zetia/Vytorin say? RIGHT -- IN BOLDED OUTSIZED TYPE, ON THE IRST PAGE, HERE:

"Unlike some statins, ZETIA has not been shown to prevent heart disease or heart attacks."

LINK:

http://www.zetia.com/ezetimibe/zetia/consumer/index.jsp

AND HERE:

"VYTORIN has not been shown to reduce heart attacks or strokes more than Zocor alone."

LINK:

http://www.vytorin.com/ezetimibe_sim...umer/index.jsp

Did you catch that? "UNLIKE SOME STATINS. . ." -- sure you did.

If you do choose to respond, please provide FACTS next time -- not spin.

Originally Posted by Anonymous

Let's take the initiative and email the study to all those reporters and news stations...so that the CASHMERE trial gets the same coverage as the ENHANCE trial did...it's up to us...or will we continue to take it because our corporate Marketing departments are a joke compared to Pfizer and Astrazeneca?

Are all of you at SPG brain dead or just so brainwashed that you can't see the reality of your situation. For the last time. Your credibility with Vytorin has nothing to do with the results of lack of results from Enhance. The credibility issue with your company is the cover up that occurred with your Sr. Leadership. There have been many failed statin studies but none that were handled as poorly at Enhance. Your company is being investigated and will likely be found guilty of insider trading and manipulation of clinical data to maintain stock valuation. Not to mention the millions made by your executives in stock option sales before the bottom fell out. Vytorin is now known as the big lie and will never recover from the shoddy management of the whole Enhance fiasco. Indictments likely. Convictions? Well time will tell. This is a great story for those running for election or re-election.

I can't think of one company that hasn't taken its time releasing info that isn't favorable. Plus there wasn't anything dangerous that came out of the enhance study.

You will be proven correct the day I see Dr.Jarvik telling us why he takes Lipitor over a sugar pill when he knows it won't make a difference in his CIMT

Originally Posted by Anonymous

Are all of you at SPG brain dead or just so brainwashed that you can't see the reality of your situation. For the last time. Your credibility with Vytorin has nothing to do with the results of lack of results from Enhance. The credibility issue with your company is the cover up that occurred with your Sr. Leadership. There have been many failed statin studies but none that were handled as poorly at Enhance. Your company is being investigated and will likely be found guilty of insider trading and manipulation of clinical data to maintain stock valuation. Not to mention the millions made by your executives in stock option sales before the bottom fell out. Vytorin is now known as the big lie and will never recover from the shoddy management of the whole Enhance fiasco. Indictments likely. Convictions? Well time will tell. This is a great story for those running for election or re-election.

New Pfizer Lipitor Study Could Fuel Cholesterol-Drug Debate

July 03, 2008: 01:04 PM EST


A study showing Pfizer Inc.'s (PFE) cholesterol drug Lipitor was no better than a fake pill in slowing artery thickening has raised questions about the imaging technique used in that trial - and in a previous study that caused sales of rival drug Vytorin to fall.

The results of the so-called Cashmere study were unexpected because previous studies have shown that Lipitor, the world's best-selling prescription drug, reduces the risk of heart attacks and cardiovascular events.

"The question is not the agent in this study because we know Lipitor works," BMO Capital Markets analyst Robert Hazlett said.

Instead, Hazlett said it raises questions about the reliability of the study's imaging technique when used in certain patient populations. Hazlett recently discovered the study's results on the Web site clinicalstudyresults.org and issued a research note about the trial Thursday.

Interestingly, the new Lipitor data provides ammunition to defenders of rival cholesterol drugs Vytorin and Zetia, which are marketed by a joint venture of Merck & Co. (MRK) and Schering-Plough Corp. (SGP). The Cashmere study's design used the same imaging technique as the "Enhance" study of Vytorin, which showed Vytorin was no better than the statin drug simvastatin at slowing artery thickening.

Merck and Schering-Plough have defended Vytorin's effectiveness in lowering bad cholesterol levels, but prescription volumes for both Vytorin and Zetia have plummeted since Enhance results were released in January. Vytorin is a combination of Zetia and simvastatin.

In both studies, patients at the start of the trial had relatively low artery disease burden, possibly because of prior treatment with cholesterol drugs. That could help explain why the study drugs were unable to show a significant benefit as measured by an imaging technique known as carotid intima-media thickness, or CIMT, a noninvasive ultrasound test.

Merck recently discontinued a separate CIMT trial of an experimental cholesterol drug, MK-524A, saying the imaging technique wasn't appropriate for the study's patient population.

One key difference between Lipitor and Vytorin, however, is that there are still no data proving that Vytorin reduces the risk of heart attacks more than simvastatin alone, whereas Lipitor's benefit in that regard has been proven in past trials. A large trial designed to test Vytorin's effect on outcomes is several years away from completion.

Spokespeople for New York-based Pfizer couldn't immediately be reached Thursday morning.

Lipitor is crucial to Pfizer's fortunes. It generated $12.7 billion in sales last year, roughly one-fourth of total company revenue. Lipitor sales have been under pressure mainly because of the 2006 introduction of generic versions of simvastatin, which was previously a blockbuster drug for Merck under the brand Zocor.

Also, Pfizer recently halted television ads for Lipitor following criticism that the doctor featured in the ads wasn't licensed to practice. Pfizer recently agreed to settle patent litigation that is expected to keep generic Lipitor copycats off the U.S. market until 2011.

The Cashmere study evaluated the effect of Lipitor on CIMT in nearly 400 post- menopausal women with moderately high levels of bad cholesterol. Roughly half were given an 80-milligram dose of Lipitor - the highest available dose - daily for up to 12 months, and the other half took a fake pill, or placebo. Patients' artery thickness was measured at the beginning and end of treatment by CIMT tests.

The study found "no statistically significant treatment difference" between Lipitor and placebo in changes in artery thickness. Thickness increased 2.9% in the Lipitor group and 2.5% in the placebo group.

Lipitor did show a significant decrease in bad cholesterol levels versus placebo, however. People taking Lipitor experience side effects such as muscle pain and kidney infection. A higher percentage of Lipitor users discontinued treatment due to side effects than in the placebo group.

BMO's Hazlett noted that the patients in both the Enhance and Cashmere studies had relatively low artery thickness at the start of the trials, when compared to patients in some other CIMT trials.

Quote nothing -- for nothing (above, in opposition) should be dignified with a specific response -- it is that far off the wall.

This thread has become positively-stultifying.

Really. This is an unbecomingl- silly defense of Vytorin. Pointing to other study failures?

That is your "defense" of Vytorin/Zetia. Wow. Great work.

I think that is all I need to know. Thanks for confirming what the other anonymous poster suggested, here -- as to delaying any failed study's-release -- if you think that (whether factual, or mythical) "other people have done it" is a meritorious defense to the ENHANCE fiasco, you are wearing the same set of beer-goggles the Top Six at Schering-Plough are wearing.

And, so -- I guess. . .. "Congrats! This makes you executive officer material at the maroon and cream!"

Do enjoy the perks -- at least until they fit you for that snazzy orange jumpsuit.

Cheers!

Originally Posted by The Condor

Quote nothing -- for nothing (above, in opposition) should be dignified with a specific response -- it is that far off the wall.

This thread has become positively-stultifying.

Really. This is an unbecomingl- silly defense of Vytorin. Pointing to other study failures?

That is your "defense" of Vytorin/Zetia. Wow. Great work.

I think that is all I need to know. Thanks for confirming what the other anonymous poster suggested, here -- as to delaying any failed study's-release -- if you think that (whether factual, or mythical) "other people have done it" is a meritorious defense to the ENHANCE fiasco, you are wearing the same set of beer-goggles the Top Six at Schering-Plough are wearing.

And, so -- I guess. . .. "Congrats! This makes you executive officer material at the maroon and cream!"

Do enjoy the perks -- at least until they fit you for that snazzy orange jumpsuit.

Cheers!

Finally, someone else understands that it is not about the trial, the crime was in the attempted coverup and the unprecedented delay in releasing the results of a critical trial. You may believe it or not but it will not change the situation with SGP or Vytorin. Both are experiencing a slow and agonizing death due to arrogance and greed from your executive team.

If you choose to reply please provide facts instead of persoanl feelings. LOL. Wah, I'm condor, I have no friends and schering fired me for being an idiot so I cry all day on a blog, waaaaahhhi was hoping for a reply to my previous comment about the Lipitor PI not saving lives but I guess you couldn't come up with anything. Or you are just too busy wackin it to child porn and stock tickers. Oh by the way, in regards to bashing SP about sitting on the data, the Cashmere study was completed only 3 months after Enhance. Funny why no has heard anything about it until now

Originally Posted by The Condor

Quote nothing -- for nothing (above, in opposition) should be dignified with a specific response -- it is that far off the wall.

This thread has become positively-stultifying.

Really. This is an unbecomingl- silly defense of Vytorin. Pointing to other study failures?

That is your "defense" of Vytorin/Zetia. Wow. Great work.

I think that is all I need to know. Thanks for confirming what the other anonymous poster suggested, here -- as to delaying any failed study's-release -- if you think that (whether factual, or mythical) "other people have done it" is a meritorious defense to the ENHANCE fiasco, you are wearing the same set of beer-goggles the Top Six at Schering-Plough are wearing.

And, so -- I guess. . .. "Congrats! This makes you executive officer material at the maroon and cream!"

Do enjoy the perks -- at least until they fit you for that snazzy orange jumpsuit.

Cheers!

Originally Posted by Anonymous

Finally, someone else understands that it is not about the trial, the crime was in the attempted coverup and the unprecedented delay in releasing the results of a critical trial. You may believe it or not but it will not change the situation with SGP or Vytorin. Both are experiencing a slow and agonizing death due to arrogance and greed from your executive team.

OP Here.

Actually, it IS about the clinical trial. More specifically, it is about HOW we are gathering information, because Cashmere results clearly contradict what prior clinical studies have proven (other Lipitor outcomes data). The investigation into SP is a separate matter which I never mentioned. Re-read my original message, and please post your gripes about corporate greed elsewhere. It's only a matter of time before the next big company (pharma or otherwise) gets bad press about its corporate executives. It's the world we live in - and it may be true or untrue, but the reality is that it sells newspapers.

But that is not my point.

My point is simply this: If this study gets any attention at all, it will raise questions about the reliability of the study's imaging technique.

Enough scrutiny and debate over CIMT may lead medical professional s and scientists to re-evaluate (or re-interpret if possible) data from previous studies designed in a similar fashion.

It is impossible that ENHANCE would be excluded from this discussion.

Originally Posted by Anonymous

OP Here.

Actually, it IS about the clinical trial. More specifically, it is about HOW we are gathering information, because Cashmere results clearly contradict what prior clinical studies have proven (other Lipitor outcomes data). The investigation into SP is a separate matter which I never mentioned. Re-read my original message, and please post your gripes about corporate greed elsewhere. It's only a matter of time before the next big company (pharma or otherwise) gets bad press about its corporate executives. It's the world we live in - and it may be true or untrue, but the reality is that it sells newspapers.

But that is not my point.

My point is simply this: If this study gets any attention at all, it will raise questions about the reliability of the study's imaging technique.

Enough scrutiny and debate over CIMT may lead medical professional s and scientists to re-evaluate (or re-interpret if possible) data from previous studies designed in a similar fashion.

It is impossible that ENHANCE would be excluded from this discussion.

Unfortunately, in Condor, you have someone whose investments are threatened by the possibility of this having a positive effect on how Vytorin is perceived...because he's betting on Vytorin sales shrinking to nothing so he can make money. All this talk about corporate greed and his little crusade against it is total fabrication. Otherwise, he would be even more sickened by the fact that Pfizer sat on this data for more than two years, which is longer than the alleged infraction by SGP.

But notice how he's not hammering Pfizer...because, quite clearly, he doesn't have $15 puts on that stock.

True motivations will always reveal themselves.

Originally Posted by Anonymous

Unfortunately, in Condor, you have someone whose investments are threatened by the possibility of this having a positive effect on how Vytorin is perceived...because he's betting on Vytorin sales shrinking to nothing so he can make money. All this talk about corporate greed and his little crusade against it is total fabrication. Otherwise, he would be even more sickened by the fact that Pfizer sat on this data for more than two years, which is longer than the alleged infraction by SGP.

But notice how he's not hammering Pfizer...because, quite clearly, he doesn't have $15 puts on that stock.

True motivations will always reveal themselves.

Interesting how you are attempting to boost the integrity of SP by comparing yourself to Pfizer. How about comparing your leadership to Hitler for Christ sakes? The fact is that your leadership sat on the Enhance data and tried to corrupt the investigators into changing the end point to hide the fact that no positive results were reached and worst, Vytorin underperformed Simva alone. Then they totally humiliated the Chief Investigator by releasing the data outside of standard protocol. No company in history has ever done that. Not one. Either your leadership is dumber than a box of doornobs, or it was pure greed for self interests. Either way, it was a total FUBAR from which it will take many years to recover the integrity and trust of the Cardiologists.

Originally Posted by Anonymous

Interesting how you are attempting to boost the integrity of SP by comparing yourself to Pfizer. How about comparing your leadership to Hitler for Christ sakes? The fact is that your leadership sat on the Enhance data and tried to corrupt the investigators into changing the end point to hide the fact that no positive results were reached and worst, Vytorin underperformed Simva alone. Then they totally humiliated the Chief Investigator by releasing the data outside of standard protocol. No company in history has ever done that. Not one. Either your leadership is dumber than a box of doornobs, or it was pure greed for self interests. Either way, it was a total FUBAR from which it will take many years to recover the integrity and trust of the Cardiologists.

http://en.wikipedia.org/wiki/Godwin%27s_law

and this was such an interesting thread till now

OP Again.

I agree with the above poster about Godwin's Law. But I think this conversation is worth pursuing, now that information is starting to circulate about Cashmere.

WSJ has posted a bit of news about SP's and Merck's stock prices climbing up today. The article is unrelated to Cashmere and makes no mention of Enhance, BUT, the very first comment (scroll down through the ads to the comments section) should spark some interesting discussion: http://www.marketwatch.com/news/stor...%7D&dist=msr_3

Condor? How are you doing today?

Condor is crying. He is completely out of ammo and has nowhere to go. He can't stope the SP juggernaut. The leaks about SEAS will rock Vytorin and Zetia sales. SP is coming back Bird Boy!

Originally Posted by Anonymous

Condor is crying. He is completely out of ammo and has nowhere to go. He can't stope the SP juggernaut. The leaks about SEAS will rock Vytorin and Zetia sales. SP is coming back Bird Boy!

Coming back? Are you on Crack? Vytorin has lost over 25% of its market share and has lost formulary position with the largest Payors. Payors are wise to the fact that they can get as much benefit from a generic for pennies per day which is the primary component in WYTORIN anyway. Your company and executives are being investigated for insider trading, contract violations, price fixing, off label promotion, improper use of Advisory Boards to influence prescribing, ..... not to mention driving up the cost of Medicaid. If any of these charges stick, SP will come back as a perfect example of the corruption and greed that has ruined Big Pharma in the eyes of the public.

Maybe the CIMT is an OK way to test.

Did you ever think that statins have no effect on plaque formation????

Maybe that is why the NNT is 50-100 fr the statins!

Originally Posted by Anonymous

Coming back? Are you on Crack? Vytorin has lost over 25% of its market share and has lost formulary position with the largest Payors. Payors are wise to the fact that they can get as much benefit from a generic for pennies per day which is the primary component in WYTORIN anyway. Your company and executives are being investigated for insider trading, contract violations, price fixing, off label promotion, improper use of Advisory Boards to influence prescribing, ..... not to mention driving up the cost of Medicaid. If any of these charges stick, SP will come back as a perfect example of the corruption and greed that has ruined Big Pharma in the eyes of the public.

Yup, SP did it all! Right under the nose of the CIA! The execs got away with millions and will never serve a minute in jail.

http://www.forbes.com/2008/07/09/vyt...09lipitor.html

several top cardiologists say that drawing any conclusions about CIMT in general or ENHANCE in particular is going a step too far. "To say that this study reflects on ENHANCE in any way is a huge stretch of the imagination," says James Stein, a CIMT expert at the University of Wisconsin, Madison.

ENHANCE followed 720 high-risk patients with a disease called familial hypercholesterolemia for two years. CASHMERE followed 400 post-menopausal women at relatively low risk of heart disease for one year.

These post-menopausal women had somewhat high LDL ("bad" cholesterol), but they were otherwise healthy, with an average age of 56 (that's young) and an average HDL ("good" cholesterol) of 67 (that's high). Stein says those healthy numbers would have made it pretty tough to show a difference.

It is not actually clear that Lipitor should have had an effect on the arteries of post-menopausal women whose main risk factor for heart diseases was high LDL. "What evidence do we have that statins work in that group?" says Harlan Krumholz of Yale University.

Originally Posted by Anonymous

Yup, SP did it all! Right under the nose of the CIA! The execs got away with millions and will never serve a minute in jail.

You are wrong about one thing. Eventually, there will be huge fines to pay and likely jail time for a few higher ups. If you don't think this is likely then watch for early signs. People from middle management in finance and marketing leaving the company and you will be told it was voluntary. People leaving from Legal will be next. They left for another opportunity. Then you will begin to see some surprises at VP or higher who will be let go suddenly with a package. The package locks them to a confidentiality agreement which to the Feds doesn't mean squat. The smart ones will turn State's witness for protection and Whistleblower status. You don't want to be the last one standing holding the bag of shit like Nixon.

Originally Posted by Anonymous

Yup, SP did it all! Right under the nose of the CIA! The execs got away with millions and will never serve a minute in jail.

I heard that violations that took place under the CIA are punishable by jail time. If this is true, then Fred and Carrie, along with others like Ellen, Margriet, and Sean should be shaking in their boots. Add Russo the slime to that. They'll have lots of money, but will be wearing orange suits. I think that the government should be taking the blood money from them. If the investigators go inside KW instead of requesting info, they'd find lots. Certainly, there's got to be enough now to get them a way in.

Cashmere wasn't the first failed Lipitor study. Take a look at their placebo controlled outcome study called ASPEN.

It is interesting that there hasn't been much press about Cashmere. Does anyone know when/where the actual study is going to be published?

When people started talking about Enhance, SP was forced to publish the study within a certain time frame (something like 30 days I think?). I'm curious to know why the same critics haven't jumped on Pfizer for more info about this study. As one poster commented, this study was finished around the same time Enhance was finished. Why aren't people asking questions? Or, why aren't they publishing the answers?

THE MORE WE TALK ABOUT CASHMERE AND EMAIL LINKS TO NEWS REPORTERS AND POST ON OTHER WEBSITES...THE MORE THESE SITES WILL WRITE ABOUT IT AND NEWS MEDIA WILL PICK IT UP....GUYS, DON'T DROP THE BALL ON THIS...HELL....YOU CAN EVEN THINK ABOUT FAXING COPIES OF THESE ARTICLES TO DOCTORS THAT HAD AN ATTACK REGARDING ENHANCE...SO THEY CAN SEE THE REALITY OF USING CIMT ON THESE TYPES OF PATIENTS...NOT SO MUCH LIPITOR, WE COULD GIVE A RATS ASS...CASHMERE IS ABOUT VINDICATING ENHANCE AND PISSING ON STEVE NISSEN AND THE REST OF THE ACC PANEL THAT BASHED VYTORIN/ZETIA AND ENHANCE

PSST.....Cooooondooooor...........coooooondooooooo orrrr....

Where have you been my friend? Cat got your tongue?