EMSA OF THE FUTURE

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WOW so finally Dr. No Murray has done it. Selling and sending messages related to Zetia and Vytorin disaster in the Wall Street Journal. So help me understand how is EMSA "independent" from commercial interests of the Joint Venture? And get this he is reporting to a McMahon president of the Sales Division. I'd say things at Merck have reached a stupidity phase. No lessons learned from Vioxx which costs billons and now another disaster in the billions.
 






'Very Serious' Allegations

Did Vytorin's makers intentionally suppress unfavorable trial results? Rep. Bart Stupak will hold hearings to try to find out.
By Jennifer Barrett
Newsweek Web Exclusive
Updated: 6:14 PM ET Jan 17, 2008

When Vytorin was approved by the Food and Drug Administration in 2004, the drug--which combines Zetia (which decreases cholesterol absorption) and Zocor (a lipid-lowering agent now available in generic versions)--was touted as an attractive alternative to statins like Pfizer's Lipitor, the country's top-selling drug. Because of its unique combination, Vytorin was designed to both inhibit the body's own production of cholesterol and block the body's absorption of cholesterol from food. Sure enough, the drug hit $1.9 billion in sales for 2006, becoming a big hit for the companies behind them, Merck and Schering-Plough.

But there's little doubt sales would have been substantially lower had the companies immediately released unfavorable results from a clinical trial of Vytorin that ended in the spring of 2006. The so-called ENHANCE trial, made public this week, found that Vytorin was no more effective than using the generic version of Zocor (simvastin) alone. The delay in releasing the results has attracted the attention not only of patients but politicians. The House Committee on Energy and Commerce plans to hold hearings in the next several weeks. NEWSWEEK's Jennifer Barrett spoke with Rep. Bart Stupak, a Democrat from Michigan, who chairs the Subcommittee on Oversight and Investigations. Excerpts:

NEWSWEEK: You actually began investigating the delay in releasing results from the ENHANCE study last fall. What brought the Vytorin clinical trial to your attention before the public was informed?
Bart Stupak: We have medical people assigned to the staff who had been hearing rumblings in the medical community. Cardiologists, for example, who might have had a patient or two enrolled in the study had sent the information in a long time ago and never heard back about the results. They were wondering: what happened?

The trial ended in April 2006, but the results weren't released until this month. How have Merck and Schering-Plough explained the delay?
They're used a couple different explanations. They've said they used ultrasound machines to get pictures of the participants' plaque levels [the build-up of cholesterol and other substances that, when found in the arteries, can result in heart disease]. They said the ultrasound images were of poor quality and they were trying to get better quality ultrasound. And they've said they didn't have all the information available and that it was biologically implausible. [Skip Irvine, spokesperson for Merck/Schering-Plough Pharmaceuticals, a joint venture of the two companies, responds: "The rigorous study design and analytical process … was time consuming and took longer than we originally anticipated."]

How could the data be "biologically implausible?"
That comment, to us, was the red flag that their study tanked and they were trying to hide that.

When did the companies register the clinical trial on clinicaltrials.gov?
They may have done the basic outline in October [2007] but they didn't put out a release until Jan. 14. They registered the study but not the results.

That's an important distinction.
Even that [October] is almost 18 months after the study ended.

It appears that Merck and Schering-Plough not only postponed the release of the data but considered changing the study's endpoints, which could effectively change the study's results. What changes did they make?
We don't know that and that's why we're still asking for more information. When the results weren't what they thought they would be, they asked an internal advisory panel--these so-called "independent" people--to look at it. And they said, here are the results. How do we put lipstick on this pig? [Irvine says the end points did not change and, even if they had, the end results would not have differed.]

Do we have more information on who was on that panel? I understand some of the members were doctors who were on the companies' payroll.
We know the names and our preliminary understanding is that three of five had some sort of financial interest with these companies. Dr. [John J.P.] Kastelein [of the University of the Netherlands], the principal investigator, was not included in the independent panel. If he is their expert, don't you think the person who designed the trial should be involved in any decision to change the endpoints of the trial? … We're still trying to understand what the communications were between the doctor and Merck and Schering-Plough and the doctors on this panel. [Irvine says that Kastelein "chose to decline to participate in that meeting so that his attendance would not bias the results."]

If it's determined that the companies intentionally withheld the unfavorable study results from the public for nearly two years, could that be punishable under current law?
At the time that this particular study was completed in April of 2006, there was no requirement and there would be no punishment for not putting it online. [A law passed last year now requires the registration and publication of such trial results online.] There is a problem with the delay, though, and it can be punished administratively and maybe elsewhere in the FDA rules and regulations.

What role could the FDA have in this?
Well, we don't know if they contacted the FDA. It's not clear what role the FDA had, or if they were even aware of [the trial data].

Do you think that Schering-Plough and Merck intentionally sought to delay the release of this data?
Do I think they knew about it and attempted to put lipstick on the pig, so to speak? Yes. They knew about it. This was their blockbuster drug. Take away $5 billion or more from these companies, and man … These allegations are very serious though. We've been on this since October, and we have enough information to go for a hearing now. But we've asked for more information. [The company has denied intentionally delaying the release because of the unfavorable results. "Obviously a positive result would have been more favorable," says Irvine. "(But) this was a very challenging study, given the high hurdle set by the study."]

It appears that at least one top executive at Schering-Plough, executive vice president Carrie Cox, sold millions of dollars worth of company stock after the trial ended but before the results were made public. How concerned are you about the timing of such stock sales?
Before it's made public, if you have insider information, it's definitely illegal. That bothers us quite a bit. They kept it for so long [without releasing the results] then tried to rehabilitate the study and then that fails. Do they then start dumping the stock? We really want to get into this a little more. [Stephen Galpin, a spokesperson for Schering-Plough, responds: "The company has a rigorous process that executives follow before initiating any transaction in company securities including pre-clearance with a securities lawyer. Carrie Cox followed these processes as well as filing required SEC disclosures about the transactions on time. To date the company has received no inquiry from a regulatory body relating to her trades. These trades go back to the spring of 2007 and the data for this trial were only unblinded about two weeks ago."]

According to estimates, the companies have spent more than $250 million in the last couple of years to advertise Vytorin.
In April 2006, when the trial ended, I probably didn't know what Vytorin was. But with the heavy advertising in the last year or so, we all know what it is now. Those ads, which show the food and the relatives [two sources of cholesterol], target a certain patient. The assumption is that lower cholesterol means reduced plaque means reduced risk of heart attack and stroke. But in some patients in this study, the amount of plaque increased … What we're wondering now is, was there an uptick in advertising after they knew the trial results? [Irvine declines to answer that question directly but says the company has "supported Vytorin competitively in all aspects of marketing, sales and managed care since it launch in 2004, including direct to consumer advertising ... in a manner that is consistent with what would be expected of a top-tier product in a highly competitive therapeutic category."]

Doctors wrote about 18 million prescriptions for Vytorin and about 14 million for Zetia in 2006, making them among the most commonly prescribed cholesterol-lowering drugs, and their popularity has continued to grow. Is there concern here that some of those patients might have been better served by other cholesterol-lowering drugs--or, at least, could have saved money by using a generic version of Zocor?
From what I understand, it's just under $4 per pill for Vytorin and about $2 for Zocor [or generic versions].

That could be an issue for patients who are on a tight budget and are paying out of pocket.
It's also an issue for the government, and for taxpayers, because of Medicare and Medicaid--we pay for all that. So we want to see how much Medicaid and Medicare has spent on Vytorin since April 2006 to the present day.

Did the FDA approve these drugs prematurely?
Drug studies go through four phases, really--the fourth is always the American people. You had very limited studies, and the theory behind it is, you had a key group of people you are trying to treat. The protocol of the study--the FDA approved that--and therefore the companies could use it. I have a problem, though, with: Where is the FDA? Whey aren't they bringing all this out? To get them to do anything after they approve a drug, it's hard.

So what happens now?
More letters are going out [from Stupak's committee to the companies] zeroing in on specific issues. We're asking specifically about the cashing in on stock options. There will be hearings ... The night before the hearings, they'll probably drop off all the documents and then we'll probably find the nuggets we're looking for.
URL: http://www.newsweek.com/id/94969
 






Anonymous said:
so i'm a bit confused, do you like working with/for schuck and murray or would you rather have someone else
Click to expand...

the point is that emsa is all screwed up by keane, murray,greenberg et al. one thing about lou sherwood.... had vision and stature outside of merck. his screw up was getting aligned with the vioxx bullshit.
obvious the current arrogant doctors are not going to solve merck's public trust problem. by all accounts murray is a self promoting narcissist with no credibility except that he is the appointed vp of emsa....a big mistake since he is a poor administrator and manager of people.
 






Anonymous said:
'Very Serious' Allegations

Did Vytorin's makers intentionally suppress unfavorable trial results? Rep. Bart Stupak will hold hearings to try to find out.
By Jennifer Barrett
Newsweek Web Exclusive
Updated: 6:14 PM ET Jan 17, 2008

When Vytorin was approved by the Food and Drug Administration in 2004, the drug--which combines Zetia (which decreases cholesterol absorption) and Zocor (a lipid-lowering agent now available in generic versions)--was touted as an attractive alternative to statins like Pfizer's Lipitor, the country's top-selling drug. Because of its unique combination, Vytorin was designed to both inhibit the body's own production of cholesterol and block the body's absorption of cholesterol from food. Sure enough, the drug hit $1.9 billion in sales for 2006, becoming a big hit for the companies behind them, Merck and Schering-Plough.

But there's little doubt sales would have been substantially lower had the companies immediately released unfavorable results from a clinical trial of Vytorin that ended in the spring of 2006. The so-called ENHANCE trial, made public this week, found that Vytorin was no more effective than using the generic version of Zocor (simvastin) alone. The delay in releasing the results has attracted the attention not only of patients but politicians. The House Committee on Energy and Commerce plans to hold hearings in the next several weeks. NEWSWEEK's Jennifer Barrett spoke with Rep. Bart Stupak, a Democrat from Michigan, who chairs the Subcommittee on Oversight and Investigations. Excerpts:

NEWSWEEK: You actually began investigating the delay in releasing results from the ENHANCE study last fall. What brought the Vytorin clinical trial to your attention before the public was informed?
Bart Stupak: We have medical people assigned to the staff who had been hearing rumblings in the medical community. Cardiologists, for example, who might have had a patient or two enrolled in the study had sent the information in a long time ago and never heard back about the results. They were wondering: what happened?

The trial ended in April 2006, but the results weren't released until this month. How have Merck and Schering-Plough explained the delay?
They're used a couple different explanations. They've said they used ultrasound machines to get pictures of the participants' plaque levels [the build-up of cholesterol and other substances that, when found in the arteries, can result in heart disease]. They said the ultrasound images were of poor quality and they were trying to get better quality ultrasound. And they've said they didn't have all the information available and that it was biologically implausible. [Skip Irvine, spokesperson for Merck/Schering-Plough Pharmaceuticals, a joint venture of the two companies, responds: "The rigorous study design and analytical process … was time consuming and took longer than we originally anticipated."]

How could the data be "biologically implausible?"
That comment, to us, was the red flag that their study tanked and they were trying to hide that.

When did the companies register the clinical trial on clinicaltrials.gov?
They may have done the basic outline in October [2007] but they didn't put out a release until Jan. 14. They registered the study but not the results.

That's an important distinction.
Even that [October] is almost 18 months after the study ended.

It appears that Merck and Schering-Plough not only postponed the release of the data but considered changing the study's endpoints, which could effectively change the study's results. What changes did they make?
We don't know that and that's why we're still asking for more information. When the results weren't what they thought they would be, they asked an internal advisory panel--these so-called "independent" people--to look at it. And they said, here are the results. How do we put lipstick on this pig? [Irvine says the end points did not change and, even if they had, the end results would not have differed.]

Do we have more information on who was on that panel? I understand some of the members were doctors who were on the companies' payroll.
We know the names and our preliminary understanding is that three of five had some sort of financial interest with these companies. Dr. [John J.P.] Kastelein [of the University of the Netherlands], the principal investigator, was not included in the independent panel. If he is their expert, don't you think the person who designed the trial should be involved in any decision to change the endpoints of the trial? … We're still trying to understand what the communications were between the doctor and Merck and Schering-Plough and the doctors on this panel. [Irvine says that Kastelein "chose to decline to participate in that meeting so that his attendance would not bias the results."]

If it's determined that the companies intentionally withheld the unfavorable study results from the public for nearly two years, could that be punishable under current law?
At the time that this particular study was completed in April of 2006, there was no requirement and there would be no punishment for not putting it online. [A law passed last year now requires the registration and publication of such trial results online.] There is a problem with the delay, though, and it can be punished administratively and maybe elsewhere in the FDA rules and regulations.

What role could the FDA have in this?
Well, we don't know if they contacted the FDA. It's not clear what role the FDA had, or if they were even aware of [the trial data].

Do you think that Schering-Plough and Merck intentionally sought to delay the release of this data?
Do I think they knew about it and attempted to put lipstick on the pig, so to speak? Yes. They knew about it. This was their blockbuster drug. Take away $5 billion or more from these companies, and man … These allegations are very serious though. We've been on this since October, and we have enough information to go for a hearing now. But we've asked for more information. [The company has denied intentionally delaying the release because of the unfavorable results. "Obviously a positive result would have been more favorable," says Irvine. "(But) this was a very challenging study, given the high hurdle set by the study."]

It appears that at least one top executive at Schering-Plough, executive vice president Carrie Cox, sold millions of dollars worth of company stock after the trial ended but before the results were made public. How concerned are you about the timing of such stock sales?
Before it's made public, if you have insider information, it's definitely illegal. That bothers us quite a bit. They kept it for so long [without releasing the results] then tried to rehabilitate the study and then that fails. Do they then start dumping the stock? We really want to get into this a little more. [Stephen Galpin, a spokesperson for Schering-Plough, responds: "The company has a rigorous process that executives follow before initiating any transaction in company securities including pre-clearance with a securities lawyer. Carrie Cox followed these processes as well as filing required SEC disclosures about the transactions on time. To date the company has received no inquiry from a regulatory body relating to her trades. These trades go back to the spring of 2007 and the data for this trial were only unblinded about two weeks ago."]

According to estimates, the companies have spent more than $250 million in the last couple of years to advertise Vytorin.
In April 2006, when the trial ended, I probably didn't know what Vytorin was. But with the heavy advertising in the last year or so, we all know what it is now. Those ads, which show the food and the relatives [two sources of cholesterol], target a certain patient. The assumption is that lower cholesterol means reduced plaque means reduced risk of heart attack and stroke. But in some patients in this study, the amount of plaque increased … What we're wondering now is, was there an uptick in advertising after they knew the trial results? [Irvine declines to answer that question directly but says the company has "supported Vytorin competitively in all aspects of marketing, sales and managed care since it launch in 2004, including direct to consumer advertising ... in a manner that is consistent with what would be expected of a top-tier product in a highly competitive therapeutic category."]

Doctors wrote about 18 million prescriptions for Vytorin and about 14 million for Zetia in 2006, making them among the most commonly prescribed cholesterol-lowering drugs, and their popularity has continued to grow. Is there concern here that some of those patients might have been better served by other cholesterol-lowering drugs--or, at least, could have saved money by using a generic version of Zocor?
From what I understand, it's just under $4 per pill for Vytorin and about $2 for Zocor [or generic versions].

That could be an issue for patients who are on a tight budget and are paying out of pocket.
It's also an issue for the government, and for taxpayers, because of Medicare and Medicaid--we pay for all that. So we want to see how much Medicaid and Medicare has spent on Vytorin since April 2006 to the present day.

Did the FDA approve these drugs prematurely?
Drug studies go through four phases, really--the fourth is always the American people. You had very limited studies, and the theory behind it is, you had a key group of people you are trying to treat. The protocol of the study--the FDA approved that--and therefore the companies could use it. I have a problem, though, with: Where is the FDA? Whey aren't they bringing all this out? To get them to do anything after they approve a drug, it's hard.

So what happens now?
More letters are going out [from Stupak's committee to the companies] zeroing in on specific issues. We're asking specifically about the cashing in on stock options. There will be hearings ... The night before the hearings, they'll probably drop off all the documents and then we'll probably find the nuggets we're looking for.
URL: http://www.newsweek.com/id/94969
Click to expand...

So the focus will be what did who know when....clark, murray, schuck, schechter, mcmahon, hassan, veltri and others all have to answer with their so called truth and go to jail. who is going to turn on who...stay tuned.
 






Congress Sends Letters to ACC and AHA Over ENHANCE Press Release and Industry Funding
from Heartwire — a professional news service of WebMD

Michael O'Riordan
Information from Industry
Assess clinically focused product information on Medscape.

* Click Here for Product Infosites -- Information from Industry.


January 25, 2008 (Washington, DC) – More than 10 days since results of the ENHANCE trial were made public in a press release issued by Merck/Schering-Plough Pharmaceuticals, the makers of the ezetimibe and simvastatin cholesterol-lowering combination (Vytorin), the drug remains in the spotlight. This time, however, the companies, as well as the American Heart Association (AHA) and the American College of Cardiology (ACC), are in the sights of the media and government oversight committees.

Yesterday, the US House Committee on Energy and Commerce sent letters to the AHA, the ACC, and to Merck/Schering-Plough Pharmaceuticals, asking about their financial arrangements. Both the AHA and ACC have come under fire for statements issued in the wake of the release of the ENHANCE study findings, statements that urged patients not to panic about the findings and that clinical decisions not be made based on the data of this surrogate-end-point trial.

"Conclusions should not be made until the three large clinical-outcome trials are presented within the next two to three years," read the January 15, 2008 ACC press release. "The ACC recommends that Zetia [ezetimibe] 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 tolerate only a low-dose statin."

The AHA issued a similar statement a day after ENHANCE was released, telling the public the study was too limited and not designed to draw conclusions about the drug's ability to reduce hard clinical end points. The AHA advised patients not to stop the drug without talking to their doctors.

Where the AHA and ACC have drawn fire is in the funding both receive from industry. In their statement, the AHA failed to disclose that it receives $2 million annually from Merck/Schering-Plough, the joint venture that funded the study and currently markets the ezetimibe/simvastatin combination. In addition, a link from the AHA website to external sites did not make explicitly clear that these external sites were sponsored by large contributions from Merck/Schering-Plough and other drug companies. The AHA has since changed the site to make the sponsorship of these companies clear.

Rumors and innuendo

With the release of so much of the ENHANCE data on January 14, 2008, there are questions surrounding the presentation of the study results at the upcoming ACC Scientific Sessions in Chicago, IL, this March. Specifically, there are issues related to embargo and whether or not Merck/Schering-Plough broke the embargo with the release of data to the public prior to their scheduled presentation at the ACC meeting.

Amy Murphy, associate director of media relations with the ACC, told heartwire that no decision has yet been made with regards to ENHANCE. There will be discussions with the late-breaking clinical-trials' cochairs, along with ACC president Dr James Dove, about the placement of the study within the meeting. She suspects the study will not be included in the late-breaking clinical-trials session but presented at the meeting in a different forum.

More information on the fate of ENHANCE at the ACC will follow as available.

Today, the US Food and Drug Administration issued an early communication regarding its ongoing review of Vytorin and the ENHANCE trial. The agency said it would continue to review the data to determine what course of action to take with the drug. The report is expected to take about six months. At present, the FDA said it does not yet have the full results of the ENHANCE trial.

Drawing the ire of the House

The Energy and Commerce Committee, according to documents obtained by the Wall Street Journal, is interested in whether or not the ACC urged Merck/Schering-Plough to release the ENHANCE results, an issue that came to light when the company was criticized for not presenting the results sooner [1]. The committee also wants to know the names of the doctors responsible for drafting the ACC statement.

Both the AHA and ACC deny that funding from Merck/Schering-Plough had anything to do with the press releases issued after the ENHANCE data were made public. Dr Daniel Jones (University of Mississippi Medical Center, Jackson), president of the AHA, told the New York Times that the association does not list industry funding when issuing statements for patients [2].

Last night, in a request from heartwire, the ACC issued a statement: "The American College of Cardiology is in receipt of the letters from the Senate Finance Committee and the House Committee on Energy and Commerce regarding our January 15, 2008 statement on the release of the ENHANCE trial results. The ACC appreciates the committees' acknowledgement of the college's long-standing reputation as being objective, impartial, and trusted by patients and doctors alike. The ACC will comply with all congressional requests for information related to the January 15 statement."

More Vytorin news . . .

Merck/Schering-Plough have suspended their ubiquitous Vytorin television advertisements, although they will continue to run print ads. According to company officials, the television ads have been suspended because of the "misinterpretation" of the ENHANCE results. Not coincidentally, US Congress is now poking its nose into the marketing of Vytorin and the $102 million the companies spent to market the drug in 2007.

In a letter to the FDA, Congress is "concerned that the study's results may have been available to Schering-Plough and Merck officials and yet the massive advertisement campaign for Vytorin was allowed to continue."

It is also investigating whether the companies withheld the ENHANCE data and used misleading statements in their advertisements. And finally, Congress is pressing Merck/Schering-Plough for information on the timing of executive stock sales, specifically sales that might have occurred during a delay in the release of the results.

Today, the companies issued a press release responding to "mischaracterizations" about the ENHANCE trial, particularly the delay in presenting the data [3].

"While the ENHANCE trial was time-consuming and took longer than originally anticipated to complete, our companies acted with integrity and good faith in connection with the trial," Dr Thomas Koestler, president of the Schering-Plough Research Institute, is quoted in the release. "We took numerous actions to ensure the quality of the reading of the ultrasound images."

The companies state they look forward to "participating in rigorous scientific debates" about Vytorin, noting that the ENHANCE study is expected to be presented at the ACC meeting in March.

In addition to the press statement, the companies issued a five-page chronology of the ENHANCE trial, beginning in late 2000 when the protocol for the trial was first discussed and concluding in January 2008 with the submission of a late-breaker place-holder abstract for the ACC meeting [4].

1. Goldstein J. Vytoringate! Senate boards bandwagon. Wall Street Journal Health Blog, January 24, 2008. Available at: http://www.wsj.com.
2. Saul S. Heart group backs drug made by ally. New York Times, January 24, 2008. Available at: http://www.nytimes.com.
3. Merck/Schering-Plough. Merck and Schering-Plough respond to issues raised about ENHANCE clinical trial [press release]. January 25, 2008. Available at: http://www.sch-plough.com/schering_plough/news/release.jsp?releaseID=1100091.
4. Merck/Schering-Plough. ENHANCE Chronology. January 25, 2008. Available at: http://media.corporate-ir.net/media_files/IROL/89/89839/ENHANCE_Chronology_012508.pdf.

The complete contents of Heartwire, a professional news service of WebMD, can be found at www.theheart.org, a Web site for cardiovascular healthcare professionals.
 












January 31, 2008
Prominent cardiologist: Schering-Plough could have known the result of Vytorin trial before unblinding data.

One important aspect of the "who knew what and when" story related to Schering-Plough executives selling massive amounts of SP stock in 2007 is that while the treatment arms of the Vytorin trial were blinded, the treatment effect on the primary end point—change in mean carotid intima-media thickness (CIMT) after two years—was similar in the Zocor (simvastatin-alone) and Vytorin (ezetimibe/simvastatin-combination) groups.

Some cardiologists believe that unblinding the results would have been unnecessary to know the treatment effect was neutral:

Enhance333

Chart courtesy of ************.

Taylor

"Somebody had looked at the end-point examination, the IMT results, and, irrespective of group assignment, could know that a groupwise comparison of CIMT changes showed no statistically significant difference," Dr Allen Taylor (Walter Reed Army Medical Center, Washington, DC) told heartwire. "In my view, once that is known, the trial is functionally unblinded."

Taylor, a researcher involved in numerous clinical trials, including his role as the lead investigator of the Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol (ARBITER-2) CIMT study, stressed that he has no inside knowledge of when the end-point analysis was completed and does not know whether company officials looked at the blinded data, although he believes it that remains open to speculation.

He said it would be difficult to look across all the data without assigning patients to treatment groups and make any sense of presumed outliers. He added that the 18-month gap after the trial was completed and the reporting of the results leaves the companies wide open to question, especially Merck/Schering Plough's contention that they sought to address quality issues with the images.

"Their sequence of actions to rehabilitate the data is in many ways a signal of distress," said Taylor. "What was fueling that? I can see some may readily speculate that it seems highly implausible that 18 months were spent working on the data without there being a reason related to the overall trial results being known to be negative."

Posted on January 31, 2008 | Permalink | Comments (1) | TrackBack (0)

January 30, 2008
New evidence indicates Schering-Plough insiders knew the Vytorin trial was "a bust" on March 13, 2007.

Evidence has just surfaced that Schering-Plough insiders may have known as early as March 13, 2007 that the ENHANCE trial would not show any statistically significant difference between Vytorin and generic Zocor.

What Schering employees knew--and when--is important, since there have been questions about Schering-Plough President Carrie Cox's sales of $28 million of SP stock in April and May 2007 as well as the fact that Thomas Sabatino, Executive Vice President and General Counsel, Brent Saunders, Senior Vice President and President, Consumer Health Care, C. Ron Cheeley, Senior Vice President, Global Human Resources also sold millions of dollars of SP stock at the same time.

Schering responded to these questions with an SEC filing which detailed not only the date when the Vytorin data was unblinded, a few weeks ago, but also the actual time of the day when various SP executives learned of the unblinded data. The underlying assumption was that no one knew anything until the data was unblinded.

A survey of Schering Plough's message board on Cafe Pharma has now crushed that assumption.

Every entry on the Cafe Pharma message board is date and time stamped. The message board is mostly frequented by sales reps, but also by others. We don't know who posted, but we do know what was written, and often the language makes it highly probable that these individuals were indeed insiders.

As early as March 13, 2007, there is a detailed record on Schering-Plough's message board of the outcome of the ENHANCE trial, information that was officially available only a few weeks ago. And here's the proof:


http://www.brandweeknrx.com/2008/01/new-evidence-in.html
 


















Dr Murray & all his band of doctors cleaned up on the bonus pool. Dr harvey got 120K in bonus for doing nothing. Working 3 days a week from Atlanta. This 10/20/60/10 forced rating is such bullshit. Hey Harvey good reason for you to coast to retirement.
 






Anonymous said:
Dr Murray & all his band of doctors cleaned up on the bonus pool. Dr harvey got 120K in bonus for doing nothing. Working 3 days a week from Atlanta. This 10/20/60/10 forced rating is such bullshit. Hey Harvey good reason for you to coast to retirement.
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Reminds me of how I was graded in organic chemistry. The nice thing about it was that 23/100 could be an A!
 






Anonymous said:
Reminds me of how I was graded in organic chemistry. The nice thing about it was that 23/100 could be an A!
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If only the point scoring was merit based. The problem is the point scoring system is rigged towards who ever dr. murray decides to give the points to. the drs come first. We the non physicians work hard to maintain these relationship with these difficult societies and then a physicians shows up and takes all the credit. The relationship work has turned into low value work since Harvey has no credibility within the company.
 
























Re: 1.5 Billion in clean shave

What happened in Chicago and who is being held accountable for the screw up Dr. Murray?
Surely there was no screw up just usual incompetence which resulted in 1.5 billion dollars of revenues being shaved off.
Any more talk of further cuts in EMSA?
 












DENIED....NO SCIENCE AND NO COMMON SENSE LEFT IN THE MANAGEMENT.

JUST MERCK COOL AIDE.

A Company with no credibility, trust and a compass for the future.

This arrogant culture must be dismantled for us survive.
 






Science and money....The widely publicized results from the ENHANCE study of simvastatin and ezetimibe (Zetia) (combination tablet sold as Vytorin by Schering-Plough
SCHERING PLOUGH C
$18.75
Change: 0.00 - 0.00%
as of 4/28/2008 4:00pm
and Merck) in patients with familial hypercholesterolemia. The study looked at the effects of the combination versus simvastatin alone on carotid intima-media thickness. My previous opinions of the study’s meaning aren’t changed with publication of the final results in the NEJM to coincide with the ACC meeting. In case you were asleep for the past couple of months, ENHANCE was negative for signs of IMT improvement with the combo.

Expert opinion of the findings has been decidedly negative and prescriptions for ezetimibe (a $5 billion a year drug, counting both Zetia and Vytorin) have tumbled. Schering-Plough
SCHERING PLOUGH C
$18.75
Change: 0.00 - 0.00%
as of 4/28/2008 4:00pm
reported that scripts were 3.2 million in January and 2.8 million in February for both drugs combined (a 12.5% drop), while others have reported that Vytorin scripts have fallen 18%. Several sell-side analysts believe the latest pronouncements from experts at the ACC will further erode sales of Zetia and Vytorin and have cut their sales forecasts and share-price targets for Merck and Schering-Plough
SCHERING PLOUGH C
$18.75
Change: 0.00 - 0.00%
as of 4/28/2008 4:00pm
. Given the overreaction to the results thus far, it’s hard to find fault with their reasoning.

I await results from ongoing studies (particularly IMPROVE-IT) with hard CV outcomes as the primary endpoint in a less highly selected population before changing my own use of Zetia. If ezetimibe doesn’t work to reduce hard CV outcomes despite robust LDL-C reductions, the findings will be strong evidence supporting pleiotropic benefits of statins and arguing against routine use of ezetimibe. If ezetimibe does work, the utility of CIMT progression in hypercholesterolemia will be dubious.
 






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