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Showing posts with label Zetia. Show all posts
Showing posts with label Zetia. Show all posts
Monday, November 16, 2009
More Zetia quotes
Zetia "has been on the market for about seven years and we still haven't proven that it improves clinical outcomes," said Dr. Roger Blumenthal, preventive cardiology chief at Johns Hopkins University.
"It should be better for the arteries and it wasn't," Dr. Allen Taylor said of Zetia. "The drug wasn't operating as you otherwise would expect it to," raising concern that its effects are not fully understood, he said.
Dr. Anthony DeMaria, a past president of the American College of Cardiology from the University of California at San Diego, said the study "doesn't quite put the nail in the coffin" for Zetia, but pushes it way down on the list of things to try.
Another Vytorin Mess For Merck - Matt Herper
via forbes.com
"How is it possible for a drug to have $4 billion in sales without any evidence of benefit?" says Harlan Krumholz, a cardiologist at Yale University. He said that the small size of the two imaging studies mean they couldn't render a clear verdict on Zetia. "But they don't instill any confidence in it either. "
Friday, November 13, 2009
Merck - Vytorin: Blue Monday?
“If you’re going to go to the expense, risk and trouble to take a pill every day to improve your longevity, don’t you really want to know if it works?” said Dr. Allen J. Taylor, a cardiologist at Washington Hospital Center, in Washington, who led the study. He said he could not talk about the results until Monday.
NYT
NYT
Sunday, October 11, 2009
Get yer free Vytorin info here
For a limited time, http://www.worstpills.org/ is providing you with information about Vytorin at no charge.
- Full statement: Drug companies, FDA lagged in warning public about Zetia, Vytorin
- Our article warning consumers not to take Zetia (Ezetimibe) and Vytorin (Ezetimibe with Simvastatin)
- Summaries of all of our work on high cholesterol, including information available to subscribers only
Monday, March 09, 2009
Merck buy Schering Plough - megamergers a la mode
Bye bye.Merck & Co Inc said on Monday that it would acquire Schering-Plough Corp for $41.1 billion, uniting the makers of cholesterol drugs Zetia and Vytorin, in the second megadeal for Big Pharma in weeks.
Source
Thursday, February 12, 2009
Schering Plough - Vytorin: the magic of functional unblinding
The Condor writes:
While outlining the path of inference that Senator Grassley first forged, back in February of 2008 (to deduce that Schering had acheived "functional unblinding" of the ENHANCE data), the plaintiffs, again in Manson (Case 08-397), offer perhaps the most succinct piece of skepticism I have yet read on the Schering ENHANCE disclosure delay (this is from another brief filed on last Friday -- full 50 page PDF file):
. . . .Schering’s ability to disclose the purportedly unanalyzable ENHANCE results so quickly after Congress exerted pressure supports a strong inference of scienter. Defendants make no attempt to reconcile how the supposedly intractable data problems that led Schering to withhold the results for over twenty months were magically overcome after just a few weeks of Congressional scrutiny. . . .
Source
While outlining the path of inference that Senator Grassley first forged, back in February of 2008 (to deduce that Schering had acheived "functional unblinding" of the ENHANCE data), the plaintiffs, again in Manson (Case 08-397), offer perhaps the most succinct piece of skepticism I have yet read on the Schering ENHANCE disclosure delay (this is from another brief filed on last Friday -- full 50 page PDF file):
. . . .Schering’s ability to disclose the purportedly unanalyzable ENHANCE results so quickly after Congress exerted pressure supports a strong inference of scienter. Defendants make no attempt to reconcile how the supposedly intractable data problems that led Schering to withhold the results for over twenty months were magically overcome after just a few weeks of Congressional scrutiny. . . .
Source
Thursday, September 18, 2008
Tuesday, September 02, 2008
Alex Berenson on the evidence gap for Vytorin
Nice job Alex.
The lack of data about ezetimibe highlights an aspect of the drug approval system that even sophisticated patients may not understand. Many medicines are approved on the basis of what scientists call surrogate endpoints, like proof that they lower cholesterol, rather than because they have been shown to reduce the risk of death or disease.
“The only place people should be taking (ezetimibe) is in a clinical trial,”
Dr. Allen J. Taylor of the Walter Reed Army Medical Center
More
The lack of data about ezetimibe highlights an aspect of the drug approval system that even sophisticated patients may not understand. Many medicines are approved on the basis of what scientists call surrogate endpoints, like proof that they lower cholesterol, rather than because they have been shown to reduce the risk of death or disease.
“The only place people should be taking (ezetimibe) is in a clinical trial,”
Dr. Allen J. Taylor of the Walter Reed Army Medical Center
More
Thursday, August 28, 2008
Quote of the week
"I believe that [Zetia] is clinically beneficial, but I cannot prove that."
Dr. Roger Blumenthal, Director, The Johns Hopkins Ciccarone Center for the Prevention of Heart Disease.
Thursday, April 24, 2008
Wednesday, April 23, 2008
Vytorin contd. - that tricky Merck / Schering Plough relationship
Monday, April 21, 2008
Merck - the price of ENHANCE
Around $300 million in lost sales in the first quarter of 2008.
Tell 'em Mike.
Tell 'em Mike.
The Vytorin Saga contd. - The Condor speaks
What a blog!
Here we get some insights into its author as they answer questions:
I am a. . . . reader, I guess. I've spent some time really "reading up" on SGP, over the past three months.
Now, your questions do deserve answers, and I do have my opinions(!), but I want to be careful not to libel/defame any private person. I do think Dr. Bots was right. I think the data were "fine." I think it likely that Schering and Merck just didn't "like" what the data pretty-plainly implied. Note that I've echoed, and amplified, Sen. Grassley's publicly-aired concerns that the very-likely outcomes from even the "blinded" data, were discernible to a medically-trained eye, long-before the data were actually, formally, unblinded.
So, I think -- emphasis on "think", here -- Schering and Merck asked to have the data "refined" -- to try and tease some statistically-significant outcome, from it. But even the expert panelists then later agreed, on November 16, 2007, that it was likely that any variance in the "blinded data" could be the result of pure chance, not treatment/control arm outcomes.
The Condor finshes with:
Now, I will say that -- as a matter of law -- even innocently delaying such data, and then selling stock to the public at $27.50 (near the high-price for the year!), is generally-frowned upon, over at the SEC.
Note that Schering sold $3.8 billion of equity, and another ~$4 billion of debt -- right in the middle of this "entirely innocent delay" on a project that impacted (or should I say sustained) 60-plus percent of Schering's 2007 profitability. That much is entirely undisputed -- and fascinating, no?. . . .
Thursday, April 17, 2008
The Vytorin Saga - The MedPage Debate
Evan A. Stein, M.D., Ph.D., of the Metabolic and Atherosclerosis Research Center in Cincinnati and the only U.S. ENHANCE investigator, defended the use of ezetimibe.
Taking the opposing view is Allen J. Taylor, M.D., of the Uniformed Services University of the Health Sciences Walter Reed Army Medical Center in Washington and co-author of a New England Journal of Medicine editorial on the ENHANCE trial.
Drs. Taylor and Stein were interviewed separately at the MedPage Today offices in Little Falls, N.J., on April 9 and 10 by Peggy Peck, Executive Editor, MedPage Today.
The physicians received no honoraria from MedPage Today. They were reimbursed for travel expenses.
Tuesday, April 15, 2008
Schering Plough - Vytorin: quote(s) of the week
"I'm an honest guy, and my first obligation is to tell the truth. Even if it means I'll probably never get to do a scientific investigation with Schering-Plough again."
And:
"For anyone to say the data in the study are bad, they either need to say that John Kastelein is a liar, which I'm certain he is not, or they need to talk to the [Schering-Plough] statisticians for the study and ask them if there are any problems with the data,"
Professor James Stein - speaking to Matt Herper
And:
"For anyone to say the data in the study are bad, they either need to say that John Kastelein is a liar, which I'm certain he is not, or they need to talk to the [Schering-Plough] statisticians for the study and ask them if there are any problems with the data,"
Professor James Stein - speaking to Matt Herper
James H. Stein, MD is a Professor in the Division of Cardiovascular Medicine at the University of Wisconsin School of Medicine and Public Health in Madison, Wisconsin. He is Director of the Preventive Cardiology Program and Director of the Vascular Health Screening Program at the University of Wisconsin Hospital and Clinics. Dr. Stein also is the Director of the University of Wisconsin Atherosclerosis Imaging Research Program.
Dr. Stein received his baccalaureate degree with honors from the University of Wisconsin. He received his Doctor of Medicine (cum laude) degree from the Yale University School of Medicine in New Haven, Connecticut. His Internship and Residency in Internal Medicine were at the University of Chicago Medical Center in Illinois. He completed a Cardiology Fellowship at Rush-Presbyterian-St. Luke's Medical Center in Chicago, Illinois.
Dr. Stein has been named one of Madison's “Top Docs” in Cardiology by Madison Magazine since 2000 and in 2007 was named one of the 20 best cardiologists in America by Men’s Health Magazine.
Thursday, April 10, 2008
Thursday, April 03, 2008
Schering Plough - Hassan's hard new realities
The pressures that Schering-Plough has been suffering amid the criticism of its cholesteriol drugs Vytorin and Zetia, sold through a joint venture with Merck & Co, has led the firm to announce major job cuts and plant closures.
S-P has unveiled what it calls a “productivity transformation programme”, which targets $1.5 billion in annual savings and includes previously-announced synergy targets of $500 million from the November 2007 acquisition of Organon BioSciences from Akzo Nobel.
The company said the move is a response to “dramatically intensifying pressures on the pharmaceutical industry, especially new pressures in the USA, and also to the confusion in the US market around cholesterol management”. It is expected that around 10% of its 55,000 workforce will be laid off.
This specifically refers to the results of the controversial ENHANCE study confirmed at the American College of Cardiology meeting in Chicago which demonstrated that Vytorin, a combination of Zetia (ezetimibe) and Zocor (simvastatin), may not be any more effective than cheaper statins, notably generic Zocor, in preventing heart disease. As a result, panellists at the ACC recommended that widespread use of Vytorin and Zetia should be curtailed.
Specific details of the programme have not yet been finalised but S-P said that more than 80%, of the planned savings are targeted to be accomplished by the end of 2010. As well as the reduction of the number of facilities across the world, it will create “more focused and high-efficiency plants by 2012”.
Chief executive Fred Hassan said “savings and productivity improvements will be realised across the company and around the world. No area will be exempt”. He added that the first step will be to reduce “higher management levels in the company's headquarters and elsewhere”, noting that “a major focus will be the USA, where the most intense new pressures on our industry and our company are centred."
Mr Hassan, claiming that S-P will “not engage in across-the-board cost-cutting” and “will avoid unwise short term actions”, said the firm is progressing well, citing the Organon purchase. He insisted that “we now have perhaps the most impressive late-stage pipeline in our peer group -- including cutting edge projects as TRA for deadly blood clots, and sugammadex in anaesthesiology".
However the firm has seen its stock plummet in the past few months and "hard new realities are requiring the hard new actions" he added, claiming that “the reality is that we face today a new political and overall environment in the USA that is increasingly discouraging pharmaceutical innovation." An example of this, Mr Hassan said, "has been the confusion in the cholesterol market largely caused by the overreaction to conflicting results of the relatively small ENHANCE clinical trial, involving Vytorin”.
He continued: “This confusion, in the absence of an open and balanced scientific discussion of this clinical trial, have caused an unwarranted concern among millions of patients who need to get to their cholesterol goals". The Vytorin tale “has been a case study of the impact of the hard new realities," he added.
Source: PharmaTimes
S-P has unveiled what it calls a “productivity transformation programme”, which targets $1.5 billion in annual savings and includes previously-announced synergy targets of $500 million from the November 2007 acquisition of Organon BioSciences from Akzo Nobel.
The company said the move is a response to “dramatically intensifying pressures on the pharmaceutical industry, especially new pressures in the USA, and also to the confusion in the US market around cholesterol management”. It is expected that around 10% of its 55,000 workforce will be laid off.
This specifically refers to the results of the controversial ENHANCE study confirmed at the American College of Cardiology meeting in Chicago which demonstrated that Vytorin, a combination of Zetia (ezetimibe) and Zocor (simvastatin), may not be any more effective than cheaper statins, notably generic Zocor, in preventing heart disease. As a result, panellists at the ACC recommended that widespread use of Vytorin and Zetia should be curtailed.
Specific details of the programme have not yet been finalised but S-P said that more than 80%, of the planned savings are targeted to be accomplished by the end of 2010. As well as the reduction of the number of facilities across the world, it will create “more focused and high-efficiency plants by 2012”.
Chief executive Fred Hassan said “savings and productivity improvements will be realised across the company and around the world. No area will be exempt”. He added that the first step will be to reduce “higher management levels in the company's headquarters and elsewhere”, noting that “a major focus will be the USA, where the most intense new pressures on our industry and our company are centred."
Mr Hassan, claiming that S-P will “not engage in across-the-board cost-cutting” and “will avoid unwise short term actions”, said the firm is progressing well, citing the Organon purchase. He insisted that “we now have perhaps the most impressive late-stage pipeline in our peer group -- including cutting edge projects as TRA for deadly blood clots, and sugammadex in anaesthesiology".
However the firm has seen its stock plummet in the past few months and "hard new realities are requiring the hard new actions" he added, claiming that “the reality is that we face today a new political and overall environment in the USA that is increasingly discouraging pharmaceutical innovation." An example of this, Mr Hassan said, "has been the confusion in the cholesterol market largely caused by the overreaction to conflicting results of the relatively small ENHANCE clinical trial, involving Vytorin”.
He continued: “This confusion, in the absence of an open and balanced scientific discussion of this clinical trial, have caused an unwarranted concern among millions of patients who need to get to their cholesterol goals". The Vytorin tale “has been a case study of the impact of the hard new realities," he added.
Source: PharmaTimes
Vytorin - a drug that dodged scrutiny
The Ledger writes:
The study that sent Merck and Schering-Plough stock plung ing and put doctors in a tizzy this week did not find any harm from taking the drug Vytorin -- except to pocketbooks.
The problem was that while there was no harm, there was not much benefit either. Vytorin, which combines Merck's drug Zocor and Schering-Plough's Zetia, does not seem to clear arteries any better than taking Zocor alone -- and generic Zocor sells for a mere one-fifth of Vytorin's price.
The other problem for the pharmaceutical giants is that some members of Congress are investigating whether the companies delayed the release of the study's not-so-good news to protect profits for as long as possible.
If so, they did it at the expense of stockholders as well as consumers and insurance programs, including Medicaid and Medicare, which paid for Vytorin when cheaper Zocor would have done. Was the combined drug about science or a market device to up the price of one old drug by dressing it up as something new?
There are still unanswered scientific questions. Merck and Schering-Plough chose to study Vytorin in patients with an elevated genetic predisposition for very high cholesterol. Vytorin reduced the so-called bad cholesterol levels although not as low as target levels set by experts.
Reducing the buildup of plaque on artery walls is the business end of cholesterol control, and Vytorin did not perform any better than plain old, cheap Zocor. Why not? Might the results be different in a more typical population? In a larger study?
Those are important questions. So is this one, for Congress and the Food and Drug Administration: Why is it that Vytorin has been on the market for years, has saturated consumer and medical minds with $140 million a year in advertising and raked in more than $5 billion in sales -- yet we're just getting around to finding out if it works?
Insider's view: Hear hear!
The FDA should, and will, be more cautious when approving NCE's like ezetemibe based only on weak surrogate endpoints.
Pargluva was stopped with a request for harder data.
I wonder which drugs in development will now have the bar raised for them!?
The study that sent Merck and Schering-Plough stock plung ing and put doctors in a tizzy this week did not find any harm from taking the drug Vytorin -- except to pocketbooks.
The problem was that while there was no harm, there was not much benefit either. Vytorin, which combines Merck's drug Zocor and Schering-Plough's Zetia, does not seem to clear arteries any better than taking Zocor alone -- and generic Zocor sells for a mere one-fifth of Vytorin's price.
The other problem for the pharmaceutical giants is that some members of Congress are investigating whether the companies delayed the release of the study's not-so-good news to protect profits for as long as possible.
If so, they did it at the expense of stockholders as well as consumers and insurance programs, including Medicaid and Medicare, which paid for Vytorin when cheaper Zocor would have done. Was the combined drug about science or a market device to up the price of one old drug by dressing it up as something new?
There are still unanswered scientific questions. Merck and Schering-Plough chose to study Vytorin in patients with an elevated genetic predisposition for very high cholesterol. Vytorin reduced the so-called bad cholesterol levels although not as low as target levels set by experts.
Reducing the buildup of plaque on artery walls is the business end of cholesterol control, and Vytorin did not perform any better than plain old, cheap Zocor. Why not? Might the results be different in a more typical population? In a larger study?
Those are important questions. So is this one, for Congress and the Food and Drug Administration: Why is it that Vytorin has been on the market for years, has saturated consumer and medical minds with $140 million a year in advertising and raked in more than $5 billion in sales -- yet we're just getting around to finding out if it works?
Insider's view: Hear hear!
The FDA should, and will, be more cautious when approving NCE's like ezetemibe based only on weak surrogate endpoints.
Pargluva was stopped with a request for harder data.
I wonder which drugs in development will now have the bar raised for them!?
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