Showing posts with label Schering Plough. Show all posts
Showing posts with label Schering Plough. Show all posts
Tuesday, October 05, 2010
Tuesday, November 03, 2009
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
Wednesday, November 05, 2008
Merck Schering Plough - Vytorin: DoJ investigating
The U.S. Department of Justice has begun investigating the conduct of Merck and Schering-Plough in the marketing of the cholesterol drug Vytorin, according to a regulatory filing.
Lawsuits against the companies related to Vytorin marketing also are piling up, Merck said in a filing late Monday to the Securities and Exchange Commission.
The Justice Department's Civil Division notified Merck in a Sept. 10 letter that the agency was investigating whether the drugmakers' promotion of Vytorin resulted in false claims to federal health-care programs, Merck noted. If so, federal health programs could seek to recover money they have spent on the drug.
Thirty-five state attorneys general are jointly investigating whether the partners violated state consumer-protection laws in marketing Vytorin, Merck said.
More
Lawsuits against the companies related to Vytorin marketing also are piling up, Merck said in a filing late Monday to the Securities and Exchange Commission.
The Justice Department's Civil Division notified Merck in a Sept. 10 letter that the agency was investigating whether the drugmakers' promotion of Vytorin resulted in false claims to federal health-care programs, Merck noted. If so, federal health programs could seek to recover money they have spent on the drug.
Thirty-five state attorneys general are jointly investigating whether the partners violated state consumer-protection laws in marketing Vytorin, Merck said.
More
Thursday, September 18, 2008
Wednesday, September 17, 2008
Schering Plough - ENHANCE: dear oh dear oh dear
I do hope Fred Hassan is sitting down!
258. To reduce the possibility of the results being biased, clinical trials are often “double-blinded,” meaning that neither the patient nor the doctor (nor, with most trials, the pharmaceutical company sponsor) knows whether the patient is in the experimental group (i.e., the group taking the drug under study) or the control group (i.e., the group taking placebo or another drug with known effects in the study population). Despite the obvious (and intended) limitations of blinding a clinical trial, if certain data about the population in the trial are made available, it is possible to discern useful information about the trial’s results, even while the treatment assignments remain blinded. Recognizing this, on February 11, 2008, in the Second Senate Letter, Senator Grassley wrote to Hassan that ENHANCE statisticians would not have needed to unblind the ENHANCE data to know that the study was not likely to show a statistically-significant difference between treatment arms:
It has come to my attention that Schering Plough and Merck would not need to unblind the data to understand that Vytorin performed no better than generic simvastatin. . . . These studies try to detect a statistically significant difference between treatment groups on the primary endpoint. Once the results are recorded, the study is then unblinded to determine which drug is the better performer. However, if the drugs performed the same, meaning there is no statistically significant difference in the treatments, then this information is apparent before the study has been unblinded.
259. Dr. Allen Taylor of Walter Reed reached the same conclusion. Dr. Taylor told Heartwire that, “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. . . . In my view, once that is known, the trial is functionally unblinded.”
258. To reduce the possibility of the results being biased, clinical trials are often “double-blinded,” meaning that neither the patient nor the doctor (nor, with most trials, the pharmaceutical company sponsor) knows whether the patient is in the experimental group (i.e., the group taking the drug under study) or the control group (i.e., the group taking placebo or another drug with known effects in the study population). Despite the obvious (and intended) limitations of blinding a clinical trial, if certain data about the population in the trial are made available, it is possible to discern useful information about the trial’s results, even while the treatment assignments remain blinded. Recognizing this, on February 11, 2008, in the Second Senate Letter, Senator Grassley wrote to Hassan that ENHANCE statisticians would not have needed to unblind the ENHANCE data to know that the study was not likely to show a statistically-significant difference between treatment arms:
It has come to my attention that Schering Plough and Merck would not need to unblind the data to understand that Vytorin performed no better than generic simvastatin. . . . These studies try to detect a statistically significant difference between treatment groups on the primary endpoint. Once the results are recorded, the study is then unblinded to determine which drug is the better performer. However, if the drugs performed the same, meaning there is no statistically significant difference in the treatments, then this information is apparent before the study has been unblinded.
259. Dr. Allen Taylor of Walter Reed reached the same conclusion. Dr. Taylor told Heartwire that, “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. . . . In my view, once that is known, the trial is functionally unblinded.”
Tuesday, September 16, 2008
A Tale of Two Medicines - Vytorin and Lucentis
The world's pharmaceutical giants invent and market medicines that save, prolong and vastly improve the quality of our lives. In return, we give them more money than most people can imagine.
That's not entirely a bad trade, except that the highly complex nature of evaluating drugs, the ever-improving marketing savvy of the drug companies and the weakness of the Food and Drug Administration are clearly combining to tilt the deal too far on the side of profits and too little on the side of human health.
A small outburst of reports in recent days provides enough of a sample to build a scary theory about how drug makers are getting the better of the FDA, doctors and patients.
One case involves two different medicines made by the same company, Genentech Inc.
One drug, Avastin, is approved, marketed, prescribed and, apparently, effective as a cancer treatment. But some doctors who have been trying it out on their own patients believe it also shows great promise as a way to fight an eye disease known as age-related macular degeneration, or AMD. The other drug, Lucentis, is approved for AMD and, as far as modern science can tell, works.
But using Lucentis for AMD costs $2,000 per treatment, while using Avastin for the same malady would cost only $60 per treatment. Formally approving the cheaper drug for AMD treatments, and possibly preventing blindness in thousands of people a year, would require a new round of clinical trials to make sure it works without any unacceptable level of side-effects.
But Genentech, looking at a difference of $1,940 per dose -- or more than $1 billion a year nationally -- won't play along. And the FDA, which doesn't have the staff or the money to conduct such tests without drug companies' full cooperation, is stuck. And so are doctors who could prescribe, insurance companies that could pay less for, and patients who could benefit from the less expensive preparation.
Meanwhile, over in the heart and cholesterol aisle, the heavily marketed drug Vytorin is under suspicion by some experts as being a big, and potentially harmful, dud. Well, half of it is.
Vytorin is a mix of two medicines, a long-proven cholesterol- fighting statin and a newer medicine called Zetia. But the Zetia part has yet to establish that it actually helps people avoid heart attacks, live longer, healthier lives, or to do anything else but spend a lot more money on the new drug than it did on the old one. And one study in Norway has, very tentatively, linked Zetia to cancer.
In these cases, and many others, the FDA and the public are overly reliant on the good graces of drug companies to properly vet their medications to be as sure as possible that they not only help with disease but also don't cause any horrible problems along the way.
Such assurances require not only extensive premarket trials but also exhaustive monitoring and follow-up afterward, which is when the drugs are used by enough people over enough time to give a real indication of their benefits and risks. That's a moral responsibility -- but if corporations don't realize that, it should also be a mandated one.
Source
That's not entirely a bad trade, except that the highly complex nature of evaluating drugs, the ever-improving marketing savvy of the drug companies and the weakness of the Food and Drug Administration are clearly combining to tilt the deal too far on the side of profits and too little on the side of human health.
A small outburst of reports in recent days provides enough of a sample to build a scary theory about how drug makers are getting the better of the FDA, doctors and patients.
One case involves two different medicines made by the same company, Genentech Inc.
One drug, Avastin, is approved, marketed, prescribed and, apparently, effective as a cancer treatment. But some doctors who have been trying it out on their own patients believe it also shows great promise as a way to fight an eye disease known as age-related macular degeneration, or AMD. The other drug, Lucentis, is approved for AMD and, as far as modern science can tell, works.
But using Lucentis for AMD costs $2,000 per treatment, while using Avastin for the same malady would cost only $60 per treatment. Formally approving the cheaper drug for AMD treatments, and possibly preventing blindness in thousands of people a year, would require a new round of clinical trials to make sure it works without any unacceptable level of side-effects.
But Genentech, looking at a difference of $1,940 per dose -- or more than $1 billion a year nationally -- won't play along. And the FDA, which doesn't have the staff or the money to conduct such tests without drug companies' full cooperation, is stuck. And so are doctors who could prescribe, insurance companies that could pay less for, and patients who could benefit from the less expensive preparation.
Meanwhile, over in the heart and cholesterol aisle, the heavily marketed drug Vytorin is under suspicion by some experts as being a big, and potentially harmful, dud. Well, half of it is.
Vytorin is a mix of two medicines, a long-proven cholesterol- fighting statin and a newer medicine called Zetia. But the Zetia part has yet to establish that it actually helps people avoid heart attacks, live longer, healthier lives, or to do anything else but spend a lot more money on the new drug than it did on the old one. And one study in Norway has, very tentatively, linked Zetia to cancer.
In these cases, and many others, the FDA and the public are overly reliant on the good graces of drug companies to properly vet their medications to be as sure as possible that they not only help with disease but also don't cause any horrible problems along the way.
Such assurances require not only extensive premarket trials but also exhaustive monitoring and follow-up afterward, which is when the drugs are used by enough people over enough time to give a real indication of their benefits and risks. That's a moral responsibility -- but if corporations don't realize that, it should also be a mandated one.
Source
Tuesday, September 02, 2008
New Vytorin SEAS data - today
An update on SEAS will be presented during a press conference in London at 1 p.m. EST.
Click here for the Webcast of the event.
A "select group" of cardiologists will be briefed about the study an hour earlier.
Click here for the Webcast of the event.
A "select group" of cardiologists will be briefed about the study an hour earlier.
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.
Wednesday, August 27, 2008
Merck Schering Plough - EMEA says "no" to paediatric Vytorin
The European Medicine Agency’s (EMEA) Paediatric Committee has decided not to recommend use of Vytorin and a related treatment that Merck submitted for treating high cholesterol in children.
The cholesterol drugs “do not represent a significant therapeutic benefit over existing treatments,” the EMEA says in a statement.
The decision is the latest setback on Vytorin (ezetimibe/simvastatin) for Merck, which does business in Europe as Merck Sharp & Dohme. The drugmaker markets Vytorin through a joint venture with Schering-Plough. The other treatment rejected by the EMEA is comprised of nicotinic acid (also known as niacin or vitamin B3) in an extended-release form combined with Zocor (simvastatin) and laropiprant.
Souurce
Thanks to PM
The cholesterol drugs “do not represent a significant therapeutic benefit over existing treatments,” the EMEA says in a statement.
The decision is the latest setback on Vytorin (ezetimibe/simvastatin) for Merck, which does business in Europe as Merck Sharp & Dohme. The drugmaker markets Vytorin through a joint venture with Schering-Plough. The other treatment rejected by the EMEA is comprised of nicotinic acid (also known as niacin or vitamin B3) in an extended-release form combined with Zocor (simvastatin) and laropiprant.
Souurce
Thanks to PM
Tuesday, August 19, 2008
Friday, August 01, 2008
A wake up for Schering Plough?
Schering-Plough's drug sugammadex for the reversal of general anesthesia was rejected by U.S. regulators.
They received a ``not-approvable'' letter from the Food and Drug Administration, the drugmaker said today in a statement. Schering-Plough said it would work with the agency to ``address the issues, which are primarily related to hypersensitivity/allergic reactions.''
More
They received a ``not-approvable'' letter from the Food and Drug Administration, the drugmaker said today in a statement. Schering-Plough said it would work with the agency to ``address the issues, which are primarily related to hypersensitivity/allergic reactions.''
More
Tuesday, July 29, 2008
Tuesday, July 22, 2008
Schering Plough - Vytorin: the bottom line
"We just don't have evidence here for a benefit for Vytorin," Dr Steve Nissen says. "Let's stick with the statins, because we know they work."
BusinessWeek
BusinessWeek
Monday, July 21, 2008
Tuesday, July 08, 2008
A question for the Merck Schering Plough statisticians
Do they consider comparing clinical trial endpoint data between the study groups in a manner lacking specific identifiers as 'blinded'?
Functional unblinding - a tutorial.
Functional unblinding - a tutorial.
Sunday, July 06, 2008
Dissecting ezetemibe and ENHANCE
The manufacturer "has invested far more in marketing than in science".
At present, ezetimibe’s mechanism of
action is not fully understood, and its benefit—
for now, only mild LDL-C reduction—is too
uncertain for us to be spending $5.2 billion a
year for it. Its manufacturer is fortunate that
the drug is even licensed, given the current
and seemingly appropriate regulatory changes
under which drugs introducing new therapeutic
classes are scrutinized more closely for benefit.
At present, ezetimibe’s mechanism of
action is not fully understood, and its benefit—
for now, only mild LDL-C reduction—is too
uncertain for us to be spending $5.2 billion a
year for it. Its manufacturer is fortunate that
the drug is even licensed, given the current
and seemingly appropriate regulatory changes
under which drugs introducing new therapeutic
classes are scrutinized more closely for benefit.
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