Matt Herper is “In the Zone” — the “No-Spin, All Science” Zone, at Least for Tonight. . . .

A trifecta, of sorts, for the Forbes wunderkind — three in a row, here — do read the full article, but consider this tasty morsel:

. . . .One of the most prominent statisticians in the U.S. is taking issue with an analysis that claims there is no credible evidence the cholesterol drug Vytorin increases the risk of cancer death.

“There are clinically important increases in the risk of cancer-related death that are not ruled out by this data,” writes Thomas Fleming of the University of Washington in an editorial published on the Web site of the New England Journal of Medicine. . . .

Now, if we parse that last link (in the Herper-piece pull-quote), we read why it is that Fleming believes (peer-reviewed in the New England Journal of Medicine) cancer cannot be ruled out for Vytorin:

. . . .Given the possibility that simvastatin–ezetimibe could have an effect on the rate of cancer-related deaths through a cancer-promoter mechanism, separate analyses should be performed for the end point of cancer-related mortality. Unfortunately, these two trials indicate an increase in the number of cancer-related deaths associated with active treatment, as compared with control therapy (97 vs. 72 deaths; approximate hazard ratio, 1.34; 95% CI, 0.98 to 1.84), indicating an increase in risk of 34%. Given this confidence interval, investigators cannot exclude a relative increase of as much as 84% in the risk of cancer-related death associated with the use of simvastatin–ezetimibe. Hence, there are clinically important increases in the risk of cancer-related death that are not ruled out by these data. . . .

[Emphasis supplied.]

That, too, will leave a mark. A perhaps indelible mark.

Matt Herper is "In the Zone" — the "No-Spin, All Science" Zone, at Least for Tonight. . . .

A trifecta, of sorts, for the Forbes wunderkind — three in a row, here — do read the full article, but consider this tasty morsel:

. . . .One of the most prominent statisticians in the U.S. is taking issue with an analysis that claims there is no credible evidence the cholesterol drug Vytorin increases the risk of cancer death.

“There are clinically important increases in the risk of cancer-related death that are not ruled out by this data,” writes Thomas Fleming of the University of Washington in an editorial published on the Web site of the New England Journal of Medicine. . . .

Now, if we parse that last link (in the Herper-piece pull-quote), we read why it is that Fleming believes (peer-reviewed in the New England Journal of Medicine) cancer cannot be ruled out for Vytorin:

. . . .Given the possibility that simvastatin–ezetimibe could have an effect on the rate of cancer-related deaths through a cancer-promoter mechanism, separate analyses should be performed for the end point of cancer-related mortality. Unfortunately, these two trials indicate an increase in the number of cancer-related deaths associated with active treatment, as compared with control therapy (97 vs. 72 deaths; approximate hazard ratio, 1.34; 95% CI, 0.98 to 1.84), indicating an increase in risk of 34%. Given this confidence interval, investigators cannot exclude a relative increase of as much as 84% in the risk of cancer-related death associated with the use of simvastatin–ezetimibe. Hence, there are clinically important increases in the risk of cancer-related death that are not ruled out by these data. . . .

[Emphasis supplied.]

That, too, will leave a mark. A perhaps indelible mark.

“Vytorin Study’s Ethical Morass” — Forbes’ Matt Herper

This is very tough, but very fair — and probing — coverage. Do read Mr. Herper this morning, en todo, but here is a pull-quote from the always on-point Dr. Steve Nissen (Chairman of the Cardiology Department at the prestigious Cleveland Clinic):

. . . .Merck and Schering have come under heavy criticism for another Vytorin study, called ENHANCE. The lead investigator of that trial has said that the results might have been out a year earlier had the companies left the decision to analyze the data up to him.

Steven Nissen, chairman of cardiology at the Cleveland Clinic and a Vytorin critic, says that he thinks the rush to release the information was improper.

“What you’re seeing here is the behavior of a company that is under siege by the failure to do the right studies,” Nissen says, “And they’re trying to spin the results using media relations strategies rather than the proper scientific approach. . . .”

Science first — and commerce second — in order to regain the respect of the cardiologists and the public, Mr. Hassan.

"Vytorin Study’s Ethical Morass" — Forbes’ Matt Herper

This is very tough, but very fair — and probing — coverage. Do read Mr. Herper this morning, en todo, but here is a pull-quote from the always on-point Dr. Steve Nissen (Chairman of the Cardiology Department at the prestigious Cleveland Clinic):

. . . .Merck and Schering have come under heavy criticism for another Vytorin study, called ENHANCE. The lead investigator of that trial has said that the results might have been out a year earlier had the companies left the decision to analyze the data up to him.

Steven Nissen, chairman of cardiology at the Cleveland Clinic and a Vytorin critic, says that he thinks the rush to release the information was improper.

“What you’re seeing here is the behavior of a company that is under siege by the failure to do the right studies,” Nissen says, “And they’re trying to spin the results using media relations strategies rather than the proper scientific approach. . . .”

Science first — and commerce second — in order to regain the respect of the cardiologists, and the public, Mr. Hassan.