Once Again, The Drugmonkey Gets Results. Merck and Schering's Head Partially Emerges From Their Ass.

It was a little over a month ago that I wrote the two titans of Big Pharma a public letter in this very blog:

Dear Merck/Schering.

Your bullshit has been called. Please remove your head from your ass and do the right thing.

Sincerely,

Drugmonkey, Master of Pharmacy.

Regular readers of my little blog garden already know that what had my boxers in such a bunch was Merck and Schering's decision to alter the definition of the Enhance study's "primary endpoint." For those of you playing along at home, that means they started this study with one definition of what they were going to measure, then when the data actually came in decided that no, they changed their mind and they were going to look for something else. This kind of thing is not done in science, and the Drugmonkey was not going to let them get away with it.

Behold, the caving of Big Pharma:

The lead researcher of a long-delayed drug study says he regrets not standing up to Merck & Co. and Schering-Plough Corp. when they first told him last month that they planned to alter the statistical analysis of their jointly sponsored trial.

Under mounting criticism, the companies last week reversed the earlier decision to change the primary measure to evaluate the drug. The study, called Enhance, tested 720 people to determine whether a combination of Schering-Plough's Zetia and Merck's now off-patent cholesterol fighter Zocor works better than Zocor alone.

John P. Kastelein, a cardiologist at Academic Medical Center, Amsterdam, and principal investigator of the study, said he breathed a "sigh of relief" when the companies told him last week they were reversing course.

"It's never, ever right to change the primary endpoint of a study," especially after all the data are in, he says. "It is statistically not good and it gives the wrong impression to the outside world." He says he initially went along with the plan but now regrets not firmly resisting it from the outset.

You are now my bitch John P. Kastelein. You now say you wish you had opposed this cockamanie plan from the moment you heard of it. I did. I own you.

Big Pharma is so afraid of me they couldn't even personally tell me of their decision, leaving it up to an alert reader to inform me of my triumph. That was kinda rude of them. Not to mention they are still hiding the extent to which they know Zetia can harm your liver. We know that the number of people who had to stop taking Zetia in the Enhance study due to elevated liver enzymes was somewhere between 1 and everyone. Merck and Schering will not be more specific than this. We also know Merck and Schering have done other studies that raise questions about Zetia's risks to the liver, but never bothered to publish them. It's time for another letter:

Dear Merck/Schering,

While your head appears to have moved, possibly to the part of your large intestine just above the rectum, it still has a ways to go to get completely out of your ass.

Consider me your laxative.

Sincerely,

Drugmonkey, Master of Pharmacy