Wednesday, November 21, 2007

Do Me A Favor. Print Out The Article I Link To Here And Shove It Down The Throat Of The Next Merck Or Schering Rep That Sets Foot In Your Store.

This wasn't supposed to happen anymore.

After Glaxo Smith Kline got busted for withholding studies that suggested Paxil may increase the risk of suicide in children, Big Pharma promised to be good. "We have learned our lesson" they metaphorically said. "And we are so ashamed of what we have done to the good name of science we shall not oppose mandating that we put all our clinical trials in a database searchable by anyone. All our data shall be absolutely transparent from this day forward"

"Don't worry about including any penalties in this mandate though, because we will be forever good and pure."

Well today we have this, From The New York Times:

Nearly two years after (the makers of cholesterol lowering drugs Zetia and Vytorin,) Merck and Schering-Plough completed a clinical trial of the drugs, they still have not released the findings. The delay has led to a growing chorus of complaints from cardiologists. And yesterday, the companies responded by promising to publish a portion of the results next March — but not the entire set of data.

Doctors say that decision is highly unusual and will do little to quell concerns about the trial, as well as broader questions about the effectiveness of the drugs.


"BBBBWWWAAAHHHHAAAHAHHAAAAHHAAAHHAAAAAA!!!!!!! SSSSSUUUCCKKKEERRRRR!!!!!!! WE NEVER SAID WHEN WE'D RELEASE ANYTHING TO YOUR LITTLE DATABASE!" That is my interpretation of an actual quote you would get from a Big Pharma executive under the influence of truth serum.

Wait. That was just the opening act. There's more:

Of particular concern in this case is that Merck and Schering-Plough said yesterday that they had changed the trial’s “primary endpoint” — the main medical result being measured. The companies now say that they will use only partial results to assess the trial’s success in deterring the formation of plaque that can cause artery blockages and lead to heart attacks.
The companies had said they would measure the thickness of plaque in two arteries — the carotid, which runs through the neck and supplies the brain with blood, and the femoral, which runs through the hips and supplies the legs. The primary endpoint of the trial was supposed to be the amount of plaque at three points in the carotid artery.

But the companies said yesterday that they had changed the primary endpoint to measuring thickness at just one place in the carotid. And they do not expect to release any results at all from the femoral artery.


Let me make sure we all understand what's happened here. Merck and Schering started a study, and once the data started rolling in, they decided to change the definition of what they were looking for. Why would they do this? Here's a guess. The data wasn't going to give the result Merck and Schering wanted. Of course I have no way of knowing this, but ask yourself what Merck and Schering would be doing if they were looking at numbers that suggested Zetia and/or Vytorin were clearly lowering heart disease risk more than any other therapy. They'd have an ex-college cheerleader sales rep in every doctor's office in the country waving those numbers in front of their cleavage, that's what they'd be doing.

Here's my favorite part. Even though a source in the Times article is quoted as saying this type of action "sounds highly unusual to me" Merck/Schering says it's OK because:

A panel of outside scientists recommended the change last Friday, said Lee Davies, a spokesman for Schering. Mr. Davies declined to disclose the members of the panel.


So........a panel that for all we know could consist of Santa Claus, The Unabomber, and the president of The National Association for The Promotion of Heart Attacks says it's OK to make a "highly unusual" move......and we're supposed to feel better about that? Sigh. How the fuck stupid do they think we are?

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.

4 comments:

Anonymous said...

Thanks for the info.

Mother Jones RN said...

Drug Monkey, there is a simple explanation for why big pharm changed the study’s primary endpoint: Santa Claus and the other distinguished panelists didn’t want to embarrass the competition right before Christmas. The drug makers went along with the idea because they didn't want to hurt anyone's feelings, and because they didn’t want to get a lump of coal in the Christmas stockings. See, they really do have a heart. Shame on you for being so cynical.

CrankyProf said...

You wouldn't be suggesting that a giant, for-profit, soul-sucking corporation might suppress data to inflate their profit margin, despite the danger to customers, would you?

That would be downright unAmerican!

Anonymous said...

Did you see the new warnings on Tamiflu and Rozerem? Delusions or Self Injury?
I predict this will be the new drug of choice for those X taking people.