PETER ROST: PHARMA MARKETING EXPERT WITNESS. AWP, MEDICAL DEVICE EXPERT.: Schering-Plough and Merck in panic: Another Vytorin trial delayed.
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PETER ROST: PHARMA MARKETING EXPERT WITNESS. AWP, MEDICAL DEVICE EXPERT.

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Schering-Plough and Merck in panic: Another Vytorin trial delayed.

Things are getting more and more scary over at Schering-Plough and Merck.

Most readers are aware of the ongoing Vytorin scandal and the Enhance trial debacle.

Vytorin is marketed by a joint venture of Merck & Co. (MRK) and Schering- Plough Corp. (SGP), and has come under fire because the Enhance study raised questions about its effectiveness. Full results of that study are set to be presented Sunday at a conference in Chicago.

Turns out there are more ongoing Vytorin trials that the companies fear could result in more problems.

So what do they do?

Well, at 4 p.m. Friday they sent out a press release, announcing that they are ALMOST DOUBLING the patient population in another key, ongoing study called "Improve-It," in which they are testing whether the cholesterol drug Vytorin can reduce heart attacks - a move expected to delay its completion by about a year, to 2012.

However, "the actual date of completion is highly dependent on the observed event rates" and "therefore it is not possible to determine with precision the exact date when the trial will end."

THE VYTORIN PATENT EXPIRES in 2017 --AND QUESTION AUTHORITY PREDICTS THAT THE 2012 DATE WILL COME AND GO AND THERE WILL BE A FEW MORE YEARS UNTIL THE DATA IS ACTUALLY PUBLISHED.

Clearly, the companies are not too worried about the delay.

Uh, Perhaps this is what they hoped for?

Of course, they also hope not too many people will notice the press release, that's the reason they sent it out on a Friday at 4 p.m.

And, they don't want to take responsibility for this decision, so the press release doesn't contain the Schering-Plough or Merck logos; in fact, it is rather anonymous looking.

Instead it is the doctors leading the study, titled "Improve-It," which began in 2005, who state in the press release that the trial's enrollment is being expanded to as many as 18,000 patients from the ORIGINAL PROTOCOL which had a target of 10,000.

Merck and Schering-Plough are funding the Improve-It study, but the researchers claim it was their decision to expand the study's size.

"Merck/Schering-Plough Pharmaceuticals agrees with the recommendation being made by the academic leadership of the Improve-It trial," Merck spokseman Skip Irvine said Friday.

Hahahahahahahaha. Of course they do. Clearly they expect this trial was on its way to become a second debacle, and so, they hope to delay the results as long as possible. To be specific--until the patent is gone, if possible.

Problem for Merck and Schering-Plough is that there has been no evidence that Vytorin can reduce risk of heart attacks and related problems any more than the generic drug simvastatin alone; its FDA approval was based on its ability to lower bad cholesterol to a greater degree. The companies and heart specialists have in the past suggested that the Improve-It trial will provide the definitive answer to whether Vytorin's cholesterol-lowering translates into clinical benefits. Now we won't know until the patent is gone.

Funny thing is the researches were able to determine that they needed many more patients based on the results of blinded data they've received so far. Makes you go hmmmmmmmmmmm.

Let's not forget that Merck and Schering-Plough were just critized for trying to make changes to the Enhance study midstream, and for attempting to change the study's primary measure after it was completed--and reversed that effort after a Congressional inquiry. They were also criticized for not releasing the Enhance results for nearly two years after its 2006 completion.

AND NOW THEY DO THIS AGAIN????????

When "researchers" start changing a study in the middle of the trial, you know it is bad news and you know that science has already taken a second position--to sales.

2 Comments:

Blogger MarilynMann said...

Note also:

"An independent Data Monitoring Committee is evaluating the trial results periodically in an unblinded fashion and could recommend earlier cessation if a definitive excess of benefit or harm were found. At their last evaluation, held on February 18, 2008, the Data Monitoring Committee advised that it found no indication in the data of adverse safety signals that would warrant a change in the protocol, and recommended that the study be continued."

Translation: no significant difference between the two arms.

Marilyn

3/29/2008  
Anonymous Anonymous said...

I realize that you are aiming for effect with your piece, but the vytorin patent doesn't expire in 2013. Check another source, it will not be available as a generic in the US until ~2017.

3/30/2008  

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