Wednesday, September 3, 2008

"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.

4 comments:

Anonymous said...

Any update on VYCTOR?

Anonymous said...

Unfortunately, my "source" has clammed-up -- I'll continue to try other avenues, though. . . .

It was suggested, by a very wise friend of this blog, privately, that VYCTOR may have been a "seeding" study, in Mexico -- to drive demand there. It is, afterall, a pretty large market.

That may well prove to be right.

VYCTOR was presented at ESC 2007, as a poster -- and while nominally positive, it broke no new ground.

The enduring mystery, thus far, is why did Merck wait until mid-August 2008 to file the study with CLinicalTrials.gov?

That is what I'll continue to pursue -- the "why" for that multi-year delay.

Thanks for asking, Anon.!

Do stop back!

Anonymous said...

Condor,

Even for those of us who follow this the Forbes article is confusing. I had to do a little review myself to realize what the underlying story was.

1. Enhance does not show greater efficacy of Vytorin on clinical endpoints (not biomarkers) so analysis and publications of the results are delayed.

2. Enhance results are released and SP takes a nosedive.

3. To recover from the nosedive a preliminary and inappropriate look-see of SEAS may have occured.

4. An inappropriate looksee of SEAS results in finding a possible increased risk of Cancer.

5. Nissen's complaint appears to be that if SP had actually not delayed the analysis and reporting of Enhance a lot of people wouldn't have been taking it inappropriately. Then they could have completed SEAS and looked at all the data at the right time and determined if the cardiac benefits in this patient population outweighed any risk of Cancer in the same population, even if there's a true increase in cancer.

Salmon

Anonymous said...

I see what you are getting at, Salmon.

The first paragraph quoted refers to ENHANCE; the second and third refer to SEAS.

The "rush" Dr. Nissen refers to, is the rush to "spin" SEAS cancer incidence data as a "false signal".

Thus I admonished "science first; commerce (marketing) second. . . ."

I actually thought that seemed clear from Herper's. And, as ever, I generally omit the background, trusting that the readership will read the links if they don't get the context.

But all that said -- I agree with what you wrote -- well-put.