« Why did the FDA propose making off-label marketing legal? | Main | U.S. Court tries to shut down whistleblower site Wikileaks and fails. »

February 18, 2008

Schering-Plough statisticians reviewed raw study data already in April 2006. "That is the key irregularity," says Eric Topol, a respected cardiologist.

The NJ Star Ledger today has a very intersting review article on the Vytorin-study debacle. Here are a few excerpts (full article here):

The most troubling shortcoming, the experts said, came when Schering-Plough's statisticians reviewed some raw study data in April 2006 before the examinations of all 750 volunteer test subjects at 11 sites around the globe were complete.

Critics protest the statisticians may have had a hint of the study's disappointing outcome.

"That is the key irregularity," said Eric Topol, a respected cardiologist and director of the Scripps Translational Science Institute, in La Jolla, Calif., who criticized the study's "poor organization, poor planning."

The experts point to four critical flaws with the study:

Schering-Plough's statisticians reviewed preliminary results before the study was complete, a medical research taboo because it may have revealed the disappointing results months in advance of their formal release. Several company executives sold millions of dollars of stock last summer. Schering-Plough denies any wrongdoing.

In a break from standard research procedures, no outside scientists supervised the study or monitored the safety of the clinical trial subjects.

The study used a new ultrasound procedure to measure plaque at difficult-to-read sites on the carotid artery in the neck, but there was no procedure in place to handle faulty images when they occurred.

The people selected for the study did not have abnormal amounts of plaque in their arteries to begin with, setting a high hurdle for Vytorin to reduce it.

What should have taken a few months to read the images and compile the results turned into an 18-month project. In fact, the ultrasounds of the carotid artery in the neck were so inconsistent Merck and Schering-Plough briefly changed the study's endpoint, or goal, to measurement of plaque in the femoral artery in the leg.

The change prompted an outcry from the cardiology community, which resulted two months later in the companies announcing they would continue to work through problems with the carotid images.

Congressional and state probes are focused on delays in the release of the trail results -- and whether Schering-Plough executives profited from advance knowledge of the results.

The company said CEO Hassen and top executives only learned of the final results in January.

Congressional investigators are focused on the period of more than six months earlier, when some of Schering-Plough's senior executive sold tens of millions of dollars in stock.

The company has said all the sales were approved in advance, including $28 million in transactions by Carrie Cox, the company's president, in April and May 2007, about the same time researchers were rushing to compile the disappointing Vytorin study results for presentation at the American Heart Association's annual convention.

Dr. Rost is a pharma litigation consultant and pharmaceutical marketing expert. He is also the author of Killer Drug and The Whistleblower.

Posted on February 18, 2008 |

TrackBack

TrackBack URL for this entry:
http://www.typepad.com/services/trackback/6a00d834519bc269e200e5506ae4b78834

Listed below are links to weblogs that reference Schering-Plough statisticians reviewed raw study data already in April 2006. "That is the key irregularity," says Eric Topol, a respected cardiologist. :

The comments to this entry are closed.

 
© 2010 Brandweek. All rights reserved. Terms Of Use and Privacy Policy Additional Terms Of Use and Privacy Policy.