Schering-Plough and Merck have been delaying the release of results of a key lipid lowering trial for two years. The study was designed to determine whether Vytorin - a combination of Zetia and Zocor - was more effective in reducing the growth of plaque in blood vessel walls than Zocor alone.
Last year all hell broke lose in the press which resulted in a Congressional inquiry about the delay, and the two companies scrambled to explain why they couldn't present the trial.
It leaked out that the two drugmakers had started messing around; changed the primary endpoint, and failed to include the lead investigator in the decision; they then refused to name members of what supposedly was an "independent panel" to review the data. Turns out that panel wasn't so independent, after all.
Today, we got the results and the findings explain the long delay and all the attempts to mess with the data - there was no statistically significant difference between treatment groups on the primary endpoint, including the common carotid artery, according to a press release.
What does this all prove?
It proves that if it wasn't for the press following this story closely, we would have been hoodwinked with another dirty trial with changed endpoints and data massaged to suit the marketing departments.
The reaction from the rank-and-file at Schering Plough?
Here it is:
"Managed care is going to eat us alive! Say bye-bye to half of our business!"
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