Drug makers to pay for withholding negative studies

Posted July 15, 2009 2:49 p.m. EDT
Updated July 15, 2009 3:32 p.m. EDT

— Drug makers Merck & Co. and Schering-Plough Corp. must submit to scrutiny of their advertisements and clinical trials and pay $5.4 million to North Carolina and 35 other states, Attorney General Roy Cooper said Wednesday.

Cooper and other attorneys general were concerned about the time it took Merck and Schering-Plough to release potentially negative information from a clinical trial involving the popular cholesterol-lowering medication Vytorin, which is a combination of the brand-name drug Zetia and the generic simvastatin.

A clinical trial completed in May 2006 showed that Vytorin was no more effective at lowering cholesterol than the cheaper generic simvastatin used alone. The two drug companies, which market Vytorin and Zetia under a joint venture, didn’t report any results from the trial until January 2008, and didn’t share the complete results for another three months.

During that time, Merck and Schering-Plough promoted Vytorin heavily with advertisements.

“Accurate and timely information about prescription drugs is essential to doctors and patients,” Cooper said in a statement. “Delaying study results because they might hurt profits is just plain wrong.”

Under a settlement reached between the companies and the attorneys general, Merck and Schering-Plough agreed to pay $5.4 million to the states, including $100,000 to North Carolina. The companies must also obtain approval from the U.S. Food and Drug Administration before airing any direct-to-consumer television advertisements; comply with FDA suggestions to modify drug advertising; register clinical trials and post their results; prohibit ghost-writing of articles; reduce conflicts of interest for boards that ensure the safety of clinical trial participants; and comply with detailed rules prohibiting the deceptive use of clinical trials.

The settlement follows a 2008 agreement with Merck over the marketing of arthritis pain reliever Vioxx. Under that agreement, Merck paid $58 million to the states and agreed to a number of restrictions, including submitting all television ads to the FDA for approval.