The makers of the highly popular cholesterol drugs Zetia and Vytorin have agreed to pay $5.4 million in legal costs to 35 states and the District of Columbia. The legal probe conducted by the states’ attorneys’ general centered on allegations that the drug companies’ attempt to conceal the results of an unfavorable study concerning the effectiveness of the expensive cholesterol drugs. In January 2008, Merck and Schering-Plough released the results of the study and were criticized for not releasing it in 2006 when the findings had been completed. The study showed that Zetia and Vytorin were less effective in fighting plaque build-up in the neck than the older, much cheaper drug Zocor. Later studies have called into question Zetia and Vytorin’s effectiveness and safety in comparison to the older cholesterol drugs. In addition to the $5.4 million, the drug companies must do the following: obtain preapproval from the FDA for all DTC advertisements, comply with FDA suggestions to modify their drug advertising,register their clinical trials and post the trials’ results, reduce the possibility of conflicts of interest involving external Data Safety Monitoring Boards for company-sponsored trials,and comply with other detailed rules to prevent the deceptive use of clinical trial results.
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