MERCK, FDA BATTLED OVER LABEL
September 30, 2005 03:35

Fearing a warning about Vioxx's cardiac risks would hurt the painkiller's sales, Merck & Co. battled with federal regulators for two years to keep the information out of the "warnings" section of the package insert, the company's top marketing official testified. Under questioning by plaintiff's attorney & ATLA member Chris Seeger, David Anstice acknowledged Merck forecast a $500 million drop in sales for the $2.5 billion-a-year blockbuster drug if Merck lost its bid to instead put information about heart attack risks in the insert's less-urgent "precautions" section. It was during those negotiations between Merck and the Food and Drug Administration that Frederick "Mike" Humeston suffered a heart attack, two months after he began taking Vioxx, said Seeger. Merck prevailed on the label issue, but withdrew the drug from the market last September.

Alzheimer's disease patients who took Vioxx in two studies had higher death rates than those on a placebo, but Merck & Co. never notified physicians or its sales representatives, its former chief scientist conceded in testimony played in court. Edward Scolnick, former president of Merck Research Laboratories, said under questioning by a lawyer for a postal worker suing the Vioxx maker that doctors prescribing the popular arthritis drug should have been told about the data in 2001. http://www.sfgate.com/cgi-bin/article.cgi?f=/n/a/2005/09/27/financial/f165812D19.DTL&feed=rss.news