Data suggesting users of Vioxx could be at increased risk of heart problems within 4 months

Posted February 22, 2005 · February 22, 2005

http://money.cnn.com/2005/02/07/news/fortune500/merck.reut/index.htm?cnn=yes

Merck had early Vioxx warning?WSJ: Records show safety committee had data showing users could develop heart problems in 4 months.February 7, 2005: 6:38 AM EST

NEW YORK (Reuters) - Records from Merck & Co. Inc. show that a committee monitoring the safety of arthritis drug Vioxx in a clinical trial had early data suggesting users could be at increased risk of heart problems after as little as four months, the Wall Street Journal reported Monday.

Merck (Research) was forced to withdraw its blockbuster arthritis treatment last year after a long-term clinical trial showed it doubled the risk of heart attack and strokes in patients who had taken it for over 18 months to prevent recurrence of colon polyps.

The newspaper said that notes from the meetings of the external committee show that from their first meeting, members were watching the "concerning nature of the trends" about Vioxx's possible effects on heart attacks and strokes.

According to the article, the records show the committee kept the trial going in hopes of seeing if Vioxx might be effective in reducing colon polyps.

The Wall Street Journal said that Joan Wainwright, Merck's vice president of public affairs, said in a written statement the committee "provided the exact kind of oversight and monitoring of patient safety that is needed in a clinical trial and met its professional and ethical responsibilities in raising safety concerns when it did."

The article also said the records show that the five-person committee included one Merck employee and two doctors who had done consulting work for Merck.

In a statement to the paper, the Merck spokeswoman said that any suggestion that committee members "lacked independence and acted inappropriately" is "wrong and not supported by the facts."