Merck & Co has come under fire again, this time because safety records appear to show that the committee monitoring the safety of its now withdrawn pain drug, Vioxx (rofecoxib), had early trial data suggesting that patients were at an increased risk of suffering cardiovascular side effects as early as four months, according to industry reports.
Citing a Wall Street Journal article, Reuters yesterday claimed that committee records show members’ concern over the possible heart attack and stroke risk early on in the trial, and that they were closely monitoring the tendency. However, they did not halt the trial because they hoped data would determine whether Vioxx was in fact effective in preventing the recurrence of colorectal polyps. Merck withdrew Vioxx from the market last year after long-term clinical trial data showed that there was twice the increased risk of heart attack amongst those taking Vioxx, versus placebo [[01/10/04a]].
However, the company has defended its actions, and Joan Wainwright, vice president of public affairs at Merck said in a statement to the paper that the committee had “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.”