Merck's VIOXX®

On September 30, 2004, Merck & Company announced the withdrawal of its popular and profitable COX-2 inhibitor VIOXX®. The same day, Etopia Media Medical News Network ran an audio interview with a spokesperson for Merck, discussing this recall.

Three days later, in "Etopia Media Medical News Network #18: VIOXX® risks have been known for years, other COX-2 inhibitors may be equally dangerous," this web site ran a follow-up article, based on an examination of online sources, that demonstrated both the fact that, and a possible mechanism by which, the COX-2 inhibitor rofecoxib (VIOXX) caused damage to the cardiovascular systems of those taking it.

Now, a month later, a vastly more-prestigious and well-known medical journal The Lancet, after a vastly more-expensive and more-thorough examination of the scientific literature on the question of VIOXX's safety, or lack thereof, has come to the same conclusion:

"Our findings indicate that rofecoxib [VIOXX] should have been withdrawn several years earlier. The reasons why manufacturer and drug licensing authorities did not continuously monitor and summarize the accumulating evidence need to be clarified."

The Lancet's complete report can be accessed by clicking here.

The full report concludes:

"If Merck's statement in their current press release that "given the availability of alternative therapies, and the questions raised by the data, we concluded that a voluntary withdrawal is the responsible course to take" was appropriate in September, 2004, then the same statement could and should have been made several years earlier, when the data summarized here first became available. Instead, Merck continued to market the safety of rofecoxib."

The Lancet had already, by October 7, 2004, in an editorial entitled "Vioxx: an unequal partnership between safety and efficacy," fiercely attacked both VIOXX-maker Merck and the FDA that was supposed to be regulating it, when it said:

"The Vioxx story is one of blindly aggressive marketing by Merck mixed with repeated episodes of complacency by drug regulators. We need clear statements from all parties in this sorry tale about the lessons to be learned. Without more vigilant drug regulation in the future, doctors will continue to be misled and patients' lives will continue to be endangered.”

Yesterday, in another editorial, entitled "Vioxx, the implosion of Merck, and aftershocks at the FDA," about the marketing of VIOXX by Merck in the face of what The Lancet had shown was known about its dangers, the influential, Elsevier-published journal used language even stronger than that of a month earlier, concluding:

"Why clinical investigators studying Vioxx did not do more to raise concerns is a fair question that needs to be answered. But in doing so, we must not diminish the importance of the covenant of trust that society has established with powerful commercial and governmental institutions. For with Vioxx, Merck and the FDA acted out of ruthless, short-sighted, and irresponsible self-interest."

Apparently, the editors at The Lancet were not the only ones looking into what Merck & Company knew and when it knew it. An account in the November 1, 2004, Wall Street Journal, here repeated in a BBC story entitled, "Merck shares dive on Vioxx fears," reports that there may be a "smoking gun" detailing how Merck continued to market VIOXX for years after it knew it was dangerous. According to the BBC article:

"The Wall Street Journal quoted internal company e-mails, including one from Merck's head of research Edward Scolnick in March 2000 to colleagues saying that cardiovascular problems with Vioxx 'are clearly there'."

Merck now faces an onslaught of medical liability lawsuits, a review of its credit by Standard and Poor's, which has threatened to lower its credit rating, and a falling stock price.

Defending itself against these charges, Merck issued a press release yesterday, entitled "Response to Article by Juni et al. Published in The Lancet on Nov. 5".