Merck could have found out Vioxx risks earlier

The New York Times (NYT) is reporting that Merck does not tell the truth when it is not convenient for it in the Vioxx recall case. The paper is reporting that "...(Merck) was poised to begin a major cardiovascular study of the drug in 2002, and abruptly dropped the project just before it was set to start. The trial was scheduled to produce data by March 2004 but may have provided answers about Vioxx's risks even earlier if patients had shown ill effects." (Related article: Merck knew of Vioxx side effects, according to WSJ)

Merck recalled Vioxx on September 30, 2004 when it was found that it increased the risk of heart attacks. As many as 140,000 Americans alone are estimated to be injured by Vioxx. Merck consistently acted to make sure that bad news about Vioxx was never researched or if anything bad came up, it never got published. The company threatened Dr. Gurkipal Singh, an adjunct professor of medicine at Stanford University, when he started to investigate side effects of Vioxx. It also forced a Merck scientist to withdraw her name from a published paper linking Vioxx to heart attacks according to Drs. Daniel Solomon and Jerry Avorn of Boston's Brigham and Women's Hospital who were collaborating with Merck on the study. (Related article: Will Vioxx recall bankrupt Merck?)

According to the documents reviewed by The Times, Merck had done a lot of work in preparation to start the study but abandoned it. It is not clear why Merck did so. NYT quotes from an internal Merck memo that announced the stop of the study, "...upper management is in the process of reviewing the various study options."

What makes this analysis by The Times intriguing is that work on the Valor trial was abandoned at a time when both the FDA and Merck were trying to figure out if Vioxx label needed to be changed to reflect higher cardiovascular risk, as concluded from the so-called VIGOR study.

Since Vioxx litigation started, newspapers and Vioxx lawyers have been able to get access to thousands of internal Merck documents. At the same time, due to the pending investigations and legal proceedings, the company is very guarded in its response and can conveniently refuse to answer questions from reporters citing legal proceedings. But it is obvious that as the Vioxx class action lawsuits proceed forward, Merck executives will have no choice but to tell the truth. Even Merck CEO Raymond Gilmartin will be deposed in the court and tell the inside story of how Merck continued to market Vioxx to millions of people worldwide when many in the company clearly knew that something was not right.

In a related story, Pfizer, the maker of Celebrex, is doing something similar. For instance, it has decided to exclude data from independent agencies in arguing that Celebrex is a safe drug. (Related article: Pfizer reaffirms Celebrex safety) Similarly, it is not submitting any data on Bextra, which has been banned by Kaiser Permanente due to safety concerns, arguing that there is no need since it is similar to Celebrex.

Recommended article: Tens of thousands of Vioxx class action lawsuit plaintiffs