Merck knew of Vioxx side effects

Recently obtained records from Vioxx manufacturer Merck clearly indicate that a committee monitoring the safety of the drug in a clinical trial had early data pointing to higher risk of heart attacks after a mere 4 months, according to an investigation by The Wall Street Journal, a business publication. (Related article: Why Merck did not recall Vioxx earlier?)

Merck has consistently denied that it ever knew that Vioxx was a dangerous drug and was injuring arthritis patients. The company continues to maintain its innocence and has repeatedly claimed that it came to know of problems only during the last week of September 2004 and acted quickly to recall Vioxx on September 30, 2004. Many articles and reports since then have pointed out that Merck may not be telling the whole story. WSJ found last year that the company was actively training it sales staff to dodge questions from doctors about the safety of Vioxx. The company forced one of its scientists to withdraw her name from a study that showed a link between Vioxx and heart diseases. It also tried to attack anyone who would question the safety of Vioxx through aggressive direct-to-consumer advertising and hired consultants who defended the drug at medical conferences and in scientific journals. (Related article: Merck shows no sympathy for Vioxx victims)

It may be recalled that Merck with the active collaboration of the FDA used the fast track process to get Vioxx approved and now FDA scientist Dr David Graham says that Vioxx should have never been approved. Dr Eric Topol, highly respected cardiologist and an early critic of Vioxx and other Cox-2 drugs, has also argued that these drugs are simply not worth the risk that they pose to patients. Both Merck and its competitor Pfizer (the maker of Celebrex and Bextra) deny that Cox-2 drugs are a problem. (Related article: Update on other Cox-2 drugs like Arcoxia and Prexige)

The new documents will definitely strengthen the case of Vioxx patients who have been attacked by Merck as if they (and not Merck) are the problem. No wonder, Vioxx victims have had no choice but to join forces in class action lawsuits against Merck. Analysts expect that Vioxx class action lawsuits plaintiffs may run into tens of thousands since an estimated 140,000 Americans alone have been injured by Vioxx.

In Vioxx litigation developments so far, Merck has been arguing that Vioxx did not hurt even a single patient and those that are making any such claims already have an existing medical condition. Emergence of such evidence shows that Merck may have a lot of explaining to do in the courts.

Recommended article: Vioxx litigation update