I have never been happy with the attack on Vioxx. It has focused mainly on “ad hominem” accusations against the company rather than on the medical evidence. Let me summarize that evidence briefly: Less than one half of one percent of people taking Vioxx get heart attacks and most of them are in frail health anyway. But that tiny rate of heart attacks is still 2 to 4 times greater than the rate observed with some other Cox2 inhibitor drugs. And here is the kicker: Even though Vioxx takers get more heart attacks, they DON’T DIE of them at a rate higher than that seen among patients on other Cox2 inhibitors.

The fact is that all Cox2 inhibitors have troublesome side-effects but the side effects differ somewhat. So patients and their doctors should have a choice: A patient not doing well on one Cox2 inhibitor might do well on Vioxx. But that option has now been taken away. A patient might well have been ready to accept the slightly elevated risk of a non-fatal heart attack in order to have their arthritic pain relieved without other side-effects

The blockbuster anti-athritis drug Vioxx doubled the risk of heart attacks and was not fit to be on the market for arthritis pain, a federal court judge has found. In a landmark decision, Justice Christopher Jessup this morning awarded compensation of $278,000 plus interest to Graeme Peterson, who claimed the drug caused him to have a heart attack in 2003. Mr Peterson sued US pharmaceutical giant Merck claiming he was no longer able to work because of the heart attack.

“I have concluded that across a population the consumption of Vioxx about doubled the risk of heart attack,” Judge Jessup said. “I have held that because Vioxx involved about a doubling of the risk of heart attack, it was not reasonably fit for the purpose of being used for the relief of arthritic pain.”

Mr Peterson, acting on behalf of every Australian who took the drug from its launch in 2001 to its voluntary recall in September 2004, claims that Vioxx contributed to his heart attack in December 2003. He also alleged in the three-month trial held last year that Merck & Co and its Australian subsidiary, Merck, Sharp and Dohme, knew about the cardiovascular risks of the drug and covered it up and engaged in inappropriate marketing tactics.

It was the first civil trial against the pharmaceutical giant outside the US after Merck settled hundreds of lawsuits over Vioxx in the US for $US4.8 billion in late 2007 but did not admit any liability.

The Federal Court case heard allegations that Merck created a “hit list” of doctors critical of the drug who needed to be “neutralised”; trained sales representatives in a Men in Black-style workshop to overcome doctors’ concerns that Vioxx caused heart attacks and writing songs (“Go Vioxx, go Vioxx, go Vioxx!!!”) to Ricky Martin-style music to motivate sales staff

Merck has announced that it will appeal the decision.

SOURCE

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