Thais
Joined: 07 Aug 2004
Posts: 1000
Location: UK Joined: 07 Aug 2004Location: UK
Posted: Sat Feb 26, 2005 10:02 am Post subject: Vioxx back on the shelves
The decision last Friday by the FDA, America's drug regulator, to allow the COX-2 painkiller Vioxx back on the shelves after it had been voluntarily withdrawn by the manufacturer will surprise some.
It is even more surprising after hearing the evidence put to the expert panel. Even the panel's chairman Dr Alastair Wood didn't sound too happy about letting the drug back on the list. "It's important to recognize that this is a far larger randomized safety signal than we have seen from any of the drugs that have been withdrawn for safety reasons," he said in summarizing the evidence put forward during the three-day hearing. "The committee needs to act in a way that limits the hazard to patients."
As expected, drugs 'whistleblower' Dr David Graham came up with the most compelling evidence to keep Vioxx off the market - with the suggestion that other COX-2 drugs such as Celebrex and Vextra should also be withdrawn. "There's a 1-in-50 chance that a male aged 65 to 74 will have a heart attack this year. Increase that five-fold with high doses of Vioxx," he told FDA advisers.
Despite the damning evidence and the hesitancy of the chairman, the committee recommended that Vioxx be reinstated.
Why?
It might have something to with the fact that Merck, Vioxx's manufacturer, was making noises that it was going to bring back the drug anyway. Clearly the FDA didn't relish a showdown with the drug giant.
In its defence, Merck stated: "Since we withdrew Vioxx from the market, the science has continued to evolve and new data on some of the alternative therapies have become available."
Opaque?
Let us translate. "If you insist we keep Vioxx off the market, we'll blow the whistle on the other drugs that are equally as dangerous. So how lucky are you feeling, punk?" would seem to be roughly what they were saying.
And that's why Vioxx is available from your friendly family doctor today. VIOXX: Why it's back on the shelvesThe decision last Friday by the FDA, America's drug regulator, to allow the COX-2 painkiller Vioxx back on the shelves after it had been voluntarily withdrawn by the manufacturer will surprise some.It is even more surprising after hearing the evidence put to the expert panel. Even the panel's chairman Dr Alastair Wood didn't sound too happy about letting the drug back on the list. "It's important to recognize that this is a far larger randomized safety signal than we have seen from any of the drugs that have been withdrawn for safety reasons," he said in summarizing the evidence put forward during the three-day hearing. "The committee needs to act in a way that limits the hazard to patients."As expected, drugs 'whistleblower' Dr David Graham came up with the most compelling evidence to keep Vioxx off the market - with the suggestion that other COX-2 drugs such as Celebrex and Vextra should also be withdrawn. "There's a 1-in-50 chance that a male aged 65 to 74 will have a heart attack this year. Increase that five-fold with high doses of Vioxx," he told FDA advisers.Despite the damning evidence and the hesitancy of the chairman, the committee recommended that Vioxx be reinstated.Why?It might have something to with the fact that Merck, Vioxx's manufacturer, was making noises that it was going to bring back the drug anyway. Clearly the FDA didn't relish a showdown with the drug giant.In its defence, Merck stated: "Since we withdrew Vioxx from the market, the science has continued to evolve and new data on some of the alternative therapies have become available."Opaque?Let us translate. "If you insist we keep Vioxx off the market, we'll blow the whistle on the other drugs that are equally as dangerous. So how lucky are you feeling, punk?" would seem to be roughly what they were saying.And that's why Vioxx is available from your friendly family doctor today.
Drug maker Merck & Co. was found liable for a person's death concerning the use of the pain medication Vioxx, according to a jury verdict in a Texas court.  

The plaintiff's case, headed by the widow of Robert Ernst, who died in 2001 of an irregular heartbeat and of clogged arteries while on the drug Vioxx, was successfully awarded $253.4 million dollars.  Vioxx was pulled from the shelves in 2004 after a study discovered it could double the risk of a heart attack or stroke if taken for longer than 1.5 years. However, the US government agency, the FDA, decided in February of this year to allow the product back on the shelves.

Merck's stock price dropped 10% within minutes of the verdict being announced, and continued to fall hours after. There are in excess of 4,200 other Vioxx-related lawsuits pending across the USA. 

The company plans to appeal the decision.