Bextra recall focuses light on painkillers
After Bextra recall last week, the spotlight is back on all Cox-2 drugs, including Celebrex, which will now carry a black box warning. Apart from numerous stories in the print and online media, the television stations are highlighting the drug recalls. The "Four Corners" program on ABC in Australia is similar to the Dateline (on NBC) in the United States. No wonder then that the TV station did an excellent program on Vioxx recall (and the decision to ban Bextra, as well as the controversy surrounding Celebrex). (Related article: Bextra banned worldwide)
Jonathan Holmes, the reporter for Four Corners, reports that as many as 300,000 Australians used Vioxx before it was recalled in September of 2004. Professor Les Cleland, of the Royal Adelaide Hospital in Australia, who has analyzed the data (along the lines of the analysis by Dr. David Graham), disclosed on the program that Vioxx has caused more than 1,000 cases of personal injury in Australia, with up to 300 Australians dead. In the United States, as many as 140,000 injuries are attributed to Vioxx. Holmes writes, "...in Australia, where high doses of Vioxx were never authorised, itÂ’s feared the number of dead and injured might dwarf the toll of Australian life in the Bali bombings." Like the United States, where Vioxx class action lawsuits have exploded, Australian victims are also considering Vioxx litigation against Merck.
The Vioxx controversy has been a big story in Australia and the number of deaths has led to widespread condemnation of both Merck and and Therapeutic Goods Administration (TGA). Holmes says, "...few questions are being asked in Australia about the role of our regulator, the Therapeutic Goods Administration, which is entirely funded by fees from drug companies." While the FDA is not 100% funded by drug companies, a large portion of the budget does come from American drugmakers through user fees. The drugmakers also employ as many as 600 lobbyists who try to influence decision making at the FDA.
The program invited Pfizer to participate but Pfizer's office in Australia declined a request for an interview saying that, "...it may prejudice our application for a Ministerial review." "Ministerial review" in Australia means that since Pfizer does not agree with the conclusions of the Therapeutic Goods Administration in the case of Celebrex and Bextra, it is asking for a review of the decision.
Pfizer also continues to stand by the safety of Celebrex, arguing that it is no more dangerous than other painkillers. In a letter to the TV station, it says, "...it is important to note that just one published study shows a potential adverse CV effect - and that was at four times the usual dose used in Australia...The cardiovascular safety of Celebrex has been specifically studied to a much greater extent than traditional NSAIDs."
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