"The company didn't believe (the warning) was supported by the data," he said.
When Mr Back, who is now the company's associate director of regulatory affairs, was asked by Mr Burnside who the warnings had to be made "palatable" for, he said it was for Ms Loran (a Merck marketing exec in the U.S.).
The court heard that the TGA finally accepted the revisions in November 2001 after Merck successfully changed the warning from Vioxx-specific to just referring to the class of drug.
Lead plaintiff Graeme Peterson, representing more than 1000 other Australians, claims Vioxx caused his heart attack in 2003. He is suing Merck & Co and Merck, Sharp and Dohme for compensation."
For excellent discussion of the issues, take a look at Concurring Opinion for its discussion of "mercketing". And for the particularly serious problem of pharmaceutical companies like Merck's ghost-writing medical literature, see Sergio Sismondo's Ghosts in the Machine.
Thanks to Mass Tort Litigation blog for the tips on Concurring Opinion and Sismondo.