Vioxx made heart warnings softer

SENIOR staff at pharmaceutical giant Merck & Co sought to make "more palatable" a recommended warning by the government drugs regulatory body against the long-term use of Vioxx by people with a history of heart conditions.

SENIOR staff at pharmaceutical giant Merck & Co sought to make "more palatable" a recommended warning by the government drugs regulatory body against the long-term use of Vioxx by people with a history of heart conditions.

The Federal Court heard the Australian company's regulatory affairs manager emailed his US boss to workshop product information amendments requested by the Therapeutic Goods Administration, after a study raised cardiovascular concerns about the anti-arthritis drug.

Warren Back of Merck Sharp and Dohme emailed Bea Loran in October 2001 to work out how to negotiate the three revisions urged by the Australian Drug Evaluation Committee, an offshoot of the TGA, which included a warning on increased heart attack risks for long-term patients.

The amended warning request followed the release of the Vigor study in 2000, which found patients on Vioxx experienced increased cardiovascular events compared with another drug.

The class action against Merck & Co was told yesterday that Ms Loran - who Mr Back referred to as a "labelling scientist in the US" - asked Mr Back whether they could argue against including this line in the product information because there was no "justification" on the available clinical data.

"The CV sentence is probably a bit more difficult ... do you think we have a chance to argue against the inclusion of such wording ... ?" she wrote in the email, which was read to the court by counsel acting for the plaintiff, Julian Burnside.

The court heard Mr Back's response was that it would be hard to argue their case against the inclusion of a sentence which warned against the long-term use of the drug. Rather, "we should try to play with the wording to make it more palatable", he said, according to Mr Burnside.

On the witness stand yesterday, Mr Back admitted the company "pushed back" on the wording of the suggested warnings by the TGA in the product information, which was aimed at doctors.

"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.

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.

The trial continues.