Wednesday, April 15, 2009

Merck - Vioxx: never mind the bollocks here's the cheatsheet


SALES representatives for pharmaceutical giant Merck&Co were given line-by-line instructions on how to convince concerned doctors that possible links between anti-arthritis drug Vioxx and heart attacks were simply "bollocks".

In a rare insight into the aggressive strategies used by international drug companies to market their products, documents tendered to the Federal Court reveal Merck armed its sales team with "objections handling" cards to deal with any concerns over the safety of Vioxx, despite research showing an increased risk of cardiovascular problems.

The company allegedly used role playing, in which sales staff would act as doctors, to practise rote-learned responses to any difficult questions raised by GPs.

According to evidence given yesterday by marketing expert Robert Donovan (pic), sales staff were given instruction cards from which to memorise the company-authorised response.

"Doctor, I can understand your concern, however, let me reassure you that when you consider all of the available data, there is no difference in cardiovascular events between Vioxx and placebo," read one instruction card, according to Professor Donovan, who inspected the marketing documents.

"Vioxx is an appropriate and efficacious therapy for your patients with osteoarthritis ... Vioxx can be used in patients at risk of cardiovascular disease," the card allegedly said.

The alleged marketing tools were revealed as part of a class action against US company Merck and its Australian subsidiary Merck, Sharpe and Dohme for compensation.

Lead plaintiff Graeme Peterson and more than 1000 Australians claim Vioxx caused them to have a heart attack or stroke. They also claim Merck played down the risks of the drug before it was withdrawn in 2004 for safety reasons.

Vioxx was launched in 1999 and at the height of its popularity was used by 80 million people worldwide because it did not cause stomach problems as traditional anti-inflammatory drugs did.

Merck last year settled thousands of lawsuits in the US over the effects of Vioxx for $US4.85billion but made no admission of guilt. The company is fighting the class action in Australia.

Professor Donovan said in his witness statement, tendered in court, that Merck conducted a highly sophisticated and well-resourced marketing campaign that was able to "minimise" the awareness of safety risks of Vioxx.

"Merck appears to have rigorously trained its sales representatives to ... convey the message that there was no increased cardiovascular risk associated with Vioxx," he said. "The tenor of all training provided to sales representatives was that the cardiovascular risk was simply non-existent ('a myth', 'bollocks' ...) and likely to be promulgated by their competitors. This enabled Merck representatives to internalise the idea that the cardiovascular risk was not a real risk that doctors needed to be aware of, but an unfounded objection that needed to be handled with correct(ive) scientific information."

Professor Donovan, called by the plaintiff, said a key part of the sales representative training was how to handle objections from customers. "Considerable effort was put into anticipating the potential objections that doctors might raise and crafting a ... convincing response," he said.

The Curtin University professor of behavioural research said an example was a sales aid Merck developed called the "cardiovascular objection handling card", in the wake of research in 2000. The research, known as the VIGOR study, found Vioxx did decrease stomach problems but caused more heart attacks compared with another anti-inflammatory drug.

Professor Donovan said the cards instructed sales representatives to provide "perspective" to concerned doctors on the increased heart attack "myth" results from the VIGOR trial.

"The use of the word 'myth' removes any basis for the sales representatives to consider the merits or otherwise of contrary information about cardiovascular-adverse events," Professor Donovan said. "It also suggests that the cardiovascular concerns are not founded on any scientific or substantial evidence - they are simply untrue."

He said his inspection of Merck's marketing material also revealed the company broke down its target market of GPs in three groups: younger male, younger female and older male. It then tailored its sales pitches around the groups.

"The Merck marketing plan was comprehensive, highly sophisticated and well-resourced," the professor said. "The Merck marketing campaign throughout the period of time that Vioxx was available in Australia was highly effective in promoting the message that Vioxx was a safe drug."

Counsel acting for Merck, Peter Garling, questioned Professor Donovan on how much marketing experience he had in the field of pharmaceuticals.

The trial continues.

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