IT started with "a cunning plan".
In 1999, an email was sent by an Australian employee of pharmaceutical giant Merck & Co with an idea to bring a Vioxx-friendly expert from the US to spruik the company's new anti-arthritis drug, but who would pose at a seminar for doctors as an independent scientist.
The plan, according to the email tendered in the Federal Court class action against the company, was to get an expert who "favours" Vioxx to run an independent education session for medical specialists about the next generation of anti-inflammatory drugs.
The expert needed to be "street smart" enough to "drop a few concerns" about Merck's rivals Searle and Pfizer and their products.
"Hi Warren (do people call you Wozza?), We have a plan, a cunning plan," Merck associate product manager Russell Powter writes in the email to the company's senior regulatory affairs associate, Warren Back.
"Yes, it is a cocky idea, but I want to know if it will be a foolish idea. There will be no mention of Vioxx ... in any of the materials and the speaker will be just an American with real experience. BUT does this hurt the approval process from your point of view? Are there any things we should be cautious about?"
In a response dated June 4, 1999, Mr Back states that he thinks they can get away with the scheme in the lead-up to the Australian launch of Vioxx as long as they do not mention the specific drug too much during the so-called education sessions.
"Yes, people do call me Wazza," he writes. "I have discussed your cunning plan with Judith. We both feel that it should be OK ... so long as the presentation is not totally biased, both rofecoxib (Vioxx) and celecoxib (the opposition drug Celebrex) are mentioned together... and the trade name use is kept to an absolute minimum, then there should be no regulatory issues."
Mr Back also writes that much to the chagrin of the company's marketing team, the "takeaway material" given out at the seminar should be scientific articles rather than promotional articles. "I know this will hurt marketing people," he says.
The extraordinary email was one of dozens of documents tendered by the plaintiff in a class action against the US company Merck & Co and its Australian subsidiary Merck, Sharpe and Dohme and released to the public yesterday.
Lead plaintiff Graeme Peterson - along with more than 1000 other Australians - claims the anti-arthritis drug caused him to have a heart attack in December 2003. He also alleges the company played down the risks of cardiovascular problems that the drug caused in the years leading up to its voluntary recall in 2004.
Vioxx was launched in 1999, and at its height was used by 80million people worldwide because it did not cause stomach problems as did other anti-inflammatory drugs.
Concerns began emerging about Vioxx when research conducted in 2000 - known as the VIGOR trial - found the drug carried an increased risk of heart attacks and strokes compared with another anti-inflammatory drug. A later clinical trial testing these potential side-effects was aborted for safety reasons a few years later and the drug was voluntarily taken off the market.
Merck has already settled thousands of lawsuits in the US over the effects of Vioxx for $US4.85 billion, but has made no admission of guilt. The company is fighting the class action in Australia. This is the first time details of its Australian marketing strategies have been revealed.
The evidence put before the Federal Court this week by the plaintiffs focused on the marketing techniques used by Merck to promote Vioxx when it was launched, and the lengths it went to convince doctors there were no cardiovascular risks associated with the drug.
Marketing expert Robert Donovan, from Curtin University, testified - both in his witness statements and again during cross-examination by lawyers for Merck - that the company trained its sales staff to repeat a mantra that the link between the drug and increased risks of heart attacks were "non-existent".
He said that his inspection of internal marketing documents revealed staff were given line-by-line instructions, known as "objections handling cards" on how to deal with any GP concerned about the drug. "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," Professor Donovan said in his witness statement. "Considerable effort was put into anticipating the potential objections that doctors might raise and crafting a ... convincing response."
The plaintiff's claims of "fierce" marketing techniques used by Merck in Australia were supported by scores of internal documents they tendered to the court. The emails, training manuals and newsletters give a rare insight into the internal workings of a big pharmaceutical company, from the launch of a blockbuster product through to its recall.
"Objective: to minimise potential adverse publicity and maintain credibility of both Vioxx and MSDA (Merck Sharpe and Dohme Australia), by pro-active, low-key contact with key audiences," one document says.
Titled "VIGOR issues management plan", the 2001 document lists the potential impacts of the US Food and Drug Administration's negative review of Vioxx in the wake of the VIGOR results and how to cope with negative publicity.
It advises that approaches to doctors and specialists by Merck staff "should be kept low-key and casual" and even suggests an "external script" for staff.
"MSD staff to advise selected external audiences of the overarching message directly by phone," it reads. "To be pitched as a routine update and courtesy call, keeping the tone light, friendly and casual ... 'you may have seen a lot of press, just wanted to ..."'
The plan goes on to list recommended "key opinion leaders" to be briefed by sales representatives who are instructed to "not proactively highlight" the adverse drug reactions. The list includes "bureaucrats"; the Therapeutic Goods Administration and the Adverse Drugs Reaction Advisory Committee, "patient groups"; the Australian Arthritis Foundation and Consumers Health Forum and even the "government/opposition"; John Neros (from then federal health minister Michael Wooldridge's office).
Another internal document dated November 2001 tells staff that the primary goal in the face of "negative publicity" about Vioxx and its class of anti-inflammatory drugs is to restore the confidence of doctors in prescribing Vioxx.
"To counter this we have put together a comprehensive campaign ... which includes advertorials in various journals and mailings to doctors and pharmacists," writes Merck employee Melissa Pryor.
The documents before the court, seen by The Australian, do not detail whether the "cunning plan" thought up by the two Australian Merck employees ever materialised. Professor Donovan testified that the documents tendered this week reveal an alarming "mindset" of the way the pharmaceutical giant marketed its products and trained its sales representatives.
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