Case shines light on Merck

WARREN Back received his instructions by telephone at 5.30pm on September 29, 2004, sitting in his nondescript hotel room in the US city of Philadelphia.

WARREN Back received his instructions by telephone at 5.30pm on September 29, 2004, sitting in his nondescript hotel room in the US city of Philadelphia. He was told to collect a series of envelopes and distribute them to his international colleagues who had already gathered in the hotel for a conference, and keep one for himself.

Inside his envelope was a typed message telling him to go back to his hotel room and wait by the phone to receive a call from his superiors. He took the call two hours later and was stunned by what he heard.

This may sound like an elaborate plot of a spy thriller but Back was no CIA agent and he was not trading state secrets. Back was the Australian regulatory affairs manager for pharmaceutical giant Merck & Co and he was being informed that its blockbuster anti-arthritis drug Vioxx was being voluntarily recalled amid concerns it could increase the risk of heart attack.

These precautions, bordering on the clandestine, are indicative of the determination with which Merck & Co went about marketing, promoting and selling Vioxx, which at one point was used by more than 80 million people. More alarming, however, was the way the drug company dealt with obstacles that stood in the way of selling Vioxx and meeting its profit target.

The fairly sterile courtroom 6A at the Federal Court building in Melbourne has been witness for the past three months to a class-action civil trial involving stories of extraordinary marketing tactics and a cast of colourful characters who developed, promoted, protected and, most important, believed in Vioxx.

Lead plaintiff Graeme Peterson, acting on behalf of every Australian who took the drug from its launch in 2001 to its voluntary recall in September 2004, claims that Vioxx contributed to his heart attack in December 2003. He also alleges Merck & Co and its Australian subsidiary, Merck, Sharp and Dohme, knew about the cardiovascular risks of the drug and covered it up.

It is the first civil trial against the pharmaceutical giant outside the US and has been keenly watched by lawyers across the world. The evidence put by both sides and the final outcome of the case will have implications on any potential legal action elsewhere. Merck contends there is no direct medical way of proving its drug could have contributed to a heart attack and there is no marker that it did in Peterson's case.

Merck settled hundreds of lawsuits over Vioxx in the US for $US4.8 billion in late 2007 but did not admit any liability. Its hired PR guns, who briefed reporters during the early days of the Melbourne trial, claim the settlement occurred purely because of the unique and costly US civil law system, in which juries award compensation.

Therefore the company and its various subsidiaries across the world are prepared to fight every case outside the US, including the Australian civil action, claiming there is no definitive scientific proof that Vioxx caused heart attacks. It also says the marketing techniques were reasonable and based on all the available medical data the company had at the time.

The case has provided a rare peek behind the closed doors of pharmaceutical companies, revealing how they operate and what they will do to get doctors to prescribe their drugs to their patients.

There have been allegations of the creation of a hit list of doctors critical of the drug who needed to be "neutralised"; training sales representatives in a Men in Black-style workshop to overcome doctors' concerns that Vioxx caused heart attacks; paying nurses to pore through patient records to find potential candidates for the drug; coming up with "cunning plans" to promote Vioxx to doctors; and even faking a medical journal promoting the company's product.

Other evidence has included the production of educational videos hosted by television personality David Koch spruiking the drug to general practitioners; plans to give away $6million worth of drug samples in one year; bombardment of doctors with hundreds of visits from sales representatives; wining and dining experts in the field; writing songs ("Go Vioxx, go Vioxx, go Vioxx!!!") to Ricky Martin-style music to motivate sales staff; and setting up a patients' loyalty program to ensure "compliance" to the drug. They were revealed during the civil trial, which finished this week.

The uneasy relationship between pharmaceutical companies, doctors and researchers also was explored in the case, during which claims were made that Merck paid top scientists to put their name on in-house studies and arthritis specialists were compensated to promote Vioxx to doctors.

Not only is the case being covered in the Australian media but the trial also has been picked up by The New York Times, Britain's The Guardian and several mainstream medical journals.

Then you have the scores of industry blogs and websites. Some are doing daily updates of the case and lampooning Merck with pictures of movie and TV characters that bear resemblance to what is coming out in court (Blackadder sidekick Baldrick, who is known for his line, "I have a cunning plan", being one example). Another blog has even hatched a new term to describe the questionable marketing techniques allegedly used by the company: "Merckting".

Merck has a lot to lose in this case and the least of its worries is the financial cost. Compared with the multibillion-dollar payout in the US, any compensation in the Australian case would be a drop in the ocean. But as one of the biggest players in the pharmaceutical game, with scores of products on the market, including the cervical cancer vaccine Gardasil, it does not want any damage done to consumer confidence. It is doing everything it can to make sure it wins.

In the courtroom almost daily, behind its team of barristers headed by Sydney SC Peter Garling, sat an impressive number of lawyers from firm Clayton Utz acting for Merck. Mostly middle-aged men in dark suits, short hair and glasses, some tapped away on their laptops as proceedings unfolded before them. They also seemed to rise in number as the case progressed. At one point, when witnesses for Merck took the stand, there were as many as 10 men matching this description crowding their part of the courtroom.

They were joined in the early part of the trial by up to three PR executives who kept a close eye on journalists, often sitting next to the media. Reporters felt their notebooks were under view. Media releases and background statements were distributed on the day's evidence.

Complaining phone calls and letters to theeditor were also part of the strategy. After The Australian ran an expose on their activities in May, they all but disappeared from the courtroom.

The imposing legal team hired by Merck also tended to make the plaintiff's side of the courtroom look fairly sparse. The only consistent seat-filler on that side was Peterson or his wife, Julia, who dutifully came to court most days. Holding hands, whispering to each other as the drier legal points were debated around them, and often talking with Peter Gordon, who heads Slater & Gordon, the law firm representing the class action, the pair has been the one constant reminder of why everyone is there is the first place.

For at the crux of the case stands Peterson and what he has allegedly gone through. Whether Vioxx materially increased the risk of him having a heart attack is the key phrase in the plaintiffs' statement of claim. Peterson, in his witness statement, describes how frightened he was when he suffered his heart attack in December 2003.

"It was a horrifying feeling, like I'd been hit very hard in the solar plexus ... I was stunned and almost choking ... (I didn't) know whether I was going to live or die," he said in his statement.

"I tried to put a brave face on for my family, as I know they were very scared, even though I was very scared as well. My granddaughter came in to see me one day (in the hospital) and wouldn't let go of my hand, telling me I had to come home with her and not leave because she needs me."

But Peterson was a key candidate for a heart attack. In his 50s, a former smoker with weight issues, there is no doubt he fulfils all the risk criteria. Garling has argued it was just a matter of time before the 58-year-old former navy medic would have had a cardiac arrest. He says there is no evidence to say that Vioxx caused it over any of the other factors.

Garling told Federal Court judge Christopher Jessup in his closing address there was no discreet chemical signature left behind in the body to prove that Vioxx caused Peterson's heart attack. He also argued, after evidence from his expert witnesses in cardiology, that there was no medical mechanism to prove the drug causes cardiac arrests. There was no mark left on Peterson's damaged heart. This is a significant point in the case.

But two cardiologists testifying for the plaintiff provided a different view. They argued several medical conditions in the world could not be mechanically explained but still were accepted, including the link between smoking and lung cancer. Julian Burnside QC, acting for the plaintiff, argued there was enough scientific proof in Merck's own clinical trials of an association between Vioxx and increased heart attacks.

The other interesting evidence in the case has come from the Merck witnesses. It is not so much what they have said; rather, it is what they haven't. And who has been put on the stand and who has not.

Most of the key players involved with Vioxx - from the former head of Merck, Sharp and Dohme, Will Delaat, to the head of Merck's US research arm, Ed Scolnick - were nowhere to be seen.

The remaining Merck witnesses, especially the Australian staff, have all suffered from memory lapses. Back, marketing manager Penny Dobson, sales manager Keiran McAuley and US researcher Alise Reicin all stated they "could not recall", "can't comment on the specifics" or simply "couldn't remember" in response to key questions asked by the plaintiff's counsel about internal decisions on Vioxx. Their responses and the absence of other key employees have frustrated the plaintiff. Burnside said in his closing address that it was surprising that Dobson, in particular, "did not know much at all". He also stated Scolnick's absence from the witness box "was highly significant".

Delaat did in fact surface to defend Merck & Co during the trial, just in the wrong arena. He appeared on the SBS show Insight as the new chairman of Medicines Australia, defending his former employer. Delaat said Merck did nothing wrong and he could still sleep at night over his involvement with Vioxx.

"I worked for almost 20 years and I know the values of that company in putting patients and patient outcomes first. I think it's only fair to say that the company acted responsibly at all times," he told the program.

It is up to Jessup to decide on Merck's conduct. It will not be an easy task. He retired for deliberations this week and has to consider thousands of tendered documents and evaluate more than three months' evidence. He has to decide whether Vioxx materially increased the risk of Peterson's heart attack and whether Merck acted reasonably in its marketing efforts for the drug.

It's no pointer to an outcome, but Jessup has said in the last days of the case that drug companies were entitled to market their products and be "profit-driven".

Whatever the outcome, questions have been raised about the conduct of pharmaceutical companies in the marketing of their drugs. What used to be in the realm of popular fiction or conspiracy theorists about the behaviour of big pharmaceuticals has been alleged in the Federal Court as a reality. Merck & Co's slogan - "Where patients come first" - may invite scepticism.