Healthy Skepticism Library item: 15595
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Rout M.
Drug company claims were 'scientifically unsound'
The Australian 2009 May 7
http://www.theaustralian.news.com.au/story/0,25197,25441165-23289,00.html
Full text:
PHARMACEUTICAL giant Merck & Co put its patients at risk of heart attack by making “scientifically unsound” claims and corrupting studies about its blockbuster drug Vioxx, a leading arthritis expert told the Federal Court.
Royal Adelaide Hospital director of rheumatology Les Cleland, who was identified by Merck marketing staff as a Vioxx critic who needed urgent attention in 2004, said he believed the company “minimised” the risks of potential cardiovascular problems by skewing research.
Professor Cleland testified in the class action against Merck & Co that the company implausibly claimed a study that found Vioxx caused more heart attacks when compared with anti-inflammatory drug Naproxen could be explained by Naproxen having heart protect-ive properties rather than Vioxx being unsafe.
“The attribution of benefit to Naproxen and implied null effect of (Vioxx) with regard to the (cardio-vascular) risk was scientifically unsound and, by design or other-wise, had the effect of minimising or avoiding perceptions of CV risk associated with Vioxx,” he said in his witness statement, tendered to the court on behalf of the plaintiff.
“That this interpretation could have put patients at risk for CV events is obvious.”
Professor Cleland said he became concerned about the safety of Vioxx after the Vigor study came out in 2000. He started advising his patients not to go on the drug.
He said he also publicly expressed his fears in presentations to rheumatology conferences, in medical journal articles and by raising the issue in the media.
Professor Cleland said the “Naproxen theory” — heavily promoted by Merck in its Vioxx marketing material — was implausible because Naproxen had been around for 30 years and never been regarded as having cardio-protective properties.
Professor Cleland was testifying on behalf of lead plaintiff Graeme Peterson, who claims Vioxx caused him to have a heart attack in December 2003. The former navy medic and more than 1000 other Australians allege the US company and its Australian subsidiary knew about the increased cardiovascular risk of Vioxx and played it down in the lead-up to the drug being voluntarily recalled in 2004.
Another arthritis expert, called by the lawyers representing Merck, yesterday testified that the withdrawal of the Vioxx was not the “endpoint” of the debate over the safety of the drug. James Bertouch also said in his statement that the reason behind the increase in cardiovascular events revealed in the Vigor study was unclear.
The trial continues.
