Healthy Skepticism Library item: 15361
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
Hagan K.
Firm denies drug cover-up
The Advertising Age 2009 Mar 30
http://www.theage.com.au/national/firm-denies-drug-coverup-20090329-9fkp.html
Full text:
A US drug company and its Australian subsidiary will fight claims they covered up an increased risk of cardiovascular problems, including heart attack and stroke, attached to their anti-arthritis drug Vioxx, in a class action due to begin in the Federal Court today.
About 300,000 Australians used Vioxx until Merck Australia withdrew it from sale in September 2004. Its US parent company, Merck Inc, one of the world’s largest pharmaceutical companies, issued a global recall.
In the US, Merck Inc agreed to pay $US4.85 billion in 2007 to settle 27,000 lawsuits with people who said Vioxx had led to their heart attack or stroke, but has not admitted fault.
An employee of the US Food and Drug Administration has estimated that Vioxx caused between 88,000 and 139,000 heart attacks, 30 to 40 per cent of which were probably fatal, in the five years the drug was on the market.
In the first Australian trial over Vioxx, law firm Slater & Gordon is suing on behalf of every person who suffered cardiovascular conditions, including heart attack and stroke, after completing one or more prescriptions of Vioxx between June 30, 1999, and the drug’s 2004 recall.
The group includes more than 1000 people, some of whom have died. Lead claimant Graeme Peterson, 58, suffered a heart attack in 2003 after taking a single 25-milligram Vioxx tablet daily between May 2001 and September 2004.
A statement of claim filed with the Federal Court alleges that Merck Australia failed to have regard to research showing an increased risk of heart attack and stroke associated with Vioxx.
It says the drug company instead ran a marketing campaign targeted at doctors and pharmacists claiming the drug did not increase the incidence of adverse cardiovascular events.
The statement of claim alleges that any information given by Merck Australia about a heart attack risk was “incorrect, misleading, exaggerated and unreliable”.
In its defence filed with the court, Merck says Australia’s regulatory agency, the Therapeutic Goods Administration, had been “satisfied of the quality, safety and efficacy” of Vioxx in granting approval for its registration for the treatment of osteoarthritis in 1999, and rheumatoid arthritis in 2002.
Merck says it did not owe claimants a duty of care “by virtue of compliance with the relevant legislative requirements imposed on it by the TGA”.
The company denies it had any scientific or technical knowledge that Vioxx increased the risk of heart attack or stroke.
