Merck & Company was hit with a $253.4 million product liability judgement in the case of a Texas man who died from a Vioxx induced heart attack.
Merck has approximatley 4,200 more Vioxx cases pending around the country.
Vioxx, which was once a blockbuster painkiller for Merck was the subject of a voluntary withdrawal in 2004 long after it had conducted studies which showed that the use of the drug significantly increased the risk of heart attack.
Dr. Eric J. Topol, chairman of cardiovascular medicine at The Cleveland Clinic, laid the blame for leaving an unsafe drug on the market too long at the feet of Merck and the FDA.
“Neither Merck nor the FDA fulfilled its responsibilities to the public,” says Dr. Topol.
Merck needed to conduct a drug trial in patients with established coronary artery disease after the first in a line of studies started to appear in 2000 showing a link between Vioxx and risk of heart attack and stroke. The high coincidence of coronary disease and arthritis meant that more people with heart problems would be taking Vioxx. Instead of conducting that trial, Merck issued press releases and papers in peer-reviewed medical literature reconfirming the safety of Vioxx, sponsored symposiums for continuing education for medical professionals to debunk concerns, including those published by Dr. Topol. Furthermore, Merck spent more than $100 million per year in direct-to-consumer advertising for Vioxx during this period.
“The FDA should have stopped Merck,” says Dr. Topol.
The Food and Drug Administration has been accused of silencing one of its drug experts who raised safety concerns weeks before Merck withdrew Vioxx from the market.
Dr. David J. Graham of the FDA’s Office of Drug Safety told Senate investigators he faced resistance to his findings within the FDA and that instead of acting as a public watchdog, the Food and Drug Administration was busy challenging its own expert and calling his work scientific rumor.
Some experts have said Vioxx can increase your risk of heart attack and stroke by 50%.
JJT
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