Vioxx Milestones on the Path to Withdrawal

Merck Ignored Vioxx Studies, FDA Expert Slighted

Merck's voluntary withdrawal of Vioxx from the market has spurred a plethora of news articles and editorials, but the voice of Dr. Eric J. Topol has brought to light some disconcerting facts about Vioxx. Dr. Topol, chairman of cardiovascular medicine at The Cleveland Clinic, has 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, he says, 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.

Dr. Graham was involved with a research project that studied the records of 1.39 million Kaiser Permanente patients. The study found that high doses of Vioxx, known as rofecoxib, tripled risks of heart attacks and sudden cardiac death. Dr. Graham was scheduled to present those findings in late August during an epidemiology conference in France, but said he ran into resistance when the FDA reviewed his abstract and the conclusion Dr. Graham presented in France was revised due to pressure.

An editorial in The Wall Street Journal on October 7, 2004 by Dr. Marcia Angell of Harvard Medical School says "The fact that Vioxx probably increased the risk of heart attacks and strokes was known for three years but Merck downplayed it and did not undertake sutdies to settle the matter, while the FDA sat on its hands.

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