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Week-in-Review Editorial: Vioxx settlement does not settle

This week, Merck & Co paid USD 4.9bn to settle the many thousands of lawsuits filed over its painkiller Vioxx, which caused heart attacks or strokes in patients prescribed the drug

This week, Merck & Co paid USD 4.9bn to settle the many thousands of lawsuits filed over its painkiller Vioxx (rofecoxib), which caused heart attacks or strokes in patients prescribed the drug.

In an attempt to draw a line under the case in US state and federal courts, Merck & Co said it regarded the mass settlement as preferable to litigation continuing for years or decades.

Vioxx, an anti-inflammatory drug also sold under the brand names Ceoxx and Ceeoxx, was developed by Merck & Co to treat a number of conditions, such as acute pain, including osteoarthritis. The FDA approved the drug for the US market in May 1999 and was prescribed to millions of patients around the world.

On growing evidence that long-term use of Vioxx could increase the risk of heart attack and stroke, Merck voluntarily withdrew Vioxx from the market in September 2004.

The settlement, however, does not entirely rule out Merck & Co's own liability. Accusations have been made that the company concealed clinical data which could have halted injury and death, had it taken the drug off market sooner. All these incidents damage Merck & Co's public image, but more importantly raise questions about the effectiveness of regulatory strictures imposed by the FDA and other government health bodies.

The Vioxx case has cast into doubt the reliability of the FDA when it approves drugs for the market and when it should take action to protect the public when it appears an unsafe drug has been approved. The FDA has to take some of the blame, as it was Merck & Co rather than the FDA, which finally withdraw Vioxx.

The lack of transparency in the FDA regarding its relationship with the pharmaceutical industry has caused the US government to question its independence and effectiveness with regards to other drugs and food. The FDA's financial relationship with the pharmaceutical industry is also under scrutiny. And of course, it wasn't just the FDA, but other healthcare agencies across the globe also approved Vioxx.

While the pharmaceutical industry is trying to clean up its public image, global healthcare systems should also to be proactive and independent regarding the processes and regulations which protect the public from unsafe products.

In a risk-averse culture, this kind of event further damages the public perception of the "independent" relationship between government healthcare organisations and the pharmaceutical industry. The current upheavals in the market and the sky-rocketing costs of health provision signal the time to reassess what partnerships between stakeholders are actually supposed to achieve.

30th September 2008

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