Integrity Matters
December 1 , 2004

Vioxx case undermines trust of Merck

Question: (E-152)

Dear Jim:

How can Merck rightfully claim it withdrew the cardiac medication Vioxx based upon "unexpected" new findings on Sept. 30 when its own internal documents show it knew Vioxx had adverse cardiovascular effects dating back to 1997?


The questions are predictable: What did they know and when did they know it? A friend of mine offered this insight: "You may not always be able to make money on integrity, but you can lose a great deal without it." Billions of dollars lost by investors through the resulting stock market price drop are a clear signal that many people have lost trust in Merck's integrity. What caused the leadership of Merck to move slowly, possibly even self-serving manner? Was it greed? Was it arrogance? Was it irresponsibility?

Let's take greed first. Vioxx was launched in the United States in 1999 and has been marketed in more than 80 countries.

Worldwide sales of Vioxxin 2003 were $2.5 billion. By the time it was withdrawn, an estimated 80 million people worldwide had taken the drug. A memo posted Nov. 2 on the U.S. Food and Drug Administration's Web site suggests Vioxx may have contributed to almost 28,000 heart attacks in the United States between 1999 and 2003.

What about arrogance? On Sept. 30, the Merck pharmaceutical company issued a worldwide recall of Vioxx, halting its sales in light of unequivocal results from a clinical trial demonstrating that it greatly increases risk of heart attack and stroke over the long term. "We are taking this action because we believe it best serves the interests of patients," said Raymond V. Gilmartin, chairman, president and chief executive officer of Merck. "Although we believe it would have been possible to continue to market Vioxx with labeling that would incorporate these new data, given the availability of alternative therapies, and the questions raised by the data, we concluded that a voluntary withdrawal is the responsible course to take."

Then there's irresponsibility. Merck's response that they only recently learned of the risks of Vioxx will be challenged, seriously and globally. On Oct. 5, Kenneth B. Moll & Associates, Ltd. filed the first worldwide class-action lawsuit against Merck, on behalf of all persons who were prescribed Vioxx. From there is a report that Vioxx posed heart risks for years before Merck took action to remove it. Scientific evidence of increased heart attack risk associated with Vioxx was available as early as 2000, according to Swiss scientists.

Integrity is the backbone of medical care, including the products and services available to the public.

This case has already shaken confidence in the pharmaceutical industry. Merck, if guilty of malfeasance, might set back society's trust in the delivery of medicine and pharmaceutical company promises for a long, long time.

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