December 1 , 2004
Vioxx case undermines trust of Merck
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
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By the time it was withdrawn, an estimated 80 million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 NewScientist.com
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.