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Heart death
painkiller research defended
"Merck acted responsibly and
appropriately as it developed and
marketed Vioxx. From the
beginning of the clinical
development program for Vioxx,
Merck conducted well- controlled
randomized clinical trials, which
we believe are the best way to
examine and establish the safety
and efficacy of a drug. The
results of these studies have
been published in peer- reviewed
major medical journals and
reviewed at two public FDA
Advisory Comm- ittee Meetings. We
are confident in our research and
in how Merck has communicated
about Vioxx since its approval to
this day.
"When questions arose about
the safety of Vioxx, Merck took
steps to investigate and address
these issues. The Company worked
diligently with FDA and the
regulatory authorities in other
countries to ensure that the
safety profile of Vioxx was
reflected appropriately in the
prescrib- ing information. Merck
believed that the prospective,
randomized, controlled clinical
trials that we undertook would
provide the data to further
evaluate the cardiovascular
profile of Vioxx. It was
precisely in this type of study,
the APPROVe trial, in which, for
the first time, there was an
increased risk of confirmed
cardio- vascular events beginning
after 18 months of treatment in
patients taking Vioxx compared to
those taking placebo. Within one
week of learning those results,
Merck acted in what it believed
was the best interest of patients
and voluntarily withdrew Vioxx
from the market."
- Merck UK
statement, issued November 4 2004
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"I
believe strongly in the need for
research to improve the quality
of patient care, and have
dedicated much of my professional
life to this goal, whilst
striving to bring a bal- anced
and objective viewpoint to my
work."
- Statement by Professor
Michael Langman, August 4 2005
*****
"The
Victor study is run to the
highest ethical and scientific
standards."
- Statement by Professor
David J Kerr, CBE, August 5 2005
*****
You
can contact Brian
Deer via this website, which
updates in the light of Vioxx
developments.
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