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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
*****
"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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