Risk and Responsibility
The Roles of FDA and Pharmaceutical Companies in Ensuring the
Safety of Approved Drugs, Like Vioxx - Exerpt from opening statement of
Chairman of the Government Reform Committee Tom Davis on May 5, 2005
"… The Committee is here today to
discuss the roles of the Food and Drug Administration (FDA) and pharmaceutical
companies in ensuring the safety of approved drugs. More specifically, we will
examine the post-approval actions taken by FDA and Merck & Co., Inc.
(Merck) related to the arthritis and acute pain medication, Vioxx, and
highlight concerns arising from our investigation into the relationship between
offices within FDA's Center for Drug Evaluation and Research."
"This
Committee's investigation began after Merck's September 30, 2004, voluntary
world-wide withdrawal of Vioxx. The Vioxx recall came after 5 years on the
market, with Merck's annual sales for the drug topping $2.5 billion, and more
than 80 million patients having taken the drug. The decision to withdraw Vioxx
was made after Merck's own clinical study showed that 3.5% of Vioxx takers
suffered a heart attack or stroke, compared with 1.9% of patients taking a
placebo. That study followed an earlier study that showed a significant
disparity in heart attacks between those patients taking Vioxx and those taking
naproxen (commonly sold as Aleve). The earlier study had resulted in the use of
new labeling on Vioxx that had been in effect since April 2002." 
"This Committee's investigation began after Merck's
September 30, 2004, voluntary world-wide withdrawal of Vioxx. The Vioxx recall
came after 5 years on the market, with Merck's annual sales for the drug
topping $2.5 billion, and more than 80 million patients having taken the drug.
The decision to withdraw Vioxx was made after Merck's own clinical study showed
that 3.5% of Vioxx takers suffered a heart attack or stroke, compared with 1.9%
of patients taking a placebo. That study followed an earlier study that showed
a significant disparity in heart attacks between those patients taking Vioxx
and those taking naproxen (commonly sold as Aleve). The earlier study had
resulted in the use of new labeling on Vioxx that had been in effect since
April 2002."
"On April 7, 2005, after reviewing the recommendations of
the Advisory Committee, FDA asked Pfizer to remove Bextra from the market and
to include a "black box" warning on Celebrex. FDA made no official ruling or
recommendation regarding Vioxx since Merck voluntarily removed it from the
market."
"This brings us to why we are here today. Most average
Americans believe that once the FDA approves a drug, that drug carries the Good
Housekeeping Seal of Approval. If this were the case, there would be no need
for post-marketing surveillance of any drug. Due to the inability of any
company to enlist millions of people to participate in pre-approval trials, it
is imperative that deliberate post-approval surveillance takes place and that
doctors and pharmaceutical companies report to the FDA the adverse reactions of
drugs."
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"Our investigation also raised
questions about the FDA's role in ensuring the safety of drugs after formal
approval for sale to the public. Is there a need to strengthen FDA's role in
updating safety warnings of previously approved drugs? …"
"As the
Committee conducted its investigation, it became apparent that the relationship
between the Office of New Drugs and the Office of Drug Safety has it
challenges. It appears that a lack of communication between the offices, as
well as communication up the chain of command of these offices has contributed
to some discord within CDER (pronounced See-Der). We are pleased to have the
Directors of CDER, Office of New Drugs, and Office of Drug Safety here to
discuss the steps FDA is taking to address interaction and coordination between
the offices, including the creation of the Drug Safety Monitoring Board to
monitor post-marketing risks and benefits of drugs."
"… We are
here to ensure that FDA has taken the necessary actions to ensure better
communication between the Office of New Drugs and the Office of Drug Safety and
that the public is informed regarding the safety of drugs. Finally, we are
here to examine Merck's responsibility in informing physicians and the public
about the efficacy and safety of Vioxx."
© 2009 Drug-Free Alliance