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In a move that surprised and shook up many people - from patients
to stock analysts -- Merck & Co. announced the withdrawal of
the popular anti-inflammatory drug Vioxx from the market late last
week due to a study that shows patients taking the drug face twice
the risk of heart attack compared to those taking a placebo, especially
those who had been taking the drug longer than 18 months.
Still, the Vioxx example raises concerns about FDA's review process
along with how long it took Merck to remove the drug from the market.
Vioxx is the first prescription drug to be pulled from pharmacy
shelves in three years for safety concerns. A FDA spokeswoman says
the agency has been pressured from all sides - medicine, industry
and consumers - to approve new drugs more quickly or slowly depending
on the demand or risk.
Another major concern: A Wake Forest professor who has researched
clinical trials for three decades points out more than half of all
drugs introduced in the market have a new side effect after their
approval with the current system. In a related issue, medical experts
are finding older, proven pharmaceuticals have become far more deadly
when combined with newer drugs.
These issues point to a gap in FDA regulations to fail to assess
the safety of pharmaceuticals after their approval. Although the
federal agency received some 2,400 agreements these after-the-fact
studies, less than 900 were actually conducted, according to a 2002
FDA report.
Some believe longer clinical trials could be the solution to the
problem. For example, the increased risk of heart attacks and strokes
among Vioxx users didn't happen until they took the drug for 18
months. In fact, the Center for Drug Evaluations and Research says
FDA will move in that direction for comparable drugs those that
may be approved down the road.
The news also hit Merck hard on the Dow Jones Industrial Exchange.
Shares of Merck & Co. lost more than a quarter of their value
last Thursday after the company pulled Vioxx from the market, plunging
26.8 percent to close at $33. Stock prices have bounced back a dollar
about $33.50 a share as of late yesterday.
In the meantime, a tidal wave of lawsuits have hit the courts in
the United States, Canada and as far away as Israel. One lawsuit
filed in Cook County Circuit Court alleges Merck knew about Vioxx's
harmful side effects at least since the drug had been formally approved.
Merck, argued one attorney, "intentionally tried to downplay
the risks" until the evidence "was so overwhelming they
had no choice."
The lawsuit could do serious harm to the company: Vioxx currently
has 2 million users worldwide and some 84 million people have taken
the drug since its approval by the FDA in 1999.
In reaction to the withdrawal of Vioxx, Pfizer Inc. has informing
wholesalers, pharmacy chains, pharmacy benefit managers and other
managed care organizations that they will manufacture enough Celebrex,
their Cox-2 inhibitor, to meet the patient demand. The company also
cited three long-term studies of Celebrex that showed the drug does
not have any significant safety issues.
Wired
October 3, 2004
Senior
Journal.com September 30, 2004
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