WITHDRAWN
PAINKILLER LINKED
TO HUNDREDS OF DEATHS
The
Sunday Times (London) February 13 2005
Brian
Deer
DOCTORS
have reported 103 deaths they suspect were due to the
painkiller Vioxx, which was withdrawn from sale over
safety fears last September.
The
figures released by the drug safety agency also show
there were 7,150 adverse reactions to the drug during
its five years on sale in Britain.
Experts
say, however, that under-reporting through the
government’s “yellow card” system,
could mean the true death figure may be as high as
2,000.
Vioxx
was licensed in April 1999 with claims that it was
safer than traditional painkillers, such as ibuprofen
and diclofenac, for its main use in relieving
arthritis. It was backed by a massive media campaign,
often featuring middle-aged celebrities ice skating,
and with a huge push to doctors through sales reps.
In Britain about 10m prescriptions were written.
But
evidence from studies sponsored by its manufacturer,
Merck Inc, aimed at expanding the drug’s use
into other medical conditions, found a dramatic rise
in heart attacks and strokes, prompting its overnight
withdrawal.
New
Jersey-based Merck, one of the world’s biggest
pharmaceutical groups, said its priority was patient
safety.
According
to Merck, about 400,000 mostly older people were
taking Vioxx in Britain when the company voluntarily
withdrew it worldwide. Some patients had been won to
the product from other drugs, but many were new to
taking regular painkillers. Prescriptions often
provided a month’s supply and a typical patient
used Vioxx for two years.
Calculations
based on the yellow card reports suggest 2,000
patients may have died, a death rate of 1 in 400. The
company disputed these figures this weekend, but the
calculations support those of Dr David Graham, an
official of the US government’s Food and Drug
Administration (FDA), who became a whistleblower
claiming that Vioxx was responsible for 140,000 heart
disease cases and up to 56,000 American deaths.
This
week the FDA is to hold crisis hearings in Washington
over Vioxx and other drugs of its kind. “In a
huge number of cases, the benefits of these new drugs
just wasn’t worth the risk,” said Professor
Andrew Herxheimer of the UK Cochrane Centre in
Oxford, who is one of Britain’s drug safety
experts. He believes only about 5% of problems are
reported through the yellow card system.
Britain’s
notification arrangements by the Medicines and
Healthcare Products Regulatory Agency are considered
among the best in the world, but research by
Herxheimer and others reveals huge underestimates.
One survey found that only 16% of doctors had ever
sent a yellow card, while another found that 80% of
the reports were filed by only 7% of doctors.
Numbers
do little to reveal the human tragedy of premature
deaths. “People say time is a great healer, but
you never get over it,” said Maureen Watt, 64,
of Bargoed, south Wales, whose husband, Alexander,
died of a heart attack at the age of 58 while taking
Vioxx. “In my heart I know that tablet killed
him,” she said.
The
Watt case has been taken up by lawyers hoping to add
British clients to a tide of Vioxx litigation now
sweeping America. But turning statistical links of
harm into evidence that a drug was responsible for
any particular death is fraught with difficulties.
Merck’s
UK subsidiary said adverse reaction figures had to be
compared with those for traditional painkillers,
which caused about 2,000 deaths a year. “We
withdrew the drug as soon as we recognised there was
a problem,” said a spokeswoman.
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Brian Deer. All rights reserved. No portion of this
article on Vioxx (rofecoxib) may be copied,
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