Brian
Deer: Vioxx -
a killer painkiller
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This page
indexes resources from a
London Sunday
Times
investigation
by Brian
Deer
into the UK connections
with Merck's blockbuster
painkiller Vioxx,
linked with up to 60,000
deaths from
heart attacks and strokes |
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| Death toll:
When in September 2004, Merck Inc
withdrew Vioxx, it must
have expected a deluge of lawsuits. But
nobody could have predicted that, in
August 2005, a Texas jury would hit the
drugs giant with an award of a quarter
billion dollars. This was also the moment
for publication of Brian Deer's
long-in-preparation investigation of the
UK link. The Sunday Times, August
21 2005 |
Trial and
error: At the
core of Brian Deer's investigation was a
UK clinical trial of Vioxx, known by the
acronym "Victor". Among its
volunteers was retired laboratory
technician Kenneth Wood,
of Madeley, Shropshire, who died of a
heart attack after 17 months of
participation. A confidential Merck document, obtained during
Deer's inquiries, showed that a Royal
Shrewsbury hospital consultant said that Vioxx
was "probably" responsible for
Wood's death. Another document - the Victor
informed consent sheet - revealed that
Wood had never been told of possibly fatal
side-effects long reported to be
associated with the drug. Wood's widow,
Margaret, only learnt the facts from Deer
Warned of
what?: Although
the possibility of Merck's blockbuster
Vioxx painkiller causing heart attacks
and strokes was noted in official
licensing documents, discussed by the UK
government's Committee on
Safety of Medicines, before Victor
ever started, they were never notified to
volunteers taking part in the project,
even weeks before the trial
was abandoned |
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by drug:
On August 21 2005, Brian Deer's
probe into the UK dimension to
the Vioxx painkiller scandal was
published |
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Powerful
friends: The UK's
top champion for Vioxx was Professor Michael
Langman, former dean of
Birmingham University's medical school,
and not only a member of the drugs
watchdog, the Committee on Safety of
Medicines, but also co-principal
investigator of the controversial
Victor trial. The trial's other
principal investigator was Professor David Kerr, of Oxford
University, a major player in Labour
party health circles. Both declined to be
interviewed by Brian Deer, but supplied
statements, at the links above. Both
denied error, and said that the trial,
which aimed to enroll 7,000, had been run
to the "highest ethical
and scientific
standards"
Ethics
concerns:
In addition to never warning Victor
volunteers of the possible heart attack
and stroke risks they ran by taking part,
the trial's organisers had to be brought
to heel by the UK's West Midlands medical
ethics committee over failing to state
the risks of potentially fatal stomach
ulcers caused by painkillers of
the class including Vioxx |
| The first
major pharmaceutical scandal of the 21st
century had important offshoots in
Britain |
Readers
respond: After
the publication of Brian Deer's reports
in The Sunday Times,
readers emailed with their own
experiences of Vioxx, and with other
information. A selection of responses are
published here, and more are invited from
visitors to this website
Rights
denied by animal activists:
[pdf] Following a complaint in 2005 from Brian
Deer over a refusal by the UK
Medicines and Healthcare products
Regulatory Agency to release the names of
experts advising on Vioxx and other
drugs, a ruling in June 2006 from the
Information Commissioner declared that,
due to the risk from animal
rights activists, this
information would remain secret
Contact
Brian at this link: Visitors
often offer vital information for this
and other investigations. Please feel
free to email Brian Deer
with your suggestions, comments and
ideas. If you plan to quote from this
site, please acknowledge, and check the copyright notice. Links to this
site are greatly appreciated, and may
help to further journalistic inquiries
which you would want to see advanced
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News:
Withdrawn painkiller
linked to hundreds of
deaths
The Sunday Times
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... [read
this report]
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