- VIOXX
DEATH TOLL MAY HIT 2,000 IN UK
The
Sunday Times (London) August 21 2005
Brian
Deer
THE
families of as many as 2,000 British patients who
died after using the painkiller Vioxx could join a
potential multi-billion-dollar lawsuit against the
drug’s manufacturers.
Lawyers
for many of the relatives are considering filing
claims in US courts against Merck, the
pharmaceuticals giant, after the Legal Services
Commission decided not to fund any cases in Britain.
The
worldwide damages bill for Merck of £12 billion,
predicted by Wall Street analysts, could rise even
further after a landmark verdict in Texas on Friday
when a court found the company negligent in the death
of Robert Ernst, 59, and awarded his widow £141m.
A
Sunday Times investigation today reveals that
volunteers taking part in a clinical trial of the
drug in Britain were not shown essential safety
information, including warnings of potentially fatal
hazards.
A
total of 103 suspected Vioxx-related deaths have been
officially notified in Britain. Most died of heart or
gut complications after taking the drug. But
calculations by The Sunday Times, based on known
levels of under-reporting by doctors of
medicine-related deaths, suggest that the true toll
is closer to 2,000. About 60,000 people worldwide are
estimated to have died from the drug.
The
families of the dead will be joined by patients who
survived but who blame serious conditions, such as
strokes and paralysis, on the drug.
The
Sunday Times evidence is similar to some of the
revelations to emerge in the American courts, where
4,200 Vioxx cases are pending. Information about
risks, available to the company and its experts, was
not promptly given to patients.
In
one British case, Kenneth Wood, 71, a retired
Shropshire laboratory technician, died of a massive
heart attack while taking part in a trial to see if
the painkiller could also be effective in treating
colon cancer.
A
confidential Merck report, not revealed to
Wood’s widow, described his death as
“probably” caused by the drug. Other
participants who suffered problems included a
73-year-old Leeds man who died from the complications
of stomach bleeding; a 78-year-old man from Grimsby
who developed angina; and a Yeovil woman, aged 64,
whose heart failed after she started taking Vioxx.
Informed
consent documents and other confidential papers show
that Wood was not told of any serious risks and that
mounting concerns among scientists and regulators,
which had surfaced several years earlier, were kept
from trial participants.
The
trial, codenamed Victor, started in 2002 financed by
Merck and was led by two of Britain’s most
senior doctors. Professor Michael Langman, former
dean of Birmingham University medical school, has
been a member of the government’s committee on
safety of medicines since 1987. Professor David Kerr
of Oxford
University is a leading figure among Labour health
advisers and devised plans to reorganise
Scotland’s health service.
Both
men issued statements defending their actions.
“The Victor study was run to the highest ethical
and scientific standards,” said Kerr.
Merck
achieved a worldwide market of some 20m users,
including 400,000 in Britain, by promoting Vioxx as a
miracle drug. It was said to offer all the
painkilling and other properties of aspirin, but
without the commonest side effect: stomach ulcers.
Doctors prescribed it for pain control for everything
from arthritis to sports injuries.
The
documents that have emerged suggest evidence of
serious problems with Vioxx which were downplayed.
Enthusiastic marketing of the drug continued until
its sudden withdrawal last year.
The
company has said that it will fight every case and
will appeal against the Texas verdict. “We
believe that the plaintiff did not meet the standard
set by Texas law to prove Vioxx caused Mr
Ernst’s death,” said a member of
Merck’s defence team.
Earlier
this year the company’s British subsidiary
insisted that it had acted promptly on information
about risks: “We are confident in our research
and how Merck has communicated about Vioxx.”
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