Vioxx death toll may hit 2,000 in UK

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Brian Deer</span>

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<td valign="top">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.

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</td></tr></t></table>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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Thank god we are protected from harmful things like medical marijuana in the UK!!</font>


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Edited by: enquirewithin