Vioxx disaster

The Sunday Times

Vioxx death toll may

hit 2,000 in UK

The Sunday Times, 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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