UK links to drug side-effects disaster
Merck's folly

Brian Deer: Vioxx - a killer painkiller

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This page indexes resources from a 2005 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

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 investigation of the UK link. The Sunday Times, August 21 2005
Sunday Times Vioxx splash

Patients never told of known Vioxx dangers

Trial and error: At the core of 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 participation

 

A confidential Merck document, obtained during Deer's inquiries, showed that a hospital consultant said that Vioxx was "probably" responsible for Wood's death. An informed consent sheet, meanwhile, revealed that he had never been told of the possibly fatal side-effects long reported to be associated with the drug. Wood's widow, Margaret, only learnt the facts from Deer

Top British doctors behind approvals for drug

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, but supplied statements, at these links. Both denied error, and said that the trial, which aimed to enroll 7,000, had been run to the "highest ethical and scientific standards"

Vioxx Sunday Times investigation
Vioxx packaging

Risks of Vioxx were known but not explained

Warned of what?: Although the possibility of Merck's blockbuster Vioxx painkiller causing heart attacks and strokes was noted in official licensing documents, and discussed by the UK government's Committee on Safety of Medicines, before the Victor project involving Woods ever started, these risks were never notified to volunteers taking part in the project. Even weeks before Victor was abandoned, amid mounting concerns over the death toll in the United States, they were still not told that the drug could kill them

Painkiller Vioxx linked to hundreds of UK deaths

Earlier report: 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. The Sunday Times, February 13 2005

Merck logo
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
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
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