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Brian Deer: Vioxx - a killer painkiller

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






   
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 Vioxx causing heart attacks was noted in official licensing documents, discussed by the UK's Committee on Safety of Medicines, before Victor ever started, they were never notified to volunteers, even weeks before the trial was abandoned
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 possible heart risks, the trial's organisers had to be brought to heel by the UK's West Midlands medical ethics committee over failing to state risks of potentially fatal stomach ulcers caused by painkillers, including Vioxx
   
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
   
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