Brian Deer: Vioxx – a killer painkiller
NOTE: This legacy page relates to material published at an earlier build of the briandeer.com website, and now serves purely gateway purposes
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.
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.
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”
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.
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.
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