Brian Deer: Vioxx - a killer painkiller
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Patients never told of known Vioxx dangersTrial 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 drugPowerful 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" |
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Risks of Vioxx were known but not explainedWarned 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 deathsEarlier 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Doctors have reported 103 deaths they suspect were due to the painkiller Vioxx, which was withdrawn from sale over safety fears last September.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. |
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