Story here - seattletimes.nwsource.com/html/l … xx16m.html
The maker of the controversial arthritis drug Vioxx knew of dangers associated with it for as many as three years before a massive nationwide recall, but withheld the information from federal officials and played down the number of deaths associated with the pain medication, according to an analysis published today by University of Washington professors.
The article, which appears today in the prominent Journal of the American Medical Association (JAMA), contends that Merck, which pulled Vioxx from the market in 2004, knew internally as early as 2001 that people at risk of Alzheimer’s disease who were enrolled in two Vioxx clinical trials were dying at three times the rate of those taking a placebo.
The article, which examined previously secret Merck documents, contends the company switched calculations to minimize the number of deaths.
In an accompanying editorial, JAMA’s top editors call for “drastic actions” against corporate manipulation of clinical research and the practice of ghostwriting medical articles by unnamed authors on corporate payroll. It argues that researchers, regulators and even editors of medical journals such as JAMA are complicit. It singled out doctors who lend their names as authors on research papers for money for behavior “that is unprofessional and demeaning to the medical profession.”
But information was available well before 2004 that showed that Vioxx posed serious potential harm to subjects in clinical trials. As early as June 2000, unpublished data submitted to the Food and Drug Administration showed that taking Vioxx significantly raised the rate of heart attacks and strokes, as well as edema and hypertension, according to subsequent analysis by independent researchers.
In the latest JAMA article, the UW researchers compared internal Merck memos about two Vioxx studies involving patients at risk of dementia against information the company submitted to the FDA and published later in two clinical papers.
In April 2001, a Merck statistician concluded that 34 people in the Vioxx groups had died, compared with 12 in the two placebo groups. But in its submissions to the FDA three months later, Merck used different methods to reduce the mortality risk, coming up with 29 deaths among Vioxx takers and 17 in the placebo groups.
Merck apparently did this in part by omitting some of the deaths that occurred after the subjects had stopped taking the drug, said Psaty.
“They were not being forthright,” he said in an interview today. “They minimized the appearance of risk.”
Similar scenario is happening with our dilemma. You can switch Vioxx with Propecia and the minimization of risks and failure of being forthright is just as true. Same company too. Thought I would pass this along.