http://www.theatlantic.com/doc/200911/brownlee-h1n1
try to ignore the political references to hurricane Katrina etc; there's some good incites in this one on how statistics are used to deceive
Jackson’s findings showed that outside of flu season, the baseline risk of death among people who did not get vaccinated was approximately 60 percent higher than among those who did, lending support to the hypothesis that on average, healthy people chose to get the vaccine, while the “frail elderly” didn’t or couldn’t. In fact, the healthy-user effect explained the entire benefit that other researchers were attributing to flu vaccine, suggesting that the vaccine itself might not reduce mortality at all. Jackson’s papers “are beautiful,” says Lone Simonsen, who is a professor of global health at George Washington University, in Washington, D.C., and an internationally recognized expert in influenza and vaccine epidemiology. “They are classic studies in epidemiology, they are so carefully done.”
The one area where the seasonal flu shot has been shown to reduce mortality (vaccinating the elderly) shows such a dramatic decrease in mortality from ALL CAUSES that some independent thinkers had to dig deeper.
Tom Jefferson, a physician based in Rome and the head of the Vaccines Field at the Cochrane Collaboration, a highly respected international network of researchers who appraise medical evidence, says: “For a vaccine to reduce mortality by 50 percent and up to 90 percent in some studies means it has to prevent deaths not just from influenza, but also from falls, fires, heart disease, strokes, and car accidents. That’s not a vaccine, that’s a miracle.”
Thursday, October 15, 2009
An oldie but goodie
http://www.center4research.org/news/fda-app-safety.html
2006 study of the practices of the advisory panels for the FDA which are the front lines of the approval process for new drugs and devices
The results indicate that advisory committees recommended approval for 76% of new drugs and 82% of new medical devices. Some committees are more discriminating than others. Many panel members and some committee members recommended approval for every product they considered year after year. For example, 98% of the votes by members of the advisory committee reviewing arthritis drugs over the eight years of the study recommended approval; almost all, like Vioxx®, were recommended unanimously. The committee reviewing medical devices for vision correction and eye diseases unanimously recommended approval for every medical device they considered for the last six years of the study. About 96% of these drugs and devices were subsequently approved by the FDA.
2006 study of the practices of the advisory panels for the FDA which are the front lines of the approval process for new drugs and devices
The results indicate that advisory committees recommended approval for 76% of new drugs and 82% of new medical devices. Some committees are more discriminating than others. Many panel members and some committee members recommended approval for every product they considered year after year. For example, 98% of the votes by members of the advisory committee reviewing arthritis drugs over the eight years of the study recommended approval; almost all, like Vioxx®, were recommended unanimously. The committee reviewing medical devices for vision correction and eye diseases unanimously recommended approval for every medical device they considered for the last six years of the study. About 96% of these drugs and devices were subsequently approved by the FDA.
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