Excerpts
On the morning of March 2, 2005, a 14-year-old Japanese girl woke up scared. At first she thought someone was outside the house watching her, but then she decided the stranger must be inside. She wandered restlessly and, despite the cold weather, threw open all the windows. Later, over a meal, she declared, "The salad is poisoned." Two days later, she said she wanted to kill herself.
That Japanese girl, whose case was detailed in an FDA report, did not kill herself. But at least 70 people have died, many of them by suicide, after Tamiflu-induced episodes. The deaths were almost surreal: A 14-year-old who took Tamiflu jumped off a balcony, and a 17-year-old on the drug ran in front of a truck. Scientists documented other cases of "psychopathic events," including a South Korean girl who temporarily developed bipolar disorder and an 8-year-old Japanese boy who wouldn't answer to his name and began to growl.
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But evidence released earlier this year by Cochrane Collaboration, a London-based nonprofit, shows that a significant amount of negative data from the drug's clinical trials were hidden from the public.
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The most infamous case of publication bias is a 1980 study in which heart attack patients were split into two groups: One group received a drug called lorcainide, while the other group received a placebo. Researchers wanted to find out whether lorcainide cures dangerous abnormal heart rhythms, which it does. But during the study, nine of the lorcainide patients died, compared with just one of the placebo patients. Lorcainide's maker stopped production soon after for unrelated commercial reasons, and consequently the researchers never published their report. They believed the deaths to be "an effect of chance."
But physicians continued prescribing drugs similar to lorcainide. Finally, in 1993, the researchers apologized for withholding the study, which they said could have "provided an early warning of trouble ahead." But the damage was done: Throughout the '80s, an estimated 20,000 to 75,000 people died in the U.S. each year from the inappropriate prescription of antiarrhythmic drugs, according to a 2003 editorial by Kay Dickersin and Drummond Rennie in The Journal of the American Medical Association.
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