About clinical trials

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.

This teenager with no history of mental illness was diagnosed with delirium. The night before the hallucinations started, she began taking an anti-influenza drug called Tamiflu (generic name: oseltamivir), which governments around the world have spent billions stockpiling for the next major flu outbreak.

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. The Food and Drug Administration (FDA) knew about it, but the medical community did not; the U.S. Centers for Disease Control and Prevention (CDC), which doesn’t have the same access to unpublished data as regulators, had recommended the drug without being able to see the full picture. When results from those unpublished trials finally did emerge, they cast doubt over whether Tamiflu is as effective as the manufacturer says.

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