Tag Archives: Food and Drug Administration

Cooking the Books:The statistical games behind “off-label” prescription drug use

Study patients took the anti-seizure drug Neurontin, and researchers measured tons of possible outcomes (like pain with touch, pain with cold, excessive pain with pinpricks, more than a dozen different scales for psychiatric symptoms, and so on). By random chance, if you measure enough outcomes, at least some of them will appear better after drug treatment. When the time came to report the findings, however, the researchers systematically omitted the outcomes on which the drug had no effect—and presented only the data showing benefit. That’s like dealing dozens of hands of poker to yourself but showing only the hand with good cards.

FDA ‘considers’ Antipsychotic drug labels warning of weight gain/diabetes. Considers? Do your job-issue the warnings.

A study published last month in the Journal of the American Medical Association found the drugs caused children and adolescents to gain an average of 19 pounds in 11 weeks of treatment. The concern with weight gain seen with most antipsychotic drugs is whether it causes additional problems such as diabetes and cardiovascular disease. A top Food and Drug Administration official said Tuesday the agency is considering strengthening the labels of antipsychotic drugs to warn about weight gain and diabetes amid concerns the impact could be stronger in children compared to adults.