Analyze the short case and answer the 2 questions:
Using placebos, vulnerable subjects:
A psychiatrist wants to study a new investigational medication for Attention Deficit Hyperactivity Disorder (ADHD). Children ages 10-17 with ADHD will be withdrawn from their current medications, if any, and then randomized to receive either placebo or the investigational agent for six weeks. The primary outcome measures are 2 standardized assessment scales, one to be completed by each subject and one by the subject’s parents. Subjects and their parents will be asked to complete these assessments twice a day and return them by phone, fax or e-mail to the research center.
Questions:
1. Is use of a placebo justified? How about for subjects who are being effectively treated with current medications?
2. Would your answers change if you knew that a pharmaceutical firm sponsored this study?
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