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benefit: FDA only looked at risk, ignored benefits Off-label use: Doctors prescribe drugs off-label all the time Patient access: People are suffering and need options Regulatory capture: Big Pharma doesn't want cheap peptides competing The problem with these arguments: It's NOT off-label use — Off-label only applies to FDA-approved drugs

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Academic Editor: Alex Loukas, Queensland Institute of Medical Research, Australia Received: August 2, 2006