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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

In consequence very little of this medication would be absorbed by the infant orally even if found in breast milk

Not because the process is complex, but because the consequences of storage mistakes are invisible until the therapeutic effect disappears entirely

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