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Head to Head Comparisons will Help Patients but Hurt Profits

May 27, 2008

Analysis of:Warning over drug trial’s effects on testing | www.ft.com

Direct comparisons between potential competing agents often do not exist Initial FDA approval is usually based on comparisons to placebo A new approval does necessarily mean that the new agent is better than existing ones, although this is implied by industry Industry bears all the costs of efficacy trials prior to FDA approval Head to head comparisons are what doctors really need to treat patients Head to head comparisons will require different methodology, larger samples, and could also be failed studies. Industry may be more reluctant to develop new agents which might become only "me too" or second class in a crowded market

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