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Approval of new drugs by the Therapeutic Goods Administration is no guarantee that they are superior or even equivalent to drugs already on the market. The drug evaluation process only assesses quality, safety and efficacy, not the therapeutic value of a drug. Assessments of the value of new drugs from Canada, France and the USA all show that at best one third of new drugs offer some additional clinical benefit and perhaps as few as 3% are major therapeutic advances. Drug companies are spending an estimated $1–1.5 billion per year promoting their drugs in Australia.1 One group of drugs that are heavily promoted as being better than existing products are single enantiomers of drugs that were initially introduced as racemic mixtures. The two prime examples of this phenomenon are esomeprazole which is the S-enantiomer of racemic S,R-omeprazole, and escitalopram which is the S-enantiomer of racemic citalopram. Evaluation of both new products has not demonstrated any advantages in safety or effectiveness, over their respective racemic mixtures at appropriate doses.2,3

Are new drugs as good as they claim to be?