It May be New – But is It Better?

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apothecaryThis is not a question that the FDA normally asks before approving a new drug, but researchers at Stanford University Medical School have called for a change in labelling to include information about how effective the new drug is compared with existing treatments. And, if this information is not available, the researchers believe that the label should clearly say so. With the exception of situations where it would be unethical to withhold active treatment from one study group, as in the case of cancer patients or those with HIV/AIDS, the FDA requires only that a drug should be deemed safe and effective in order to receive marketing approval. In many cases, ‘efficacy’ is determined solely on the basis of superiority to placebo.

Writing in the New England Journal of Medicine, the authors suggest that including comparative efficacy information on labels would allow more informed choices by clinicians, patients and providers and also curb increases in healthcare costs. The authors cite several reasons for the current practice of carrying out placebo-controlled trials; smaller sample size, reduced cost, and lowered risk of generating unexpected unfavourable results (for example, neither active comparator found to be better than placebo). Drug development is an inherently long and risky business and, although some products represent true therapeutic breakthroughs, many offer little benefit over existing therapies. The authors argue that the current regulatory climate provides few incentives to conduct active-comparator trials and favours creation of products that differ minimally from existing therapies.


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