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The possibility of more widespread application of 'personalized medicine', in which therapy is tailored to factors such as an individual's genetic make-up, has been on the horizon for years, but so far, translation of this concept to clinical practice has been limited. What might it take to change this situation?
As concerns over the adverse effects of the diabetes drug rosiglitazone (Avandia; GlaxoSmithKline) keep the spotlight focused on safety issues in the ongoing debate on drug regulation and the role of regulators such as the FDA and EMEA, it is important that the value of continuing to improve the regulatory processes leading to drug approval is not forgotten.
Despite the pressing need for new antibiotics in order to avoid a public-health crisis, antibacterial R&Dhas dwindled seriously in recent years, in part owing to a lack of incentives for companies to make investments in this field. So, the recent passing of an amendment to US legislation that will provide new incentives for antibacterial R&D is to be welcomed.
Growing public interest in earlier access to experimental drugs for life-threatening conditions such as cancer has stimulated proposals for legislation that would promote or even create rights to access. But if the importance of properly conducted clinical trials is not valued appropriately, such actions could be detrimental to drug development and patient care.
