It was only after I started working in drug regulation that I fully appreciated the role of risk/benefit analysis for medicines. I thinks it’s a testimony to the skill of the regulators that balancing the benefit of a medicine against the risk has been performed so well that, as a consumer, I expected any medicine would have negligible side effects.

Risk/benefit is a balancing act that depends on the severity of the medical condition, the availability of other treatment options and the patient population who is to receive the medicine. If the medicine is to be prescribed to healthy people to prevent a disease then the risk should be very low. If the medicine is intended for seriously ill patients, for whom there is no other medicines on the market, these patients could gain a far greater benefit so a higher risk may be acceptable. For example, an acceptable adverse reaction profile for a chemotherapy drug is significantly different to that of cold and flu medications; one is life-threatening and the other a self-limiting condition. The risk/benefit analysis is conducted under the overarching umbrella of ethics and ensuring that patients have access to both quality medical care and medicines.

Image courtesy of CSIRO.