Clinical Risk Assessments

This quotation, attributed to Eli Lilly, then CEO of the company that bore his (and his grandfather’s) name was reportedly made after Mr. Lilly received a dose of the “miracle drug” penicillin in the early 1940’s. The product’s formulation—required at the time—resulted in an extremely painful injection. Mr. Lilly’s quote speaks to the essence of the benefit/risk assessment:

Does the medication’s benefit outweigh the risk to the patient to a degree sufficient to justify its use?

Today is no different. And with more therapeutic options available for the treatment of similar conditions it is critical that the benefit/risk profile accurately reflects the incremental value that product provides.