Patients, their doctors, nonsteroidal anti-inflammatory drugs and the perception of risk

Risk is inherent to essentially all drug therapy. Any pharmacological therapy is likely to have some risk of adverse effects in some patients. If an adverse event is mild and reversible it generally is not a significant issue in the choice of drug therapy for clinicians or patients. If the potential adverse event is considered severe and/or serious, however, it becomes more relevant to therapeutic decision-making [1]. If any risk were unacceptable then new drug development would halt [2]. This is often not very clear to patients, to oversight government committees or even at times to practicing clinicians. The recent firestorm associated with the extensive risk assessment of the COX-2 selective inhibitors (coxibs) has clearly demonstrated the dilemma. Patients rely upon their health care providers to prescribe therapies that will benefit them and will not place them at risk for a drug-induced adverse event. Even with the empowered general public of the twenty-first century there is still the implied contract with the physician that they are able to determine the appropriate and safe therapy for a patient's specific problem. Conveying risk to the patient while allowing them to understand the decision-making process leading to the use of the specific therapy remains daunting. The issue of the relative risk for a therapeutic in the context of its relative benefit should nonetheless continue to drive this process of assigning drug therapy to patients.A generic and daunting vulnerability in drug development worldwide is the lack of quantitative risk–benefit assessment and the lack of comparative risk–benefit when other therapies exist for a given condition. Without some quantitation of the risks associated with specific therapies, doctors and patients cannot make an optimal risk–benefit calculation. Patients may forgo effective therapies for which benefits may still outweigh risks; or may opt for therapies with less well-publicized toxicities of even greater frequency or