Taking Drug Safety Seriously

Health hazards – nuclear reactors, guns, and contaminated foods – surround all of us, so governments take an active role in limiting these hazards through regulations, which, in many cases, are very successful. But the situation is far different concerning the safety of prescription drugs. Indeed, as far as protecting the public is concerned, drug safety is the regulator’s neglected stepchild.

The magnitude of the problem is huge. In the United States alone, it is estimated that every year up to 100,000 patients die due to serious adverse drug reactions (ADR’s). If true, drug-induced death would qualify as the fourth or fifth leading cause of death (depending on which mortality estimates are used). Moreover, the direct annual hospital costs attributable to ADR’s run into the billions of dollars, and this does not include all the suffering that ADR’s cause that does not lead to hospitalization (or death).

The difficulties in determining cause and effect must be acknowledged. Whether a patient’s death or hospitalization is due to a particular drug, the underlying illness, or a combination of the two can be hard to determine. But this makes drug safety all the more important.