Wednesday, February 25, 2009

FIRESIDE CHAT: One Difference Between Pharmaceuticals and Pollutants

In recent months, psychiatric side-effects, including suicide, have been associated with the asthma medication Singulair, raising the technical issue of whether such associations are ‘causal or casual’. Media coverage has verged on exposé tone, leaving the impression that this pharmaceutical might have slipped through an FDA licensing process that should have been based upon two time-honored criteria: safety and efficacy. If Singulair were an air pollutant instead of a medicine, associated risks such as suicidal ideation and action should result in control (by EPA) to levels well below the danger point for even the most sensitive populations. These would include pregnant women and, for many or most pollutants, their fetuses and infants. Not so for Singulair: this conservative principle of pollutant regulation works differently for pharmaceuticals.

We want pharmacologically active agents to be available, specifically for cases where risks of a disease greatly outweigh risks posed by a treatment agent. That's why physicians can prescribe chemotherapeutic agents against cancer, even though the agents infrequently may also cause cancers. It's why they can prescribe immunizations, even though the vaccines infrequently may also cause adverse, including lethal, effects.

The death from suicide, even of one patient taking Singulair, is tragic, and illustrates a painful quandary: when to use (or not use) a medication that might prevent 10 or 100 or 1000 times the number of deaths that it causes. If properly prescribed, each medicine added to our arsenal of disease fighting agents contributes to public health, even though it infrequently might also exert adverse effects on an individual's health. I don't claim to know the way out of this quandary, but I do think that media coverage should be balanced by reporting both sides of the benefit-cost analysis. Medications are licensed for prescription use only, not because they are without risk, but because their proper use can mitigate enormously greater risks.

Copyright © 2009 by The Center for Health Risk Assessment and Management, a Division of RAM TRAC Corporation