Why Don’t Drug Labels Make the Actual Harms and Benefits Clear?

By Jacob Molyneux, blog editor/senior editor

How can we know if a drug really works? Gary Schwitzer, publisher of HealthNewsReview.org (an incisive Website that grades the quality of health news reporting) addresses this question on his blog this week by drawing attention to a recent perspective piece published in the New England Journal of Medicine (NEJM). It’s called “Lost in Transmission — FDA Drug Information That Never Reaches Clinicians” and it states the problem clearly:

The 2009 federal stimulus package included $1.1 billion to support comparative-effectiveness research about medical treatments. No money has been allocated — and relatively little would be needed — to disseminate existing but practically inaccessible information about the benefits and harms of prescription drugs. Much critical information that the Food and Drug Administration (FDA) has at the time of approval may fail to make its way into the drug label and relevant journal articles.

The most direct way that the FDA communicates the prescribing information that clinicians need is through the drug label. Labels, the package inserts that come with medications, are reprinted in the Physicians’ Desk Reference and excerpted in electronic references. To ensure that labels do not exaggerate benefits or play down harms, Congress might have required that the FDA or another disinterested party write them. But it did not. Drug labels are written by drug companies, then negotiated and approved by the FDA.

One example given in the NEJM article is the sleeping pill Lunesta:

Clinicians who are interested in (Lunesta’s) efficacy cannot find efficacy information in […]