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

October 22, 2009

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 the label: it states only that Lunesta is superior to placebo. The FDA’s medical review provides efficacy data, albeit not until page 306 of the 403-page document. In the longest, largest phase 3 trial, patients in the Lunesta group reported falling asleep an average of 15 minutes faster and sleeping an average of 37 minutes longer than those in the placebo group. However, on average, Lunesta patients still met criteria for insomnia and reported no clinically meaningful improvement in next-day alertness or functioning.

What is the real benefit of a particular drug? You may not find it in the label.

FDA approval does not mean that a drug works well; it means only that the agency deemed its benefits to outweigh its harms. This judgment can be difficult to make: benefits may be small, important harms may not have been ruled out, and the quality of the trials may be questionable. Since the nature — or even existence — of reviewer uncertainty is not addressed in the label, clinicians cannot distinguish drugs that reviewers endorsed enthusiastically from those they viewed with great skepticism.

How can we make sure existing evidence reaches consumers and clinicians in a direct and useful fashion? The authors recommend that drug labels include an easily found box listing the evidence regarding harms and benefits of the drug. Or should we just go on buying drugs like Lunesta because their television advertisements suggest they have magical transformative properties?

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