The Art of the Black Box

  • by: |
  • 11/18/2005

Here’s some new research that’s not surprising but enormously important —patients and doctors frequently don’t comply with some of the so-called black-box warnings on prescription drugs. This according to a Harvard Medical School study of nearly a million patients.

Researchers from Harvard and several hospitals and health plans found that compliance with the warnings varied substantially — from extremely good for certain drugs that can’t be taken during pregnancy, to poor for others that should be followed with regular diagnostic tests.

The findings, published today in the journal Pharmacoepidemiology and Drug Safety, suggest that pharmacists and regulators “need to find out how we can communicate the content of the warning clearly to clinicians and patients,” said Anita Wagner, the study’s lead author and an assistant professor in the department of ambulatory care and prevention at Harvard Medical School.

The Wall Street Journal reports that Paul J. Seligman, who oversees post-marketing drug surveillance at the FDA, says the study shows the need for more research to give doctors and patients clearer warnings. Dr. Seligman says it’s important to “develop the science for monitoring adverse events in ways that will allow us to give adequate warnings.”

Paul is a talented and dedicated career professional — but he and others at the agency must realize that before FDA can be a part of the solution, they must first stop being part of the problem. The move to more and more black box warnings as well as other warnings based on very early science is causing “warning fatigue” and it should be no wonder that both physicians and patients are taking them less seriously.

Further, it’s not only about learning how to better monitor adverse events — it’s about learning how best to communicate with doctors, pharmacists and consumers the risks associated with various medicines. And that’s as much science as art.

But first, do no harm.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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