Drug Effects On Kids Uncertain

A study published in the September 13, 2006 issue of the Journal of the American Medical Association (JAMA) starts off with a chilling statement. “Much of pediatric drug use is off-label because appropriate pediatric studies have not been conducted and the drugs have not been labeled by the US Food and Drug Administration (FDA) for use in children.” In other words, according to the authors in JAMA, most of the drugs being sold for children have not been approved by the FDA for use in children.

The study, also reported on in a September 13, 2006 Associated Press story, notes that very little of the research that is done gets published in scientific journals. This then makes it hard for doctors to know about the medications or the study results. Dr. Danny Benjamin, an associate professor at Duke University who led the study and also works for the U.S. Food and Drug Administration commented, “Ironically, some of the times when drugs do work (in children), they’re still not getting published.”

Dr. Benjamin noted that many of the studies that do get done are never submitted for publication in journals. Dr. Catherine DeAngelis, JAMA editor-in-chief noted in the AP story that few studies submitted to JAMA involve the effects of medication on children.

It is not known if the reason for these lack of submissions is the change in 2004 by many of the scientific journals that now require drug tests be pre-registered before the testing in order to be considered for publication after the tests are complete. The reason the publications did this was because drug companies were running multiple studies on some drugs then only publishing the best results from drug trials while hiding the ones that may not have been so successful. Gregory D. Curfman, executive editor of the New England Journal of Medicine explains the rationale by stating, “When a pharmaceutical company sponsors a clinical trial and the results turn out not to be in the best financial interests of the company, it has been our experience these results are never made public.”

By not submitting the pediatric drug tests for publication in the journals, the drug companies could conceivably bury those tests that were not favorable, while distributing only those that seemed to work. In response, Scott Lassman of Pharmaceutical Research and Manufacturers of America, noted that drug companies often present data at medical conferences and or post them on an online industry database. This type of dissemination does not undergo the same scrutiny as publication in a peer reviewed scientific journal.