Children’s Prescription Drug Studies Go Unpublished
Fewer than half of studies conducted on the effects of prescription drugs in children are published in medical journals, according to a study in the Journal of the American Medical Association published on Wednesday, the AP/Lexington Herald-Leader reports.
Study authors Danny Benjamin, an associate professor at Duke University, and Dianne Murphy, director of FDA's office of pediatric therapeutics, examined the impact of a 1997 FDA program that granted longer patent protection to drug companies if they engage in studies involving drugs and children. The researchers found that between the years 1998 and 2004, 253 pediatric studies were submitted to FDA under the program, but only 45% were published in peer-reviewed journals.
Benjamin said the research does not get published mainly because researchers and sponsors do not submit it for publication. According to Benjamin, drug companies are mostly motivated to market their drug, "not to tend to the public health concerns."
The researchers also noted that parents can be hesitant to enroll their children in studies, and low enrollment can complicate data compiling and submission. Study authors said the lack of data dissemination could cause doctors to prescribe drugs that could be harmful to children.
"We've just got to get the data out to people who are caring for children," Benjamin said.
Peter Lurie of Public Citizen's Health Research Group said drug companies and academics need to promote publishing. "It is really like the tree falling in the woods. The study is of no use whatsoever if it never reaches the practicing physician," Lurie said.
Scott Lassman of PhRMA said drug companies should not be faulted for not submitting data. While publishing studies in peer-reviewed journals is "the gold standard for getting information out," he said companies also often release data at medical conferences or on online databases (Tanner, AP/Lexington Herald-Leader, 9/13).
NPR's "Morning Edition" on Wednesday reported on the study. The segment includes comments from Benjamin; Richard Gorman, spokesperson for the American Academy of Pediatrics; and Lassman (Rovner, "Morning Edition," NPR, 9/13).
The complete segment is available online in RealPlayer.