Companies Withhold Research on Medications and Children
RENE MONTAGNE, host:
Here's a story about a government program that's working, but maybe not as well as it could. Nine years ago, Congress tried to encourage research on how drugs affect children by providing financial incentives to drug makers. The incentives worked; hundreds of studies have been done. Still a new report finds that most of those studies have not been published in medical journals.
As NPR's Julie Rovner reports that means many pediatricians still don't know about the affects of those drugs on their patients.
JULIE ROVNER: Virtually all of the drugs approved by the Food and Drug Administration are tested solely on adults. That leaves pediatricians mostly guessing, says Danny Benjamin, an associate professor of pediatrics at Duke University.
Mr. DANNY BENJAMIN (Associate Professor, Pediatrics, Duke University): For most of the drugs that we use in children, we don't know what the right dose is. We don't know whether or not it's safe.
ROVNER: At least some of that changed in 1997, when Congress passed the Better Pharmaceuticals for Children act. The new law gave drug makers, who agreed to conduct studies of how their products worked in children, a valuable reward -six additional months without generic competition. Benjamin, who also works for the FDA, says it's been a huge success.
Mr. BENJAMIN: We've really got good data from approximately 120 products.
ROVNER: The FDA has changed some labeling information for the drugs as a result of the studies and published summaries of the research on its own Web site. But Benjamin and half a dozen colleagues report in today's Journal of the American Medical Association, that fewer than half of the 253 studies submitted to the FDA have gone on to be published in a peer reviewed medical journal. Benjamin likens that statistic to a failed football play.
Mr. BENJAMIN: Imagine watching your home team run the ball back 99 yards only to fumble at the goal line. Because when we don't publish the results, then the results are not easily available to pediatricians who take care of these children.
ROVNER: Benjamin wants Congress to change the law when it's up for renewal next year, to allow what he calls neutral third parties to publish the studies if the drug makers don't.
Drug makers, however, aren't sure there's really a problem. Scott Lassman is an attorney for the Pharmaceutical Research and Manufacturers of America. He says that while peer reviewed journals are considered the gold standard of medical communications, they're hardly the only way to get information to practitioners.
Mr. SCOTT LASSMAN (Attorney, Pharmaceutical Research and Manufacturers of America): We can do it as part of CME programs.
ROVNER: That's Continuing Medical Education.
Mr. LASSMAN: You can do it on the Internet. One thing that we have done - we established about two years ago, a publicly available database of clinical trial results. Currently, there are about 300 drugs listed on it, several hundred thousand individual studies.
ROVNER: But not all the unpublished pediatric studies are there. Still, even some of the laws biggest backers don't think the lack of publication of most of the studies is a major flaw.
Richard Gorman(ph) is a pediatrician in private practice in Maryland and a spokesman on the issue for the American Academy of Pediatrics. He points out, that summaries of all the studies are available on the FDA's Web site.
Dr. RICHARD GORMAN (Spokesman, American Academy of Pediatrics, Maryland): Now, is it buried on their Web site? Yes, it is a little bit buried. You have to go through a couple of clicks. You have to get to the page that talks about the clinical summaries of the drug trials. So this information, is in fact, being disseminated by the Food and Drug Administration - not as effectively as peer review journals do, but it is there for people who are looking for it.
ROVNER: This issue probably won't be the only one before Congress when it reconsiders the incentive program next year. Some members of Congress have complained that the six months of extended patent life for the drugs is too generous, that it gives the drug-makers far more money than the pediatric studies cost. Benjamin says his next research project will try to find out if that's true.
Julie Rovner, NPR News.