Skip to Main Content
Project on Government Oversight




Children's Ears & Antibiotics: Gold Mine for Pharmaceutical Companies, Land Mine for Children

March 1, 1994 


The federal government is about to formally approve treatment for a common childhood illness which is not justified by the evidence, but will benefit pharmaceutical companies and will increase the risk of developing antibiotic-resistant bacteria. The research used to justify the use of antibiotic therapy to treat fluid in children's middle ears, or otitis media with effusion (OME) was funded both by pharmaceutical companies as well as by the federal government.

The current emphasis on antibiotic therapy has an enormous impact, as otitis media (including both OME and acute otitis media -- AOM) are the most common diagnosis by physicians for children under fifteen; middle ear fluid is the principal diagnosis between 20% - 35% of the time; and according to the Centers for Disease Control antibiotics are prescribed for fluid in the middle ear 99% of the time. This case is illustrative of the growing problem caused by the general overuse of antibiotics -- the creation of so-called antibiotic-resistant "superbugs."

This report details our evidence that the conclusions drawn from the studies evaluating the efficacy of antibiotics on pediatric OME did not reflect the data. The late Rep. Ted Weiss conducted an investigation into these studies, and found that there was an "apparent bias" in the research. In 1990, as a result of the Congressional hearings, the Public Health Service performed an inquiry into the research that resulted in a five-year probation for the Primary Investigator of the research. The Scholar-in-Residence at the National Academy of Sciences' Institute of Medicine, and editorial board member of the New England Journal of Medicine, Dr. John Bailar, is writing a paper in which he reports that his statistical review of the data concludes that the antibiotics were no more effective than placebos. He writes, "This remarkable trend . . . seems to demolish the conclusion that antibiotics (of the mixed types in the studies summarized in these meta-analyses) improve the outcome." In fact, the FDA has never approved the use of antibiotics for this purpose. Despite these very credible and damning condemnations of the research, parents and pediatricians have not been adequately alerted to the significant evidence that suggests against prescribing antibiotics for OME.

The Department of Health and Human Services has assembled a Guideline Panel that is in the process of issuing guidelines for the treatment of OME. The prescription of antibiotics for this purpose is about to be approved by the Guidelines Panel, and sent to all pediatricians, HMO's and insurance companies, despite the fact they acknowledge their evidence is "limited and inconsistent". In a phone interview, Dr. Larry Culpepper, a member of the Guideline Panel, said "The Guideline Panel did not find evidence supporting effectiveness of antibiotics in changing outcomes beyond one month. Not treating with antibiotics (watchful waiting) remains a very viable option." According to officials at the AHCPR, the Guidelines report will not take this position on the effectiveness of antibiotics.

Scholars in the field, such as the President of the American Society of Pediatric Otolaryngology, are warning of the recent emergence of antibiotic-resistant bacteria of the variety that are associated with OME -- hemophilus influenzae and streptococcal pneumonia due to the overuse of antibiotics in the treatment of OME. To make matters worse, the Centers for Disease Control has found that among children under two years old, the incidence of both OME and AOM increased 224% between 1976 and 1990.  

Founded in 1981, the Project On Government Oversight (POGO) is a nonpartisan independent watchdog that champions good government reforms. POGO's investigations into corruption, misconduct, and conflicts of interest achieve a more effective, accountable, open, and ethical federal government.

# # #