Children's Ears & Antibiotics
Gold Mine for Pharmaceutical Companies, Land Mine for Children
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International Responses to Treating Otitis Media

It is particularly interesting to compare the pro-antibiotic culture in the United States to that of Scandinavia and other countries in Northern Europe, where antibiotics are rarely -- if ever -- administered for OME. In fact, even in cases of acute otitis media antibiotics are very rarely administered in these countries. Instead, they rely on pain-killers, and have not "medicalized" the problem the way doctors and parents have in the United States. Of particular interest is that antibiotic resistant hemophilus influenzae bacteria develops in only three to five percent of children in Northern Europe -- a dramatic comparison to the United States.

Even as long ago as 1974, research emanating from Scandinavia indicated that it is the overuse of antibiotics that might in fact cause repeated episodes of acute otitis media:

". . . frequency of recurrence of otitis media in the first month after recovery is low as compared with that in those 'routinely' treated with antibiotics from any of the first seven days of disease; in those treated with antibiotics, risk of recurrence is high, especially when treatment was begun from the first day of disease." (Diamant and Diamant, Arch Otolaryngology, 1974)

In a study of over 4,800 children in The Netherlands, it was found that over 90% of children with acute otitis media were cured within a few days through a treatment of nose drops and pain-killers. The study concluded, ". . . treatment of acute otitis media in children can be limited to nose drops and analgesics alone for the first three to four days. An antibiotic, preferably a penicillin, can be given in the severe cases (still ill after three to four days with persistent high temperature or severe pain, or both) and to patients who do not clinically appear to be ill but still have discharge of the ear after two weeks." (F.L. van Buchem et al, British Medical Journal, 1985)

A more recent study of the antibiotic treatment of acute otitis media in over 3600 children in nine countries (Australia, Belgium, Canada, Great Britain, Israel, The Netherlands, New Zealand, Switzerland and the United States) also suggests that the repeated use of antibiotics hindered a patient's ability to heal:

"Patients who did not take antibiotics had a higher rate of recovery than those who did; the rate of recovery did not differ between different types of antibiotic. . . Antibiotic treatment did not improve the rate of recovery of patients in this study." (Froom, Culpepper et al, British Medical Journal 1990)

Acute Otitis Media in the United States

In 1991, Bluestone himself published a paper on the efficacy of Amoxicillin for treating acute otitis media, reporting the results of research conducted between 1981-1985. His paper states that, "It is concluded that children with acute otitis media should routinely be treated with amoxicillin (or an equivalent antimicrobial drug)." This conclusion was reached even though his data showed that Amoxicillin was successful in treating AOM 96% of the time, while children without antibiotics were cured 92.5% of the time. (Kaleida, Casselbrant, Rockette, Paradise, Bluestone et al., Pediatrics 1991)

Dr. Kenneth Grundfast and Cynthia J. Carney, both members of the AHCPR Guideline Panel, wrote in their book, Ear Infections in Your Child, "Studies have shown that, in many instances, acute symptoms of otitis media subside without treatment in 24 to 72 hours in 70 to 80 percent of children."

Despite this, children are nearly certain to be prescribed antibiotics in the United States when diagnosed with acute otitis media. This practice is used as a preventive measure to ensure that the few children who should ultimately receive antibiotics do not fall between the cracks and develop such serious complications as mastoiditis or meningitis.

"The Cantekin Affair"

Dr. Erdem Cantekin, Director of Research at the OMRC and a member of Bluestone's research team, took exception with Bluestone's conclusions in the New England Journal of Medicine's article on antibiotics and OME, as well as Bluestone's many speeches supporting the use of antibiotics. Cantekin's analysis of the data concluded that there was no evidence that Amoxicillin was any more effective than placebos.

A 1990 Congressional report about the "Cantekin Affair", by the late Rep. Ted Weiss (D-NY), found Cantekin's case to be valid. The report concluded that none of the several investigations into the matter had objectively and thoroughly reviewed the allegations. In two sub-headings of their report, the Weiss committee wrote, "The University of Pittsburgh Medical School's misconduct investigation erroneously dismissed the charges against Dr. Bluestone" and further that "Despite conclusive evidence of wrongdoing, NIH has defended Dr. Bluestone's failure to disclose non-federal research funds on his NIH grant applications."

As Dr. Bluestone is the founder of the OMRC, and has been very successful at bringing in both federal and private research funding at the University of Pittsburgh facility, it should not be surprising the University staunchly denied any of the accusations against Bluestone or his research. And, in fact, the University of Pittsburgh filed misconduct charges against Cantekin for submitting his dissenting paper based on the same research to the New England Journal of Medicine (NEJM). The University went so far as to move his office out of the medical complex.

Finally, in 1991, the Journal of the American Medical Association (JAMA) published Cantekin's dissenting paper -- after writing an unprecedented five-page editorial discussing the controversy. JAMA's editor criticized the University of Pittsburgh's attack on Cantekin, and wrote:

"So after all these years and all these inquiries, so costly in time, money, and emotions, the public have yet to see the counter view. Looking back, surely publication of this dissenting view would have been very greatly to the benefit of all parties. We are now publishing it so that our readers can decide for themselves." (Appendix J)

The Cantekin et al. analysis concluded, "Amoxicillin with and without decongestant-antihistamine combination is not effective for the treatment of persistent asymptomatic middle-ear effusions in infants and children." (Appendix J)

Cantekin has written a critique of the AHCPR Guidelines Panel report, and recommends that, "(T)he Guidelines Panel should be reformulated to represent the world expertise on this subject, and not merely the view -- prevalent only in the United States -- that drug treatment followed by surgical intervention is the answer to otitis media."

Public Policy Impact

In addition to the obvious significance of challenging the current practice of treating fluid in the middle ear in children with antibiotics, this case represents a much bigger issue for federal scientific research. It is common practice in medical research to mingle federal and corporate research money. It is even common for scientists to receive honoraria or consulting fees from the companies whose product they are evaluating for the government. A July 1992 Department of Health and Human Services Inspector General report concluded:

"We found that gifts and offers of value related to studies, speaking engagements, and program attendance are used by pharmaceutical companies to promote their drugs. We also found that promotional practices involving items of value appear to affect physicians' prescribing decisions."("Prescription Drug Promotion Involving Payments and Gifts: Physicians' Perspectives", p.i)

In the Bluestone case, the controversy only arose because of questions regarding his reporting of these sources of research funding, honoraria and travel expenses. The assumption that science researchers display such integrity that money will not have any impact on their science, goes contrary to the laws of human nature. It is unfair and unrealistic to place such temptations in such a competitive, high-stakes arena. Tax dollars spent on medical research should be pure and unadulterated by corporate funding.

The Project on Government Oversight believes that this case is not only significant on its own merit, but should open the door to a public discussion and review of the assumptions that lie behind the mixing of public and private funds for medical research today.