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November 1994

Business magazine probes medical research ethics

Focuses on antibiotic therapy and children

A remarkable piece of investigative journalism, published in the Fall 1994 issue of Financial World, scrutinizes the complex world of medical research and explores accusations of corruption and fraud directed at scientists studying the effectiveness of antibiotic therapy for children.

At the heart of the issue is research conducted in the 1980s by the Otitis Media Research Center (OMRC), part of the University of Pittsburgh, which received $18.5 million in grants from the National Institutes of Health (NIH).

The article, "A Child's Guide to Medical Ethics," by Andrew W. Osterland, notes that OMRC, and the University's principal researcher Dr. Charles Bluestone, also received approximately $3.5 million in funding from various pharmaceutical companies -- including several which manufacture antibiotics used to treat otitis media.

Because of the OMRC's association with the University, and Bluestone's own impressive credentials, few people questioned the researchers' conclusion that antibiotic therapy was effective in treating children's common ear infections.

However, one of the team researchers, Dr. Erdem Cantekin, director of research at the Ear, Nose and Throat Department at the Children's Hospital of Pittsburgh -- who proudly calls himself a "pariah of the medical-industrial complex" -- claimed the research results were influenced by drug company money.

The Financial World article detailed the actions taken by Cantekin to expose what he saw as bias and corruption, including his outspoken accusation that Bluestone is "in the pockets of the pharmaceutical companies."

The article also provided in-depth information into the investigation by the NIH, which concluded that the OMRC had not properly disclosed its funding from drug companies. The investigation, FW reported, also revealed that those companies had paid Bluestone $262,000 over five years in speaking engagement fees and annual travel expenses of $25,000.

The NIH re-examined the data from the OMRC's research project and concluded that "these data do not provide support for the long-term effectiveness of any of the antibiotic drugs, relative to placebo, through sixteen weeks."

That might have been the end of the situation, except that researchers have continued to use Bluestone's report in other studies, FW explained.

For example, in November 1991, the Agency on Health Care Policy and Research (AHCPR), a division of the Department of Health and Human Services, formed a panel to develop treatment protocol for otitis media. According to the FW article, "The panels' own objectivity has been questioned by government and medical authorities. Much of the data examined by the panel came from Bluestone's studies and several of the panel members, including the chairman, are from the University of Pittsburgh."

Earlier this year, the AHCPR panel finally released its report and the conclusions are so vague that they appear to try to cover all the bases. Although admitting that non-acute infections (often called "glue ear") often clear up spontaneously, it added that antibiotics "appear to clear up the condition in a small number of children and should be considered as an option ... during the first three months."

As ambiguous as such recommendations are, they still came under fire by some health care professionals. FW provided this quote from Dr. Robert Ruben, chairman of the Department of Otolaryngology at the Albert Einstein College of Medicine and the Montefiore Medial Center: "It's hard to teach old dogs new tricks. Antibiotics don't help with recurring infection, or pain, or hearing loss, and they have serious side effects. So why use them?"

Although the attention is focused on the use of antibiotics for children's ear infections, the bigger picture is even more worrisome for medical ethicists. As Daniell Brian, director of the nonprofit Project on Government Oversight, noted in the FW article, "Imagine a weapons analyst for the Pentagon being paid by one of the defense contractors. It wouldn't happen."

Although, in 1989, the NIH proposed research guidelines to address the issues of economic influences on researchers, both the pharmaceutical and medical communities fought the proposals until they were withdrawn.

In a remarkably courageous statement -- considering the power wielded by the medical and drug industries -- FW concluded its article with a warning not to expect much change in the current situation. "The medical profession is a self-governing body," Osterland stated, "and loathe to give up any ground to the government, especially when it comes to its dealings with the pharmaceutical industry."

 

 

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