Placebo Trials Risky for Asthmatic Children

Involving asthmatic children in the placebo arm of a clinical trial can be harmful and is ethically unjustified, according to a study published in the January 2004 issue of Pediatrics.

Researchers made a systematic review of all clinical trials involving asthmatic children between 1998 and 2001. They found that children with asthma were more than twice as likely to be forced to withdraw because of asthma exacerbation if they did not receive standard asthma therapy, compared to children who received standard treatment. Out of 70 published studies, 45 compared a drug against a placebo and all involved subjects under 18, while 14 studies involved only children. Although 22 studies required all subjects to begin or continue their medications, 48 of the studies did not. In only 18 studies, subjects with more than mild asthma were taking anti-inflammatory medications prior to the study.

"These children have been exposed to unnecessary risks and harm because the very medication they depend on is being withheld from them during these studies,” noted Lainie Briedman Ross, M.D., Ph.D., associate professor of pediatrics at the University of Chicago (IL, USA; www.uchicago.edu), who led the study. "It's unconscionable that children are not properly treated when joining these studies. Those who don't get the experimental drug should get standard treatment.”

Moreover, said the researchers, many of the studies were not groundbreaking, were testing therapies similar to what was already available, and nearly all were funded by pharmaceutical companies.



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