We need safer drugs for our kids

STORY HIGHLIGHTS

Editor's note: Harriet A. Washington is a medical ethicist, a former research fellow at Harvard Medical School and the author of two books, "Medical Apartheid" and "Deadly Monopolies."

(CNN) -- What if most of the drugs your doctor gave you were untested, forcing him or her to guess at the correct medication and dosage -- making you an unwitting research subject whenever you took a pill?

Dr. Florence Bourgeois and her colleagues at Harvard University have just reminded us that today, this very situation confronts the world's children.

Four of every five kids hospitalized in the United States are treated with drugs that have never been tested in them, according to Bourgeois' report in this week's Pediatrics journal. They are approved by the Food and Drug Administration only for adults. And outside the hospital, one-third of all children take such medications.

Doctors can legally use such drugs, but determining a safe, effective dose -- if there is one -- can be a matter of guesswork, because little ones can metabolize drugs very differently than adults.

For instance, the cheap broad-spectrum antibiotic chloramphenicol, used most frequently in low-income countries, can debilitate infants, causing vomiting, low blood pressure and impaired heart function in a rare but often fatal "gray-baby syndrome." And debate rages over whether antipsychotic drugs that mute the ravages of mental illness in adults can damage the developing brains of children to whom they are prescribed.

A child is not a Mini-Me, but according to Bourgeois' report, we tend to act as if kids are because drug trials conducted in children are too few, of poor quality and too often focus on medications that are important for disorders of adults, not children.

Why don't drug companies test more medications in children? Bourgeois suggests that the small size of the market and the difficulties of meeting heightened ethical constraints for children may play a role.

It's true that children typically lack the comprehension and judgment needed to give informed consent, so parents and guardians must render consent for them. Also, healthy children cannot be legally enrolled in studies that pose more than a minimal risk.

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We need safer drugs for our kids