Medical History: Clinical Trials and Retrolental Fibroplasia
Some Fifty Years Ago a Baby-Blinding Epidemic Confounded Experts -- Until a Pioneering Study Conclusively Tied Cause and Effect, and Enshrined Clinical Trials in Medical Practice
By David Brown
The Washington Post
Tuesday, April 19, 2005; Page HE01
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The story of oxygen and blindness is a distant mirror of these therapeutic surprises. But it is much more as well.
Of all the elements on the periodic table, oxygen is the one that seems most to symbolize life and health itself. Could extra oxygen be dangerous to tiny babies struggling to survive? It seemed inconceivable!
But it was true. Two doctors proved it more than a half-century ago in a clinical experiment run in the wards of a hospital in Washington. The medical world didn't believe them, at least not enough to change routine practice. So a second, bigger experiment was conducted at more than a dozen American hospitals.
Fifty years ago this summer, the preliminary results of that trial were published. They changed medical history. Almost overnight, physicians stopped automatically giving supplemental oxygen to preemies, ending the epidemic of retrolental fibroplasia (RLF), as the disease was called then. (It is now known as retinopathy of prematurity.)
But the study's results did something else equally important and historic. They convinced many American physicians of the usefulness of randomized controlled trials, which had been "invented" less than 10 years earlier in Britain. Not least, the study taught doctors they couldn't assume that what seemed like a good idea -- extra oxygen -- would necessarily lead to a good outcome.
"Doctors have to approach their patients, and what they think they know, with a certain amount of humility," said Steven Goodman, a physician at Johns Hopkins University's Bloomberg School of Public Health and editor of the journal Clinical Trials. "This is one of the trials that taught us humility."