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69 LESSON 9 IF YOU THINK YOU’RE RIGHT, KEEP PUSHING Never doubt that a single individual can change the world. Indeed, it is the only thing that ever has. margaret mead Ileft Indonesia in 1979 with plans to launch a randomized trial to determine whether large doses of oral vitamin A given just twice a year could prevent blinding xerophthalmia among young children. If it could, the impact could be enormous. It would make a global blindness-prevention program financially and practically feasible. Our surveys had revealed that xerophthalmia was extremely common in Aceh Province, on the island of Sumatra . It would therefore be the perfect place for the study. It took two years to assemble the funds and another year to obtain government clearance and to build the teams and infrastructure needed to carry it out. The Indonesian government was by then committed to a vitamin A supplementation program. Purposely denying children vitamin A, by randomly assigning them to receive a placebo, which could lead to blindness, was completely off the table. However, the government’s planned intervention program was to be rolled out over five years, covering an ad- 70 TEN LESSONS IN PUBLIC HEALTH ditional one-fifth of all villages in each succeeding year. So, we asked that the government allow us to randomize the order in which the villages were added to the program. That way, we could conduct a properly randomized trial, comparing villages randomly assigned to be in the program with neighboring villages randomly assigned to join the program subsequently, without interfering with the coverage the government hoped to achieve. Our approach abandoned the traditional use of placebos in the control villages. Placebos are most critical when a study’s outcome of interest is subjective, like a patient’s perceived level of pain, wellness, or improvement. Such subjective outcomes can be influenced by the patient’s and the researcher’s expectations regarding the treatment. Blindness , or lack thereof, is a “hard” clinical manifestation, about as hard as it gets, short of death. The placebo-less approach was also the only design for which the Indonesian government would provide its ethical approval. While I did not see the absence of a traditional placebo as a significant shortcoming of the study, later opponents did! Just before launching the project, I had a sudden, unexpected (and dramatic) cause to alter its primary objective. Every member of our group refers to this observation, one that changed our lives and careers, and more importantly, global health policy, as the “holy cow moment.” (In honesty, “cow” was not the noun I originally uttered.) Late one afternoon in 1982, over the Christmas holidays, when patients rarely came in for cataract or glaucoma surgery , I was poring over computer printouts of the (by then “old”) Indonesian study in which we’d examined village children every three months for eighteen months. The purpose of that study had been to determine whether certain attributes (diet, illnesses) distinguished those children who later developed xerophthalmia from those who didn’t. IF YOU THINK YOU’RE RIGHT, KEEP PUSHING 71 In flipping through the printouts, I noticed something entirely unexpected. Children found to have night blindness or Bitot’s spots (early symptoms and signs of xerophthalmia) on one examination were less likely than non-xerophthalmic children to present for their follow-up examination three months later. It turned out that children with signs of “mild xerophthalmia” were more likely than non-xerophthalmic children to have died in the interim. I rang up my statistician , Joanne Katz (now a senior professor at Johns Hopkins), that evening and asked her to come in over the weekend to formally rerun the data, this time focusing on mortality as the outcome of interest. The formal, computerized analysis confirmed my backof -the-envelope calculations: children with night blindness had died at three times the rate of children with normal eyes; children with Bitot’s spots (slightly more vitamin A deficient) died at six times the rate; and children with both night blindness and Bitot’s spots (more deficient still) died at nearly nine times the rate of their unaffected peers. We were stunned by the apparent strength of the association between vitamin A deficiency and childhood mortality! In science, certainty is hard to demonstrate. While we knew that vitamin A deficiency might have been responsible for this excess childhood mortality, we also realized that the association might not have been causal; vitamin A status could have been “tracking” other characteristics, which...


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