Historian's Perspective
When the 'Gold Standard' Was Controversial
By Rosser Matthews
For many researchers at NIH, the usefulness of large population-based studies seems self-evident. In its most rigorous form as a randomized controlled clinical trial, it is often held up as the "gold standard" for scientific inquiry. However, it is important to remember that today's "taken-for-granted" assumptions often conceal yesterday's controversies. One interesting example of this phenomenon involves the National Collaborative Perinatal Project, which was launched by the National Institute of Neurological Diseases and Blindness in the 1950s.
Conceived by the institute's first director Dr. Pearce Bailey, the project followed more than 50,000 women from the time of their pregnancies until their children reached age 8. The study, which collected data into the 1970s, generated an enormous amount of empirical information. In a 1986 editorial in the New England Journal of Medicine, epidemiologist Nigel Paneth praised the support that had been provided by NIH and singled out Dr. Richard L. Masland, director of NINDB from 1959 to 1968: "The kind of vision that Richard Masland demonstrated when he created the National Collaborative Perinatal Project may yet be found among our funding agencies. Research is costly, but childhood neurologic handicap is costlier still."
Anyone who read only Paneth's comments might assume that the scientific merit of the NCPP had never been questioned. The historical record, however, indicates otherwise. In the 1950s, the human embryology and development study section voiced concern that large amounts of money would be spent without adequate oversight. In 1965, a presidential committee urged that all collaborative projects be kept "as small as possible." In 1967, Charles W. Whalen, a Republican Congressman, cited the $75 million that had been spent on the NCPP as an example that "the taxpayers' dollars are not always wisely spent."
Despite these criticisms, the NCPP survived. By promoting interdisciplinary research, the project helped establish the contemporary field of pediatric neurology. Also, it was one of a number of studies that led researchers to question the belief that birth asphyxia (suffocation) often contributed to cerebral palsy.
What is the historical lesson of the NCPP? It can serve as an antidote to complacency. In an era when "evidence-based medicine" is widely touted (often in the name of cost-effectiveness), it is important to remember that the process of collecting empirical evidence can itself be a very costly (and potentially controversial) process.
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