S. Claiborne Johnston
A study in the April 22, 2006, issue of
Lancet finds that estimated conservatively, the economic benefit in the United States from just eight National Institutes of Health (NIH)-funded clinical trials exceeded $15 billion over the course of 10 years. The study also found that the new discoveries from the trials were responsible for an estimated 470,000 healthy years of life.
S. Claiborne Johnston, MD, associate professor of neurology at UCSF, was the lead investigator in this study, which evaluated the costs and public benefits of all 28 phase III clinical trials supported by the National Institute of Neurological Disorders and Stroke (NINDS) between 1977 and 2000.
In an accompanying editorial, Colin Blakemore, head of the British Medical Research Council, and John Davidson state, "The results, which add substantially to reports in the field, will be welcomed by researchers and governments alike. . . . Their conclusions underline the benefits to society of investment in high-quality medical research."
The investigators used a measure called "quality-adjusted life years" (QALYs) to measure the impact of improvements in health and survival from changes in medical practice associated with the trials. Using this measure, a year of life in perfect health is considered equal to one QALY, and a year of suboptimal health is assigned a numerical value between zero and one, based on the severity of the impairment. The value of a single QALY was estimated at $40,310, which was the average economic productivity of a US resident in 2004, regardless of employment or age, according to the US Bureau of Labor Statistics. The total societal economic impact for the trials was calculated as the total net health benefit in QALYs, multiplied by average economic productivity, minus the increase in costs related to the tested therapies and the total cost of the clinical trials.
"While the study put us in the unfortunate situation of putting a dollar value on human life, those numbers really drive home the point of how valuable clinical trials are," Johnston said. "And added to that, when you look at the years of healthy life gained, it makes this information even more valuable."
Johnston also pointed out that the study reinforces the importance of participation in clinical trials. "These trials could not have been completed without people participating," he said. "The benefit to humanity is incalculable."
"The results of this analysis demonstrate the return of the public investment in NIH research for the American people, not only in economic terms, but in additional healthy years of life," said Elias A. Zerhouni, MD, director of the NIH. "We are transforming the practice of medicine by moving into an era when treatment will increasingly become more predictive, personalized and preemptive."
"This has been a time of belt-tightening for the NIH, and this study helps justify having its budget doubled," Johnston said. "While we looked at only one program - NINDS - I believe other NIH programs are at least as valuable. It's important to remind people that this is science paid for by the NIH, and this investment is really paying off."
Among the trials analyzed in this study were some of NINDS' better-known successes. One was a trial of tissue plasminogen activator (t-PA) for ischemic stroke that showed t-PA could prevent brain damage if used within the first three hours after a stroke begins. Another was the Randomized Indomethacin Germinal Matrix/Intraventricular Hemorrhage Prevention Trial, which showed that using indomethacin in premature babies can prevent brain hemorrhage. Each of these studies had an estimated net value of more than $6 billion over 10 years.
The research was funded by NINDS, but to reduce bias, it was performed independently and the sponsor had no control over the content of the analysis. In addition, an independent panel of health policy experts audited the analysis and reviewed the manuscript.
