Over the past decade, the number of clinical trials for drugs that were funded by the National Institutes of Health has dropped while the number of studies financed by drug companies has risen substantially. This is not a surprise, given the diminished NIH budget, but one researcher said this is detrimental to public health.
Overall, the number of trials registered on ClinicalTrials.gov, the federal database, doubled from 9,321 in 2006 to 18,400 in 2014, according to a research letter published in the latest issue of the Journal of the American Medical Association.
Breaking that down, the number of industry-funded trials during that period rose 43 percent, while studies that were funded by the NIH fell by 24 percent. At the same time, financing from other federal agencies rose 29 percent and funding from still other sources — such as individuals, universities and organizations — rose by 227 percent.
Why might this matter?
Trials funded by drug makers may offer limited information, according to Dr. Stephan Ehrhardt, a coauthor and professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health. Companies typically test their medicines against a placebo in order to win regulatory approval, but this approach may not give physicians enough information to make the best treatment decisions, he said.
“Let’s say a company develops drug No. 121 for lowering blood pressure and it was tested against a placebo, and is proven better,” he explained. “What do I do with that information? There are 120 others out there. Which one do I prescribe? For that answer, you need more trials that compare different drugs and treatment approaches. For this, we need funding free from commercial interests.”
He continued that industry-funded trials aren’t necessarily wrong, but “we contend that the sharp decline in NIH-funded trials is not good for public health because these are the trials that are most likely to inform decision makers about the best treatment options for patients.”
Such notions are not new, but Ehrhardt noted the research appears to be the first time that an analysis was undertaken to compare funding sources of registered studies.
But with a possible boost to NIH funding, the tide may turn.
The 2014 NIH budget, which amounted to $30 billion, is 14 percent less than the 2006 budget, when adjusted for inflation, but the NIH is slated to get a $2 billion funding increase in the federal spending bill released today, which would mark the first time in more than 12 years the agency budget would receive such a big boost. Of course, this assumes the spending bill is passed.
Ehrhardt suggested increased funding could be designated for specific research. He also believes that industry should team more often with independent investigators to run comparative studies. “The incentive to do this comes from public pressure,” he said, “because every company is interested in how they appear to the public. We need solutions and they don’t want to be seen as part of the problem.”