ROI slipping in biomedical research

The increasing amount of money spent on biomedical research in the US over the past 50 years has resulted in diminished return on investment in terms of life-expectancy gains and new drug approvals, according to researchers from the Johns Hopkins Bloomberg School of Public Health.

Writing in the journal Proceedings of the National Academy of Sciences, the researchers found that while the number of scientists has increased more than ninefold since 1965 and the National Institutes of Health’s (NIH) budget has increased fourfold, the number of new drugs approved by the FDA has only increased a little more than twofold. Meanwhile, life-expectancy gains have remained constant at roughly two months per year.

“We are spending more money now just to get the same results we always have, and this is going to keep happening if we don’t fix things,” said study co-author Professor Arturo Casadevall.

The NIH budget grew substantially from 1965 to 2003, before a steady decrease from 2003 to 2014. Meanwhile, the cost per new drug, in millions of dollars of NIH budget, has grown rapidly since the 1980s. According to Professor Casadevall’s co-author, Anthony Bowen, “There is something wrong in the process, but there are no simple answers.

“It may be a confluence of factors that are causing us not to be getting more bang for our buck,” Bowen said. The authors suggest that these factors may include the following:

• Increased regulations, adding to the non-scientific burdens of scientists who could otherwise spend more time at the bench.
• The fact that all the ‘easy cures’ have been found, and that to tackle Alzheimer’s disease, cancers and autoimmune diseases is inherently more complex.
• ‘Perverse’ incentives for researchers to cut corners or oversimplify their studies to gain acceptance into top-tier medical journals, resulting in findings that cannot be reproduced and are therefore worthless.

“The culture of science appears to be changing,” Professor Casadevall said. “Less important work is being hyped, when the quality of work may not be clear until decades later when someone builds on your success to find a cure.” One recent study estimated that more than $28 billion is spent each year in the US on preclinical research that can’t be reproduced and that the prevalence of these studies in the literature is 50%.

While new drug approvals and life-expectancy rates are not the only measures by which to judge the efficiency of biomedical research, the authors argue that a sick person will ultimately need either medicine or surgery to save their life. Many times these medicines haven’t been developed, they state, with Professor Casadevall noting that many of the best drugs being used to treat conditions today were developed many decades ago.

“Scientists, regulators and citizens need to take a hard look at the scientific enterprise and see which are problems that can be resolved,” concluded Professor Casadevall.

“We need a system with rigour, reproducibility and integrity, and we need to find a way to get there as soon as we can.”