GoKawiilFor 80 years, federally supported research in the United States has fuelled scientific and technological advancements, including the Internet, space exploration and the development of semiconductors and biotechnologies. In biomedicine, innovations have led to vaccines and therapeutics, breakthroughs in cancer and cardiovascular care and gains in life expectancy and quality of life.
How data can help to guide NIH funding policy
Yet, the accelerating pace of innovation, alongside the complexity and scale of today’s societal challenges, requires a shift in how research investments are prioritized and governed. For example, artificial intelligence, big data and continuously collected health information are enabling more-precise prediction and prevention strategies. Such advances could reduce the burden of disease by detecting risks earlier, offering personalized interventions and improving treatment outcomes.
The roll-out of breakthroughs in the United States has conventionally followed the ‘linear’ framework laid out in science adviser Vannevar Bush’s 1945 report to then US president Harry S. Truman1. In Bush’s model, the federal government distributes money through its agencies; academics generate discoveries that companies translate into commercial applications; and intellectual-property rights boost private-sector investment and markets. This framework has catalysed decades of economic and technological gains, and has been copied worldwide. However, the private sector’s growing emphasis on reducing risk and maximizing returns is distorting research priorities in ways that Bush did not anticipate.
Companies are focusing on some diseases at the expense of others. For example, in 2022, more than half of US Food and Drug Administration (FDA) approvals of new drugs were for those targeting cancer and rare diseases2. Such areas generate high revenues because drug prices are high, people are willing to pay for the latest treatments and accelerated approval pathways shorten the time to market. For well-understood diseases such as these with clear therapeutic targets, the development risk for sponsors is low.
By contrast, new psychiatric therapies accounted for only 4.8% of FDA approvals from 2018 to 20223, despite more than one in five US adults living with mental illness in 2022 (see go.nature.com/4tygtd5). Developers might have been put off from entering this area because the understanding of complex disease mechanisms is limited and clinical trials often fail — which increases cost, uncertainty and risk.
A mainly market-driven approach also encourages companies to prolong monopolies and limit competition from generic versions of drugs. A product’s commercial life can be extended by varying its formulations, routes of administration and methods of use. Maintaining patent protections and market exclusivity hinders access by patients to affordable treatments, and contributed to an average price increase of 68% for the 12 best-selling drugs in the United States between 2012 and 20194.
Addressing the societal challenges of health security, chronic disease and population wellness requires a long-term, multidisciplinary approach, which is difficult to achieve through typical four-to-five-year government grants. Translation into the clinic and follow-up trials can take more than a decade.
Making progress in US biomedicine will require balancing market incentives and public needs.Credit: Wolfgang Hoffmann/Design Pics Editorial/Universal Images Group via Getty
Reforms are needed to ensure that the public is able to benefit appropriately from the research investments that are paid for by taxation. A coordinated strategy that balances market incentives with public needs is necessary to shape the next era of biomedical progress.
... continue reading