Biden's health moonshot

LONDON  —  Although US President Joe Biden promised to lead with “science and truth”, his administration’s efforts to advance science have fallen short. Biden only recently named a commissioner of the Food and Drug Administration, and he has yet to fill many other key science-policy positions, including the office of the White House Science Adviser and the director of the National Institutes of Health (NIH).

Nonetheless, Biden has made up some lost ground with his proposal to create a new health agency modeled on the Defence Advanced Research Projects Agency (DARPA). Earlier this month, Congress allocated $1 billion to establish the Advanced Research Projects Agency for Health (ARPA-H). ARPA-H will use emerging science to create new biotechnologies and medicines, just as DARPA has applied basic research in defense, communications, and other sectors.

Improving clinical medicine requires bold thinking, a greater appetite for risk, and sustained commitment to goal-oriented research. Yet America has lacked an agency devoted to radical health innovation. Instead, this task has fallen to DARPA, which has managed to punch above its weight in delivering new medicines and vaccines. DARPA has been working on pandemic countermeasures since 2013, and in 2017 it founded the Pandemic Prevention Platform, which focused on developing RNA- and DNA-based vaccine and antibody technologies years before SARS-CoV-2 emerged.

The same model of innovation could pave the way for more biotechnology breakthroughs. Unfortunately, like DARPA, ARPA-H has been budgeted only a fraction of what it really needs, and less than one-sixth of what Biden requested. Moreover, ARPA-H’s operational structure remains uncertain, because lawmakers, White House advisers, and the US Department of Health and Human Services disagree about whether it should be a standalone agency or a subsidiary of the NIH.

Given ARPA-H’s stated mission, it absolutely should be a standalone agency with the authority to fund radical, breakthrough science. Pushing technological boundaries and shaping new markets is a hallmark of the DARPA model, which accelerates innovation by taking big risks. DARPA relies heavily on independent program managers who are pursuing ambitious, clearly defined goals, and who work closely with contractors to ensure a project’s success and commercial viability.

More to the point, the DARPA model stands in stark contrast to that of the NIH. Although the NIH plays a crucial role in funding basic research, it lacks the boldness, risk appetite, and staff of innovative program officers that have made DARPA such a success. It takes a more conservative approach, because it is subject to an independent review process that reduces its tolerance for risk and failure. Whereas DARPA evaluates each project according to a specific need, the NIH must score all proposals against each other.

Risky investments in biotechnology innovation belong in a category of their own. That is why both Biden and former NIH director Francis Collins have argued for ARPA-H to be a standalone agency. The point of the agency is to fill major gaps in the current innovation pipeline for biotechnology: the stages from basic research through clinical trials. To succeed in accelerating innovation and reducing drug costs, ARPA-H will need a much larger budget than DARPA’s Biological Technologies Office, and it will need to adopt established approaches to health innovation.

To that end, ARPA-H should incorporate an “extended pipeline” model of innovation that supports innovation all the way from research to commercialisation, as DARPA does. It should take a mission-oriented approach to fill gaps in biomedical innovation. It should focus on funding radical innovation. And it should ensure control over drug prices and access. At a time when Big Pharma is spending more on share buybacks (to boost share prices, stock options, and executive pay) than on research and development, such conditionalities are necessary to ensure that innovation serves the public good.

The establishment of ARPA-H will create many new opportunities. The agency could reinforce an emphasis on public health, broaden access to technology, reduce prices, enhance knowledge transfer and rationalise procurement at the international level. And with a clear DARPA-inspired design, it could ensure that taxpayer-funded drug innovation actually benefits the taxpayer, not just Big Pharma’s shareholders.

In its own collaboration with the private sector, the NIH has consistently failed to establish conditions that would ensure benefits to the wider public. ARPA-H must follow a different model. Why fund innovations that people will be unable to access? The United States needs purpose-oriented agencies to address its mounting problems. The opioid crisis has highlighted the strong links between public-health problems and inequality, and the COVID-19 pandemic has underscored the need for more government-funded procurement of medicines and vaccines.

Government programmes should be designed to serve the needs of the public, not just private-sector profits. ARPA-H is an opportunity to demonstrate the wisdom of that approach.

Mariana Mazzucato, professor of Innovation and Public Value at University College London, is the author of “Mission Economy: A Moonshot Guide to Changing Capitalism” (Penguin Books, 2022). Travis Whitfill, a health policy researcher at Yale University, is a partner at Bios Partners and a graduate researcher at University College London’s Institute for Innovation and Public Purpose. Copyright: Project Syndicate, 2022. www.project-syndicate.org