Nominated by President Joe Biden, the National Institutes of Health’s (NIH) new director Monica M. Bertagnolli took the reins of the world’s largest public funder of biomedical research earlier this month. With a clear focus on improving access and clinical trial diversity, Bertagnolli’s priorities for the role appear to align with the Biden administration’s broader healthcare agenda.

 

We should be able to guarantee that the American people are getting a return on their investment by ensuring that health-care innovations are available and affordable for everyone

Monica M. Bertagnolli, NIH director

 

Endorsed by Biden

The National Institutes of Health (NIH), part of the US Department of Health and Human Services, is the main agency within the United States government responsible for biomedical and public health research as well as the world’s largest public funder of biomedical research. The NIH invests most of its nearly USD 48 billion budget in medical research through some 50,000 competitive grants to researchers at universities, medical schools, and other research institutions throughout the country, as well as in-house research at NIH labs at its campus in Bethesda, Maryland.

Lacking a permanent director after Dr Francis S. Collins stepped down nearly two years ago, earlier this year President Joe Biden nominated Monica M. Bertagnolli to fill the leadership gap. At the beginning of November, Bertagnolli became the NIH’s new director and the second woman to lead the agency.

Former director of the National Cancer Institute who has served on the board of directors of the American Society of Clinical Oncology (ASCO), Bertagnolli is a surgical oncologist who previously worked at the Division of Surgical Oncology at Brigham and Women’s Hospital, the Dana-Farber Cancer Institute, and as professor of surgery at Harvard Medical School.

President Biden praised Bertagnolli’s career and underlined her commitment to equitable access. “Dr Bertagnolli has spent her career pioneering scientific discovery and pushing the boundaries of what is possible to improve cancer prevention and treatment for patients and ensuring that patients in every community have access to quality care,” he said in his nomination announcement.

 

Improving Access

Improving access is indeed central to Dr Bertagnolli’s vision for the country’s top research agency. In her acceptance speech she spoke about supporting research that is both equitable and accessible to all. “I have seen the transformative power of the NIH research to produce results that save lives,” she said. “But I’ve also seen the patients whose prospects were compromised by preventable factors. We should be able to guarantee that the American people are getting a return on their investment by ensuring that health-care innovations are available and affordable for everyone.”

“Dr Bertagnolli understands not only the importance of advancing discovery but the criticality of ensuring that innovation is accessible to all. She played a key role in helping to advance the American Cancer Society Cancer Action Network’s work on Medicaid expansion,” commented Karen Knudsen, CEO of the American Cancer Society and American Cancer Society Cancer Action Network.

Having grown up in rural Wyoming, Bertagnolli says that she has witnessed access challenges, particularly those facing rural communities.

 

Diversity in Clinical Trials

In a country where clinical trials are largely carried out among the white population —75 percent in 2020 according to Food and Drug Administration (FDA) data— one of Bertagnolli’s key priorities will be to increase diversity in clinical trials.

“As NIH director, I look forward to ensuring that NIH continues to be the steward of our nation’s medical research while engaging all people and communities in the research effort,” she stated. Bertagnolli did in fact initiate efforts during her tenure as NCI Director to expand cancer clinical trials and increase the diversity and number of participants in NCI-supported research.

 

Reinforcing Biden’s Healthcare Agenda

Bertagnolli’s appointment appears to align with the Biden administration’s healthcare agenda, which has consistently brought forward policies and initiatives to lower healthcare costs and improve access to care.

Biden has shown his ongoing support for the Affordable Care Act (ACA) initially enacted by former President Obama and has introduced new actions to reinforce it, cracking down what is known as “junk” insurance policies and surprise medical bills. The president has also launched programmes such as the Persistent Poverty Initiative, designed to address the structural and institutional factors of persistent poverty in the context of cancer.

However, the Inflation Reduction Act (IRA) is by far the Biden administration’s boldest move to lower Americans’ healthcare costs. Passed last year, the IRA enables the US government to negotiate the prices of the drugs its Medicare healthcare program for over 65s spends the most on.