President Joe Biden announced this week plans to nominate Dr. Monica Bertagnolli, director of the National Cancer Institute (NCI), to lead the NIH, filling the vacant slot left by former director Dr. Francis Collins when he stepped down from the role in 2021. Bertagnolli, however, could be in for a tougher Senate confirmation process than her predecessors, as the agency has faced an onslaught of criticism from both sides of the aisle over the last few months.
Background: A cancer surgeon and the first woman appointed to lead the NCI, Bertagnolli was an expected pick for the position given President Biden’s focus on oncology research and recent pledge to cut cancer death rates by 50% in the next 25 years. Having served in the top NCI spot since 2021, Bertagnolli has played an integral role in developing the administration’s National Cancer Plan — an eight-pronged, cross-sector goal to slice the cancer death rate. In that role, and throughout her career, Bertagnolli has also been keenly focused on improving health equity in medical research.
As former president of the American Society of Clinical Oncology (ASCO), she strove to increase racial and ethnic diversity among the oncology workforce, arguing that fewer disparities in the makeup of care providers would improve minority health outcomes. The theme she chose for the ASCO conference that year was “Caring for every patient, learning from every patient.” Prior to that position, she put her understanding of diversity issues into practice as a physician while trying to enroll Native American participants in a cancer genetics trial in Utah. When she and her team learned that the community operated on a barter system, they began giving participants “specially designed paper summaries” after visits, and engagement numbers began to increase.
Her approach to decreasing disparate outcomes is informed by her childhood growing up on a 4,800-acre ranch in Wyoming, where her father had to travel eight hours to the nearest healthcare facility to receive cancer treatment. More recently, her mission in healthcare, and particularly cancer care, has become even more personal. In 2022, while serving as NCI director, Bertagnolli was diagnosed with breast cancer and began receiving treatment at the two hospitals where she practiced as a surgeon: Brigham and Women’s Hospital and Dana-Farber Cancer Institute.
“As doctors, we are also human, and we are not fundamentally different from the people that we care for just because we are on the provider side of things,” she’s said of how her diagnosis has impacted her approach at NCI. “The patient experience is something that I think everyone goes through in life — although each individual’s experience is unique, especially when it comes to cancer.”
Why it matters: Bertagnolli is entering the national healthcare conversation at a contentious time for the NIH, as it battles an array of criticism on its role in the COVID-19 pandemic, current drug pricing debates and heightened scrutiny over the value of federal research dollars.
Congressional Republicans have two ongoing investigations into the Institutes: One focused on NIH-funded virus research in Wuhan, China, and another examining its $1 billion in spending on public relations services over the last five years.
“As doctors, we are also human, and we are not fundamentally different from the people that we care for just because we are on the provider side of things."
Dr. Monica Bertagnolli
Biden's nominee to lead the NIH
“The NIH — operating without a permanent leader for nearly a year and a half — has fallen short of its core mission ‘to exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science,” Rep. Cathy McMorris Rodgers, who leads the House Energy and Commerce Committee, with oversight over the NIH, said. “I congratulate Dr. Bertagnolli on her nomination. If confirmed, she has an opportunity to begin rebuilding public trust in NIH so it can effectively conduct important and potentially life-saving research.”
On the other side of the aisle, Senate Democrats are likely to press Bertagnolli on the NIH’s use of march-in rights granted under the Bayh-Dole Act of 1980. The rights allow the NIH to revoke a drug patent from a company that received federal funds and relicense it to other manufacturers. Earlier this year, acting NIH director Lawrence Tabak declined a petition to lower the price of the prostate cancer treatment Xtandi, exercising those rights. Since then, the HHS and Department of Commerce have begun reviewing the government’s march-in authority and developing a framework for implementation of the policy. But that likely won’t influence Sen. Bernie Sanders, who chairs the Senate Committee on Health, Education, Labor and Pensions (HELP) and will preside over Bertagnolli’s nomination.
“I will strongly oppose any future nominee to a major federal health agency who is not prepared to significantly lower the price of prescription drugs in this country,” Sanders said in a recent letter to President Biden, which was published after initial reports that Biden was considering Bertagnolli for the NIH job.
To make matters more fraught for Bertagnolli, NIH has faced more questions over the last few months about the value of its research dollars. In February, an analysis found that, out of the 354 pediatric trials the NIH funded and $362 million it spent over a three-year period, there was little oversight into trial operations and only a 54% chance that results would be published within four years after the grant was completed. And with the $1 billion the NIH has so far allocated to long-COVID research, it still has yet to enroll a patient in a trial testing a potential treatment.
President Biden’s 2023 budget proposal also included only a small increase in funding for the agency, with more than half of the $920 million increase allocated to the Cancer Moonshot Initiative. Meanwhile, the NIH’s new sister agency, the Advanced Research Projects Agency for Health, known as ARPA-H, was slated to receive a $1 billion bump in the proposal, leading to concerns even among HHS leadership that the two agencies could see internal competition in the future.
With the swell of issues facing the NIH, Bertagnolli could become a key voice in the major conversations not only at the agency, but the life sciences community as a whole. And, if she receives the Senate’s stamp of approval, she’ll have a full plate of work ahead.