President Biden’s presumed pick to lead the National Institutes of Health, Monica Bertagnolli, will face a slew of questions on the multibillion-dollar agency’s spending and oversight in her upcoming confirmation battle.

This week, though, she won’t face what otherwise would have been Congress’s first round. A source close to the top cancer official, who announced her own cancer diagnosis last December, said she had to drop out of a scheduled Senate Appropriations Committee hearing Thursday because of previously scheduled routine cancer treatment, though she remains healthy.

The National Cancer Institute’s second-in-command, Douglas Lowy, will testify instead, alongside acting NIH director Lawrence Tabak and other senior NIH officials.

In the backdrop of Bertagnolli’s absence are White House plans to announce her as the NIH Director nominee as soon as this week; she has already been vetted for the role and her nomination was originally planned for late April, according to two people familiar with the planning.

Spokespeople for the Senate committee and the White House did not respond to requests for comment. It is not clear why the administration delayed the announcement to fill a role vacant since longtime director Francis Collins stepped down in December 2021.

In the 17 months since, administration officials including Collins — still working as an adviser to Biden — courted scientists from some of the country’s top universities including Elizabeth Jaffee, deputy director of Johns Hopkins Cancer Center, and Mary Klotman, dean of Duke’s School of Medicine, according to multiple sources. Collins has told media outlets he hoped his replacement would be a woman.

While each potential nominee had their own reasons for turning down the post, the prospect of a Senate confirmation process defending the health research agenda during a politically divisive time loomed large, those sources said.

Ultimately, Bertagnolli stands to inherit a well-funded and typically bipartisan agency that nevertheless has been beset in recent years by accusations of a slow bureaucratic culture, lack of accountability around massive spending, and charges of irresponsible infectious disease research.

“Turning around a battleship — and that’s what the NIH is — is a daunting task for anybody,” said Liz Feld, former president of cancer advocacy group Suzanne Wright Foundation, which advocated for years to establish a separate agency cutting through the bureaucratic red tape that critics say slow down NIH projects. Biden launched a version of that vision, the Advanced Research Projects Agency for Health, last year, with a fraction of the funding he requested.

But there’s still a range of issues surrounding NIH culture, including its lack of diversity and general complacency among institute leaders, many of whom are in their 60s and 70s, according to advocates including Greg Simon, former president of the Biden Cancer Initiative, the now-president’s nonprofit effort to realize his Cancer Moonshot goals.

“Right now, people tend to think that once we give the NIH the budget they should have, we’re done. That’s a real problem,” Simon said. “It’s not about the money, it’s about culture. And if we don’t change the culture, we keep spending money in the wrong way.”

While Bertagnolli won’t appear before the Senate panel on Thursday, her colleagues can expect lawmakers to question everything from the administration’s proposed budget increase to the agency’s controversial $1 billion spend on long Covid research that has, so far, nothing to show for itself. There are also likely to be questions about NIH’s approach to infectious diseases and its spending on gain-of-function research, a hot topic that has been thrown back into the spotlight amid the Covid-19 pandemic — a preview of the confirmation process to come.

Republican lawmakers in particular have called for a ban on gain-of-function research, which is when scientists alter a pathogen, often making it more transmissible, in order to better understand its spread and how to develop countermeasures. The research is also at the center of some still-unproven theories about how the coronavirus originated. A panel of NIH advisers in January advised boosted oversight of these types of studies but stopped short of recommending a renewed moratorium (the Trump administration lifted the last ban).

Recently retired National Institute of Infectious Disease and Allergy Director Anthony Fauci, who has vehemently denied that his agency funded gain-of-function studies in Wuhan, China, has blasted moves to ban the research even as GOP lawmakers such as Sen. Rand Paul (R-Ky.) question its value to infectious disease research.

“Some want to pass a law: All gain-of-function should be stopped,” he told The New York Times in April. “But if all gain-of-function stops, you will have no vaccines for flu. You will have no vaccines for any of the other diseases, because all of that manipulates a virus or a pathogen to gain a certain function to be able to make a vaccine.”

While she’s entering an increasingly political arena around scientific research, multiple people who spoke to STAT praised Bertagnolli’s credentials, citing her medical background as a surgical oncologist and her quick leadership at NCI.

“Even through a very challenging time for her personally, she has become a superstar, very energetic and well-liked,” said Ellen Sigal, founder and chair of the Friends of Cancer Research. “She views the job — the NCI job, but certainly would [view] the NIH job — as not in a silo. Cancer patients get diabetes and Alzheimer’s and all these other diseases too.”

Bertagnolli took over the National Cancer Institute in October with promises to diversify clinical trials and speed access to treatment. She was heralded as the first woman to run the $7.8 billion institute after years as a cancer surgeon in the Boston area, where she also was the first woman named to head the Dana-Farber Cancer Institute’s surgical oncology unit.

When Bertagnolli announced her cancer diagnosis, roughly two months into her tenure, she stressed that she would stay on the job and weave her cancer experience into her work.

“It’s one thing to know about cancer as a physician, but it is another to experience it firsthand as a patient as well,” she said in a statement at the time. “To anyone with cancer today: I am truly in this together with you.”

https://www.statnews.com/2023/05/03/bertagnolli-nih-political-questions/