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Biden’s Likely NIH Pick to Face March-in, Covid Origin Questions

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President Joe Biden’s potential nominee to lead the NIH will likely face questions about Covid-19’s origins and seizing patents to lower drug prices, but research advocates say it won’t stop her from securing the top medical research post.

The White House is reportedly gearing up to nominate Monica Bertagnolli, who’s currently the director of the National Cancer Institute, to run the National Institutes of Health. If confirmed, Bertagnolli would be only the second woman to lead the agency as a permanent director since the creation of that position in 1887, after the late Bernadine Healy, who served under George H.W. Bush. The late Ruth L. Kirschstein served as acting director from 2000 to 2002, as well as in 1993, under Bill Clinton.

Bertagnolli is already the first woman to lead the NCI, a position she’s held since October.

Bertagnolli’s likely nomination was first reported by The Wall Street Journal. A White House official told Bloomberg Law on Thursday there’s no decision yet.

Research advocates say it makes sense to elevate the personable head of NIH’s largest institute to run the entire $47 billion agency. She’s a physician-scientist who spent nearly a quarter century at the Brigham and Women’s Hospital and Dana-Farber Cancer Center in Boston before joining the NCI last fall. Her appointment would come after nearly a year and a half without a permanent director.

“There will be concerns raised from past activities NIH has done that the majority in the House in particular doesn’t agree,” Ellie Dehoney, senior vice president of policy and advocacy for Research!America, said if Bertagnolli’s nominated. “But I do think that this is a strong leader, a charismatic leader. She brings experience and the right combination of outward and inward focus to do this job really well.”

‘Real World Experience’

Bertagnolli, 64, is a widely respected cancer surgeon and researcher who has prioritized advancing health equity, which is one of the centerpieces of the Biden administration. She’s also leading the cancer research agency while undergoing her own treatment for cancer.

“She’s a cancer researcher that is experiencing cancer. So she brings she brings actual, real world experience to this role. That’s going to be hard for the Senate on both sides of the aisle to not see as really important,” Dehoney said.

In her six months leading NCI, Bertagnolli has already made waves working with other government agencies, patient groups, and professional societies, Ellen V. Sigal, chairperson and founder of Friends of Cancer Research, said. “She is someone that in a very short time has been well known and extremely well liked,” Sigal said. “Her broad perspective, as a researcher, surgeon, patient and a woman will add another dimension that we have not seen before—if confirmed.”

Erik Fatemi, a principal at Cornerstone Government Affairs who specialized in NIH appropriations when he was a Senate Democratic staffer, said Bertagnolli’s expertise already aligns with the president’s top research priority in cancer. She also doesn’t need convincing to leave a higher paying job in academia or the private industry because she already made that decision last year, he said.

“She checks a lot of boxes,” Fatemi said.

She’s also already been vetted by the White House for a presidentially appointed position, potentially shaving time off for her formal nomination to reach the Senate Health, Education, Labor and Pensions Committee.

Sudip Parikh, CEO of the American Association for the Advancement of Science, said he expects a lot of support from the scientific community if Bertagnolli receives the nomination. “She’s got just the street cred that among scientists, both the clinical, the basic—and the knowledge of being a patient.”

New Leadership, Potential Criticisms

At the same time, Bertagnolli would face a Senate panel with leadership that’s only been at the helm for several months and hasn’t confirmed any health nominees yet.

Senate HELP Chairman Bernie Sanders (I-Vt.), who has made lowering prescription drug costs one of his top priorities, has already criticized the NIH. Sanders issued a statement last month saying he was “extremely disappointed” about the NIH’s decision not to seize patents on Astellas Pharma Inc.’s Xtandi to lower the price of the prostate cancer drug.

Bertagnolli will have to be really prepared to address march-in rights “because that will be a very important topic of conversation in those hearings,” Fatemi said.

Sanders may try to get her on the record that she would vote differently on a citizens petition to exercise march-in rights, but that will likely be unsuccessful, Dehoney said. “At the end of the day, he’s got to believe that having a permanent director at NIH is better than not, and I don’t see him feeling good about a decision to block her nomination.”

It’s also been more than two decades since Senate HELP convened an NIH confirmation hearing. The last one happened in April 2002, when George W. Bush nominated radiologist Elias Zerhouni. The Senate unanimously confirmed the next nominee, geneticist Francis S. Collins, without a confirmation, after Barack Obama nominated him in 2009. Collins went on to serve Donald Trump and Biden until he stepped down at the end of 2021.

While Sen. Rand Paul (R-Ky.) has criticized the agency—particularly in a public spat with Anthony S. Fauci, the former infectious disease director—over questions of whether Covid-19 originated from a lab leak and whether the agency funded research that could produce a pandemic pathogen. With Republicans on the House coronavirus subcommittee and Energy and Commerce Committee, Bertagnolli may face more questions about these issues.

“She’s probably not super steeped yet in the details of the Covid origin controversy or how NIH performed during the pandemic,” Fatemi said. “But on the other side, she doesn’t come with any baggage. I think she can plausibly say, even to critics of NIH, that she’d be a clean slate.”

Parikh said he expects her to face tough questions about infectious diseases, misinformation, and other topics that fall outside of cancer, including march-in rights and Covid origins.

“Part of what the Senate will weigh is not necessarily the answers, but the framework with which she uses to get to those answers,” Parikh said. “That’ll be really important for her to articulate.”