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President Joe Biden this week nominated cancer specialist Dr. Monica Bertagnolli for director of the National Institutes of Health (NIH) — a move that has already generated controversy because of Bertagnolli’s longstanding financial ties to Pfizer and other pharmaceutical companies.
If confirmed, Bertagnolli will replace the NIH’s acting director, Lawrence Tabak, D.D.S., Ph.D., who has held the position since the NIH’s previous permanent director, Francis Collins, M.D., Ph.D., resigned in December 2021.
She will oversee a $47 billion budget that encompasses “a wide variety of medical research beyond cancer, including infectious diseases, heart disease, Alzheimer’s and other brain disorders, diabetes, drug addiction and mental health,” according to The Associated Press.
Bertagnolli is director of the National Cancer Institute (NCI), the largest of the 19 institutes and seven centers under the aegis of the NIH. Biden named her NCI director in August, making her the first woman to hold the position.
In announcing the nomination, Biden highlighted Bertagnolli’s past experience as a professor of surgical oncology at Harvard Medical School and a surgeon at Brigham and Women’s Hospital in Boston; CEO of Alliance Foundation Trials, LLC, which conducts international cancer clinical trials; and group chair of the Alliance for Clinical Trials in Oncology.
Under Bertagnolli’s leadership, the Alliance for Clinical Trials in Oncology has received more than $323 million in funding from Pfizer and other Big Pharma firms, according to Open Payments data revealed by The Daily Signal and The Heritage Foundation’s Oversight Project.
In a series of tweets, Robert F. Kennedy Jr., Children’s Health Defense chairman on leave and Democratic candidate for president in 2024, criticized Bertagnolli’s nomination, noting that “The White House left the Pfizer connection out of its announcement of the nomination.”
“Does this mean Dr. Bertagnolli is personally corrupt? Not at all. But it does mean that she will probably represent the viewpoints and priorities of the pharmaceutical industry. That is how agencies are captured,” Kennedy wrote.
Yesterday, President Biden announced Dr. Monica Bertagnolli as his intended nominee for Director of the NIH. Guess what? From 2015-2021, Bertagnolli received more than 116 grants from Pfizer, totaling $290.8 million. This amount made up 89% of all her. research grants.…
— Robert F. Kennedy Jr (@RobertKennedyJr) May 16, 2023
Dr. Anthony Fauci, the recently retired director of the National Institute of Allergy and Infectious Diseases, also part of the NIH, told The Washington Post that he personally advocated for Bertagnolli’s nomination, citing her “very solid” academic record.
“She’s got the kind of personality that I think is important for the director of NIH,” Fauci said.
Bertagnolli also previously led gastrointestinal science initiatives at the NIH-funded Cancer Cooperative Groups, headed Dana-Farber Brigham Cancer Center’s surgical oncology division, was founding chair of the Minimal Common Oncology Data Elements executive committee, and was former president of the American Society of Clinical Oncology.
Biden ‘well aware’ of Bertagnolli’s ties to pharma
Between 2015 and 2021, Bertagnolli, via the Alliance for Clinical Trials in Oncology, received $290.8 million in funding from Pfizer alone, according to The Daily Signal. The funding consisted of at least 116 grants and made up 89% of the total grant monies she received during this period.
The data, collected from Open Payments — a national transparency platform operated by the Centers for Medicare & Medicaid Services — also revealed that Bertagnolli received $17.4 million in grant funding from Janssen Research & Development, LLC, a subsidiary of Johnson & Johnson (J&J).
Both Pfizer and J&J received Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) for their COVID-19 vaccines.
The Daily Signal reported on the funding in August 2022, at the time of Bertagnolli’s confirmation as NCI director. In an email to The Daily Signal at the time, Bertagnolli said:
“The funding from Pfizer (and all other industry funding allocated to me) was not in the form of grants to me directly. This funding was in the form of contracts entered into by the Alliance for Clinical Trials in Oncology.
“All industry contracts were used by the Alliance’s 3,000+ member clinical trials group to conduct cancer clinical trials. Importantly, virtually all of the funding from Pfizer was for a single large international breast cancer clinical trial — a very high $$ total because it enrolled over 6,000 patients over quite a number of countries.
“The funding was distributed across many different health care institutions — both academic and community — to conduct the trial. Alliance overall does not have more involvement with one industry partner over another — it’s just that this one Pfizer trial was very large and therefore very expensive.”
Oncology is a significant moneymaker for Pfizer — in its second-quarter report for 2022, the drugmaker reported $3 billion in revenue from its oncology division.
Journalist Paul D. Thacker questioned the likely Big Pharma lobbying behind Bertagnolli’s nomination, implying that public knowledge of her ties to Pfizer and other companies would not have been possible without the transparency afforded by the Open Payments platform:
This is why I did 70 hour work-weeks for several years to get this law passed. How much you wanna bet Pfizer lobbied the White House for their multi-million dollar researcher Monica Bertagnolli to run NIH?
How much you wanna bet pharma lobbyists are hitting Senate committees to… pic.twitter.com/Gce0LIgbYD
— Paul D. Thacker (@thackerpd) May 16, 2023
“This is why I did 70 hour work-weeks for several years to get this law passed” Thacker said, referring to the Physician Payments Sunshine Act, which requires companies to report any gifts or payments they received exceeding $10. The bill also led to the development of the Open Payments platform.
Thacker previously worked with Sen. Chuck Grassley (R-Iowa) and U.S. Senate lawyers to write the bill.
Prior to Bertagnolli’s nomination, on April 26, Sen. Bernie Sanders (I-Vt.), who chairs the Senate’s health panel, sent Biden a letter saying he would “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 does not appear to have publicly commented on Bertagnolli’s nomination, as of the time of this writing.
WashPost reports Sanders will oppose nominees who won’t “stand up and fight” the drug industry.
— Paul D. Thacker (@thackerpd) May 16, 2023
In an interview with The Defender, Thacker questioned Bertagnolli’s ability to resist pressure and lobbying from Big Pharma.
“How do you confront Big Pharma when the vast majority of your research portfolio is funded by Big Pharma?” Thacker asked.
Thacker noted that the Biden administration, despite not mentioning Bertagnolli’s Big Pharma ties in its official announcement, is well aware of her ties with drugmakers.
“I worked in the Senate, so I know how these things work,” he said. “They vetted her.”
“Probably what’s going on already is, you’ve got Pharma and the NIH and the NIH-funded Pharma people going to all these Senate committees to smooth her transition to become NIH leader,” Thacker added.
Thacker referenced a 2005 book, “The Truth About the Drug Companies: How They Deceive Us and What to Do About It,” which noted that the vast majority of Big Pharma’s research is done via NIH-funded studies.
“They don’t do basic research,” Thacker said. “The Pharma companies don’t do that anymore. They rely on the taxpayers to do all the research. We pay for all the basic research that they then go on to develop a drug off of.”
Big Pharma “wants taxpayers to fund basic research and Pharma-focused research,” Thacker said, “and all they want to do is scoop up all the intellectual property created through taxpayer-funded research and then ram that through the FDA, and we’re paying for this stuff.”
“Why do we have to keep paying all the time to do Pharma’s research? It’s ridiculous,” he said. “This money belongs to the taxpayers. It belongs to us. It doesn’t belong to Pharma.”
Thacker told The Defender the NIH is “stalling” congressional efforts to collect documents regarding the origins of COVID-19.
“I’ve never seen the NIH behave this way,” Thacker said. “Their behavior is disgusting.”
As a result, Thacker suggested that Bertagnolli’s confirmation should be withheld at least “until NIH responds to all questions, to all Congressional requests about the origins of COVID.”
In a statement released as part of the White House announcement, Bertagnolli did not address her Big Pharma funding or any such controversies. She said, in part:
“I am honored that President Biden has announced his intention to nominate me to be the next Director of the National Institutes of Health. I will continue to serve as NCI Director until the Senate confirmation process is completed.
“As NCI Director, I am privileged to serve alongside so many talented individuals dedicated to ending cancer as we know it, and I remain committed to working together to improve the health of all people. I thank you for your continued support.”
In December 2022, Bertagnolli revealed she was diagnosed with early-stage breast cancer. At the time, she said that this experience gives her a patient’s perspective on treatment. According to AP, she stated:
“It’s one thing to know about cancer as a physician but it is another to experience it firsthand as a patient as well. To anyone with cancer today: I am truly in this together with you.”