President Joe Biden’s nominee to lead the National Institutes of Health testified before the Senate’s health committee Wednesday, responding to questions from Republicans who pressured her on transparency regarding the COVID-19 pandemic and NIH’s research on transgender medical interventions.
Dr. Monica Bertagnolli, director of the National Cancer Institute, spoke before the Senate Committee on Health, Education, Labor and Pensions after Sen. Bernie Sanders, I-Vt., held up her nomination as NIH director for months, demanding a “comprehensive” plan from the Biden administration on lowering drug prices.
Sanders, who chairs the health committee, said America needs “fundamental changes” in the way NIH assesses prescription drugs. He urged Bertagnolli to “take on the greed of the pharmaceutical industry.”
Sen. Bill Cassidy, R-La., asked the nominee about two specific policies aimed at decreasing drug prices. Cassidy quoted Harold E. Varmus, NIH director under President Bill Clinton, who wrote that reasonable pricing clauses in NIH contracts had “driven industry away from potentially beneficial scientific collaborations.”
Cassidy asked Bertagnolli whether she would apply reasonable pricing clauses to NIH contracts, but she declined to answer.
“My concern is, based upon Dr. Varmus’ experience, that if you do institute [the clauses], you’re going to stop the translation of basic research to taking care of patients,” Cassidy said. “History tells us that if you do it, patients are damaged.”
The Louisiana Republican also asked Bertagnolli about the “march-in provision” in the 1980 Bayh Dole Act that allows the federal government to require the relicensing of a patent resulting from any amount of federal funding, if good-faith efforts are not being made to commercialize the research. He asked whether she would use such rights to lower drug prices, even though the law doesn’t allow for “march-in” rights for that purpose.
Bertagnolli declined to promise not to do so.
Advancing American Freedom, a nonprofit founded by former Vice President Mike Pence, opposes Bertagnolli’s confirmation. The Pence organization warns: “Monica Bertagnolli’s nomination is a Trojan horse for the progressive movement to further its anti-competitive and anti-innovation policy agenda that harms consumers’ access to quality healthcare and undermines critical research and development.”
Republican senators also pressed Bertagnolli on transparency regarding the COVID-19 pandemic.
Sen. Mike Braun, R-Ind., noted that the House Oversight Committee subpoenaed acting NIH Director Lawrence A. Tabak for documents regarding a top aide to Dr. Anthony Fauci, then chief medical adviser to the president, who used a private email address to avoid public scrutiny.
“If confirmed, will you comply with any subpoenas the House sends to you relating to the origins of COVID-19?” Braun asked .
Bertagnolli said she takes her “responsibility” to “be compliant with policies regarding [congressional] oversight very seriously.”
Braun also asked her to commit to not using a personal email account for official business.
“Yes, absolutely,” she said.
Multiple Republicans mentioned an National Institutes of Health study of the effectiveness of experimental medical interventions for youth who claim to identify as transgender.
The NIH granted $477,444 over five years to Boston Children’s Hospital, the University of California at San Francisco, and Lurie Children’s Hospital of Chicago for the study, titled “Psychosocial Functioning in Transgender Youth after 2 Years of Hormones.” Dr. Diane Chen at Lurie Children’s Hospital led the study, which the New England Journal of Medicine published in January.
The study analyzed 315 participants, identified as transgender and nonbinary, between the ages of 12 and 20, over the course of two years. These participants received “gender-affirming hormones,” i.e. hormones to make their male or female bodies resemble bodies of the opposite sex.
“During the study period, appearance congruence, positive affect, and life satisfaction increased, and depression and anxiety symptoms decreased,” Chen’s article on the study claims.
However, 11 participants in the NIH-funded study experienced suicidal ideation and two committed suicide. The medical organization Do No Harm found the study “fatally flawed and borderline unscientific.”
In a May letter, Republican senators expressed “grave concerns” about the study, noting that 240 of the 315 participants were minors. Besides the two who killed themselves and the 11 who had suicidal ideation, the GOP senators noted, the drugs taken by participants likely will sterilize them.
Sen. Tommy Tuberville, R-Ala., asked Bertagnolli about the NIH-funded study.
“As you know, two young people committed suicide who were part of this study,” Tuberville said. “That’s obviously a tragedy, but what concerns me even more is the fact the NIH was funding this research. And beyond that, I believe the NIH even called the study a success. That’s sick.”
“It sounds to me like the NIH totally dropped the ball on quality control and oversight,” the Alabama Republican added. “So, if confirmed, how will you make sure nothing like that ever happens on your watch?”
Bertagnolli insisted that she would make it her “highest priority” to ensure that “any research that we do that involves human beings, people, is conducted according to the highest ethical principles, so that we make sure that the research is intending to do no harm, to achieve benefit, and is done in ways that have maximum respect for the dignity of people.”
Sen. Roger Marshall, R-Kan., also asked the nominee about the study.
“Should taxpayers fund gender-reassignment experiments or research that are purely cosmetic, where you destroy health tissue and organs, or when they use FDA-approved products off-label with significant negative irreversible impacts?” Marshall asked. “Again, this off-label use isn’t treating diseases or illnesses.”
“It’s very clear that you share my concern over the well-being of the LGBTQ community, especially young vulnerable people,” Bertagnolli responded. “What I can tell you is that if confirmed, I will commit to leading NIH to conduct the research that will achieve the very best health for these vulnerable individuals.”
“Do you believe it’s OK to fund this type of research?” Marshall asked. “Do you think there’s any experiment that you can think would justify irreversibly damaging these poor little boys and girls, who are 14, 15 years old?”
“Any research that we do, Senator, with regard to human subjects, has to be done in a way that does no harm and produces the maximum benefit to the people that are participating in the research,” Bertagnolli replied.
