Bertagnoli named new director of National Institutes of Health

The Senate on Tuesday voted 62-36 to confirm cancer surgeon Monica M. Bertagnoli to head the National Institutes of Health, after months of controversy involving key senators. Ensured that flagship biomedical institutions had permanent leaders. Derail her nomination.

Bertagnoli will be the second woman to lead the approximately $48 billion agency. The agency plays a central role in the nation’s scientific agenda by providing grants to hundreds of thousands of researchers, overseeing clinical trials at its Maryland campus, and supporting drug development and other efforts. plays a role. therapeutic drug.

The NIH has not had a permanent director since December 2021, with longtime NIH official Lawrence A. Tabak serving as acting director of the agency. Biden officials and allies have spent months urging the Senate to move quickly on Bertagnoli’s nomination, saying the vacancy threatens U.S. biomedical research. The agency has been the subject of multiple congressional investigations in the wake of the coronavirus pandemic, has come under attack from Florida Gov. Ron DeSantis (R) and other prominent Republicans, and has been criticized by NIH leaders. claims it mismanaged the virus response and is calling for a review of the agency. .

Research America, a nonprofit medical and health research organization, sent a letter to Senate leaders last week warning that it “strongly believes that Dr. Bertagnoli is the right leader at the right time,” and warned that “Dr. Bertagnoli is the right leader at the right time.” He warned that “there are” threats to funding and policies behind the move. Nothing is more obvious than this. ”

Biden officials welcomed Tuesday’s bipartisan vote, noting that 13 Republicans, along with 47 Democrats and two independents, voiced support for Bertagnoli, and supported the new leadership of the NIH. He said widespread support would help empower the agency.

“I have no doubt that she will reconsider the limits of what is possible when it comes to what NIH can accomplish,” Health and Human Services Secretary Xavier Becerra said in a statement after the vote.

Mr. Bertagnoli is a Harvard-trained physician and former chief of surgical oncology at Dana-Farber Brigham Cancer Center in Boston, where he currently serves as the 73rd largest of the 27 institutes and centers that make up the NIH. He heads the billion-dollar National Cancer Institute. President Biden nominated Bertagnoli to head the NIH 175 days ago in May, but his confirmation was delayed by Sen. Bernie Sanders (I-Vt.), chairman of the Senate Health Committee, and Bertagnoli was nominated as Biden’s nominee in May. We have made it clear that we will not allow anyone to do so. It will be required to undergo approval hearings until the president’s team presents a comprehensive plan to lower drug prices in the United States.

Sanders said in a statement that he authorized Bertagnoli’s nomination to be advanced in September after receiving assurances from the White House that Bertagnoli “continues to work to lower prescription drug prices,” and that the federal health department will be responsible for future health care costs. He stated that he had taken steps to curb the spread of the virus. COVID-19 treatment. However, the Senate Health Committee chairman still voted against Bertagnoli after his confirmation hearing, saying he remained dissatisfied with Bertagnoli’s stated plans for the NIH and that Americans should not receive NIH support. It cited data that shows it consistently pays higher prices than people in other countries for the medicines it develops. .

“Dr. Monica Bertagnoli is an intelligent and caring person who is ready to take on the greed and power of the pharmaceutical and medical industries and fight for the changes that the NIH needs at this critical moment. That doesn’t make sense to me,” Sanders said. In a statement last month. A senator from Vermont pressured the NIH to reinstate the “fair pricing” provision. The provision was created by the NIH in the early 1990s to control the price of HIV drugs and was later repealed under pressure from the pharmaceutical industry.

During his confirmation hearing last month, Bertagnoli declined to commit to reinstating the provision, but vowed to work with Sanders on efforts to lower drug prices.

“I will do everything I can to…make care affordable and available to everyone who needs it,” she said, adding that she could not divulge details of the plan. Bertagnoli also addressed some Democrats’ concerns about the revolving door between regulators and the pharmaceutical industry, asking Sen. Elizabeth Warren (D-Mass.) to work for a major pharmaceutical company immediately after leaving office. I promised not.

Other lawmakers have expressed concerns about the NIH, saying it is too bureaucratic and has lost public trust during the pandemic.

“First and foremost, he will be tasked with rebuilding his relationship with Congress and the public as a leader who represents the interests of the scientific community as well as the American people,” said Sen. Bill Cassidy of Louisiana, the top Republican. he said. During Bertagnoli’s confirmation hearing last month, he told the Senate Health Committee before voting in her favor. “This means making our agencies more transparent and accountable to Congress while advancing cutting-edge science.”

Bertagnoli grew up on a ranch in Wyoming, attended undergraduate school at Princeton University, and then studied medicine at the University of Utah. She later served as president of the American Society of Clinical Oncology and led the Oncology Clinical Trials Alliance, collaborating with thousands of cancer experts to test new cancer treatments.

“She is a different kind of leader for NIH. But I think it’s time for someone who really understands the importance of clinical research and clinical trials to take the helm,” FDA Commissioner Robert M. Califf said this week. said in an interview.

The head of the country’s cancer institute was also diagnosed with breast cancer herself last year and spoke about how her experience helped her personalize it. Califf said Bertagnoli regularly calls his brother, an internist who was diagnosed with cancer, to check on him. He was impressed by this personal touch.

“I understood Monica’s true feelings…it’s quite remarkable,” Khalif said.

Bertagnoli is likely to face intense scrutiny from Republicans in Congress, who are looking into the U.S. government’s response to the coronavirus. They have targeted multiple current and former NIH officials, including Anthony S. Fauci, who led the NIH’s Center for Infectious Diseases, and former NIH Director Francis S. Collins. – Claims that NIH-funded bat coronavirus research in China may have unintentionally contributed to the start of the pandemic.

“The American taxpayer must answer,” Rep. Cathy McMorris Rodgers (R-Wash.), chairwoman of the House Energy and Commerce Committee, which oversees the NIH, said in a statement after Tuesday’s vote. .

The NIH and its former officials have also come under fire for their handling of the pandemic during the campaign. DeSantis, who is running for president, said the institutions need to “stand up” after leaders of the NIH and other federal health agencies encouraged closures and other measures.

Fauci, Collins and other current and former officials rejected Republican claims about the agency’s potential role in the origins of the pandemic. Although U.S. intelligence agencies are inconclusive about the possible origins of COVID-19 and refuse to rule out the possibility of a laboratory leak, virologists generally believe the pandemic is an infectious disease. This supports the theory that it began as a natural spillover from animals that were infected.

Bertagnoli told senators during his confirmation hearing that he is committed to investigating the origins of the pandemic and would “make reasonable assumptions” about the virus after reviewing available data.

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