Jay Bhattacharya is now the National Institutes of Health (NIH) director, and one of his first priorities is to do something that the last three administrations have been unable to accomplish.
Bhattacharya must implement ironclad, binding regulations on researchers who want to play "mad scientist" and experiment with what's known as "gain-of-function" research.
Gain-of-function research is modifying a virus at the molecular level to make it "more capable of doing something, such as replicating more efficiently, infecting a wider range of species, or becoming more transmissible."
Short version: It makes a bad bug worse.
The research has a place in science as long as strict controls are placed on scientists and the labs where the research is conducted. The benefits of crafting powerful drugs and vaccines to counter what nature throws at us have been proven before using gain-of-function research.
The SARS-CoV-2 coronavirus was probably the result of a gain-of-function research project that escaped into the wild. The result was the COVID-19 pandemic that contributed to six million deaths around the world.
The Obama and first Trump administrations tried to curtail and place guardrails around gain-of-function experiments. However, they kept hitting a brick wall at the NIH with administrator Francis Collins and Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, who were both big boosters of gain-of-function research.
It appears that Fauci kept changing the definition of the research. Joe Biden's pardon has given him immunity for lying to Congress and for his unpardonable responsibility for the pandemic.
At this point, Bhattacharya is stuck. The new regulations the Biden administration drew up have been paused until the Trump administration can write its own rules, which may include banning gain-of-function research altogether.
In May 2024, the Biden administration issued a new regulatory framework that clarified when research funding agencies like the NIH needed to forward research proposals involving the enhancement of potential pandemic-causing pathogens up the chain for independent department-level risk-benefit review.
That framework is supposed to go into effect on May 6. But back in January, the White House paused implementation of any pending regulations from the last administration, which include its pandemic research regulations.
The new regulations will thus remain stalled unless, and until, the White House decides otherwise.
The Trump administration is considering pausing all gain-of-function research until proper safeguards can be developed. Also, Sen. Rand Paul (R-Ky.) has reintroduced a bill to create an "independent Life Sciences Research Security Board within the executive branch." The board would have to sign off on any proposed gain-of-function research.
Last year, when Paul's bill passed out of committee, Bhattacharya praised it, saying it was a "great step forward toward the goal of protecting the American people from scientists conducting the kinds of dangerous experiments that likely led to the COVID pandemic."
In recent weeks, Fauci and Collins have come under renewed, mainstream scrutiny for suppressing the early debate about whether its funding of risky pandemic research in Wuhan, China, could have caused the pandemic.
Richard Ebright, a molecular biologist at Rutgers University and arch-critic of gain-of-function research, argues that the change in personnel at NIH is just as important as any change in the executive regulations on gain-of-function research.
"The difference is if you have an NIH director who has a serious interest in this subject and wishes to reflect the public interest rather than his own interest and the interest of a very small set of high-risk researchers," he says.
Fauci and Collins will never be held fully responsible. They'll never see the inside of a criminal courtroom. But in the court of public opinion, they can be held accountable for letting loose a virus on the world that killed millions.
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