On July 11, I received a letter from the National Institutes of Health ordering me to stop my research on Mycobacterium tuberculosis, the bacterium that causes tuberculosis, because the work was deemed too “dangerous.” Surely this must be a mistake, I thought, since my lab has been operating safely for more than a decade.
I am an associate professor of molecular and cell biology at University of California, Berkeley, where I study TB. I’m also a principal investigator on two grants from the NIH in which experiments using routine techniques were abruptly flagged as possible “dangerous gain-of-function research.” My work isn’t dangerous, but stopping research that could lead to cures could be.
Advertisement
In wealthy countries, people think TB is a disease of the past. Advances in medicine and public health have virtually eradicated it from the U.S. and western Europe. Yet globally, TB kills more people than any other infectious disease and is also becoming more difficult to treat as drug resistance increases. If we lose the ability to treat TB with existing drugs, the whole world, including the United States, is at risk.
Researchers in my lab and many others across the country are striving to perform research that is essential for the discovery of new drugs to eradicate TB and prevent its worldwide resurgence. The 2024-25 TB outbreak in Kansas City — more than 100 cases, making it the largest in the U.S. in decades — is a clear reminder that the risk is not just theoretical.
Technically, my work on TB does involve gain of function, a category of research that has been both politicized and widely misunderstood.
Advertisement
Related Story The Kansas City TB outbreak shows the value of U.S. government health funding
“Gain of function” is a broad category of research that involves genetically altering an organism to give it new abilities. Gain-of-function experiments have been crucial for increasing our understanding of bacteria like M. tuberculosis in the pursuit of discovering new treatments. These techniques have also been essential in developing new therapies for cancer, new vaccines, and treatments to improve crop resiliency and animal health. Gain-of-function research has provided enormous benefits for clinical therapies, including the hepatitis B vaccine, CAR T-cells for cancer, and modified adenoviruses used in gene therapies for muscular dystrophy.
The NIH letter terminating my research cited a May executive order in which the president ordered a stop to “dangerous gain-of-function research.” That is a very small subset of gain-of-function research, in which a potentially disease-causing organism is made more virulent, more transmissible, or more capable of infecting new hosts. Because this type of research can be risky, I fully support requiring robust safety measures to ensure it is conducted responsibly. Decisions designating research as “dangerous” must be transparent, deliberative, and scientifically informed. This approach is vital to prevent the unwarranted curtailment of safe research that serves the public good.
... continue reading