Nearly 400 years ago, Galileo dared challenge the prevailing views of his time, facing persecution for his belief that the earth revolved around the sun. Today, echoes of this opposition to science still persist in the form of disinformation campaigns on social media, anti-science platforms endorsed by influential politicians, and rising vaccine hesitancy that in childhood vaccination rates. As a virologist, I find it alarming that this climate of distrust now threatens the progress of biomedical research in the U.S.
The Republican-controlled House of Representatives recently to the that prohibits federal funding for all gain-of-function (GoF) research -- that which endows a pathogen with a new or enhanced property. Many scientists are hopeful that the bill will fail in the Democratic-controlled Senate, but if this vaguely-worded provision becomes law, it could halt research pertaining to a wide variety of public concerns, including gene therapy, cancer treatment, and pandemic preparedness.
Congressional attacks on science extend beyond this amendment. House Republicans, holding a majority in the , have skewed the narrative on COVID-19 toward an unsupported link with GoF research, citing communications between government officials and the authors of a as to suppress the lab origin theory. Rather than leveraging their authority to foster balanced discussion among experts in an effort to learn from the pandemic, the subcommittee has engaged in months of hearings on this single topic.
By vilifying public officials, demonizing virus research, and turning discussion on GoF research into political spectacle, House Republicans are stoking the flames of an already smoldering anti-science, fear-based movement. If the broad restrictions on GoF research approved by the House become law, they could stifle the potential for revolutionary medical advancements, especially those that result from viral engineering.
While it is true that GoF approaches can lead to more dangerous viruses, that is usually not the outcome or goal. Viruses have shown significant potential as tools for medical research, and GoF studies are fundamental to the ability to engineer them for these purposes. It is therefore crucial to undertake GoF research within the guidelines of current oversight frameworks.
More than half of the currently FDA-approved gene therapies are based on , with several more in the pipeline. The approval of Sarepta's delandistrogene moxeparvovec (Elevidys) marks the first gene therapy for Duchenne's muscular dystrophy (DMD), a life-limiting disease affecting approximately 1 in 3,300 male births worldwide. This revolutionary treatment is the result of GoF research that enabled an adeno-associated virus to deliver a therapeutic gene to patients.
Oncolytic virotherapy, a promising emerging class of anticancer immunotherapies, relies on viruses that selectively infect and destroy cancer cells. Although oncolytic viruses occur naturally, genetic modifications have improved their safety and specificity. BioVex/Amgen's talimogene laherparepvec (T-VEC, Imlygic) -- an FDA-approved therapy for unresectable metastatic melanoma -- uses a genetically-modified herpes virus that preferentially infects tumor cells to boost the anti-tumor response. Not only has this first-in-class treatment of patients with advanced melanoma, but its success would not have been possible without GoF research.
Viral vector-based vaccines also benefit from GoF research. Two such vaccines -- the Oxford-AstraZeneca and Janssen COVID-19 vaccines -- generate protective immunity through an engineered adenovirus that delivers into cells the genetic instructions to make SARS-CoV-2 spike protein. As part of a massive public health response, these vaccines contributed to preventing an in the first year of COVID-19 vaccination.
Merck's ERVEBO vaccine uses a genetically modified vesicular stomatitis virus to protect against Ebola, a disease typically fatal in 70-90% of cases left untreated. During the 2014-2016 Ebola outbreak in Guinea, prevented Ebola virus disease in all of the nearly 4,000 close contacts of confirmed cases. These life-saving vaccines, along with countless more in development, involve the introduction of a foreign gene into a virus, which by definition constitutes GoF research.
While it is crucial to acknowledge the rare side effects associated with virus-based treatments, it is equally important to recognize that the benefits to human health far outweigh the risks in most cases. Researchers still face challenges regarding the specific and efficient delivery of gene therapies to a target cell or organ. While this obstacle is not unique to virus-based technologies, virus engineering provides an elegant solution.
If Congress terminates funding for all GoF research, it could devastate the potential for groundbreaking medical advancements. We must urge Congress to collaborate with scientists and public health authorities in reviewing and revising existing ethical and biosecurity guidelines for research that could make viruses more dangerous. If we fail to do so, the consequences of a blanket legislation banning GoF research could stifle crucial avenues of research, denying hope to countless patients and impeding progress toward life-saving therapies.
is a virologist and science communicator in the Department of Microbiology at New York University Langone Health in New York City.