Gain-of-Disfunction? Research Method Comes Under Fire

Gain-of-function research comes with great risks and not enough transparency. That’s just 2 of the topics explored in an approximately 4700-word expose by the Washington Post last week.

The article also focused on the role that 2 icons in the medical field have had in such research. Critics quoted in the article suggest that Francis Collins, MD, the director of the National Institutes of Health (NIH); and Anthony Fauci, MD, the director of the National Institute of Allergy and Infectious Diseases (NIAID) and the Chief Medical Advisor to the President, may be exposing society to undo risk by their backing of the controversial research method, and not being transparent enough about the projects that they have approved.

Michael J. Imperiale, PhD, a University of Michigan virologist who served from 2005 to 2012 on the biosecurity board and who now is editor in chief of mBio, a journal of the American Society for Microbiology, tells the Post that “if you’re going to ask society to take on a higher-than-normal level of risk, then I think there’s got to be more openness.”

Richard H. Ebright, PhD, a professor of chemical biology at Rutgers University, tells the newspaper that “everyone on the planet now knows what a pandemic is, what that means for their families, their communities, their incomes.”

The idea behind gain-of-function research is for scientists to increase the lethality of pathogens in an effort to get a better handle on how to contain future pandemics. But there are significant risks, says Kevin Kavanagh, MD, a member of Infection Control Today^®’s (ICT^®’s) Editorial Advisory Board (who was not quoted in the Post’s article)—mishaps that can cause a world-wide catastrophe.

“Gain-of-function research on viral pathogens is one of the most dangerous academic endeavors which can be undertaken by mankind,” says Kavanagh. “Just the gain-of-function research on avian influenza has the potential of wiping out large percentages of the world’s population. It is hard to imagine a benefit which justifies the risk, but when one is identified such research should only be undertaken with an assumption that a lab accident may occur. There must be a viable plan which has a very high probability of success for containment of any escaped pathogen and the identification and quarantining of exposed personnel, without a risk of spreading to the general population.”

Such a “viable plan” that Kavanagh refers to seems to have been in place when investigators with Osaka University in Japan recently created the pseudo-virus Delta 4+ in making the case that future mutations in the Delta variant could help it to evade antibodies in COVID-19 vaccines. Kavanagh says that the Osaka University research “is an example of gain-of-function research using a pseudo-virus which is extremely beneficial.”

In this example, gain-of-function research may have helped sound the alarm, Kavanagh adds. “The research reported that the Delta virus is one mutation away from fully escaping the vaccine.”

It’s one thing to create deadly experimental pathogens in a laboratory. It’s quite another to contain them. Deadly pathogens can escape, or leak, from laboratories—as has been suggested might have been the event that ignited the COVID-19 pandemic. The theory goes that SARS-CoV-2 escaped from a laboratory in Wuhan, China. The idea had for months been dismissed out of hand and not much investigated by the mainstream media. However, in the last few months publications—including (ICT^®)—have published stories that the possibility at least merits investigation. (See here, here, and here.)

The Post’s expose doesn’t deal with that issue. “Speculation about the work in Wuhan has focused new attention on gain-of-function research,” the article states. “This report details the U.S. support for such experiments and the secrecy undergirding them. It does not illuminate whether the coronavirus pandemic resulted from gain-of-function research.”

The Post does illuminate that Fauci and Collins have backed gain-of-function research over the years, distributing federal funds for the work, even though other health care experts questioned whether that was wise.

David A. Relman, a Stanford University physician and microbiologist who has advised NIH and other federal agencies on biosecurity, tells the Post that “the risks are absolutely real. They’re not intellectual constructs or hypotheticals…. [S]omething that you make or information that you release will result in an accident of some kind.”

The NIH used ferrets to create a lethal flu virus about 10 years ago. When Obama administration officials got word of that they became alarmed.

“The NIH leaders and the Department of Health and Human Services pledged to subject the work to increased transparency and vetting” the Post article states. “This included forming a review group of federal officials—known informally as a ‘Ferrets Committee’—to vet proposed projects for safety and worthiness.”

The Post alleges that Fauci and Collins have tried to undercut the committee’s authority. In 2017, for instance, the regulation giving the committee the power to block projects was removed.

The Post interviewed both Fauci and Collins who denied that their actions have lessened oversight of the gain-of-function projects.

Collins told the Post that “reasonable people do not all completely agree on the ideal way to frame the oversight of these very sensitive experiments…. There are some who see the risks as greater and the benefits as less. And vice versa.”

Fauci said that “to the extent that we can be transparent, that the system would allow us to be transparent, we go overboard to be transparent.”