Dangerous gain-of-function research continues in the US because of poor oversight, says a damning congressional oversight report prompted by the revelation
- A federal watchdog criticized the government’s weak oversight of risky research
- Gain-of-function research has come under the spotlight thanks to Covid-19
- The group also called out a lack of transparency in lab funding
Poor oversight and loopholes mean risky virus research feared to have sparked the Covid pandemic in China is continuing in the US.
That’s the damning conclusion of a report – prompted by an explosive revelation – about rules surrounding gain-of-function studies.
Congressional oversight group, the Government Accountability Office (GAO), concluded that federal oversight of the most sensitive scientific experiments was far too weak and ineffective.
In October, this website shockingly revealed that a Boston University team had developed a new strain of Covid with an 80 percent kill rate in mice, although questions remain as to whether similar experiments resulted in the release of Covid.
Boston University’s National Emerging Infectious Diseases Laboratories is one of 13 biosafety level 4 laboratories in the United States
Full-body, air-supplied pressure suits are worn and workers are required to change their clothing before entering and shower before exiting
This type of research aims to understand the genetic makeup of viruses and how mutations can alter their biological functions to become more transmissible and virulent. It often involves manipulating pathogens to be more deadly or infectious, making stricter infection control procedures imperative.
Proponents of winning functional tests say it will help humanity forestall future pandemics, but critics say the risk of triggering an outbreak outweighs any theoretical benefit.
Many scientists believe that Covid is showing signs of human manipulation and that the virus was the product of a leak from the Wuhan Institute of Virology in China, where scientists conducted gain-of-function experiments on bat coronaviruses, which were closely related to Covid.
In the US, researchers with a proposal to conduct the type of research involving “elevated potential pandemic agents” must be approved by the Department of Health and Human Services (HHS).
HHS developed a framework for approving such experiments in 2017 after a three-year moratorium that suspended all regulatory reviews of research proposals and funding for such experiments.
Under the rules, HHS will assemble a panel of reviewers to conduct a risk-benefit analysis.
The review panel examines three criteria: whether the benefits outweigh the disadvantages, whether there are no other equally effective but less risky options, and whether the research team and facility are able to perform the work safely and securely and respond quickly if accidents occur or security breaches.
But the new GAO report said the language in the rules was too vague and the review process wasn’t transparent.
Under the framework, researchers submit proposals for studies that are “reasonably expected to generate, transmit, or use enhanced potential pandemic agents.”
But it doesn’t explain what “reasonably” means in this case.
“The phrase ‘reasonably expected’ allows for subjective interpretation and covers a range of certainties related to the intent of the research and the likelihood of the results,” states the report.
The departmental review group that reviews research proposals also lacks transparency, according to the GAO
The agency’s study found that the composition of the group and the application of the framework standards when examining proposals lacked transparency.
The report states: “Because little is known about the composition of the departmental review group, it is not clear whether the departmental review group has the full range of technical expertise needed to assess risks associated with proposed research to critically evaluate potential pandemic pathogens .’
GAO made three recommendations for reform: that HHS adopt a standard for the term “reasonably expected” to provide clarity, that non-sensitive information regarding the department’s review process be shared with Congress and the public, and that HHS and the Centers for Disease Control and Prevention (CDC) are making changes to the Division of Select Agents and Toxins (DSAT), which maintains a list of pathogens that pose a serious public health threat.
The term “gain-of-function” became popular in 2012 after it was revealed that two separate experiments were being conducted at the Erasmus Medical Center in Rotterdam and the University of Wisconsin.
Scientists had successfully genetically engineered a strain of the highly virulent bird flu so that it could be transmitted through the air between humans. They injected ferrets with bird flu, which caused the virus to replicate and then spread it to other ferrets. The fact that it multiplied among ferrets means it could also spread among humans.
Haven’t we learned anything? 40 new biochemical laboratories dealing with dangerous viruses are being built worldwide
The coronavirus pandemic has prompted a global surge in laboratories handling dangerous viruses – despite concerns that Covid may have been the result of the risky experiments.
More than 40 facilities certified as Biosafety Level 3 (BSL-3) or BSL-4 have either been built or under construction since 2020, mostly in Asia.
Many countries believe they have been caught flat-footed by Covid and want to forestall the next devastating outbreak by studying pathogens that pose a threat to humans.
Experiments in these labs often involve tinkering with animal viruses to advance treatments and vaccines that could be used in a future outbreak.
But there are widespread concerns that these experiments could actually increase the risk of pandemics – something some experts believe was the case with Covid.
The virus first started spreading from a wet market in Wuhan, about eight miles from the Wuhan Institute of Virology (WIV), a high-security biolab working with dangerous bat coronaviruses.
There, scientists were working on some of Covid’s closest relatives. They were also found to have wiped vital databases and stifled independent investigations into the lab’s links to the pandemic.
Professor Paul Hunter, an infectious disease expert at the University of East Anglia in England, told he was concerned about what all the new labs would be used for.
“The question is what you’re going to use [the labs] for,” he told this website. “If they are used for diagnostic purposes, then you need them. But I don’t think every country needs a BSL-4.”
He added, “If they start having a dual purpose for research that has offensive military implications, that’s the concern.”
Russia has outlined its proposals for 15 of the maximum safety labs and India is targeting a total of 18 BSL-3 and BSL-4 labs. The US is also adding another top-level biosafety laboratory to its existing 12.