Since January 2024, Dr. Wain-Hobson has written weekly essays for Biosafety Now discussing risky research in virology. You can read his entire series here.
On reading President Trump’s Executive Order stopping dangerous GOF research in the US at the federal level. Fact Sheet: President Donald J. Trump achieves improved safety and security of biological research
It’s been a 14 yearlong roller coaster ride with a self-proclaimed moratorium on GOF 2.0 research that was quickly lifted, another proclaimed by the Obama White House that lasted three years but was quietly lifted in the last moments of his administration. Finally, an Executive Order (EO) signed by President Trump on May 5 puts a stop to this dangerous GOF research.
What does it say? Is it clear, for as the cliché goes, the devil is in the details.
The wording is rather good, clear and shows commonsense. The target is ‘dangerous GOF research’ which is defined by way of seven short sentences which are given at the bottom of this essay. One example: (e) altering the host range or tropism of the agent or toxin.
This is good for it uses the jargon of virologists and so eliminates ambiguity. Altering host range covers adapting a bird flu virus to growth on human cells. Altering tropism covers, say, adapting a virus that infects intestinal cells to infecting lung cells.
This makes sure that the genesis of novel agents is covered specifically. The Fouchier & Kawaoka experiments are out of bounds.
(c) conferring to the agent or toxin resistance to clinically or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitating their ability to evade detection methodologies; This is good for a malevolent mind could wreak havoc with a novel plant or animal virus (Potential pathogenic plant pathogens). An essay is coming up on animal viruses.
(f) enhancing the susceptibility of a human host population to the agent or toxin. This is something few have done deliberately. However, the 1997 Russian flu pandemic resulted from unintended human intervention.
For the record, six of these seven examples can be found in the 2004 Fink Report that emerged following the anthrax attacks on the Capitol Hill in 2001. The overlap is considerable which is hardly surprising. The new addition is (g) generating or reconstituting an eradicated or extinct agent or toxin. When the Fink report was released resurrection of the Spanish flu virus had not yet become public knowledge.
My Administration will balance the prevention of catastrophic consequences with maintaining readiness against biological threats and driving global leadership in biotechnology, biological countermeasures, biosecurity, and health research.
By using the adjective dangerous it allows GOF 1.0 research to go ahead unfettered. We have seen how GOF 2.0 was willfully blended with GOF 1.0 research to allow the former to sneak through. Many of us advocating control of GOF 2.0 research were worried that the legislators pen would be too broad and englobe swaths of GOF 1.0 thus hurting US biomedical research.
With these seven examples there are no risks to US science which can live with this Executive Order.
The other sections and the accompanying fact sheet explain the mechanics of this new policy and how it will be enforced and by whom. We learn that the EO seeks to strengthen top-down independent oversight. It is concerned by dangerous GOF research that may occur outside of federal financing. For example, Section 5. …shall develop and implement a strategy to govern, limit, and track dangerous gain-of-function research across the United States that occurs without Federal funding and other life-science research that could cause significant societal consequences.
For completeness, the international dimension is covered in Section 3. end Federal funding of other life-science research that is occurring in countries of concern or foreign countries where there is not adequate oversight to ensure that the countries are compliant with United States oversight standards and policies and that could reasonably pose a threat to public health, public safety, and economic or national security, as determined by the heads of relevant agencies.
China is mentioned. Yet in the Biden Administration document that was published in April 2024 there was more; the USG would not fund DURC (ex-GOF) research in North Korea, Iran, Russia, China, Cuba, Syria and Venezuela, so nothing new.
The NIH came out with an announcement. The NIH intends to suspend ongoing funding in accordance with guidance developed under Section 3(b) of the Executive Order which makes sense. You can’t stop dangerous GOF in the future and leave currently funded work to run its course. As the text says, As life sciences research evolves, so must the framework for safeguarding its conduct and results. Some will argue this is unfair, that once funded a project should not be stopped.
First, these GOF experiments have nothing to give to public health experts and the public, plus they carry a small but potentially catastrophic risk. Ongoing projects should not have been finded in the first place. Second, as Mike Imperiale has said several times, these experiments represent one “really tiny part” of research on infectious diseases. Banning them will not hamstring infectious disease research. If it did, On reading would be on the other side.
This Executive Order on dangerous GOF research brings the curtain down neatly.
Reactions?
Top scientific journal Nature - “This is what I was expecting — an executive order banning gain-of-function research but defined in such a way that it bans all virology research,” says Gigi Gronvall, a biosecurity specialist at Johns Hopkins University in Baltimore, Maryland. There is far, far more to virology than gain of function research, as any virologist will tell you. Dixit Mike Imperiale. Yet nobody in the Nature office caught this science fiction?
Top scientific journal Science - A remarkable trilogy is served up. In fact, the new order could be read to ban huge swaths of infectious disease research, such as cloning or culturing viruses in a cell line, cautions Angela Rasmussen, a virologist at the University of Saskatchewan. There have been many Executive Orders of late, perhaps you confused it with another. This is willful nonsense.
Gigi Gronvall comes up with another beauty; In this administration’s outlook, diseases come from labs, not nature, so they aren’t doing anything about it. She wants to trash it. No arguments, just statements which is not how science is done. This is topped off with a quote from Allen Segal of the American Society of Microbiology (ASM). Otherwise, what we’re going to wind up doing is encouraging researchers to go places where there’s less stringent regulation.
Researchers should be looking to work on something else for dangerous GOF research in virology cannot deliver anything of use to public health. US scientists aren’t going to face down this Executive Order especially as the biggest funder for this work globally has been the NIH.
MSNBC. Two legal scholars, Lawrence Gostein and Alexandra Finch from Georgetown University performed well. That means the administration could stop funding important research even if it doesn’t involve a gain of function. The EO has dangerous GOF research in its title. All seven examples in section 8 on definitions are those of dangerous GOF experiments so distinguishing it from GOF research general that cuts across biology. Yet they see the text as enveloping non-GOF research.
They do so want to disagree, for example, It is mere political theater, rather than a serious plan to strengthen our preparedness for the next pandemic. Or take the title of their piece: Trump just took a sledgehammer to our pandemic preparedness.
Thinking it through, the EO will reduce the risk of leaks from US labs, so it does strengthen biosafety which is part of pandemic preparedness. So by opposing the Executive Order they are opposing part of pandemic preparedness. Imagine if they used such sloppy arguments in court. Their clients would be scuppered.
Global Biodefense. In a staff authored article entitled The Cost of Caution: How the Trump Administration’s Ban on Gain-of-Function Research Undermines Pandemic Preparedness, we learn that this politically motivated policy could dangerously hobble the very scientific tools needed to anticipate, understand, and prevent the next pandemic. …by simulating how viruses might evolve in nature, researchers can anticipate public health threats and develop vaccines or treatments before outbreaks spiral out of control.
No, dangerous GOF research can’t anticipate public health threats. The second quote is pure Fouchier and Kawaoka, circa 2012. Fortunately these gents have moved on. Meanwhile, the entire staff of Global Biodefence are languishing in a 2012 time warp. Ground control to Major Tom…
NY Times. Perhaps a little more is said about COVID and the origins of SARS-CoV-2 than dangerous GOF research. Carl Zimmer and Emily Anthes take time out to say the that evidence strongly suggests that wild mammals picked up a bat coronavirus and that when the animals were sold at the market, they passed the virus to people. These studies are riddled with errors and assumptions. Journalists taking sides in a national newspaper while the scientific jury is out is no better than betting on greyhounds.
NPR. This provides good coverage and brings up points mostly overlooked elsewhere. Dr. Jay Bhattacharya, the director of the National Institutes of Health is quoted thus: The conduct of this research does not protect us against pandemics, as some people might say, it doesn't protect us against other nations. There's always a danger that in doing this research, it might leak out, just by accident even, and cause a pandemic. He’s right on all points.
What is striking is the number of people outside of virology who speak out as though their opinions mattered. We’ve taken a look at journalists (Some housekeeping) and a bunch of scientists from outside infectious diseases (Off target). We’ve come across plenty of comments from those stuck in the past unaware the field has moved on. An upcoming essay will deal with a think tank.
My apologies, I didn’t hear you. You would like some data? Of course.
• Our findings indicate that dissemination of viruses at these levels is unlikely and offers an explanation as to why, despite significant numbers of human infections, a mammalian transmissible H5N1 has not yet emerged.
• We conclude that human-adapted H7N9 viruses are unlikely to emerge during typical spillover infections. Our findings are instead consistent with a model in which the emergence of a human-transmissible virus would be a rare and unpredictable, though highly consequential, “jackpot” event.
The authors of both these statements have been supporters of dangerous GOF research on virology in 2012. Now they have understood.
The controversial dangerous GOF studies on H5N1 bird flu viruses didn’t help the US prepare for H5N1 infection of cows.
While a politician signed the Executive Order, the subject is a scientific one and consequently requires hard-nosed arguments. Those scientists stuck in 2012 and/or espousing illogical arguments don’t realize they are bringing themselves, their professions and institutions into discredit. When they churn out nonsense, people end up disbelieving them. That pushes science into the danger zone.
The cacophony is confounded by journalists, law professors, think tanks and more muscling into virus evolution who know much less than the academics. Hopefully they find virology exciting, On reading thinks it is top (Virology is the Queen of the Biological Sciences), but do read up and ask around.
In an earlier essay On reading called for a Hippocratic oath for PhDs. Perhaps this needs to be broadened to cover everybody. First, do no harm. Second, get your facts straight. Third, shut up if you can’t master them.
Conclusion
This Executive Order puts an end to this gain of folly. Sure, it must be turned into policy, but that will happen. Let’s see what the Europeans say or do, for as another cliché goes, microbes don’t respect borders.
Aside 1
EO on Dangerous GOF Research
Sec. 8. Definitions. For the purposes of this order,
“dangerous gain-of-function research” means scientific research on an infectious agent or toxin with the potential to cause disease by enhancing its pathogenicity or increasing its transmissibility. Covered research activities are those that could result in significant societal consequences and that seek or achieve one or more of the following outcomes:
(a) enhancing the harmful consequences of the agent or toxin;
(b) disrupting beneficial immunological response or the effectiveness of an immunization against the agent or toxin;
(c) conferring to the agent or toxin resistance to clinically or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitating their ability to evade detection methodologies;
(d) increasing the stability, transmissibility, or the ability to disseminate the agent or toxin;
(e) altering the host range or tropism of the agent or toxin;
(f) enhancing the susceptibility of a human host population to the agent or toxin; or
(g) generating or reconstituting an eradicated or extinct agent or toxin.
Aside 2
Fink Report Experiments of Concern would be those that:
1. Would demonstrate how to render a vaccine ineffective.
2. Would confer resistance to therapeutically useful antibiotics or antiviral agents.
3. Would enhance the virulence of a pathogen or render a nonpathogen virulent.
4. Would increase transmissibility of a pathogen.
5. Would alter the host range of a pathogen.
6. Would enable the evasion of diagnostic/detection modalities.
7. Would enable the weaponization of a biological agent or toxin.
Aside 3
There were some thoughtful comments of course and the reader can find them in the hyperlinks. It’s the silly and unsubstantiated comments that need calling out.
“On Reading” should be required reading for every mainstream media journalist.