New USG DURC policy - national security and ethics
"On reading," by Simon Wain-Hobson, is a weekly discussion of scientific papers and news articles around gain of function research in virology.
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.
Welcome back. These essays continue to discuss risky virology being performed in academic labs that generates novel human viruses. Using quotes from published papers – given in italics - the essays show how many studies are unable to generate meaningful results. Or they highlight inconsistencies and false statements using their own words. Occasionally it’s breathtaking.
References are embedded in the text, previous essays are referred to in brackets while a few tangential remarks that might slow the flow, are pushed aside.
Hope you enjoyed the Olympics and Paralympics against some wonderful backdrops.
On reading the United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential and Implementation Guidance document.
The new policy is for research on microbes that could be engineered into deadly human pathogens. A few salient points are:
• The term GOF is gone, DURC is back. Finished the deliberate and cynical rebranding of dangerous virology. Finished those papers deliberately confusing classical GOF research, known for donkey’s years and which was never at stake, and the Fouchier/Kawaoka like research on bird flu viruses. What a waste of time and paper (Deconstructing the portrait; GOF: game over).
• It’s the outcome of the experiment that counts, not the starting point. This was so obvious it beggars’ belief that it is only now accepted, 12 years down the line.
• Plant pathogens are now included. Another glaring omission corrected. Just contemplate for a moment global rice consumption.
In future essays we will come back to other aspects of the policy document. However, On reading has a problem with if upon exposure or misuse of the pathogen the nation’s hospital systems were to become inundated with patients infected with a pathogen causing moderate to severe disease morbidity and/or mortality, it would pose a significant threat to public health, the capacity of health systems to function, or national security.
The immediate reaction was to wonder if the authors understood their own words. Does anyone dare risk a COVID-29 or COVID-37 pandemic even if the probability is very low?
We can agree that if the nation’s hospital systems were to be inundated then it would be a significant threat to public health. So first, there’s a pleonasm. Second, health care workers would be among those taken out so exacerbating stress and testing resilience. Third, the armed forces too would be hit. Just for the record, Spanish flu was first identified among US troops in Kansas very early on. Just see the 2010 film Contagion to get an idea as to what might happen inside the US.
Given this, what are the three words or national security doing tagged on at the end? Is that something else? Although On reading is no aficionado of national security concepts or jargon, in English if the nation’s hospitals are on their knees, health care workers, police, fire services and armed forces personnel incapacitated, albeit temporarily, then you have a national security problem. A further pleonasm.
Taking the editor’s pen to the sentence gives: if upon exposure or misuse of the pathogen it would pose a significant threat to national security.
While the new policy comes from the Office of Science and Technology Policy (OSTP) at the White House, which has within its national security brief - work to reduce catastrophic risks at the intersection of technology and global security, spanning nuclear, biological, cyber, and autonomous technologies, associated risks of war, pandemics - it will be executed by federal departments.
The policy allows for requests for information and advice to go up the ladder to the department-level review group may include ex officio and/or ad hoc members from other federal departments and agencies as deemed appropriate by the department. (Section H.2.B of the Implementation Guidance pdf).
As the US DHHS will be managing the bulk of these grant proposals can we be reassured that they are sufficiently wired into national security to have the requisite expertise? The question is germane given that the US lead at the UN Biological Weapons Convention in Geneva is the State Department. And the research in question is civilian driven biological warfare – after all this is what Dual Use Research of Concern can be.
What about the US National Security Council chaired by the President, the National Security Agency and the plethora of intelligence community agencies?
Remember the edited sentence above: if upon exposure or misuse of the pathogen it would pose a significant threat to national security. Their words. It doesn’t sound right that the Department that executes this new policy which funds the equivalent of biological warfare by civilian scientists gets to make the national security calls when the stakes are so high. Some independent USG oversight is needed.
Delving further into the policy document we learn that the Principal Investigator (PI) of any grant proposal that comes under the scope of this new policy must come up with a risk/benefit analysis and a mitigation plan. This has to be signed off by an Institutional Review Entity (IRE), basically an internal committee at the PI’s institution, before submission of the grant.
But.
The USG commissioned Gryphon Scientific report of 2015 into GOF research was over 1000 pages and had three chapters on risk analysis and one on benefits. Two salient sentences from the report are:
• Collectively, these sources of uncertainty significantly compromise the predictive value of molecular markers for mammalian adaptation, transmissibility, and virulence (p309).
• However, the major caveat associated with GoF approaches is that results gleaned from laboratory studies involving animal models may not translate to human disease in nature (p310).
So, the benefits are uncertain to say the least. For the record, On reading concurs.
At no place in the Gryphon report are we told how to weigh up the risks – rising to catastrophic risk, aka an accidental pandemic – and the benefits – see the above quotes and other essays. The fact is that there was a choice by the NIH to support this work, ‘nonetheless’ (Chilled virology), when common sense – a pandemic vs. the above two sentences – shows it’s a no brainer.
The new USG policy requires that a PI performs a risk-benefit analysis when we know the answer – Fouchier & Kawaoka like work on viruses didn’t deliver anything useful for public health. On top of which there has been a 12 year look back period and the facts and conclusions haven’t changed.
Yet the PI will be helped by the IRE. However, they are no better prepared. Once the grant is submitted to the NIH the PI will have help from them. On reading’s guess is that the risk benefit analyses will end up being a condensed cut and paste job based of the Gryphon report and approved, nonetheless.
Scientists should read carefully the pdf.
• In a section entitled Considerations for Weighing Benefits and Risks of Communicating Research Findings we find all options like talking up the benefits with contextual information (?), redacting key data, limited sharing and even Do not disseminate the research results in any manner. This shows up elsewhere in the policy document.
Although given the Fouchier & Kawaoka precedent, the probability is small this will happen, even though in the event of an accident, the work could result in hospitals being overwhelmed.
• Establish a mechanism to ensure that the resulting biological agent or toxin… are properly accounted for and destroyed when no longer needed if not already required to do so by existing law and regulation. Here’s an interesting twist that came up in the essay on Rinderpest. On reading would like to know if the stocks of resurrected 1918 Spanish flu virus, or the engineered Fouchier and Kawaoka flu viruses, which are out of date if nothing else, have been destroyed?
Moving on, as mentioned in an earlier essay (GOF: game over) the highly ambiguous term GOF was used to deflect from the toxic nature of the work. It has been ditched in the new policy and replaced by DURC the definition being life sciences research that based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be misapplied to do harm with no, or only minor, modification to pose a significant threat with potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security. Emphasis added. Source? The new policy document. Back up and absorb with no, or only minor, modification. The malevolent mind will see biological weapons.
We learn that USG will not fund DURC (ex-GOF) research in North Korea, Iran, Russia, China, Cuba, Syria and Venezuela, although Departments may make exceptions on a case-by-case basis in exceptional circumstances. Rules with exceptions as always. Yet the Fouchier and Kawaoka flu studies, along with others funded by USG were published without any details redacted. This information is freely available to those countries on the exclusion list.
In the future, these excluded countries will just have to be patient and wait for publication to get the information free of charge, courtesy of the US taxpayer, peer reviewers and a publishing house. Nobody’s exactly in a hurry in this field - not USG oversight - except the proponents of this work.
It's worth repeating that this is not rocket science - technologies that could be misapplied to do harm with no, or only minor, modification. And although not anybody can do the Fouchier and Kawaoka experiments, enough research groups around the globe can.
Shifting gears, we learn that first among the Guiding Principles of the new policy, It is critical that such research be conducted ethically.
On reading had hoped that the edited sentence, if upon exposure or misuse of the pathogen it would pose a significant threat to national security, would solicit incredulity and bring such work to a stop on the basics of ethics alone, not to mention common sense, making the world a more dangerous place, publishing recipes that countries on the USG exclusion list can use, doing no harm and the zero underpinning in basic virology. But no.
So much for ethics.
What is the ethical basis on which OSTP allows policy containing such a frightening sentence/spectre/scenario in the face of so many counter arguments?
This policy document reeks of ‘this is our domain, we’re the experts, leave it to us’. Given past performance, the policy is still to invest in this risky research.
There are plenty of avenues that can be explored, to invest taxpayer’s dollars in trying to prepare for and blunt the next pandemic that does not involve risky research.
It is pretence to believe that you can predict the next pandemic. It is pretence to believe that with more investment, more work, this will finally be possible. This is a wish, a belief which is fine, but not one founded in science and reason. If it was possible, there wouldn’t be a controversy.
The new policy document fails to grapple with the issue.
Aside 1
On reading will come back to this policy document.
Aside 2
While first among the Guiding Principles is ethics, how come this policy is limited to USG? Any such work in the US private sector could also result in an accident whereby if upon exposure or misuse of the pathogen it would pose a significant threat to national security.
Clearly legislation is needed to cover the private sector. A bigger discussion is needed as the report says, even though we’re already 14 years on. There is a long way to go, fast.
Aside 3
This is the equivalent of biological weapons research being done in plain sight by university academics and made freely available. Yet it is critical that such research be conducted ethically. Playing the Jesuit, does this mean that the work can be done, just that it must be conducted ethically?
Meanwhile the rest of the world, with the signal exception of the German Ethics Council doesn’t move. Very strange.
Aside 4
Take a look at a short piece entitled Why Pandemics Are National Security Threats, by Pamela Faber who is a senior research scientist The Center for Naval Analysis in Arlington, Virginia. There is no mention of the threat to public health, hospitals folding, National Guard and armed services being discombobulated. Remember, that next time the death rate could be higher and/or the development of an efficient vaccine may prove much harder. Remember no vaccines for HIV or HCV despite billions being invested.
There is talk of violent extremist organizations, etc. Post COVID, you wonder whether the biomedical research and national security communities communicate. Separate turf?
Aside 5
For another pandemic/national security take try Margaret Kossal in the fall of 2023. How COVID-19 is reshaping U.S. national security policy. A hypothesis is that the most significant underrecognized problem associated with COVID-19 is disinformation and the weakening of confidence in institutions, including governments, and how adversaries may exploit that blind spot.
