Posted on 06/08/2021 11:45:13 PM PDT by Mount Athos
The US moratorium on gain-of-function experiments has been rescinded, but scientists are split over the benefits—and risks—of such studies. Talha Burki reports.
On Dec 19, 2017, the US National Institutes of Health (NIH) announced that they would resume funding gain-of-function experiments involving influenza, Middle East respiratory syndrome coronavirus, and severe acute respiratory syndrome coronavirus. A moratorium had been in place since October, 2014. At the time, the NIH had stated that the moratorium “will be effective until a robust and broad deliberative process is completed that results in the adoption of a new US Government gain-of-function research policy”. This process has now concluded. It was spearheaded by the National Science Advisory Board for Biosecurity (NSABB) and led to the development of a new framework for assessing funding decisions for research involving pathogens with enhanced pandemic potential. The release of the framework by the Department of Health and Human Services (HHS), of which NIH is part, signalled the end of the funding pause.
The situation has its roots in 2011, when the NSABB suppressed two studies involving H5N1 viruses that had been modified to allow airborne transmission from ferret to ferret. They worried that malign actors could replicate the work to deliberately cause an outbreak in human beings. After much debate, the studies were published in full in 2012. HHS subsequently issued guidelines for funding decisions on experiments likely to result in highly pathogenic H5N1 viruses transmissible from mammal to mammal via respiratory droplets. The guidelines were later expanded to include H7N9 viruses.
In 2014, several breaches of protocol at US government laboratories brought matters to a head. The news that dozens of workers at the Centers for Disease Control and Prevention (CDC) might have been exposed to anthrax, that vials of smallpox virus had been left lying around in an NIH storeroom, and that the CDC had unwittingly sent out samples of ordinary influenza virus contaminated with H5N1, shook faith in the country's biosafety procedures. Over 200 scientists signed the Cambridge Working Group declaration arguing for a cessation of experiments creating potential pandemic pathogens “until there has been a quantitative, objective and credible assessment of the risks, potential benefits, and opportunities for risk mitigation, as well as comparison against safer experimental approaches”.
The debate is focused on a subset of gain-of-function studies that manipulate deadly viruses to increase their transmissibility or virulence. “This is what happens to viruses in the wild”, explains Carrie Wolinetz, head of the NIH Office of Science Policy. “Gain-of-function experiments allow us to understand how pandemic viruses evolve, so that we can make predictions, develop countermeasures, and do disease surveillance”. Although none of the widely publicised mishaps of 2014 involved such work, the NIH decided to suspend funding for gain-of-function studies involving influenza, MERS-CoV, and SARS-CoV.
The new framework stipulates that decisions on whether federal funding should be granted to a particular gain-of-function experiment will be decided on a case-by-case basis by a multidisciplinary review board at HHS. The board will evaluate the scientific merit of the experiment and examine whether there are viable, less risky approaches to tackle the same question. “The funding agency will be responsible for ongoing review as experiments move forward”, adds Wolinetz. Aside from the review board, the funding agency and the institutional biosafety committee will supervise the research. “There will be multiple layers of oversight throughout the life cycle of the experiment”, said Wolinetz.
In 2016, the NSABB issued a set of recommendations for the evaluation of proposed gain-of-function research. The document, which informs the HHS framework, outlines criteria for assessing the potential risks and benefits. “The first question is: how likely is the research to result in benefits and how great would these benefits be, and how likely is the research to result in harm, and how great would these harms be?”, Michael Selgelid (Monash University, Melbourne, VIC, Australia) told The Lancet Infectious Diseases. “But risk–benefit assessment is not an exact science, nor is it perfectly objective—a lot of the time, it is going to be very difficult to say what constitutes a situation where the benefits outweigh the risks.”
The likelihood of an accident leading to an outbreak, epidemic, or pandemic is extremely difficult to predict, as are the probable scientific advances. Proponents of gain-of-function experiments argue that their work could facilitate vaccine development. “We cannot even predict what the current seasonal influenza strains are going to do from one season to the next”, retorts Ian Mackay (University of Queensland, Brisbane, QLD, Australia). “We have vaccines, but they are not much good, and instead of concentrating on understanding these viruses and improving the vaccines, people prefer to worry about viruses that have not yet become transmissible and may never do so.”
Wolinetz points out that the viruses produced by gain-of-function experiments often pale in comparison with potential pandemic viruses that are found in the wild. “These experiments will help us get ahead of viruses that are already out there and pose a real and present danger to human health”, she said. “It is the only way we can really understand at a molecular level how these processes occur, and then we can take that information to develop the tools that we need to protect against these diseases”.
Arguments over whether a particular non-gain-of-function experiment could deliver the same answer as a proposed gain-of-function experiment could continue indefinitely (Mackay advocates doing more with loss-of-function experiments). And even if this could all be satisfactorily resolved, the question still remains of what to do with the information. “It depends on how risk-averse people are, and this differs between individuals and countries”, said Selgelid. Put another way: how should a given improvement in surveillance be weighed against a given chance of an outbreak or epidemic resulting from an accidental or deliberate release?
“Insofar as policymaking should be democratic, you might think that it should reflect the risk-taking strategies of citizens of a democratic country; things become more thorny when an issue crosses borders—is it OK for one nation to impose risks on citizens of another nation?”, asks Selgelid. He welcomes USA's willingness to take the lead on one of the most important problems facing bioethics, but stresses the importance of global coordination. Smallpox research, which is overseen by WHO, offers a precedent for this. “There should not be a complete ban on gain-of-function research—there are plenty of cases where it is appropriate and sometimes it may even be less dangerous than non-gain-of-function research”, said Selgelid. “But there should be an international review of the most worrisome kind of studies.”
Marc Lipsitch (Harvard University, MA, USA) is a founding member of the Cambridge Working Group. “I still do not believe a compelling argument has been made for why these studies are necessary from a public health point-of-view; all we have heard is that there are certain narrow scientific questions that you can ask only with dangerous experiments”, he said. “I would hope that when each HHS review is performed someone will make the case that strains are all different, and we can learn a lot about dangerous strains without making them transmissible.” He pointed out that every mutation that has been highlighted as important by a gain-of-function experiment has been previously highlighted by completely safe studies. “There is nothing for the purposes of surveillance that we did not already know”, said Lipsitch. “Enhancing potential pandemic pathogens in this manner is simply not worth the risk.”
Statistics on the number of breaches in the 1500 or so high containment laboratories in the USA are hard to come by. Serious events are extremely rare, ones that result in an infection in the community are virtually unknown. Nonetheless, the incidents that occurred in 2014 all involved material emerging from high-containment laboratories; dangerous live pathogens were accidentally sent to laboratories that were neither expecting them nor equipped to deal with them. “One cannot legislate for every accident or human error; all manner of things can go wrong, and if an outbreak spreads to the community the consequences could be horrendous”, said Mackay.
Looks like the guidelines were adhered to as closely and properly as those for the Foreign Intelligence Surveillance Court that approved spying on Trump based on a dossier fabricated at the behest of top Democrat politicos.
The Lancet is a fake medical journal controlled by China.
How is a lab experimenting on a virus that would normally infect animals without effecting humans experimenting on how they can bridge this gap and infect humans is not evil??
Why isn't anyone asking the question "Why did these accidents spike in 2014?" Or was it just that the media, for whatever reason, chose to highlight incidents that year but had no urgent need to report on them as much in other years?
2014 : (SPAIN-—EBOLA, BITCOIN) Spanish intelligence has intercepted messages passed between jihadists online discussing the weaponisation of the deadly Ebola virus for use against the West, while a blackmailer in Prague has threatened to unleash the virus unless the Czech Republic pay him one million bitcoin, a volume of online currency worth over £200 million. .—— Spanish Intelligence Intercepts Plot to Weaponise Ebola, Breitbart London ^ | October 30, 2014 | Oliver Lane (VIDEO-AT-LINK)
OCTOBER 2014 : (THREE DEMS INCLUDING RADICALS KEITH ELLISON [see NOI, CAIR] AND BARBARA LEE CALL FOR US TROOPS IN WEST AFRICA TO PROVIDE “DIRECT CARE” TO EBOLA PATIENTS —— See WEST AFRICA, EBOLA OUTBREAK, PANDEMICS, BIOSECURITY) —— House Dems call for U.S. troops to give direct Ebola care, The Hill ^ | October 15, 2014 | Peter Sullivan
Three House Democrats are calling on President Obama to allow U.S. troops in West Africa to provide direct care to Ebola patients. The Obama administration has already committed around 4,000 U.S. troops to help fight Ebola in the affected West African countries, but they are performing tasks such as building treatment centers and training local providers, not directly providing care. Reps. Keith Ellison (Minn.), Karen Bass (Calif.), and Barbara Lee (Calif.) want to change that. “We write to urge you to consider building on the current response to the Ebola epidemic by allowing military medical and technical personnel to provide...
—— House Dems call for U.S. troops to give direct Ebola care, The Hill ^ | October 15, 2014 | Peter Sullivan
2014 : (EBOLA CZAR [RON KLAIN {see AL GORE}] TO REPORT TO SUSAN RICE...WTF? [WHY THE CUTBACK IN CDC?])
Most of the so called “conservative media” and many Republican politicians have been trashing the Obama regime for the appointment of new “Ebola Czar” Ron Klain. Most of the trashing has been based on the fact that Klain is not a medical doctor by trade, and that all he has ever done was be in charge of Al Gore’s staff. The fact that the Ebola Czar won’t report directly to our Glorious President Obama, but instead to Susan Rice – well how can you argue with that logic (please note the sarcasm).
Republicans and the conservative media are missing the point – why do we need an Ebola Czar? Maybe I’m missing something here, but isn’t the CDC (aka Center for Disease Control) supposed to handle such things? If the “Center for Disease Control” is not capable of handling something such as, let’s say – the outbreak of a potentially incurable disease, well then why do we have a CDC?
Also of interest should be that our Glorious President Barack Obama in 2014 put in a request for the CDC in the amount of $6.6 billion, a decrease of 270 million dollars from fiscal year 2012. -— Do we really need an Ebola Czar?, American Thinker ^ | 10/21/2014 | S. John Massoud Posted on ?10?/?21?/?2014? ?10?:?03?:?23? ?AM by SeekAndFind
2014 : (EBOLA CZAR [RON KLAIN {see DEMOCRACY ALLIANCE, AL GORE}] TO REPORT TO SUSAN RICE...WTF? [WHY THE CUTBACK IN CDC?])
OCTOBER 2014 : (EBOLA CZAR RON KLAIN [see Democracy Alliance] TOO BUSY TO SHOW UP FOR WORK?) THIS JUST IN-— Ron Klain, New Ebola Czar, skips second WH Ebola Meeting...
OCTOBER 15, 2014 : (CLINTON TEAM INSTRUCTS DATTO TO BEGIN PURGING EMAILS [DESTROY EVIDENCE])
10/15/14 Clinton team instructs Datto to begin purging emails from their backup storage devices, which they apparently failed to do
Exam http://www.washingtonexaminer.com/clintons-tech-firm-worried-about-involvement-in-cover-up/article/2573526-— VIA -— DIRECTORBLUE.BLOGSPOT TIMELINE
Amonth before the October 2014 GoF moratorium there was a weird incident in Africa involving a US air marshall:
SEPTEMBER 2014 : (NIGERIA : WEIRD- FEDERAL AIR MARSHALL IS INJECTED WITH AN UNKNOWN SUBSTANCE BY AN ASSAILANT -— see CDC, BIOSECURITY) —— US federal air marshal attacked with syringe in Lagos airport, Fox News ^ | 8 Sep 2014 | Jana Winter
EXCLUSIVE – The FBI and CDC are investigating an attack on a federal air marshal who was injected with a syringe full of an unknown substance inside the Lagos, Nigeria airport on Sunday, according to a Situational Awareness notice obtained by FoxNews.com.
A federal air marshal reported being attacked by a subject while on the public side of the Lagos Airport on Sunday, according to an alert from TSA’s Transportation Security Operations Center distributed throughout the agency on Monday afternoon.
It appeared to be an isolated incident, the alert says.
“The [air marshal] reported that the subject stuck him with a syringe and it is believed he was injected with an unknown substance,” the alert says.
The State Department responded to the airport to assist the air marshal and his team.
“After consultation with the consulate and physicians, the [federal air marshal] was given precautionary medication,” according to the alert.
The air marshal and the rest of his team—along with the syringe used in the attack— were immediately flown out of Nigeria and back to the U.S.
The syringe also was transported back to the U.S. for testing.
An FBI spokesman said Monday night, “out of an abundance of caution, the Centers for Disease Control and Prevention conducted an on-scene screening of the victim when United Flight 143 landed in Houston early Monday morning. The victim did not exhibit any signs of illness during the flight and was transported to a hospital upon landing for further testing. None of the testing conducted has indicated a danger to other passengers.”
The CDC and the FBI are involved and have opened investigations, the alert states.
“This investigation is still in the preliminary stage and early indications are limited to a criminal nexus.”(Excerpt) Read more at foxnews.com ...
Well what happened to the Marshall?
Breaking — Ron Klain to step down as Biden chief of staff…
Citizen Free Press ^ | 1/21/23 | Kane
Posted on 1/21/2023, 2:55:25 PM by CFW
Breaking News: Ron Klain is expected to step down as White House chief of staff in coming weeks, according to Biden administration officials.
More at link
(Excerpt) Read more at citizenfreepress.com ...
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