GOF risk-benefit analysis unveiled ahead of NSABB

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   GOF risk-benefit analysis unveiled ahead of NSABB debate

An analysis group under contract with the National Institutes of Health (NIH) today released a risk-benefit analysis of gain-of-function (GOF) research, a key part of ongoing federal review of controversial experiments on H5N1 avian influenza and other disease threats.

Gryphon Scientific, a life sciences policy analysis group based in Takoma Park, Md., was awarded the $1.1 million contract in March. The contract stems from Obama administration announcements in October 2014 declaring a pause on federally funded GOF research and asking the National Science Advisory Board for Biosecurity (NSABB) to come up with policies on federal funding for the research, which are closely tied to the risk-benefit analysis.

The government's steps are aimed at studies that enhance pathogenicity, transmissibility, or host range of a pathogen to better understand the disease and help with vaccine and drug development. Such studies, however, have triggered "dual-use" worries—that methods could be used not only for beneficial purposes, but in the wrong hands could be used to create bioterror threats.

Some experts have also raised concerns about an intentional or accidental release of the experimental pathogens, especially in light of recent safety lapses involving federal facilities.

A year ago federal officials loosened the moratorium on a few GOF studies, some involving Middle East respiratory syndrome coronavirus (MERS-CoV) and influenza.

Gryphon's 1,001-page risk-benefit assessment is on the agenda for the NSABB's next meeting that begins on Jan 7 and is posted on the group's Web page. Dated Dec 8, the document is also posted on Gryphon's Web site.

The 2-day meeting will include panel discussions that include experts on both sides of the GOF debate, including two scientists who led the H5N1 GOF studies that sparked the initial debate: Ron Fouchier, PhD, from Erasmus Medical Center in the Netherlands and Yoshihiro Kawaoka, DVM, PhD, from the University of Wisconsin, Madison.

Two assessment approaches

Analysts from Gryphon had three main tasks: to look at risks from accidents and natural disasters, assess biosecurity, and gauge benefits from the work. In its executive summary, the group noted that the biosecurity section has two parts, each of which required a different assessment approach: one covering malicious attacks on labs and the other on misuse of published GOF research.

Documents for the NSABB's upcoming meeting also include an ethics white paper written by Michael Selgelid, PhD, that will be discussed on the first day of the meeting. Selgelid directs the Centre for Human Bioethics at Monash University in Melbourne, Australia, and is with the World Health Organization's Collaborating Center for Bioethics.

The NSABB will discuss a draft of its research funding policy recommendations on the second day of the meeting.

http://www.cidrap.umn.edu/news-perspective/2015/12/gof-risk-benefit-analysis-unveiled-ahead-nsabb-debate

complete Gyphonscientific study

http://www.gryphonscientific.com/wp-content/uploads/2015/12/Final-Gain-of-Function-Risk-Benefit-Analysis-Report-12.11.2015.pdf

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arirish Members Profile Send Private Message Find Members Posts Add to Buddy List Admin Group Joined: June 19 2013 Location: Arkansas Status: Offline Points: 39215	Post Options Post Reply Quote arirish Report Post Thanks(0) Quote Reply Topic: GOF risk-benefit analysis unveiled ahead of NSABB Posted: December 14 2015 at 9:00am
	GOF risk-benefit analysis unveiled ahead of NSABB debate An analysis group under contract with the National Institutes of Health (NIH) today released a risk-benefit analysis of gain-of-function (GOF) research, a key part of ongoing federal review of controversial experiments on H5N1 avian influenza and other disease threats. Gryphon Scientific, a life sciences policy analysis group based in Takoma Park, Md., was awarded the $1.1 million contract in March. The contract stems from Obama administration announcements in October 2014 declaring a pause on federally funded GOF research and asking the National Science Advisory Board for Biosecurity (NSABB) to come up with policies on federal funding for the research, which are closely tied to the risk-benefit analysis. The government's steps are aimed at studies that enhance pathogenicity, transmissibility, or host range of a pathogen to better understand the disease and help with vaccine and drug development. Such studies, however, have triggered "dual-use" worries—that methods could be used not only for beneficial purposes, but in the wrong hands could be used to create bioterror threats. Some experts have also raised concerns about an intentional or accidental release of the experimental pathogens, especially in light of recent safety lapses involving federal facilities. A year ago federal officials loosened the moratorium on a few GOF studies, some involving Middle East respiratory syndrome coronavirus (MERS-CoV) and influenza. Gryphon's 1,001-page risk-benefit assessment is on the agenda for the NSABB's next meeting that begins on Jan 7 and is posted on the group's Web page. Dated Dec 8, the document is also posted on Gryphon's Web site. The 2-day meeting will include panel discussions that include experts on both sides of the GOF debate, including two scientists who led the H5N1 GOF studies that sparked the initial debate: Ron Fouchier, PhD, from Erasmus Medical Center in the Netherlands and Yoshihiro Kawaoka, DVM, PhD, from the University of Wisconsin, Madison. Two assessment approaches Analysts from Gryphon had three main tasks: to look at risks from accidents and natural disasters, assess biosecurity, and gauge benefits from the work. In its executive summary, the group noted that the biosecurity section has two parts, each of which required a different assessment approach: one covering malicious attacks on labs and the other on misuse of published GOF research. Documents for the NSABB's upcoming meeting also include an ethics white paper written by Michael Selgelid, PhD, that will be discussed on the first day of the meeting. Selgelid directs the Centre for Human Bioethics at Monash University in Melbourne, Australia, and is with the World Health Organization's Collaborating Center for Bioethics. The NSABB will discuss a draft of its research funding policy recommendations on the second day of the meeting. http://www.cidrap.umn.edu/news-perspective/2015/12/gof-risk-benefit-analysis-unveiled-ahead-nsabb-debate complete Gyphonscientific study http://www.gryphonscientific.com/wp-content/uploads/2015/12/Final-Gain-of-Function-Risk-Benefit-Analysis-Report-12.11.2015.pdf
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CRS, DrPH Members Profile Send Private Message Find Members Posts Add to Buddy List Expert Level Adviser Joined: January 20 2014 Location: Arizona Status: Offline Points: 26660	Post Options Post Reply Quote CRS, DrPH Report Post Thanks(0) Quote Reply Posted: December 14 2015 at 4:52pm
	Thanks! I'm a signatory of this group's statement: http://www.cambridgeworkinggroup.org We take a dim view of all of this GOF stuff. It is mostly academic arrogance. We can't even keep track of all the smallpox vials floating around, I don't support this nonsense. Making lab-generated mutations has no bearing on what might erupt in nature, we should spend the money on surveillance and field work.
	CRS, DrPH

arirish Members Profile Send Private Message Find Members Posts Add to Buddy List Admin Group Joined: June 19 2013 Location: Arkansas Status: Offline Points: 39215	Post Options Post Reply Quote arirish Report Post Thanks(0) Quote Reply Posted: December 15 2015 at 7:27am
	Chuck- I could not agree more! There are enough monsters in the world. We don't need DR. Frankenstein's help! Keep up the good work!
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Guests Members Profile Send Private Message Find Members Posts Add to Buddy List Guest Group	Post Options Post Reply Quote Guests Thanks(0) Quote Reply Posted: December 15 2015 at 9:47am
	The low down on this story as I understand it is this Yoshihiro Kawaoka wanted to produce a pandemic strain of flu, his argument is that it must be a strain different for all previous strains of pandemic flu so he choose H5N1 as H5 has never produced a pandemic. Whats the chances of two completely independent teams of scientists Ron Fouchier and Yoshihiro Kawaoka choosing an obscure flu like H5 for pandemic research ??? Ron Fouchier's team in the Netherlands and Yoshihiro Kawaoka's team in the USA are essentially tentacles of the same monster, these teams are collaborating with each and have developed a H5N1 pandemic strain of flu capable of human depopulation, Yoshihiro Kawaoka says the reason for this research is to be able to identify a wild strain of flu that is about acquire pandemic potential so that a early warning can be raised and a vaccine developed should a pandemic ensue. Firstly a pandemic strain may not acquire pandemic potential in the same way as the LAB (variant)H5N1, using Yoshihiro Kawaoka own argument it must be different from all previous strains of pandemic flu so he choose H5N1 hold that thought for a second, it's a bit like mathematics there are many routes available to obtain the final solution. There maybe and quite likely no warning of a approaching pandemic from a wild strain and thus nullifying any potential health benefits of the pandemic research however it does make a useful bioweapon against the general population that is about to raise up against the Dragon Kings for stealing all their wealth and assets. Still unsure ? Who funds this pandemic research, the Bill & Milenda Gates Foundation. Bill gates has poured at lot of resources into the Biotech and Big Pharma Racket in recent years, what is his business plan ? Bill Gates is on public record saying vaccines can help reduce world population and he's not kidding I am sure some of you will be familiar with Mike Adams the highly respected health ranger even he is worried. http://www.bibliotecapleyades.net/salud/salud_vacunas55.htm Don't forget Bill & Milenda Gates Foundation are also big Sponsors of the WHO, when it came to overturning the objections of the NSABB with regard to publication of pandemic research of (variant)H5N1 the final decision was conveniently taken away from the NSABB and given to WHO to decided, over a two day conference in Geneva, WHO approved the publication of the manuscripts. Now when a viral outbreak occurs, it wasn't me, the recipe is published and in the public domain it could have been anybody, it was probably ISIS that done it. Dragon Kings you can't manipulate the physical laws of science, for every action their is a equal and opposite reaction.

CRS, DrPH Members Profile Send Private Message Find Members Posts Add to Buddy List Expert Level Adviser Joined: January 20 2014 Location: Arizona Status: Offline Points: 26660	Post Options Post Reply Quote CRS, DrPH Report Post Thanks(0) Quote Reply Posted: January 08 2016 at 12:31pm
	I submitted these comments to the NSABB in time for their meeting (note, I had to redact a few words to conceal my own relationships with the US): I am a Public Health Advisor to the XXXXXXX and have this comment regarding your upcoming NSABB meeting. I have reviewed the “Risk and Benefit Analysis of Gain of Function Research” Draft Final Report, December 2015 and am VERY concerned that the largest, deadliest incident of domestic breach of biosafety, namely the “Amerithrax” incident involving the late Bruce Ivins PhD, was only mentioned once in 1006 pages. The incident of Dr. Ivins is very troubling because he had a high-level US Government security clearance, worked within the government’s secure bioterrorism research infrastructure, had privileged access to dangerous infectious materials, and was able to single-handedly conduct an attack upon the American public that resulted in five deaths and other injuries. Ivin’s actions put scores of US government workers, including law enforcement, politicians, postal service and others at risk, and this event cost untold millions in remediation and lost business. Gain of Function research entails a similar risk to the public. I consider the likelihood of a researcher releasing potentially pandemic agents much higher than an armed assault upon university laboratories by terrorists or criminals, but this scenario is downplayed. Motivations could include mental illness, coercion by a foreign power, or self-aggrandizement as seemed to be the case for Ivins. Thank you for your consideration of my comments for your meeting.
	CRS, DrPH

CRS, DrPH Members Profile Send Private Message Find Members Posts Add to Buddy List Expert Level Adviser Joined: January 20 2014 Location: Arizona Status: Offline Points: 26660	Post Options Post Reply Quote CRS, DrPH Report Post Thanks(0) Quote Reply Posted: January 08 2016 at 12:39pm
	p.s. the entire Risk-Benefit Analysis report that I critiqued is here: http://www.gryphonscientific.com/wp-content/uploads/2015/12/Final-Gain-of-Function-Risk-Benefit-Analysis-Report-12.14.2015.pdf Guys like Kawaoka are a hazard to humanity.
	CRS, DrPH