HHS: Call For Public Comment On H5N1 Research

BSL-4 Lab Worker - Photo Credit –USAMRIID  

 

# 6639

 

 

During the first half of 2012, the big infectious disease story was the ongoing debate over H5N1 genetic research by Yoshihiro Kawaoka and Ron Fouchier which each led to the creation of a mammalian-adapted, easily transmissible form of the bird flu virus.

 

After prolonged, and often heated debate, the decision to publish both papers was finally made, but what was intended to be a 60 day self-imposed moratorium on similar research – implemented in February of 2012 – remains in place.

 

Many unresolved issues surround how projects determined to be DURC – Dual Use Research of Concern – should be handled. For those unfamiliar with the lexicon of biomedical research, DURC is defined as:

 

. . . life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.

 

Last March the Office of Science Policy at the NIH released a 4 page set of guidelines for DURC projects, and ordered a review of all current life sciences projects (U.S. Issues New DURC Oversight Rules), but there remain many areas ripe for debate.

 

In a attempt to gauge public sentiment, the HHS has published in the Federal Register a Request For Information And Comment that will remain open for the next 60 days.

 

Influenza Viruses Containing the Hemagglutinin from the Goose/Guangdong/1/96 Lineage

A Proposed Rule by the Health and Human Services Department on 10/17/2012

Summary

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) announces the opening of a docket to obtain information and comments from the public to questions concerning highly pathogenic avian influenza (HPAI) H5N1 viruses that contain a hemagglutinin (HA) from the Goose/Guangdong/1/96 lineage, and their potential to pose a severe threat to public health and safety. This information will be considered in a determination of whether such viruses should be listed as HHS select agents, by revising the HHS Select Agent Regulations (42 CFR Part 73).

 

 

The HHS oversees the CDC’s Select Agent Program, which today `oversees the activities of possession of biological agents and toxins that have the potential to pose a severe threat to public, animal or plant health, or to animal or plant products’.

 

Recently,we saw the SARS Virus Placed On Select Agents List, which essentially dictates who, and under what laboratory security conditions, can conduct experiments with that virus.

 

Returning to the Federal Register.

 

DATES: Back to Top

Electronic or written comments should be received on or before December 17, 2012.

ADDRESSES: Back to Top

You may submit comments identified by Docket Number CDC-2012-0010, by any of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov . Follow the instructions for submitting comments.
• Mail: Division of Select Agents and Toxins, Centers for Disease Control and Prevention, 1600 Clifton Road NE., Mailstop A-46, Atlanta, Georgia 30333, Attn: Docket Number: CDC-2012-0010.

Instructions: All submissions received must include the agency name and docket number (CDC-2012-0010) for this notice. All relevant comments received will be posted without change to www.regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to www.regulations.gov.

(Continue for Extensive Supplemental Information . . . )

 

DURC encompasses far more than just H5N1 research. For more on the issues, the NIH produced this 7 minute video in 2010 highlighting the concerns of DURC, called Dual Use Research: A dialogue.  Click the link, or the image below to watch.

 

»» Read More

mBio: Should The H5N1 Research Moratorium End?

 

BSL-4 Lab Worker - Photo Credit –USAMRIID  

 

 

# 6618

 

Ten months ago, during the prolonged debate over the publication of a pair of controversial research papers (see The Furor Over H5N1 Research Continues), a group of the world’s leading researchers announced a 60 day moratorium on specific types of bird flu research (see Scientists Announce 60 Day Moratorium On Some H5N1 Research).

 

While the research papers by Fouchier and Kawaoka on the genetic changes needed to provide H5N1 with enhanced transmissibility have now been published, the self-imposed moratorium remains in place.

 

Scientists, biosecurity experts, and policy makers continue to struggle with how to proceed with H5N1 research that potentially falls under the category of DURC -  Dual Use Research of Concern.

 

For those unfamiliar with the lexicon of biomedical research, DURC is defined as:

 

. . . life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.

 

Last March the Office of Science Policy at the NIH released a 4 page set of guidelines for DURC projects, and ordered a review of all current life sciences projects (U.S. Issues New DURC Oversight Rules).

 

Later today the journal mBio will publish a series of opinion pieces regarding H5N1 research by some of the most influential researchers in influenza virology and biosecurity.

We’ve got a preview from a press release, which ought to whet or appetites until the new issue goes live later today (LINK).    Some excerpts follow:

 

202-942-9297
American Society for Microbiology

Research on enhanced transmissibility in H5N1 influenza: Should the moratorium end?

How can scientists safely conduct avian flu research if the results could potentially threaten, as well as save, millions of lives? In a series of commentaries appearing on Tuesday, October 9 in mBio®, the online open-access journal of the American Society for Microbiology, prominent microbiologists and physicians argue the cases both for and against lifting a voluntary moratorium on experiments to enhance the ability of the H5N1 virus to move from mammal to mammal, so-called "gain-of-function" research, and discuss the level of biosecurity that would be appropriate for moving that research forward.

 

<SNIP>

 

Enhancing and analyzing the transmissibility of the H5N1 virus could, on the one hand, provide insights that could help prevent or treat a future outbreak of H5N1 , or, on the other hand, it may provide a roadmap for a "bad actor" to deliberately bring about an influenza pandemic or lead to an inadvertent release of a virus with enhanced transmissibility.

Authors of the commentaries are prominent scientists, including:

• Ron Fouchier of Erasmus MC Rotterdam in The Netherlands, Adolfo García-Sastre of the Mount Sinai School of Medicine, and Yoshihiro Kawaoka of the University of Wisconsin-Madison, lead authors of the two papers that began the controversy, argue that in the eight months since the moratorium was agreed upon, the international research community has had sufficient time to review biosafety and biosecurity measures and that H5N1 transmission studies ought to proceed.
• Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases contributes his voice as a representative of an organization that is a key funder of influenza research. Although Fauci acknowledges that the benefits of gain-of-function research outweigh the risks, he argues that scientists have yet to fully meet their responsibility for engaging the public in weighing these matters and making the case for proceeding. He outlines how the U.S. government plans to augment policy guidelines related to "dual use research of concern" like the experiments on enhanced influenza transmission.
• Marc Lipsitch and Barry R. Bloom of the Harvard School of Public Health explain why they view H5N1 with enhanced transmissibility as a "potential pandemic pathogen," representing an even greater threat to global health than Ebola and other biosafety level 4 (BSL-4) pathogens. They argue that research on enhanced H5N1 and other potential pandemic pathogens requires a new, more stringent set of guidelines for safety, thorough public discussion of the risks and benefits involved, and global guidelines for laboratory procedures, among other measures to minimize the risk of laboratory-released infections or epidemics.
• Ian Lipkin of Columbia University argues that once research on enhanced strains of H5N1 continues it may be advisable to conduct the work only in BSL-3 Ag laboratories that meet additional, enhanced guidelines for handling agents with pandemic potential. Lipkin proposes that any course should be charted in consultation with and oversight from the global scientific and regulatory community.
• Stanley Falkow of Stanford University provides perspective on the H5N1 research moratorium based on his own experiences with a similar situation in the 1970s, when research in recombinant DNA techniques was halted while a committee of scientists and non-scientists could establish a set of guidelines for conducting the work safely. Falkow argues that research on H5N1 viruses with enhanced transmissibility should move forward once scientists work with the public to establish standardized guidelines using common sense and scientific creativity.

(Continue . . . )

 

While the papers of Fouchier and Kawaoka sparked this vigorous (and at times heated) debate over the risks of creating a better bird flu virus, many of the same issues apply to other areas of biological research.

 

Among them:

• How are we to handle this brave new world of life sciences, where new viruses and other life forms can be created in the laboratory?
• Who is to decide on what is appropriate, or safe research?
• Who decides what should be published, and who should have access to redacted information?
• What laboratory protocols and protections are necessary for working the the H5N1 virus, and other virulent pathogens?

 

We are entering a new era of scientific discovery, one where great things are possible. But those advances will be for naught if the public loses faith in the science, or the scientists.

 

You can create a genetically modified dengue-resistant mosquito, but if the public fears it more than the disease, all you have is an expensive laboratory curiosity.

 

And a universal flu vaccine – one that could forever stave off the global threat of influenza pandemics -only works if it is accepted by the vast majority of the public as being safe, effective, and necessary.

 

As I wrote in Science At The Crossroads, the public’s faith in science and technology is teetering. 

 

According to a UK poll (Public Attitudes To Science, May 2011), while the majority of respondents (79%) believe science has, on the whole, made our lives easier . . .  astonishingly, just 54% believe that the benefits of science are greater than any harmful effect.

 

One only has to look at the deep divisions over climate change, evolution, vaccine safety, nuclear power, and genetically modified food crops to realize just how wide this rift between the public, and scientists, has become.

 

Which makes getting policy on H5N1 research (and other DURC projects) right, and as safe as possible, absolutely imperative.

 

Given the public’s sentiment, the burgeoning field of Life Sciences (which includes bio-engineering) can ill afford a misstep if they hope to gain and hold the public’s acceptance.

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Reminder: National Academies Webcast Today On H5N1 Research

 

# 6308

 

Today the National Academies will stream a day-long webinar on the issues surrounding Dual Use Research of Concern (DURC).  The webcast begins at 8:30 EDT.

 

You can view the agenda watch via the web at:

 

http://events.tvworldwide.com/Events/IOM/IOM120501.aspx

 

Issues Raised, Lessons Learned, and Paths Forward for Dual-Use Research in the Life Sciences: The H5N1 Research Controversy

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Fouchier Research To be Debated In The Netherlands This Week

BSL-4 Lab Worker - Photo Credit –USAMRIID

 

# 6296

 

Although the United States has officially withdrawn its objections to the publication of Ron Fouchier’s H5N1 ferret research study (see The Biosecurity Debate On H5N1 Research for background on this issue), there remains another bureaucratic obstacle to publication in the form of an export license from the Dutch government.

 

According to a Radio Netherlands report, the debate will be taken up tomorrow, and there remains considerable opposition to the publication. 

 

A hat tip to Pathfinder on FluTrackers for this link.

 

Publication ban on virus research: security or censorship?

Published on : 21 April 2012 - 6:41pm | By Willemien Groot

On Monday, Dutch experts will debate whether or not Dr Ron Fouchier should be allowed to publish the results of his research, which has created a potentially dangerous strain of the H5N1 bird flu virus. The United States biosecurity watchdog has withdrawn its objections to publication. Dutch Deputy Minister for Innovation Henk Bleker, on the other hand, still fears the research could be used by terrorists. Fouchier rejects any ban on publication of his work. A row is in the making.

(Continue . . . )

 

 

Fouchier has reportedly not applied for an export license, and has stated that he intends to publish his research with – or without – the sanctioning of his government.

 

According to a report by CIDRAP NEWS last week (see Fouchier plans to flout Dutch export law, publish H5N1 study),  Fouchier could conceivably find himself facing criminal charges if he attempts to publish his data without government permission.

 

While the U.S. has withdrawn its objections to the publication of Fouchier’s research (and Professor Yoshihiro Kawaoka’s in Wisconsin), and has recently issued new regulations regarding oversight of Dual Use Research of Concern (see U.S. Issues New DURC Oversight Rules), there remain many unresolved bio-security issues surrounding the life sciences and bioengineering fields.

 

Among them:

• How are we to handle this brave new world of life sciences, where new viruses and other life forms can be created in the laboratory?
• Who is to decide on what is appropriate, or safe research?
• Who decides what should be published, and who should have access to redacted information?
• What laboratory protocols and protections are necessary for working the the H5N1 virus, and other virulent pathogens?

 

Regardless of what the Dutch government decides in the near term on the publication of Fouchier’s research, the problem of what to do about future DURC research projects are not going away.

 

These are serious biosecurity concerns that must be faced, debated, and agreed upon internationally, not just by individual countries.

And better sooner, rather than later. 

»» Read More

NIH Video: Dual Use Research Of Concern (DURC)

 

NIH Brochure on Dual Use Research

 

# 6264

 

 

Over the past few months an obscure acronym has made it’s way into numerous blogs, news headlines, and even popular usage; DURC -  Dual Use Research of Concern.

 

While it is the current debate over controversial H5N1 transmissibility studies that has prompted its emergence (see The Biosecurity Debate On H5N1 Research), DURC has been a matter of national concern for a number of years.

 

The NIH produced a 7 minute video in 2010 highlighting the concerns of DURC, called Dual Use Research: A dialogue.  Click the link, or the image below to watch.

 

 

 

Last week the  Office of Science Policy at the NIH released a 4 page set of guidelines for DURC (Duel Use Research of Concern) projects designed to beef up oversight and biosecurity of U.S. funded projects.

 

The scope of this new policy is to cover research on the most dangerous of biological organisms, listing;

 

a)  Avian influenza virus (highly pathogenic) 
b)  Bacillus anthracis
c)  Botulinum neurotoxin
d)  Burkholderia mallei
e)  Burkholderia pseudomallei
f)  Ebola virus
g)  Foot-and-mouth disease virus
h)  Francisella tularensis
i)  Marburg virus

j)  Reconstructed 1918 Influenza virus

k)  Rinderpest virus
l)  Toxin-producing strains of Clostridium botulinum
m) Variola major virus
n)  Variola minor virus
o)  Yersinia pestis

 

Specifically any research that seeks to:

 

a)  Enhances the harmful consequences of the agent or toxin; 

b)  Disrupts immunity or the effectiveness of an immunization against the agent or toxin without
clinical or agricultural justification;

c)  Confers to the  agent or toxin resistance to clinically or agriculturally useful prophylactic or
therapeutic interventions against that agent or toxin or facilitates their ability to evade detection methodologies;

d)  Increases the stability, transmissibility, or the ability to disseminate the agent or toxin; 

e)  Alters the host range or tropism of the agent or toxin;  

f)  Enhances the susceptibility of a host population to the agent or toxin; or

g)  Generates or reconstitutes an eradicated or extinct agent or toxin listed in Section (III.1) above.

 

 

For more on DURC, the NSABB, and the Office of Biotechnology Activities, you may wish to visit the following links.

Brochure on Dual Use Research

Video on Dual Use Research

International Meetings

NSABB FAQs

Summary of NSABB Reports and Activities

Responsible Communication of Life Sciences Research with Dual Use Potential

Global Status of Strategies for Addressing the Intersection of Science and Security

Roundtable at the ASM Biodefense and Emerging Diseases Research meeting

»» Read More

U.S. Issues New DURC Oversight Rules

BSL-4 Lab Worker - Photo Credit –USAMRIID

 

# 6252

 

 

While the current H5N1 research row has centered around the publication of two specific research projects (see NSABB To Re-examine H5N1 Research Risks), the bigger issues at play involve how we oversee (and fund) future life sciences research in order to avoid future controversies.

 

To that end, today the Office of Science Policy at the NIH released a 4 page set of guidelines for DURC (Duel Use Research of Concern) projects, and ordered a review of all current life sciences projects.

 

For those unfamiliar with the lexicon of biomedical research, DURC in this new policy is defined as:

 

. . . life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security

 

The scope of this new policy is to cover research on the most dangerous of biological organisms, listing;

 

a)  Avian influenza virus (highly pathogenic) 
b)  Bacillus anthracis
c)  Botulinum neurotoxin
d)  Burkholderia mallei
e)  Burkholderia pseudomallei
f)  Ebola virus
g)  Foot-and-mouth disease virus
h)  Francisella tularensis
i)  Marburg virus

j)  Reconstructed 1918 Influenza virus

k)  Rinderpest virus
l)  Toxin-producing strains of Clostridium botulinum
m) Variola major virus
n)  Variola minor virus
o)  Yersinia pestis

Specifically any research that seeks to:

 

a)  Enhances the harmful consequences of the agent or toxin; 

b)  Disrupts immunity or the effectiveness of an immunization against the agent or toxin without
clinical or agricultural justification;

c)  Confers to the  agent or toxin resistance to clinically or agriculturally useful prophylactic or
therapeutic interventions against that agent or toxin or facilitates their ability to evade detection methodologies;

d)  Increases the stability, transmissibility, or the ability to disseminate the agent or toxin; 

e)  Alters the host range or tropism of the agent or toxin;  

f)  Enhances the susceptibility of a host population to the agent or toxin; or

g)  Generates or reconstitutes an eradicated or extinct agent or toxin listed in Section (III.1) above.

 

 

While this new policy does not automatically halt or defund research found to meet the DURC definition, it does require greater agency oversight and an assessment of the risks and benefits of any research, along with the development of appropriate risk and safety measures.

 

As far as `teeth’ in this new policy, if perceived risks cannot be satisfactorily mitigated Federal Agencies may request voluntary redaction of scientific papers, may move to `classify’ the research, or may withhold or terminate financial support.

 

Agencies that conduct or fund life sciences research are instructed to perform a review to identify any projects that meet the DURC definition, and if found, to:

 

 

c)  Assess the risks and benefits of such projects, including how research methodologies may
generate risks and/or whether open access to the knowledge, information, products, or technologies  generates risk.

d)  Based on the risk assessment, in collaboration with the institution or researcher, develop a risk
mitigation plan to apply any necessary and appropriate risk mitigation measures.  In addition:

• i)  For DURC that is proposed and not yet funded, departments and agencies will assess
  whether to incorporate risk mitigation measures in the grant, contract, or agreement.

• ii)  For currently funded DURC, funding departments and agencies will consider modifying the grant, contract, or agreement to incorporate risk mitigation measures. If such modifications are not possible or desirable, departments and agencies will seek voluntary implementation of mitigation measures by the institution. 

 

 

You can access the full policy on the Office of Biotechnology Activity’s News Page:

 

Now Available:

US Government Issues Policy on Oversight of Life Science Dual Use Resarch of Concern:

The purpose of this Policy is to establish regular review of United States Government funded or conducted research with certain high-consequence pathogens and toxins for its potential to be dual use research of concern (DURC) in order to: (a) mitigate risks where appropriate; and (b) collect information needed to inform the development of an updated policy, as needed, for the oversight of DURC. The fundamental aim of this oversight is to preserve the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research.

(March 29, 2012)

 

 

And just as I was finishing this post up, I saw that Lisa Schnirring at CIDRAP NEWS has an excellent overview of this new policy.   Read it at:

 

US debuts life sciences dual-use research policy

Lisa Schnirring Staff Writer

 

It will be interesting to see how this new policy is received by scientists working in the life sciences field.

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