[Senate Hearing 112-535]
[From the U.S. Government Printing Office]
S. Hrg. 112-535
BIOLOGICAL SECURITY: THE RISK OF DUAL-USE RESEARCH
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HEARING
before the
COMMITTEE ON
HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
UNITED STATES SENATE
ONE HUNDRED TWELFTH CONGRESS
SECOND SESSION
__________
APRIL 26, 2012
__________
Available via the World Wide Web: http://www.fdsys.gov/
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Committee on Homeland Security and Governmental Affairs
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COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
JOSEPH I. LIEBERMAN, Connecticut, Chairman
CARL LEVIN, Michigan SUSAN M. COLLINS, Maine
DANIEL K. AKAKA, Hawaii TOM COBURN, Oklahoma
THOMAS R. CARPER, Delaware SCOTT P. BROWN, Massachusetts
MARK L. PRYOR, Arkansas JOHN McCAIN, Arizona
MARY L. LANDRIEU, Louisiana RON JOHNSON, Wisconsin
CLAIRE McCASKILL, Missouri ROB PORTMAN, Ohio
JON TESTER, Montana RAND PAUL, Kentucky
MARK BEGICH, Alaska JERRY MORAN, Kansas
Michael L. Alexander, Staff Director
Christian J. Beckner, Associate Staff Director for Homeland Security
Prevention and Protection
Carly A. Covieo, Professional Staff Member
Nicholas A. Rossi, Minority Staff Director
Brendan P. Shields, Minority Director of Homeland Security Policy
Jared F. Golden, Minority Professional Staff Member
Trina Driessnack Tyrer, Chief Clerk
Patricia R. Hogan, Publications Clerk
Laura W. Kilbride, Hearing Clerk
C O N T E N T S
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Opening statements:
Page
Senator Lieberman............................................ 1
Senator Collins.............................................. 3
Prepared statements:
Senator Lieberman............................................ 29
Senator Collins.............................................. 32
WITNESSES
Thursday, April 21, 2012
Anthony S. Fauci, M.D., Director, National Institute of Allergy
and Infectious Diseases, National Institutes of Health, U.S.
Department of Health and Human Services........................ 5
Daniel M. Gerstein, Ph.D., Deputy Under Secretary for Science and
Technology, U.S. Department of Homeland Security............... 7
Paul S. Keim, Ph.D., Acting Chairman, National Science Advisory
Board for Biosecurity, National Institutes of Health, U.S.
Department of Health and Human Services........................ 11
Thomas V. Inglesby, M.D., Chief Executive Officer and Director,
Center for Biosecurity, University of Pittsburgh Medical Center 14
Alphabetical List of Witnesses
Fauci, Anthony S., M.D.:
Testimony.................................................... 5
Prepared statement with attachments.......................... 34
Gerstein, Daniel M., Ph.D.:
Testimony.................................................... 7
Prepared statement........................................... 53
Inglesby, Thomas V., M.D.:
Testimony.................................................... 14
Prepared statement........................................... 63
Keim, Paul S., Ph.D.:
Testimony.................................................... 11
Prepared statement........................................... 59
APPENDIX
Letter from Michael T. Osterholm, Ph.D., M.P.H., Director Center
for Infectious Disease Research and Policy, University of
Minnesota, to Amy P. Patterson, M.D., Associate Director for
Science Policy, National Institutes of Health, dated April 12,
2012, submitted by Senator Lieberman........................... 76
Response to post-hearing questions for the Record:
Dr. Fauci.................................................... 83
Dr. Gerstein................................................. 88
Dr. Keim..................................................... 96
BIOLOGICAL SECURITY: THE RISK OF
DUAL-USE RESEARCH
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THURSDAY, APRIL 26, 2012
U.S. Senate,
Committee on Homeland Security
and Governmental Affairs,
Washington, DC.
The Committee met, pursuant to notice, at 10:06 a.m., in
room SD-342, Dirksen Senate Office Building, Hon. Joseph I.
Lieberman, presiding.
Present: Senators Lieberman and Collins.
OPENING STATEMENT OF CHAIRMAN LIEBERMAN
Chairman Lieberman. The hearing will come to order.
Good morning, and thanks very much to our really
distinguished panel of witnesses. We use the word
``distinguished'' around here very easily, but it actually does
relate to this panel and I thank you for being here.
If I may begin by looking back a bit, in 1851, a revolution
in medicine already underway was crystallized in a letter Louis
Pasteur wrote to a friend, ``I am on the edge,'' he said, ``of
mysteries and the veil is getting thinner and thinner.'' Thanks
to the work of Pasteur and succeeding generations of
scientists, the mysteries of the microbial world have slowly
been revealed and we are all a lot healthier and living a lot
longer as a result. Childhood diseases like polio and measles
have, in many ways, been vanquished. Scientists were able to
identify the acquired immunodeficiency syndrome (AIDS) virus,
which helped lead to treatments. And according to one of our
witnesses today, the real possibility of a cure for AIDS is in
sight.
The last global pandemic, the Spanish Flu pandemic, which
killed on a massive scale, at least 50 million people, was
almost a century ago. I remember this because it deprived me of
ever knowing one of my grandmothers, my paternal grandmother
who died as a young woman in New York in that pandemic.
But in addition to all the medical miracles that were
underneath that veil Pasteur began to peel back, there were, of
course, also dangers. Research that could lead to cures,
extending life for millions, also could kill many if a rogue
pathogen were released either by accident or because it fell
into what I will call evil hands. And it is this paradox of
dual-use research that we gather together today to consider at
this hearing.
Last fall, the world was shaken by the news that two
research teams, working independently had been able to engineer
a new strain of the H5N1 virus, which we know as Bird Flu, that
could easily infect humans. Epidemiologists have long feared
that if the H5N1 virus ever made the jump from a virus mostly
confined to birds to one easily transmitted among humans, it
could swiftly cause a pandemic. The mortality rate for the few
reported cases in humans who have been infected is as high as
60 percent. By contrast, the Spanish Flu, which I mentioned
earlier, had a mortality rate of about 2 percent.
The researchers that I referred to, based both at Erasmus
University in the Netherlands and at the University of
Wisconsin, announced that they were going to publish the
results of their studies in the journal, Science and Nature.
This set off what I would call a global ethics debate in the
scientific community about whether to publish or not publish
these results, and if the experiments, which were funded by the
National Institutes of Health (NIH), should have been
undertaken at all.
On the one hand, there are those who say that getting this
information out could help other scientists better understand
the mutant strain so they could prepare for a possible pandemic
by looking for natural mutations and developing vaccines and
medications. The fact that these two research teams were able
to create this new strain from existing genetic material means
that nature could create it, as well. In fact, many scientists
said that that was quite likely.
But given the lethality of the virus, others argued that
publishing the results would create a huge security risk
because it would offer a blueprint for a deadly biological
weapon to rogue states or terrorists, and, of course, that is
where this Committee's interest is drawn because of our
responsibility for homeland security.
In a recent speech at a biological weapons conference in
Geneva, Secretary of State Clinton warned that al-Qaeda in the
Arabian Peninsula had, in fact, issued a call for ``brothers
with degrees in microbiology or chemistry to develop a weapon
of mass destruction.'' And, of course, there is also a danger
that the manufactured strain might somehow escape, so to speak,
from the laboratory, which is something we have worried about
in the past.
Last December, at the request of the Department of Health
and Human Services (HHS), the National Science Advisory Board
for Biosecurity (NSABB), was asked to review the H5N1 research
papers. The NSABB concluded that more needed to be known before
the research was made public and they asked the editors of
Science and Nature to delay publication.
Last month, after further review, the NSABB withdrew its
objections and voted unanimously to allow the University of
Wisconsin study to be published, and by a divided vote of 12-6
to allow the Netherlands study to be published with some
revisions and clarifications.
One of the things that apparently influenced the Board's
decision was the revelation that the modified strains of H5N1
had become less lethal. But as the members of the panel know, I
am sure, that decision has drawn criticism from Dr. Michael T.
Osterholm, Director of the Center for Infectious Disease
Research and Policy at the University of Minnesota and an NSABB
Board member himself. In a letter to the NIH, he wrote that the
NSABB had deliberately ignored the voice of scientists who
believed publication of the H5N1 research was dangerous, and I
quote from his letter. ``I believe there was a bias toward
finding a solution that was a lot less about a robust science
and policy-based risk-benefit analysis and more about how to
get out of this difficult situation.'' He then added, ``We
cannot just kick the can down the road without coming to grips
with the very difficult task of managing,'' and I know he was
referring to dual-use research. So this is a serious charge,
which I hope as the morning goes on the panel will respond to.
The publish or not publish debate continued earlier this
month during a 2-day conference of the world's leading
scientists convened by the Royal Society in London. One point I
learned that most of the attendees seemed to agree on is that
we need to put in place better systems to track this kind of
research at each experimental stage rather than waiting until
it is ready for publication to make decisions about what can be
revealed. That is another question that I hope our panelists
will discuss today.
Although this particular controversy about publication
appears to have been resolved, it is going to recur and, as Dr.
Osterholm said, we cannot just kick the can down the road and
deal with it on an ad hoc basis. What systems to monitor dual-
use research that could produce dangerous results were in place
at the time these experiments were begun? What new systems are
being in place now? Are more needed? And how do we balance
these against our obvious valuation of the valuing of the
question for knowledge, of free scientific inquiry?
Etched into the National Academy of Sciences headquarters
wall are the words of Einstein, one of Einstein's many phases
that are quoted often, ``The right to search for truth implies
also a duty. One must not conceal any part of what one has
recognized to be true.'' But, of course, this matter before us
this morning raises another question that is relevant, which is
what if peeling away nature's veil, in Pasteur's term,
unleashes dangers to the world?
Those are difficult questions to balance, and again, I
repeat that we ask them here in this Committee because of the
direct connection between the scientific work and the homeland
security of the American people, which it is our first
responsibility to protect. I really look forward to your
testimony and the question and answer period, and again, I
thank you for being here.
Senator Collins.
OPENING STATEMENT OF SENATOR COLLINS
Senator Collins. Thank you, Mr. Chairman.
It has been almost a century since the 1918 Spanish
influenza virus infected one-fifth of the world's population,
killing more than 50 million people and claiming some 600,000
American lives. Yet virulent strains of influenza are still a
major threat.
The H1N1 strain, more commonly known as the Swine Flu,
claimed more than 18,000 lives during the 2009 outbreak and
exposed gaps in our preparedness capabilities for response to a
global pandemic, especially in the development, production, and
distribution of life-saving vaccines.
In 2008, this Committee held a hearing on the report by the
Commission on the Prevention of Weapons of Mass Destruction,
which examined the security of biological pathogens on the
select agent list. The testimony by the Chairmen of the
Commission, former Senators Bob Graham and Jim Talent, helped
to raise awareness on the issue of biosecurity and the need to
ensure that deadly pathogens and the research carried out on
them are contained in secure lab facilities.
This Committee has also held numerous hearings on the
Nation's efforts to prevent, prepare for, and mitigate the
impact of a pandemic influenza outbreak. In 2009, the
Administration's failure to ensure that the government was
prepared to rapidly distribute vaccines was and remains a cause
for great concern.
Preparedness also requires investing in critical life
sciences research to expand our knowledge base and technologies
to help us better respond to the next potential global
pandemic. Such a pandemic could be even more communicable than
the 1918 influenza virus or as virulent as the Avian Flu virus.
The World Health Organization (WHO) has documented 576 human
cases of Avian Flu infection worldwide since 2003, 339 of those
cases resulted in death.
Recently, research funded by the National Institutes of
Health and conducted in Wisconsin and the Netherlands resulted
in genetic changes to a strain of Avian Flu that allowed its
airborne transmissibility. The NIH-funded researchers planned
to publish their full findings in two academic journals. Now,
publication, peer review, and replication of findings are
obviously important steps in a vigorous scientific process. But
others have expressed concern that the publication of the
methodology and some of the data could help create a road map
for terrorists and others seeking to further modify the virus
into a bio-weapon. That is why a government advisory board, the
National Science Advisory Board for Biosecurity, recommended in
late December that partial information be withheld from
publication.
Late last month, however, the Board--with some dissenters--
reversed course, and is now advocating for the full publication
of the research done in Wisconsin as revised, and the
publication of a revised paper on the research performed in the
Netherlands. The decision and its reversal have been part of a
larger debate within the scientific and national security
communities and there are important arguments being made on
both sides. When the American people pay for scientific
research intended for the common good, they have a right to
expect that their money will not be used to facilitate
terrorism.
These are not hypothetical threats. Before he was killed,
Anwar al-Awlaki reportedly sought poisons to attack the United
States. Adding to these concerns, the new leader of al-Qaeda
has a medical background. Therefore, he may have an even
greater interest in pursuing chemical and biological terrorism.
At the same time, there is a legitimate concern about
government censorship that could chill academic freedom and
scientific inquiry or even limit the sharing of information
necessary to save lives or improve public health. Recently, NIH
released a new policy for the oversight of dual-use research of
concern. This policy is intended to improve our awareness of
current and proposed dual-use research of concern and provide
some guidelines for mitigating the associated risks. This new
policy, however, is only the beginning of what must be a
straightforward dialogue among science, health, national
security, and government experts and leaders in order to
promote scientific research while protecting the safety of
Americans and others around the world.
I look forward this morning to hearing and reviewing the
testimony of our witnesses about these challenging issues and
how we can strike the right balance.
I do want to apologize that I will, however, have to leave
early due to a markup in the Appropriations Committee that
begins at 10:30, but I will certainly review the transcript of
this hearing.
Thank you, Mr. Chairman.
Chairman Lieberman. Thank you, Senator Collins, for that
thoughtful statement. I am sure whether it is at this
particular hearing, Appropriations, or others, you will be
watching out for the budgets of NIH, the Department of Homeland
Security (DHS), and others that may be recipients on the panel.
Senator Collins. Absolutely.
Chairman Lieberman. That is your record, I know.
Our first witness is Dr. Anthony Fauci--really a national
hero, at least a hero of mine and I am sure others--Director of
the National Institute of Allergy and Infectious Diseases at
NIH. I really appreciate that you are here today and we look
forward to your testimony now.
TESTIMONY OF ANTHONY S. FAUCI, M.D.,\1\ DIRECTOR, NATIONAL
INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL
INSTITUTES OF HEALTH, U.S. DEPARTMENT OF HEALTH AND HUMAN
SERVICES
Dr. Fauci. Thank you very much, Mr. Chairman and Senator
Collins. Thank you for the opportunity to testify today on the
NIH mission of performing biomedical research for the purpose
of preparing for and responding to naturally emerging and
reemerging infectious diseases and the relationship of this
type of research to biological security.
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\1\ The prepared statement of Dr. Fauci with attachments appear in
the Appendix on page 34.
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As you mentioned in your statement, the issue at hand is
the ongoing threat of the emergence of an H5N1 pandemic
influenza and the research that was supported by the NIH to
address this threat. The publication of the results of such
research in the form of the two manuscripts that you mentioned
has focused considerable public attention on the issue of dual-
use research, namely research that is directed at providing new
information critical to the public health, but at the same time
has the potential for malevolent applications.
My written testimony is submitted for the record, and in my
few minutes of time, I will highlight just a few important
aspects of this issue.
First, the public health challenge. Seasonal influenza is
an ongoing threat to public health worldwide and is among the
leading global causes of death due to infectious diseases. Each
year, influenza causes more than 200,000 hospitalizations and
up to 49,000 deaths in the United States and up to a half-a-
million deaths globally. Yet influenza has animal reservoirs,
especially in birds, and these viruses can undergo extensive
genetic changes and jump species, resulting in an influenza
virus to which humans are highly vulnerable.
Such an event can and historically has led to global
disasters, such as the one you mentioned, the prime example
being the 1918 global influenza pandemic that killed up to 100
million people worldwide and caused enormous social and
economic disruption. There is a clear and present danger that
we will have another influenza pandemic, since these viruses
continue to circulate in the world and are constantly evolving
toward pandemic capability, as we have seen in 1957, 1968, and
2009.
Over the last decade, a highly pathogenic H5N1 influenza
has emerged among chickens. Rarely, the virus spreads to
humans. Since 2003, approximately 600 confirmed cases have
occurred in humans in more than a dozen countries shown in red
on this poster.\1\ Nearly 60 percent of those reported cases
have resulted in death. Should the virus mutate to transmit
more efficiently to and among people, a widespread influenza
pandemic could ensue.
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\1\ The poster referenced by Dr. Fauci appears in the Appendix on
page 48.
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Indeed, nature itself is the most dangerous bioterrorist,
and even as we meet today, H5N1 and other influenza viruses are
naturally mutating and changing with the potential of a
catastrophic pandemic. This is not a theoretical danger. It is
a real danger.
For decades, NIH has supported basic influenza research
included on transmissibility, host adaptation, and virulence.
The goal is to anticipate what the virus is continually trying
to do on its own in the wild and to prepare for it. Such goals
were pursued by the NIH-funded scientists Kawaoka and Fouchier
and could have important positive implications for pandemic
influenza prediction, prevention, diagnosis, and treatment.
Kawaoka and Fouchier constructed variants of H5N1 avian
influenza in order to identify which genetic mutations might
alter the transmissibility of the virus. In their studies, they
employed a standard influenza animal model, namely the ferret.
This poster shows the basic design of the experiments,\2\ in
which the virus was modified to allow for aerosol transmission
from one ferret to another.
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\2\ The poster referenced by Dr. Fauci appears in the Appendix on
page 50.
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I might point out that one of the causes of the public
misunderstanding was the widespread belief that the virus that
was transmitted by aerosol from one ferret to another actually
killed the ferrets when, in fact, that was not the case.
We feel that these studies provide critical information and
it was important to determine if H5N1 virus that has this
enhanced transmissibility would remain sensitive to existing
anti-influenza drugs and vaccines. In addition, and
importantly, knowledge of the genetic mutations that facilitate
transmission may be critical for global surveillance of
emerging influenza viruses.
Yet since transmissibility of a virulent virus was
increased, this constitutes dual-use research of concern
(DURC), which is shown on this poster.\1\ If a particular
research experiment is identified as DURC, that designation
does not necessarily mean that such research should not be
published, nor should it even be prohibited in the first place.
However, it does call for us, as you mentioned, to balance
carefully the benefit of the research to the public health, the
biosafety and biosecurity conditions under which the research
is conducted, and the potential risk that the knowledge gained
from such research might fall into the hands of those with ill
intent.
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\1\ The poster referenced by Dr. Fauci appears in the Appendix on
page 51.
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In this regard, the National Science Advisory Board for
Biosecurity was asked to advise the U.S. Government on the
publication of these manuscripts. You will hear in detail from
Dr. Paul Keim, the Chair of that group, about the Board's
deliberations. Importantly, the public attention and concern
generated by this issue has triggered a voluntary moratorium or
pause on this type of research on the part of the influenza
research community as well as a fresh look at how the U.S.
Government handles DURC, as manifested by a formalization of a
government-wide policy to address the issue.
This policy, which was released on March 29, strengthens
and formalizes ongoing efforts in DURC oversight and is
described in my written testimony. The ultimate goal of the NIH
in its embrace of this new policy is to ensure that the conduct
and communication of research in this area remain transparent
and open at the same time as the risk-benefit ratio of such
research clearly tips towards benefitting society.
The public, which has a stake in the risks as well as in
the benefits of such research, deserves a rational and
transparent explanation of how these decisions are made. The
upcoming dialogue related to this policy certainly will be
informative and, hopefully, productive in its goal of
benefiting the public with the fruits of such research while
ameliorating the associated risks. Thank you.
Chairman Lieberman. Thanks very much, Dr. Fauci. That was
an excellent introduction to the topic and I look forward to
asking you some questions.
Next, Dr. Daniel M. Gerstein, Deputy Under Secretary for
Science and Technology at the U.S. Department of Homeland
Security, obviously sharing with the Committee the concern
about whether this research represents a real threat to our
homeland security, and if so, what we should do about it.
Thanks so much for being here, and we welcome your testimony
now.
TESTIMONY OF DANIEL M. GERSTEIN, PH.D.,\2\ DEPUTY UNDER
SECRETARY FOR SCIENCE AND TECHNOLOGY, U.S. DEPARTMENT OF
HOMELAND SECURITY
Mr. Gerstein. Thank you. Good morning, Chairman Lieberman
and Senator Collins. I thank you for the opportunity to testify
today regarding dual-use life science research of concern.
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\2\ The prepared statement of Mr. Gerstein appears in the Appendix
on page 53.
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My testimony today will describe both Department of
Homeland Security mechanisms for addressing and mitigating
dual-use concerns arising from internal life sciences research
that DHS funds or performs as well as DHS involvement in U.S.
Government and other efforts to address security concerns
arising from the life sciences research.
As the Department considers the DURC issue, several
principles help guide our thinking. First, DURC is an extremely
complex issue for the scientific research and development
community, balancing our Nation's need to excel in science and
exploration of robust technologies with ensuring our Nation's
security by preventing the misuse of such technology.
Second, almost all research conducted today in bioscience
and biotechnology contains some degree of dual-use application.
Third, dual-use concerns must be addressed at a variety of
different levels, from research funded by governments, to
research funded privately, to experimentation done by
individual scientists.
And finally, there are both domestic and international
dimensions to the DURC issue, as the recent H5N1 papers have
clearly demonstrated.
DHS performs research which might be considered DURC
through a variety of different mechanisms, including our
internal laboratories, such as the National Biodefense Analysis
and Countermeasures Center (NBACC), and Plum Island Animal
Disease Center (PIADC). We also sponsor and collaborate with
other departments. Additionally, we provide funding to colleges
and universities, primarily through our DHS Centers of
Excellence Program.
One vignette that demonstrates the degree to which dual-use
research is both ongoing and critical to the DHS mission is the
development of a recombinant foot-and-mouth (FMD) disease
vaccine. The recombinant vaccine components are being developed
through our DHS Center of Excellence at Texas A&M. The material
is then shipped to Plum Island, where it is used in challenge
tests employing live FMD virus. At Plum Island, DHS and the
U.S. Department of Agriculture are working shoulder to shoulder
in this effort. Once approved for licensure, a commercial
company will produce the vaccine. This cross-cutting project
demonstrates the importance of collaborative efforts in dual-
use research.
DHS's primary objective in funding activity in the life
sciences is to meet our homeland security mission. We,
therefore, exercise control of the information where necessary
through non-publication or non-disclosure mechanisms. Research
conducted or funded by DHS in the areas of biological and
chemical defense undergo particular scrutiny and high-level
departmental review because of the potential to raise concerns
regarding security, nonproliferation, and treaty compliance.
At DHS, our approach to dual-use research is multi-
dimensional. At the lowest levels, project managers are trained
to understand and assess their programs for possible dual-use
implications. The National Science Advisory Board for
Biosecurity, definition of DURC embodied in the NSABB's seven
experiments of concern serves as the basis for this
understanding. These same criteria have been identified for use
in the new Federal-wide DURC policy.
The DHS Compliance Assurance Program Office (CAPO) reviews
projects that are to be conducted. This review divides
potential projects into tiers based on whether they include
NSABB experiments of concern, raise perceptions of
noncompliance with arms control agreements, utilize select
agents or toxins, have the potential to generate or reveal
national security vulnerabilities, or provide information on
threat agent production or dissemination.
At the highest levels of the Department, our Compliance
Review Group (CRG), chaired by our Deputy Secretary with full
participation across the staff, reviews all DURC with a
particular eye toward ensuring compliance with the Chemical
Weapons Convention and Biological Weapons Convention (BWC).
DHS routinely contracts for life science research that
involves use of select agents and toxins or that require
special biosafety provisions. In all cases, we ensure that
contracts contain clauses to ensure conformity with applicable
laws, regulations, and internal policies. In addition, research
contracts for life sciences work typically provide for DHS to
object to publication or disclosure. Further, depending on the
type of proposed publication or disclosure, the information to
be released must go through an internal review process. In the
unlikely event that sensitive or classified material is
produced from research projects funded through grants to
academia, DHS requires grant recipients to create information
protection plans which detail how the information would be
identified and secured.
Now, I have been discussing the internal management of DURC
within DHS. Let me now turn briefly to the broader DURC issue.
DHS has been an extremely active participant in the formulation
of the U.S. Government policy on the dual-use research,
including the March 29 government policy for DURC oversight. We
are in complete agreement that strengthening DURC oversight and
establishing regular reviews of U.S. Government funded or
conducted research is both necessary and a responsible
approach.
However, even with the kind of internal DHS oversight
policies described previously and the U.S. Government-wide
policy on oversight of U.S. funded life sciences research, DHS
believes that security-related concerns to DURC cannot be
entirely resolved by formal U.S. Government policies. The
international nature of life sciences research, coupled with
the explosion in biotechnology funded by private sources, means
that much of the DURC being conducted is not under direct U.S.
Government control. Advances in the life sciences will
undoubtedly create technological capabilities that will be of
tremendous benefit to humankind but will also require careful
stewardship, including development of appropriate regulations
and policies, as well as continued emphasis on strong bio-risk
management programs that emphasize biosafety, biosecurity, and
bioethics.
In working through this issue, we must find ways to
mitigate risk associated with the potential malicious use of
DURC while at the same time allowing for open and unfettered
innovation by our Nation's scientists and laboratories. At the
end of the day, the DURC issue comes down to a risk-benefit
evaluation of whether the balance is in favor of sharing the
information for the good of humankind for public health,
medical, or biotechnology advancement versus the potential for
misuse.
Ultimately, the international life sciences community must
appreciate the DURC problem and internalize these concerns
while developing and conducting research. In this regard, the
H5N1 papers have served as a necessary wake-up call for the
life sciences community.
Thank you for giving us the opportunity to testify today
and we look forward to your questions.
Chairman Lieberman. Thanks, Dr. Gerstein.
Just clarify for the record, and for me, what the role of
the Department of Homeland Security is with regard to dual-use
research happening outside of DHS grantees.
Mr. Gerstein. Well, Senator, we sit as part of the
interagency body that deliberates, and so we have a strong
voice. And in fact, as I am sure we will talk more about later,
the March 29 policy actually reflects much of the work that we
have been doing previously in fulfilling our Biological Weapons
Convention requirements. We made use of the NSABB's seven
experiments of concern. We have always looked at the select
agent program to make sure that we are in accordance with the
requirements and the reporting requirements. So we do that
tiered process in order to make sure that experiments do fall
in full compliance with the BWC.
What we have done, though, is because of the alignment of
the March 29 policy and the work that we have done previously,
we essentially have a leg up on the implementation of the March
29 policy.
Chairman Lieberman. And just to take this one step further,
the board on which you sit, is this to determine government-
wide policy or also to approve and evaluate particular research
projects?
Mr. Gerstein. These are internal boards that are designed
to look at the Department's experimentation, the projects that
we are to be conducting.
Chairman Lieberman. And then, finally, just give us a
sense, and I do not think you have to get into too much detail
here, about how widely dual-use research projects are being
carried out or funded in the Federal Government. In other
words, the natural place to think about it is NIH, but I
presume DOD is also funding projects, etc.
Mr. Gerstein. Well, Senator, I would like to stick to my
Department and just tell you what we are doing in the
Department of Homeland Security. Through our review process,
our Compliance Review Group looks at a total of about 200
projects that fall into what we call Tier One, just regular
experiments that do not rise to the level of concern. In the
Tier Two, ones that could perhaps have some issues with
perception----
Chairman Lieberman. Right.
Mr. Gerstein [continuing]. We do 12 to 15 experiments. And
then in the highest category, we do 5 to 10 experiments. So a
total of about 225 experiments per year, of which all run
through our Compliance Review Group process.
Chairman Lieberman. And those are all funded within DHS?
Mr. Gerstein. They are, yes.
Chairman Lieberman. So maybe, Dr. Fauci, you are the one to
turn to to give us for the record a kind of broader sense of
how widely dual-use research is either being done in Federal
agencies or funded by Federal agencies.
Dr. Fauci. So that is a very good question, Mr. Chairman,
and it is important, as you did yourself, to distinguish
between dual-use research and dual-use research of concern.
Chairman Lieberman. Right.
Dr. Fauci. Almost any time you even go near a microbe, it
is dual-use research. If you are talking about dual-use
research of concern, just for this purpose, as part of the
implementation of the March 29 government-wide policy, we did
an inventory of what we do both with our own scientists at the
National Institute of Allergy and Infectious Diseases (NIAID)
as well as the external extramural grantees and contractors.
And just to give you some examples, when we did an
inventory of what we do mostly on our Bethesda campus and in
our Rocky Mountain campus, there were 404 intramural projects
that could be dual-use plus 147 manuscripts and none were found
to be dual-use research of concern. When we did the extramural
inventory of all of the grantees--there were 381 grantees or
contractors--10 of those grants were designated as DURC. Seven
of them were in influenza, one in anthrax, one in plague, and
one in botulism. So out of 381, there were only 10, and those
are the ones we are now going through the process that is
delineated very carefully in the new policy. So that is the
scope of what we are doing at NIAID.
Chairman Lieberman. That is very helpful. And just
generally, am I right to assume there may be dual-use research
projects of concern, for instance, funded by the Department of
Defense?
Dr. Fauci. I would hesitate to make a statement about the
Department of Defense, but we collaborate a lot with them----
Chairman Lieberman. Yes.
Dr. Fauci [continuing]. And yes, I cannot imagine that they
are not doing some.
Chairman Lieberman. Good enough.
Dr. Fauci. But probably a really small amount. But they
clearly are doing some.
Chairman Lieberman. So most is probably coming through NIH?
Dr. Fauci. Right.
Chairman Lieberman. Thanks very much.
Next, Dr. Paul Keim, Acting Chairman of the aforementioned
National Science Advisory Board for Biosecurity. We thank you
very much, Dr. Keim, for being here, and please proceed with
your testimony now.
TESTIMONY OF PAUL S. KEIM, PH.D.,\1\ ACTING CHAIRMAN, NATIONAL
SCIENCE ADVISORY BOARD FOR BIOSECURITY, NATIONAL INSTITUTES OF
HEALTH, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Mr. Keim. Chairman Lieberman, thank you for holding this
hearing on ``Biological Security: The Risk of Dual-Use
Research.'' I am Paul Keim, the Acting Chair of the National
Science Advisory Board for Biosecurity. I appreciate the
opportunity to speak to you about dual-use research and in
particular about the Board's activities and our recent
evaluation of two scientific papers concerning the H5N1
influenza virus.
---------------------------------------------------------------------------
\1\ The prepared statement of Mr. Keim appears in the Appendix on
page 59.
---------------------------------------------------------------------------
It has been recognized for many years that science and
technology can be used for both good purposes and bad. It is
this two-sided coin that we refer to as dual-use research. The
problem is that all biological research can be construed as
having potential bad applications as well as their good ones.
The NSABB created a new term, dual-use research of concern
to distinguish normal research from that with exceptionally
high potential to be misused. The parameters defining DURC
would include the magnitude of any danger and the immediacy of
any threat as balanced against the overall benefits of the
work.
Over the last 8 years, the Board has advised the U.S.
Government on best practices and policy approaches for research
communication, personnel reliability standards, codes of
conduct, and international engagement for issues associated
with DURC. The Board has recognized that good policy needs to
protect us from scientific misuse and protect the scientific
enterprise from being overburdened with unnecessary regulation.
Both are essential for our country to be safe, productive, and
remain a global leader.
The National Science Advisory Board for Biosecurity is
comprised of well respected scientists, lawyers, infectious
disease experts, scientific editors, and public health experts.
We have an 8-year track record of protecting academic freedom
while seeking policy recommendations that will minimize the
misuse of biological sciences research.
With that in mind, recognize the significance for the Board
to unanimously recommend against the publication of two
scientific papers in November 2011 due to their potential to be
misused. The U.S. Government asked the Board to review two NIH-
funded studies reporting mutations that allowed a highly
dangerous bird flu virus to transmit from one ferret to
another. By a split vote, the Board instead recommended to the
government that key elements of the studies not be published
and that only redacted papers were acceptable for general
distribution.
These recommendations were based upon the Board's finding
that if this avian influenza virus acquires the capacity for
human-to-human spread and retained its current virulence, the
world could face a pandemic of significant proportions. We
found that the potential risk for public harm to be of
unusually high magnitude.
The Board has published its recommendations to the U.S.
Government along with its rationale. Importantly, we pointed
out that an international discussion was needed amongst
multiple societal components to develop policy in this arena of
high-consequence DURC. I would further note that in the few
months since our recommendations were released, there has been
a flurry of U.S. and international meetings to discuss the
risks and benefits of these experiments.
The research issues and policy consequences are now
commonly known and being debated. This continuing global
conversation is important for the scientific endeavor and for
our biosecurity.
In late March 2012, the U.S. Government tasked NSABB with
reviewing revised versions of the two original manuscripts.
This was coupled with a face-to-face meeting such that the
Board could hear directly from the investigators about their
research. In this meeting, the Board received non-public
information about the risks and benefits of the research from
the international public health and research community as well
as from the U.S. Government intelligence community.
In a classified briefing from national intelligence counsel
and National Counterterrorism Center representatives, the Board
heard an assessment of the risk for misuse and of the global
political ramifications associated with these papers. The
details of these briefings are classified, but I can tell you
that many of the Board were left with the impression that the
risk of misuse did not appreciably increase with full
publication, and there is a high likelihood of undesirable
political consequences to not publishing.
In addition, the U.S. Government has recently issued new
policy guidelines targeting high consequence DURC. This was
based upon the NSABB's own definition of DURC and seven
categories of experiments that warrant special consideration
and targeting particular high-consequence pathogens.
It is in this context that the Board arrived at different
recommendations for the revised manuscripts. One paper was
unanimously recommended for full publication while the other
was recommended by a split vote of 12-6. In balancing the risks
against the benefits of the revised manuscripts in the context
of additional information and new U.S. Government policy, the
Board shifted its position.
In my opinion, the split vote is highly significant and
signals that the Board still believes that there is great
potential for misuse of information generated by these types of
experiments. The majority of the Board members voted for
publication, but they were clearly still troubled by this
research and its potential to be misused. It is fair to say
that the Board believes that these types of experiments will
arise again and that these issues are not fully settled. As one
Board member noted, we have only kicked this can down the road
and will be dealing with it again in the future.
It is critical that we establish policy that intensely
monitors high potential DURC research from cradle to grave in
order to protect us from misuse, but also to free low-potential
DURC research from onerous regulations. We must be careful that
we do not destroy the scientific enterprise as we try to
protect against misuse of some research. Thank you.
Chairman Lieberman. Thanks very much, Dr. Keim.
Let me just ask you, while the phrase is in my mind, what
did you mean when you said or referred to undesirable political
consequences from not publishing?
Mr. Keim. This information was conveyed in a classified
briefing and we cannot talk about it in detail, but there are
many international collaborative projects here in public health
to try to control, predict, and understand influenza pandemics.
Some of those political agreements are very fragile, and I
think that it is fair to say that not releasing this
information was seen by the intelligence community as having a
detrimental effect upon those fragile relationships.
Chairman Lieberman. Understood. Thank you.
Our final witness is Dr. Thomas Inglesby, Chief Executive
Officer and Director, Center for Biosecurity, University of
Pittsburgh Medical Center. Welcome back.
TESTIMONY OF THOMAS V. INGLESBY, M.D.,\1\ CHIEF EXECUTIVE
OFFICER AND DIRECTOR, CENTER FOR BIOSECURITY, UNIVERSITY OF
PITTSBURGH MEDICAL CENTER
Dr. Inglesby. Mr. Chairman, thank you for the chance to
speak to you today. My name is Tom Inglesby. I am the Director
for the Center for Biosecurity of University of Pittsburgh
Medical Center. I am an infectious disease physician by
training, and over the last two decades, I have seen many
patients with influenza die despite excellent medical care in
American hospitals.
---------------------------------------------------------------------------
\1\ The prepared statement of Dr. Inglesby appears in the Appendix
on page 63.
---------------------------------------------------------------------------
For many years, my Center colleagues and I have been
studying avian pandemic flu and the public health actions that
need to be taken to protect us from those challenges, and like
all of you, I am deeply concerned that H5N1 is a major global
threat.
I have been opposed to the publication of the revised
Fouchier manuscript. The breakthrough in that work was making
H5N1 transmissible through the air between ferrets. Just as
wild type H5N1 kills ferrets when instilled into their
tracheas, this engineered virus also kills ferrets the same
way. So there is no evidence that I have seen publicly
presented that this engineered virus would have less virulence
in humans than wild type H5N1 infection would.
Were this virus to cause a human infection, it could
acquire new, unpredictable virulence properties. So if this
work were replicated after publication and if it led to human
infection following accident or misuse, we cannot rule out the
chance that it would lead to high case fatality in a spreading
epidemic difficult to stop with quarantine, vaccine, or
antivirals. As you noted, there are others in the scientific
and public health communities who share this concern.
That said, I appreciate that a deliberative process has
taken place in the last 6 months. The majority of NSABB
members, the U.S. Government agencies, and the journal, Science
and Nature, have decided that this work should be published. I
am concerned about this, but I recognize this decision has been
made. So now it is time to look ahead and anticipate the future
of H5N1 mammalian transmissibility research, which scientists
are now poised to pursue. Here are some brief thoughts on
benefits and risks of further pursuing this line of research.
Will further engineering H5N1 mammalian transmissible
viruses help improve surveillance? In my view, in the short
term, it is unlikely. Genetic mutation data is not widely
collected in avian flu surveillance systems. Very few sequences
are analyzed in real time. Even if we could identify
experimental mutations in birds in real time, the prescribed
response would still be the same: Culling of infected birds,
all flocks, regardless of the mutations of the virus. Until we
have a surveillance system in place that collects far more
genetic sequence, does so in time frames that are meaningful,
and have predictive value sufficient to lead to additional
action in the field, this action seems unlikely to practically
improve surveillance. Nor is this research necessary to making
H5N1 vaccine for reasons I explain in my written testimony.
What could go wrong with mammalian transmissible H5N1?
Could an accident occur? Biosafety at modern labs is generally
excellent. Accidents are uncommon, and most pathogens have
little capacity for societal spread. But the accidental escape
of an engineered mammalian transmissible H5N1 could result in
catastrophe. Although it is uncommon, accidents do happen. In
1977, H1N1 caused a mini-pandemic, probably from a lab escape.
Nine years ago, during the severe acute respiratory syndrome
(SARS) outbreak, there were at least three incidents in which
researchers working in Biosafety Level 3 (BSL-3) or BSL-4 labs
in Singapore, Taiwan, and China accidentally infected
themselves with SARS. I am not meaning to single out
laboratorians for criticism. Mistakes are made by all types of
professionals, doctors, pilots, rocket scientists, all of us,
because we are human. We have to factor the possibility of
human error, surprise, and accidents into our calculations of
the risk of this research.
Can we assure this research will not be replicated and
deliberately misused? No. We can hope no potential adversary
will have the competence or the intention to pursue this, but
we cannot accurately predict the chances this work will be
replicated by a malevolent or disaffected scientist somewhere
in the world, or a terrorist group or a Nation State.
What happens if a mammalian transmissible H5N1 starts to
spread? Seasonal flu infects 10 to 20 percent of the world
every year, as much as a billion people or more. The case
fatality rate of wild H5N1 in the WHO database is nearly 60
percent, as you indicated. So if a strain of H5N1 with that
fatality rate were engineered to spread like seasonal flu,
hundreds of millions of people's lives would be at risk. Even a
strain 100 times less lethal would place at risk millions of
people's lives.
So what should be done about H5N1 mammalian transmissible
research going forward? First, I would extend the moratorium
that Dr. Fauci discussed. The reasons many experts agreed with
the moratorium are still valid. Before proceeding, we should
have more confidence this research will lead to practical
benefits, and we should look for other ways to study
transmissibility that do not require engineering mammalian
transmissible strains. If this work is allowed to continue, we
should limit it to the smallest number of labs. My
understanding is that the United Kingdom and Canada have
indicated their concern by deciding this work can only be
performed in BSL-4 labs. We should have these discussions in an
open, transparent way that includes the scientific and public
health communities.
Second, let us decide if there are red lines that should
not be crossed. For example, should increased lethality be
engineered into mammalian transmissible strains in order to
understand virulence? Should other avian flu strains be
engineered for mammalian transmissibility? Should transmissible
H5N1 strains be engineered to make them resistant to vaccines
or antivirals so we can understand the genetics of those
problems? We should decide now if there are any uncrossable
lines.
And third, the United States should continue to strengthen
its pandemic preparedness efforts. Priorities should include
the capacity to manufacture flu vaccine on a large scale--a
universal flu vaccine and new antivirals--and better
surveillance and culling of infected flocks. Preparing for
pandemic and avian flu is critically important.
Let me turn to the policy for DURC that was recently
announced. This policy is a good step towards addressing the
kinds of issues raised by the H5N1 controversy. The success of
the policy will depend on how it is implemented. In my written
testimony, I provide recommendations for success of the policy
and I will highlight four of them here.
First, implement effectively at the local level.
Scientists, their institutions, and their institutional
biosafety committees will be crucial to the success of this
policy. This is new territory for them, so training and
education will be key. They will also need new members, new
resources, and a clear process for elevating concerns.
Second, learn from experience. This process will need to
evolve as we learn. I understand that the NIH review of the
portfolio found that 10 experiments warranted further risk
management. It would be a valuable learning tool for the
science community to understand these 10 cases. What caused the
concerns? How were risks mitigated? I think this could be done
in an unidentified way to protect the scientists.
It would also be useful to learn as much as we can from the
H5N1 risk assessment and risk management process. How were
risks assessed? How were conflicts of interest managed? How did
the process ensure all relevant judgments were considered and
data seen? Going forward, the success of the DURC policy will
depend on these issues.
Third, attend to the regulatory burden. This new policy
will add another process to be navigated by a scientific
community that is already heavily regulated. We have to make
sure we do not impose such a regulatory burden that scientists
cannot continue their important work. And so to this end, I
would recommend asking the National Academies to examine the
effects of existing policy and regulatory burdens on U.S.
scientists.
And last, reaffirm the role of NSABB. It deserves a lot of
credit for its work. NSABB members have done substantial public
service. They have prepared valuable dual-use guidelines and
spent a great deal of energy, intellect, and time on this H5N1
debate. An independent and strong NSABB should have an
important role in DURC policy implementation going forward, and
I hope that the NSABB will rarely be in the position of getting
invited into the process after manuscripts have been submitted.
I think we all agree in this room that the risk assessment and
management process should happen early in the research process.
To conclude, scientists who research influenza and other
infectious diseases are working to improve our understanding of
biology and to better the world. The United States needs to
continue supporting entrepreneurial and talented scientists
with the best ideas. At the same time, we need to acknowledge
there are rare situations where the consequences of an accident
or misuse are so serious that special processes are needed to
manage the risk to the public, and this new DURC policy is a
good step in that direction.
Chairman Lieberman. Thanks, Dr. Inglesby.
When we hear about accidental escape of pathogens from
laboratories, we get alarmed. Talk a little more about it. Does
that normally happen?
Dr. Inglesby. No.
Chairman Lieberman. Because the example you have stated,
the infection of workers or personnel in the labs----
Dr. Inglesby. Yes. In all the cases that I mentioned and in
other cases, that is typically the way that an infection would
escape a lab. A laboratorian would get infected. Usually when
laboratorians are infected, though, they do not spread it to
anybody else.
Chairman Lieberman. Right.
Dr. Inglesby. So the risk really is primarily to the person
working in the laboratory. It is rare for the laboratorian to
pose a risk outside the lab.
Chairman Lieberman. Right. Dr. Fauci, I assume that all the
regulations, both before and after March 29, were intent on
limiting the possibility of exposure to personnel?
Dr. Fauci. Definitely, Mr. Chairman. In general,
definitely. And specifically, in the two cases that we are
discussing as prototypes here today, the two laboratories, one
in Wisconsin and one at Erasmus University, were very highly
qualified, inspected multiple times, and given a rating of
``meet or exceed'' the standards for the kinds of protection we
are talking about.
Chairman Lieberman. Good. Dr. Keim, let me ask you first
about the two laboratories that were the subject of this
concern. To the extent that you can, why was the ultimate
decision unanimous in the case of Wisconsin and then mixed in
the case of Erasmus University?
Mr. Keim. The underlying science and approaches that each
laboratory took for doing these experiments were different.
While the two studies lumped together a lot in our discussions,
they were distinct. We viewed Dr. Yoshihiro Kawaoka's
approaches as having a greater biological control of the risks.
It is one of the aspects that we have instituted routinely in
biosafety experiments in the United States, where these types
of experiments are performed in a biological context that would
be less dangerous. For example, if we do an experiment where we
add a novel gene or biological property to an organism, we
prefer to do it with a pathogen that has been disarmed, or
attenuated, to lessen the risk.
And so in distinguishing the two research groups and their
scientific approaches, the biggest difference is that one
worked on a biological platform, the H1N1 virus that was viewed
as less risky, and not as virulent than the other one. In
contrast, taking the wild type H5N1 avian influenza virus, the
raw material from nature, and then directly changing the
transmissibility on that genetic platform was viewed as a
potentially very risky experiment.
Chairman Lieberman. And if I understand, that difference
had more to do with the scientific decisions of each team as
opposed to differing levels of safety standards that they were
operating under in their respective institutions or countries.
Mr. Keim. Yes. As Dr. Fauci has already pointed out, both
institutions were heavily regulated, heavily reviewed, and both
exceeded the current requirements for biological safety that
are required to perform these types of experiments.
Chairman Lieberman. Dr. Keim and Dr. Fauci, I want to give
you an opportunity to respond to the dissent in the letter
which was, I gather, originally a confidential letter and then
was leaked, from Michael Osterholm in his criticism of the
NSABB decisions.\1\ And to some extent, Dr. Inglesby expressed
some concern about the decision.
---------------------------------------------------------------------------
\1\ The letter referenced by Senator Lieberman appears in the
Appendix on page 76.
---------------------------------------------------------------------------
Dr. Keim, please begin.
Mr. Keim. So first off, we are a Board of almost 25 highly
qualified individuals and we rarely agree 100 percent on
anything.
Chairman Lieberman. It sounds like Congress. [Laughter.]
Mr. Keim. I know.
Chairman Lieberman. Although we may not be highly
qualified. [Laughter.]
Mr. Keim. I must say that we actually embrace this dissent,
we use it and we actually cherish the different members and
their differing opinions. This is true for this particular
example, as well.
I believe that this letter that was meant for an internal
constructive criticism process, and to help us to understand in
a retrospective fashion what we had done and what we had just
come through as a board. As such, I view it as a very
constructive type of communication. It was unfortunate that it
was leaked and it became part of the public dialogue. The
public nature of the ensuing debate has made it harder to have
a constructive and proactive type conversation.
That aside, many of the things that he said are worth
carefully examining. One point made in the letter is that there
was a bias in the witness list. I think that is true. The
primary briefers that were brought to the hearing, were, in
fact, the investigators themselves. They are inherently biased
with an easily identifiable conflict of interest. They wanted
their work published in these prestigious journals. In
addition, we brought in a third investigator who has been
collaborating with two primary research groups. His report and
work was on how you use the mutation information for
surveillance purposes. Again, this was an individual who would
like to see their work published and, it can be argued, that
they would see the benefits far clearer than the risks.
However, I do not think this is of great concern, Mr.
Chairman. The Board is comprised of experienced scientists and
what we routinely do in our profession is look at scientific
data and critically examine other scientists' work. And so the
biases that were inherent in those types of witnesses, I think,
were not a problem for us. In fact, I think, that we dealt with
the briefers' conflict of interest very well. We had ample
opportunity to ask very tough questions of the investigators.
Dr. Ron Fouchier, for example, was in front of us for over 2
hours with lots of intense questioning about his work. In the
end, I think that those inherent biases were something the
Board could and did deal with quite well.
One part of Dr. Osterholm's letter criticized the
intelligence briefing. This was a classified briefing that was
presented by the U.S. Government intelligence community. Most
of the Board members came into the briefing as academic
scientists and we pretty much had to take this assessment on
faith. We could not examine the data or assumptions and had to
assume that the assessments of the risks and the political
consequences were fact. This is an environment where the Board
is perhaps a little bit naive and did not have the capability
to look behind these assessments in a critical fashion. The
briefing was held at the ``secret'' level before we were told
that the supporting information was at a higher level of
classification. The intelligence community briefers were quite
confident, and suggested to us that the risks of publishing
these papers were minimal while the political consequences of
not publishing were great. I think that this briefing had a
great effect upon individual Board members' deliberations and
our ultimate decisions. Dr. Osterholm's criticism of the
briefing is hard for me to evaluate. I think that summary-type
classified briefings may be unavoidable. At some level, all
advisory boards will be faced with accepting such an evaluation
at face value.
The March 29 and 30 Board meeting was never set up to be a
point-counterpoint debate but rather a fact finding endeavor
with heavily emphasis on the researchers themselves. So we did
not have time in the 6 hours to hear from every witness in the
world. But we did succeed in hearing the most important
witnesses, even if they were inherently biased.
Chairman Lieberman. Interesting. So if you had it to do
over again----
Mr. Keim. Absolutely, I would do many things different, Mr.
Chairman. For one, I would make sure that DURC review was being
performed long before it ever came to the Board. We were
brought these papers under a very tight timeline back in
October, 2011.
Chairman Lieberman. Right.
Mr. Keim. In retrospect, the amount of effort it took to
review this science was too large for the time line we were on.
The process and the number of hours we put into reviewing
these two papers was massive. It is clear that the new
government policy for identifying DURC early in the research
cycle is going to be critical for moving much of this
evaluation early on, before it is submitted for publication.
Chairman Lieberman. Yes, that is a very important point. I
mean, I agree with you that the dissent, even to some extent
the bias, is not of itself of concern, particularly in
scientific debate and discussion. But, obviously, from a
homeland security point of view, we are concerned about the
impact. Am I right that you are essentially, to the best of
your ability, providing assurances that information is not
going to be released in the two studies, particularly in the
Fouchier study, that would significantly increase the risk of
deliberate or accidental release of H5N1?
Mr. Keim. The Board was pretty confident in the case of the
Kawaoka paper and the vote was unanimous. In the case of the
Fouchier paper, it was a split vote. The vote was 12-6 and
there were strong feelings on both sides.
In this type of an advisory Board process, each of us had
to weigh the evidence and it was not black and white. There
were great uncertainties in this research. A relatively small
number of ferrets were actually used in these experiments
making the data less than definitive in some cases. Our
understanding the biological properties of these viruses is not
100 percent certain. In the end, the 18 Board members had to
weigh the evidence as best they could.
And I will tell you, you will not find a better group of
people to do this. This Board is extremely qualified and
capable to do this assessment. We worked very hard at
understanding the risks and benefits, but were not unanimous
and came to a split vote on the Fouchier paper.
Chairman Lieberman. Dr. Fauci, do you want to respond to
the Osterholm complaints, and to some extent, to Dr. Inglesby's
concerns?
Dr. Fauci. Sure. Well, with regard to the letter, as you
probably know, because I am sure that your staff or you have a
copy of the letter, there were several issues that were brought
up in there. I have to say that I agree with many of the things
that Dr. Keim said in the sense of this is a strong Board, a
really good Board. We have worked with them for a long time and
I do not think they are going to be significantly influenced by
what they might perceive as a bias. So if they did, I believe,
as Dr. Keim has done in the past, if you have an issue with
something, you bring it up.
The letter was sent to the Executive Secretary of the
NSABB, who is at NIH, Dr. Amy Patterson. We have responded on a
point-by-point basis to everything in that letter, so we would
be more than happy to make that response available to you so
that you could see the point-by-point discussion.
Again, there were important issues about looking forward.
There were several things in there that I must say, quite
frankly, Mr. Chairman, that I actually disagree with, one of
which was the concern about the security briefing. I have a
great deal of trust in the Director of the National
Intelligence to tell us what we need to know. So that is just
one example.
The idea, as you mentioned, about the picking of people who
would be on the agenda, we did not get any indication from Dr.
Osterholm of people that he wanted to see there that were not
there.
So rather than go tit for tat on that, I can just say that
I think the general principles that were brought up by Dr.
Keim, I totally agree with. I just have to say for the record
that I disagree with many of the things in his letter.
Chairman Lieberman. No, I appreciate that directness and I
thank you for it.
Do you have a reaction to Dr. Inglesby's suggestion that
the moratorium should be extended, and if so, for how long?
Dr. Fauci. I totally agree with Dr. Inglesby about an
extension of the moratorium. The real critical issue is for how
long.
Chairman Lieberman. Right.
Dr. Fauci. This is a voluntary moratorium, and I think that
is something that the public needs to understand. This is a
voluntary moratorium on the part of the scientific community.
Chairman Lieberman. Right.
Dr. Fauci. I had discussions with the influenza scientists
and encouraged them and actually, to their credit and to the
discussion that Dr. Keim himself had in the NSABB, this was
something that they agreed upon. Exactly when to call it off,
we are very actively involved in pushing forward the principles
and the implementation of the March 29 government-wide DURC
policy. That is going to have an important impact on when we
can feel comfortable that we can then go on, as long as people
understand both the principles and the implementation
mechanisms of how you address DURC. Several of the labs that
are involved understand that now. We need to make sure that is
broadly understood. So I definitely agree with that.
I just want to make one point----
Chairman Lieberman. Go ahead.
Dr. Fauci [continuing]. Of minor disagreement, if you want
to call it that, with what my esteemed colleague, Dr. Inglesby,
says. If we only looked at the short-term benefit of research,
we would not do a lot of research at the NIH because you very
often have a situation where it is incremental and you build up
into something that really becomes important. So although I
understand the point that is being made, if you look at what
immediate benefit those mutations are going to have right now,
sure, you can say that there is not a lot of surveillance
capabilities of high sequencing, etc. But the incremental
accumulation of knowledge is one of the fundamental principles
that the NIH research agenda is built upon.
So I think there is a little bit of a disagreement on that.
I do not think you need to have an absolute immediate benefit
for research to be ultimately important to do and to publish.
Chairman Lieberman. Do you want to respond?
Dr. Inglesby. Yes. Well, actually, I completely agree with
what you just said, so I do not think we disagree on that. I
agree that fundamental research into understanding biological
principles is critical and it is a critical part of the science
mission. I think this is just one very specific and rare
example where I think the bar for whether to proceed with this
line of research should be beyond a deeper fundamental
understanding of biology.
In general, I completely agree that the test for basic
science should not be whether it has practical benefits in the
next year. But in this case, a lot of the proponents of the
research have been arguing for urgent practical benefit, and in
my view, I just have not seen a compelling case for that.
Chairman Lieberman. It is not worth it.
This leads me to ask you, Dr. Fauci, and anybody else who
wants to answer--and in some sense, it is a question at the
margins--when considering future research that would be seen as
DURC, can you imagine instances in which you would conclude
that research should not be undertaken under any circumstances?
Dr. Fauci. I do. I think it would be scientific hubris for
scientists to say we can do anything that we want to do,
regardless, just for the curiosity of it, for understanding it.
So I do think there are some experiments that would better not
be done. I think that would be a very rare situation, Mr.
Chairman, I mean, you can fantasize about ridiculous and
dangerous experiments just for the sake of doing it. Those, we
do not even bother with. But in the realm of trying to keep up
with something that is a clear and present danger of happening
in nature itself--that is the critical thing that we are
dealing with here and that is the reason why we agree so much
on it, and yet all of us at the table know that this is a
delicate issue.
If you are doing something in an experimental fashion that
you might be pushing the envelope of creating something that
would give you some information but it is not really addressing
any danger, then I think that is very ill advised to go there.
But when you have a situation where nature itself is already
doing some of the things that you are trying to stay ahead of,
that is when you really have to seriously consider it.
The short answer to your question, the principles of the
new government-wide DURC policy that we put out on March 29
actually put that into the consideration. So when you look at
the number of experiments that you can do--there are now seven
classic experiments, that if they come up, you have to decide
if you have a risk mitigation for that particular result or
experiment.
One of the risk mitigations very well may be to not do the
experiment. So it really falls very nicely into the answer to
your question. It is built into the new government-wide DURC
policy, that is, in fact, an option.
Chairman Lieberman. So I presume that this is not an area
where you can draw a very clear red line, right? In other
words, what you have described are the standards adopted in the
policy, and particularly with regard to risk mitigation, and
that in a given case, the decisionmakers might decide that in
the interest of risk mitigation, the research simply should not
be conducted.
Dr. Fauci. It is essentially a continual evaluation of
risk-benefit.
Chairman Lieberman. Right.
Dr. Fauci. And you take each individual case and you look
at it, and it could turn out that, clearly, the risk and our
ability to mitigate the risk might be such that it is just not
worth doing.
Chairman Lieberman. Dr. Gerstein, from a homeland security
point of view, talk to us a little about whether you think that
there ought to be clearer red lines here or whether this is an
area of scientific inquiry where it is simply impossible to
state a red line unless you see it in a particular proposal for
a research project of concern.
Mr. Gerstein. Well, Senator, I agree exactly with what Dr.
Fauci said. I think there are some experiments that should not
be done. In fact, that is actually the intent of the Compliance
Review Group----
Chairman Lieberman. Right.
Mr. Gerstein [continuing]. Looking at the NSABB seven
experiments and looking at the type of pathogens we routinely
work with in this sort of threat analysis and characterizations
that we do. So we look at these very hard. We make sure that
all of them are needed. We make sure that we are doing them in
the safest possible ways, in the appropriate facilities. But at
the end of the day, we recognize that DHS needs to look at some
of these different capabilities and assess what sort of threats
they pose.
Still, we are doing them in the highest containment. For
the Department, we do most of our internal work in our
facilities, the Fort Detrick facility, NBACC, and then the Plum
Island facility, PIADC. So we are very keen on that.
Chairman Lieberman. We have talked so far about the U.S.
Government response to this challenge of dual-use research of
concern, but, obviously, scientific research is global, and in
this case one team is in Wisconsin, and one team is in the
Netherlands. So help the Committee understand for the record,
what is the state of the discussion of standards
internationally? Are there international scientific bodies that
are moving to adopt standards such as the March 29 U.S. policy?
Are there national standards being adopted in individual
countries throughout the world? What is happening, because
obviously we are talking here about a fear, in one sense, of a
global pandemic. So if something wrong happens in a laboratory
halfway around the world, it could still affect the lives of
people here in the United States.
Dr. Fauci. Let me take a shot at that, Mr. Chairman.
Chairman Lieberman. Please.
Dr. Fauci. It is very interesting, because this gets into
what we refer to as the culture of responsibility, a global
culture of responsibility. Back in the 1970s when the
revolution in DNA technology took place globally, but
fundamentally here in the United States, scientists got
together--it is strikingly similar to the challenges that we
are facing now--and came up with what we ultimately have right
now, the DNA Recombinant Advisory Committee (RAC).
And although that only pertains when you talk specifically
about government-funded research here in the United States,
what has happened is that the fundamental principles, the codes
of conduct, and the culture of responsibility that was
engendered by the discussions back in the 1970s regarding
recombinant DNA technology, without any capability of enforcing
it globally, essentially permeated the global approach towards
recombinant DNA technology. So although we did not have any
enforcement capability, it became something that was widely
shared throughout the world.
Now, other countries, including the Netherlands right now,
are addressing in a very serious manner how they are going to
approach this because it was one of their scientists. But this
is also going on in the United Kingdom, in France, and places
like that. So what we hope and what we envision is that as a
result of this, there will be a culture of responsibility that
even though we do not have the carrot and the stick of funding
and withdrawing funding, that these kinds of principles will
actually be implemented throughout the world. We are all hoping
for that, and I actually have confidence that it will.
Chairman Lieberman. Good. Dr. Gerstein, I know that
Secretary Janet Napolitano and people in the Department now are
developing ongoing relations with homeland security departments
or comparable departments around the world. Is there discussion
of this particular concern in those international meetings?
Mr. Gerstein. Senator, there is. We have had a number of
bilaterals, for example, in the Directorate of Science and
Technology (S&T). We have 12 nations with whom we have
bilateral discussions.
Chairman Lieberman. Right.
Mr. Gerstein. And we have had these discussions. The
nations feel very similar to us, but there is not all good news
as far as this is concerned, and I would take you back to the
Biological Weapons Convention. Some interesting things come out
when you look at that.
There is a London-based Verification, Research, Training,
and Information Center (VERTIC), and in one analysis they did a
couple of years ago, they discovered that very few nations of
the 87 that they surveyed even had laws or definitions of what
a select agent is, and they did not have laws against
developing, stockpiling, or storing biological material. And
the news does not get any better when you talk about export
control measures.
So it highlights the fact that we may be working very hard
in this country and we may put in place the proper provisions,
but it is important that we do the international outreach,
especially into some of the countries that may not have the
same sense of the life science issue and the DURC issue that we
do.
Chairman Lieberman. Yes, Doctor.
Dr. Inglesby. Can I just add to the good news side of the
story.
Chairman Lieberman. Yes.
Dr. Inglesby. First of all, I think the H5N1 debate, as
painful as it has been in the last 6 months, has been somewhat
useful internationally because people are all paying attention
to this issue. So I think that one good consequence of this has
been enlightenment or awakening in many places in the world
which were not paying attention to this.
The second point is at a science meeting 2 weeks ago when
this question came up and there was concern that private
foundations would not follow the lead of the U.S. Government in
the new policy, a representative from one of the most important
science foundations stood up and said, let me make very clear,
if the U.S. Government is going to pursue this policy, we
absolutely intend to follow it ourselves, and I imagine that
others will.
And the third point of good news was an article published
in the journal Nature yesterday, one of the most important
science journals in the world, said that the United States is
taking an important leadership position on this DURC policy and
that other nations should follow suit.
So there are some indications that maybe this will move in
a direction where other people are doing similar things.
Chairman Lieberman. Well, that is encouraging.
Let me go to a different aspect of the DURC policy which
interested me, which is that it requires departments and
agencies to report to the White House National Security Staff
in the next several months on their current DURC projects and
on risk and mitigation measures. The National Security Council
(NSC) staff is probably larger than most people think, but it
is still relatively small for the range and responsibilities it
is given, particularly those on the NSC staff that work on
biosecurity and bioterrorism issues. And I wonder whether you
have a sense of how the information is going to be used to
support oversight of such research and whether any of you
expect your agencies and/or the NSABB will be asked to support
the oversight that the White House National Security Staff is
charged with carrying out here. Maybe I will start with you,
Dr. Gerstein.
Mr. Gerstein. Well, Senator, that would be somewhat
speculative. I would just like to take you back to the
deliberations to date. We have used those deliberations to
better understand what has gone on with the papers. We have
been briefed on the science. We have been briefed on the
policies, the issues that have surfaced. And I think what has
come out of the March 29 White House-led effort is a good first
start. What we expect is that this will continue, that this is
not an end point, so to speak, but it is the beginning of a
process that we will continue to look and try to ensure that
our policies with regard to DURC are as good as they can be to
ensure national security, but also homeland security as well as
ensuring scientific work goes on unfettered. So in that regard,
we are very hopeful.
It is a reporting requirement. All departments and agencies
are submitting to that. And we have not come up with the next
step, so to speak, in trying to finalize the policy. This has
generated, though, incredible discussions across the
interagency where departments are getting together and
discussing how they are handling it. We received several phone
calls to see how we were dealing with our university grants
program and the language that we have inserted that provides us
at least a stop-gap measure should it be necessary to ensure
that publication of certain materials would not proceed.
So this has actually been a very positive outcome, I think,
across the government.
Chairman Lieberman. Good. Dr. Keim, do you anticipate that
the NSABB may be asked to help the White House in these
reviews?
Mr. Keim. We do whatever the Administration asks us to do
and we do not do anything they do not. [Laughter.]
Chairman Lieberman. A good standard. Thank you for that.
Dr. Fauci, do you want to comment on that at all?
Dr. Fauci. Well, I actually agree with what Dr. Gerstein
said. If you look carefully at the DURC policy--the part about
within 60 days to give an inventory, within 90 days to
determine how you are going to do risk mitigation--that was
really the first cut at making sure we know what is going on
right now. I think this is going to be an evolving process.
Ultimately, we are going to try and make sure that when you get
down to the local level of the institutional biosafety
committees, a lot of the kinds of monitoring that will be done
will be essentially automatic by well-trained people.
Chairman Lieberman. I agree.
Let me ask this question. In your testimony, Dr. Fauci, you
discussed NIH-funded efforts to develop a universal influenza
vaccine, and Dr. Inglesby highlights the ongoing efforts to
develop vaccines focused on H5N1. I wonder whether the findings
of these kinds of studies will lead NIH and other organizations
that fund vaccine research to increase the priority that you
are placing on these kinds of research efforts?
Dr. Fauci. The answer is a resounding yes. There are a
couple of ways of getting rid of this problem. One of them, I
think, Dr. Inglesby mentioned in his testimony, certainly in
some discussions we have had, is to just kill the chickens that
have H5N1 and make sure that we just get rid of the reservoir.
That is very difficult to do because you have countries that
are not necessarily interested for economic and other reasons.
The other thing is to have available countermeasures that
actually work really very well. The idea of getting a universal
influenza vaccine is not only going to be very important for
seasonal influenza, so we do not have to keep chasing each year
getting the right combination and matching it with what is
circulating out there, but also, it is a major countermeasure
against the emergence of a pandemic.
So we are putting a considerable amount of effort, and we
have had some very encouraging scientific advances over the
past year and a half to 2 years on understanding much better
the type of immune response that you need to induce in an
individual to cover virtually all strains. We are not there
yet, but this is something that we see as the light at the end
of the tunnel. It is always risky to predict when you are going
to get a vaccine for whatever, but unlike it was a few years
ago, we now see that we have the scientific mechanisms and
wherewithal that we are on the road to developing a universal
flu vaccine.
Chairman Lieberman. Well, that is tremendously encouraging,
and, of course, that is exactly the kind of work even in a
budget-constrained atmosphere that I hope we will find adequate
funds for.
Do you want to comment at all on that, Dr. Inglesby?
Dr. Inglesby. I would say that it is extremely encouraging.
It is exciting. If we had a universal flu vaccine, it would
change the risk equation for everything we have talked about
today in the realm of influenza. So I would just strongly
support the efforts that are going on at NIH by the industry on
that.
Chairman Lieberman. I have a final question, which is the
kind of question, I must say for the benefit of staff, that my
friend and colleague from Delaware, Senator Carper, would
normally ask if he were here. Incidentally, I learned a lot
from the testimony today and, overall, I am reassured by the
government policies that have been put into effect. Even at the
far end that we have set up a decisionmaking process that
considers and values risk mitigation and says, in some cases,
it may be that there will be a decision that research should
not proceed because it is impossible to adequately mitigate the
risks.
So the question Senator Carper would ask, I believe, if he
were here, is if you were a member of the Committee, is there
anything more that we, with our primary concern about homeland
security, ought to be either asking the government to do or
doing ourselves, either by way of encouraging regulation or, in
the extreme, some kind of legislation? Dr. Inglesby.
Dr. Inglesby. I do not see at this point any legislative or
regulatory proposal that would substantially improve the
situation. I do think it is very useful to have oversight like
this on the development of the new policy because I think there
are a lot of things along the way that are going to be
challenging. I think, for example, understanding the criteria
for risk assessment and how we manage those risks is going to
be very important. I think the composition and responsibilities
of the NSABB will be very important.
So asking reasonable questions of the government about how
this new DURC policy is working as it evolves is very
important, and I think, in particular, paying attention to the
very specific case of H5N1 mammalian transmissibility research.
While the decision has been made to move on to publication for
this experiment--which I am concerned about--I think the next
issue is going to come up relatively soon unless there is a
change in course. I think that will come up again, so I think
you just have to pay attention to that.
Chairman Lieberman. Thank you. Dr. Keim.
Mr. Keim. I would just reiterate what Mr. Davis just said,
that how the new policy is implemented is going to be very key.
One important role that the NSABB has played is that we are an
independent body. We are non-government.
Chairman Lieberman. Right.
Mr. Keim. And I think it is very important that we have
``external eyes'' as a part of this new policy's
implementation. There are inherent conflicts of interest
between the funding agencies and the investigators, and the
investigators themselves. While the board has infectious
disease researchers, we were outside the small influenza
research community and we were independent of the funding
agencies. We are able to look at this problem in a way that is
unique, and I think that is an important part to what needs to
happen in the future.
Chairman Lieberman. I agree. Dr. Gerstein.
Mr. Gerstein. Thank you, Senator. Well, I will go back to
the original remarks I made, that I think it is a very complex
issue. It requires balancing outcomes. We do not want to do
something precipitously that is going to have a deleterious
effect on the science. On the other hand, we have a very
important mission in Homeland Security that we must ensure is
well served.
We do have to avoid red lines because the minute you put
out a red line, somebody is going to figure out a way to cross
it. And so the best way to do it is through very thoughtful,
very judgmental type bodies like the NSABB that has played an
extraordinarily important role in getting us through these two
papers and understanding what was going on with those papers.
So it really does come down to a matter of judgment.
On the direct question, do we need legislation right now or
regulations, I would say the Executive Branch has a lot of work
to do to work through the policies. As we talked about, the
March 29 government policy is a first step. We are making great
headway. We are continuing those deliberations. We are learning
from each other. We think in DHS we have a lot of good policies
that we have implemented. We are sharing those to the maximum
extent possible.
So I would like to put down a marker that says that perhaps
later, after we have had some more time working through the
March 29 policy and adding more meat to the bones, that we come
and consult with Congress on this very critical issue.
Chairman Lieberman. That makes sense. I hope you will do
that. Dr. Fauci.
Dr. Fauci. Yes. Mr. Chairman, I do not see any immediate
legislative issue that would be appropriate at this point. But
I think when you asked, if I were on the Committee, what would
I do, I think what you just did today was really a very
important thing. That is really very beneficial to this
difficult process that we are going through, particularly with
the new policy and trying to get it right and implemented
right.
And the fact that an important Committee like this
Committee, with yourself as Chairman, is actually interested in
the subject, is looking at us--we know that we will come back
to you sometime, and maybe soon, to just give you follow-up
about how we are progressing on the implementation of this
policy. So you have already done something, I think, that is
very important and valuable to us, because not only here in the
United States, but globally, people are aware that the U.S.
Senate and this Committee are interested in this problem, and
that adds a degree of seriousness to it which we appreciate.
Chairman Lieberman. Well, I appreciate you saying that, and
that clearly is our intention. So let us agree we will keep in
touch. As you know, we want the benefits of scientific inquiry.
We need them. We also need to mitigate risk, and I think the
policy that we have now is clearly aimed at doing exactly that.
So we will follow it to see how it is going. Maybe we will come
back again and do one more hearing toward the end of the year.
But I thank you very much for the work you did on your
prepared testimony, which will be entered into the record of
the hearing, and for the testimony this morning. We are going
to leave the record of the hearing open for 15 days for any
additional questions or statements.
With that, I thank you very much and the hearing is
adjourned.
[Whereupon, at 11:36 a.m., the Committee was adjourned.]
A P P E N D I X
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