Why Robert Malone keeps saying that a US Biowarfare Expert in Wuhan was a CIA Agent.
He's saying that area of reporting is classified.
On no less than three occasions that I am aware of, Robert Malone has said or implied that Michael Callahan was employed by the CIA while in or around Wuhan, China, around the time of a reported biowarfare event near Wuhan, China.
You’d think that might be news. Michael Callahan is a biowarfare expert who testified to Congress in 2005 on subjects like bioterrorism, the former Soviet Union’s biological weapons program that he helped to “dismantle,” methods to produce engineered bioweapons of mass destruction by removing their antigens, and methods to cheaply produce mass quantities of Anthrax. The full text of Callahan’s remarks to Congress are provided below.
Other than Stew Peters and myself at this point, the media treats that set of circumstances like it doesn’t even exist. As everyone should agree to at least to an extent at this point, all of the major media in the United States is controlled and directed by the CIA. Therefore, I think it’s safe to say that the CIA-controlled media does not want to talk about the CIA biowarfare expert in Wuhan China. I’ve written more about Callahan’s COVID journey here.
From an individual perspective, when it’s just me, Malone and Stew Peters talking about it, something is very wrong with that picture.
The rest will be below a pay line. It’s mainly my perspective of the censorship methods related to calling someone a CIA employee. Also included is the full text of Michael Callahan’s remarks to Congress in 2005, because the public is unfamiliar with him due to censorship.
What’s the censorship method? I’m going to include the remarks to Congress of Oscar Calloway in 1917 where he informed Congress that J.P. Morgan had purchased controlling interests in all of the US Media, and had further selected editors for the papers to control all media narratives. The point being, our media has been controlled Propaganda since before the CIA even existed. The CIA just came along in 1947 as a central managing agency for all criminal activities and began managing that already controlled industry.
The CIA uses their position in the DOJ to block investigations into themselves within the rest of the DOJ. One of their powers is the classification of information. They limit the information that others in the DOJ can use to prosecute the CIA. Essentially, anything that the CIA does is considered classified information. The CIA hides their criminal activities behind rules of classification. Nice scam. This scam tactic has proven to be effectively impossible to prosecute so far.
As for Malone’s repeated mass communications describing Callahan as a CIA agent, they serve the purpose of letting media managers around the US and the world know that the information about Michael Callahan’s activities in China are classified information according to the rules these media editors are expected to obey, even if they are not founded in Law.
If say, some doe-eyed new hire with a journalism degree at the NYT or WaPo went to the editor and said “hey editor, did you hear the one about the CIA guy in Wuhan? I think I want to follow up on that…”. What do you think the editor would say?
The editor can shut it down by whatever rules he uses to control information at the paper. The editor does not need to have any communications with the CIA that the role of Michael Callahan in China was related to the CIA, and therefore classified intelligence, according to previous agreements and understandings of the methods of cooperation and understanding between the CIA and the media outlet by which the editor is allowed to hold his position at the media outlet.
In other words, Malone is doing their job for them. Malone is the one effectively saying do not investigate or report this area. The media editors can truthfully deny the CIA ever told them not to censor the topic.
A major point to consider here is that the last time we had someone “outing” a CIA agent, Valerie Plame in 2003, Scooter Libby went to prison over an investigation related to that. Libby wasn’t charged with the “leak” per se, but instead with Obstruction of Justice and Perjury. Now, the thing about the “Plame Affair” was, Plame was upset about it. She made it known that she expected the issue to be investigated. In the case with Malone and Callahan, Callahan hasn’t responded. I suspect that Callahan is pleased to be identified as CIA because he knows that will limit the amount of press that will investigate him. In other words, Callahan and the CIA aren’t complaining about Malone’s remarks that Callahan was a CIA employee.
I also note that Malone told Tucker Carlson that an unidentified reporter from the New York Times, who he believed was employed by the CIA, informed him that Micheal Callahan was “ex-CIA.” I think that’s important to note because it apparently didn’t slowed Malone’s use of the acronym to describe Callahan. Further, Malone told Carlson that this NYT reporter asked Malone to go back through all of his emails. Malone described this NYT reporter as a “disinformation” expert. It may be that her role was to develop a disinformation strategy to protect Malone and Callahan that involved Malone’s public descriptions of Callahan as CIA agent, which would block certain aspects of any criminal investigations and media reporting surrounding that fact. The NYT deleted an article that included details of Malone’s announcement on LinkedIn about Famotidine in February 2020.
I think the public needs to become more aware of the background of Callahan.
The following text comes from a link from the Federation of American Scientists (FAS). It is the testimony of Michael Callahan to the Subcommittee on Prevention of Nuclear and Biological Attack of the Committee on Homeland Security, House of Representatives, July 13, 2005. And below that, I’ll put the Congressional testimony of Oscar Callaway to Congress in 1917.
HEARING
before the
SUBCOMMITTEE ON PREVENTION OF NUCLEAR AND BIOLOGICAL ATTACK
of the
COMMITTEE ON HOMELAND SECURITY
HOUSE OF REPRESENTATIVES
ONE HUNDRED NINTH CONGRESS
FIRST SESSION JULY 13, 2005
__________
Serial No. 109-30
__________
Printed for the use of the Committee on Homeland Security
[GRAPHIC] [TIFF OMITTED] TONGRESS.#13
Available via the World Wide Web: http://www.gpoaccess.gov/congress/
index.html
Prepared Statement of Dr. Michael V. Callahan
Mr. Chairman, distinguished Members, it is an honor to appear before you to present information on the threat of traditional and next-generation biological weapons. My perspective is derived from experiences as a tropical medicine physician who studies and treats the diseases caused by these agents, from experiences working with former biological weapon scientists in Russia, and threat assessment activities on behalf of the Department of Homeland Security's National Bioterrorism Analysis and Countermeasures Center (NBACC).
I am a staff physician in the Division of Infectious Diseases at Massachusetts General Hospital in Boston, Massachusetts, and the Director of Biological Threat Defense at the Center for Integration of Medicine and Innovative Technology (CIMIT). CIMIT is a multi-institution, non-profit research organization funded by the U.S. Government to identify near-term solutions for critical military and civilian medical problems. Since January 2002, I have also worked with the U.S. Department of State, in particular with the Bio-Industry Initiative (BII), a program which uses the U.S. biotechnology market and academic collaborations to redirect former Soviet biological weapons scientists to peaceful, sustainable medical research. Prior to this position I was on faculty at the Center for International Health at Boston University where I served as clinical investigator for tropical medicine research projects in sub-Saharan Africa. I currently maintain tropical disease research activities in five developing countries, which is pertinent to the discussion below. Since the October 2001 anthrax attack, I have worked with biological terrorism working groups from the National Academy of Science, the Department of Defense, and the Department of Homeland Security. My focus areas are risk analysis of small scale biological weapon production, and consequence management following mass-casualty infections and poisonings.
This subcommittee has asked that I provide some perspective on the threat of engineered biological weapons. As there is considerable debate about several aspects of biological weapons, I have attempted to support this testimony with photographs from the field and from laboratory modeling activities. I will emphasize here that I am not an expert on the former U.S. biological weapons program that was disbanded in 1971. I also understand that Dr. Alibek will provide testimony on the Soviet biological weapons program under Biopreparat. My reference to the FSU (Former Soviet Union) program will therefore, be restricted to information gained from ongoing research collaborations with ex-biological weapons scientists from 10 Russian institutes. It should be emphasized that my experiences helping BII to develop drug and vaccine commercialization opportunities for former weapons scientists have resulted in access to several institutions previously closed to westerners (Figure 1). Further transparency is gained, perhaps ironically, by relationships forged from my medical care of former weapons scientists and their family members, and on occasion, emergency medical consultation to infections resulting from laboratory accidents. Finally, it is probably relevant that my experiences conducting clinical research in remote African and Asian locales have sensitized me to some of the challenges a terrorist lab would encounter when attempting to make a biological weapon in an austere environment
(Figure 2).
What is our current understanding of engineered biological weapons?
Most experts agree that biological weapons are the original weapons of mass destruction. Throughout history, the overwhelming majority of biological weapons were used in a crude form. For example the first recorded use of biological agents was in 1346 when the Tartars catapulted plague-ridden corpses into the city of Kafka. In more recent history, a branch of the Japanese army, Unit 731, reportedly dropped plague-infected fleas in ceramic bomblets over cities in China in WWII, which likely accounts for unusual changes in the epidemiology of this disease in several regions. Prior to the genomic revolution of the last two decades, laboratories in several countries worked with variable success to stabilize infectious microorganisms and toxins so that they could be stored and deployed with greater efficiency and predictability. The advent of molecular biology, advances in our understanding of infectious diseases and immune regulation, and advances in micro-particle engineering and micro-encapsulation have all resulted in technologies that can be used to either advance the properties of biological weapons or as countermeasures to protect against them.
Past military interest in biological weapons was driven by the realization that a comparatively small investment is required to make a tactical weapon capable of killing a large number of enemies. In rare cases, military weapons programs considered biological weapons as part of strategic campaigns. The interest in using biological toxins and infectious microorganisms as weapons was also driven by characteristics of the agents themselves. For example, in contrast with other munitions such as nuclear, chemical and conventional high explosives, only biological weapons are self-replicating. Moreover, these agents can be scaled-up from seed stock to a full stockpile on short notice and with considerably less engineering, manufacturing, capital investment and production signature than would be produced by nuclear or chemical weapons. A related characteristic is that biological weapons can be covertly transported as either minute quantities or in a form that leaves no signature, thus allowing the agents to cross international borders and be produced behind enemy lines. Military strategists also noted that only biological weapons could be successfully deployed without detection, a desirable characteristic if attribution is to be avoided. By the time clinical symptoms would appear, those that deployed the weapon would be many hours or days distant. Most ominously, and in stark contrast to chemical and nuclear weapons, contagious biological weapons such as killer influenza and smallpox, have the unique capacity to cause casualties far beyond the immediate impact zone.
Biological Weapons and Terrorism
Many of the characteristics that make biological weapons attractive to past military programs also make them desirable to the terrorist. Fortunately, the convening of biological weapon capability and terrorist intent has not as yet resulted in a mass-casualty incident. Unfortunately, several disquieting observations of the October 2001 anthrax attack using the U.S. mail system merit emphasis. First, the attack illustrated that advanced expertise had readily been exploited by a bioterrorist; the preparation in the Daschle letter contained extraordinarily high concentrations of purified endospores. Second, the spore preparation was coated with an incipient which helped retard electrostatic attraction, thus increasing aerosolization of the agent. Third, the choice of the near-ubiquitous Ames strain, combined with the absence of forensic details in either the agent or the letters, indicate that the terrorist is scientifically informed, wary of detection and extremely dangerous.
I use this well-publicized case to demonstrate that from the perspective of the terrorist, biological weapons are likely to be the optimal choice for inducing terror. As a practical point, the terrorist is likely to be attracted to any means which causes maximal disruption, terror and loss of confidence while using the minimal amount of skilled personnel, specialized resources and financial investment. For example, the skills required for bioweapon manufacture may be derived from manufacturing practices that use similar technologies such as the fermentative and agricultural sciences, vaccine manufacture, potable water treatment and environmental microbiology. In this regard, bioweapons offer specific advantages for covert manufacture by the terrorist:
1. The agent may be produced using equipment designed for other peaceful purposes (so called `dual use').
2. Production requires minimal space and time, a characteristic that is increasing with modern technology.
3. Unlike any other weapon, infectious microorganisms are self-perpetuating, and therefore may be propagated among the terrorist groups or cells.
4. Several agents can cause casualties beyond those originally infected.
5. When human assets need to be preserved, these weapons allow the perpetrator to escape detection.
From the perspective of the threat analyst, there are 7 overlapping conditions that need to be present for a terrorist group to produce an effective biological weapon. Failure to meet any of the following conditions can thwart an attempt at weapons production. These conditions are consolidated from consensus opinion of different U.S. Government working groups, by CIMIT's modeling activities and from field experiences working with over one hundred laboratories in Southeast Asia and sub-Saharan Africa (reference Figure 1: a clinical infectious disease laboratory in rural northern Nigeria. The laboratory technician and I are holding up red blood cell agar plates containing the non-hemolytic Bacillus anthracis which was isolated from the skin lesion on a local goat herdsman. In this region, estimates of 15-40 cases of cutaneous anthrax are observed annually): the seven conditions for biological weapon production are:
1. Access to agent: this condition requires that the terrorist has the ability to isolate or procure the microorganism or biological toxin. Note that many threat agents are endemic in Neotropical regions of the globe, including all countries of concern to the U.S. Naturally-occurring infections resulting from these microorganisms are routinely encountered in domestic animals, as is the local expertise required to recognize these infections. Procurement can involve coercion, misrepresentation of intent, or illegal purchase from a former weapons program or strain collection.
2. Reagents: this condition includes availability of factors required for successful biological isolation and amplification. Examples include specialized or improvised culture media, sporulation-inducers, and incipients to stabilize the agent or to improve purity.
3. Expertise: technical know-how can be derived from other disciplines. In modeling studies stated knowledge gaps to weapons manufacture may be overcome using internet based literature and patent reviews, use of out of print texts, and identification of solutions from parallel scientific or manufacturing disciplines.
4. Support technology: this category includes laboratory assess such as roller bottles, agar trays, fermentors, lyophilizers, egg incubators, cold storage capability, animal testing capability and biochemical test kits. The recent commercialization of an unnamed technology has dramatically simplified the challenges to manufacture of one bioweapon by allowing a less refined preparation to be used.
5. Budget: in both resource rich and austere economies, the financial cost of procurement, laboratory consumables, animals and maintenance of laboratory operations is significant. In modeling studies, the anticipated budget required to complete all manufacture tasks posed a greater challenge to a minimally resourced terrorist group than did other tasks.
6. Covert production: modeling for small scale anthrax suggests that a small appropriately-equipped laboratory with a footprint of 250 ft2 would meet the production needs of a small scale spore weapon. Although many agents can be purified and engineered in simple microbiology laboratories (which are found worldwide), large scale production, coating and stabilization would require a purpose-designated facility.
7. Laboratory Safety: skilled technicians require protection, however the procurement of specialized safety equipment is closely monitored. For this reason safety capability may be improvised, or lab workers may be hyper-vaccinated and maintained on antimicrobial prophylaxis to permit lower levels of containment to be used.
What can the Former Soviet Union Weapons Program teach us about Engineered biological weapons and bioterrorism?
Recent terrorist attacks in Russia have prompted government actions to protect against terrorism. However, an ethnically diverse population, poor border controls, regional corruption, and the continued conflict in Chechnya have all produced conditions that could still result in a biological weapons attack by terrorists. According to one Russian government official, ``In no other place do the microbes, the expertise, the infrastructure co-exist in such close proximity with terrorist groups and chaotic times'' (name omitted). In the last 2 yrs the concern about terrorism has prompted new levels of disclosure and cooperation between the Russian Federation and the United States. In the last 2 years there have been 4 conferences in Moscow and St Petersburg where prevention and response to bioterrorism was a major topic. These conferences are important for a second reason in that they provide a forum whereby the FSU scientists present previously unknown countermeasures or vaccine strategies which were used to protect production workers or government personnel from the USSR agents. Some recently described technologies, such as non-specific immune enhancers (immune modulators) have little precedence in Western biodefense and are exciting new additions to the BII's Advanced Vaccine and Drug Development program.
Traditional weapons programs
Traditional biological weapon manufacture is best illustrated by the former U.S., British and Soviet era production methods. In the Soviet era program, simple methodologies such as microbial fermentation were conducted on a grander scale. In two former production institutes (Stepnogorsk and Berdsk) fermentors used to produce weapon strains were many thousands of liters in volume, over two stories in height and under continuous stringent environmental control.
In these programs the kill efficiencies of the weapons were increased by maximizing the number of viable microorganisms in the final munition rather than focusing on engineering of the organisms (which came later). SRCAM scientists recount that in the case of anthrax, attention was focused on increasing fermentation and spore production efficiency, and spore recovery using a number of methods such as foam flotation. Other expertise was directed at improved methods of milling to produce progressively smaller clusters of spores, a condition for successful delivery and sequestration in the terminal alveoli of the lung. By report, there were occasional production misadventures where fermentation runs were contaminated by other bacteria or anti-bacterial phages which destroyed the entire production run.
In the years since the end of the Russian program, our scientific understanding of microbial metabolism and the improved efficiency of automated small scale fermentors have increased the amount of vegetative bacteria that can be produced with minimal resources. Parallel sciences, such as biological insecticides which use bacterial spores afor peaceful purposes, have provided clues to maximize yield in a small laboratory. Perhaps most disturbing is the growing availability of small scale, autonomous operating fermentation systems which reduce the need for skilled technicians and a complex support infrastructure (e.g. Bioflo IV Fermentor, New Brunswick, Inc). These systems are becoming more common in agricultural regions of Africa.
When considered as a whole, traditional weapons technologies with alterations rather than genetic engineering are the most likely to be employed by a moderately resourced, moderately skilled terrorist group. There are many open sources and skilled personnel who can provide guidance to help assemble the critical components necessary for weapons development. Potentially, a former weapons scientist from Stepnogorsk could travel to country in the Middle East and reconvene a weapons capability from available veterinary, agricultural and clinical microbiology resources. For Middle Eastern countries, the easiest solution would be to isolate a virulent epizoonotic pathogen from a local infected animal. These scientists need not bring anything with them but their expertise.
To summarize, efforts to prevent traditional biological weapon production should include efforts to prevent migration of skilled personnel to hostile groups. Additional measures for prevention of weapons development include tight scrutiny of international collaborations and tracking the importation of small scale bacterial growth systems and close human and animal surveillance efforts to detect infections resulting from deficits in the safety of a weapons laboratory.
Next-generation Biological Weapons
Next-generation biological weapons are those that benefit from new technologies, those made from previously unknown infectious agents or biological toxins, and those where a traditional agent is dramatically altered by the addition of a high-tech capability. One concept that is central to discussions of enhanced virulence biological weapons is that the same open source methodologies that advance our ability to improve upon human health may also be commandeered for nefarious purposes. A second point is that traditional biological weapons such as those produced in military weapons programs can be modernized to achieve new levels of lethality. The following case is used to illustrate this point.
In the former U.S. weapons program, estimates were made about the number of anthrax spores required for an LD50 (dose required to kill 50% of a population) and LD90 (dose required to kill 90% of a population). Extrapolations from these estimates indicate that between 8,000-10,000 spores would be required for infection. These estimates are likely accurate for the anthrax strains used in the pre-1971 program. Unfortunately, in recent years there have been dramatic advances in the modeling of airflow in the human lung which in turn has driven the field of aerosolized drug and vaccine delivery. In the last 8 years, particle physicists and pulmonary scientists have worked together to improve the efficiency with which drugs reach the alveoli of the lung, which is also the preferred target for the aerosolized anthrax spore. A parallel advancement has occurred in the field of immunology where new organic coatings have been invented which dramatically increase the uptake of particles by the specialized cells in the alveoli. Unfortunately these cells are also responsible for providing the anthrax bacillus with a protected beachhead for replication. The result is that two unrelated technologies, a method for generating small drug and vaccine aerosols, and the development of a specialized coating, are responsible for dramatically reducing the number of spores required to produce a successful infection. (Figure 3 depicts the methods used to produce a coated anti-floculated spore as well as the calculated reduction in spore concentration required for infecting 80,000 people in a large city. Select steps and information omitted for this testimony)
Genetic engineering has also played a role in altering the capability of biological weapons. Toward the end of the Soviet biological weapons program an effort had been made to make several agents resistant to antibiotics. Much of this work was done using techniques considered inefficient by today's standards. Biological weapon analysts with expertise in molecular biology believe that drug resistant biological weapons are a moderate probability event that could have disastrous consequences. The reasons for this are based in the current health care impact of antibiotic-resistant microorganisms, which are arising as a consequence of indiscriminate antibiotic use. What is not clear is how likely it is that a biological weapons scientist could make a threat agent that is both highly resistant and highly virulent. Such balanced capability would require that the organism be continuously tested against animals to maintain virulence. Thus in this case, the requirements needed to engineer-in genes for antibiotic resistance might also require an attendant investment to insure that the agent remained highly pathogenic.
Next generation biological weapons may also be engineered using negative selection techniques. In this case antigens to which the patient's immune response is directed are removed from the biological weapon. In worse case scenarios, the terrorist might eliminate the antigen on a bacteria, virus or toxin that was used as the basis for a government vaccine. If the patient was exposed to one of these antigen-negative biological weapons, they would be immunologically naive resulting in more severe infection and/or death. These types of agents are known as vaccine-evading biological weapons. Unfortunately, the concept that such agents could be developed is dramatically illustrated by the need for new vaccines to protect against circulating strains of influenza A/H3N2.
Next-generation biological weapons also include the engineering-in of properties that influence the ability of the body to mount an immune response. In recent years, there have been several publications which have demonstrated this concept to biodefense scientists and potentially, to any terrorist with internet access. One of the most disquieting publication in 2002 described a method for defeating vaccine-protected animals by inserting a gene which down-regulated the immune system resulting in overwhelming infection and depth (reference provided upon request). Another publication which will appear in an international journal this September describes a methodology which single-handedly solves two separate challenges facing a biological terrorist: how to move virulence genes from one agent to another, and how to store a biological weapon without depending on freezers and liquid nitrogen (reference provided upon request).
One of the most ominous of engineering feats that could be used by biological weapon scientists is to induce host tropism into the agent, whereby the agent is altered to favor infection of a specific human genotype. This seemingly far-fetched concept is already demonstrated by certain tropical parasite infections that cause more significant infections and sequelae in certain ethnic groups.
The efforts of the biological terrorist to produce a new threat agent can also be assisted by natural events. This scenario is best illustrated by current experience with avian influenza in Southeast Asia. Since 1998, the pathogenicity of this bird virus has increased as has its ability to infect the upper respiratory systems of pigs and humans. The result is that infected patients are exposed to a novel, highly pathogenic respiratory virus to which their immune system is completely naive. The danger of this event is exacerbated by the fact that influenza, unlike anthrax, can be transmitted from person to person.
I will summarize this written testimony by reaffirming the concept that the dark science of biological weapon design and manufacture parallels that of the health sciences and the cross mixed disciplines of modern technology. Potential advances in biological weapon lethality will in part be the byproduct of peaceful scientific progress. So, until the time when there are no more terrorists, the U.S. Government and the American people will depend on the scientific leaders of their field to identify any potential dark side aspect to every achievement.
Again, I appreciate the opportunity to present this information before the Committee. I shall be happy to answer your questions and to provide additional documentation supporting the material presented.
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Mr. Linder. Thank you very much. I want to thank all of you
for your reassuring testimony.
This is quite alarming stuff, and I think we are just
beginning with it. I have said to many people this is a
subcommittee to prevent nuclear and biological attack, and
nuclear is really easy compared to biological.
I will recognize myself for 5 minutes to begin the
questioning.
Dr. Alibek, did they ever weaponize the biology in the
former Soviet Union? Was the biological weapons, were they
weaponized or were they just--
Dr. Alibek. The Soviet Union weaponized a big number of
biological weapons and had industrial facilities to manufacture
biological weapons.
Mr. Dicks. Could you pull your mike up?
Dr. Alibek. The Soviet Union weaponized a big number of
biological agents, and had some biological weapons stockpiled,
and had big production capacity to manufacture many stocks of
biological weapons, specifically anthrax, plague, tularemia,
glanders, melioidosis, bacterial biological weapons. Viral
biological weapons, the smallpox, Venezuelan equine
encephalomyeltis, new types of biological weapons based on
Ebola, a GTU hemorrhagic fever.
In this case, let me put it this way, this new paradigm
actually appeared when the Soviet Union started manufacturing
some old antibiotic-resistant biological weapons, antibody-
resistant anthrax, antibody-resistant plague, antibody-
resistant--in the 1980s, there was a big number of attempts to
develop immune-subverting biological weapons, and so on and so
forth.
Mr. Linder. That answer is yes.
Dr. Callahan, are we getting good access to the labs in the
former Soviet Union?
Dr. Callahan. Yes. And what is also critical to know is
that Dr. Alibek is referring to the production capability,
which is really 4 to 6 institutions, the Croftburg, Stavuguart,
and several of the others. But the Russians choose those
programs--and Ken can talk about this in great detail--based on
the return on the investment, on the capital investment, some
large fermentation capability involving multi-story, tens of
thousands of liter fermenters were used. The Russians also had
a B plan, though. Those were the very expensive high efficiency
agents that sat on bench tops, and these--the pace to improve
the efficiency of these agents remained in single scientific
labs. And this is one of our critical focus areas is going
after the former Soviet Union B plans. Short answer, yes, there
is multiple levels of weaponization, there were multiple levels
of technical development, and all have benefited from the
evolution of technology and their migration across
international borders.
Mr. Linder. Dr. Brent, are we wasting $20 billion?
Dr. Brent. Good question, sir. I don't think in a
democratic society, it is possible not to make defenses against
known threats, smallpox and anthrax; I don't necessarily think
those are bad things, in fact, I don't think those are bad
things at all. I do think a defense posture based exclusively
on stockpiling responses to known threats at a time when what
is going to come at you is impossible to predict, is not going
to work in the end.
So what proportion of our resources we spend on flexible
detection and agility versus the known threat is a key
political question.
Mr. Linder. We are going to face flu every year, and every
year it is going to be a different version and need a different
antidote. If a SARS outbreak occurred, something like that,
could somebody with a modicum talent in this business
genetically alter that virus and make it more virulent, spread
faster and make it more difficult to treat?
Dr. Brent. The short answer is yes, sir. At least--you have
clear paths to taking a virus like SARS and making it more
deadly, you don't know that the thing you end up with would be
as contagious as the thing you began with, but it might. So
maybe a nation state doesn't take that bet, but maybe a
terrorist group says what the heck.
Mr. Linder. But the blow back would concern them just as
much.
Dr. Brent. Might.
Dr. Callahan. I also need to add in here, working the Avian
Influenza Syndrome and surveillance program throughout Asia, we
are critically concerned about Avian Flu. I understand Sue
Simonson has talked to you. We used the tippy top of the
international flu community to help understand how to mitigate
against this threat. It is a catastrophe. And one of the
biggest evidence of this is that the influenza R&D; for
weaponization is occurring in small chicken farms throughout
southeast Asia; you can't forget that. Second point is that the
co-infection between a normal circulating strain are current
H3N2 and an H5N1 is statistically extremely probable. And what
we see with the evolution of influenza in Southeast Asia, be it
southern China, Hong Kong, the Himalayan region, and we go and
see these patients and work with these collaborators, we are
finding it slightly different from each other. That is bad
news. That means it is not a single point transition, but it is
a virus trying to find its way. And this is a very important
point and is a live fire exercise for biological defense of
this country.
Mr. Linder. Thank you. My time is--the Chair will now
recognize Mr. Langevin for 5 minutes.
Mr. Langevin. Thank you, Mr. Chairman. And thank you,
gentlemen, for your testimony again.
I would like to start, if I could, going back to Dr.
Callahan, you mentioned choke points during your testimony, and
I mentioned it in my opening statement, which are actionable.
One you mentioned was vaccination of the terrorist weapon-
builders. Can you expand on that and other choke points, and
steps that we could take to identify--how we can identify these
individuals?
Dr. Callahan. The sad misfortune is that vaccination
technology is as old as dinner, I mean, it is literally two
centuries old, and for that reason the technologies to
vaccinate and protect an underresourced biological weapons
scientist working in a remote lab are preexisting.
I will note, though, that vaccines have a certain amount of
efficacy. Our current vaccines are woefully inadequate, with
the exception of potentially the smallpox dry vac. Without
exception, our currently deployed stockpiles of vaccines are
less effective. We use these vaccines as clinical infectious
disease doctors protecting our people that go into harm's way.
We are not very interested in their long-term efficacy because,
quite frankly, there is going to be the need for other care.
So choke points on vaccines are a difficult issue. One of
the ones that has shown up, though, in the laboratory modeling
though has not been control of the agents, has not been
tracking the vaccines, it has been tracking a critical recently
emerged technology. In this year alone, in the first 4 months
of 2005, there are 19 papers that have been produced which
provide heavy, excellent answers for the challenges facing a
biological weapon scientist working in the Khandalar cave. They
usually allow them to forego cold chain refrigeration to store
their agent. That way they could acquire genome in one place
and put it into an agent to be used for dissemination.
So certain technologies are a critical choke point. And Dr.
Brent can probably comment more on that, as can those that are
tracking technologies and migration around the planet, so I
will stop there.
Mr. Linder. Dr. Brent, did you want to comment?
Dr. Brent. I would like to, if I could. You wish there were
more choke points, or that those points felt more narrow than
they do. Again, there is probably hundreds of thousands of
people with the expertise in the world and the access to
laboratory equipment to make anthrax resistant to the main
drug, Ciproflaxin, it is not hard. So the reagents, you know,
the equipment and reagents, they are sold to worldwide market.
The vendors of technologies and synthetic DNAs are all over the
world, they are in basements in Shanghai selling to the U.S.
market. They are bombarding you by your e-mail on the Internet
with special deals and cut price offers.
I am not convinced that there are very good choke points,
particularly when you move from this paradigm of a Cold War
Germ War program with weaponization and so on, to this specter
of an individual or a dedicated group of individuals who is
willing to infect themselves and infect other people. Then one
of the choke points becomes the ability to work with viruses or
synthetic DNA. There may be tens of thousands of people with
such expertise in the world, half of them in the U.S., half
not.
Mr. Langevin. Dr. Brent--and the other two can comment--you
seem to indicate in your testimony that fixed response
capabilities are really inadequate, stockpiling certain
antidotes may only have a very limited value. Can you expand on
that? And what are we to do if there really is a minimal
limited value?
Dr. Brent. Well, okay. This is a delicate and important
point. For example, I mean, a Ciproflaxin stockpile, if I am a
terrorist, I will immediately make sure that my anthrax is
Ciproflaxin resistant; so that is just a flag, outflank me. So
that is among the easiest manipulations to perform.
The amount of the resources you spend on such fixed
defenses versus the amount you spend trying to devise a more
flexible detection system and a more flexible response system
is one of the key questions, but there are almost-- Dr.
Callahan can correct me--60 pathogens on the so-called select
agent list. We don't want us to be spending a couple billion
dollars on each of these agents on the select agent list,
working down the category, we would bankrupt the country and we
wouldn't make ourselves more safe.
Mr. Langevin. Dr. Alibek.
Mr. Alibek. Just a couple of words to add to his
discussion.
Not all genetically-engineered pathogens would require
completely new therapeutic measures. For example, if you talk
about anthrax-resistant Ciproflaxin, we have got some other
antibiotics which can handle this infection, for example,
Doxycycline. Doxycycline, they are good antibiotics to treat
anthrax. For example, we have new technologies now, for
example, we develop antibodies, specific antibodies for anthrax
treatment. The antibodies don't care whether this pathogen is
antibiotic resistant. And we have such a huge number of
examples. In some cases, let me say some genetic manipulations
will create a completely new pathogen and our defense wouldn't
work against this pathogen.
But in some cases our existing defense, they are still
capable to deal with these pathogens. So the only issue in this
case, we need to understand what kind of technologies can bring
a completely new paradigm against these type of pathogens. We
need to develop new defense against war pathogens; we shouldn't
do anything because our existent war is being developed,
medical measures are capable to protect against these
pathogens.
Mr. Linder. The time of the gentleman has expired. We might
have another round.
The Chair now recognizes Chairman Cox for 5 minutes.
Mr. Cox. Thank you.
We have before us three witnesses, each of whom deserves
about a half hour time to himself, and I am sorry we have the
5-minute rule here. I am just going to dive in with a solitary
question that is unrelated to what I really want to pursue, but
it is just something, Dr. Brent, that you said in your
testimony that I hadn't really considered before.
Are you suggesting the possibility, or are you
contemplating the possibility of suicide coughers? You know, we
have got people, as we saw with 9/11, who were content to fly
airplanes into buildings, I suppose there isn't any reason to
think that such people wouldn't mind infecting themselves and
then just spreading themselves about as the agents.
And what you suggest, therefore, is that the Cold War
model, or really the model of all prior history in warfare, is
out the window; we shouldn't be looking necessarily for
weaponization, the terrorists themselves become the weapons. Is
that what you are suggesting?
Dr. Brent. That is correct, sir. That is not to say that if
a nation state had a lot of money and could employ many
hundreds of people to make a program, they might not want to
weaponize their agents and make them more controllable. And
perhaps, anthrax is easily disseminated but it is not that
infectious, but a terrorist group might want to use a
contagious disease, or a disaffected individual. Already the
technology exists to resynthesize small viral genomes. And an
important thing to do in the 21st century is to, beyond the
terrorist, make sure the hacker doesn't appear, the person who
makes something and just wants to--
Mr. Cox. And that is really the point I want to get back to
with you and Dr. Callahan. But first a question for Dr. Alibek.
When the Soviet Union was at large, the Soviet Union produced
genetically-altered super plague, and also antibiotic-resistant
anthrax. By the cease fire of the Gulf War in 1991, when we
discovered that Iraq had weaponized anthrax, were they using
the same kind of antibiotic-resistant anthrax that the Soviet
Union had developed?
Dr. Alibek. No. The Soviet Union, the major anthrax
biological weapon developed and manufactured in the Soviet
Union, it was so-called natural anthrax. It didn't have--
because this technology was quite old, first technology was
developed sometime in the 1950s for industrial production,
another technology was developed in the 1980s. It is a new type
of biological weapon. But it was a biological weapon for
military deployment, not for terrorist deployment.
New research on antibiotic-resistant anthrax started
sometimes in the 1970s, and it resulted in new types of
antibiotic-resistant anthrax sometime in the second part of the
1980s. And this new type of anthrax was tested and was ready to
be accepted by the Minister of Defense for military deployment.
Mr. Cox. But to your knowledge, this has been contained
within the Soviet Union, and now Russia.
Dr. Alibek. Yes. This is what I would like to see in this
case. The Soviet Union never had desire to share this
technology with anybody else. Officially there was no, let me
say, exchange between the Soviet Union and any other country.
The program was highly secretive, and nobody wanted to share
any information whatsoever.
Mr. Cox. Well, that really takes us then to Dr. Brent's
point about the garage hackers. If is it true that biotech is
right now on the cusp of an explosion and it is like computers
in 1965, and it is very primitive right now compared to what it
is going to become 10 years, 20 years, 30 years from now and
there is going to be a great democratization in opportunity to
produce things that up until now have been very sophisticated,
it poses very serious problems for those of us planning
defenses.
I think, Dr. Callahan, you have been very helpful to the
committee in providing what I would refer to as the seven
habits of highly effective bioterrorists. The seven
characteristics that you describe as sine qua non of terrorist
groups that might want to produce bioweapons, to what extent
would this phenomenon of the garage hacker, if you will, if it
is real, defeat our ability to rely on these seven
characteristics? I mean, would it really require the kind of
budget, for example--which is one of your seven factors that
presently it does--would we be able to drill down on these
preconditions to prevent terrorism, or do we need to rethink
it.
Dr. Callahan. Yes. Those are focus areas for interdiction,
both for the intelligence community and for those that are
monitoring migration technologies and agents. Using the garage
hacker as a term, I need to stress that the technologies are
now being downsized to the point where the laboratories operate
autonomously. Before the scientific community and the
biotechnology community was dependent on critical pieces of
hardware in other institutions, gene chip machines, PCR
machines, trial fermenters, and these sort of kept these
programs very integrated for biodefense, or the normal
construction of our understanding of clinical infectious
diseases. The problem now is that there is an incredible
community which is producing technologies, an entrepreneurial
community which is producing technologies for civilian peaceful
use that involved the propagation of infectious agents and
their byproducts that marry medicine and vaccines, biological
insecticides, fermentation sciences, endermatic control
systems, and basically countermeasure flocculents and
environmental mediation systems all use critical elements that
are downsized. Literally our 30 liter process fermenter weighs
130 pounds, it is easy to transport with two people.
So these systems are throughout Africa. We see them all the
time, they are a normal part of agricultural pesticide
generating systems.
There is a key point that I need to also instill on this,
it is that the biological technology revolution, if you compare
it to your analogy of the computer revolution, it is not 1965,
we are in the late 1980s and the speed is picking up. We are
consistently spending a lot of our attention looking at the
open source published literature, and it is outpacing the
Department of Homeland Security's ability to do threat
assessment. We can't read fast enough nor cross-train enough
for the infectious disease or molecular biologists at the pace
necessary to determine what is the threat.
So we are just picking up the big stuff, and we are
probably about a year behind. We have received several red
alerts this month alone for publications that will show up next
month.
And you mentioned, also, this interesting point about the
suicide biological weaponeer. What is missing in our calculus,
with the exception of the intelligence community's
contribution, is terrorist intent and what they are willing to
do. And think of our situation, when we were responsible for
controlling the public health security of the homeland during
2003 SARS epidemic, and we have an international airline en
route from Hong Kong and we get an alert that there are two
SARS contacts on board. So what do we do? If we have that
alert, it is a normal public health problem, it is going to
inconvenience every passenger on that jet while we do contact
tracing, but imagine if the intent is different and there is no
alert. Imagine how that changes the response among civilian
groups. This has been modeled, not by the Americans, but by the
Europeans, looking at the American economy and the impact on
our financial centers. And for the reasons that are obvious in
an open source forum, we can't go into the specifics, but it is
intent.
So an e-mail to The New York Times saying, hey, I have
already been there and done my coughing versus somebody that
you catch on the plane, these are very different responses to
basically the same biological threat, the preexisting live fire
and natural experience, someone with SARS coming to the U.S.
that we pick up at the borders, versus someone that doesn't
want you to know.
Mr. Linder. Dr. Brent.
Dr. Brent. I couldn't agree more. But to back off a bit,
maybe there is other ways to approach the issue. So, for
example, let's not think in terms of the technology. Your
hacker, if it is a kind of slightly antisocial male teenager,
may be deterred by a mandatory life imprisonment. If you let
something out and it hurts people, it won't be funny, you won't
get a slap on the wrist, you will go to jail for the rest of
your life, and people would spit at you on the street when you
are released, should you ever be released. So it is, you know,
so we can begin to think what deterrents would look like for
the different kinds of attackers. Deterrence is probably the
hardest for members of the dedicated terrorist organization.
Mr. Linder. Thank you. The time has expired.
The Chair recognizes the gentleman from Washington State
for 5 minutes.
Mr. Dicks. Let me ask a question, and any of you can take a
shot at this. Yesterday we had a hearing in another
subcommittee on what we are doing in our BioShield program, and
one of the things that was disturbing was that the Department
of Homeland Security has only done four material threat
assessments on--you talked about 60 possibilities here, only
four of them have been done, and one of them on radiological
hasn't been transferred over to the Department--or hasn't been
accepted by Health and Human Services. So it seems as if we are
not doing a very effective job of looking at vaccines or
various countermeasures, whether they--how effective they would
be is a question that has been raised here this morning.
But have you looked at this, is this an area of grave
concern, the slowness in which Homeland Security is reacting
and doing these threat assessments.
Dr. Alibek. Thank you. It is very important in my opinion,
a very interesting question. I have been watching what was
going on in the field of biodefense for the last four or five
days after we heard the anthrax attack, and I noticed that many
things have been done correctly, but at the same time, I see
big holes in our preparedness for biodefense.
And BioShield program was a very good program, good
program, let me say, by its intent; but you know, when we came,
let me say, to the evolution of this problem, we started
noticing that we still have huge numbers of issues that are
unresolved. And our problem actually exists on two levels.
First level is just to understand the reality of one another
type of threat. First to understand what kind of threat we
should consider as most and least of threats at this point in
time, for example, just in terms of types of the pathogens and
types of biological weapons.
Second, what would be the most probable way of deploying
biological agents? We need to know there are very many
different ways to deploy biological agents.
Third, what kind of consequences would you expect from each
type of threat? We should not use something like, say, in the
case of anthrax attack, we are going to suffer having 1 million
casualties. Of course, it doesn't work this way. We still, in a
kind of nonscientific field, are saying just try in some cases
to reduce the understanding of threat, in some cases to
increase and make it kind of catastrophic.
The situation is completely different. We haven't even
started doing much to understand the differences. Let me give
you a simple example, because in the field of military
biotechnology and military biological weapons and biological
weapons defense, we always analyzed the possible number of
casualties based on a specific age and range of people--young
adults, people between the 18 and 50 years old, in this case
because everything was based on the use of biological weapons
against troops. But now we have got a completely different
paradigm.
We have got a situation where we are going to have a big
number of children infected with biological agents; we are
going to have a big number of elderly people. This is the most
vulnerable population, and the level of threat posed by
biological weapons to these people is much more grave than when
we talk about young adult populations.
Just take a look at a simple example. A lady could die in
Connecticut. She was 94 years old. It was obvious the
infectious dose for this lady was much, much lower. She didn't
require 10,000 to 20,000 spores to get infected. This is one of
the examples, and we have dozens of areas we haven't started to
explore.
Mr. Dicks. So you are concerned we are not reacting and
coming up with various strategies?
Dr. Alibek. In my opinion, what is going on at this point
of time, we haven't identified all types of threats, we haven't
identified all types of specific research we need to conduct;
and, of course, based on this, we don't have appropriate
treatment for all possible threats we are going to face.
Mr. Dicks. Dr. Brent.
Dr. Brent. Mr. Dicks, if I could, I think whatever good
there is--and there is probably some good in enumerating
possible threats and then detailing detailed responses to
those--what good that has is coming to the end of its shelf
life, if it hasn't already.
So we should not call these things strategies, either; we
should call them tactics. An individual defense against an
individual thing is a tactic. So I would not think it is a good
use of time, personally, for the Department of Homeland
Security to list 100 threats.
Mr. Dicks. But they can't spend any money out of the
biological fund, out of the bioweapons fund, until they have
done a material threat assessment.
Dr. Brent. Understood, sir.
Mr. Dicks. So the HHS says, I am sorry, we can't fund you,
Mr. Pharmaceutical Company or small firm, to develop a
countermeasure, because the Department of Homeland Security has
not done its material threat assessment.
I don't think Congress intended to hold up everything to
come up with some comprehensive document, and they have only
touched on four areas out of 60 possibilities that you have
discussed here today.
Doctor, do you have anything you want to add?
Dr. Callahan. I am intimately involved with the material
threat assessments and can tell you about their benefits and
their lessons. The key point here though is, if you step back
and look at it the way our former enemy looks at it, each of
these strategies is easy to defeat. We have vaccine-evading
biological weapons. We have detector-evading biological
munitions. These systems are currentlySec.
Mr. Dicks. So do we do nothing?
Dr. Callahan. Negative. What happens is, there needs to be
a paradigm shift with our approach to the problem.
Dr. Alibek actually has worked and has expertise in
nonspecific immunomodulators, the way you enhance immune
response in a way that will bolster nonspecific immunity.
It is absolutely critical to understand that you might not
get anthrax, you might get something that is anthrax-like. It
has the guts and the payload of the anthrax bacillus put inside
another spore. It will defeat our public health surveillance
capability because it won't grow on the right plates in our
reference labs. It will defeat the clinical diagnostic criteria
because it may not show up correctly in the hospital labs, and
it will present, clinically, differences so that you don't get
necrotic skin lesions in the injuries.
So, again, we need to sort of step back and think of an
integrated approach that involves all elements of our
scientific discipline, spanning molecular biology, but
certainly more terrorist intent and understanding the force and
futures that modulate the strategic thinking to make these
offensive agents.
They are agents of terrorism. They want to get away with
the crime, and they also want to be culpable and say, look what
we did to you.
Mr. Dicks. But is anybody doing that actually?
Dr. Callahan. Think of the subject matter that must have
been convened by Homeland Security through DHHS in part. What
happened is that we used an anthrax expert. We used a botulism
expert. We used a tularemia expert. These people are mono-bug
people. They have been working all their life with one agent
and their ability to think like a terrorist in a Kandahar cave
cannot be replicated by a well-resourced scientist in some
major academic or biotechnology institution.
We need to step back and produce a realistic premise for
the force and features which influence these technologies in
bringing them together for bad use. So we really need an
integrated plan. The detectors need to not detect a single
antigen on an anthrax spore, they need to detect difference in
change, rapid amplitude escalations we need for the unknown.
And quite frankly, this has a tremendous return for our public
health preparedness for avian influenza and the as yet unknown
infectious diseases that give me job security for next year.
Nature is working for me.
Mr. Linder. Your time has expired.
The gentleman from Connecticut is recognized for 5 minutes.
Mr. Shays. Thank you.
One of the points I think you make, Dr. Callahan, is that
one of the advantages you all have in biological warfare is you
get everyday practice from Mother Nature; and unlike our
defense for other types of threats, what we do for Mother
Nature, we can then transfer in terms of what we ultimately do
for someone who is manipulating the process.
It points out, I will just make this observation, the most
important thing we can do in this country is to have a
capability to detect so we can prevent an attack. Consequence
management, it is huge when it comes to biological warfare; it
not as important, frankly, when it comes to even the horrific
bombing that happened in London. But it points out the need to
have the PATRIOT Act, the ability to get into these cells, the
ability to know what they are thinking before they do it.
Just an observation I want to put on the table.
Dr. Alibek, I have been to some of your stomping grounds in
Russia, and it is pretty frightening still to see biological
agents that are in refrigerators with string and wax. And it is
not to prevent someone from opening that refrigerator; it is
just to know when they did it.
Speaking about Mother Nature, and I want to know if this is
true, I was told, as the permafrost melts, that there are
biological agents that have been basically in a frozen state
for years that may come to threaten us again.
Is that hype or is that a possibility, particularly as it
relates to animals?
Dr. Alibek. Unfortunately, I participated in the first
discussion we started in 1989 in terms of the possibility of
finding the smallpox virus in permafrost. Unfortunately for us,
what I would like to say is, one of the reasons why one of the
scientific entities in the Soviet Union started the discussion
was because of the possible threat that the United States would
start accusing that facility in working with smallpox when the
smallpox work was prohibited. The reason to create this story
about permafrost and the possibility to find a viable virus was
based on a desire to cover the actual work with the smallpox
virus.
Then it became--I have no idea at what point it became kind
of a scientific entity and many scientific groups started
visiting some locations. But I was a part of a very small
meeting in 1989 with individuals involving the Deputy Minister
of Health of Russia, the director of microbiology work and
myself when I was--
Mr. Shays. Give me the bottom line here.
Dr. Alibek. The general idea was, we need to find some
explanation to cover our work with the smallpox virus.
Mr. Shays. One of the great organizations in the world, in
my judgment, is the World Health Organization. They go
anywhere. They have limited resources. I am just interested in
knowing, do you feel that we could be using the World Health
Organization better than we are using it today?
Let me just start with you, Dr. Brent.
The question is, can we be using the World Health
Organization better than we are today?
Dr. Brent. Certainly, sir. These things like the Centers
for Disease Control and WHO, which is a little bit more of a
paper-shuffling place, but not totally, these are like the fire
department; we need every one of them we can get and we owe
them our support.
I would personally like to see a greatly beefed-up World
Health Organization. The Centers for Disease Control has
something called the EIS, the Epidemic Investigation Service,
which is one of the most prestigious postings a young person
who is interested in public health can have.
The director of the WHO has called for a world EIS which
would attract the best young people in the world. I think any
support we can give them is money that is extremely well spent.
Mr. Shays. When I went to Geneva a few years ago, and we
said we wanted to have a meeting with the World Health
Organization about biological warfare, the director basically
said, well, they don't really get into that. This was a number
of years ago. We said, well, we are coming anyway.
We started to meet with people that he didn't even,
frankly, know--this is a former director, didn't even know were
involved in this effort. I thought that was rather curious.
Let me just go to Dr. Callahan and I will come to you.
Dr. Callahan. Things have changed at the WHO. They
recognize their importance as an integrated group to be able to
do offensive use biological threat mitigation because their
representative countries include areas that are not often
traveled by Americans specifically.
Let me take you, as a practical example, to the benefits of
the WHO versus agencies of the United States Government. During
the SARS epidemic the CDC was deployed also to Hong Kong and to
the Quandong Province in South China. I was on the WHO
attachment, and I went to all the closed areas, and there were
no other Americans permitted to go there.
So this is a critical point, that in order to have--you
need to be card carrying and integrated into the international
agencies in order to be not deemed as, you know, a country of
their concern. So the WHOs can be very critical, unless you
have some excellent new talent in the WHO from the current
administration who can continue to further this issue.
Dr. Alibek. Just a couple of words. I have visited many
countries, talked to many government officials, talked to many
experts in the field of biological weapons defense in many
countries, and what I noticed in many cases they try to acquire
as much as possible information from the United States
defensive program. They analyze our publications, they analyze
what we do, they analyze our CDC efforts and so on and so
forth.
At this point in time, in my opinion, the international
community is not involved appropriately in being a part of a
kind of international biodefense effort. In my opinion, it is
time to start a bigger international program, and maybe the WHO
would be a good place to start the program.
Mr. Shays. If I can respond to the chairman, Mr. Chairman,
this might be one of the reports that we get out to encourage
this. I would recommend to this committee we go visit the World
Health Organization.
Mr. Linder. We expect to do that. Thank you.
The Chair recognizes the gentleman from Massachusetts for 5
minutes.
Mr. Markey. Thank you, Mr. Chairman.
Dr. Alibek, back in the fall of 2001, Mr. Shays and I had
you in to testify to our nonproliferation task force on these
issues, and you recommended if there was ever any anthrax
attack, that the best prevention was to ion the mail, to make
sure all mail was ioned.
The next day, this complex was evacuated because of an
anthrax attack and all of our mail is now irradiated. But you
gave us a warning with 24 hours' notice that hit us.
Now, Michal Freedhoff on my staff, she was actually in one
of the rooms that was hit in the Longworth Building, and she
wound up on Cipro for 2 months. But we very much appreciate
your warning.
My question to you would be, what else should we be worried
about? Give us a scenario that we might be concerned about,
attacking the Capitol or attacking some other facility in the
United States.
Dr. Alibek. First of all, thank you very much for
remembering what I suggested.
But it had a kind of downside, because immediately after I
said this, CDC started blasting me, saying, never ion the mail,
because it is going to result in the acceleration of anthrax
spores. And I was kind of shocked because it was absolutely
obvious that people who were concerned, they could do this,
because it was absolutely obvious that spores could be killed
quite easily.
In my opinion, the lady who died in Connecticut, if she had
had a chance to ion this mail, covering it with some piece of
fabric, the probability was for her to be alive.
Mr. Markey. Who attacked you at that time?
Dr. Alibek. CDC.
Mr. Markey. And what was their misperception?
Dr. Alibek. It is always, when you put on the scale, two
things. For example, okay, you ion mail and have got a lower
probability to get infected, and you don't do this in the high
probability. You have to choose.
Mr. Markey. Give us a warning today. Give us something.
Dr. Alibek. First of all, what I would like to say, of
course, I don't want to be a kind of alarmist, but I strongly
believe it is not a matter of if, it is a matter of when, when
we are going to see the second attack. If you ask me what is
the probability of using different pathogens in terms of the
attack, in my opinion, anthrax will be again the weapon of
choice.
What kind of deployment? There are different scenarios. In
this case, one of the probable cases--again, maybe anthrax--but
the number of places to be mailed could be quite large.
In this case, our preparedness should be based on several
principles: first, fast identification, fast diagnosis, fast
treatment of people and providing antibiotics as fast as
possible.
What is absolutely essential, just organize a visual
monitoring system. Any person who is appearing with more or
less obvious symptoms or suspected symptoms of anthrax should
be treated immediately. It should not be discussion whether or
not it is anthrax.
In this case, one more thing: In my opinion, we need to pay
attention to what DARPA is doing in the field of anthrax
protection. In my opinion, DARPA is the most sophisticated
entity at this point of time, and it knows what kind of
research and what kind of development needs to be done in this
field to protect against anthrax.
If we are able to commercialize everything that is being
paid and funded by DARPA, within in the next 2 or 3 years we
are going to have three or four very good therapeutic measures,
new vaccines, highly effective, fast-working vaccines. Second,
antibiotics, existing and improved antibiotics for anthrax, we
have very good approaches on specific antibodies to treat which
could be used compared to antibiotic treatments and several
other approaches.
Mr. Markey. Let me go quickly to Dr. Brent, only because
time is limited.
Dr. Brent. I would like to echo Dr. Alibek's point that
DARPA maybe is the most effective government agency right now
able to prosecute kind of the applied research that is
sometimes necessary. I would say, however, that if I am an
adversary and I see there are four or five good anthrax
countermeasures, I will not attack you with anthrax. So I don't
know how useful it is to scenariolize.
Mr. Markey. Dr. Callahan, do you think that we have
adequate security around biohazard storage facilities in the
United States?
Dr. Callahan. Yes, I think they have dramatically improved
in recent years, but they are easily circumvented by the novel
engineering of a new agent. And getting a new anthrax strain
out of Texas, South Dakota or Maine, we can have a few in about
10 days.
Mr. Markey. I thank each of you very much for your
important work in this area. Thank you.
Mr. Linder. The Chair recognizes the gentleman from
Louisiana for 5 minutes.
Mr. Jindal. Thank you, Mr. Chairman.
In an earlier comment, I heard the panel, and just now,
talk about these novel bioengineered agents that could be used
in an attack that might circumvent our detection equipment, our
treatment, our vaccines.
My first question is, how easy would it be for a terrorist
group--an individual agent as opposed to a state-sponsored
group, how easy would it be for them to manufacture such an
agent that would easily circumvent our defenses and our
vaccines? Is that something that a terrorist group acting alone
can do today, or is the technology diffuse enough that they
could easily do this today?
Dr. Brent. I am afraid it is, sir. There are tens of
thousands of DNA synthesizers worldwide, and the kind of
capital costs for a lab that you would use to, let's say,
resynthesize a virus and get live virus out, it is probably a
couple of million dollars, if that, $1 million worth of capital
equipment. There are probably more than 1,000 research groups,
more than 10,000 people with the kind of generalist training to
do that.
So is there any intersection between the people who know
how to do it and the people who might want to do it? I can't
answer that. Is it likely there will be such an intersection in
the future? I believe there will be.
Mr. Jindal. Given that--and I know the ultimate answer is
obviously we would want to do all these things and we want to
have an integrated approach, but given that answer, how would
you allocate scarce resources? As you have to choose between
hardening targets; as you have to choose between boosting
generic, as you talked about, nonspecific immunity; as you
think about developing new vaccines; as you think about new
detection centers, how do you set priorities?
Dr. Brent. Sir, if I can, flexible detection. We know we
have been hit, this is what hit us. Agile response.
Components of agile response now that could be gotten going
quickly include things like being able to make prophylactic
antibodies against a new agent. They may involve new phase
therapies. There are ways to make vaccines quickly. There are
ways to speed up drug discovery.
There is a great amount of creativity within the biological
community in the U.S. which is kind of up for that. So that
would be the mantra.
Mr. Jindal. I am sorry. Yes?
Dr. Alibek. In my opinion, when we think about a bio
threat, in addition to vaccine development, it is going to be a
long shot to develop vaccines. We need to start working very
hard in the field of developing immunomodulating preparations
to modulate our immunity response. Because this is the way to
create, let me say, a kind of broad spectrum of preparations
capable for self-administration. This is first.
Second, we need to begin to focus on our--in many cases,
for viral and bacterial infections, for late-stage and
therapeutic modalities and preparations, because, for example,
you would talk about anthrax. The early stages of anthrax we
can treat. As soon as the disease has come to the late stage,
we have serious problems and these diseases are becoming
incurable. We need to be put attention to this.
In my opinion, what is absolutely essential, there are some
new signs emerging now, that especially, probably, Dr. Brent
could support. Recently they started developing a new science;
the name of the science is bioinformatics. Bioinformatics
actually allows us to develop, let me say, completely new
principles for vaccines and, specifically, antibodies. This
principle we call reverse vaccinology principle, meaning that
we don't need any pathogen, we don't need to dissect the
pathogen. What we can do is bioanalysis of genome and
pathogenics of the pathogen; we can define specific targets.
And actually, just recent data, emerging data, shows that
actually it is maybe science fiction now, but it is a way to
develop multipathogen vaccines and multipathogen antibodies.
This is what I am saying for the first time in this
audience, because this is just first ideas, and these ideas are
feasible; and maybe if we start exploring these directions, in
3 to 5 years we will be able to bring first vaccines that will
be effective against three to five different pathogens, for
example, anthrax and plague.
Mr. Jindal. One final question. I am sorry to interrupt
you, but our time is limited.
Are there other countries, is there any other country out
there that you see that is further along than we are in terms
of equipping their public health sector, their emergency rooms?
Is there anybody out there that is doing this better than we
are today?
Dr. Alibek. No. No. The United States is the most
sophisticated country in this field.
Mr. Dicks. But is it adequate?
Dr. Alibek. It is the most sophisticated in the world. But
when we talk about how much we can achieve, of course, we have
a significant gap yet.
Dr. Brent. Mr. Jindal, if I can go back to the flexible
detection and response, let me say that is what you want to get
going now, but at the same time you put in things like
understanding how to gin up the human immune system. That is
probably a 20-year kind of goal-directed research program to
get to that.
So you start doing both now, build your detector network,
build your agile response, do what you can to conceptualize
that system, but put the money into something that will pay off
more properly in decades.
Mr. Jindal. Thank you, Mr. Chairman.
Mr. Linder. The Chair recognizes Dr. Christensen for 5
minutes.
Mrs. Christensen. Thank you, Mr. Chairman.
Just for the record, Mr. Alibek, when you responded to the
gentleman from Massachusetts on what instructions you might
give, I note that the instructions were around normal public
health responses, something that we are stressing. I don't feel
that we are adequately prepared in this country, and it is a
point that many of us make over and over again.
Let me ask a question about a bill that we had introduced
last year and were planning to reintroduce again called Rapid
Cures. I have always been concerned as we went through
BioShield hearings last year that we were talking about
preparing for agents and we had no clue as to what the
biological agent might be, what form it might come in, whether
it would respond to any of the things that we were spending all
this money to create the countermeasures for. The Rapid Cures
Act would help us to shorten the time if an agent came that we
had not previously identified to developing a cure, a vaccine,
and so forth.
Would you suggest that in addition to research that would
boost the general immunity and provide some general protection,
that we pursue a course of trying to develop the time to
develop countermeasures? Anyone can answer that.
Dr. Alibek. You touched a very important topic. In my
opinion, you are absolutely right when we talk about the
BioShield program. The program actually is based on old
traditional approaches, how we deal with these infectious
diseases. We are talking about diagnostics systems, vaccines
and therapeutics.
What we need to do, in my opinion, first, we need to
develop a new program, we need to analyze new and traditional
novel approaches for protection development. We haven't started
doing this work yet.
Second, in addition to when we talk about specific
modulation of immunity response, we are hearing very positive
things. Let me say we allow the immune system to build its own
defense while the victim is still alive.
But what is important in this case, and this is one of the
critical points, when we talk about many diseases, especially
contagious diseases, we need to keep in mind two things. First,
we need to save the life of the victim; second, to reduce the
infectiousness, the contagiousness of this victim; and, third,
we need to create immunity for the population.
In this case, let me say, in order to solve all three
problems, we need to develop some new preparations, and some
preparations already exist. A person is becoming less
contagious. We reduce the severity of this infection. This
issue is important for bioterrorism events and for emerging
infections, like the common avian flu.
For example, we try to develop vaccines, but we don't pay
attention to some other cultures. In many cases, we do two
things: Either our victim survives or dies. In this case, if he
or she survives this infection, it is much better than if this
person dies. It is obvious.
In this case, when we talk about modulating in a community,
it is not an issue of saving lives, it is an issue of, first,
increasing the probability of survival; second, reducing the
contagiousness of this person; and, third, creating a kind of
immunity population. In this case, we would be able to prevent
an epidemic.
In this case, this is just a short explanation that not all
directions have we explored yet.
Dr. Brent. Mrs. Christensen, not only is having anything
that enables you to move more quickly from a new pathogen to a
new drug a good thing, but I want to point out one consequence
in addition to helping the defense.
Anything that streamlines drug discovery cuts the cost. The
cost is significant, the drug company might say $800 million, I
might say $400 million, but it is a lot of money. Cut the time
drastically, cut the cost drastically, and that enables things
like the Wellcome Trust, foundations like that; now they can
spend $40 million for a drug and use it in the developing
world.
So national security and some of the other properties in
the world go hand-in-hand.
Dr. Callahan. I would comment only that the natural
experience of facing a threat agent that you don't understand,
we haven't done very well. If we think back about SARS, that
was using 2003 technology. It was using some of the most
resource-rich laboratories around the planet. It took 19 days
to actually isolate the specific genera of the organism, and
that came from an electronmicrograph of a patient's lung.
By the time we returned to Hong Kong, there were 470 people
on ventilators, and we were flying ventilators all around in
Southeast Asia to try to shore up their health care capability,
which, by the way, is a Western standard.
So, to your first point, to mitigate against these events,
an unknown threat agent, we are going to do poorly based on
what our current success record has been with avian influenza
in the past, orthopox viruses in the past, particularly the
recent cow pox from several years ago, and SARS being a crystal
clear example of our capability when put on the line.
The second point is, DARPA has been mentioned, as has BII.
These two extremes of resources have not been capitalized on in
a major way. The reason why I will suggest to you that we need
a closer attention here to support the Homeland Security effort
is because BII in Russia is looking at countermeasures that
haven't even been considered by the Western cognition, by the
American sort of way of thinking. Classic antibiotics and
vaccines for one bug, nonspecific immune enhancers and
bolstering the immunity of a population have some principles in
natural history and, of course, military history.
The last and final point is that DARPA is certainly one of
the convening arms for these technologies and needs to be
supported with subject matter expertise, it needs to be read in
and integrated.
This just raises a critical concern because imagine being
that biotechnology company that you are trying to entice with
biodefense dollars, and yet your antigen, the thing in the bug
that you are trying to block, needs to be classified because it
is so easy to circumvent it if you are a terrorist. So that is
not the way that science and certainly not the way basic
science infectious disease has operated.
So these are some of the dilemmas which are procedural,
which are policy relevant and involve all the basic science
community, which is intending to publish, as well as our
intelligence and medical intelligence communities.
Thank you.
Mr. Linder. The Chair recognizes the gentleman from
Mississippi for 5 minutes.
Mr. Thompson. Thank you very much, Mr. Chairman.
I guess, as I listen to the testimony, I am real concerned
as to whether or not the approach that we are taking as a
country and as a committee is the proper approach.
We heard testimony yesterday on BioShield, and I am
wondering, first, are we approaching BioShield in a manner that
the scientific community supports, or are we just putting money
out there and people are chasing the money? I hope you
understand what I am saying.
I will take any answer.
Dr. Callahan. Clearly, these are large appropriations and
large allocations, and they entice a lot of competitive grants.
The trouble is that the best of the experts are oftentimes
individual scientists in small laboratories and they are
largely disengaged from the system.
The second point is, there is a huge resource in the
biotechnology-for-profit sector. The best of the minds get
bought away from the academic centers. As opposed to the DHS
effort, it capitalizes heavily on the national labs, usually
driven by the need for security clearances and to put big
fences around things. The trouble is that those shops tend to
be single shops and they try to keep everybody else out.
If we are truly mission driven and we are truly trying to
get the best of the talent at the table, we need to step back a
little bit to a great review using the best of our review
capabilities out of NIAID, CDC, DARPA specifically, and
USAMRID, to find these agents that can really help us with
this.
Dr. Brent. Just that BioShield may be necessary, but not
sufficient, or at least some parts of it might not be. It is
not a bad thing that there is now enough smallpox vaccine to
vaccinate everybody in the United States. But it is limited
after that.
Then I am going to just cite what Dr. Callahan said. We
need to engage. There is all the talent here to make the
defense work, but it needs to be engaged perhaps by
complementary mechanisms.
Dr. Alibek. Unfortunately, I don't want to be over-
critical. In 1998 or 1999 when I testified first on the Hill, I
said if we don't develop in the beginning our concept of
biodefense and agree to develop a good threat assessment in
terms of bioterrorism, we are going to suffer and we will never
have any appropriate defense. This suggestion, of course, my
testimony could be found in the archives.
Now, 7 years later, we are still there. I am not saying we
were not able to develop a better biodefense. Yes, we did. But
we still suffer because, in many cases, what I notice--and it
looks like this is what you actually asked--in many cases, when
some solicitation appears, a huge number of companies start
applying for these solicitations, in many cases having no
knowledge in the field.
What they do in this case, they hire some consultants, they
put a good list of people who would work for this work. They
get funding from the government. Then they throw away these
consultants and start doing this work. In this case, we
shouldn't expect any kind of good results from this type of
approach.
In this case, in my opinion, a national register, for
example, of the most effective biodefense entities, we need to
establish it, and we need to establish some kind of entity to
determine what we need first for the country.
Mr. Thompson. I am going to get back to you, Dr. Brent.
One of the things, Mr. Chairman, I think at some point we
are going to have to look at whether or not we are moving along
in the right direction. We are spending an awful lot of money.
But if we are spending money on a Model T instead of the latest
and best science, we are just spending money.
Mr. Linder. If the gentleman would yield for a moment, it
gets back to the point that I keep repeating, that there are a
finite number of terrorists and an infinite number of ways to
hurt us, and we ought to be looking for people instead of
things.
The other point I want to make is, we heard testimony
yesterday that HHS gave a sole-source contract for a vaccine to
a company that had never produced the vaccine. I just think
that that is not a sound business practice. Here we are a year
from having the vaccine brought to us, and we sole-sourced it.
We didn't put it on the market. We went out and bought a
temporary supply of vaccine from another company.
I am just concerned that with all this money out with
BioShield and people responding sometimes to RFPs, but
sometimes just sole-sourcing of the product, that we are still
not doing what is in the best interests of this country.
Dr. Brent?
Dr. Brent. Sir, I would be inclined to cut people a little
slack on the procurement. There are only six companies or so
that even have standing in the vaccine business now, and they
are scrambling. So my inclination would be to cut some slack on
things like sole-source procurement, but to recognize that the
procurement model is not alone going to get us through.
We need technical development programs tantamount to kind
of radar and ICBMs during the Cold War. You can't just go out
and shop for that; you have to begin to think how to configure
the right defense complex.
Mr. Thompson. So you sole-source it to somebody who hasn't
done it?
Dr. Brent. In the first year maybe you cut them a little
slack.
Mr. Dicks. If the gentleman would yield for a second, are
you suggesting that we should do R&D;, or do like the Defense
Department does, spend some money on research and development
before we go out and try to buy the finished product?
Dr. Callahan. The critical issue, I think, is to test the
system for its responsiveness. It is research fleet-afoot. We
can do that again with natural experiments. We are doing it
with avian influenza at this time by producing an integrated
surveillance, ironically, in using former Russian biological
weapons scientists who are capturing avian flu as it migrates
south.
The second point is looking at the case studies from SARS
and West Nile virus. We are doing really badly, and these are
diseases that, in hindsight, are actually fairly easy to
subtype. These are practice experiments, they are live-fire
exercises, they demand capital investment; and everybody is
working hard, because they know the threat is real. It is not a
scenario, like TOPOFF or another event. It is a real event;
people are dying and are on ventilators.
Dr. Alibek. I talked to both companies, BioPort and VaxGen.
Both of them, let me say, present the same vaccine, actually,
based on different technologies. When I talked to
representatives of these companies, they tried to convince that
their vaccine is the best one, but when you analyze it, of
course--let me put it this way.
I haven't seen anything with the VaxGen vaccine which would
make this vaccine more appropriate than the existing vaccine.
In this case, of course, it is not my business; it is the
business of DHHS. But, for me, it is very difficult to
comprehend why we are trying to buy a vaccine from a company
which hasn't proven--which doesn't have a proven record yet,
instead of, let me say, promoting the existing vaccine.
I am not supportive of this company, Emerging BioSolutions,
or BioPort. I know they have got problems. But when we put them
on the same scale, two different vaccines, I see no big
difference.
What needs to be done, in my opinion, of course, we try to
spend about $1 billion to buy this vaccine. Why, for example,
we don't support at this point of time--when we don't have a
new vaccine, we support this production, but at the same time
we develop new regulations, new requirements for new vaccines,
second generation vaccines, which would be working much better
than existing vaccines.
In my opinion, this is the way to go, because when you have
two different vaccines--which actually are the same, in my
opinion, of course--it makes no sense to me.
Mr. Linder. The gentleman's time has expired.
Ms. Norton is recognized for 5 minutes.
Ms. Norton. Thank you, Mr. Chairman. I apologize that
another hearing kept me away from hearing all of the testimony.
I understand that before I came in there was some mention of
something that is of special interest to me, that perhaps the
most likely biometrics attack would be an anthrax attack, an
attack of the kind we have already had, the one kind of attack
we know something about.
The one place that is protected to any degree, of course,
is the Capitol and the Federal agencies in the event of an
anthrax attack. Whether anthrax or some other substance, I
think the public is far more focused on what would happen if
there were an attack in a closed system like a subway or a bus,
the kind we have just had in London.
I just reintroduced a bill for ordinary security protection
in public transportation systems and rail. That is just the
ordinary stuff, cameras and so forth. But I think there is far
more concern about some kind of bioweapons attack, which some
might regard as easier to do, coordinated London-style.
I am wondering what you think the consequences of such a
use, some kind of biological substance, would be in a subway
system like here in the District of Columbia or in New York.
Also I am interested in what I understand was some mention
of broad spectrum antibiotics. Whoever would be best informed
on those subjects.
Dr. Callahan. I think that you are hitting a critical
point, which is that fairly moderate efficiency biological
weapons gain efficiency when kept contained. They also, if we
model HVAC systems for indoor air attack and HVAC systems such
as serving this room, allow for remote delivery of an agent,
allowing chances for folks to get away.
The third point, which is very much in evidence in the
community here, is that buildings tend to house a lot of the
same type of people, and if those are desirable targets, be it
military personnel, government officials, school kids, whoever,
you get a higher return. This is actually modern military
strategy, it falls into the CARVER-SHOCK analysis.
So indoor air attack is absolutely critical. The detectors
are woefully inadequate and the currently deployed ones all
have device-defeat capability with currently existing
technology. That is a fact.
Ms. Norton. Well, if that happened, let us say, in a subway
car, would you end up shutting down your entire subway system
for a long time just to decontaminate it? What would be the
consequences?
Dr. Callahan. The area denial consequences are vast. The
current projections right now, for example, if we have another
SARS event on an airplane, because that happened in Southeast
Asia, is, you don't decontaminate the plane, you scrap it.
With subway systems, the amount of effort that would be
required to decontaminate those systems to allow for the return
of public confidence in those systems is so extraordinary, you
might call upon the cost of the Brentwood postal facility decon
as an example for that.
Ms. Norton. Yes.
Dr. Brent. Ms. Norton, the reference to the anthrax attack
may be fighting the last war. It may not be. I can't say that.
But it implies an attack that is confined in space. It is an
event. It happens at a given time. It infects a given place.
Not all the threats that are conceivable are of that kind.
There can be just contagious disease, in which case the
consequences are catastrophic and the task of defending against
them is harder even than what you said.
Ms. Norton. And I take it, we don't have any defense at the
moment against such an attack in a closed system such as a bus
or subway.
Dr. Brent. Well, with SARS, no.
Dr. Callahan. No, and the key point is the migration.
Remember, these are not conventional high explosive events,
neither are they really dirty bombs; but these materials,
particularly if infectious, but also in the case of anthrax
spores, they are going to migrate. So your contaminated zone,
how big a yellow circle you draw around the District of
Columbia, the city of Boston or New York, gets bigger and
bigger over time. And if these are infected patients, a
contagious disease such as killer flu or another agent like
that, then your problems have a tremendous magnitude.
Ms. Norton. So I take it the problem of infection is even
worse than the problem of death.
Dr. Callahan. Oh, absolutely. It is how big a ring you need
to treat. And also there are huge consequences to treatment.
There are several people in this room who have been on Cipro
for 2 months. That had a burden to them, and for clinical
infectious disease, we are realizing it now.
Dr. Alibek. Just again a couple of words. I still believe--
maybe not everybody is going to support this--anthrax at this
point of time is the biggest challenge and the biggest threat
for us. Why I am saying this? I know anthrax firsthand. I know
it is a very stable pathogen. It can be manufactured easily. It
produces very severe effects. It could cause contamination. All
parameters, unfortunately, are saying that anthrax is still a
big threat.
The issue is this, of course: Even if we discuss that if we
develop good protection against anthrax, somebody would use
something else, it is absolutely correct. But what we need to
do, in my opinion, we need to focus on anthrax for many points.
Just imagine a situation, an anthrax attack in our subway
system. In this case, even just--of course, it is very hard to
say how many casualties we are going to have. It depends on
many factors, the severity of the attack, the amount dispersed,
how soon was the attack, how fast we organize treatment and so
on and so forth.
But one of the biggest problems is going to be the full
contamination of the entire Metro system. In this case, can we
imagine this: Washington, D.C. with a nonfunctional Metro
system. In this case, people wouldn't go visit the Metro system
until we say the entire system is absolutely decontaminated.
In this case, in addition to all these challenges, we are
going to face the challenge for weeks or for months to just do
the decontamination work. We can imagine what kind of chaotic
situation we are going to have in Washington, D.C.
That is why, in my opinion, when we talk about anthrax--I
talked to the Department of Transportation, I discussed these
issues with them. We need to develop--in my opinion, the
problem we should be focusing on specifically on anthrax as the
first pathogen we need to take off the table.
Mr. Linder. The time of the gentlelady has expired.
Would you be willing to sit through a few more questions? I
have a couple of questions.
Dr. Callahan, you talked about the 19 studies that have
come out this year, talking about the migration and movement of
these facilities. Would you expand on that?
Dr. Callahan. Can you restate the question?
Mr. Linder. You talked earlier about 19 studies you read
this year about the movement of some of these labs and the
migration of the expertise.
Dr. Callahan. Yes, and the tragedy is how difficult it is
to find a forum outside of Homeland Security and the
Intelligence Community to share that information. The reports
come in because they shore up the capability of remotely
operating terrorists, specifically for small-scale
laboratories.
Most of the reports have to do with the new methodology
which has been proposed by a well-intentioned group which is
thinking about another problem, the preservation of genomic
material being a specific example. Then what happens is, they
go ahead and put it out there, and because of the lack of
review at the international level and the fact that many of
these journals are international and Internet-based, that
allows the information to get out there.
So there is no single group in the United States at this
time that is doing formalized reviews, and this is an excellent
space for the Homeland Security to convene expertise here. The
closest is the National Bioterrorism Analysis and
Countermeasures Center, which is a part of Homeland Security,
based at Fort Detrick.
But that makes use of highly specific basic scientists.
Unfortunately, the real space is the convening of all these
disciplines to help determine the threat waiting, and those
people are remarkably rare. We have to grow them, in fact.
Mr. Linder. Did you want to comment on that?
Dr. Brent. I concur.
Mr. Linder. You also mentioned several times avian flu. Is
there a way you think that terrorists could expand on that?
Dr. Callahan. Yes. We find avian influenza disquieting in
the extreme, and the reasons are basically that most of the
work is already being done for the terrorists. The second point
is that the number of countries that are demonstrating cases of
avian influenza in humans are increasing by the month,
effectively, as are the number of cases within each of those
countries.
Several of those countries have become more difficult to
work with in recent history because these are economically
relevant diseases and can stress their economies greatly. I
call your attention to the reports on 2003 SARS and its impact
on the Government of China's economy.
But think also about DPRK. Avian influenza is found on both
sides of DPRK, and we know it migrates on the wings of birds,
so you can bet that North Korea has a critical threat to its
protein stocks. Since one out of three chickens eaten on the
planet is grown, raised and eaten in China, including in these
countries, it is a big deal.
So what do we do about avian influenza? The first thing is,
we don't know exactly what the final humanized version of avian
influenza is going to be like. We do have important
countermeasures from a chemotherapeutic standpoint. These are
the new inhibitors, drugs that have been on the market for some
period of time; and it would be technically more difficult--not
impossible, but more difficult--to clone out or negatively
select out the resistance of those features.
So investing in this new class of drug, broadening its
capability and then, most critically, investing in a fast
through-put vaccine capability to make this system, to make
this use of a threat agent less viable, is an appropriate
investment of resources; and it fits our routine public health
needs as well as our needs in biodefense.
Mr. Linder. Thank you.
Mr. Dicks?
Mr. Dicks. Thank you.
Just following up on that, Mr. Chairman, you said prepare a
quick vaccine preparation capability. Is that what you are
saying?
Dr. Callahan. Yes.
Mr. Dicks. Talk about that a little bit. Some of these
vaccines cost $800 million, or they are very expensive.
Dr. Callahan. Yes. It is interesting that the production
cost is actually much smaller. Remember, the majority of these
vaccines have never been tested with exposure in humans.
Mr. Linder. If the gentleman will yield, I think Dr. Brent
said 400 is closer to it.
Dr. Brent. That is for a small molecule drug, sir.
Mr. Linder. But when the pharmaceutical firms tell us $800
million, they are also considering opportunity costs. If they
spend $400 million for a drug, what could they have made if
they had invested it elsewhere? Would they have doubled their
cost?
Mr. Dicks. How much does it cost to have this kind of a
capability? Do we have it now?
Dr. Brent. The vaccine--not to bore you with the kind of
decline of the vaccine industry in the U.S. over the past 40
years, but the number of companies has contracted. They are
hunkered down by threats of product liability lawsuits; cost of
development has gone up, et cetera, at the same time that the
technical capabilities for making new vaccines have exploded.
Recombinant DNA taught us how to make flu vaccine that
would be pretty good within a week or two of sequencing the
latest flu strain. We don't have that production capability, we
don't have the kind of precertified and good to go.
There are other more experimental things, like DNA
vaccines. I personally believe that a prudent defense strategy
in the United States would have several kinds of pretty good
vaccine capabilities stacked up in addition to the ones--
Mr. Dicks. Should that be done at HHS? Where is it done?
Dr. Brent. It should be done by creation of a government
bioindustrial complex, and likely it should be orchestrated by
the government, but done by the private sector, which is
somewhat different from the pharmaceutical biotech private
sector that exists.
Dr. Callahan. And critically important to national health
security is that that be American-owned. Our current vaccines
are purchased overseas, and we know from working with our close
European partners that vaccines purchased by the U.S. were not
available for U.S. use when our own vaccines for the past H3N2
season became compromised with a contaminant.
In other words, we own vaccines manufactured in offshore
locations that can be commandeered by the host countries to
meet their own emergency public health needs. So that is a
critical point.
Mr. Dicks. But who should take the lead on this? HHS?
Dr. Callahan. HHS is absolutely the source for basic
science expertise. I believe that the biotechnology sector is
going to advance this, because their incentives are greater and
they think very much outside of the box.
Mr. Dicks. The companies themselves?
Dr. Callahan. The companies.
Mr. Dicks. They are going to need some incentive from the
government to do this, right?
Dr. Callahan. Indeed, the process for which that could be
executed is not completely clear at this time.
Mr. Dicks. Since we have not done these material threat
assessments and we have this money left in project BioShield,
the $5.6 billion of which only a small part has been committed,
should we start using that money? Would that be a possible
source?
Dr. Callahan. Creating models that mimic the threat for
which a technology user and a technology response like a
company can respond to are absolutely valid ways of testing the
system, absolutely valid.
The last point I will just mention is computational. Dr.
Alibek has talked about this. We can predict mutations that can
arise in an agent. This involves computational science, which
is a fairly recent intersect with biotechnology and molecular
biology.
But we can take flu and understand the permutations in its
genome that will happen over time and anticipate in advance our
vaccines needs. It will not be in production, which commands
huge investment in our resources, but it can be there as a
prototype, as a seedling that is ready to go.
The last point is that the $800 million--which Dr. Brent
and others can talk about; we all consult with biotechnology
companies so we understand their perspective--is that, A, they
are not getting good guidance; B, they find that the BAAs and
the allocations and appropriations are not very linear for them
and easy to decipher; and, C, they don't have the capability to
test their system and to argue in the marketplace that they
have the best deal for the government to choose. And the
discussion of sole-source appropriations, I think, is pertinent
here as well.
Mr. Dicks. Dr. Brent?
Dr. Brent. Mr. Dicks, where the home for this thing is
within the government almost doesn't matter so much to me from
the outside. This will be with us for many decades. It is
important that there be a centralized science and technology
development apparatus which is able to orchestrate, a la the
way that DARPA and the other agencies within the Defense
Department do.
Mr. Dicks. Should that be at HHS, NIH, CDC? Where would you
put it?
Dr. Brent. I would put it either in DHS personally or in
some new entity. There needs to be DARPA-like technology
development.
Mr. Dicks. The reason DHS I think is suspect is because
they have not handled this material threat assessment thing
very effectively, and some people feel there is--Chertoff is
going to come out today and say we need a doctor, somebody with
medical and the kind of training you have, in the Department of
Homeland Security, to provide a person who understands all of
these kinds of issues and how this should work, which we don't
have at this juncture.
Dr. Brent. That is a start, sir.
Mr. Dicks. Well, thank you.
Dr. Alibek. Unfortunately, I must say this: What we haven't
done yet, we haven't developed a good committee or group of
very, I would say, respected people, knowledgeable in the field
of biological weapons threat.
Unfortunately again, many people try to pretend that they
know biological weapons threats. But in many cases we have, I
would say, a number of people inside the United States who have
firsthand knowledge of the field of biological weapon threat,
and they understand what kind of agents could be the more
threatening agents and what types of threats we need to handle.
In this case, you establish such a panel, working either
for Congress or any kind of agency, and they will determine
first, for example, the level of threat coming from different
pathogens. We do have many, many projects of this type.
But when we see that kind of standard, not very
comprehensive, not very sophisticated knowledge, if we want to
start this work, we need to stop for a second, we need to do
this work. It is not going to take much time, 3 months, 6
months, and it could be done.
Next, after we define the threat, we will start working
with a bigger group of scientists and figure out what kind of
technologies we have available to mitigate each type of threat,
specific technologies, and what kind of prospective
technologies we have at different stages of development to meet
prospective threats.
As soon as we have got this done, in my opinion the picture
is becoming absolutely clear. But at some point--we discussed
this in 1998, in 2000, immediately after 2001-2002, and now it
is 2005 and already 8 years, and we still aren't there.
Mr. Linder. Mr. Shays, do you wish to inquire further?
Mr. Shays. Thank you very much. This is a great panel.
Frankly, this is a terrific committee. If you had said 6 years
ago that we would be in the Ways and Means Committee Room
talking about the issues that we are talking about, I look at
these old pictures of former chairmen and I think this is a
strange world we are in.
But the one thing that is fairly clear to me is, the
technology is going to continue to advance, and I use that with
quotes, so that less sophisticated operatives will be able to
do horrific things.
One of the hearings that I had in my National Security
Subcommittee before September 11 that blew me away was a noted
doctor of a major medical magazine, and he ended the hearing by
saying, ``My biggest concern is that a small group of dedicated
scientists will be able to create an altered biological agent
that could wipe out humanity as we know it.''
That is why I think, Mr. Chairman, the work that you are
doing is essential. The likelihood of this happening is smaller
than a conventional attack; the consequences, though, are
horrific.
I want to know if I should dispose quickly of this issue.
In 1972, the U.S. and more than 100 nations signed a Biological
and Toxin Weapons Convention, which basically barred possession
of deadly biological agents except for defense research.
However, and this is the issue, no mechanism was set up to make
sure people abided by it; and the city inspector I saw in
Russia proved that no one was paying attention to it.
Do you think it is conceivable that we will be able to have
a convention process that will enable us to look at biological
sites and be somewhat assured that bad things are not
happening, or do you think it is almost pointless because folks
can be in garages and elsewhere?
Nodding heads will not be on the record here. I will start
with you, Dr. Brent. What is the answer?
Dr. Brent. I think that having conventions that track down
technologies and look for particular things might well give a
false sense of security, so I don't think you can do it like
that.
I think there is a great deal of value to be had in not
only criminalizing, but stigmatizing, maybe even hyper-
stigmatizing, deliberate research in biological weapons in the
U.S. and worldwide, the idea being to create a moral climate in
which if somebody down the hall was doing something sinister
and you were worried about it, you might drop a dime to your
local enforcement agency.
So I think there is some value in conventions prohibiting
things. I don't think there is going to be security in
surveilling sites and stuff.
Mr. Shays. Thank you.
Dr. Alibek. I would absolutely agree in my opinion, because
terrorist groups, they don't sign agreements. Of course,
whatever we decide, they are not going to follow the rules of
war.
Mr. Shays. They are not going to tell us where they are
making it either.
Dr. Alibek. At the same time, what I would like to say,
what we are missing now when we talk about a threat is coming,
what kind of threat and so on and so forth, and what we can do
about this, in my opinion there is one more important piece
missing, and this piece is so essential in my opinion, if we
don't pay strong attention to this issue, we are going to
suffer again.
Dr. Alibek. Because what we don't have, for example, in the
field of any kind of discipline--science, technology--we have
got special, let me say, programs; universities which are
teaching, let me say, special extras--
Mr. Shays. What is your bottom-line point? What is the
point you want to make?
Dr. Alibek. What I want like to say, we need to establish a
national educational program for biodefense extras in the field
of nonproliferation, counterterrorism, investigation--
Mr. Shays. So your point is that in the United States we
don't have enough qualified people going into this area?
Dr. Alibek. We don't have enough qualified people who would
be able, let me say, to deal with the more, let me say,
sophisticated threat.
Mr. Shays. Let me go to you, Dr. Callahan.
Dr. Callahan. My only two points in response to that is,
with regard to the treaties, we can use all of our other
benefits and attributes of the United States, such as our
health care, to get out there and to penetrate into the
countries of concern. Using Russia as a specific example, is
that we are in almost all the nooks and crannies of the open
programs in the Ministry of Health, kept out only of the
Ministry of Defense programs and a couple little shops out in
the far east of Russia.
The key point is that those have been driven by strong
incentives for sustainable value and economic development,
quite frankly, because we bring Merck and Pfizer with us rather
than the Department of Defense. We bring money and we bring
autonomy, and we bring the ability for them to work in a
private market.
It is that second group that you talked about, the Ted
Kaczynski bioweaponeer, someone in the basement who is
supported by novel technologies, who is going to be the more
dramatic of the two and make a loud bang in a small place. That
can happen behind national lines in university laboratories,
and then there are smaller biotech shops. And that is where the
intelligence community needs to intersect with the biodefense
community to provide steering and guidance, because those
communities remain largely disengaged because of the need for
clearances and the need to keep your subject matter experts
operating in open source. Some mechanisms to get a large number
of people informed for informed research and development to
mitigate against these threats is absolutely critical.
Mr. Shays. Thank you. Thank you, Mr. Chairman
Mr. Linder. Does Mr. Thompson wish to inquire?
Mr. Thompson. Yes, Mr. Chairman. And let me say that I am
absolutely appreciative of the three gentlemen and their
testimony. It has been quite enlightening, and I do appreciate
it.
One thing I would like to kind of get your individual
thoughts on, everybody pretty much agrees anthrax is kind of
number one on the list, or something like that--
Mr. Shays. No. You have got a shaking head here.
Mr. Thompson. Well, all right. Then give me number one and
number two, and then I will ask for number three.
Mr. Shays. Yeah, I want to know that, too.
Mr. Thompson. So if it is not--
Dr. Callahan. These are probability estimates. And we are
all products of our experience in a formal weapons program, in
molecular biology and technology, and in the remote developing
countries where you see these diseases all the time.
I do actually put anthrax up there because of the technical
challenges; you don't have to store it, it lives forever, and
you don't have to feed it. It is also easy to get because it is
found in almost every neotropical country that is available. So
I do actually put anthrax up there. And there is also a great
cache with it right now; it is easy to recognize in all of the
cultures in the world, including terrorist cultures. And also
it has huge public health importance in countries of concern
because it kills a lot of meat stock. It is a huge pathogen in
veterinarian populations. It happens in areas there.
After that, I am going to go to avian influenza. And this
is another wild-type agent, meaning naturally occurring agent,
which could be commandeered and used for ill purposes. And it
is a great example where you will have tremendous impact in
undermining of confidence, for which you do not have an
effective disease, and for which you will have guaranteed
contagion and transmission, so that would be number two.
Third would be the moderately engineered pathogens, those
that are hardened to survive in sunlight and survive in low-
halogen environments. They make them difficult to decon.
And after that, we are going to get into much more
complicated agents, and then go back to those zoological
pathogens, such as Glanders and those that will affect your
agriculture reserves and meat stocks.
Dr. Brent. I think Dr. Callahan just made the key point,
which is that in my mind a potential adversary might go with
what they knew and felt comfortable with. So Dr. Callahan can
run around the world picking clinical isolates out of disease
outbreaks and prioritize things that way. Dr. Alibek worked in
a successful Soviet program which had anthrax as one of its
major weapons.
If I were, you know, doing things, I might do what I know.
I might resynthesize SARS, put a toxin on it, infect myself,
and cough on people. I don't know that it is worth while to
prioritize the risk if every expert who imagines an attack
imagines things through the prism of what they would find to be
easy and devastating.
Dr. Alibek. What I would like to say, yes, when we talk
about terrorist groups, in many cases they have no scientific
ability or technological sophistication, for example, just to
work on 5, 10, 15 different pathogens and to choose the best
one just to deploy.
In this case, it is the issue of what they can have access
to or what they can achieve and so on and so forth. But
unfortunately, even if we proceed from this point,
unfortunately anthrax is becoming first. And too, the ability,
technological and so forth, anthrax is there. In this case,
whether or not we like it, anthrax is the weapon of choice, and
we need to get rid of anthrax. I am not saying that we
shouldn't prepare for other agents. There is a huge network of
agents and we need to have preparation, but in terms of
probability, actual ability, anthrax is taking place number
one.
Mr. Thompson. Thank you, Mr. Chairman.
Mr. Linder. Thank you, gentlemen. This has been an eye-
opening experience, and I expect we are going to do this again.
It makes me wonder if we have blown the $20 billion I talked to
you about, and if we should keep that money and be flexible and
quick.
I have one question to each of you. What would you say if I
told you a scientist from Sweden said that Iranian children
emigrating with their parents from Iran to Sweden have all been
vaccinated for smallpox; what would that mean to you?
Dr. Alibek. It is very hard to say. They are two different
ways of explaining it. First, analyzing the Iranians, I have
noticed they still believe that smallpox could come back. And
they do some vaccinations of smallpox and some development and
so on and so forth. That is why if, for example, when they
vaccinate against smallpox, meaning that it could come back
without having actual knowledge, or it could be a special
agent, because if they have some information that Iran is
working with smallpox virus.
Talking about Iran, I am finishing some analytical work,
and hopefully I will deliver it quite soon to one of the
government departments. I see that Iran is having a very big
interest in military-type biotechnology and medical biology. In
this case, I didn't see smallpox, but what I saw, actually, is
quite disturbing. In this case, looks like there is some
biological weapons activity in Iran.
Mr. Linder. Thank you very much. This hearing is adjourned.
[Whereupon, at 12:10 p.m., the subcommittee was adjourned.]
Also as promised, the speech of Oscar Calloway, 1917.
END