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Planned Malaysian Biolab Raises Security Concerns

Plans to construct a high-security biological research laboratory in Malaysia have caused some worry over possible proliferation of highly lethal disease materials, ProPublica reported yesterday.

Maryland-based Emergent BioSolutions and Ninebio Sdn Bhd., which is funded by the Malaysian Health Ministry, in 2008 announced a joint plan to construct a large complex at an industrial site not far from Kuala Lumpur for "vaccine development and manufacturing."

Emergent is the producer of the only U.S.-licensed anthrax vaccine. The Emergent-Ninebio venture intends to manufacture halal-compliant vaccines for the international Muslim market. The complex is currently slated to begin work in 2013, according to an Emergent release.

The two firms intend to construct a"biocontainment R&D facility that includes BSL ... 3 and 4 laboratories," According to online architectural plans for the 52,000-square-foot complex.

Biosafety Level 4 laboratories perform countermeasure research on diseases for which there are no known cures, such as the Ebola and Marburg viruses. There are fewer than 40 such facilities in the world and none in Malaysia. The nation has three BSL-3 laboratories, which handle potentially deadly pathogens like anthrax and plague.

Biosecurity specialists point out that high-containment BSL-4 laboratories are high-value targets for terrorists, both for the deadly disease agents they house and for the advanced engineering tools which permits researchers to work with lethal pathogens without being infected.

U.S. Assistant Secretary of State Vann Van Diepen said during a House panel hearing in March that a critical aspect of today's biological weapon fears is "the growing biotechnology capacity in areas of the world with a terrorist presence."

Malaysia's history with terrorism includes the 2002 bomb attack by Malaysian-based extremists from Jemaah Islamiyah that killed 202 people at a popular nightclub in Bali, Indonesia. Kuala Lumpur served as the "primary operational launchpad" for al-Qaeda senior operatives planning the Sept. 11 attacks, according to the FBI. The Malaysian capital was also a key hub in the nuclear technology smuggling ring operated by Pakistani nuclear scientist Abdul Qadeer Khan.

This has led some specialists to question if it is a good idea to support building a BSL-4 facility in the country.

"The question for (U.S. officials) is, 'How can we ensure a 'responsible' biotech sector in places like Malaysia, which are Muslim and are cranking out capable and well-educated scientists and have the money to build state-of-the-art facilities,'" said Edward Hammond, former head of the biological watchdog Sunshine Project.

Security specialists argue that having a U.S. firm such as Emergent involved in Malaysia's growing biotechnology industry would give Washington some degree of clout and authority over international biodefense work.

Malaysian authorities want the high-tech laboratories to respond to local epidemics of diseases such as SARS and Japanese encephalitis in addition to advancing research on cures for biological materials that could be used in acts of terrorism.

Kuala Lumpur has started to develop new biological security regulations that would meet U.S. standards. It has received assistance in the effort from the U.S. Energy Department's Sandia National Laboratories, ProPublica reported.

European and U.S. nonproliferation specialists are pressing for stronger monitoring of ventures such as the Emergent-Ninebio project. Such controls include stricter export requirements, a "harmonizing" of international processes for guarding high-risk disease agents, and monitoring of biological manufacturing installations under the Biological Weapons Convention. The United States and Russia, however, are against site inspections and the likelihood of more effective oversight controls being put into effect is not known.

University of Illinois international law professor Francis Boyle, a longtime opponent of U.S. biodefense work, speculated that ventures like the one in Malaysia could be used to get around U.S. laws that prohibit biological research that could have offensive uses.

"It seems to me that this could be a very dangerous end-run by [Emergent BioSolutions] and its government funders around the numerous legal restrictions now put in place since 9/11 making it difficult to research, develop and test bioweapons domestically," Boyle said.

He said it made sense to question whether the Malaysian laboratory would be used in classified Defense Department and CIA-funded "laboratory threat characterization research" programs in which researchers create and test new disease agents under the auspices of improving medical treatments for those materials.

The Pentagon has not ruled out the possibility that such "Black Project" research could take place in Malaysia.

"We currently do not have [BSL-4] labs in Malaysia but we would be happy to collaborate with the government of Malaysia on biosurveillance, safety and security in the future," a Defense Department spokesman said (Coen/Nadler, ProPublica, Sept. 7).

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(Sep. 10) - A man looks at a model DNA strand at a 2003 medical exhibition in Taiwan. Some scientists have expressed concern that terrorists might one day use man-made genetic material as a basis for recreating or adapting dangerous disease agents (Sam Yeh/Getty Images).

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Synthetic Pathogens Might Pose Bioterror Threat, Scientists Warn
By Rachel Oswald

WASHINGTON --The newfound ability of scientists to produce disease materials from scratch has led to concerns that extremists might seek the same capabilities to carry out acts of bioterrorism.

Synthetic pathogens are man-made infectious agents that are produced either from the manufacture or adaptation of DNA, cells and other biological structures.

While scientists have been engineering genetic sequences for decades and commercial gene sequencing has been around for years, the field continues to move into uncharted territory. This year, researchers for the first time were able to design and produce cells that do not exist in nature without using pre-existing biological matter -- marking the latest evolution in the rapidly advancing field of synthetic biology.

Additionally, recent technological advances and lower equipment costs now allow amateur scientists to conduct complex biological experiments such as DNA duplication outside of institutional settings and with machinery purchased online.

The developments could pave the way for advancements in medicine, energy and agriculture, but also could put sensitive materials in the wrong hands, analysts warn.

"With the advent of DNA synthesis technology, simply restricting access to the actual pathogen no longer provides the security that it once did. Since the gene sequence is a blueprint, once an organism has been sequenced it can be synthesized without using samples of existing cultures or stock DNA," issue specialists Ethel Machi and Jena Baker McNeill wrote for the Heritage Foundation in an August memo on the issue.

The federal government classifies 82 pathogens and biological toxins such as anthrax and smallpox as "select agents" that pose an extreme threat to public health. Access to those materials is strictly regulated. However, the complete genetic sequences, known as the genome, for many of these select agents are now available through the Internet.

"The problem is that now you can make DNA. For a number of these, you really don’t need to have access to the sample. The genome of these pathogens are in publicly available databases," said Jean Peccoud, an associate professor at the Virginia Bioinformatics Institute at Virginia Tech. "For a few thousand dollars you can get the Ebola genome."

The genetic sequence is not harmful in itself. It must be inserted into a recipient cell and begin replicating to pose a physical threat. "I could have the entire genome of the Ebola virus and eat it with my breakfast," said Gigi Kwik Gronvall, a senior associate with the University of Pittsburgh's Center for Biosecurity. "In order to have a pathogen, the sequence needs to be processed by a cell."

A scenario presently exists in which terrorists could place an Internet order for the DNA sequence of a select agent and then use the sequence and synthetic biology techniques to recreate or even genetically modify the pathogen in a laboratory.

The likelihood of success in this area, however, is considered very small for anyone working without at least a graduate level of education in the field and years of practice synthesizing sequences, according to a September 2009 University of California, Berkeley working paper on biosecurity concerns by synthetic genomic industry experts.

Still, multiple scientists and security experts interviewed for this article by Global Security Newswire declined to describe in detail the bioterrorism possibilities of synthetic biology for fear of giving extremists insights on how to create or adapt lethal disease agents.

"There has not been an incident yet but the technology is very cheap. I think there is definitely a risk. The question is trying to figure out where is the risk," Peccoud said.

Under the auspices of researching and combating infectious agents, scientists in 2008 used synthetic biology to recreate the SARS virus. Three years earlier, researchers successfully reconstructed the 1918 flu virus, which caused a worldwide pandemic estimated to have killed 50 million people.

"Eventually, it will almost certainly be possible to recreate bacterial pathogens like smallpox. We might also be able to enhance these pathogens. Some work in Australia on mousepox suggests ways of making smallpox more potent, for example. In theory, entirely new pathogens could be created," Hastings Center Report Editor Gregory Kaebnick said in congressional testimony during a May hearing on Capitol Hill.

At a 2003 closed seminar hosted by the National Academy of Sciences, scientists discussed the possibility that new "designer" biological weapons could be engineered. Possibilities include genetically modifying two innocuous agents to become lethal when combined or engineering viruses to cause low-level symptoms that become deadly when the infected person takes a common treatment such as aspirin.

Machi and McNeill speculated that malicious actors could acquire the capability to re-engineer organisms to create novel biological weapons by 2020.

"If a lab has an ordinary strain of influenza, you could engineer it into the 1918 strain. If you have a bacterium that is resistant to six drugs, it isn’t too hard to make it resistant to eight drugs," said George Church, a genetics professor at Harvard University and the founder of the Personal Genome Project.

There is today very limited federal oversight on the sale of genetic sequences. While large scientific institutions that receive federal funding must follow reporting requirements on the type of research they are doing, there are no such rules for the growing number of amateur biologists who are now performing genetic experiments on their own, Church said.

"I think most of my colleagues would [say] that it requires a great deal of education to do just about anything [in the synthetic biology field]. I am less certain of that," Church said. "The 9/11 guys didn’t need a lot of education in flying planes."

Even if terrorists are unable to weaponize select agents for widespread dissemination, their ability to produce a lethal pathogen could have dire ramifications if, for example, they unintentionally infect themselves and then proceed to infect others, he said.

Though the intellectual expertise required to perform synthetic bioengineering should not be underestimated, the increasing accessibility of sensitive technology must also be recognized, said James LeDuc, director of the Galveston National Laboratory at the University of Texas Medical Branch.

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Guarding Against the Threat

Commercial gene synthesis companies, working in the United States and abroad sell their products to a range of buyers including pharmaceutical firms, nonprofit laboratories and unaffiliated hobbyist biologists.

The gene synthesis firms begin their work by manufacturing the short building blocks of DNA known as "oligonucleotides." These "oligos" are then assembled into a full gene, the gene is inserted onto a plasmid and the plasmid is injected into a bacterium. Lastly, genes are grown and withdrawn from the cloned bacteria, according to the Berkeley working paper.

"None of the foregoing steps is beyond a well-trained microbiologist who routinely performs cloning experiments. For this reason, attempts to deny commercial gene synthesis services to nation states like Russia or even Iran have only limited value," states the paper. "Terrorists, on the other hand, have notoriously small budgets ... and are very sensitive to cost and technical risk. For this reason, barriers that add even modestly to cost ($100,000) or failure risk (10 percent) are typically worth considering."

In November 2009, the U.S. Health and Human Services Department released screening guidance for the gene synthesis industry. The voluntary guidance recommends sellers know their customers for genomic products and be aware if the product constitutes a theoretical public hazard.

The guidelines advise sellers to do background checks on their customers for warning signs such as evasiveness about a buyer's identity or affiliations, information that cannot be verified, an exceptionally large order of DNA sequences or several orders of the same sequence placed in a short amount of time.

Requested sequences should also be checked to see if they match select agents or "sequences of concern," according to Washington. If flags are raised from the customer or sequence screening, follow-up checks should be carried out. If security concerns persist, sequence manufacturers should contact the FBI or Commerce Department.

Researchers with the American Association for the Advancement of Science stated in a January report that many individual gene synthesis providers have already begun to screen their orders for select agent sequences and report that it is "very rare" for a customer or DNA request to raise security concerns.

However, there is presently no framework for DNA suppliers to trade information on buyers and sequence requests so fellow providers can be alerted about denied orders. This creates the possibility that requests rejected by one supplier could be filled by another.

The AAAS report recommends the scientific community build a curated database of harmful sequences that dealers could check for sequences that might "confer pathogenicity" -- the ability to produce infectious agents in a host organism.

"The important thing is to make sure that the database that companies check has the capability of evolving with new information," Gronvall said. The system should be managed by the private sector, which is more adaptive to change than the federal government, she added.

Machi and McNeill concurred in their paper: "Further advances in gene sequencing and synthesis would be severely hindered by government regulation of these databases." They recommended that Washington commission risk assessments to develop regulations that fit the present realities of genomic technologies.

President Barack Obama has assigned his bioethics commission to study potential applications and risks in synthetic biology and to report back to him with recommendations by November. According to the Hasting Center’s Kaebnick, the FBI and the National Institutes of Health’s National Science Advisory Board for Biosecurity are also developing a policy to regulate purchases of synthetic DNA sequences that could represent biosecurity threats.

The U.S. government lists select agents by their names and categorizes them by whether they pose a threat to humans, the agricultural sector or both. Last month, the National Academy of Sciences issued a report that recommends moving from that name-based system to a classification scheme in which pathogens are defined by their gene sequences.

Under the present classification system, natural variation among pathogens and the deliberate modification of DNA sequences could allow malicious actors to skirt biosecurity regulations and obtain select agent sequences by purchasing them from companies that are unaware the order matches a dangerous pathogenic sequence, according to the report.

LeDuc, who chaired the NAS committee that wrote the report, said a sequence-based definition would provide a more precise classification of the disease agents and would also boost scientists’ ability to recognize if subtle changes have been made to pathogen sequences. This could be done using computer analysis to compare customer sequence orders to the genetic sequences of select agents.

Harvard’s Church has developed his own proposal for regulating the synthetic biology industry. It focuses on restricting access to the machines needed to synthesize DNA fragments to only licensed government, nonprofit and commercial entities.

Gronvall, however, said she believes it is too late to try to limit access to gene synthesis equipment: "The technology … it is everywhere. It’s exquisitely dual use."

An Overblown Danger?

There are some in the scientific community who believe the biological weapons threat posed by synthetic pathogens is being exaggerated and risks strangling a promising new industry which has the potential to lead to many positive advancement like the engineering of microbes capable of digesting waste or producing fuel.

"We in the community debated long and hard about this. There’s lots and lots of good things happening [in the field]. We didn’t want to overburden the fledgling biosynthesis industry," LeDuc said. "On the other hand, we did recognize that there’s the potential for some abuse of the system, for some activities that could be very threatening to public health and national security."

University of Illinois international law professor Francis Boyle, however, believes the U.S. government is wrong to spend money researching the bioterror possibilities of synthetic biology.

"We need no more money allocated to biowarfare research. It’s a joke and a fraud," said Boyle, a longtime opponent of U.S. biodefense work and the author of the 1989 Biological Weapons Antiterrorism Act, which made it illegal for anyone in the United States to develop or possess biological weapons.

"The real danger is that scientists in the United States, working for and with and the United States government, want to either get rid of my act or to amend it out of meaningful existence so that they can go right ahead and pursue so-called synthetic biology to their heart’s content with no regulation," he asserted.

Boyle said the real public health danger lies in biodefense research conducted in laboratories at the behest of the federal government in which scientists recreate, modify and test disease agents for the stated purpose of improving medical treatments to these biological threats.

"It’s the Wild West out there," he said. "It’s literally a catastrophe waiting to happen when you have all these laboratories out there and all of these researchers out there with all of this access to deadly pathogens and many of them trying to make up new ones themselves."

In contrast, Church said he thinks Washington should spend enough money to ensure the right kind of regulations are developed that guard against bioterror risks while not suffocating legitimate scientific research.

"A few regulations don’t cost that much money and if you spend a little more money you get more intelligent regulations," Church said. "If you try to do regulations on a shoe string without anyone paying attention then you’re going to get something like our tax code."

Church also supports regular electronic surveillance of laboratories conducting synthetic biology experiments with dangerous pathogens. Regulation without monitoring is not enough, he said. "You have to explicitly say there should be surveillance. Electronic monitoring at the minimum."

Gronvall argued the federal government should divide its energies between studying the bioterrorism possibilities in synthetic biology and improving its ability to respond to a biological attack.

"You don’t want to put every egg in one basket but where I think the majority of eggs should be is the ability to respond to diseases whether they are accidental, natural or deliberate," she said.

Others point out that the U.S. government, by commissioning studies and holding public hearings, could be drawing extremist attention to the bioterrorism possibilities in synthetic genomics where they had previously been unaware.

"The process of dreaming itself is dangerous," Church said. "We don’t need to come up with hypothetical plans."

Peccoud, though, pointed out that if the "white hats" do not start thinking about the biowarfare implications of synthetic biology, then they will be leaving "someone with a black hat" to do all of the planning.

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Variable endemicity for DF/DHF in countries of SEA Region

Although Dengue/Dengue Haemorrhagic Fever is endemic in most countries of the region, all four serotypes have been detected in all the countries . The transmission potential, however , is different both at the macro- and micro levels.

The current situation of DF/DHF in countries of the South East Asia Region can be stratified as follows:

Category A (Indonesia, Thailand, Sri Lanka and Timor- Leste)

*Major public health problem

*Leading cause of hospitalization and death among children

*Cyclical epidemics in urban centers

*Spreading to rural areas

*Multiple virus serotypes circulating

Category B (Bangladesh, India, Maldives)

*Cyclical epidemics are becoming more frequent

*Multiple virus serotypes circulating

*Expanding geographically within countries

Category C ( Bhutan and Nepal )

*Endemicity uncertain

*Bhutan: First outbreak reported in 2004

*Nepal: Reported dengue cases for the first time in November 2006.

Category D ( DPR Korea )

*No evidence of endemicity.

While the ecological and climatic factors influence the seasonal prevalence of the species, factors related to human ecology determine the extent and intensity of breeding. On the basis of climatic factors, the countries oft the Region can be divided into four distinct climatic zones with different DF/DHF transmission potential. These are as follows:

*Tropical Monsoon and Equatorial Climatic Zone

*Deciduous Dry and wet Climatic Zone

*Sub-Himalayan foothill Region

*Temterate Climate Region

Tropical Monsoon and Equatorial Climatic Zone

This zone includes four countries, viz. Indonesia, Myanmar, Thailand and Timor-Leste. The annualrainfall in this zone is >150 cm. Aedes aegypti is widespread in both urban and rural areas. Transmission is extended and DHF epidemics occur in 3-5 years cycles, associated with high morbidity in children.

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Dengue and dengue haemorrhagic fever

Key facts
•Dengue is a mosquito-borne infection that causes a severe flu-like illness, and sometimes a potentially lethal complication called dengue haemorrhagic fever.
•Global incidence of dengue has grown dramatically in recent decades.
•About two fifths of the world's population are now at risk.
•Dengue is found in tropical and sub-tropical climates worldwide, mostly in urban and semi-urban areas.
•Dengue haemorrhagic fever is a leading cause of serious illness and death among children in some Asian countries.
•There is no specific treatment for dengue, but appropriate medical care frequently saves the lives of patients with the more serious dengue haemorrhagic fever.
•The only way to prevent dengue virus transmission is to combat the disease-carrying mosquitoes.

Dengue is a mosquito-borne infection that in recent decades has become a major international public health concern. Dengue is found in tropical and sub-tropical regions around the world, predominantly in urban and semi-urban areas.

Dengue haemorrhagic fever (DHF), a potentially lethal complication, was first recognized in the 1950s during dengue epidemics in the Philippines and Thailand. Today DHF affects most Asian countries and has become a leading cause of hospitalization and death among children in the region.

There are four distinct, but closely related, viruses that cause dengue. Recovery from infection by one provides lifelong immunity against that virus but confers only partial and transient protection against subsequent infection by the other three viruses. There is good evidence that sequential infection increases the risk of developing DHF.

Global burden of dengue

The incidence of dengue has grown dramatically around the world in recent decades. Some 2.5 billion people – two fifths of the world's population – are now at risk from dengue. WHO currently estimates there may be 50 million dengue infections worldwide every year.

The disease is now endemic in more than 100 countries in Africa, the Americas, the Eastern Mediterranean, South-east Asia and the Western Pacific. South-east Asia and the Western Pacific are the most seriously affected. Before 1970 only nine countries had experienced DHF epidemics, a number that had increased more than four-fold by 1995.

Not only is the number of cases increasing as the disease is spreading to new areas, but explosive outbreaks are occurring.

Some other statistics:

•During epidemics of dengue, infection rates among those who have not been previously exposed to the virus are often 40% to 50%, but can reach 80% to 90%.
•An estimated 500 000 people with DHF require hospitalization each year, a very large proportion of whom are children. About 2.5% of those affected die.
•Without proper treatment, DHF fatality rates can exceed 20%. Wider access to medical care from health providers with knowledge about DHF - physicians and nurses who recognize its symptoms and know how to treat its effects - can reduce death rates to less than 1%.

The spread of dengue is attributed to expanding geographic distribution of the four dengue viruses and their mosquito vectors, the most important of which is the predominantly urban species Aedes aegypti. A rapid rise in urban mosquito populations is bringing ever greater numbers of people into contact with this vector, especially in areas that are favourable for mosquito breeding, e.g. where household water storage is common and where solid waste disposal services are inadequate.

Transmission

Dengue viruses are transmitted to humans through the bites of infective female Aedes mosquitoes. Mosquitoes generally acquire the virus while feeding on the blood of an infected person. After virus incubation for eight to 10 days, an infected mosquito is capable, during probing and blood feeding, of transmitting the virus for the rest of its life. Infected female mosquitoes may also transmit the virus to their offspring by transovarial (via the eggs) transmission, but the role of this in sustaining transmission of the virus to humans has not yet been defined.

Infected humans are the main carriers and multipliers of the virus, serving as a source of the virus for uninfected mosquitoes. The virus circulates in the blood of infected humans for two to seven days, at approximately the same time that they have a fever; Aedes mosquitoes may acquire the virus when they feed on an individual during this period. Some studies have shown that monkeys in some parts of the world play a similar role in transmission.

Characteristics

Dengue fever is a severe, flu-like illness that affects infants, young children and adults, but seldom causes death.

The clinical features of dengue fever vary according to the age of the patient. Infants and young children may have a fever with rash. Older children and adults may have either a mild fever or the classical incapacitating disease with abrupt onset and high fever, severe headache, pain behind the eyes, muscle and joint pains, and rash.

Dengue haemorrhagic fever (DHF) is a potentially deadly complication that is characterized by high fever, often with enlargement of the liver, and in severe cases circulatory failure. The illness often begins with a sudden rise in temperature accompanied by facial flush and other flu-like symptoms. The fever usually continues for two to seven days and can be as high as 41°C, possibly with convulsions and other complications.

In moderate DHF cases, all signs and symptoms abate after the fever subsides. In severe cases, the patient's condition may suddenly deteriorate after a few days of fever; the temperature drops, followed by signs of circulatory failure, and the patient may rapidly go into a critical state of shock and die within 12 to 24 hours, or quickly recover following appropriate medical treatment (see below).

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Treatment

There is no specific treatment for dengue fever.

For DHF, medical care by physicians and nurses experienced with the effects and progression of the complicating haemorrhagic fever can frequently save lives - decreasing mortality rates from more than 20% to less than 1%. Maintenance of the patient's circulating fluid volume is the central feature of DHF care.

Immunization

There is no vaccine to protect against dengue. Although progress is underway, developing a vaccine against the disease - in either its mild or severe form - is challenging.

•With four closely related viruses that can cause the disease, the vaccine must immunize against all four types to be effective.
•There is limited understanding of how the disease typically behaves and how the virus interacts with the immune system.
•There is a lack of laboratory animal models available to test immune responses to potential vaccines.

Despite these challenges, two vaccine candidates have advanced to evaluation in human subjects in countries with endemic disease, and several potential vaccines are in earlier stages of development. WHO provides technical advice and guidance to countries and private partners to support vaccine research and evaluation.

Prevention and control

At present, the only method of controlling or preventing dengue virus transmission is to combat the vector mosquitoes.

In Asia and the Americas, Aedes aegypti breeds primarily in man-made containers like earthenware jars, metal drums and concrete cisterns used for domestic water storage, as well as discarded plastic food containers, used automobile tyres and other items that collect rainwater. In Africa the mosquito also breeds extensively in natural habitats such as tree holes, and leaves that gather to form "cups" and catch water.

In recent years, Aedes albopictus, a secondary dengue vector in Asia, has become established in the United States, several Latin American and Caribbean countries, parts of Europe and Africa. The rapid geographic spread of this species is largely attributed to the international trade in used tyres, a breeding habitat.

Vector control is implemented using environmental management and chemical methods. Proper solid waste disposal and improved water storage practices, including covering containers to prevent access by egg-laying female mosquitoes are among methods that are encouraged through community-based programmes.

The application of appropriate insecticides to larval habitats, particularly those that are useful in households, e.g. water storage vessels, prevents mosquito breeding for several weeks but must be re-applied periodically. Small, mosquito-eating fish and copepods (tiny crustaceans) have also been used with some success.

During outbreaks, emergency vector control measures can also include broad application of insecticides as space sprays using portable or truck-mounted machines or even aircraft. However, the mosquito-killing effect is transient, variable in its effectiveness because the aerosol droplets may not penetrate indoors to microhabitats where adult mosquitoes are sequestered, and the procedure is costly and operationally difficult. Regular monitoring of the vectors' susceptibility to widely used insecticides is necessary to ensure the appropriate choice of chemicals. Active monitoring and surveillance of the natural mosquito population should accompany control efforts to determine programme effectiveness.

For more information contact:

WHO Media centre
Telephone: +41 22 791 2222
E-mail: mediainquiries@who.int

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Texas A&M Launches Biosecurity Foundation

The Texas A&M University System last week announced the creation of the National Biosecurity Foundation, which aims to improve public-private collaboration for addressing naturally developing or intentional disease threats.

The National Biosecurity Foundation plans to join the know-how of the biotechnology and pharmaceutical sectors with the "interdisciplinary innovation" of leading academic entities, according to a Texas A&M press release.

The foundation intends to foster a wide-reaching international consortium of top industry, academic and nonprofit institutions focused on developing and putting in place systems for improving U.S. biodefenses. It also would be dedicated to providing high-level "collaboration, research and technology commercialization across diverse organizations," the release states.

The effort is a response to Washington's urging for Centers for Innovation in Advanced Development and Manufacturing as a means to address problems in the current vaccine production process.

"The threat of a new emerging epidemic or intentional biological attack is among the greatest facing our nation," Texas A&M Vice Chancellor for Research Brett Giroir, the foundation's president and chief executive officer, said in the release. "This summer, the comprehensive biosecurity review sponsored by the federal Department of Health and Human Services indicated that the United States needs a new model, as well as significant investment, to provide the flexible, assured capability required for lasting biosecurity."

Texas A&M scientists are leading experimental research in a variety of biodefense-associated efforts that include "a high-throughput cell platform for discovering new drug and vaccine targets" (Texas A&M University release, Sept. 9).

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Army Issues $30M Contract for Bioagent Detectors

The U.S. Army has issued a $30 million contract for production and support of systems for detection of biological weapons agents, the Associated Press reported Friday.

The deal covers six years of work by a branch of Virginia-based defense contractor General Dynamics. There is no set limit to the number of devices that could be manufactured under the contract (Associated Press/Businessweek, Sept. 10).

General Dynamics' Armament and Technical Products unit could be paid $300 million "if all options are exercised," the company said in a press release.

The company since 2001 has provided the Army with more than 700 Joint Biological Point Detection System devices, which can be produced for deployment on ships, trailers, shelters or personnel. The new contract calls for manufacturing to begin in April of next year (General Dynamics release, Sept. 10).

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GAO to Examine FBI Methods in Anthrax Case

The U.S. Government Accountability Office has agreed to review the technical and scientific processes the FBI used in identifying military microbiologist Bruce Ivins as the perpetrator of the 2001 anthrax mailings that killed five people, Reuters reported yesterday.

Sep. 17) - Hazardous materials personnel exit the Dirksen Senate Office Building on November 18, 2001, after a letter contaminated with anthrax was found addressed to Senator Patrick Leahy (D-Vt.). Congressional investigators have announced plans to examine methods used in the FBI's probe of the anthrax mailings (Alex Wong/Getty Images)

Ivins killed himself in July 2008 before any charges were filed. The FBI formally closed the investigation in February of this year.

The request for the review came from Representative Rush Holt (D-N.J.), who represents the area from which the anthrax spores were sent and who has been critical of the investigation. Some of Ivins' colleagues and others have also questioned the conclusion that the anthrax spores used in the attacks were derived from material produced and held in Ivins' laboratory at Fort Detrick, Md. (Jeremy Pelofsky, Reuters/Yahoo!News, Sept. 16).

"The American people need credible answers to many questions raised by the original attacks and the subsequent FBI handling of the case," Holt said in a press release. "I’m pleased the GAO has responded to our request and will look into the scientific methods used by the FBI."

The GAO review will be more expansive than a National Academy of Sciences examination requested by the FBI, Holt said.

"Specifically, the GAO will seek to answer the following questions: 1) What microbial and technical forensic methods did the FBI use to conclude that Bruce Ivins was the perpetrator of the 2001 anthrax attack; how reliable and reproductive were those methods; and were the methods validated? 2) What scientific concerns and uncertainties, if any, remain? 3) What agencies, including intelligence agencies, are responsible for monitoring high containment laboratories in the U.S. and abroad; how do they monitor these laboratories; and how effective is their monitoring?" according to the release (U.S. Representative Rush Holt release, Sept. 15).

"Please know that we may encounter challenges to our access to sensitive and classified information from the FBI and the intelligence agencies," read a late-August letter from GAO Congressional Relations Managing Director Ralph Dawn to Holt (Pelofsky, Reuters, Sept. 16).

Dawn said the National Academy review was expected to be completed this fall (U.S. Government Accountability Office letter, Aug. 27).

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Extremists Warn of Biological Strike in India

An extremist entity indicated it would carry out a biological strike on the Indian state of Assam if its backers were not released within 24 hours, Iran's Islamic Republic News Agency reported yesterday.

“Free all our Jihadi brothers who are in Central Jail, Guwahati, stop all activities against Jihad in Assam, stop all project of develop (sic) in Assam,” says the e-mail, sent to a Guwahati-based television station by a group calling itself "Indian Mujahideen (Assam)."

“For your kind information, biological war contain all disease that make death to all and biological weapon too,” says the document, signed by Tohik Khan, the organization's self-described head of marketing.

Local authorities were attempting to identify the IP address from which the e-mail message was sent.

“We are taking the matter seriously and already experts are on the job to ascertain from where the e-mail originated and also about the credentials of the group on whose banner the mail was sent,” said Inspector General of Assam Police Pallab Bhattacharya.

“We really don’t know or heard about any such outfit named Indian Mujahideen (Assam). But then we shall surely investigate,” a second law enforcement official added (Islamic Republic News Agency/GlobalSecurity.org, Oct. 3).

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HHS Seeks to Deter Creation of Synthetic Pathogens

The U.S. Health and Human Services Department yesterday issued advice to help companies that sell synthetic gene sequences prevent their products from being used to produce biological weapons, the Center for Infectious Disease Research and Policy reported.

The Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA seeks to reduce the potential for terrorists to use synthesized DNA sequences to reproduce or create deadly pathogens while also not unreasonably hindering the development of the synthetic biology industry, the department said in releasing the document.

The voluntary guidance urges commercial providers of genomic products to do background checks on their buyers and assess the suitability of their request. They should also screen the requested genetic sequences to see if they match the genetic formula of "select agents," which are subject to strict U.S. regulations, or to determine whether they are "sequences of concern."

If either the customer or sequence purchase order raises "red flags," additional checks are recommended. If those checks do not assuage potential issues, synthesis firms are advised to get in touch with the U.S. government for further help.

Recent advances in synthetic biology such as the creation from scratch of genetic material have been heralded as paving the way for future medical, agricultural and energy breakthroughs.

Synthetic biology also "has great potential to be used to generate organisms, both currently existing and novel, including pathogens that could threaten public health, agriculture, plants, animals, the environment or materiel," the screening guidance states.

"While there are significant potential benefits, synthetic DNA could potentially be used to recreate dangerous organisms that are covered under existing regulations. As such, development of technologies utilizing synthetic DNA must be encouraged in a safe and secure manner," an HHS press release noted.

The guidance was devised by a diverse expert group comprised of specialists from the government, academic institutions and the synthetic biology business community. The group is to routinely re-examine and update the guidance as necessitated, the press release said.

"This guidance is an important step in ensuring that synthetic DNA is used to promote, not threaten, public health," HHS Assistant Secretary Nicole Lurie said in released remarks. "The guidance also recognizes the steps industry has taken proactively to address potential biosecurity risks and seeks to minimize negative impacts on research and business" (Center for Infectious Disease Research and Policy release, Oct. 13).

[sunny]

Pa. Lab Opens Before Receiving Biodefense Clearance
Friday, Oct. 22, 2010

A biological defense laboratory in Allegheny County, Pa., has begun some operations, but it has yet to receive federal approval to work with lethal disease agents like anthrax and smallpox, the Pittsburgh Tribune-Review reported.

The laboratory could be inducted this year into the Laboratory Response Network managed by the Centers for Disease Control and Prevention. That would enable the facility, a 500-square-foot portion of a larger biological security facility, to begin work with potential terrorism agents, Allegheny Country Health Department Director Bruce Dixon said.

The biodefense laboratory undertook some work this summer, including testing of tuberculosis and HIV, Dixon noted. The area failed a safety inspection in August 2009, forcing a delay of its planned opening until the following month, a goal that was also missed.

The laboratory hosts four technical experts holding FBI security clearances, and the county might recruit one or two additional technicians, Dixon said. The experts could conduct analyses for the presence of harmful disease agents, but the state government would have to verify their findings

The biodefense site, which has overrun its construction budget by $2 million or more, is one component of the county's now-operating $6.4 million biosecurity facility in Lawrenceville (Tim Puko, Pittsburgh Tribune-Review, Oct. 21).

The danger of biological terrorism poses an increasing danger to the United States, an expert on Tuesday told a conference convened in Alabama to address the subject. A strike by state-backed or independent actors could produce tens or hundreds of thousands of deaths, according to Kansas State University biologist Jerry Jaax.

"There is a serious problem for us out there that is not going to go away," Jaax told the Huntsville Times. "We're not going to be able to say in 15 years, 'We've got it licked.'"

The Soviet Union launched a drive three years before its collapse to destroy hundreds of tons of anthrax and other disease agents, but U.S. scientists later discovered live anthrax spores where remnants of the material had been buried.

"They had huge programs we were unable to detect," Jaax said. "And we certainly have indications that the bad guys, the nonstate actors, are saying they would do this if they could figure out a way to do it, and some of these agents don't require very sophisticated biotechnology."

Biological weapon-related equipment and expertise is in danger of falling into the hands of terrorists, the expert said, adding that agricultural diseases and water contaminants also pose a threat.

"The government is taking it seriously," Jaax said. "There has been a proliferation of biocontainment facilities that have been sponsored by the federal government.

"There certainly is a sense that people seeing the valid threat information recognize what a problem it is," he said.

"The question is, is it sustainable," Jaax said of the effort to counter biological threats. "Is it going to continue... in this (economic) environment?"

Research in the sector must continue, he argued.

"The alternative is to cross your fingers and do nothing," Jaax said. "I think that's a big mistake" (Lee Roop, Huntsville Times, Oct. 20).

[ฅนไท]

มาลาเรียดื้อยาอาจระบาดเอเชีย-ฮ่องกงตื่น! เจอหวัดนก

องค์การอนามัยโลกเตือนมาลาเรียดื้อยาอาร์ตินิซินีน อาจแพร่กระจายจากชายแดนไทย-กัมพูชาไปทั่วทวีปเอเชียแล้ว ขณะที่ฮ่องกงพบผู้ป่วยไข้หวัดนกรายแรกในรอบ 7 ปี สั่งเฝ้าระวังเข้ม หวั่นกลับพาแพร่ระบาดอีก

องค์การอนามัยโลก หรือ WHO ออกคำเตือนว่า ขณะนี้ มาลาเรีย ดื้อยาในกลุ่มอาร์ตินิซินีน และอาจกำลังระบาดจากชายแดนไทย-กัมพูชากระจายไปทั่วเอเชียแล้วในขณะนี้ โดยมีหลักฐานเบื้องต้นว่า พบมาลาเรีย ดื้อยาในกลุ่มอาร์ตินิซินีน ที่ชายแดนไทย-กัมพูชา นอกจากนี้ ยังพบผู้ป่วยร้อยละ 10-20 บริเวณชายแดนไทย-พม่า เริ่มแสดงอาการดื้อยาในกลุ่มนี้เช่นกัน เพราะยังมีเชื้อปรสิตในกระแสเลือดหลังจากรับประทานยาไป 3 วันแล้ว เช่นเดียวกับผู้ป่วย 1 ใน 4 บริเวณชายแดนจีน-พม่า ที่มีอาการดื้อยาอาร์ทีซูเนต ซึ่งเป็นหนึ่งในกลุ่มอาร์ตินิซินีน

ทั้งนี้ องค์การอนามัยโลก ยังแสดงความเป็นห่วงว่า มาลาเรีย ดื้อยาในกลุ่มนี้ อาจระบาดไปไกลถึงทวีปแอฟริกา เหมือนที่เกิดขึ้นกับมาลาเรีย ดื้อยาคลอโรควิน และยาซัลฟาด็อกซิน-ไพริเมธามีน ในคริสต์ทศวรรษ หลังปี 1960 และ 1970 และขณะนี้ องค์การอนามัยโลกก็กำลังศึกษาเพิ่มเติม เพื่อยืนยันในเรื่องดังกล่าว และคาดต้องใช้ระยะเวลาประมาณ 1 ปี

นอกเหนือจากเรื่องมาลาเรียแล้ว ได้มีรายงานจากฮ่องกงว่า พบผู้ป่วยไข้หวัดนก หรือสายพันธุ์ H5 รายแรกของประเทศในรอบ 7 ปี โดยเป็นหญิงวัย 59 ปี เพิ่งเดินทางกลับมาจากการท่องเที่ยวที่นานกิง เซี่ยงไฮ้ และหังโจว ประเทศจีนพร้อมกับลูกและสามี เมื่อต้นเดือนที่ผ่านมา ก่อนที่จะป่วยด้วยอาการปอดบวม ไอ และมีไข้ เมื่อวันที่ 14 พ.ย.ที่ผ่านมา และพักรักษาตัวอยู่ในโรงพยาบาลแห่งหนึ่ง โดยขณะนี้ผู้ป่วยมีอาการหนัก แพทย์ต้องแยกตัวออกมาจากคนไข้รายอื่น ๆ อย่างไรก็ตาม ยังไม่มีการยืนยันว่า หญิงคนดังกล่าวติดเชื้อไข้หวัดนกมาจากประเทศจีนหรือไม่

ทั้งนี้ หลังจากข่าวนี้ได้เผยแพร่ออกไป ทำให้เกิดความตื่นตระหนกไปทั่วฮ่องกง เนื่องจากเกรงว่า ไข้หวัดนกจะกลับมาระบาดอีกครั้ง หลังจากเคยเป็นพื้นที่แรกที่พบการระบาดของไข้หวัดนกในมนุษย์จนมีผู้เสียชีวิต 6 ราย เมื่อปี 2540 ก่อนที่จะการระบาดของไข้หวัดนกจะหายไปในปี 2546 ซึ่งทางรัฐบาลของฮ่องกงได้สั่งเพิ่มระดับเฝ้าระวังภัยไข้หวัดนกเป็นขั้นร้ายแรงแล้ว เนื่องจากมีความเสี่ยงที่โรคจะกลับมาแพร่ระบาดอีกครั้ง