Sept. 8: This post has been clarified.
Fears about bioterrorism have prompted new efforts by corporations and governments worldwide to build defenses against germ attacks. But some of these arrangements themselves raise security issues.
Consider the spirited global contest to corner the franchise on providing halal inoculations against anthrax and other deadly pathogens to the world's 1.7 billion Muslims.
Devout Muslims have an understandable aversion to being injected with vaccines grown in pig cells or alcohol, the methods traditionally used by the world's leading pharmaceutical firms to manufacture such drugs. The reluctance of Muslims to accept non-halal polio injections has been linked to the re-emergence of polio in 27 countries that had been free of the debilitating disease, including Pakistan and Afghanistan.
Enter Emergent BioSolutions, a Rockville, Md., firm with expanding multinational operations that sells a vaccine against anthrax to the U.S. government.
In January 2008, in a little-noticed deal, Emergent, or EBS, announced a joint venture with a firm funded by the Malaysian Health Ministry to build 52,000 square feet of "vaccine development and manufacturing infrastructure" on a 62-acre site in an industrial park just outside of Kuala Lumpur.
"It is our belief that this joint venture will not only expand the use of our anthrax vaccine in this market, but will also serve as a platform for joint product development and manufacturing activities," Fuad El-Hibri, chief executive of Emergent (the majority partner), said of the deal with Ninebio Sdn Bhd.
"It is anticipated that the joint venture will also supply such products and services to certain member countries of the Organization of the Islamic Conference ("OIC") and other countries within Asia," an EBS press release said. The facility was originally scheduled to open this year, but is now set to begin operations in 2013.
On a Web page describing architectural plans for the Malaysian venture is a sentence that has raised some eyebrows. It says the companies plan to build a "biocontainment R&D facility that includes BSL ... 3 and 4 laboratories."
Biosafety Level 3 ("high-containment") labs are for disease-causing organisms that can cause death in humans, such as anthrax, plague and SARS. Malaysia already has three BSL-3 labs, and there are several thousand worldwide (1,356 in the U.S. alone).
Biosafety Level 4 (BSL-4) labs are for diseases that are one step up in the pathogen chain -- invariably fatal, highly contagious and for which no known vaccine or cure exists. Within these labs, the most-dangerous "select agents" -- Ebola virus, Marburg virus, Lassa fever and other hemorrhagic fevers -- are used in countermeasure research, including vaccines, to thwart 21st-century delivery systems and genetic manipulation of these natural horrors. BSL-4's have special safety features, including the use of full-body suits equipped with life support systems.
These would be Malaysia's first BSL-4 labs. Proliferation experts note that these high-security laboratories -- fewer than three dozen are currently operating worldwide -- are themselves valuable items. The specialized engineering that allows scientists to safely handle such deadly germs is coveted by terrorists as much as the pathogens within carefully secured walls.
Geography also counts. In March, Assistant Secretary of State Vann H. Van Diepen told the House Foreign Affairs Subcommittee on Terrorism that one key component of the new "biological threat" is "the growing biotechnology capacity in areas of the world with a terrorist presence."
Malaysia, where six in 10 citizens are Muslims, was tied to several terrorist plots earlier in the decade. Al-Qaida leaders used Kuala Lumpur as the "primary operational launch pad" for the 9/11 attacks, the FBI says. An organization known as Jemaah Islamiyah operating out of Malaysia bombed a disco in neighboring Bali in 2002, killing 202 people; the group's leaders were subsequently arrested and executed by Indonesian authorities.
More disturbing are recent revelations that Kuala Lumpur was a crucial base of operations in the lucrative black-market nuclear centrifuge network put together by Pakistani scientist A.Q. Khan.
For some experts, this raises a question of whether it is wise to encourage the creation of a BSL-4 lab there.
Building such a facility in Malaysia does have benefits for American interests in the region. Security analysts see the development of an advanced biotech sector in the developing world as inevitable. A U.S. partner allows the American government to have some measure of influence and control on foreign "biodefense" efforts.
Malaysian officials say they want the advanced labs to deal with local outbreaks of SARS, dengue, Japanese encephalitis and the lethal Nipah virus, as well as to develop possible bioterrorism vaccines. Such regional self-sufficiency is embraced by the World Health Organization.
"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?'" says Edward Hammond, who used to head the Sunshine Project, which monitors biosecurity efforts. Hammond has long criticized lax U.S. government oversight of facilities handling dangerous bio-agents. He said strategic imperatives have, by and large, trumped security concerns about new overseas labs.
In Malaysia, says Hammond, U.S. officials are especially wary of China's biotech industries (Chinese vaccine exports to the developing world shot up 20 percent last year.): "The argument is, of course we have the best technology, but the Chinese can make respectable vaccines ... We certainly don't want budding Malaysian biotech companies to turn to China for equipment and expertise."
Instead, the Malaysian government turned to EBS -- which holds the exclusive U.S. government contract to supply the controversial anthrax vaccine to the military and the National Strategic Stockpile. Despite FDA approval, health complaints about the vaccine, called BioThrax, persist among those vaccinated.
From a modest $24 million investment in 1998, EBS, formerly known as BioPort, has signed U.S. government vaccine contracts worth almost $1 billion, and today operates subsidiaries in 15 countries. Its BioThrax vaccine sets the pace in the expanding anthrax market.
Customers include the military, first responders, mail carriers and, potentially, the general public under threat scenarios now being drafted on the local, state, federal and international levels. Booster shots of BioThrax are recommended every year during possible exposure to anthrax.
EBS can claim a special feel for the Muslim world. El-Hibri, its CEO, is a prominent Muslim businessman born of a Lebanese father and a German mother. He grew up in Lebanon and Europe before coming to the U.S. and earning a bachelor's degree in economics from Stanford and a master's in public and private management from Yale. In addition to his biotech labors, he has worked for Citigroup in New York and Saudi Arabia and in telecommunications in Russia and Venezuela. His British holding -- Porton International -- provided the anthrax vaccine to Saudi Arabia during the first Persian Gulf War.
El-Hibri brought his vaccine operations to America in the late 1990s, cultivating U.S. military, intelligence and political support. One of the original investors/partners in BioPort was the late Adm. William J. Crowe, chairman of the Joint Chiefs of Staff under Ronald Reagan and later Bill Clinton's ambassador to Britain. Today, EBS directors include Louis Sullivan, the Health and Human Services secretary under President George H.W. Bush, and Jerome Hauer, the emergency preparedness czar under former New York Mayor Rudolph Giuliani.
In the anxious days after 9/11, Michigan Gov. John Engler ordered the National Guard to surround BioPort's anthrax vaccine plant in Lansing because anthrax bacteria were present there.
There have been persistent reports that al-Qaida has an interest in producing bioweapons. In 2003, coalition forces raiding a safe house believed to be used by al-Qaida in Iraq discovered a copy of the 1997 environmental assessment of renovations to BioPort's anthrax manufacturing plant in Lansing.
Malaysia has promised to be vigilant, which would set it apart from some Asian counterparts. In 2006, Sandia National Laboratories surveyed Asian scientists, including some from Malaysia, and half of them reported that they had no guards at the entrances of their facilities. Only half said there was restricted access to laboratories, and just 54 percent kept a current inventory of toxins and infectious agents they handled.
To its credit, the Malaysian government has begun crafting new biosecurity rules and regulations in line with U.S. standards, with the help of Sandia and the encouragement of the State Department.
We asked EBS if it had begun the application process for licensing the transfer of sensitive biological commodities administered by the Departments of Commerce, State and Defense. The Export Control Act and the International Trafficking in Arms Regulations require companies to get permission when exporting material useful for biowarfare and bioterrorism.
We also asked the company some questions about what will be happening in its BSL-3 and BSL-4 labs in Malaysia:
What biological agents will be handled?
How will the pathogens get on site?
Will the work include genetic manipulation or DNA recombination of select agents? Will any of that work be classified?
EBS hasn't responded to written questions and phone messages. Its Malaysian partner, Ninebio, likewise refused to answer inquiries. The U.S. government also declined to comment. The State Department redirected our inquiry to the Commerce Department, which wouldn't say anything about the EBS-Malaysia deal: "Pursuant to Section 12(c) of the Export Administration Act, the Department of Commerce does not publicly release any information on export license applications, including whether any particular transactions were the subject of license applications."
Arms control experts in Europe and the United States are pushing for more effective oversight on deals like the Malaysia project. These include: tougher export controls; a "harmonizing" of international guidelines for securing dangerous pathogens; and international inspection of biological production facilities under the Biological Weapons Convention. The latter is opposed by the U.S. and Russia on commercial as well as effectiveness grounds. The prospects for such reforms are uncertain, and approvals for potentially dangerous deals apparently keep on coming.
Why the rush?
Well, there's the money of course -- $70 billion in U.S. government money alone this past decade for programs for battlefield defense, civilian preparedness and response, and countermeasures including vaccines.
Francis Boyle, a law professor at the University of Illinois, suspects that more than just commercial considerations may be at play. Professor Boyle helped to draft the Biological Weapons Anti-Terrorism Act of 1989, which makes it a federal crime to develop or produce biological weapons.
He wonders if projects like the Malaysian lab could be used to circumvent U.S. rules against biological projects with offensive applications.
Since the 9/11 attacks, the government, via the USA Patriot Act (2001) and the Bioterrorism Preparedness and Response Act (2002), tightened controls over dangerous pathogens and toxins stored, used and transferred within the United States.
"It seems to me that this could be a very dangerous end-run by EBS 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," says Boyle.
Boyle says it's reasonable to ask if the Kuala Lumpur operation will be part of the U.S. government's controversial "laboratory threat characterization research" programs, under which scientists are charged with developing and testing newly bioengineered pathogens under the rubric of developing medical countermeasures for a potential threat. This type of research, mandated by a presidential directive in April 2004, is conducted within classified "Black Projects" sponsored by the Pentagon and the CIA and carried out by private contractors.
For its part, the Defense Department says it's not ruling anything out. Asked if such efforts could take place in these Malaysian BSL-4 labs, a spokesman said, "We currently do not have labs in Malaysia but we would be happy to collaborate with the government of Malaysia on bio surveillance, safety and security in the future."
Suspicions are further fueled by the addition of Ronald Richard to the EBS board of directors. Richard used to head In-Q-Tel (IQT), the high-tech venture capital arm of the CIA. IQT, started by the CIA in 1999 as an independent, not-for-profit private company, has a unique mission, according to its website, to "attract and build relationships with technology startups outside the reach of the Intelligence community."
All of this could be coincidental. But until the government lifts some of the limits imposed by trade laws and national security rules, the risks and benefits of this project remain difficult to assess. In this instance, a little transparency would go a long way.
Filmmakers Bob Coen and Eric Nadler's documentary "Anthrax War," www.anthraxwar.com, will be broadcast on the ARTE Network in Europe Tuesday night.
Clarification: The caption of the main image of this story originally implied that there was a Biosafety Level-4 (BSL-4) lab at Dugway Proving Ground in Utah. There is not actually a Biosafety Level-4 lab at Dugway Proving Ground.