On biology: promise and peril

We live in an age of breathtaking advances in the life sciences. Achievements in sequencing, or plotting the genetic blueprint of an organism, have been astounding, and may lead to great benefits in public health and medicine. But biological research can be dual-use: that which improves the lot of mankind can also be flipped around to create disease.

Mother nature does this through mutation. But how serious is the threat that a person would deliberately create a dangerous agent, and harm others with it? Do terrorists, or nations, harbor the intention, and can they summon the capability?

While some diseases occur easily in nature and are highly contagious, others require sophisticated work before they can be used as a weapon, and are probably too difficult for today’s terrorist groups, although not for nation-states. The Aum Shinrikyo cult in Japan tried to make a biological weapon but failed. During the Cold War, the Soviet Union clandestinely build a massive biological weapons research and production complex. In 2001, five letters carrying anthrax spores were put in the U.S. mail, at least 22 people were sickened and five died. According to the FBI, it was the act of a lone insider in a U.S. military biological defense laboratory. (For a look at bioweapons over the last century, see this article by Milton Leitenberg, senior research scholar at the Center for International Security Studies, University of Maryland.)

Two recent events have rekindled long-standing questions about how far we should go to prevent the deliberate creation and spread of biological agents for use in war and terrorism. There aren’t easy answers.

The first event is the just-completed review conference in Geneva for the Biological and Toxin Weapons Convention. Signed in 1972 and put into force in 1975, the treaty bans the development, production, acquisition, retention, stockpiling and transfer of infectious disease agents and natural poisons (toxins) for hostile purposes, and the weapons or other delivery systems for them. Unfortunately, the agreement has never had a serious verification mechanism. The treaty failed to stop the Soviet Union, South Africa and Iraq from attempting to build illicit biological weapons programs.

Every five years, a treaty review conference is held in Geneva. On Dec. 7, Secretary of State Hillary Rodham Clinton became the first U.S. Secretary of State to address a review conference.  She declared that the risk of a bioweapons attack is "both a serious national security challenge and a foreign policy priority" for the United States. "A crude, but effective, terrorist weapon can be made by using a small sample of any number of widely available pathogens, inexpensive equipment, and college-level chemistry and biology," she declared.

But at the same time, the United States has abandoned efforts to put legally-binding verification measures into the treaty. The argument is that scientific research has advanced so swiftly that traditional arms control measures are obsolete. In 2001, the Bush administration scuttled a negotiation over the previous six and a half years aimed at creating a protocol for improved verification and transparency. President Obama has not changed this position. Clinton told the review conference "it is not possible, in our opinion, to create a verification regime that will achieve" the goal of bolstering confidence that all nations are complying with the treaty. Instead, she called for some "other steps" such as revising the annual reporting system in which countries are supposed to be transparent about potentially dangerous biological activities.

Judging by some preliminary reports from those who attended, the review conference made little or no progress in strengthening the treaty. Five countries — Pakistan, Russia, India, Iran and China — largely blocked any major progress. As a result, the conference outcome was to once again kick the can down the road to future meetings.

Consider this: a three-person staff, known as the "Implementation Support Unit," is assigned to work on treaty issues in between the review conferences. A proposal to expand the staff to five people failed to gain support in Geneva. In contrast, the Organization for the Prohibition of Chemical Weapons, which oversees the 1993 chemical weapons treaty, has a staff of about 500 people. That pact contains tough verification provisions.

How dysfunctional is the biological weapons treaty? There is a reporting system, created in 1987. Each year, nations are supposed to submit a report known as a Confidence Building Measure detailing research, disease outbreaks, legislation and past activities, among other things. In the last year, fewer than 40 percent of signatories to the treaty even bothered to submit the forms. If nations can’t lift a finger to do the paperwork, how much effort are they going to put into watching out for abuses?

At the review conference, there was renewed discussion about focusing on the rapid changes in life sciences. Sounds good. But there seems to be little willpower, either in the United States or elsewhere, to do anything about the fact that the biological weapons convention is a toothless tiger.

The second recent event was caused by a laboratory experiment. Researchers led by Ron Fouchier of Erasmus Medical Center in Rotterdam modified the H5N1 virus, better known as avian influenza or bird flu. Up until now, the virus has been quite lethal in humans, with a fatality rate of about 60 percent in confirmed cases, but it has not been very transmissible among people. The researchers under Fouchier introduced a number of mutations into the virus that could make it highly transmissible through the air, and they demonstrated this in ferrets, which are considered a good stand-in model for humans in testing influenza strains. The experiment was carried out in a special, high-security laboratory, but it raised a terrifying prospect — if the modified strain got out, or was created somehow by a person with malevolent intent, it could lead to a devastating pandemic. In announcing his results, Fouchier said he wanted to help prevent just such a deadly crisis: “We now know which mutations to watch for in the case of an outbreak and we can then stop the outbreak before it is too late. Furthermore, the finding will help in the timely development of vaccinations and medication.”

The research raised the question of whether the results should be published. (Another study along similar lines was also performed by scientists at the University of Wisconsin and University of Tokyo.) After a review by the National Science Advisory Board for Biosecurity, the U.S. government took the unprecedented step of recommending  that two prominent journals, Science and Nature, withhold key details of the research, so that it would not fall into the wrong hands.

Understandably, this is a thorny problem. Scientists chafe at restrictions which could stifle discovery and innovation, potentially hurting society more than helping it. The results of the Fouchier research could be valuable to those combatting influenza, a virus that mutates rapidly and can pose a real threat to populations. Some experts suggested that it be distributed on a need-to-know basis. The secrecy is worrisome, but it might also be prudent in this case. Paul Keim, chairman of the science advisory board, told ScienceInsider, "I can’t think of another pathogenic organism that is as scary as this one." He added, "I don’t think anthrax is scary at all compared to this."

Similar worries were touched upon last year by a U.S. presidential commission studying developments in synthetic biology, which involves using engineering techniques to create new biological parts or devices, or re-designing existing ones. More regulation is not necessary at this time, the panel said, but synthetic biology should be watched closely. Separately, efforts are being made in the United States to improve the monitoring of biological research by scientists, companies and government. Yet much of it remains voluntary. What happens if a real rogue actor comes along and breezes right past the voluntary roadblocks?

At the same time, it is impossible to put this remarkable and fast-moving science under lock and key. These are not nuclear warheads. Biological research can be carried out in small laboratories the size of a garage and agents carried in a test tube that fits in a shirt pocket. We need to encourage the science, without forsaking security. It will require new thinking. We’re not there yet.