Industry is moving full-bore on synthetic biology as well. Maverick biologist J. Craig Venter, famous for setting up a private company that raced the NIH to be the first to synthesize the human genome more than a decade ago, violated no rules in 2010 when his private research institute published detailed how-to steps for inserting the genome of one species of bacteria into a different species, creating the ultimate Trojan horse that could sneak by human immune system defenses to deliver a lethal cargo. The experiments were so bold and dramatic that in 2010 the U.S. Presidential Commission for the Study of Bioethical Issues was tasked with finding guidelines to control private and industrial synthetic-biology experiments. It opted instead for free, unfettered science, except for first out-of-laboratory uses of man-made organisms.
In October, Nature published the genetic blueprint of Yersinia pestis, the bacterium that caused Europe's 14th-century Black Death. This followed a long list of microbial blueprint publications, complete with detailed analysis of what, genetically speaking, makes the bacteria or viruses tick: Here is the virulence sequence that kills human cells, scientists point out; these nucleotides control transmission from one human cell to another; thanks to these genes the microbe can evade the human immune system; and so on. The whole point of the work is to demonstrate how microbes infect and destroy cells, including those of human beings.
Political leaders can no longer relegate questions about bioterrorism, biological accidents, bioweapons, or bio-homicide to scientific review panels or, worse, journal editors. It is time to rethink both the BWC and the various biosecurity codes countries have created, without resorting to doomed calls for censorship.
In a 2007 speech to the NSABB, C. Kameswara Rao of India's Foundation for Biotechnology Awareness and Education almost pleaded with his American and European counterparts. India's burgeoning pharmaceutical industry is now taking in $2 billion annually, and enterprises akin to DIY biology have sprouted up from Bangalore to Mumbai. What might have once been considered unthinkable to Indians became ugly reality with the 2008 terrorist attacks in Mumbai. More than 300 people were injured and 172 died in the worst mass-casualty event in modern Indian history. Developing countries like India, Rao argued, are in desperate need of international guidelines, global governance of dual-use research, and basic know-how. Wealthy countries must, he stated, "share and provide state-of-the-art technical know-how" on biosecurity and surveillance of violations. There is a desperate need to globally "coordinate and monitor diagnostic, preventive, and remedial action." And an international funding agency must be created to support such preventive action in developing countries in order, Rao concluded, "to prevent human tragedy for want of technical know-how and financial resources." Rao was calling for nothing less than a massive global effort to train government institutions in poor and middle-income countries in the legal, biological, and public health tools necessary to control and respond to release of dangerous man-made contagions, whether deliberate or accidental.
Yanzhong Huang, senior fellow at the Council on Foreign Relations, finds a similar state incapacity to limit and surveil biothreats in China. In his estimation, Beijing has no capacity to prevent "biocrimes" or limit the synthetic-biology activities of its mushrooming biotech industry and academic science. Between them, India and China comprise much of the world's population and economic growth, have the lion's share of the new biotechnology and drug industry that could potentially execute dual-use research, and lack regulatory capacity to monitor such developments. That ought to worry all of us, whether we are in Beijing and Bangalore or Boston and Bangkok.
Developing countries' concerns put the World Health Organization (WHO) in a particularly difficult position on the H5N1 experiments and larger biosecurity issues. As H5N1 spread throughout Asia from 2003 to 2009, Indonesia experienced the majority of human cases and deaths, and virologists were eager to obtain samples of the flu viruses circulating around that vast island nation in order to comprehend why. The government declined to share viral samples, citing several concerns chiefly related to vaccine development, patents, and profits. After years of difficult negotiations, Indonesia and the World Health Assembly, the WHO's governing body, last year agreed to guidelines permitting sharing of both viruses and the profits derived from them. The resulting Pandemic Influenza Preparedness Framework is a fragile agreement governing the WHO's emerging-diseases and flu activities.