Biotechnology in the last decade has been continually driven forward by the relentless economical desires of the ever-growing biopharmaceutical industry, creating innovative technologies that have gradually taken root in our society and have transformed our daily lives. These include transgenic rodents used in laboratories worldwide to understand diseases at a molecular level, as well as genetically modified foods that are found today in our salads.

While biotechnology has the power to change our society, the renowned Dr. David Suzuki, broadcaster and professor emeritus at the University of British Columbia, explains that we have still have very limited understanding of this technology, and thus cannot accurately predict how genetic modified crops for instance could impact our health and environment in the long term.

Despite such warnings, biotechnologists continue to move forward at an alarming pace, creating technologies for which authorities have little understanding, and minimal infrastructure in place to regulate. Although biotechnology has now advanced beyond transgenics, and have moved on to creating induced pluripotent stem cells in 2006(Yamanaka et al., 2006) and the synthetic cell in 2010 (Gibson et al., 2010), it is apparent that authorities are still maintaining a rather passive approach to establish appropriate regulations to control the use of these new technologies.

A prime example of authorities’ failure to regulate new biotechnologies could be illustrated by the multiple unresolved issues stemming from the creation of induced pluripotent stem cells (IPS cells). IPS cells are essentially somatic cells that are reprogrammed into replicas of embryonic stem (ES) cells, the inner cells of a developing embryo that can give rise to any cell type in the body. As IPS cells are produced by cells intrinsic to the host, they could produce any organ suitable for the host. This has immense value in modern medicine, enabling clinicians to replace virtually any organ without rejection issues, or repair chronically injured tissues arising from spinal cord injury or stroke. In the research side of things, IPS cells enable scientists to produce cells that model the phenotype characteristic of a disease of interest. A good example is the recent finding showing that IPS cells derived from Leopard Syndrome patients, which had the remarkable ability to produce cardiac cells that reflect the hypertrophic phenotype of the patient’s diseased heart (Carvajal-Vergara et al., 2010).

However, IPS cells can also be used to clone human embryos, and thus present serious ethical concerns. Consequently, US authorities extended the laws associated with ES cells to prohibit the use of IPS technology to produce human embryos. A major drawback however is that the legislation fails to address practical issues associated with the use human IPS technology, including safety regulations in clinical translation, patient consent rights and privacy, as well as intellectual property rights. Moreover, authorities do not have regulations in place to address whether IPS cells can be used to generate valid disease models in vitro, and whether conclusions garnered from such models could be accurately used as a basis for future therapeutics.

To make things more complicated, recent studies revealed that IPS cells might not be the perfect replicas of ES cells as they carry epigenetic or “gene silencing” defects that directly impact their differentiation and ultimately their ability to produce viable embryos (Statfeld et al., 2010). In light of these findings, it is apparent that authorities should not simply lump IPS cells and ES cells together, but rather should set separate regulations to address the specific health risks and ethical concerns of these two very different stem cells.

While authorities are still contending with ethical issues of IPS cells, another biotechnology breakthrough emerges in 2010 with the creation of the synthetic cell, where biotechnologists raised the bar by building the first synthetic bacterial genome from scratch. When the bacterium’s original genome is replaced with a synthetic genome, the resulting synthetic bacteria were capable of growing into viable colonies (Gibson et al., 2010). This technology presents scientists with the ability to produce any bacteria they wish for a plethora of applications, such as the synthesis of new vaccines and drugs. However, in the post 9-11 world of terrorism, the ability to produce synthetic bacteria from scratch could present a novel arsenal for bio-terrorists. Moreover, the release of these synthetic microorganisms into the environment could result in potential health risks that could endanger society.

In a recent letter by President Obama to the presidential bioethics commission, Obama requests that studies should be made to minimize the potential security and health risks associated with this technology. While the Obama administration sets a fine example of fostering and regulating novel biotechnology for the maximum benefit of society, a major drawback is that these actions come a bit too late. Research labs at this point have already been creating these synthetic bacteria, quite possibly in facilities with minimal containment or security. While risks could be quite minimal at this early stage, the rather slack and passive regulation of these novel biotechnological innovations is indeed a cause of great concern.

While biotechnology is advancing at a rapid pace, it seems that authorities are still “behind the times” when it comes to regulating these innovations. It is apparent that government authorities should take a more proactive action to better protect the ethical values, health, safety and environment in our society. 

References and links:

Takahashi et al. (2006) Cell. 126, 663-76.

Carvajal-Vergara et al. (2010) Nature. 465, 808–812

Statfeld et al. (2010) Curr Biol. 18, 890-4.

Gibson et al. (2010) Science. (in press).