Synthetic Biology: The dark side of DNA

With its ability to create completely new living organisms, synthetic biology has more than an air of science fiction about it. But, while it has the potential to deliver huge benefits to society and the environment, it’s important to strike a balance between supporting the developments in this area and managing the risks.

The need for this approach was recognised by the World Economic Forum earlier this year. In its Global Risks 2015 report, which was published in January, it identified the misuse of technologies such as synthetic biology as a significant risk with far-reaching societal, economic and ethical implications. But it also acknowledged that this emerging technology – alongside others such as artificial intelligence and geo-engineering – offers “tremendous potential for solving the world’s most pressing problems”.

The science bit
Looking at the science behind synthetic biology explains why the WEF arrived at this position. The technology, first discovered in the early 2000s, builds on principles in other forms of biotech such as genetic engineering and bioscience.
But, while genetic engineering involves replacing DNA – taken from another organism to genetically modify an existing organism or create a new hybrid – with synthetic biology, a scientist can build DNA sequences from scratch, using them to create organisms that did not previously exist.

The Royal Society summed it up perfectly in its scientific discussion meeting in 2008 by stating that “synthetic biology covers an increasingly wide area of modern biology and although difficult to define, in essence it is about redesigning life”.
In addition, while the cost of sequencing DNA meant developments in this area were relatively slow in the early days, improvements in technology have made it much cheaper and easier. For example, the speed at which DNA can be sequenced doubles every 24 months, with the cost of this process falling from around $30 (£19.83) to extract each base pair in 1990 to around a tenth of a cent today.
Putting this into context, while it took 15 years and $3bn to sequence the first human genome, today, it takes less than a day to sequence the 3bn base pairs it contains and the price tag is a much more affordable $1000.

Benefits of synthetic biology
Being able to create new organisms means the applications for synthetic biology are many and varied. Among those already under development include using modified E.coli bacteria to turn sugar into an oil that is almost identical to diesel; medical advances such as new antibiotics, artificial kidneys and ways to use red blood cells to deliver drugs directly to cancer tumours; and environmental tools such as reprogramming bacteria to sense pollutants and new technologies for water purification and desalination.

And, as this technology is still in its infancy, the potential for further breakthroughs is enormous – which means the insurance implications are too. Professor Richard Kitney, professor of biomedical engineering and co-director of the Centre for Synthetic Biology and Innovation at Imperial College, adds: “All sorts of industries are reliant on oil, from tyre manufacturers to the electronics and pharmaceutical companies. Demand for it is increasing all the time. Being able to develop a different model where we can use a wide range of feedstocks to produce a plentiful and cheap substitute for oil is very exciting.”

What’s more, there’s a pressing need for this type of technology. Back in 2009, Lloyd’s emerging risks team compiled a report, Synthetic Biology: Influencing Development. This identified that there were 850 million undernourished people in the world and, with net population growing at more than six million a month, food supplies were likely to come under increasing pressure. In addition, it reported that one in three people currently face water shortages, with availability per person set to fall to one quarter of 1950 levels by 2030.

It argued that synthetic biology could address this growing demand on resources by helping to combat climate change, energy shortages, food security issues and water deficits.

Potential issues
But it’s not all about saving the planet and delivering societal benefits. The exact same science that offers these potential benefits has a much darker side too.

For starters, there’s the risk that it could be used to produce harmful products. The WEF report highlights the fact that synthetic biology has enabled the production of morphine from yeast and speculates it could be used to facilitate the manufacture of illicit drugs.

Possibly even more concerning is the potential for a rogue individual to use it to create a deadly virus that could then be used to support terrorism. As an illustration, the WEF suggests a virus as deadly as Ebola and as contagious as flu, referring to it as ‘a weapon of mass destruction’.

This risk is exacerbated by the way in which information is shared online in the synthetic biology space, wherein there are few controls around who can see details of a sequence once it is published.

But, even without a rogue individual, there’s still a danger that someone might inadvertently create something with unintended consequences. Anders Sandberg, James Martin research fellow at the Future of Humanity Institute at the University of Oxford, explains: “Someone might simply have a bad idea which, because they don’t think it through and consider the consequences, results in the creation of something dangerous. Similarly, although the motivation may be good there could still be risks. Someone designing a vaccine that will save peoples’ lives would need to work with the virus and they could potentially create something even more dangerous.”

“There’s also risk relating to the uncertainties surrounding this new technology. Nobody yet knows how these new organisms might interact within the environment or how they’ll evolve. This could lead to existing species being wiped out or the creation of new characteristics that were never envisaged or desired.

“Accidents happen too. This could potentially lead to a new organism being released into the environment, where it might cause pollution, contaminate existing crops or even result in health problems if it was able to get into the food chain.”

An example of the potential for problems, albeit not specifically relating to synthetic biology practices, was the leak of the foot and mouth virus from the animal health laboratories in Pirbright in Surrey. This was found to be the result of a combination of building work and leaking drains.

Regulatory requirements
Given the number of potential issues facing the synthetic biology market, robust regulation is regarded as a necessity. For example, speaking at the launch of the WEF Global Risks 2015 report, John Drzik, president of global risk and specialties at Marsh, said it was essential to anticipate the issues that will arise from emerging technologies and develop safeguards and governance to prevent avoidable disasters.

But, many are critical of the regulations that are currently in place. For example, in its report into synthetic biology, Lloyd’s highlighted the fact that regulation can lack coordination, with more than one body responsible for overseeing requirements within a region. It pointed to the field of nanotechnology, which has the National Nanotechnology Coordination Office in the US to oversee developments, as a model for the synthetic biology market.

Allowing this patchwork approach to regulation can result in a number of issues. First, as countries take different approaches, a company using synthetic biology within its products might choose to seek approval in a country with weaker regulation to enable it to come to market quickly and recoup its investment.
Similarly, as so much information is shared online, establishing a common global regulatory framework is sensible.

Sandberg is also critical of the regulation around synthetic biology, in particular, the fact that it is governed as another form of genetic engineering and is, therefore, much more geared towards large institutional stakeholders such as industries and academics. To illustrate the problems this can cause, Drzik pointed to the Glowing Plants project, which used synthetic biology to create plants that glow and could be used as natural lighting. By seeking crowdfunding through Kickstarter, it was able to distribute seeds to nearly 8,500 people without a single regulator stepping in to ensure there were any controls around where the seeds were planted.

Under control
But while there are potential issues, many within the industry believe that sufficient regulation is already in place to prevent the risks that are commonly attributed to synthetic biology.

As an example, Professor Susan Rosser, chair of synthetic biology at the University of Edinburgh, believes it’s logical to view synthetic biology as an extension of genetic engineering technology from a regulatory perspective. “There are extremely rigid and rigorous regulations in place for genetic engineering, especially in the UK and European Union. As synthetic biology presents no more risk than standard genetic engineering technology, it makes sense to include it within the same regulations,” she says.

Presently, and as a further layer of defence, checks and balances are in place to ensure synthetic biology is used appropriately. For example, the Biotechnology and Biological Sciences Research Council requires the researchers it funds to consider the ethical and social implications of their work – and will only pay grants where any issues are resolved.

As a result of this Professor Kitney also believes the current regulatory framework is sufficient for the risks synthetic biology presents. “As the field evolves, the regulation will evolve too, but I don’t believe this is necessary at the moment.”

In addition, the synthetic biology community is also looking at ways to safeguard its future. As an example, Professor Rosser points to genetic biocontainment strategies currently being developed. “These are genetic kill switches, programmed to terminate an organism if it isn’t in a controlled environment. Organisms engineered in the labs are relatively weak and can’t really compete with natural organisms anyway, but this provides a further layer of security.”

There’s also a sense from some of the academics that the risks are being given a touch of the Hollywood script makeover. In particular, there’s plenty of scepticism around the idea of terrorists creating a deadly virus. “It’s not very likely,” says Professor Kitney. “To produce a new organism you need to sequence the DNA and send it off to be synthesised. The companies that do this are part of a network and will screen every sequence they receive to ensure it’s not a risk. They also report into security agencies such as the FBI so it’s not really an option. In fact, the Blackett Review of the risks relating to synthetic biology concluded that the real threat of this nature came from organisms such as anthrax that already exist.”

In addition, the skills and equipment required to use synthetic biology create significant barriers to entry. Although a terrorist could potentially synthesise DNA without turning to one of these companies, the equipment is extremely expensive and the level of expertise required is also high.

Insurance role
While the experts may feel comfortable with the regulatory framework that’s currently in place, it must also be remembered that public perception can make or break a technology’s future. Ensuring the risks don’t overshadow the benefits is essential.

An exercise to gauge public opinion of synthetic biology was undertaken in 2010 by the BBSRC and the Engineering and Physical Sciences Research Council. This found that most people were supportive of it – but with conditions on how and why it is conducted. Although this feedback was used to shape its funding criteria, it underlines the importance of reassuring the public.

This is where insurance could have an important role to play, according to Sandberg. “Insurance could be a great way to rein in some of the more stupid applications for synthetic biology,” he explains. “If a project required liability insurance, some of the costs could be internalised by managing the risks. This would help ensure excessive risks aren’t taken.”

While the cost of cover might be an indication of the level of risk involved with a project, the insurance market could also help scientists to model the risk and gain further insight into the nature of their research. “Insurance is smarter than regulation,” adds Sandberg. “Regulation can be rather inflexible and slow to adapt. Insurance could really help this market develop.”