Synthetic biology: dangerous or promising?

Randall Mayes Contributor
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With high unemployment, lagging home sales, slow economic growth, staggering federal deficits, etc., it is no wonder the economy is the main issue concerning voters. Failed macroeconomic policies have created the need for a new paradigm for economic growth.

However, how to resurrect the economy is a contentious issue. Keynesians prefer a stimulus and deficit spending while market economists advocate business growth through supporting commerce and technology. It is both easy and appropriate to criticize deficit spending; but, it is equally important that Republicans provide an alternative game plan for jump-starting the economy.

Along with the economy, other pressing global issues including energy, global warming, healthcare, and international security all have something in common, and that is the success of technology. There is a market demand for industrial revolutions and applications that will provide solutions to these problems. An industrial revolution that has the potential to resurrect the economy is synthetic biology. Over the past decade, everyone from venture capitalists in Silicon Valley to governments, foundations, and the private sector began evaluating its potential.

In addition to creating jobs and wealth, synthetic biology researchers are poised to create revolutionary products by modifying genomes to create the next generation of plastics, agricultural products, bioremediation organisms, bioweapons, and novel enzymes with industrial applications. ExxonMobil has invested hundreds of millions of dollars on bioengineered fuels that are carbon neutral and will reduce our dependence on oil.

Basic science is also a beneficiary which will in turn provide insight into diseases and hopefully burst the genomics bubble. The medical cures and personalized medicine that researchers believed the identification of disease-related genes would lead to have yet to materialize. The Bill and Melinda Gates Foundation has given tens of millions of dollars for research on bioengineered malarial drugs.

Synthetic biology researchers have achieved a number of milestones in understanding the complexity of living systems and are closer to developing DNA vaccines. In May 2010, the journal Science published the J. Craig Venter Institute’s breakthrough of the first self-replicating synthetic cell. This article prompted President Obama to assemble a Bioethics Commission.

The commission’s first order of business is to respond to the moral and risk implications of this emerging technology. Three sessions of expert panelists are speaking before the commission. The final group of panelists is speaking at the November 16-17 session. The commission will then release a report on how to best regulate the field.

Obama’s Bioethics Commission’s website and panels provide an opportunity for a broad range of public commentary, and the commission includes a representative representing civil society groups. As they did when genetic engineering was first introduced, activists are inflating synthetic biology’s biosecurity risks and raising moral objections.

In the position paper Extreme Genetic Engineering (2007) and in several press releases, ETC Group presses the risk and morality hot buttons in hopes of persuading regulators to impose moratoriums. This will also result in the field developing slowly which will also delay any potential social benefits. ETC Group advocates the pre-cautionary approach which involves lengthy studies and the belief that an international agreement on how to develop the field will realistically materialize.

Among the world’s major problems that need immediate attention is malaria. Annually, it infects an estimated 300-500 million people and is fatal to roughly 1.5 million. Natural artemisinin is extremely effective as a treatment when combined with other drugs. Although combination therapy increases the odds of preventing the malarial parasite from developing resistance, natural artemisinin is very labor intensive to produce and currently the supply is not meeting the demand.

Representing ETC Group, panelist Jim Thomas raised one of his many objections to synthetic biology which results from the development of the bioengineered malarial drug artemisinin. Thomas told the commission, “Synthetic artemisinin will undercut the price of natural artemisinin grown by thousands of small farmers in East Africa and Southeast Asia, threatening their livelihoods.” Thomas called for an outright ban on synthetic biology. Thankfully, President Obama’s directive to the commission expressly states that it should develop recommendations on how to reap synthetic biology’s benefits. So, I assume the banning option is off the table.

Ideally, synthetic biology will develop in a safe and timely manner to ensure citizens receive the potential social benefits. Understanding the “extreme benefits” the field offers, panelist and Stanford Professor Drew Endy told the commission, “We should focus on a strategy of how to get this right.” Scientists like Endy draw upon the 1975 Asilomar Conference, which provided a successful model for the future direction of genetic engineering, to also provide the future direction of synthetic biology.

Genetic engineering enabled the production of drugs such as insulin, EPO, interferon, and human growth hormone that improve the quality of our lives. Today, rather than deriving insulin from cadavers and sheep, we have genetically engineered insulin, a Shumpeterian revolution. Genetic engineering has also provided a solution to food shortages in developing countries and a critical technology used for research on deadly influenzas.

In the absence of comprehensive federal and state laws, bioengineers are self-regulating the field. Scientists suggested NIH form a recombinant DNA advisory committee for genetic engineering to establish best practice safety guidelines, standards for conducting experiments, and oversight for NIH funded projects. The scientists preferred the flexibility of guidelines over legislation since they are less affected by the politics of Washington, D.C.

Experts in the field of synthetic biology, not politicians or civil society activists, are the logical group to distinguish any perceived risks from real risks. Each technology is unique and requires the appropriate technical expertise. During Asilomar, scientists quickly discovered that educating the public and activists is necessary so they can distinguish between sci-fi novels and reality. 

With genetic engineering, the expert scientists discovered the need for education on the distinction between genetic engineering the process and recombinant DNA the product.

The conference eventually led to recommended guidelines matching the type of containment necessary for different types of experiments such as low minimal, low, moderate, and high risk. In 1975, while covering Asilomar, Michael Rogers wrote in Rolling Stone that one proposed regulatory scheme made human sex, a process to recombine DNA, a moderate risk experiment.

We now know genetic engineering is harmless. It is its products, including drugs and GMOs, that are the target of risk assessment. Similarly, with synthetic biology, the process itself does not pose risks; rather, novel DNA and proteins, and the dual use nature of the field, require risk assessment.

Bioengineers have developed a set of guidelines to address the unique risks associated with synthetic biology. Panelist and bioengineer Rob Carlson notes that small scale start-up synthetic biology companies in garages are potentially major players in the industry since they are relatively inexpensive to create. In response, the practitioners of synthetic biology have developed precautions such as professional certification for themselves and are monitoring the sales of synthetic DNA.

A drawback of the open source biology movement’s advocacy of placing genomes in databases for common usage is that pathogen genomes are also made public. This provides more fuel for activists inflating biosecurity risks. Panelist Carlson doesn’t downplay the seriousness of bioterrorism, but refers to their scare tactics as saying “boo.” He argues, “Given the complexity of biological systems, it remains difficult to create synthetic pathogens. In most cases it is easier to just use a natural pathogen.”

As a technology policy analyst specializing in biotechnology, I believe activists are holding the development of synthetic biology to a different standard when compared to other technologies. For the self-governed fields of genetic engineering and nanotechnology, fatalities are virtually non-existent. Meanwhile, the automobile and pharmaceutical industries are heavily regulated, but human fatalities are common and tolerated in those industries.

The automobile industry and Americans have a social contract based on cost-benefit analysis. According to the National Highway Traffic Safety Administration, over the last twenty years, Americans have accepted roughly 40,000 traffic fatalities annually in return for a convenience that is engrained as part of our lifestyle.

The pharmaceutical industry uses clinical trials to regulate drugs that are cost prohibitive to the development of most industrial products. In spite of the costs, a Journal of the American Medical Association study reveals that roughly 106,000 people die each year in American hospitals as the result of side effects from medication.

Randall Mayes covers science as it relates to business, politics, and culture and is a technology policy analyst specializing in issues related to genomics, nanotechnology, and synthetic biology. His new book Revolutions: Paving the Way for the Bioeconomy is scheduled for release with Logos Press in 2012.