Friday, June 24, 2011

Synthetic biology

Should synthetic biology be policed?
By John Farrell
June 23 2011

What scares many people about the emerging field of synthetic biology is the lack of official safeguards. The Do-It-Yourself movement is taking off, with blogs and user groups of grad students and high school students publicly sharing information about how to home-brew microbes. The International Genetically Engineered Machine Competition (iGEM) draws hundreds of experiments made from basic biology toolkits from undergraduates all over the world. Students from Slovenia were the grand prize winners in 2010 for designing a DNA scaffold that accelerates the synthesis of particular proteins.

These kit-level experiments are harmless, hobbies pursued as much for educational purposes as for ingenuity. But in the wrong hands, some have warned, more than lives could be threatened.

As I mentioned in the last post, Craig Venter’s celebrated paper prompted President Obama to ask Amy Gutmann, President of University of Pennsylvania and the chair of his Bioethics Commission, to look at synthetic biology and assess what the Federal Government should do about this rapidly growing field of biotechnology.

Gutmann called three meetings between July and November of last year to consult with specialists on the question. Venter spoke at the first meeting, along with Drew Endy of Stanford, Harvard’s George Church and MIT’s Kristala Jones Prather, among many other leading resesarchers.

Church, who has made a career out of perfecting the speed with which genes can be sequenced, was emphatic about the need for the Federal government to regulate and monitor the new field. “We need to – it is not sufficient to have a set of rules and guidelines, if there isn’t testing, if there isn’t surveillance,” he told the Commission in July. “You can do licensing, as we do driver’s license, but you have to do surveillance to make sure people are obeying the laws.”

So, anyone trying to buy lab equipment or the kits needed for biology experiments online from eBay or direct from equipment manufacturers, would have to show some proof of identification so they could be tracked. This caution is noteworthy because Church is not just a proponent of synthetic biology. His lab is actively working on applications.

It took four months altogether for the Commission to issue its recommendations to the President. Ultimately, the report recommended moderate oversight. As Gutmann said at the Future Tense conference (sponsored by Slate, Arizona State University and the New America Foundation in Washington D.C early February), the Commission decided against basing its recommendations on the so-called Precautionary Principle, which guides European restrictions on GMOs. By this principle, the burden of proof is on the advocates of any new technology that has the potential to cause harm to the environment of the public.

“We felt that, given the promise of synthetic biology to provide new vaccines, such as the artemisinin being developed that could save hundreds of thousands in Africa from malaria, the cost of waiting was just too high.”

The Commission’s recommendations did not call for any new agency to be created purely to oversee synthetic biology. It recommended rather that an existing department of the Executive Office of the President oversee the existing agencies, Homeland Security, FBI, NIH, as they network closely to monitor the new field and within 18 months issue a report on current national funding for synthetic biology research.

On the whole the report has been received positively by scientists. But there have been critics.

I spoke with Professor Richard H. Ebright, molecular biologist at Rutgers. In his opinion the Commission was too laissez faire, too loose given the speed with which synthetic biology is advancing. “It’s an abdication of responsibility,” he said. “There was a tremendous middle ground here that was just missed.” Like most accountants and bankers, he added, most biologists would like minimal oversight. That’s what they got.

Ebright was hoping the Commission would at least recommend that research institutions require Internal Review Boards for synthetic biology programs, in the same way that they are currently required for human-subject research.

Given the technology as it stands, he has two concerns of what could wrong. “One is that someone could produce a pathogen, a virus that is restricted.” He pointed to the recent reverse engineering of the 1918 influenza virus which killed 50 million. The other: “The unintentional release of an organism that wreaks havoc on a local ecosystem.”

The Commission report did recommend that synthetic biologists build “suicide genes” into their organisms to prevent their thriving outside of the restrictions of the laboratory. If a synthetic bacteria does not feed on a limited number of very specific and uncommon food source, then it will die.

The downside of such a prospective safeguard, however, is what happens if an accidentally released organism doesn’t commit suicide, but mutates so that it can survive and multiply on a more accessible source of food—in the water, or in the air?

Gregory Kaebnick, a research scholar at the Hastings Center for Bioethics, who spoke to the Commission during its hearings, raised a similar point. The Commission Report largely sees the most dramatic applications of synthetic biology as safely in the future, he said, giving it a too sanguine attitude about what could go wrong in the present.

“The argument seems to be that all the applications are way off in the future, but I’m not convinced about that. Getting biotechnologies to market is a slow process if the applications are for human beings …. But synthetic biology is being applied to microbes. Though not necessarily simple, they are far simpler, and if you kill off a few billion while trying out some new approach, it’s no sweat. You can come back to the lab tomorrow and try something new. So I think interesting applications might be closer than the Commission suggests.”

And so could accidents. “I don’t really know what kind of regulation is appropriate for DIY bio, but certainly very careful monitoring is needed. The report calls for the latter, at least.

“I tend to favor a moratorium on the environmental release of synthetic organisms. We don’t have very much experience with altered microbes and how they might affect ecosystems, the results seem inherently rather unpredictable, and mistakes couldn’t be retracted. Oil spills can at least be largely cleaned up; an altered microbe that manages to survive in the wild, or passes on its genes to some other microbe, could never be rounded up and removed.”

The question arises, will this be part of the price we have to pay for entering the new era of digital biology?

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