Synthetic Bio / Return of Hwang? / FDA cozying up to Pharma (30/6/2007)

1.Venter's Trillion-Dollar Dream Spotlights Dangers of "Self-Regulation"
2.The Return of Hwang?
3.FDA Chief to Pharma: Let's Get Cozier
4.Bacteria genome switch-a-roo

NOTE: First three items all taken from the newsletter and weblog of the mighty Center for Genetics and Society - http://www.genetics-and-society.org

EXTRACTS: As early as 2003, the US Central Intelligence Agency (CIA) warned that synthetic biology could be used to produce biological agents whose effects "could be worse than any disease known to man." (item 1)

"perhaps we shouldn't be surprised that stem cell and cloning researcher Hwang Woo Suk is laying the groundwork for a comeback. Sure, he may be known best for publishing falsified papers, unethically obtaining thousands of women's eggs (even from his own subordinates), and embezzling millions of dollars..." (item 2)

"This is an important step toward the Holy Grail of whole-genome engineering." (item 4)


1.Synthetic Biology: Venter's Trillion-Dollar Dream Spotlights Dangers of "Self-Regulation"

Yesterday's announcement that biotech entrepreneur Craig Venter is one step closer to constructing a self-replicating artificial life form should be a wake-up call.

Venter's move to construct a synthetic bacterial species paves the way for the deliberate or accidental creation of pathogens of unprecedented virulence. Currently there are no laws or treaties, and few regulations, to bring this set of powerful new biotechnologies under responsible social oversight.

In 1975 scientists gathered at an emergency meeting in Asilomar, California to reluctantly impose a voluntary, short-term moratorium on their own research in the then-new field of genetic engineering. Now, 32 years later, scientists promoting the new field of synthetic biology appear far less willing to abide by even minimal precautionary values.

In March 2006 synthetic biologists at the "SynBio 2.0" conference in Berkeley, California downplayed the risks that synthetic biology poses, and resisted calls for moratoria or any effective public oversight. Those sentiments have been reinforced at the "SynBio 3.0" conference being held this week in Zurich, Switzerland.

The profound dangers of synthetic biology have been widely noted. As early as 2003, the US Central Intelligence Agency (CIA) warned [PDF] that synthetic biology could be used to produce biological agents whose effects "could be worse than any disease known to man."

A leading MIT synthetic biologist has acknowledged [PDF] that synthetic biology might allow people with a high school biology education to create "a pathogen that could cause millions of deaths."

Nonetheless, the only safeguards that most synthetic biologists appear willing to accept are a series of "self-regulatory" procedures that provide little or no protection. Their proposals for self-regulation are more public relations than a serious approach to social oversight.

For the past two decades the links between the bioscience research community and the commercial biotechnology industry have become increasingly strong. Commercial motives have been present at the creation, so to speak, of synthetic biology. Earlier this month it was disclosed that Venter had applied for both US and international patents on his proposed synthetic bacterium. He has declared his hope that it will be the world’s first "trillion dollar organism."

Organizations including the ETC Group, Greenpeace and Friends of the Earth have already begun to educate and activate [PDF] key constituencies around the immense risks posed by synthetic biology. With researchers and biotech entrepreneurs refusing to take responsibility for the consequences of their actions, it's up to civil society, national governments and international governing bodies to ensure that biotechnology is developed in ways that enhance rather than endanger the well-being of the human community and all life on earth.


ETC Group: Extreme Genetic Engineering

Civil Society Sign-On Letter [PDF]

Richard Hayes, "Our Biopolitical Future: Four Scenarios," WorldWatch [PDF]

SynBio 3.0


2.The Return of Hwang?
by Jesse Reynolds
Biopolitical Times, June 22 2007

What magnitude of transgression is needed to ruin a high-profile career? The bar seems to be pretty high. For example, the leading advocates for the current disastrous war of choice, a catastrophe now clearly based upon lies, have variously been promoted to Secretary of State, president of the World Bank, and Deputy National Security Advisor. The master of insider traders, Michael Milken is back, dispensing advice about how to improve the world. Even disgraced former US President Richard Nixon was gushingly eulogized as "an American hero."

So perhaps we shouldn't be surprised that stem cell and cloning researcher Hwang Woo Suk is laying the groundwork for a comeback. Sure, he may be known best for publishing falsified papers, unethically obtaining thousands of women's eggs (even from his own subordinates), and embezzling millions of dollars. Much like a pop group's reunion that no one really asked for, he's now got the old band back together, and they are rehearsing at an undisclosed location in the distant suburbs of Seoul. But can he churn out the hits like he used to? There are even hints they may have potential Top Ten singles in the can:

"There are many good research results that we want to boast about," Kim [Sue, one of Hwang's chief researchers] said, but declined to elaborate further. Papers are either being written or have been submitted to science journals for review, she said, and the lab hopes to have some published within a year.

Unfortunately, there are also hints that Hwang may try some of his old tricks, particularly improperly obtaining human eggs, by working around the law instead of breaking it. Hwang may be under less scrutiny, because his work is now privately funded and he might be seeking a new nation in which to establish a lab. But he's proposed to resurrect the idea of an international stem cell research consortium. The aim of the consortium, which may include a "U.S. biomedical firm," seems to be to acquire eggs - the same likely purpose the first time he advocated for such a consortium, just before his fall from grace.

Despite the fact that Hwang's team burned through over two thousand human eggs without success, his researcher Kim remains convinced that stem cell lines can be extracted from human clonal embryos - if only she and the rest of the team had access to eggs: "If we had been working on human eggs, we could have produced human stem cells. We are confident that we can do it now."


3.FDA Chief to Pharma: Let's Get Cozier

In the high-profile scandals and regulatory failures that have repeatedly rocked the US Food and Drug Administration in recent years, conflicts of interest with the pharmaceutical industry have often figured large. [READ ON AT] http://www.biopoliticaltimes.rsvp1.com/s18de11IoBI


4.Bacteria genome switch-a-roo
By Charles Q. Choi
The Scientist, 28th June 2007

New genome transplantation technique works in bacteria, and could ultimately enable synthetic biology

Scientists have successfully forced a bacterium to switch species with another closely related species by replacing one genome with the other.

This "transplantation" technique, spearheaded by J. Craig Venter and described in this week's Science, could insert synthetic genomes into cells to help create synthetic organisms, although Venter cautioned that the step is a long ways away.

Venter and colleagues at the J. Craig Venter Institute in Rockville, Md., replaced the genome of Mycoplasma capricolum with that of a closely related bacterium, Mycoplasma mycoides. They used mycoplasma because this genus has a relatively small genome (roughly 1 million base pairs) and because it lacks cell walls, making it easier to insert bulky DNA molecules.

Venter and his team suspended M. mycoides cells in agarose to protect the soon-to-be-naked donor DNA from jostling and breakage, and incubated it with enzymes to digest the cells' other components. After isolating the DNA, they incubated the donor genomes with host bacteria in a buffer containing polyethylene glycol (PEG), to promote DNA transfer. The M. mycoides genome carried a tetracycline resistance gene that allowed the researchers to later identify the transplant cells by screening with the antibiotic.

Colonies that developed after three days were genetically identical to donor cells based on Southern blot analysis. The newly formed bacteria also carried surface antigens and cell proteins specific to M. mycoides.

"We want to make sure the DNA itself can boot up the cell," Venter said in a press teleconference. If accessory proteins were also required, "that would be a huge barrier to the field of synthetic genomics. You would have to take a long time to sort out which proteins were necessary and have them at the right concentrations."

Efficiency is still a concern, the authors wrote--the procedure worked just one in 150,000 times "in our most efficient experiments." John Glass, coauthor of the study, told The Scientist in an Email that the yield was still significant, with hundreds of colonies produced in each experiment.

Applying this technique to higher organisms "is an extremely long way off, if ever," Venter said. Even simple bacterial cells contain specific restriction enzymes to protect them against invading DNA, he noted. "Adding DNA to each unique type of bacteria will require understanding their restriction systems. There's no universal formula for doing this."

The researchers could not explain how the M. capricolum genomes disappear after transplantation. Venter speculated that after cell division, donor and recipient genomes separate into different daughter cells; when tetracycline is added to the mix, non-resistant M. capricolum are culled. However, coauthor Hamilton Smith said at the teleconference that their experiments suggested the donor genome might have a mechanism to cleave and destroy the recipient genome.

Pamela Silver at Harvard, who did not participate in this study, told The Scientist in an Email, "This is an important step toward the Holy Grail of whole-genome engineering. But, she added, the final, most difficult step will be to design a genome with interesting and useful properties."

Venter recently came under fire from Action Group on Erosion, Technology and Concentration (ETC Group), a technology watchdog group based in Ottawa, Canada, when they found he had filed a patent on a synthetic bacterium containing the barebones genome needed to power a cell. The group claimed he breached ethical boundaries by trying to patent a life-form.

George Church at the Massachusetts Institute of Technology, also not a coauthor, said that the applications of the transplant technique were unclear. Venter et al's "related patent application says biofuels, but I'll be impressed if you can find someone who can explain how this enables biofuel research in a way not possible in other methods," Church said in an Email.

Venter, however, was more optimistic. He noted that synthetic organisms with minimal genomes will be energetically more efficient than genetically modified organisms when it comes to biofuels and other applications, because modified cells have extraneous metabolic pathways, "shifting energy away from chemical synthesis."

Charles Q. Choi
[email protected]

Links within this article:

C. Lartigue et al. "Genome transplantation in bacteria: Changing one species to another," Science, published online ahead of print June 28, 2007.

S. Pincock. "Venter buys history." The Scientist, August 29, 2005.

J. Lucentini, "Is this life?" The Scientist, January 1, 2006.

John Glass

C. A. Hutchinson et. al., "The new biological synthesis," The Scientist, January 1, 2006.

P Silver, "Cells by design," The Scientist, September 27, 2004.

C.Q. Choi, "DNA synthesis method yields 15-kb gene cluster", The Scientist, April 11, 2005.

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