Synthetic bio / Gene therapy / Cloning / Hype / Berkeley Lab (11/8/2007)

1.Synthetic Biology 3.0
2.Another Gene Therapy Death
3.S. Korean wolf cloning team under investigation
4.The Art of 'Jam Tomorrow'
5.Don't Bite the Hand that Feeds You
6.Few Defend UC Lab in Heated Meeting on EIR

1.Synthetic Biology 3.0
by Gregor Wolbring
Innovation Watch, July 15 2007

[EXTRACTS ONLY] My very first column published in May 2006 was called Synthetic Biology 2.0, named after the 2006 conference of the synthetic biology community. The Synthetic Biology 3.0 has just taken place at the Swiss Federal Institute of Technology (ETH) in Zurich, Switzerland, on June 24-26, 2007. This provided an opportunity to reflect on what has happened in the last year, and what did not, with respect to synthetic biology and its discourse.

...It also appears that synbio is suffering from the hyperbole and sales pitches that plague so many scientific endeavours. With a multitude of new and emerging technologies in need of funding, researchers try to outdo each other in promising solutions to every problem that has some visibility.



2.Another Gene Therapy Death
Posted by Osagie K. Obasogie
Biopolitical Times, July 30th 2007 [shortened]

In a development eerily similar to the tragic death of Jesse Gelsinger, the FDA released a statement late last week reporting yet another gene therapy death - this time during a clinical trial run by Seattle-based Targeted Genetics. Broadly put, gene therapy is a biomedical technique designed to treat diseases by replacing damaged or nonfunctioning genes with ones that work. The patients enrolled in this clinical study were testing an investigational gene therapy product designed to treat arthritis. In the course of treatment, one patient suffered a severe adverse reaction leading to the trial's suspension. The patient died a few days later.Although few other details are available at this time, many questions are being asked such as why the FDA approved a clinical trial using a risky treatment to address a non-life threatening condition.


3.S. Korean wolf cloning team under investigation
Reuters, April 10th, 2007 [extract]

SEOUL - South Korean scientists, disgraced for massive fraud in stem cell studies, are being investigated for possibly manipulating data in a paper on producing the world's first cloned wolves, officials said on Monday.


4.Do Two Friedman Units Equal One Okarma?
Jesse Reynolds
Biopolitical Times, July 20th 2007

Supporters and apologists for the American debacle in Iraq habitually promise that the situation will improve in the near future - if only support at home is maintained. A media watchdog group has noted that Thomas Friedman, The New York Times' foreign policy cliche-ist in residence, has been claiming that "the next six months" are a critical make-or-break period, and that he's been doing so for over three years. Subsequently, a progressive blogger dubbed one "Friedman Unit" (FU) as equivalent to six months of prognostication. Since then, pro-war statements by others have have been quantified in these terms.

Similarly, Geron, the leading private firm trying to commercialize human embryonic stem cell products, has stated that clinical trials will occur "next year" - for the fourth year in a row:

*February 22, 2004: "The company believes it will be cleared to start the first stem-cell therapy in human tests next year, possibly for spinal-cord injury."

*December 1, 2004: "According to Geron CEO Thomas Okarma, the company is aiming to file an investigational new drug application with the U.S. Food and Drug Administration (FDA) requesting permission to begin clinical trials using glial cells derived from embryonic stem cells to repair damaged spinal cords in 2005 or early 2006."

*February 25, 2005: "Next year [Hans Keirstead] and his corporate partner, Geron, plan to try treating people who have recent spinal cord injuries, in what would almost certainly be the first human trial of any therapy derived from such cells.

April 19, 2005: Okarma "said he believes the clinical trial could begin in mid-2006."

*September 9, 2005: "Geron plans to begin clinical trials on acute spinal cord injury treatment in early 2006, according to chief executive officer Tom Okarma."

*November 7, 2005: "[R]esearchers at Geron of Menlo Park want to take the next step -- in people. They hope to get federal permission to inject those cells into damaged spinal cords. The procedure -- which Geron intends to do next year -- would be the first human tests of a treatment derived from human embryonic stem cells, the highly versatile body cells that can be coaxed into becoming almost any tissue in the body."

*June 17, 2006: "'I'm confident that we will be in the clinic next year with the first human ESC-derived product,' said Tom Okarma, chief executive of Geron."

*August 4, 2006: "One company, in particular, Menlo Park, CA-based Geron, is taking the lead in developing experimental embryonic stem cell therapies and hopes to begin human trials next year."

*May 9, 2007: "The first clinical trial of embryonic stem cells is on track to start early next year on patients with spinal cord injury. Geron, the California-based biotechnology company, will carry out the study on accident victims in six trauma centres across the US."

Obviously, the moral terrain is not equivalent. The militarists who misled the nation into war have proposed a variety of goals, all to be achieved at the barrel of a gun. Geron just wants to maximize profits by way of developing medical therapies. But much like war backers, embryonic stem cell researchers continually lobby for more federal funds. The result on the investment, they promise, is just around the bend - maybe as soon as one Okarma Unit (OU) from now.


5.Don't Bite the Hand that Feeds You
Posted by Jesse Reynolds
Biopolitical Times, August 3rd 2007

My recent post citing the failed promises of Geron's CEO was picked up by Brandon Keim in his blog at Wired.

Keim cited my list of statements by Ted Okarma, who over the course of four years has repeatedly promised that clinical trials of embryonic stem cells would begin "next year." Keim subsequently received this comment from Hans Keirstead, a prominent stem cell researcher at the Reeve-Irvine Research Center of the University of California:

"I would also like you to know that I read a recent antagonistic article in your online journal concerning Geron's timeline to the clinic. I feel that you have done a tremendous disservice to the stem cell field in presenting Geron's path to the clinic as you did."

The truth is that Keim and I did little more than cite public statements made by Geron's chief executive. Isn't it Okarma who is disserving the stem cell field by misrepresenting the feasibility of Geron's stem cell clinical trials over and over again? No one in their right mind has ever doubted that it would take several years to get stem cell research to clinical trials. All Keim and I are asking for is a little truth in advertising. What biotech boosters such as Okarma and Keirstead continue to fail to mention is how many biotech companies to overplay their hands in order to keep share values high. Yet Keirstead in 2002 himself said that the clinical trials would be "in about a year," i.e., one Okarma Unit away.

But Keirstead's inaccurate choice of target in his response is not surprising. For years, Geron has been his "corporate partner," and it's his work on spinal cords, funded by Geron, that the company plans to use for its trials. On top of that, Keirstead owns the patent from this work for which Geron holds an exclusive license - something it seems he's failed to disclose in his numerous scientific papers on the topic.

What's more, he's been accused - even by fellow scientists - of excessive hype and haste.

This approach has served Keirstead well. His promotional work in 2004 for California's Proposition 71 helped convince voters to pony up $3 billion to fund human embryonic stem cell research. In particular, he distributed a video of a paralyzed rat which had regained some capacity for movement after Keirstead's treatment, even though the research had yet to be published in a peer-reviewed journal. One reporter said:

"Video footage of Keirstead's paralyzed rats walking after being injected with the stem cell treatment got widespread attention during the Proposition 71 campaign, and helped persuade voters that cures were right around the corner."

The video was cited by numerous proponents of the state initiative, including the paralyzed actor Christopher Reeve, who pronounced, "Stem cells have already cured paralysis in animals." In its first round of major research grants, the California program awarded Keirstead a $2.4 million grant, courtesy of the taxpayers.

That grant is only a quarter of [what] he's expecting. From the New Yorker, just before the vote on Prop. 71:

Hans Keirstead, the spinal-cord-injury researcher, is among the scientists [Prop. 71 author and campaign chair Robert] Klein has cultivated. Keirstead is also an entrepreneur; he has started two biotech companies and sold one.... Geron provides him with training and cells, and made possible five hundred thousand of the seven hundred and fifty thousand dollars his lab receives annually. Still, he believes the passage of Prop 71 would change his life....

[Keirstead] pointed out that the way Klein has structured the initiative-and is selling it-he needs revenues to be generated by the end of the first five years, when the state must begin making payments on the loans. And if Keirstead's experiments go to clinical trials sometime in 2006, they might conceivably produce revenues by the time the state needs them-depending, of course, on what kind of deal the state was able to strike. Now Keirstead walked through the math. Say, three hundred million a year, of which perhaps fifty million would go into the construction of research facilities; divide twelve-"O.K., even say it's twenty major people, not twelve"-into two hundred and fifty million. "I could get at least ten million," he concluded. "It would be huge."

Given the magnitude of Keirstead's promotional activities, his undisclosed personal financial interest, and his own statement of clinical trials "in about a year" back in 2002, his pronouncements on the timeline for embryonic stem cell trials should receive the same skepticism as those of Okarma.

Unfortunately, he's now turning to cloning-based stem cell research - an area that is even more speculative and holds more risk than typical embryonic stem cell research.


6.Few Defend UC Lab in Heated Meeting on EIR
By Richard Brenneman
The Berkeley Daily Planet

Berkeley residents came to share concerns about the fuel on the hill Wednesday night, and by the time the meeting had ended, only one voice had been raised in its unconditional defense.

Lawrence Berkeley National Laboratory (LBNL) officials called the gathering to collect comments to be addressed in the environmental impact reviews of two major projects already greenlighted by the UC Board of Regents.

The harshest critiques were leveled at the $160 million 160,000-square-foot Helios Energy Research Facility and its primary use as the designated home of the $500 million Energy Biosciences Institute, the alternative fuel research program bankrolled by BP, the rebranded British Petroleum.

But other speakers, including many long-time Berkeley land use activists, questioned the wisdom of building anything on an environmentally sensitive earthquake-, landslide- and fire-prone hillside still contaminated by past projects conducted under the aegis of the U.S. Department of Energy (DOE).


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