Thursday, November 17, 2011

Geron hESC Withdrawal 'Real Blow' to California Stem Cell Agency, Says CGS

In a sharp-edged analysis of Geron's abandonment of stem cell research, the Center for Genetics and Society yesterday described the action as a "real blow" to the California stem cell agency.

Written by Pete Shanks, a regular contributor to the Berkeley center's Biopolitical Times, the piece chronicled some of the history and hype involving Geron and hESC research. The center has long taken a skeptical view of the California stem cell agency and Geron. Shanks wrote,
"Geron has been in trouble for a while. Former CEO Thomas Okarma, who left abruptly in February, was the subject of ridicule for his repeated announcements that ESC-based clinical trials would begin "next year" — that is, 2005, 2006, 2007, 2008 — and the trial they eventually came up with was so dubious that Arthur Caplan called it "nuts and hugely risky." Even experts in the field thought that targeting spinal cord injury in the first ESC trial was dubious, though some seem to be more willing to be critical now it has ended.

"And that was on the scientific and perhaps commercial merits. The ethical problems were much worse, since the trial was intended for people who had recently suffered damage to their spinal cords. Bioethicist Laurie Zoloth (who was once on Geron's ethics advisory board, and basically approved of the study), noted at the time of its announcement that:

"'True informed consent in this very vulnerable population, people who have suffered a devastating and life-changing injury a week prior to being asked to enter the first clinical trial for such long-awaited, highly publicized and desperately needed treatment, is hard to obtain and will need to be carefully thought through.'"
Shanks also wrote,
"What of CIRM's role? After Geron's announcement, they issued a remarkably bland press statement, followed by an internal memo that expressed deep disappointment (the California Stem Cell Report has the text). It's a real blow to them: Geron was the first private company to receive funds from CIRM to run a clinical trial using ESCs.

"This was a loan, not a grant, and was only made, as the indefatigable David Jensen (publisher of the California Stem Cell Report) discovered, after a 'major departure from longstanding procedures.' The proposal received a low score (66/100) that was not publicly revealed until Jensen specifically asked for it. And the other applicants who might have competed for those funds rather surprisingly all withdrew.

"The suspicion arises that CIRM, or some people within it, badly wanted the trial to proceed in the hope that it would give them a therapeutic success to boast about. If so, the decision just backfired."
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4 comments:

  1. This is the big scoop? Someone at CIRM wanted the trial to go forward in the hope of having a therapeutic
    success?

    Wow, that is some real skullduggery uncovered.

    There is no scandal, only the sad news that people with
    spinal cord injuries will have to wait even longer.

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  2. Jon Shestack, the author of the comment on the CGS item on Geron and CIRM, is a member of the 29-person governing board of the stem cell agency. He makes a good point. CIRM is supposed to develop therapies. That means it must engage with business. The "suspicion" being raised by Shanks is whether corners were being cut in an effort to get on what was then a much-ballyhooed Geron bandwagon.

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  3. It is OF COURSE sad that people with spinal cord injuries won't have their hopes met, as (my colleague) Pete Shanks acknowledged.

    The point he is making is that their hopes were raised to a quite unreasonable extent by years of hype around the imminence of ESC-based treatments - and by a clinical trial that seems not to have been the most scientifically (or commercially) feasible test of them.

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  4. Carlson10:48 PM

    There is one good thing to come out of Geron's pioneering experience: for the first time, the FDA approved a clinical trial for a therapy based on human embryonic stem cells. that's no small accomplishment.

    It is never easy to persuade a regulatory agency -- be it the FDA, the SEC, or any other body -- that a radically new approach to an issue that breaks sharply with conventional thinking is worthy of the regulator's blessing. It's an expensive, time-consuming, and infuriating exercise.

    Geron apparently made a rational business decision that the timeframe for a return on its investment in the spinal cord therapy was either too long and/or too uncertain. But it established a precedent for subsequent embryonic stem cell therapies that should shorten the time required to receive approval to take innovation from the laboratory to the clinic.

    That's a legacy that will serve science and patients well going forward. That alone warrants praise.

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