In BUSINESS OF STEM CELLS on February 17, 2010 at 11:41 pm

This is from the UK Times. -dg


Geron engineered stem cell application so Obama could announce approval

When the US Food and Drug Administration agreed to approve the world’s first trial of a therapy based on human embryonic stem cells just over a year ago, the timing of its announcement was intriguing.

The Bush Administration had been highly obstructive of embryonic stem cell research, imposing a ban on most federal funding of such studies, which Barack Obama had pledged to overturn. Then, just days after President Obama’s inauguration, the FDA suddenly decided that the time was right to give Geron Corporation permission to start its patient trials.

It certainly looked like more than a coincidence, and the decision was widely interpreted as evidence of a sea change in the US Government’s attitude to stem cell research. But the FDA insisted that the timing was incidental — it had simply ruled on Geron’s application 30 days after it was received, as it was required to do.

It now turns out that the timing was more than a coincidence. When I met up with Geron’s chief executive, Tom Okarma, in London this week, he revealed that the announcement was deliberately planned for the immediate aftermath of President Obama’s inauguration. But it was the company, not the FDA, which set this in motion: Geron deliberately timed its application so it would be decided just after President Bush left office, so that the Obama Administration would be able to announce it.

Dr Okarma told me:

“Many people hypothesised the first time that the lifting of the hold was due to the Administration change. We have no information and no indication that that was the case. We engineered the timing, because our final submission was timed such that the 30-day window occurred after the inauguration of President Obama. That was our design, not really an Administration change. That was our timing. We did not want this to come up under the Bush Administration. We designed it.”

So a loose end is tied up. Geron’s trial, incidentally, was subsequently delayed, following the discovery of cysts in experimental animals given its stem-cell spinal injury therapy. The company now hopes to start trials in the third quarter of this year.

VIA http://timesonline.typepad.com/science/2010/02/geron-engineered-stem-cell-application-so-obama-could-approve-it.html

  1. Spend any amount of time lately with Don Margolis, founder of The Repair Stem Cell Institute, and the conversation will invariably turn to Geron and their “World’s first human clinical trial of Embryonic Stem Cell Therapy.” “Many will profit from this public relations event, but the patients and the taxpayers will lose mightily!” he states emphatically.

    America appears to be a nation in pathological denial. Here’s one extract:

    Los Angeles Times, January 24, 2009: “Stem cell therapy to be tested on spinal cord injuries: The FDA approves the first clinical trial using human embryonic stem cells, which now appear safe enough to use on humans.(1)

    Ushering in a new era in medicine, the U.S. Food and Drug Administration said Friday that it had cleared the way for the world’s first clinical trial of a therapy derived from human embryonic stem cells. By early summer, a handful of patients with severe spinal cord injuries will be eligible for injections of specialized nerve cells designed to enable electrical signals to travel between the brain and the rest of the body. (2)

    (1) That is the writer’s opinion, since no scientist is quoted. Don’s opinion is that the whole thing is PR hype to push up Geron’s stock price and that the trial will not be allowed by the super-powerful embryonic lobby. (RSCI January Newsletters)

    (2) You’d better believe that Don will be reminding you as the “early summer” comes and goes without one patient treated. Spinal cord patients are paying the false-hope price for the promoters’ benefit
    Geron has a lengthy track record of such stock manipulation, having made ten such announcements of upcoming trials over the past five years – none of which has ever happened.

    What Americans are not allowed to know from their print media is that people all over the world who were once told by their doctors that they “will never move again,” are moving because of Repair Stem Cell treatments. Indeed, in China alone, over a thousand victims of spinal cord injury have had their lives improved by Repair Stem Cell therapies combined with intensive rehab regimens.

    The REAL first human stem cell trial for Spinal Cord Injury was held seven years ago in Portugal by a REAL scientific leader in stem cell therapy, not by some stock-manipulating company in California specializing in public relations hype and little more. Spend two minutes watching Don’s video on the subject at: http://repairstemcells.org/StemCell101.php which is the home of STEM CELLS 101. Look for Class #4.

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