DAVID GRANOVSKY

Archive for February 17th, 2010|Daily archive page

GERON RULED BY POLITICAL AGENDA

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

This is from the UK Times. -dg

02/17/2010

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

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