Geron Application for Human Embryonic Stem Cell Trials Timed for Obama Okay

Bioethics   |   Steven Ertelt   |   Feb 17, 2010   |   9:00AM   |   WASHINGTON, DC

Geron Application for Human Embryonic Stem Cell Trials Timed for Obama Okay

by Steven Ertelt Editor
February 17
, 2010

Washington, DC ( — A new report indicates the application Geron Corporation submitted to the FDA to become the first to engage in human trials of embryonic stem cells was timed with a trigger to make it so it would be considered during the Obama administration. The cloning company worried it would not be approved during the administration of President George W. Bush.

Just days after Obama took office, the FDA suddenly decided to approve Geron’s application for the controversial study.

Approval came even though embryonic stem cells have yet to overcome two major hurdles — including immune system rejection issues and their tendency to form tumors.

The FDA insisted the timing of the approval was coincidental, saying it merely approved Geron’s application 30 days after the agency received it, but new reports reveal that’s not the case.

Mark Henderson, a Times writer, says Geron’s chief executive, Tom Okar, met him in London this week and provided more details about how the process took place.

Henderson writes Okar "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."

Okar told the Times writer: "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."

American bioethicist Wesley J. Smith, who has been monitoring the approval process, says he’s not surprised by the revelation.

"So much for caring exclusively about alleviating the suffering of ill and disabled people," he writes today. "Geron’s head has admitted playing politics with the timing of its request to conduct the world’s first human embryonic stem cell trials on its ESC-based product to be tried on people with acute spinal cord injury."

Smith continued, "It never ceases to amaze me how obsessed Bush’s opponents were (and remain) with his relatively moderate funding restriction. "

"This much is clear: Okarma has admitted putting political considerations at least co-equal to scientific ones in conducting his company’s business: Why am I not surprised?" Smith added.

The Geron trial has been suspended over renewed safety concerns because of the discovery of cysts in experimental animals given the spinal injury therapy.

While Geron claims the trials will begin later this year, skeptics say they will be surprised if they ever do.

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