FDA Approves Embryonic Stem Cell Research Trials on Humans Despite Concerns
by Steven Ertelt
January 23, 2009
Washington, DC (LifeNews.com) — Despite grave concerns that problems such as the causing of tumors and immune system rejection issues haven’t been solved, the FDA has approved the use of embryonic stem cells for human trial. Embryonic stem cell research has never cured or helped any patients to this point.
Only the use of adult stem cells and treatments derived from them have cured or reduced the effects of any diseases or conditions afflicting patients.
That efficacy reason, combined with the fact that embryonic stem cells can only be obtained by destroying early human life, has prompted the pro-life movement to oppose their use.
But now, the Food and Drug Administration has given biotechnology company Geron Corp., based in California, permission to conduct the first-ever human trial for a treatment derived from the controversial cells.
The trial will involve 10 spinal cord patients with injuries the company hopes to treat with an experimental drug containing embryonic stem cells.
"This is the dawn of a new era in medical therapeutics," Thomas B. Okarma, Geron’s president and chief executive officer, told the Wall St. Journal. "The hope that stem-cell therapy will repair and regenerate diseased organs and tissue goes beyond what pills and scalpels can ever do."
The timing of the announcement appears suspicious to some pro-life advocates who note that Obama campaigned on a pledge to overturn the funding limits President Bush put in place.
Bush limited spending on embryonic stem cells to existing cells and would not fund the destruction of more human lives to advance science. Instead, he spent hundreds of millions on adult stem cells because of these ethical concerns and because they were the only cells to help patients.
Karen Riley, an FDA spokeswoman, denied that politics had anything to do with the timing of the decision.
"The FDA looks to the science on these types of issues, and we approve [such applications] based on a showing of safety," she told the Journal. "Political considerations have no role in this process."
Though the FDA approved the trial, that doesn’t mean the political battle over embryonic stem cell research funding is over.
President Obama will either have to issue an executive order to overturn the Bush protections from making taxpayers fund life-destroying research or he will have to rely on Congress to do so — which seems more likely.
In a recent interview with CNN, he indicated he may rely on Congress to overturn the limits.
"I like the idea of the American people’s representatives expressing their views on an issue like this," he said.
However, the reason may be more political in nature as a Congressional bill would have the force of law and be harder for a pro-life president to overturn, as legislation would be needed to reverse the decision.
Approval of the study is no guarantee that the treatment will work or that drugs based off of it will enter the market and be available to patients on a national basis.
That’s in part because embryonic stem cell researchers have yet to overcome all of the problems that have plagued the drug in use with animals.
The cells have had two main scientific problems in that they tend to cause tumors after they are injected and the body’s immune system rejects the foreign cells. These problems are not seen in use with adult stem cells.
The patients in the trial will be ones who can receive treatment within 14 days after a spinal cord injury has left them paralyzed. They will need to be followed for a year to determine if the treatments had any effect.
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