FDA Begins Tearing Down Walls Protecting Human Embryos

Today the biotech company Geron will make an unprecedented announcement: the U.S. Food and Drug Administration (FDA) has agreed to allow the company to conduct human trials utilizing human embryonic stem cells.

Ironically (or perhaps not), the FDA’s decision came right after President Obama’s inauguration.  It is just one of the many steps planned by the new administration to tear down the walls protecting human life.

Geron plans to conduct its trial on 8 to 10 people with spinal cord injuries.  The embryonic stem cells will be injected into the spinal cord at the injury site.  Geron has emphasized that the focus of this first trial will be safety (rather than efficacy), but it’s difficult to see how Geron can “safely” protect patients from the disastrous effects embryonic stem cells have had in mice, as well as the devastating results we have seen in the use of more advanced fetal stem cells in human trials.

For example, in animal testing, embryonic stem cells cause a significant number of recipients to develop tumors.  Using more developed fetal stem cells, a 52-year-old man died when the cells implanted in his brain became hair, cartilage, and connective tissue.  In another case, a group of patients with neural degenerative diseases with violent, uncontrollable shaking received fetal cell transplants into their brains.  Rather than improving, 15-25 percent developed severe dyskinesia (worse shaking than they had before).  This failure of more specialized fetal cells is an indicator of how much more difficult it likely will be to get less specialized embryonic stem cells to work.

Furthermore, as we report in Defending Life:

One of the inherent problems in using embryonic stem cells in therapies is the problem of transplantation.  If a transplanted cell’s DNA is even minorly different from the person’s being treated, the body usually sees those cells as an invader and kills them off-much like what happens when whole-organ transplants are rejected due to an immune system response.  Without the use of drugs to depress the patient’s immune system, transplanted tissue generally doesn’t survive but a few hours or days.

– Daniel McConchie, “Working for Cures, Not Clones,” Defending Life, available at http://www.aul.org/Cures_Not_Clones.

Even other researchers in the industry are skeptical of the safety and effectiveness of Geron’s first trial.  See Andrew Pollack, “F.D.A. Approves a Stem Cell Trial,” New York Times (Jan. 23, 2009), available at http://www.nytimes.com/2009/01/23/business/23stem.html.

The lack of success in animal trials, the lack of success in human trials using more advanced fetal cells, and the skepticism of researchers in the field beg the question: Why, in this time of economic trouble, is the FDA allowing clinical research that is dangerous and ineffective?  All the while, more prominent research using adult stem cells-which has already helped human patients with over 70 different conditions and diseases-remains underfunded and underutilized.

Perhaps the answer lies in the timing of the decision — on the inauguration of the most pro-abortion President in U.S. history.