WASHINGTON (BP)–The U.S. Food and Drug Administration has put a hold on proposed clinical trials using embryonic stem cells in human beings.
The news was a blow to the hopes of the Geron Corp., which had applied for FDA approval for the first such experiments. The California-based firm had sought permission to use stem cells from human embryos in experiments seeking treatments for spinal cord injuries. Geron had reported in February it expected to begin embryonic stem cell experiments this summer, according to CNNMoney.com.
A Southern Baptist bioethicist welcomed the news but expressed skepticism about the FDA postponement.
“Any delay is good news, but it is like those human embryos used in research — it is likely to be short lived,” said C. Ben Mitchell, director of the Center for Bioethics and Human Dignity in suburban Chicago and a consultant to the Southern Baptist Ethics & Religious Liberty Commission.
“The FDA makes its decisions about drugs and procedures on the basis of safety and effectiveness,” he said. “Since they don’t regard human embryos as persons, their safety does not matter. As we know from the FDA’s approval of the abortion drug RU 486, the destruction of unborn human life is not of great importance to our federal drug agency.”
The extraction of stem cells from an embryo for research results in the destruction of the tiny human being.
Geron announced May 14 the FDA had informed it verbally of the hold on the trials.
“We are disappointed with this action given the interactions we had with the FDA over four years leading to the filing, and the breadth and depth of the submission, some 21,000 pages, predicated on those discussions with the agency,” Geron President Thomas Okarma said in a written release.
At an April 10 meeting of experts sponsored by the FDA, Steve Bauer, chief of the agency’s cell and tissue therapy branch, said it might require “particularly strong” proof early in the trials of the effectiveness of stem cell treatments, according to Bloomberg News.
So far, embryonic stem cells not only have failed to produce treatments in human beings, but they have been plagued by the development of tumors in lab animals.
In November, scientists reported they had discovered a means of producing stem cells that are virtually the same as embryonic ones without destroying human life. The cells produced from adult stem cells by the method, known as reprogramming or dedifferentiation, are called “induced pluripotent stem cells.” Embryonic stem cells are pluripotent, meaning they can develop into all of the different cell types in the body.
Stem cells from non-embryonic sources –- such as umbilical cord blood, placentas, fat and bone marrow –- are not pluripotent, but trials with them have produced treatments for at least 73 human ailments, according to Do No Harm, a coalition promoting ethics in research.
The FDA approved the sale of RU 486, a two-step abortion regimen, in 2000.
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Compiled by Tom Strode, Washington bureau chief for Baptist Press.
