Biotech firm hopeful for embryonic trials
WASHINGTON (BP)--The U.S. Food and Drug Administration may permit clinical trials using embryonic stem cells to begin within three months, a biotechnology firm has reported.
Tom Okarma, president of Geron Corp., said Oct. 15 the firm has been working to overcome a hold placed by the FDA on the company's application for a trial with human beings on a compound procured from embryonic stem cells to treat spinal cord injuries, according to a weblog on The Scientist's Internet site. The FDA placed a hold in May on the application. Geron has sought to "educate" the FDA on its methods, Okarma said.
The FDA's review process is nearly complete, and it may drop the hold within the next three months, Okarma told The Scientist, which is a magazine on the life sciences.
A Southern Baptist bioethicist says, however, that review won't solve at least one major problem.
"Clinical trials using human embryos destroyed for their stem cells present a monumental ethical obstacle," said C. Ben Mitchell, a professor of bioethics and contemporary culture at Trinity Evangelical Divinity School in suburban Chicago. "Living human beings are purposefully killed in order to test medical treatments for other human beings.
"Geron and their cheerleaders may try to spin it another way, but that is precisely what's going on. And as they grasp for hope, individuals suffering from terrible illnesses are being tempted to become complicit in the destruction. If an effective therapy eventually does emerge, people with pro-life consciences will have to refuse treatment. The whole scenario is grotesque.
"The FDA evaluates two things: safety and effectiveness," said Mitchell, a consultant on biomedical and life issues for the Southern Baptist Ethics & Religious Liberty Commission. "No matter how effective, embryo-destructive stem cell research can never be safe for the embryos who are destroyed.
"I'm certain this news will come as a surprise to many people who have been led to believe that there must be dozens, if not hundreds, of embryonic stem cell trials going on. Despite the unprecedented hype, embryonic stem cells have been a notorious failure clinically. Adult stem cells are currently being used therapeutically and are showing enormous promise for future healing and cures."
Embryonic stem cells have yet to treat any diseases in human beings and have been plagued by the development of tumors in lab animals. Unlike research using embryos, extracting stem cells from non-embryonic sources – such as umbilical cord blood, placentas, fat and bone marrow – has nearly universal support. Such research has produced treatments for at least 73 human ailments, according to Do No Harm, a coalition promoting ethics in research.
The federal government funds non-embryonic stem cell research, but, based on a decision by President Bush, refuses to provide grants for stem cell research that results in the destruction of human embryos.
Compiled by Baptist Press Washington bureau chief Tom Strode.