Source: | Written by: SUSAN GILBERT
For nearly seven years, federal funding of human embryonic stem cell research has been banned in the United States on ethical grounds. Now, looking ahead to a new administration, proponents of lifting the ban are ramping up their effort to fight ethics with ethics.

In addition to the usual ethical argument – that federal support of stem cell research could speed up the discovery of cures for Alzheimer’s disease, diabetes, and other serious conditions – proponents raise a another issue: that it could finally open the way to ethical review of stem cell research.

There is no federal ethical oversight of stem cell research in this country. That means that there are no limits on what stem cell researchers can do. Should human embryonic stem cell research be limited to embryos left over from fertility treatments? Must donors give informed consent? Can they be paid? Should there be limits on the purpose of the research – to develop life-saving therapies but not, say, cosmetics? No one knows. With no well-reasoned legal guidelines, researchers, research institutions, and policy-makers are left to go with their guts.

Hoping to change that, Rep. Diana DeGette (D-Co.) announced on May 8 that she and Rep. Michael Castle (R-Del.) would introduce legislation this summer to permit federal funding of human embryonic stem cell research and authorize the National Institutes of Health to construct a framework for ethical oversight of stem cell research.

The latest legislation will be the third attempt to repeal the ban on federal funding of human embryonic stem cell research but the first attempt to mandate a process for determining which stem cell research activities are unethical and should be illegal.

The need for this process became evident just three days after DeGette’s announcement, when The Sunday Times of London reported that Cornell University researchers had created what is believed to be the first genetically modified human embryo. Gut reactions raged immediately as critics condemned the researchers for opening the door to the creation of “designer babies.”

The researchers defended their work, saying that they had intended to use the test-tube embryo to extract stem cells for research and that the embryo, which was abnormal to begin with, could never develop into a baby. Do these factors make the research ethical? Or does genetically manipulating a human embryo for any purposes cross an ethical line? The Weill Cornell hospital IRB that approved the research thought it was okay. But no one really knows.

The need to sort out answers to these difficult questions is growing more urgent now that the first clinical trials of stem cell therapies are on the horizon. On May 14, six days after DeGette’s announcement, the first clinical trial of an embryonic stem cell therapy was put on hold by the Food and Drug Administration. The trial was for a therapy for spinal cord injuries developed by Geron Corporation.

The FDA gave no reason for its decision, but researchers speculated that it might be due to the lack of criteria on how to assess the safety of stem cell trials, a significant ethical concern. Meanwhile, other stem cell therapies being readied for clinical trials include treatments for macular degeneration and diabetes.

A federal ethical review process for stem cell research would help the FDA decide which stem cell trials should proceed, and it would assure everyone else that the decisions were based on solid, transparent criteria, not on gut reactions. Speaking about the legislation that she is drafting, Ms. DeGette told CongressDaily: “I want to be ready when we have a new president and a new Congress to pass legislation that both reverses the president’s order and makes a new commitment to ethical cell-based research.”

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Readers Respond to “Stem Cell Research: Fighting Ethics With Ethics”

Susan Gilbert hits on some extremely important issues. The need for federal ethical oversight committees is needed and in fact, has been needed for some time. And while I agree with most of her points, I’d like to highlight one that was not mentioned. The ethics of stem cell research, particularly that which depends upon government funding, must also consider how the research will benefit underserved communities suffering from health care disparities.

Residing in California, which authorized a $3 billion stem cell research initiative because of the ban on federal funding for human embryonic stem cell research, has proven an interesting ride for Californians. In California, an “independent” body (the ICOC) oversees the research grants and ethical oversight of the California Institute of Regenerative Medicine (CIRM) created to distribute the 3 billion dollars.

My organization, the Greenlining Institute, has worked to ensure that CIRM heeds its promises to support and finance research that would benefit diverse communities and low-income communities. As we move forward with scientific and medical advancements in stem cell research, it is important to assure that all people benefit from the research when there is federal or state level funding for it.

Unfortunately, the ICOC failed miserably when it had the chance to approve a grant to Children’s Oakland Hospital Research Institute. CHORI’s application included a plan to construct a new GMP cellular facility. Aside from the fact that CHORI is recognized as a national resource for cord blood and placental cell studies, CHORI staff have reported that 92% of children with sickle cell anemia have been cured following an HLA matched sibling cord blood stem cell transplantation. Right now, since less than 25% of patients with sickle cell anemia have a suitable donor for a stem cell transplant, the research proposed at CHORI has the potential to expand current transplantation practice in California and throughout the nation. It appears that the working group did not appreciate the need for CHORI’s GMP facility to successfully carry out clinical trials that would benefit our State.

Oversight committees are needed to assess the ethical nature of funding the research, what type of research should be allowed, and once that is decided, to ensure that all communities have access to and can benefit from the research.

– Jamie D. Brooks,
The Greenlining Institute