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Michael Rugnetta Headshot

A New Debate Can't Wait

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Mr. President, we are ready for your go-ahead! The ethical debate on embryonic stem cell research is moving. Scientists and ethicists have debated long enough about whether we should do embryonic stem cell research. It is now time to debate how we do the research - both at the bench and at the bedside.

The journal PLoS Medicine recently published an article about an Israeli boy who developed benign tumors from human neural fetal stem cells that scientists in Moscow had implanted in his spinal cord as a "therapy." The ethical and scientific breaches perpetrated in this so-called therapy are numerous and illustrate the finer points of where the new debate should go. First, who do we research these therapies on? What organs? What diseases? How far progressed should the disease be? And, once the therapies have been established, who gets them? This goes not just for clinical embryonic stem cell research but also for any clinical research involving stem cells that are pluripotent, or capable of transforming into any one of the over 200 cell-types in the human body.

Although it has been much maligned for recent food safety disasters, our FDA has proceeded quite tactfully on a recent decision to approve the clinical trial involving an embryonic stem cell therapy. But the process can still be better.

Here's the good part: In January, the FDA approved the first U.S. clinical trial for a human embryonic stem cell therapy. Geron, the company that developed the therapy, plans to use the cells to repair damaged spinal cords, and is proceeding cautiously with its selection of patients for the trial. Geron has specified that their cells must be injected seven to fourteen days after injury and that the injury must be located in a certain section of the spine.

But here's the caveat: In spite of the best efforts of Geron and the FDA, followers of embryonic stem cell research are waiting with bated breath since there is still a chance -- as there almost always is -- that something could go wrong with the clinical trial. A single disaster could poison the entire stem cell research enterprise.

What the Department of Health and Human Services should do is take the extra step of transparent ethical strategizing. Specifically, the NIH should convene a new working group under its Recombinant DNA Advisory Committee, or RAC. The RAC was created in 1974 to foster public acceptance of basic and clinical recombinant DNA research through open deliberation between the scientific community and the lay public. This new working group would do the same thing but with pluripotent stem cell research. It would recommend the overall ethical approach that the stem cell research community should take when moving pluripotent stem cells from the bench to the bedside. This would ensure that all stem cell research would move ahead ethically and with the best chances for success.

If a committee like this were already in place it could have fostered better public understanding of what lies ahead with Geron's promising but still risky clinical research. It could have provided a forum for airing the opinions of scientists, patient advocates, and the general public so that it could get all stakeholders on the same page and set good faith expectations. Indeed, some scientists and ethicists argue that the first clinical trial involving embryonic stem cells should not be on the spinal cord like it is with the Geron trial. Rather, they suggest that the first clinical trial take place on patients with the eye condition known as macular degeneration since the eye is a more confined structure than the spinal cord. An argument like this does not serve to undermine the work of the FDA or of Geron. Instead, it bolsters the view that pluripotent stem cell research is a worthwhile scientific enterprise even though the road to viable thearpies may be a long and difficult one.

Moreover, the goal of the working group would not be to add another level of bureaucratic red tape but simply to foster discussion, transparency, accountability, and public understanding. This would allow the public and the scientific community to proceed together in good faith without the polarized finger-pointing that has plagued this research for so long.

We no longer have the luxury of debating the profound but ultimately unanswerable questions surrounding the dignity of the embryo. The research is proceeding whether we like it or not and it needs to proceed safely, ethically, and in a manner that is trusted by the American public for its intellectual honesty. The United States must take the lead in establishing ethical precedents and safety benchmarks as embryonic stem cells are introduced into humans. The U.S. also needs to set protocols for justly and ethically selecting research subjects and therapy recipients.

The NIH has been getting the guidelines ready for the ethical conduct of non-clinical, basic human embryonic stem cell research. This would finally put the United States in its rightful place as a global leader on basic stem cell research. But if we truly want to be on the vanguard, we must move ahead into an open and thoughtful discussion of clinical research and practice.