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Commitment to Biomedical Research...Clearing Unnecessary Impediments to Progress

Professor of Oncology and Pediatrics The Johns Hopkins University School of Medicine

U.S. Senator Arlen Specter (R-PA), Ranking Member of the Subcommittee on Labor, Health and Human Services and Education Appropriations, invited STEM CELLS’ Editor-in-Chief, Curt I. Civin, M.D., to speak at the hearing focused on the progress of embryonic stem cell research since August 9, 2001 and the effectiveness of the President’s policy as it is currently being implemented. Dr. Civin was asked to present his experiences in attempting to procure embryonic stem cells, and how this has affected the pace of his research. Most people, even most scientists, thought that researchers had reasonably easy access to the more than 70 human embryonic stem (hES) cell lines on the Presidential-approved National Institutes of Health list, when, in fact, we have access to only 1-5 of these cell lines. And even these 1-5 have taken many months to acquire. To their credit, NIH has responded by facilitating access to hES cell lines, and is also educating scientists in how to culture them. NIH has also reached out to enlist extramural scientists to serve on committees to make recommendations to help foster hES research.

Senator Specter asked the witnesses at the hearing to follow up with specific policy recommendations to promote stem cell research.

The Editors of STEM CELLS are pleased to share excerpts from Dr. Civin’s follow-up correspondence to Senator Specter with our readers.

Commitment to Biomedical Research...Clearing Unnecessary Impediments to Progress

Excerpts from Letter to Senator Arlen Specter

Policy Recommendations Requested at Hearing on Human Embryonic Stem Cell Research

September 25, 2002, U.S. Senate

I share your belief that President Bush’s embryonic stem cell policy is too restrictive, and that legislation is necessary to advance the research. I also believe that in the interim, creative and pragmatic steps can be taken, within the constraints of existing policy, to encourage more researchers to enter the field and to increase the availability and accessibility of lines on NIH’s registry.

CREATE A STEM CELL REPOSITORY

As I stated in my testimony, I support the creation of a stem cell repository to act as a clearinghouse for the dissemination of embryonic stem cell lines to researchers and to provide information on the characteristics of each line. In the short term, no single action is likely to produce a greater catalyst for research.

Establishment of a stem cell repository will not be easy, but it is essential. Since NIH does not own the human embryonic stem cell lines on its Registry, intellectual property issues will have to be negotiated with the current owners. It will, however, be far more effective for the NIH, backed by the power and prestige of the U.S. government and its scientific community, to negotiate as many such agreements as possible, rather than for each of the thousands of individual researchers at institutions across the U.S. to attempt to negotiate agreements with each source independently. As I am sure you know, Britain’s Medical Research Council recently announced plans to establish a UK Stem Cell Bank for embryonic and adult stem cells to assist researchers in similar efforts.

Such an initiative would streamline the tremendous inefficiency of our current system—and lower the costs in both time and money—of obtaining stem cell lines. Under this arrangement, NIH, or an NIH-designated facility, would characterize the cell lines and then act as a technical resource and distribution center for scientists seeking to obtain them. This would eliminate duplication of effort and provide an invaluable technical resource for growing the cells. Vesting one organization with the ability to distribute all cell lines would also produce economies of scale.

LIMITATIONS OF PRESENT POLICY

While increasing the availability of approved lines is necessary, new lines will need to be developed. The universe of embryonic stem cell lines approved by the President consists of less than one hundred. This number is insufficient to develop the full potential of stem cell research in the long term. We will surely discover that many of these lines, once characterized, are of limited value in particular lines of research. For example, as I mentioned in my testimony, I need blood-forming stem cells—and I suspect that not all embryonic stem cell lines will be capable of producing these cells. There are other limitations as well. Eventually, some of the approved lines will simply stop growing—some may already be unable to reproduce in sufficient quantity. All of the lines on the NIH Registry have also been exposed to mouse-feeder cells, rendering them unusable for therapeutic treatment.

The political controversy over this research is another significant obstacle to progress. Talented young researchers are not entering the field of stem cell research because of uncertainty about policy changes that will affect its future. Research opportunities, and indeed pay, are at risk of suspension.

It is important to note that the President’s decision has not only affected federal research funding, it has also become the default position for many private research grants. For example, when I applied for a grant from a local foundation to initiate a new stem cell research project in my laboratory, I was required to restrict my investigations only to the Presidentially-approved embryonic stem cell lines.

We need to do more to foster an atmosphere that is supportive of stem cell research. The State of California’s recent enactment of stem cell legislation is a very positive step in the right direction, and I am hopeful that, with your leadership, the federal government can adopt similar measures endorsing and supporting stem cell research. Both the substance—and the symbolism—of California’s action will encourage more scientists to enter the field.

POLICY CHANGES TO PROMOTE STEM CELL RESEARCH

We need to produce additional lines and develop new research techniques in order to tap the full potential of this promising research and deliver treatments and cures to patients. It will take many years to do so, but the longer we delay, the longer it will take to achieve these life-saving results.

In recent months, the distinction between adult and embryonic stem cell research has been exaggerated. Both are necessary—and discoveries in each field will reinforce the success of the other. I am an adult stem cell researcher, but I believe that there is much that has to be learned about the limited "plasticity" (breadth of developmental potential into all cell types) and self-regenerating capacity of adult stem cells. This information can come from research on embryonic stem cells. Then we will have signposts for us to better and more rapidly develop and clinically apply adult stem cells. In short, essentially all scientists studying adult stem cells believe that progress in adult stem cell research and clinical application is dependent on basic research on embryonic stem cells.

The following policy changes are necessary to permit a broader range of embryonic stem cell research throughout the U.S.:

1. Broaden President Bush’s restrictions to allow federal funding to derive and conduct research on stem cells obtained from donated, unused embryos (leftover embryos from in vitro fertilization [IVF]), under appropriate ethical guidelines.
   We can produce additional lines safely, responsibly, and confidentially. Human embryonic stem cell lines are derived from a primitive clump of cells smaller than the period at the end of this sentence. These cells have no identifiable brain, heart, lungs, or other organs—and no responsible scientist seeks to grow the cells for research beyond this point.
   IVF clinics routinely produce more embryos per couple than are used for their treatment. When given the choice, many donors would prefer to donate these unused embryos for medical research than dispose of them. We should make it easier for couples to do so, as California has provided in its legislation. Couples with religious or other objections to use of their embryos could simply and privately decline to allow this, but their views would not affect the actions of others in our pluralistic society.
   
2. Permit nuclear transplantation to produce stem cells and allow federal funding for this laboratory technique.
   Nuclear transplantation, often referred to as therapeutic cloning, is an important tool for comparison of healthy and diseased cell development that holds great promise of understanding and treating human disease. For example, we could someday (when we learn to grow a human kidney in vitro) study the development of a kidney from an egg that contains the nucleus from a patient who developed inherited kidney failure, and we could compare that abnormal process to the development of a kidney from someone with normal kidneys. Or we could use nuclear transfer and in vitro culture to study, for example lung cancer development, with or without the addition to the organ culture of carcinogens from tobacco. Or we might artificially add, subtract, or mutate DNA in the nucleus to be transferred. In these examples, we would be culturing the tissue/organ developed from an egg that had undergone nuclear transfer; authentic scientists have no reason to grow an entire embryo (which would require implantation into a woman’s uterus).
   Some have suggested creating a moratorium on nuclear transplantation research, in part because it sounds like a harmless compromise. As you know, a moratorium on federal funding for research involving this laboratory technique is currently in place. Any moratorium does nothing but delay important decisions about setting guidelines for research, promote uncertainty, and most importantly, deny hope to millions of Americans who could be assisted by life-saving treatments developed as a result of this promising research. A delay forces scientists, especially young scientists about to launch their independent research careers, to stay away from stem cell research, or to leave the U.S. for other nations that permit the research. Finally, since the U.S. is the leader in all types of biomedical research, any moratorium on participation of U.S. scientists will keep stem cell research crawling at the speed of a caterpillar.
   

I hope this summary helps explain why we must foster, not block or delay, all forms of promising stem cell research. I know that we can do this safely and responsibly.

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