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Statement on Cloning: Legal, Medical Ethical, and Social Issues

Mr. Chairman and members of the Subcommittee, I am David Korn, M.D., Senior Vice President for Biomedical and Health Sciences Research at the Association of American Medical Colleges (AAMC). On August 31, 1997, I became Vice President and Dean of Medicine and Professor of Pathology, Emeritus, at Stanford University, where I had been on the faculty for 29 years. The AAMC represents the nation's 125 accredited medical schools, nearly 400 major teaching hospitals, more than 87,000 faculty through 86 professional and scientific societies, and the nation's 67,000 medical students and 102,000 residents.

The AAMC commends the Subcommittee for convening this hearing to begin to explore the very sensitive and complex medical, ethical, legal and social issues surrounding "human cloning." As the last few weeks have demonstrated, the poorly-understood nascent technology of somatic cell nuclear transfer has raised difficult and emotionally charged questions that have proved difficult to discuss in simple, unambiguous English language. Even scientists and physicians may disagree on some of the points that have been raised today. It is for these reasons that we encourage you and your colleagues to continue to explore these issues, patiently and deliberately, with all of the interested stakeholders.

In particular, we are pleased that you have included representatives from the patient community at this forum. Their input is vital because as the major potential beneficiaries of this powerful new technology that you have been discussing here today, they are the ultimate stakeholders in this debate. The AAMC is gratified to be participating in the panel of patient advocates because we believe that fundamental to the mission of this nation's medical schools and teaching hospitals is the obligation to represent and protect the interests of our present patients and those who will seek our care in the future. It is because of this obligation that our medical schools and teaching hospitals have become world-leading citadels of basic and clinical biomedical research and education.

As you consider the myriad, and sometimes distracting, issues that have been raised in the course of the national debate that has raged for the past few weeks, we believe there are two fundamental points that must be emphasized. The first is that this debate to a large extent has been focused on the wrong questions. This debate should not be about creating life, it should be about saving lives.

We agree with the American public that the cloning of human beings should not proceed at this time. All responsible scientists and physicians find the prospect of attempting to produce human clones by somatic cell nuclear transfer - or any other technology, for that matter - as abhorrent as do the members of this Subcommittee. Let me be clear: The medical and research communities are not interested in making people. But we are committed to producing cures for the diseases and disabilities that plague our population, resulting in devastating emotional, social and economic costs and over $1 trillion in health care expenditures each year.

The current opportunities in biomedical research to address these health challenges are unparalleled in our nation's history. This leads me to our second point. We have grave concerns that any legislative proposal that bans outright a specific scientific technology will have an extremely chilling effect on future progress in biomedical research and human healing.

It is important to keep in mind that the terms "cloning" and "somatic cell nuclear transfer" are not synonymous. Cloning refers to the production of an identical genetic copy. It occurs naturally in human beings and animals in the birth of identical twins. In contemporary biomedical research, the cloning of DNA molecules and individual cells has become commonplace, while the cloning of individual plants or animals is carried out today in both research and commercial settings. Somatic cell nuclear transfer is one specific process that can be used for cloning. The technique has been studied in amphibia and other lower animals for a very long time, and more recently has been successfully carried out in higher animals (cows and sheep) using fetal cells as the somatic cell nuclear donors.

To date, there has been only a single reported case of cloning in a higher animal using an adult somatic cell as the nuclear donor. That, of course, was the report about 1 year ago from Scotland in which Dr. Ian Wilmut described the production of Dolly. The Wilmut report contained a number of problematic features, including the fact that the technology had been successful in only one of 277 attempts. It is terribly important to understand that to date, the Wilmut result has not been successfully reproduced anywhere in the world. And within the past couple of weeks, two eminent scientists published a long letter in Science Magazine raising serious questions about the way in which Dr. Wilmut had performed and reported his experiment and interpreted his results. At the present time, the ability to use adult cells as donors in somatic cell nuclear transfer technology to produce a live-born, cloned animal has not been proved. As several eminent scientists have said, at the present time the experiment reported by Wilmut can only be considered an anecdote and not an established scientific fact.

It is also important to recognize that the somatic cell nuclear transfer technology has many exciting and potentially enormously important applications in research, medicine and industry, including the cloning of genetically engineered animals that produce large quantities of powerful pharmacological agents, or producing genetically engineered human cell cultures that would serve as "therapeutic tissues" in the treatment of currently intractable human diseases. The use of the technology to attempt to clone human beings is utterly unappealing scientifically, as well as being morally repugnant.

According to the National Institutes of Health, somatic cell nuclear transfer technology could provide an invaluable approach by which to study how cells become specialized, which in turn could provide new understanding of the mechanisms that lead to the development of abnormal cells responsible for cancers and certain birth defects. Improved understanding of cell specialization may also provide answers to how cells age or are regulated -- leading to new insights into the treatment or cure of Alzheimer's and Parkinson's diseases, or other incapacitating degenerative disease of the brain and spinal cord. The technology might also help us understand how to activate certain genes to permit the creation of customized cells for transplantation or grafting. Such cells would be genetically identical to the somatic cell donor and could therefore be transplanted into that donor without fear of immune rejection, the major biological barrier to organ and tissue transplantation at this time.

Imagine, if you will, having the ability to clone cells from a diabetic patient, manipulate them genetically in the laboratory to turn on their genes that direct the synthesis of insulin, and then being able to propagate them in culture to generate large numbers of insulin producing cells that are genetically identical to one another and to the patient. The cells could be transplanted back into the patient without risk of rejection and with no need for the powerful, chronic immunosuppressive therapy that is now mandatory for transplant recipients, and which ultimately fails.

Other types of specialized cells could be created to enable skin grafts for burn victims; bone marrow stem cells to treat leukemia and other blood diseases; nerve stem cells to treat neurodegenerative diseases such as multiple sclerosis, amyotrophic lateral sclerosis (Lou Gehrig's disease), Alzheimer's and Parkinson's disease, and to repair spinal cord injuries; muscle cell precursors to treat muscular dystrophy and heart disease; and cartilage-forming cells to reconstruct joints damaged by injury or arthritis. Somatic cell nuclear transfer technology could also be used potentially to accomplish remarkable increases in the efficiency and efficacy of gene therapy by permitting the creation of pure populations of genetically ‘corrected" cells that could then be delivered back into the patient, again with no risk of immune rejection. Indeed, this technology could well lead to the operationalization of gene therapy as a practicable and effective therapeutic modality - a goal which to date has proved elusive.

Can we guarantee that these dreams will come to fruition? Perhaps. We believe the prospects are very bright, building on the vast store of biomedical knowledge that has been amassed during the past five decades; with the continued generous support of the federal government through the National Institutes of Health and other federal research agencies, and of a robust pharmaceutical and biotechnology industry; and with the remarkable talents, perseverance and dedication of our academic and industrial scientists and other health professionals. But what we can guarantee is that we will never see the fulfillment of any of these promises if we choose to take the perilous path of banning the use of somatic cell nuclear transfer technology - or any other scientific technologies or areas of scientific inquiry - through legislation.

The United States has never, to our knowledge, banned an area of scientific exploration, or a scientific technology, by federal legislation. There are good reasons for this, and it is instructive to recall them. Legislation is a blunt instrument, and legislation of this kind, driven by emotionality, misunderstanding and fear, tends to be very difficult to modify or repeal. Any language, no matter how carefully crafted initially, can well emerge from the far end of the legislative process freighted with unintended side-effects that will limit or prohibit research progress and deny hope to tens of millions of Americans. To ban a nascent technology of such enormous potential benefit to our citizens and our economy solely for fear of a single odious application that has not even been proved to be possible would be tragic. In its June 1997 report "Cloning Human Beings," the National Bioethics Advisory Commission (NBAC) persuasively articulated several drawbacks to resorting to federal legislation to resolve issues of this kind. The report stated, "A legislative ban would represent a strong obstacle to changes in policy as scientific information develops.....It is notoriously difficulty to draft legislation at any particular moment that can serve to both exploit and govern the rapid and unpredictable advances of science." Far preferable in our judgment is to go the route of an organized, self-imposed moratorium, backed by appropriate regulatory oversight. Again to quote from the NBAC report: "Such moratoria avoid governmental intrusion into freedom of scientific inquiry via legislative fiat....[and are] largely immune from constitutional challenges....."

We know that a moratorium self-imposed by the scientific and professional communities can work. In the early 1970s, the American public and the scientific community faced a quite analogous dilemma with the emergence of another nascent technology of enormous promise that also generated widespread public fears -- recombinant DNA technology. As with any emerging technology, there were dazzling possibilities galore, but no certainties, about the potential uses of that technology, and profound concerns about its safety and potential for harm. Mass meetings were held in the research centers in which the technology had been discovered (Stanford and UCSF) or quickly applied (for example, Cambridge, MA and other major research university communities), at which prominent thought leaders predicted the undermining of the natural order, the desecration of nature, interference with Divine handiwork and other such catastrophes. The degree of passion, misunderstanding, perfervid oratory and fantasy was entirely reminiscent of that we are presently encountering with respect to somatic cell nuclear transfer technology.

At that time, the scientific community adopted a self-imposed nationwide moratorium on the use of the technology and convened the famous Asilomar Conference to begin the process of crafting the stringent guidelines and regulatory safeguards that were put in place. The guidelines were developed through a painstaking deliberative process that involved representatives from science, government, and the public - and they worked. There could easily have been prohibitive federal legislation enacted at that time, as many desired. But fortunately for all of us, reason prevailed.

The outpouring of scientific and technological advances that were unleashed by recombinant DNA technology has transformed biomedical research, is profoundly altering the practice of medicine, and spawned the biotechnology industry, one of the great economic success stories of the second half of the 20th century. The carefully overseen exploitation of recombinant DNA technology has provided tremendous benefits over the past two decades to the health and well being of all Americans, and to the vigor of our nation's economy.

Think for a moment how much poorer our world would be today if in a rush of impetuous lawmaking, recombinant DNA technology had been legislatively banned!

We strongly believe that the self-imposed nationwide five-year moratorium on the cloning of human beings, which has been adopted by AAMC, the Federation of American Societies for Experimental Biology (FASEB), the American Society for Cell Biology, the Pharmaceutical Research and Manufacturers Association (PhRMA), the Biotechnology Industry Organization (BIO), the American Society for Reproductive Medicine and scores of others in the medical research community, and by the World Medical Association and the World Health Organization, is the appropriate and much preferred course of action. This approach has an inherent flexibility and the capability of responding to advancing scientific understanding, as well as to the evolution of public thought about the ethics and morality of particular scientific applications. The adoption of a moratorium to permit thoughtful public deliberation and debate is the only approach that will ensure continued medical progress while optimally protecting the public's interest.

As in the early 1970s during the recombinant DNA debate, we are at a cross-roads in medical science. A moratorium on human cloning, buttressed by appropriate regulations enforced by the FDA and other federal agencies, would permit academic and industrial scientists to continue to explore the potential benefits of somatic cell nuclear transfer technology while protecting the public from the single, and singular, outcome that no credible biomedical scientist or medical professional believes should be attempted -- the cloning of an entire human being. We must not impede the continued exploration of the potential of somatic cell nuclear transfer technology research opportunities in our eagerness to forestall an outcome that can be accomplished just as effectively with a self-imposed moratorium. This last point bears re-emphasis: the nationwide moratorium already adopted by the nation's scientific and medical organizations embraces all of the researchers and medical practitioners in the United States who possess the knowledge and technical capability required even to attempt to clone a human being. There is no crisis or public emergency here that could possibly justify a rush to legislate.

The AAMC appreciates this opportunity to present its views, and looks forward to working with your and your colleagues as this critically important debate moves forward.