Volume 18 Number 6
November -December 2005

A Disaster in the Making
by Evan Lerner

BiDil: False Promises
by Jonathan Kahn

China's Gene Therapy Drug
by Sheldon Krimsky

Cloning in America
by Kelli Whitlock Burton

Headlines: Biotechnology in the News


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Cloning in America
by Kelli Whitlock Burton

The Genetics and Public Policy Center, a part of the Phoebe R. Berman Bioethics Institute at Johns Hopkins University, compiled the survey information found in the following article for a 2005 publication entitled “Cloning: A Public Policy Report.” This article is a summation of the Genetics and Public Policy Center’s findings on the public opinion of cloning, stem cell research, and the legal environment which regulates these fields. The original report can be found in its entirety at www.dnapolicy.org. The author of this article is a freelance writer who compiled the report on behalf of The Genetics and Public Policy Center.

The term "cloning" evokes strong responses among Americans. Opposition to cloning arises from several concerns, including ones regarding the destruction of human embryos, usurping Divine authority, interfering with the natural order, exploitation of the women from whom human eggs are obtained, and the impact of cloning human beings on those who are cloned. Support for cloning originates primarily from its potential to yield fundamental new research insights and to lead to new therapies to treat devastating illnesses.

The State of Cloning Research

Although there have been no documented cases of human reproductive cloning, scientists have been attempting to clone animals through somatic cell nuclear transfer (SCNT) for several decades. In 1996, Dr. Ian Wilmut at the Roslin Institute in Scotland and colleagues used a nucleus extracted from a mammary cell of a six-year-old sheep to create Dolly, born on July 5, 1996. [1] Dolly was the first animal cloned from a nucleus obtained from the cell of an adult animal. Since then, scientists have used SCNT to clone a variety of mammals, including mice, rabbits, pigs, cats, cows and a mule. [2-10] In December 2004, the company Genetic Savings & Clone announced the sale of the first cloned pet to a woman in Texas whose previous cat had died. [11]

Notwithstanding these research and commercial mammalian cloning examples, SCNT to date has been a very inefficient process, in that most embryos created via SCNT do not implant, and most of those that do implant do not complete gestation. [12]

Overall, only about one to four percent of animal embryos produced through SCNT result in live births. [13] In addition to its very low efficiency, animal cloning data indicate that animals produced through cloning have higher incidences of miscarriage or newborn death, experience a higher rate of severe birth defects, exhibit anomalies in gene expression known as imprinting disorders, demonstrate aberrant gene expression, and age faster and consequently have shorter life expectancies than animals produced through sexual reproduction. [14,15] When using cells from adults to create cloned embryos, scientists have observed that the cloned animals seem to age in synchrony with the animals from which their genetic material was obtained. [16]

These data reflect the scientific challenges posed by SCNT. Some scientists have argued that these and other insurmountable biological barriers always will prevent successful reproductive cloning in humans; others believe these to be only temporary technical barriers. [17-20]

Legal Environment

Currently it is illegal in the United States to use federal funds to (1) create a cloned human embryo, (2) attempt to make a baby using a cloned human embryo, or (3) derive stem cells from a human embryo, whether the embryo is obtained through IVF or SCNT. However, there is no law restricting privately funded human cloning, although many bills have been introduced in Congress that would govern the practice. That said, laws of more general applicability thus far appear to have deterred reproductive cloning efforts and also provide some oversight for research and therapeutic cloning.

The Food and Drug Administration (FDA) has stated on several occasions that it has the authority to regulate human reproductive cloning. While the FDA never has clearly articulated the basis for its jurisdiction, its assertions of authority appear to have had the intended effect, at least for the moment, of preventing reproductive cloning from taking place in the United States. [21] The FDA's authority with respect to therapeutic cloning is more readily discernible, as the agency has oversight authority over all products that are intended to treat or prevent disease. The FDA has no direct role in the oversight of research cloning, but may have indirect oversight to the extent that data from such research may be used to support an application for approval of a new therapy.

As the debate over reproductive, research, and therapeutic cloning legislation has reached what appears to be a stalemate at the federal level, some state legislatures in the United States already have decided the issue for their citizens, but have adopted widely divergent positions.

As of April 1, 2005, 12 states have passed laws directly addressing the issue of cloning, and several other state legislatures have introduced bills on the subject. Five states, Arkansas, Iowa, Michigan, North Dakota, and South Dakota, have passed laws clearly prohibiting reproductive, research, and therapeutic cloning. [22-28] In addition, Virginia has passed a law that prohibits reproductive cloning, but whose effect on research and therapeutic cloning is unclear.

Four states — California, New Jersey, Rhode Island, and, most recently, Massachusetts — expressly permit SCNT for research or therapeutic purposes, while banning the use of the procedure for reproduction.

Unlike the United States, many countries have enacted laws that ban human cloning activities either in whole or in part. At the same time, the United Nations has sought to ban human reproductive cloning without success, because of a disagreement over whether to also prohibit research and therapeutic cloning.

U.S. Attitudes

Within the United States, different religious, political, and academic organizations, as well as government advisory panels, have issued statements or recommendations regarding reproductive, therapeutic, and research cloning. These entities have reached divergent conclusions on these issues — some advocating a ban on all cloning activities and others arguing that cloning should be allowed for research purposes only. These divergent views in turn are based on different underlying values, including views of the moral worth of a human embryo, conceptions of human personhood and human dignity, the importance of human individuality, the imperative to heal the sick, the right to reproductive autonomy, and the proper role of government in socially charged and ethically complex issues.


Some oppose cloning for any purpose because they consider the embryo to constitute a full human being or at least nascent human life, and consider it immoral under any circumstances to create an embryo solely as a “means to some other end,” particularly when that requires the destruction of the embryo. [29] Some people opposed to research and therapeutic cloning have expressed the concern that the need for women's eggs involves risks to the women who contribute these eggs, as well as coercion — in particular of poor women — to supply them. [30] Others argue that there are alternative sources of stem cells available that would not require embryo destruction or the use of SCNT, pointing to adult stem cells and cord blood stem cells as providing the potential for research and therapeutic advances. [31,32] And some who might otherwise support research cloning because of its potential benefits oppose it, arguing that the “slippery slope” to human reproductive cloning is too great a threat and that once we master the technique of producing cloned human embryos, those seeking to clone human children will be able to do so.[33]

Proponents of research cloning argue that it provides a unique opportunity to conduct research on human diseases and that embryonic stem cells from cloned embryos will “help unlock secrets of developmental and pathogenic events that might not be revealed otherwise.” [34] Others contend that therapeutic cloning may lead to cures for debilitating diseases, for example by providing genetically matched tissue for transplantation. Proponents contend that, although the benefits of embryonic stem cell research have yet to be realized, the possibility for treatments and cures is compelling enough to warrant the use of stem cells from cloned embryos, since therapies developed through this research could “save countless numbers of lives, and increase the quality of life of countless others.” [35-37] For some, support for research and therapeutic cloning derives from the moral imperative to heal the sick and alleviate suffering. [38-41] Still others contend that research cloning should be permitted as part of free scientific inquiry and view banning research cloning — as well as on embryonic stem cell research more generally — as a threat to scientific freedom. [42]

Public Opinion Surveys

By all accounts and every survey of U.S. public opinion, most Americans oppose the use of cloning for reproduction. However, Americans have much more nuanced opinions regarding the use of cloning for research and therapeutic purposes, and these opinions are still anything but immutable.

One measure of the fluidity of U.S. public opinion about therapeutic and research cloning is that survey results depend to a great extent on the manner and context in which the questions are asked. For instance, whether the word “cloning” or the phrase “somatic cell nuclear transfer” (SCNT) is used in the survey and whether and how the potential harms and benefits of cloning are identified have a direct impact on the level of approval. Opinions also seem to be influenced by the media environment at the time of polling. [43]

Numerous surveys have found that a majority of Americans support research on stem cells derived from “extra” embryos donated by IVF clinics; surveys by Beliefnet/ABC News and Ipsos indicate a level of support of between 58-75 percent. [44] However, specifying that the embryo is obtained through cloning or failing to specify the source of the embryo leads to a lower level of approval. [45] For instance, in a Gallup Poll only 38 percent of respondents endorsed the use of cloned embryos for research. [46] When the word cloning is not used, but the term somatic cell nuclear transfer is defined, there appears to be significant public support for the technology. A survey conducted by the Coalition for Advancement of Medical Research reported that 72 percent of a nationally representative sample of the public approved of “SCNT stem cell research;" the word “cloning” was not mentioned in the question. [47] Whether or not the potential benefits of stem cell research and research cloning are specified in the question also can affect approval. In a survey conducted by the Juvenile Diabetes Research Foundation, 100 interviewers asked whether participants would support stem cell research on donated embryos for a list of eight well-known diseases or injuries; 65 percent of respondents approved of research for this purpose. [48]

Public opinion also appears to vary over time. The Virginia Commonwealth University fielded annual surveys from 2001 to 2004 that showed surprising variability on the question: “On the whole, how much do you favor or oppose medical research that uses stem cells from human embryos?” The source of the embryos was not specified. In September 2001, 48 percent of respondents either strongly favored or somewhat favored this approach. In September 2002, the level of approval for the same question had dropped to 35 percent; by September 2003, approval rose again to 47 percent, and then increased slightly to 53 percent in September 2004. [49]

Findings of the Genetics & Public Policy Center 2004 Survey

In 2004, the Genetics and Public Policy Center conducted a survey of 4,834 Americans age 18 and older about their attitudes concerning reproductive genetic technologies including cloning. The survey — the largest of American opinions on the topic to date — found that many Americans have incomplete or incorrect knowledge concerning the status of cloning technology.

Awareness of Genetics Technologies
As far as you know, is it scientifically possible to produce a cloned human embryo? As far as you know, is it scientifically possible to produce a cloned human baby?

Many of the people in our survey were uncertain about what is and is not possible using current cloning technologies. For example, although there is no credible evidence that any human beings have been cloned, 45 percent of those surveyed stated that it is scientifically possible to produce a cloned human baby, while 38 percent indicated they did not know, and 18 percent reported that it is not yet scientifically possible to clone a human baby. At the same time, 56 percent of those surveyed correctly stated that cloning a human embryo for research purposes is scientifically possible.

Approval of Research Cloning
In general, would you approve or disapprove of scientists working on ways to create a cloned human embryo for research?

Seventy-six percent of Americans in our survey did not approve of cloning human embryos for research purposes. More adults over age 50 disapproved of research cloning (81 percent) compared to younger age groups. Nearly one-third more men than women approved of cloning embryos for research purposes. A greater proportion of respondents with no religious affiliation reported approval of research cloning (42 percent), compared to those with a religious affiliation.

Approval of Reproductive Cloning
In general, would you approve or disapprove of scientists working on ways to create a cloned human baby? If you could clone a loved one, would you? If you could clone yourself, would you?

The vast majority of the Americans surveyed (88 percent) disapproved of using cloning to create a human baby. Men were twice as likely as women to approve: 16 percent versus fewer than 8 percent. Younger respondents were more likely to approve of reproductive cloning than those over age 50. Far fewer Evangelical or Fundamentalist Christians approved of reproductive cloning compared to other religions and those with no affiliation. In addition, more Democrats (14 percent) and those with other party affiliations (13 percent) approved of reproductive cloning compared to Republicans (8 percent).

Only a small proportion of respondents reported they would clone a loved one if given the opportunity, or would clone themselves if they could. While slightly more men (9 percent) than women (7 percent) stated they would clone someone they loved, men were twice as likely as women to say they would clone themselves.

Oversight and regulation of human cloning
Do you think human cloning to create a baby should be allowed at all?

The majority of Americans surveyed overwhelmingly stated cloning to create a human baby should not be allowed at all. Twice as many men (16 percent) as women (8 percent) stated they would allow reproductive cloning. At the same time, nearly twice as many respondents under age 50 agreed reproductive cloning should be allowed compared to those over age 50 (15 percent versus 8 percent). Fewer Blacks stated reproductive cloning should be allowed than Whites or Hispanics. A greater proportion of respondents without a religious affiliation stated reproductive cloning should be allowed, while those respondents with a religious affiliation were less approving (i.e., 23 percent versus 4 percent of Evangelical or Fundamentalist Christians).

Do you think human embryo cloning for research should be allowed at all?

The majority (76 percent) of respondents we surveyed believed research cloning should not be allowed at all. It should be noted, however, that these questions did not state the potential benefits or harms of research cloning. Many more men than women agreed that research cloning should be allowed (30 percent versus 19 percent), while younger age groups expressed greater approval than the over 50 cohort. Blacks again were less approving of research cloning than Whites or Hispanics. More than twice as many participants with a post-graduate degree agreed research cloning should be allowed, compared to participants with no college education. Finally, fewer Republicans (19 percent) than Democrats and other party affiliations (28 percent and 24 percent, respectively) expressed support for allowing research cloning.

If respondents stated that either research or reproductive cloning should be allowed, further questions were asked about the extent of regulation of cloning in general. These regulation questions did not specify whether cloning was for reproductive or research purposes. Among participants who stated that cloning for either research or reproductive purposes should be allowed, the majority (85 percent) felt that government regulation for quality and safety was imperative. Fifty-four percent of participants who stated that cloning for either research or reproductive purposes should be allowed also stated that it should be regulated based on ethics and morality.

While human cloning technology is still in its infancy, the science is outpacing the public's understanding and the formulation of coherent public policy. Therefore, the time is now to engage the public in discussions about the legal, ethical, and societal issues cloning raises. We hope that by sharing the results of our public opinion survey on these issues, we will help to promote a public debate that is both informed and balanced.


Conclusion

The Genetics and Public Policy Center survey, together with several others that have been conducted on the subject, demonstrate that differences in wording and context of questions lead to a great deal of variation in survey results, and consequently yield an unclear picture of Americans' opinions about research and reproductive cloning. In our survey, the questions regarding research and reproductive cloning were asked within the context of a larger poll to assess American attitudes toward reproductive genetic technologies. The questions preceding those on cloning queried attitudes about preimplantation genetic diagnosis, prenatal genetic testing, in vitro fertilization, scientific research, and the moral worth of human embryos. This survey did not include information regarding the benefits or harms of various applications of cloning, nor did it use the term “stem cell,” a term with which most Americans are now familiar. At the same time, these surveys show significant variability in levels of approval for research and therapeutic cloning, making it difficult to know where the American public truly stands on this issue. It could be argued that Americans' opinions about research and therapeutic cloning are not firmly held and survey questions are tapping into and reflecting positions on more familiar issues such as abortion and the value of biomedical research.

Notwithstanding the uncertain policy landscape, research cloning continues to be done both domestically and internationally. While use of this research to develop therapies — and potentially to produce children — remains a distant possibility because of scientific challenges, the time is now to foster meaningful national conversations about the legal, ethical, and societal issues raised by these various uses of cloning, as a prelude to the development of sound public policy.

 

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