Mapping Public Policy for Genetic Technologies

Chapter 4. What is Cloning?

Information Contained in this Chapter
What Is a Clone?
Ways of Duplicating Genetic Information
Cloning and Biotechnology
Vaccines
Therapeutic Proteins
Research
Point of View: National Bioethics Advisory Committee

What Is a Clone?

The word clone (from the Greek word for twig) refers to a group of individuals with identical genetic makeup. The term originally was applied to groups of plants or trees produced from a single plant by using grafts or cuttings.

More recently, the word has come to mean an exact genetic copy of any original organism, from viruses to mammals. Among mammals, sets of identical twins, triplets, quadruplets, etc. constitute a clone. And cloning has come to refer to the entire collection of techniques for producing clones.

Ways of Duplicating Genetic Information

Cloning is the reproduction of many individuals with the same genetic makeup. The word applies to a variety of techniques used in biological research and pharmaceutical production on organisms ranging from viruses and bacteria to mammalian cell culture. Recent experiments that produced a healthy newborn lamb have increased governmental interest in that aspect of cloning, with concerns about whether the technique might or should be applied to the production of humans. Current consensus is that it should not, but that animal experiments should proceed.

Cloning and Biotechnology

Biotechnology research has had two objectives: To understand the molecular basis of life, and to use that understanding to produce products-medicines, vaccines, diagnostics, crops-that improve human life and health.

This research began with studies of the simplest living organisms: viruses and bacteria. Early in the biotechnology revolution, scientists realized that they could insert foreign genes into bacteria and viruses-genes that would instruct the cell to make insulin or the human growth hormone, for example. By allowing the bacteria to reproduce, the researchers could produce millions of tiny factories for producing medicine.

This process, called "cloning the gene," remains a mainstay of modern life-science research. Cloning complete animals, such as sheep and cows, has been a significant research goal, but is not a primary technique.

Dolly and the Current Cloning Debate

In February 1997, a group of Scottish researchers from the Roslin Institute and PPL Therapeutics, led by Ian Wilmut, reported the birth of a cloned lamb named Dolly. The announcement touched off a furor in government and newspapers. People became concerned about the possibility of cloning complete human beings. Some of the more important meanings of "cloning" were lost in the debate.

For various technical reasons, by the way, Dolly resembles her donor parent less than most identical twins resemble each other. It is important to remember that animal clones, like twins, are independent individuals.

How Do We Use Artificial Clones?

Cloning refers to many kinds of biological "photocopying." Scientists use cloning as a manufacturing technique, to produce large amounts of a gene for study, or large amounts of protein (a protein like erythropoietin to stimulate blood production in patients on kidney dialysis, perhaps, or a vaccine against hepatitis B) as a medicine.

Most cloning involves only single-celled organisms or cultures of individual mammalian cells. Only a small minority of cloning experiments involve production of a complete animal.

Vaccines

Cloning can produce weakened viruses or bacteria that can be used as vaccines. Or, for greater safety, cloning techniques can produce individual proteins from disease-causing organisms to produce a subunit vaccine, which may be safer (since it does not include an entire organism). Several biotechnology vaccines produced by cloning already are on the market being used to protect people around the world against disease or death.

Therapeutic Proteins

Modern biotechnology has produced a host of medicines based on natural proteins-blood growth factors for patients who are undergoing chemotherapy or kidney dialysis, clot busters for victims of heart attack and stroke and human insulin for diabetics. These and dozens of other products already are on the market.

In many cases, the protein is more effective as medicine if it is produced in mammalian cells. Scientists have discovered methods of engineering animals like Dolly so that they can produce medicines in the animals' milk-providing a safe, abundant and natural source for much-needed therapeutics.

Research

Scientists are still trying to understand how genes work. Genes work in complex inter-regulation. It is useful to have specialized research animals for study. Access to such animals greatly speeds up research into maladies like diabetes, obesity, cancer, heart disease, arthritis, AIDS and a host of other conditions.

In 1997, fourteen states introduced legislation regarding cloning. More legislation is expected in 1998. Table 4-1 includes summaries of state cloning legislation introduced in 1997.

Point of View: National Bioethics Advisory Committee

Findings on Human Cloning
(The following is condensed from Cloning Human Beings: Report And Recommendations Of The National Bioethics Advisory Commission (Rockville, Maryland) June 1997. Please note that the NBAC's use of the phrase "somatic cell nuclear transfer cloning" has been widely criticized for scientific ambiguity.)

The commission came to the following conclusions and recommendations:

At this time it is morally unacceptable for anyone in the public or private sector, whether in a research or clinical setting, to attempt to create a child using somatic cell nuclear transfer cloning. Current scientific information indicates that this technique in not safe to use in humans at this point, and other serious ethical concerns require "much more widespread and careful public deliberation before this technology may be used." Therefore, legislators and researchers should:

Continue a moratorium on using federal funds to support an attempt to create a child by somatic cell nuclear transfer, with a voluntary moratorium on nongovernmental human cloning experiments.

Adopt legislation prohibiting any attempt- -research or clinical- -to create a child through somatic cell nuclear transfer cloning.

Include in any prohibiting legislation a sunset provision to ensure that Congress or state legislatures will review the issue after a specified interval.

Draft any legislation carefully to avoid interfering with "other important areas of scientific research." Specifically, the NBAC found, "No new regulations are required regarding the cloning of human DNA sequences and cell lines, since neither activity raises the scientific and ethical issues that arise from the attempt to create children through somatic cell nuclear transfer, and these fields of research have already provided important scientific and biomedical advances. Likewise, research on cloning animals by somatic cell nuclear transfer does not raise the issues implicated in attempting to use this technique for human cloning, and its continuation should only be subject to existing regulations regarding the humane use of animals and review by institution-based animal protection committees."

Conduct any future human somatic cell nuclear transfer cloning according to the established standards of independent review and informed consent, consistent with existing norms of human subjects protection, if such experiments should ever be permitted.

Encourage widespread and continuing deliberation on this issue to further understand the ethical and social implications of this technology and to enable society to produce appropriate long-term policies regarding this technology should the time come when present concerns about safety have been addressed.

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