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The human manipulation of the genetic material of a cell.
Genetic engineering involves isolating individual DNA fragments, coupling them with other genetic material, and causing the genes to replicate themselves. Introducing this created complex to a host cell causes it to multiply and produce clones that can later be harvested and used for a variety of purposes. Current applications of the technology include medical investigations of gene structure for the control of genetic disease, particularly through antenatal diagnosis. The synthesis of hormones and other proteins (e.g., growth hormone and insulin), which are otherwise obtainable only in their natural state, is also of interest to scientists. Applications for genetic engineering include disease control, hormone and protein synthesis, and animal research.
International Codes and Ethical Issues for Society
An international code of ethics for genetic research was first established in the World Medical Association's Declaration of Helsinki in 1964. The guide prohibited outright most forms of genetic engineering and was accepted by numerous U.S. professional medical societies, including the American Medical Association (AMA).In 1969 the AMA promulgated its own ethical guidelines for clinical investigation, key provisions of which conflicted with the Helsinki Declaration. For example, the AMA guidelines proposed that when mentally competent adults were found to be unsuitable subjects for genetic engineering studies, minors or mentally incompetent subjects could be used instead. The Helsinki Declaration did not condone testing on humans.
The growth of genetic engineering in the 1970s aroused international concern, but only limited measures were taken by governments and medical societies to control it. Concern focused on the production of dangerous bacterial mutants that could be used as harmful eugenics tools or weapons. The Genetic Manipulation Advisory Group was established in England based on the recommendations of a prominent medical group, the Williams Committee. Scientists were required to consult this group before carrying out any activity involving genetic manipulation in England. Additional measures required scientific laboratories throughout the world to include physical containment labs to prevent manipulated genes from escaping and surviving in natural conditions. These policies were subsequently adopted in the United States.
The Breakdown of Regulation: Genetic Inventions and Patents in the United States
In 1980 the Supreme Court created an economic incentive for companies to develop genetically engineered products by holding that such products could be patented. In Diamond v. Chakrabarty, 447 U.S. 303, 100 S. Ct. 2204, 65 L. Ed. 2d 144, the Court held that a patent could be issued for a novel strain of bacteria that could be used in the cleanup of oil spills. In 1986, the u.s. department of agriculture approved the sale of the first living genetically altered organism. The virus was used as a pseudorabies vaccine, from which a single gene had been cut. Within the next year, the U.S. Patent and Trademark Office announced that nonnaturally occurring, nonhuman, multicellular living organisms, including animals, were patentable under the Patent Act of 1952 (35 U.S.C.A. § 101).
The Department of Agriculture formally became involved in genetic engineering in April of 1988, when the Patent and Trademark Office issued the first animal patent, granted on a genetically engineered mouse used in cancer research. U.S. scientists began experiments with the genetic engineering of farm animals, such as creating cows that would give more milk, chickens that would lay more eggs, and pigs that would produce leaner meat. These developments only raised more objections from critics who believed that genetic experimentation on animals violated religious, moral, and ethical principles. In spite of the controversy, the U.S. House of Representatives approved the Transgenic Animal Patent Reform bill on September 13, 1988. The bill would have allowed exempted farmers to reproduce, use, or sell patented animals, although it prohibited them from selling germ cells, semen, or embryos derived from animals. However, the Senate did not vote on the act and so it did not become law.
Significant State Laws
Certain states have passed laws restricting genetic engineering. By the early 1990s, six states had enacted laws designed to curb or prohibit the spread of genetically engineered products in the marketplace (see Ill. Ann. Stat. ch. 430, § 95/1 [Smith-Hurd 1995]; Me. Rev. Stat. Ann. tit. 7, § 231 et seq. [West 1995]; Minn. Stat. Ann. § 116C.91 et seq. [West 1995]; N.C. Gen. Stat. § 106-765-780 [Supp. 1991]; Okla. Stat. Ann. tit. 2, §§ 2011–2018 [West 1996]; Wis. Stat. Ann. § 146.60 [West 1996]). North Carolina's law sets the most comprehensive restrictions on genetic engineering. Resembling the earlier measures proposed by organizations such as England's Genetic Manipulation Advisory Group, it requires scientists to hold a permit for any release of a genetically engineered product out-side a closed-containment enclosure. The North Carolina statute has been cited as a possible model for advocates of comprehensive federal regulations.
In the mid 1990s the international guidelines established by the Declaration of Helsinki were modified to allow certain forms of cell manipulation in order to develop germ cells for therapeutic purposes. Scientists are also exploring genetic engineering as a means of combating the HIV virus.
In 1997 the cloning of an adult sheep by Scottish scientist Ian Wilmut brought new urgency to the cloning issue. Prior to this development, cloning had been successful only with immature cells, not those from an adult animal. The breakthrough raised the prospect of human cloning and prompted an international debate regarding the ethical and legal implications of cloning.
Since the cloning of the sheep, nicknamed "Dolly," scientists have found the process of cloning to be more difficult than expected. Since Dolly, scientists have cloned such animals as cows, pigs, monkeys, cats, and even rare and endangered animals. The process of cloning is complex, involving the replacement of the nucleus of an egg cell with the nucleus of a cell from the subject that will be cloned. This process is meticulous, and the failure rate is high.
In November 2001, scientists first successfully inserted the DNA from one human cell into another human egg. Although the eggs began to replicate, they died shortly after the procedure. Human cloning has caused the most intense debate on the issue, with the debate focusing upon scientific, moral, and religious concerns over this possibility. Scientists do not expect that human cloning will be possible for several years.
Evidence suggests that cloned animals have experienced significant health problems, leading to concerns about the vitality of the entire process. Cloned animals tend to be larger at birth, which could cause problems for the female animals giving birth to them. The cloned organisms also tend to become obese at middle age, at least in the case of experimental cloned mice. Moreover, evidence suggests that cloned animals have died because they do not have sufficient Immunity defenses to fight disease.
Dolly lived for six years before dying in February 2003, which is about half of the normal life expectancy of a sheep. Proponents of the cloning experiments suggest that cloning opens a number of possibilities in scientific research, including the nature of certain diseases and the development of genetically-enhanced medications. Scientists have also successfully cloned endangered animals. In 2001, an Italian group cloned an endangered form of sheep, called the European mouflon. About a year and a half earlier, an American company, Advanced Cell Technology, tried unsuccessfully to clone a rare Asian ox. The cloning was initially successful, but the animal died of dysentery 48 hours after birth.
In 2000, a group of 138 countries, including the United States, approved the Cartagena Protocol on Biosafety Environment. International concerns over the handling of genetically modified organisms (GMOs) prompted the passage of the protocol. It governs such issues as the safe transfer, handling, use, and disposals of GMOs among member countries.
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