Cloning Research

RE: Cloning Research

Cloning is not specifically regulated by state or federal law. Laboratories are limited in most instances by the grant agreements that finance their research. On March 4, 1997, President Clinton announce a moratorium on using federal funds for experiments to clone humans. The scope of the moratorium may be subject to interpretation since many biotechnology experiments that stop short of cloning may be useful for cloning. According to an industry trade group, human DNA can be used to create many products, such as transgenic organs, without cloning humans. The Food and Drug Administration (FDA)must approve any products before they are used on humans. The FDA approval process considers the product's effectiveness and safety. In addition the FDA has general good practice regulations for nonclinical research laboratories. Four states, Alabama, California, Florida, and New York, are considering bills to prohibit cloning humans.

On February 22, 1997, Dr Ian Wilmut and his colleagues of the Roslin Institute in Scotland announced that they had cloned a sheep using an udder cell of a six-year-old sheep; scientists from Oregon later announced that they had cloned rhesus monkeys. Prior to these results scientists were skeptical whether cloning from a mature cell was possible, and believed even if it was, it would not be achieved until the 21st century.

Successful animal cloning is not new to science. Scientists first successfully cloned an animal from frog embryo cells in 1970. In 1981, they cloned the first mammals using embryo cells from mice; that process has since been repeated on a variety of other mammals including sheep, pigs, rabbits, goats, and monkeys. The sheep cloned in Scotland is unique because it was achieved using an adult or mature cell (known as a differentiated cell). Until this event, cloning was possible only from embryo cells, before they mature and develop organs, skin, bones, and other tissues. Differentiated cells contain the same DNA information as an embryo cell, but they have developed specialized properties to preform various functions in the body.

Successful cloning is, in part, the cumulative result of many years of genetic experimentation. Like other areas of science, the cumulative knowledge of prior studies is necessary for the next breakthrough. Genetic research is a rapidly expanding area of science. Many innovative studies are proceeding, including a project to map the entire genetic sequence (known as a genome) in humans. Other studies are trying to isolate specific individual genes that carry certain diseases; increase fertility; and produce desirable qualities in plants, fruits, and vegetables. Most of this research has promising commercial, as well as humanitarian, applications. For that reason private funding sources such as pharmaceutical companies are willing to sponsor many projects. The Roslin Institute is a government supported organization, but it is operated by a private company that stands to gain from any commercial application of research.

The Department of Public Health, the University of Connecticut Health Center (Health Center), and several biotechnology trade organizations with which we spoke, know of no state or federal regulations or laws regarding cloning other than the recent Executive Order prohibiting federal funding of human cloning experiments. According to Dr. Leslie S. Cutler, chancellor of the Health Center, generally the only substantive restraint on research is the terms of the funding grant. The laboratory must set out the scope of its research in its grant application. The Health Center receives state, federal, and private grant money. Most of the private biotechnology laboratories in Connecticut do not receive federal funds.

On March 4, 1997, two days after the sheep cloning was announced, President Clinton prohibited using federal funds for cloning humans (see Attachment 1). The President noted that there is an existing ban on using federal funds for human embryo research, but that it did not explicitly cover cloning with mature cells. In addition the President asked laboratories using private funds voluntarily to suspend or postpone any human cloning experiments until the National Bioethics Advisory Commission reports on the ethical and legal implications of cloning. The commission, established in 1995, has been researching these issues and is scheduled to report by the end of May 1997.

According to Patrick Kelly of Biotechnology Industry Organization, there are no known human cloning experiments or reported instances of anyone attempting to clone a human.

No state laws restrict or prohibit biotechnology research such as cloning. Last year Connecticut enacted two laws, PA 96-252, and PA 96-264, that provide tax incentives for biotechnology facilities.

PA 96-252 authorizes three tax benefits for biotechnology companies. First, it exempts such companies form paying sales taxes on machinery, equipment, tools, materials, fuel, and other supplies. Second, it exempts such companies from paying property tax on any machinery or equipment purchased after July 1, 1996 for use in biotechnology research and product development. Third, it allows such companies to carry forward the 20% tax credit for research and development. The act defines biotechnology as the “application of technologies, such as recumbent DNA techniques, biochemistry, molecular and cellular biology, genetics and genetic engineering, biological cell fusion techniques, and new bioprocesses, using living organisms, or parts of organisms, to produce or modify products, to improve plants or animals, to identify targets for small molecule pharmaceutical development, to transform biological systems into useful processes and products or to develop microorganisms for specific uses” (CGS § 12-81(72)).

PA 96-264 authorizes Connecticut Innovations, Inc. to provide financial assistance for plant and equipment to biotechnology companies. It also extends enterprise zone benefits, such as property tax abatement and job creation grants, to such companies that are located within a town with both an enterprise zone and a major research university.

Biotechnology is a broad field of study that includes cloning and many other forms of genetic manipulations. According to Dr. Cutler of the Health Center, biotechnology includes any studies using or manipulating biology to achieve a technological advantage or to express a desired result in an plant or animal. Biotechnology is an expanding industry in Connecticut. According to Debra Pasquale of Connecticut Union for Research Excellence (CURE) most of the research is focused on producing human therapeutic medicine, with the exception of the agriculture biotechnology program at the University of Connecticut.

1. pharmaceutical companies, such as Bayer, Bristol-Myers Squibb, Pfizer, and Boehringer-Ingelheim;

2. research universities and medical schools, such as Yale University and the University of Connecticut; and

3. small biotechnology companies, such as Alexion Pharmaceuticals (New Haven), Bios Laboratories (New Haven), CuraGen (Branford), MicroGenesys (Meriden), Neurogen (Branford), and VION Pharmaceuticals (New Haven).

One product of biotechnology research is donor organs that have human DNA codes but are grown in animals (known as transgenic organs). Transgenic organs are created by breeding animals (such as swine) using human DNA. The animals organs express human DNA genes that help reduce the risk of rejection when transplanted into the human body. According to the testimony of Dr. Leonard Bell of Alexion Pharmaceuticals, Inc of New Haven, there is a striking similarity between swine and human organ size and physiology. Using transgenic organs from swine could help alleviate the chronic shortage of donor organs.

Transgenic technology can also be used to develop and produce therapeutic drugs that cannot otherwise be produced or can only be produce in limited quantity at great expense. Dr. Bell describes several complex protein based drugs and their applications in his testimony before the U.S. Senate Subcommittee on Public Health and Safety on March 12, 1997 (see Attachment 2).

Any transgenic organs or drugs produced must be approved by the FDA before use on humans. The FDA approval process considers the product's effectiveness and safety based on the results of clinical studies and animal testing (21 CFR 310). The FDA also has laboratory good practice standards for pre-clinical research (21 CFR 58)

At least four states have introduced bills to ban cloning of human or memorializing congress to ban cloning of humans. Alabama, California, Florida, and New York have bills to ban cloning of humans (see Attachment 3). Alabama and California also have bills memorializing congress to ban cloning.

2. Testimony of Dr. Leonard Bell (March 12, 1997)

3. Cloning Bills from Alabama, California, Florida, and New York