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Ethics

A press release issued by the Biotechnology Industry Organization concerning
proposed cloning bans in the US Congress.

Headings
Cloning, nuclear transfer, legislation, US

Headline: Biotechnology Industry Organization on Cloning ...
Wire Service: PR (PR Newswire)
Date: Sun, Feb 8, 1998
Biotechnology Industry Organization on Cloning Legislation

The following memorandum was issued by Dan Eramian, Vice President, Communications of BIO, regarding cloning legislation.

The Biotechnology Industry Organization (BI0) has steadfastly opposed the cloning of a human being. The Food and Drug Administration (FDA) has already asserted its regulatory authority over cloning and announced its intention not to allow such an unsafe and unwise procedure. Still, the Senate is scheduled to take its first vote on S. 1601, Tuesday, Feb. 1O -- legislation that would not only ban the cloning of a human being, but could inadvertently interfere with ongoing and vital medical research. To avoid this, legislative language must be extremely precise, after all you are talking about legislating the world of molecular biology, which can only be seen under a microscope.
Attached please find background information on this important issue. If you have further questions, please do not hesitate to call BIO at 202-857-0244.

ANALYSIS OF S. 1601 TO BAN CLONING OF HUMAN BEINGS

The bill to ban cloning of human beings, S. 1601, sponsored by Sens. Lott, Bond, Frist, and Gregg, makes it a federal crime -- with a ten-year prison sentence and substantial civil fines -- if any individual, with or without federal finding, engages in the act of "producing an embryo (including a preimplantation embryo)" through the use of a specified technology, somatic cell nuclear transfer. It would ban the production of this embryo even if the production of such an embryo is for purposes completely unrelated to the cloning of a human being, including for research.
The bill as currently drafted prohibits many uses of somatic cell nuclear transfer related to research, separate from the goal of banning the cloning of human beings.
First of all, the bill bans research to generate "customized" stem cells to treat disease if it involves somatic cell nuclear transfer. Not all stem cell research involves somatic cell nuclear transfer. If the stem cell research does not use this technique, the research would not be banned by the bill. (See attachment, "The Science at Risk.")
The bill bans the production of an embryo (1) if it contains a fertilized nucleus, not a cloned nucleus with DNA identical to that of an existing or previously existing human being, or (2) if it contains a nucleus which has been modified in some way and is not identical to that of any person.
The bill's definition of somatic cell nuclear transfer is imprecise. The bill bans the use of somatic cell nuclear transfer to transfer a "human somatic cell" into an egg, but it does not state that this is limited to a somatic cell which contains nuclear DNA identical to that of an existing or previously existing person. This means that the bill is not limited to cloning (creating a person or embryo with nuclear DNA identical to that of someone else), but would also apply to the use of somatic cell nuclear transfer of nuclear DNA which is not identical. As currently drafted, it would, in fact, prohibit the use of somatic cell nuclear transfer where the nuclear DNA is the product of normal, sexual reproduction, which is the opposite of cloning. In addition, the bill would also prohibit the use of somatic cell nuclear transfer where the somatic cell had been modified in some way prior to the use of somatic cell nuclear transfer.
Even if the legislation were limited to the transfer of somatic cells with nuclear DNA identical to that of an existing or previously existing human being (which is not currently the case), it would still ban one type of stem cell research. This is the type of stem cell research which would create stem cells "customized" to treat an individual patient. In this case a researcher or doctor could create a human zygote to start a customized stem cell line with DNA identical to that of an existing or previously existing person through the use of somatic cell nuclear transfer to treat the individual from whom the DNA was extracted. By using the same DNA to treat the individual, the stem cell would more likely be compatible and not rejected by the person when the stem cell is transferred back to the person for treatment.
Finally, the bill would ban the use of somatic cell nuclear transfer to treat mitochondrial disease. For example, a nonidentical nucleus, such as a fertilized nucleus, is transferred from a person with mitochondrial disease into a healthy egg from which the nucleus has been removed. This treatment has already been successfully used to treat infertility.
Section 5 of the bill is entitled "Unrestricted Scientific Research" which states, "Nothing in this Act (or an amendment made by this Act) shall be construed to restrict areas of scientific research that are not specifically prohibited by this Act (or amendments)." This provision uses circular reasoning. It merely states that the bill does what it does and does not do what it does not do. The provision does nothing to modify the prohibitions on research.
To ensure that customized stem cell research is not banned by the bill, it must be substantially revised. One approach would be to include a broad exemption for biomedical research on stem cells and other technology to treat patients.

The bill includes:

* no preemption of inconsistent state laws; and
* no sunset to ensure that it is reviewed.
* It creates a new entity to review the ethics of this issue, an entity which is separate from and duplicative to the National Bioethics Advisory Commission.

The Science at Risk

Pending legislation regarding human cloning includes over broad definitions which put the science described in this paper at risk.
Scientists are developing an entirely new approach for treating human diseases that depend not on drugs like antibiotics but on living cells that can differentiate into blood, skin, heart, or brain cells and potentially treat cancers, spinal cord injuries, or heart disease. This research -- called stem cell research -- holds the potential to develop and improve cancer treatments by gaining a more complete understanding of cell division and growth and the process of metastasis. This could also lead to a variety of cancer treatment advances.
The kinds of cells that make up most of the human body are differentiated, meaning that they have already achieved some sort of specialized function such as blood, skin, heart or brain cells. The precursor cells that led to differentiated cells come from the embryo. They are called stem cells because functions stem from them like the growth of a plant. Stem cells have the capacity for self-renewal, meaning that they can produce more of themselves, and differentiation, meaning that they can specialize into a variety of cell types with different functions. In the last decade, scientists studying mice and other laboratory animals have discovered powerful new approaches involving cultured stem cells. Studies of such cells obtained from mouse stem cells show that they are capable of differentiating in vitro or in vivo into a wide variety of specialized cell types. Stem cells have been derived by culturing cells of non-human primates and promising efforts to obtain human stem cells have also recently been reported.
Stem cell research has been hailed as the "(m)ost tantalizing of all" research in this field. The reason for this is because adults do not have many stem cells. Most cells are fully differentiated into their proper functions. When differentiated cells are damaged, such as cardiac muscle when someone suffers a heart attack, the adult cells do not have the ability to regenerate. If stem cells could be derived from human sources and induced to differentiate in vitro, they could potentially be used for transplantation and tissue repair.
Using the heart attack sufferer as an example, we might be able to replace damaged cardiac cells with healthy stem cells that could differentiate into cardiac muscle. Research with these stem cells could lead to the development of "universal donor cells" of invaluable benefit to patients. Stem cell therapy could make it possible to store tissue reserves that would give health care providers a wholly new and virtually endless supply of:
cardiac muscle cells to treat heart attack victims and degenerative heart
disease;
skin cells to treat burn victims;
spinal cord neuron cells for treatment of spinal cord trauma and
paralysis;
neural cells for treating those suffering from neurodegenerative diseases;
pancreas cells to treat diabetes;
blood cells to treat cancer anemia and immunodeficiencies;
neural cells to treat Parkinson's, Huntington's and Amyotrophic Lateral
Sclerosis (ALS);
cells for use in genetic therapy to treat 5,000 genetic diseases,
including Cystic Fibrosis, Tay-Sachs disease, schizophrenia, depression,
and other diseases;
blood vessel endothelial cells for treating atherosclerosis;
liver cells for liver diseases including hepatitis and cirrhosis;
cartilage cells for treatment of osteoarthritis;
bone cells for treatment of osteoporosis;
myoblast cells for the treatment of Muscular Dystrophy;
respiratory epithelial cells for the treatment of Cystic Fibrosis and lung
cancer;
adrenal cortex cells for the treatment of Addison's disease;
retinal pigment epithelial cells for age-related macular degeneration;
modified cells for treatment of various genetic diseases;
and other cells for use in the diagnosis, treatment and prevention of
other deadly or disabling diseases or other medical conditions.

The use of stem cells to create these therapies would lead to great medical advances. We have to be sure that nothing we do in this legislation concerning human cloning would obstruct in any way this vital research.

Note: A researcher/doctor might want to "create a human zygote with DNA identical to that of an existing or previously existing person through the use of somatic cell nuclear transfer" in order to create a customized stem cell line to treat the individual from whom the DNA was extracted. By using the same DNA the stem cell would be more likely to be compatible and not rejected by the person when the stem cell is transferred (back) to the person for the treatment. The language in brackets would prohibit this technology even though its sole purpose is to provide medical treatment for the individual, not for reproduction (cloning) of that individual.

CONTACT: Dan Eramian, Vice President, Communications of BIO, 202-857-0244.

SOURCE Biotechnology Industry Organization
-0- 02/08/98
/PRNewswire -- Feb. 8/

CO: Biotechnology Industry Organization; U.S. Food and Drug Administration ST: District of Columbia IN: MTC SU: LEG





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