Company Press Release
SOURCE: Biotechnology Industry Organization
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. 2
SOURCE: Biotechnology Industry Organization