HJR 588: Medical, Ethical, and Scientific Issues Relating to Stem Cell
Research Conducted in the Commonwealth
House Joint Resolution
588 (Marshall, R. G.), the enabling resolution for the study, created
a 15-member subcommittee. There are eight members from the General Assembly,
Delegates Robert G.
Marshall (chairman), Kenneth C. Alexander, Kathy J. Byron, , David A.
Nutter, John M. O'Bannon and Senators Richard L. Saslaw (vice chairman),
Harry B. Blevins, and Janet D. Howell; three
representatives of Virginia's medical schools, Paul J. Hoehner, M.D.,
Thomas Farris Huff, PhD., and Jacob F. Mayer, Jr., PhD.; and four nonlegislative
citizen members at large, Dennis G. Fisher, PhD.,
Kris Gulden, Eileen M. Hall, RN, and Kelly Hollowell, JD, PhD.
The resolution notes
the controversy surrounding research using human embryonic stem cells
(hEMS) and comments on the often discussed "distinction between embryos
created for research purposes and those created for reproductive purposes."
The joint subcommittee's directive is broad and nonspecific, to "examine
the medical, ethical, and scientific policy implications of stem cell
research and the efficacy of research using both adult and embryonic stem
VA LAW THAT ADDRESSES
STEM CELL RESEARCH
Including SB 1194,
which became law on July 1, 2005, Virginia statutes currently contain
five references to stem cell research:
1. Section 2.2-2233.2
(SB 646, 2004) established the Biotechnology Commercialization Loan Fund
under the auspices of the Center for Innovative Technology (CIT), the
operating entity for the Innovative Technology Authority (ITA) created
in 1984 by the General Assembly. The fund is "for the sole purpose
of financing technology transfer and commercialization activities related
to biotechnology inventions made, solely or in cooperation with other
organizations, at qualifying institutions," which includes Virginia's
colleges and universities or intellectual property foundations associated
with them. The law includes the caveat that "[n]o loan shall be made
to any entity which conducts human stem cell research from human embryos,
or for any loan to conduct such research; however, research conducted
using adult stem cells may be funded."
2. Section 2.2-2818,
relating to state employees' health plan, was amended in 1995 by SB 830
(Holland, C.A.) to "[i]nclude coverage for treatment of breast cancer
by dose-intensive chemotherapy with autologous bone marrow transplants
or stem cell support when performed at a clinical program authorized to
provide such therapies as a part of clinical trials sponsored by the National
Cancer Institute. For persons previously covered under the plan, there
shall be no denial of coverage due to existence of a preexisting condition."
3. Section 38.2-3418.1:1,
relating to health insurance, was added in 1994 by HB 240 (Christian).
This law requires health insurers to "offer and make available coverage"
for "dose-intensive chemotherapy/autologous bone marrow transplants
or stem cell transplants when performed pursuant to protocols approved
by the institutional review board of any United States medical teaching
college including, but not limited to, National Cancer Institute protocols
that have been favorably reviewed and utilized by hematologists or oncologists
experienced in dose-intensive chemotherapy/autologous bone marrow transplants
or stem cell transplants."
4. Section 58.1-3506,
relating to other classifications of tangible personal property for taxation,
was amended by HB 574 (May, 2002) to add subdivision A 32. The relevant
authority for localities to tax classes of property at a different rate
(a lower rate than the local rate established for all other classes of
tangible personal property) that are "equipment used primarily for
research, development, production, or provision of biotechnology for the
purpose of developing or providing products or processes for specific
commercial or public purposes, including, but not limited to, medical,
pharmaceutical, nutritional, and other health-related purposes; agricultural
purposes; or environmental purposes but not for human cloning purposes
as defined in § 32.1-162.21 or for products or purposes related to
human embryo stem cells [emphasis added]. For purposes of this section,
biotechnology equipment means equipment directly used in activities associated
with the science of living things." In other words, equipment used
for research relating to human cloning
purposes or relating to human embryonic stem cells would not qualify for
the lower rate.
5. Section 23-286.1,
effective July 1, 2005, the Christopher Reeve Stem Cell Research Fund
was created by SB 1194 (Potts). The Fund will consist of appropriations
(if provided), gifts, grants, and donations from public or private sources
and will be administered by the existing Commonwealth Health Research
Board. Although no state appropriations are currently allocated, the law
establishes a special nonreverting, revolving, and permanent fund for
the support of stem cell research in honor of Christopher Reeve. However,
embryonic stem cell research cannot be funded.
In 2001, Chapter
5.2 of Title 32.1, Human Cloning, was added to the Code of Virginia with
passage of two identical bills, HB 2463 (McDonnell) and SB 1305 (Newman).
The law prohibits (i) human cloning, (ii) the transfer of the product
of a somatic cell nuclear transfer (cloning technology) into a uterine
environment to initiate a pregnancy, and (iii) the possession of the product
of human cloning or the shipping or receiving of that product in commerce
for the purpose of implanting the product into a uterine environment so
as to initiate a pregnancy. Cloning research or practices on animals other
than humans is not prohibited.
The study's organizational
meeting included a short chronology of the controversy relating to stem
- Scientists had
postulated the existence of adult stem cells for approximately forty
- Adult stem cells
have been identified and isolated for approximately twenty years.
- Adult stem cells
derived from blood (peripheral and cord) and bone marrow have been used
in the treatment of various cancers, including certain leukemias, breast
cancer and other diseases for at least ten years-first in clinical trials,
but currently moving into the mainstream of medical
From 1996 through
2004, the "Dickey Amendment," named for its sponsor Representative
Dickey, prohibited federal funding for the creation or destruction of
human embryos for research purposes. The amendment was added to congressional
bills, including funding for the National Institutes of Health.
On November 5, 1998,
two independent research teams, Dr. James A. Thomson and colleagues at
the University of Wisconsin and Dr. John D. Gearhart and his research
group at Johns Hopkins University School of Medicine, reported on the
same day in two different journals the discovery of human embryonic stem
In 1999, the Dickey
Amendment was analyzed as banning the funding of the derivation of stem
cell lines from human embryos, but not banning federal funding of research
on embryonic stem cells after the cell lines had been established. This
interpretation was based on the Dickey amendment definition of embryo
in terms of "an organism that, when implanted in the uterus, is capable
of becoming a human being" and the inability of an embryonic stem
cell to become a human being regardless of whether implanted in the uterus.
In 2001, President
Bush announced that federal funds may be awarded for research using human
embryonic stem cells that meet specific limiting criteria.
MEMBERS VIEW STEM
Members viewed six
relevant Internet websites in order to gain background information on
stem cell research. The National Institutes of Health's "Stem Cell
web page (http://stem
cells.nih.gov/policy/NIHFedPolicy.asp) concisely outlines the federal
limitations on human embryonic research:
9th, 2001, President George W. Bush announced that federal funds may
be awarded for
research using human embryonic stem cells if the following criteria
process (which begins with the destruction of the embryo) was initiated
prior to 9:00 P.M. EDT on August 9, 2001. The stem cells must have
been derived from an embryo that was
created for reproductive purposes and was no longer needed.
must have been obtained for the donation of the embryo and that donation
not have involved financial inducements."
The members visited
the University of California Medical Center's The Visible Embryo web page
(http://www.visembryo.com/), which is an interactive site designed
to educate medical students and other interested parties. The site depicts
a spiral that tracks human reproduction from fertilization through the
embryonic stages, including the twenty-three stages occurring during the
first trimester of pregnancy, every two-weeks during the second and third
trimesters, as well as development of the fetus to the point of birth.
A third stage link allowed the members to zoom in on a slide depicting
the early blastocyst, a stage of development occurring within three to
five days after fertilization, but prior to implantation in the uterus
at which point stem cells can be taken. A blastocyst has been described
by scientists as smaller than the dot at the end of a sentence.
Members visited the
website of the International Society for Stem Cell Research (http://www.isscr.org/).
On the "public" area of the website, the ISSCR includes the
article Stem Cell Primer, which notes the distinction between embryonic
stem cells and adult stem cells. The undifferentiated embryonic stem cells
can mature into any cell type depending on the surrounding environment,
such as brain cells, heart cells, muscle cells, blood cells, blood vessel
cells, skin cells, pancreatic islet cells that produce insulin, and bone
cells. This characteristic is referred to by scientists as "pluripotency."
Adult stem cells, on the other hand, appear to be "multipotent,"
able to differentiate into several cell types, but not all cell types.
The site also provides illustrations and diagrams of various stem cell
differentiation such as embryonic stem cells; hematopoietic stem cells,
an easily obtained type of multipotent adult stem cell found in bone marrow;
mesenchymal stem cells, also a multipotent adult stem cell obtained from
bone marrow; and the asymmetric cell division of stem cells that reproduce
exact replicas of themselves and a progeny cell which may differentiate
into various kinds of stem cells.
Primer includes a concise description of somatic cell nuclear transfer-the
technology used in reproductive or therapeutic cloning. The "profound
technical and, more importantly, biological problems," of reproductive
cloning are cited, such as obesity-including obesity at birth, infection,
and early death. Dolly, the sheep, was the first animal cloned via this
technology. The age of the donor DNA is recognized to be a problem; however,
the exact nature of the defects are unknown.
involving the nuclear transfer of a patient's cell into an oocyte, a human
egg, is believed to be a mechanism in which stem cells that are genetically
compatible can be produced and transferred to the patient to initiate
repair of tissue damaged through disease or injury.
Recent studies conducted in Korea and other countries relating to therapeutic
cloning have received media attention.
The American Medical
Association's website (http://www.ama-assn.org/ama/pub/category/13630.html)
was visited, specifically, Report 5 of the Council on Scientific Affairs,
which sets out the AMA's stem cell recommendations. The guidelines adopted
by the AMA House of Delegates as AMA policy at the 2002 AMA Annual Meeting
- Supports biomedical
research on multipotent stem cells, including adult and cord blood stem
- Supports the use
of somatic cell nuclear transfer technology in biomedical research (therapeutic
- Opposes the use
of somatic cell nuclear transfer technology for the specific purpose
of producing a human child (reproductive cloning).
- Encourages strong
public support of federal funding for research involving human pluripotent
- Will continue
to monitor developments in stem cell research and the use of somatic
cell nuclear transfer technology.
A visit to the Iacocca
Foundation website (http://www.iacoccafoundation.org/index.htm)
provided an example of a private entity that supports research, including
stem cell research. Lee Iacocca established the Foundation in 1984 in
memory of his wife, Mary, a diabetic who died in 1983 from complications
of diabetes. The Foundation's mission "is to fund innovative and
research programs and projects that will lead to a cure for the disease
and alleviate complications caused by it." Mr. Iacocca is currently
soliciting support for a study and clinical trials of a drug that may
be a viable treatment for Type I diabetes. Mr. Iacocca has already contributed
$1 million to this effort.
The final website
visited was the National Academies, a consortium of professional science
organizations, including the National Academy of Sciences, National Academy
Engineering, Institute of Medicine, and the National Research Council
The members received the prepublication copy of the April 2005 Guidelines
for Embryonic Stem Cell Research. The guidelines provide standards for
ethical conduct of human embryonic stem cell research. The guidelines
include recommendations for a new level of oversight with higher standards
than are presently required, including a separate review committee to
evaluate research proposals and limitations on in vitro embryo development.
The guidelines have been published in book form and may be purchased online
from the National Academies.
During the website
review, members asked numerous questions and discussed some of the many
possible issues, including the impact of federal funding limitations on
embryonic stem cell research, the availability and quantity of excess/unneeded
human embryos created for reproductive purposes, and the potential for
using adult and embryonic stem cells for medical treatments.
The joint subcommittee
has tentatively scheduled a meeting on August 17 in Northern Virginia.
The locations for the September 21 and November 15 will be announced and
appear on the study website.
*Links to the
websites reviewed during the meeting may be
accessed on the study web page.
The Hon. R.G. Marshall