Testimony before the Maryland House

Testimony of the Biotechnology Industry Organization (BIO)
Before the Maryland House Health and Government Operations Committee

Regarding House Bill 885
The Human Cloning Prohibition Act of 2005

Mr. Chairman and members of the committee, thank you for the opportunity to
present testimony regarding House Bill 885, the Human Cloning Prohibition Act of
2005. On behalf of the Biotechnology Industry Organization (BIO), I would like
to state for the record that, as an industry, we are opposed to reproductive human
cloning. At this time we see no ethical or medical justification for the replication
of an existing or previously existing human being. However, House Bill 885 goes
well beyond preventing human reproductive cloning. This legislation will prohibit
a very promising area of research and would make felons out of Maryland
researchers seeking to develop cures for diseases afflicting millions of people
worldwide.

BIO represents more than 1,100 biotechnology companies, academic institutions,
state biotechnology centers and related organizations in all 50 U.S. states and 33
other nations. BIO members are involved in the research and development of
health-care, agricultural, industrial and environmental biotechnology products. In
Maryland, we work closely with the Technology Council of Maryland to represent
the 300 biotechnology and lifescience companies and nearly 20,000 employees
working to develop cures for patients suffering from diseases such as cancer,
diabetes, Parkinson’s and Alzheimer’s disease as well as many others.
While we categorically oppose human reproductive cloning, we are working
closely with researchers and patient communities to promote the very promising
field of stem cell research. Human stem cells, both adult and embryonic, hold
significant potential to help scientists develop treatments and regenerate damaged
or diseased cells. House Bill 885, as it is currently written would make certain
types of stem cell research illegal and subject Maryland scientists and researchers
to arrest and punitive fines.

Specifically, House Bill 885 would prohibit a process called somatic cell nuclear
transfer (SCNT). This cloning technique allows researchers to remove the nucleus
from a donor egg cell and replace it with the nucleus from the cell of a potential
patient. The cell is then stimulated to begin the cell division process that will
create human stem cells that are genetically identical to the individual seeking the
new cells. All of this is done in vitro, or outside the human body.

Stem cells are unique in that they can become any cell in the body. Working with
these cells, scientists can harness “undifferentiated” human stem cells and direct
them to become a variety of specialized cells. Once enough specialized cells have
been developed they can then be used to repair spinal cord injuries; regenerate
damaged brain cells for people suffering from Parkinson’s or Alzheimer’s disease;
regenerate muscle or organ tissue as well as skin cells to treat burn victims. The
benefit of this type of therapeutic cloning may someday allow doctors to treat
patients suffering from these maladies with cells that are the genetic duplicates of
the patients’ own damaged cells. This could significantly reduce rejection issues
common with donor cells or organ transplants.

Committee members may be aware of a report published in the March issue of the
journal Diabetes that details very promising results of using human embryonic
stem cells in potentially curing Type 1 diabetes. Researchers at the University of
Miami were able to use embryonic stem cells to create insulin-producing islet cells
that may well lead to a cure for this debilitating disease. While University of
Miami researchers caution that a cure is still far away, if this type of research were
banned in Florida, this research could never have been conducted.

We are not alone in our support for preserving all forms of stem cell research. The
National Academy of Sciences (NAS) in a recent report concluded:
“The scientific and medical considerations that justify a ban on human
reproductive cloning at this time are not applicable to nuclear transplantation to
produce stem cells. Because of the considerable potential for developing new
medical therapies to treat life-threatening diseases and advancing biomedical
knowledge, the panel supported the conclusion of a previous National Academies’
report—Stem Cells and the Future of Regenerative Medicine—that recommends
that biomedical research using nuclear transplantation to produce stem cells be
permitted.”

Medical research has taken quantum leaps in the past decade. Scientists are
identifying and developing treatments, and potentially cures, for deadly and
seriously debilitating diseases. Cloning techniques have been invaluable in
research leading to the production of breakthrough medicines, diagnostics and
vaccines to treat heart attacks, various cancers, kidney disease, diabetes, hepatitis,
multiple sclerosis, cystic fibrosis, and other diseases. The cloning of genes already
has contributed to the development of important medicines, such as tissue
plasminogen activator (tPA) to dissolve clots after a heart attack and erythropoietin
(EPO) for anemia associated with dialysis for kidney disease.

Legislation to ban the cloning of human beings presents complex issues and
requires thoughtful debate. Recent efforts in the U.S. Congress to ban this
technology are a clear example of the complexity of this issue. However, many
states, such as California and more recently New Jersey have adopted legislation to
encourage stem cell research, while placing a ban on human reproductive cloning.
California, the state with the largest biotechnology industry presence in the
country, recognizes the promise of this technology. The state became the first in
the nation ban reproductive human cloning (1997), to create a safe harbor for all
forms of stem cell research (2001), and with the passage for Proposition 71 (2004),
the state will allocate $3 billion to stem cell research over the next 10 years.
Nearly a dozen states are now considering legislation to either create safe harbors
and/or allocate funding for stem cell research.
If the intent of the State of Maryland is to prohibit human reproductive human
cloning, we suggest that the legislature enact House Bill 1183. This legislation
expressly prohibits human reproductive cloning but makes provisions for stem cell
research. House Bill 1183 would make it illegal to implant cloned cells for the
purpose of initiating a pregnancy that could result in the birth of human child.
There are many reasons why Maryland should consider enacting legislation like
House Bill 1183. Interstate competition for biotechnology industry development is
at an all time high. States like California and New Jersey are keenly aware of this
competition and have put in place programs to promote industry development. The
passage of their respective stem cell research laws are prime examples of their
commitment to biomedical research.

Maryland holds the enviable position of having the fourth largest number of
biotechnology companies in the United States. The state has always been a
staunch supporter of the advancement of biomedical research and promoting
industry growth. Promoting research is imperative if the state is to continue to
hold its competitive advantage over other states in the country. We strongly urge
you to preserve the opportunity to conduct this promising research in the state and
recommend that the committee oppose House Bill 885.

Thank you for the opportunity to submit testimony today. Please feel free to
contact me if you have any questions or need additional information.

Respectfully Submitted,

Patrick M. Kelly
Vice President, State Government Relations
Biotechnology Industry Organization
(202) 962-9200
pkelly@bio.org E-mail
www.bio.org Website