Unregulated Stem Cell Research May Put Women's Health At Risk
Pro-Choice Groups Will Raise Concerns about an Expanding Market for Women's Eggs at March 9 Senate-Assembly Committee Hearing
Who: The Pro-Choice Alliance for Responsible Research, Our
Bodies Ourselves, the Center for Genetics and Society, and Suzanne
Parisian, M.D., a former chief medical officer for the FDA,
have joined together to call attention to the need to regulate
the harvesting of women's eggs for stem cell research.
What/Where/When: Members of the pro-choice groups will testify
about the need for regulation of egg extraction and other aspects
of stem cell research at the hearing of the California Legislature's
Implementation of Proposition 71 Oversight Committee, chaired
by State Senator Deborah Ortiz, on Wednesday, March 9, 2005
from 1:30-5 pm, State Capitol, Room 4203, Sacramento, California.
"I strongly urge that sound ethical and medical practices
are adopted regarding the manner in which eggs are extracted
from healthy women for research purposes," said Suzanne
Parisian, M.D., a former Chief Medical Officer of the U.S. Food
and Drug Administration. "As a scientist, I understand
why some have expressed enthusiasm for SCNT [somatic cell nuclear
transfer; also referred to as embryo cloning, research cloning,
or `therapeutic' cloning]. But as a physician, I cannot condone
SCNT at the potential expense of a woman's health without giving
her an opportunity for adequate informed consent and establishing
a mechanism to ensure her safety."
Dr. Parisian is a board-certified pathologist as well as a
researcher in genetics and developmental biology. She details
her concerns in an open memo for scientists, physicians, legislators,
press, and public health advocates who have an interest in SCNT
research, available at http://www.genetics-and-society.org/resources/items/200502_letter_parisian.html
Both the drugs used to "shut down" women's ovaries
and those used to "hyperstimulate" the ovaries to
produce multiple eggs are associated with serious adverse reactions,
in some cases life-threatening. Deaths have been reported.
Concerns about the health risks of egg extraction are gaining
new urgency because of the prospect of increased demand for
women's eggs for SCNT research, state funding for which was
authorized by Proposition 71. Women's health and rights leaders
have long advocated that women have the right to make informed
choices about procedures that will affect their bodies. Many
question whether women can give truly informed consent to provide
eggs when the risks have not been adequately studied.
"The long term risks of the hormonal drug treatments used
for egg extraction have not been adequately studied," said
Judy Norsigian, co-founder of the Pro-Choice Alliance for Responsible
Research and executive director of Our Bodies Ourselves. "We
should wait until the Centers for Disease Control and others
collect more complete data on risks for both these women and
their offspring. We already do know about short term problems
including ovarian hyperstimulation syndrome, which in relatively
rare instances has caused severe problems, including death.
Many of these drugs have never been approved by the FDA for
the purposes of egg extraction."
Public policy organizations believe further study is warranted.
"If researchers begin experimenting with SCNT on a large
scale, they will need eggs from many thousands of women. Payment
to these women for their eggs, even if it is considered reimbursement,
would create an economic inducement for women to put themselves
at risk. This would be especially true for poor and young women,"
said Marcy Darnovsky, associate director of the Center for Genetics
"Unlike other types of medical research, where testing
on human subjects occurs only much later in the process and
after laboratory experiments have indicated that certain safety
levels have been achieved, SCNT research requires that women
be the first guinea pigs. Protecting women's long term health
must be our highest priority," stated Susan Berke Fogel,
co-founder of the Pro-Choice Alliance for Responsible Research.
At the March 9 hearing, the following recommendations will
be made to the California state legislature:
1. California researchers should be required to adopt the safest
and most ethical approaches to collecting eggs for SCNT or other
2. Extraction at the time of an ovariectomy or a tubal ligation
would be far safer and more ethical than conventional multiple
egg extraction procedures. Even single egg extraction with natural
cycling (involving no hormonal manipulations of the ovary) would
be safer than conventional methods.
3. Before undertaking multiple egg extraction from healthy
women, all data on drugs used in such procedures should be reviewed
by a neutral, knowledgeable, and independent oversight body
whose sole purpose is to protect the safety and rights of women
wishing to provide eggs. In order to accomplish this review,
pharmaceutical firms must be required to disclose the FDA-approved
indications and all available safety data on these drugs.
4. Before undertaking multiple egg extraction from healthy
women, better quality data should be gathered that would make
true informed consent possible for women considering providing
eggs for research.
5. Every woman who provides eggs for research should have her
own physician who is independent of the research and the research
institution, and whose only job is to look out for the well-being
of the woman.