(Testimony of Francine Coeytaux, MPH, Pro-Choice Alliance for Responsible Research, before a joint hearing of the California Senate Subcommittee on Stem Cell Research Oversight, the Senate Health Committee, and the Assembly Health Committee)
Good afternoon. I appreciate the opportunity to address your
committees. My name is Francine Coeytaux. The last time I stood
before you, Senator Ortiz, I was here on behalf of the California
Advisory Committee on Human Cloning. Thank you for inviting
Today I come wearing several hats:
The first is as a social scientist and women's health advocate.
My expertise is in public health, acceptability research and
the intersection of science, politics and the interests of women.
I have spent the last twenty years working on the development
and public introduction of new reproductive technologies including:
NORPLANT, emergency contraception, microbicides and the abortion
pill. I am a founder of the Pacific Institute for Women's Health
based here in California whose mission it is to improve the
health and wellbeing of women worldwide. I also helped found
the Reproductive Health Technologies Project, an organization
based in Washington DC which focuses on consensus-building among
constituencies often at odds in their viewpoints on women's
reproductive health matters, especially issues regarding the
historical use or misuse of reproductive technologies. From
December 1998 to January 2002 I served as an appointed member
of the California Advisory Committee on Human Cloning, where
we vigorously examined and debated the very issues that are
now before this committee.
Second, I am here as a representative of the Pro-Choice Alliance
for Responsible Research. A coalition of advocates, scientists
and health professionals, we seek to promote responsible research
in the fields of genetics and reproduction.
Finally, I am here as a mother. My husband, a neuroscientist
at UCLA, and I have sixteen year old twins, a boy and a girl.
Our daughter, Sabine, was born with a chromosomal abnormality.
Because of this, we have firsthand experience with the heartbreaking
decisions parents are faced with when trying to avail themselves
of new scientific breakthroughs that might help cure or alleviate
the suffering of their children. Frankly, it is because of this
convergence of my professional and personal interests that I
have recently applied myself to addressing the many red flags
that Proposition 71 raised for me.
I am here today, on behalf of the Pro-Choice Alliance, to urge
you to use your legislative authority to demand and require
the highest ethical and medical standards for protection of
the health of women who will be asked to donate eggs for research
purposes. Our request is simple, reasonable and can be implemented
without obstructing the progress of the science. Women will
be the first human subjects of Proposition 71 funded research.
We are asking that mechanisms be put in place to ensure that
women who provide eggs be accorded all established protections
for human research subjects; that as research subjects, they
be given full information in advance about the direct and indirect
risks of the research; and that their recruitment never be coercive.
We sincerely believe these safeguards must be put in place in
order to protect the health of the research subjects, the reputations
and credibility of the scientists involved, and in general to
advance the promise of stem cell research.
We support most embryo stem cell research and also support
the use of otherwise-discarded embryos from IVF clinics. We
have had this position since before the election. However, we
do have deep reservations about the long term health consequences
for women of embryo stem cell research that involves somatic
cell nuclear transfer (SCNT), also referred to as embryo cloning,
or "therapeutic" cloning as it is currently done.
Specifically authorized by Proposition 71, somatic cell nuclear
transfer will require extracting eggs from thousands of healthy
women for research purposes.
Those who oversee the ethical conduct of research, especially
members of Institutional Review Boards (IRBs) and now members
of the ICOC, have a duty to carefully weigh the "risk/benefit"
ratio when making decisions about whether to approve a research
protocol. Embryo cloning research poses significant challenges
in this regard.
On the benefit side, stem cell research holds much promise.
And it is on the basis of the public's hopes that Proposition
71 passed. But now, with the campaigning behind, the promoters
of the Institute for Regenerative Medicine need to stop exaggerating
the promise and attempt to realistically describe and weigh
the potential gains. Particularly disingenuous in the oversell
is the failure to convey the information credible scientists
acknowledge - that the benefits are hypothetical and only a
distant promise. Preying on the hopes of families who have loved
ones with immediate needs may have been a good campaign strategy
but is exactly what we must avoid when laying out the potential
benefits in a risk analysis.
On the risk side of the equation, attention is lacking to the
substantial risks to women's health posed by the advent of embryo
cloning. Omitted from the current polarized debate is any discussion
of the thousands of women who will need to undergo egg extraction
procedures to provide eggs for such embryo cloning. Among our
primary concerns are the serious and substantial risks to women's
health posed by the practice of multiple egg extraction to harvest
eggs for SCNT and the inability to obtain true informed consent
from egg donors given the current lack of adequate safety data.
What are the risks of multiple egg extraction? Stimulation
drugs may cause Ovarian Hyper-Stimulation Syndrome (OHSS) in
about 3-8% of patients. It can progress rapidly to a life-threatening
condition days after completion of egg collection. OHSS has
been associated with death and has been reported in younger
Risks associated with Lupron™ (leuprolide acetate) - the
drug used to "shut down" the ovaries before stimulation
with other drugs - include depression, memory loss, liver disorders,
bone loss, and severe muscle, joint and bone pain. Some of these
problems persist long after the drug is first used, and the
FDA has not yet followed up on the thousands of reported adverse
drug reactions, including hundreds of hospitalizations. For
a number of years, many of the women adversely affected by Lupron
shared their experiences on the Internet as part of the "Lupron
Supporters of embryo cloning are quick to point to the fact
that the procedures for multiple egg extraction are the same
as those being performed in infertility clinics where thousands
of women undergo "in vitro fertilization" (IVF) procedures
for reproductive purposes. But there are huge problems with
First and foremost, infertility treatment is not a good model
because it has been totally unregulated. As a result we are
faced with a paucity of long term safety data accompanied by
numerous reports of serious and occasionally irreversible problems
experienced by women using these drugs.
Second, the health risks involved in multiple egg extraction
for fertility purposes are at least offset by a clear direct
benefit. In the case of IVF, the best infertility clinics can
now offer 30-40% success rates, so that women undergoing multiple
egg extraction - whether to achieve a pregnancy themselves,
or to be an egg donor for another woman - do know that there
is a clear potential direct benefit, and one that is of inestimable
value: a baby. Harvesting a woman's eggs for research has no
direct benefit to the research subject. Not only is the benefit
not direct to the egg provider, but it is neither immediate
nor certain. The potential of embryonic stem cell research to
cure and treat disease is still only a possibility. Therefore
the balance of risks and benefits of egg extraction for research
must be evaluated very differently than one might do for egg
extraction for fertility purposes.
Third, the issue of reimbursement for eggs has been a cause
for concern in the women's health community for years. Even
though fertility clinics continue to assert that the fees are
not incentives but "reimbursements", it is not uncommon
to see ads offering thousands of dollars to women who fit certain
descriptions and willing to undergo multiple egg extraction.
Most of these ads are targeted to highly educated and privileged
young women, and some might argue thus dampening the coercive
nature of the payment. This will not be the case in a market
for eggs for the purposes of embryo cloning. In SCNT the egg
is stripped of the donor's genetic material so the focus will
simply be to recruit young, healthy women. And if financial
payments are made even in the guise of "reimbursement,"
in all likelihood the majority of women offering their eggs
will be poor women. The tremendous potential for the recruitment
of donors with financial incentives that can only be construed
as coercive has been exacerbated by the infertility field and
must be addressed. Frankly, the IVF industry serves more as
an example of how not to proceed than as a model.
The lack of regulation of the infertility field is a concern
shared by a former Chief Medical Officer of the Food and Drug
Administration, Dr. Suzanne Parisian (also a former researcher
in genetics and developmental biology.) In her 3-page letter,
released this past week and of which you have a copy in your
briefing package, she emphasizes that "many of the drugs
used during these procedures have not been adequately studied
for long term safety, nor do some of these drugs have FDA approval
for these specific indications. This is not widely understood
and has led to significant misunderstanding about the risks
involved for women who donate eggs either for reproductive purposes
or for SCNT research."
Pharmaceutical firms have not been required by either the government
or physicians to collect safety data for IVF drugs regarding
risk of cancer or other serious health conditions despite the
drugs having been available in the United States for several
decades. In addition, many of the drugs being used are being
used "off label", meaning that they were never approved
by the FDA for multiple egg extraction. For example, Lupron™,
perhaps the most commonly used drug in IVF treatment, although
approved for several specific uses, is NOT approved for use
in these procedures for multiple egg extraction. Essentially,
a whole industry has arisen and flourished now for over a decade
with few of the regulatory oversights we have come to expect
of medical practice in the United States. Lack of FDA approval
and/or review of these drugs as part of egg extraction procedures
should be a major concern of anyone considering SCNT research.
Given recent attention to the harm that can result when clinical
trial data are withheld - just consider the track record with
Vioxx™, Celebrex™, and the anti-depression drugs known
as SSRIs - the public should demand that companies release all
available safety data for drugs used in egg extraction. This
would include the release of unpublished data on leuprolide
acetate collected some years ago by TAP Pharmaceuticals.
In summary, because we have such an incomplete picture of the
risks to women's health, we believe that at this date, no woman
can give truly informed consent to participate in egg extraction
for research purposes.
The Pro-Choice Alliance for Responsible Research and our Coalition
partners would like to make the following recommendations 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.
The California legislature's groundbreaking legislation banning
human reproductive cloning and allowing non-reproductive cloning
was what made Proposition 71 possible. The Human Cloning Committee
explicitly recommended that "California regulate all human
non-reproductive cloning in the State, public or private. That
regulation should do at least three things: a) prohibit the
use of pre-embryos after development of the primitive streak,
b) ensure that the persons providing cells for this purpose
gave informed consent, and c) require that the research be permitted
by an approved Institutional Review Board (IRB)." We believe
it is now your responsibility to regulate the use of this technology.
So far, in spite of our repeated attempts to raise the issue,
the Institute for Regenerative Medicine has refused to acknowledge,
much less discuss, the challenges inherent in developing standards
which guarantee true informed consent for women considering
the donation of eggs for this research. Instead, we have seen
an exaggeration of the benefits and a dismissal of any risks.
We urge this committee to take steps to ensure that California
women are not harmed as this vast experiment in medical research