Boston Egg Donor
IMPORTANT: Risks Involved
In the February 2004 issue of O Magazine,
Barbara Seaman's article, “Is This Any Way to Have a Baby?” caused quite a stir
among infertility experts and women dealing with infertility. The article
explored women's experiences with fertility drugs and underscored the paucity of
long term safety data as well as the serious, occasionally irreversible problems
experienced by some women using these drugs. In response, members of the
American Society for Reproductive Medicine (ASRM) and the Society for Assisted
Reproductive Technology (SART) posted an unusual rebuttal at the ASRM website (www.asrm.org).
In the months following this confrontation, debate over fertility drugs and
their health consequences has been steadily increasing.
Because embryonic stem cell research is poised to expand greatly, and somatic
cell nuclear transfer (SCNT*), a cloning technique in which the nucleus of an
unfertilized egg is replaced with the nucleus from a body cell, requires large
numbers of women to donate eggs for research purposes, there is renewed
attention to the larger question of risks to women's health from egg extraction
procedures. Whether eggs are extracted for reproductive purposes — as is the
case in an infertility clinic where women undergo in vitro fertilization (IVF) —
or for research purpose like SCNT, the risks involved in the procedure are the
same.
Because SCNT is such a rapidly growing field of research, the demand for eggs is
growing as well. Since women normally produce a single egg in her monthly
menstrual cycle, and the number of donors is relatively low, embryo researchers
attempt to stimulate donors' ovaries to produce a larger number of eggs.
Gonadotropin hormone regimens are administered, and although fertility doctors
try not to over-stimulate their patients' ovaries, complications can and do
occur.
Risky Drugs
The risks of multiple egg extraction do not only come in this
stage of the process, however. Lupron, or leuprolide acetate, is a drug that is
commonly used to shut down a woman's ovaries before stimulating them to produce
multiple follicles. This drug has caused a range of problems, according to the
Food and Drug Administration (FDA). Theses include rashes, vasodilation
(dilation of blood vessels causing a “hot flash”), burning sensations, tingling,
itching, headaches and migraines, dizziness, hives, hair loss, severe
non-inflammatory joint pain, difficulty breathing, chest pain, nausea,
depression, emotional instability, loss of libido, dimness of vision, fainting,
weakness, asthenia gravis hypophyseogenea (severe weakness due to loss of
pituitary function), amnesia, hypertension, rapid heart rate, muscular pain,
bone pain, abdominal pain, insomnia, swelling of hands, general edema, chronic
enlargement of the thyroid, liver function abnormality, anxiety, and vertigo.
Although the FDA approved the drug for several specific uses, such as the
treatment of endometriosis and fibroid-associated anemia, it has not approved
Lupron for use in multiple egg extraction procedures — something that is not
well understood by many women who undergo these procedures. It is legal to use a
drug for a non-approved use such as this, as long as it is marketed legally for
at least one approved use. Lupron is just one of many drugs used “off-label” in
this fashion. However, proper studies justifying its use for egg extraction have
never been formally submitted to the FDA.
The drugs used to hyperstimulate the ovaries also have negative effects, most
notably a condition called Ovarian Hyperstimulation Syndrome (OHSS). Serious
cases of this syndrome involve the development of cysts and enlargement of the
ovaries, along with massive fluid build-up in the body. As noted in an article
in Human Reproduction Update, “the reported prevalence of the severe form of
OHSS is small, ranging from .05 to 5% [of women undergoing gonadotropin
regimens]. Nevertheless, as this is an iatrogenic [medically induced]
complication of a non-vital treatment with a potentially fatal outcome, the
syndrome remains a serious problem for specialists dealing with infertility.”[1]
Also, as noted by Dr. Suzanne Parisian, a former Chief Medical Officer at the
FDA, “OHSS carries an increased risk of clotting disorders, kidney damage, and
ovarian twisting. Ovarian stimulation in general has been associated with
serious life threatening pulmonary conditions in FDA trials including
thromboembolic events, pulmonary embolism, pulmonary infarction, cerebral
vascular accident (stroke) and arterial occlusion with loss of a limb and
death.”[2] One Institutional Review Board (IRB) for Advanced Cell Technology in
Massachusetts cited the risks as including “high blood pressure; fluid
accumulation in the limbs; formation of blood clots which potentially could be
dislodged from the involved vein or artery causing damage to vital organs such
as lungs, heart or brain; intestinal problems such as decreased appetite,
constipation; nausea and vomiting, diarrhea, difficulty in swallowing;
intestinal bleeding, intestinal ulcers and polyps; thyroid enlargement; breast
tenderness; hot flashes; bone, muscle and joint pain; anxiety; depression;
blurred vision; mood swings; nervousness; numbness; taste changes; memory
problems; lightheadedness; blackouts; and headaches.” [3]
So why is multiple egg extraction the norm in IVF clinics? With such risks
involved, why don't specialists just extract the single egg that women normally
release each month? The obvious reason is that if only one egg is harvested
using the natural cycling that occurs each month in most women, there is a good
possibility that it will not be successfully fertilized. If fertilized, it may
not develop into an embryo that could be successfully implanted into a woman's
uterus, thus requiring repeated surgical procedures to extract more eggs. With
each IVF procedure, extracting multiple eggs obviously increases the likelihood
of success.
The same reasoning can be applied to the research context, as it is important to
have a larger number of eggs with which to conduct research. But, given the
early stages of embryo stem cell research, with only hypothetical benefits at
hand, it may be far wiser to protect women from the risks of multiple egg
extraction solely for SCNT research purposes and to permit only surgical
extraction of the usually single egg produced each month. Others argue that
whatever the risks are — known and unknown — a woman should nevertheless have
the choice to take these risks, especially if she has a strong personal
investment in seeing certain therapies developed, even if they are only a
distant promise.
Those who oversee the ethical conduct of research, especially members of IRBs,
are supposed to think carefully about risk/benefit ratios when deciding whether
to approve a research protocol. Embryo cloning research poses significant
challenges in this regard. The aforementioned IRB approved a protocol for SCNT
several years ago and included in the informed consent document the following
language: “Severe lung and blood clot events have resulted in death.”[4] They
clearly decided that it was ethical to ask women to take such risks as long as
they informed them about them. Others might argue just the opposite. More...