O magazine article
FURTHER RESPONSE TO O MAGAZINE ARTICLE
In response to requests form memeber, the presidents of ASRM and SART
today made available some additional comments on the article in O magazine.
This is designed for you to use with your patients who are concerned about
the article and are seeking additional information. This comment and the
letter to the editor are both available on the ASRM web site. www.asrm.org
Comments Regarding Article "Is This Any Way to Have a Baby?" by Barbara
Seaman, Oprah Magazine, February 2004
ASRM is not in the habit of commenting on individual articles that appear in
the lay press. While ASRM does not always agree with a journalist's
perspective, we generally respect the integrity of their reporting and
appreciate their genuine efforts to inform their readers. However, after
publication of the article "Is This Any Way to Have a Baby?" in the February
issue of "O Magazine", we felt compelled to express our profound objections
to the misstatements and implications in this article.
The article consists primarily of anecdotes from former infertility patients
who either failed to become pregnant or had serious health issues during or
following their infertility treatment. The manner in which these stories
are presented implies that these tragic outcomes are common rather than the
rare exception. The poorly researched reporting in this article can be
appreciated from the citation of sources such as: "I talked to some women"
and another as "A leading fertility scholar who prefers to remain anonymous
said." No sincere effort is made to provide objectivity or to distinguish
underlying medical problems that may be associated with but not caused by
the infertility treatment. Therefore, ASRM believes that this particular
situation warrants a response.
Patients often feel victimized by and angry about their infertility
condition, particularly when treatments fail or are associated with physical
and emotional discomfort. Rather than to provide useful, factual
information, this article serves merely to mislead and frighten already
vulnerable women and undermine their trust in their healthcare providers.
ASRM would expect that a reputable magazine such as "O" would welcome and
accept correction constructive criticism. ASRM would therefore like to
provide the following rebuttal to this article:
1. FERTILITYDRUGS CAUSE CANCER.
The photographs of two deceased celebrities (as the only two illustrations
in the entire piece) would imply that ovarian cancer is a common, proven
side effect of ovulation medications. Certainly, the exceptional
accomplishments of these women underscore the tragedy of their early deaths.
However, this conjecture is unsupported by any scientific data; in fact, the
preponderance of the medical literature that has addressed this subject to
date has found that ovulation medications do not increase the risk of either
ovarian or breast cancer. Women who have never been pregnant are at the
greatest risk of developing ovarian cancer. It is therefore logical that
infertility is also a risk factor for ovarian cancer. While it is an
attractive theory that excessive ovarian stimulation might increase the
risk, numerous studies have carefully scrutinized this possibility with none
demonstrating an increased cancer incidence in patients exposed to
infertility treatments. In fact, the Cochrane review cited by the author
concludes that available data do not demonstrate a statistically significant
increase in ovarian cancer associated with use of fertility medications.
The author implies that breast cancer may also be increased by fertility
medications. Whereas conditions associated with an increased lifetime
exposure to estrogen increase the risk of breast cancer, no studies have
indicated that the very short-term estrogen elevation produced by fertility
treatment increases breast cancer incidence.
2. FERTILITY MEDICATIONS LEAD TO OVARIAN HYPERSTIMULATION SYNDROME.
The case of a woman with a swollen abdomen and bloating after use of
ovulation drugs is described in the article. Severe ovarian
hyperstimulation syndrome is a serious and rare side effect of ovulation
medications. Fortunately, this is largely avoided by the careful patient
monitoring routine in IVF treatment. Less than 1% of all women undergoing
assisted reproductive technologies develop severe hyperstimulation syndrome,
although many will experience some bloating and ovarian discomfort.
Patients undergoing IVF are routinely informed about this potential
complication, and serious or long-term injury is exceedingly rare.
3. IVF INCREASES THE RISKS OF ECTOPIC PREGNANCY.
The implication that IVF causes entopic (tubal) pregnancy is extremely
misleading. Infertility due to tubal disease is one of the most common
indications for IVF, and patients with tubal factor infertility are at a
high risk for ectopic pregnancy no matter how they conceive. In fact, the
incidence of ectopic pregnancy after IVF in these women is reduced compared
to spontaneous pregnancy.
4. IVF IS INAPPROPRIATELY RECOMMENDED FOR PATIENTS WITH UNDIAGNOSED MALE
FACTOR INFERTILITY OR ABNORMALITIES OF THE UTERUS.
The article implies that, among providers at ART (Assisted Reproductive
Technology) services, there is a general failure to appreciate sperm and
uterine abnormalities that would preclude a successful pregnancy. It is the
standard of care (applied by the overwhelming majority of IVF clinics) to
evaluate both semen parameters and uterine anatomy prior to IVF treatment.
In fact, IVF is the only successful treatment for severely compromised sperm
number and/or function. Furthermore, IVF constitutes the only conclusive
test of fertilization ability. While uterine abnormalities are frequently
diagnosed in an infertility population, rarely are these abnormalities
incompatible with pregnancy and delivery of a healthy child.
5. TYPICAL IVF PRACTITIONERS ARE "ROGUE PHYSICIANS."
For reasons that are not clear, the cases of two infertility physicians who
were accused/convicted of criminal activity 10 and 15 years ago respectively
were included in this article. As the lay reader should be able to
appreciate, the implication that these reprehensible criminal activities are
typical of fertility physicians in general is ludicrous.
6. THE USE OF LUPRON FOR IVF LEADS TO OSTEOPOROSIS.
Lupron is a drug that suppresses the ability of the pituitary gland to
stimulate the ovary. While the article alleges it is used in IVF for
physician convenience, there is conclusive scientific evidence that use of
use of a GnRH agonist such as Lupron increases the pregnancy rate compared
to IVF cycles where these medications are not used. The most obvious
advantage is that Lupron prevents ovulation from occurring before the eggs
can be retrieved from the ovaries. The author focuses on the fact that this
constitutes an "off label" use with regard to FDA approval. Such off label
use of a drug for expanded indications is commonplace in medical practice,
is recognized by the FDA, and routinely brings us new therapies for many
diseases. The article implies that the use of Lupron for ovulation
induction leads to irreversible bone loss (osteoporosis). This is a blatant
example of the author's lack of understanding of the pharmacology and
physiology of ovulation induction. When used alone, Lupron results in low
estrogen levels that over time (months to years) can lead to bone loss and
osteoporosis. However, in the context of IVF, estrogen levels are
suppressed very transiently (for a few days, similar to the duration that
estrogen is low in normal menstrual cycles) followed by stimulation of the
ovaries and rapid increase in the estrogen level that is more than
sufficient to maintain bone density. Furthermore, there have been no
reported cases of osteoporosis associated with Lupron in the context of IVF
treatment.
7. THE FERTILITY INDUSTRY IS NOT REGULATED.
Despite the authors statements to the contrary, the field of reproductive
medicine is in fact heavily regulated. Physicians who specialize in
infertility care, like all physicians, are licensed to practice by the
states where they work. The Food and Drug Administration (FDA) approve all
medications and devices used in the clinic. The FDA also requires all
facilities that handle reproductive tissue to register with them, and has
issued draft regulations for the handling of those tissues. Another federal
agency, the Centers for Disease Control and Prevention (CDC) collect and
report the outcomes from ART procedures from clinics throughout the country.
This unique resource allows patients to examine the outcomes from each
clinic one at a time. There is also extensive self-regulation by the
profession. The Society for Assisted Reproductive Technology (SART) has
extensive requirements for its members, including educational and
certifications requirements for staff. The majority of infertility
practitioners have undergone specialty training and board certification in
Obstetrics and Gynecology, and many have completed additional subspecialty
fellowship training and certification in Reproductive Endocrinology.
8. AREAS OF AGREEMENT:
There are three areas where we agree with the author: 1) patients have a
right to accurate and current information about their fertility treatment;
2) it is the obligation of the health care provider to provide this
information and obtain patient consent for these elective treatments; and 3)
we agree in the value of long-term, prospective studies to evaluate all
aspects of the safety of ART for women and their children.
For more information, please see the extensive patient education materials
available at www.asrm.org <http://www.asrm.org>
ASRM and SART would like to acknowledge Mike Soules, MD and Nancy Klein, MD
for their work on this comment.
The ASRM Bulletin is published by ASRM's Office of Public Affairs to inform
Society members of important recent developments. Republication or any
other use of the contents of the Bulletin without permission is prohibited.
To request permission to quote or excerpt material from the Bulletin,
contact Sean Tipton at stipton@asrm-dc.org.
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