ASRM BULLETIN
Volume 6, Number 7
January 29, 2004
Further Response To O MAGAZINE Article
In response to many requests from members, 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.
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Comments Regarding Article
Is This Any Way to Have a Baby? by Barbara Seaman
O (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:
Fertility drugs 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.
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.
IVF increases the risk of ectopic pregnancy. The implication that IVF causes ectopic (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.
IVF is inappropriately recommended for patients with undiagnosed male 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.
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.
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.
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.
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
http://www.asrm.org
ASRM and SART would like to acknowledge Mike Soules, M.D. and Nancy Klein, M.D. 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.
Is This Any Way to Have a Baby? by Barbara Seaman article 
