Conceivability_What I Learned Exploring the Frontiers of Fertility
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When considering treatment from a particular facility, it is a good idea to check for its accreditation, for while Joint Commission–accredited institutions must maintain strict standards, members of SART and ASRM are bound only by their clinical and ethical guidelines as well as an obligation to report their activities. And alarmingly, a CDC study found that only 20 percent of clinics follow these guidelines.4 Although clinicians who violate them may face sanctions such as being kicked out of the professional societies, there are rarely legal consequences, and the errant doctors and clinics may still treat patients. The doctor responsible for “Octomom,” for instance, was dismissed in 2009 from the ASRM, which cited “behavior that violated the group’s standards,” after transferring twelve embryos into the womb of Nadya Suleman, but he was not barred from practice at that time.5 He eventually lost his California medical license in 2011 after being found guilty of gross negligence in two additional cases.
Deprived of rules that can be relied upon, fertility patients must, to a large degree, take it upon themselves to learn not only which clinics and avenues of treatment might bring the most success but also, and perhaps more disturbingly, whether proposed courses of action might lead to troubles down the way. Like me, most patients are not aware of this as they begin their journey down the rabbit hole in search of a baby.
In this area of regulation, a key aspect of fertility treatment, the United States is an outlier.
Most developed countries (and many developing countries as well) have clear and enforced regulations regarding many aspects of fertility treatment, which typically address physical and health considerations for a patient as well as ethical concerns for society at large. For example, most European countries, recognizing the risks of multiple pregnancies, limit, generally to one or two, the number of embryos that may be transferred during an IVF cycle. In contrast, in the United States, there is neither federal nor state regulation of embryo transfers, which can lead to both health problems for a mother, and an undue burden on society. Thus, only in America do we have “Octomom,” an unemployed mother of six who, after transferring an unthinkable number of embryos to her womb, gave birth to octuplets. And while this story may play well for daytime TV, its impact on society at large raises moral and ethical dimensions that should be more fully explored rather than ignored.
Mirroring the lack of restraint on fertility practices, there are no clear rules on what information about potential risks doctors are required to communicate to patients. While doctors are, or should be, concerned about multiples, many patients (myself included) are indifferent to, or even eager to embrace, the possibility of twins, and most fertility clinics are happy to indulge them.
“Our mission is to make a woman pregnant, with almost a whatever-it-takes attitude,” says Dr. Mark Sauer, now a professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Francisco, after serving as chief of the division of reproductive endocrinology at Columbia University Medical Center for twenty-one years.6 Although transferring higher numbers of embryos may in fact increase the odds of a woman getting pregnant, there is no obligation for clinics to sufficiently caution women about the numerous health risks to both mother and baby when there is a multiple pregnancy.
A woman carrying multiples, including twins, is labeled “high risk” for a reason: she faces a higher risk of high blood pressure, gestational diabetes, preeclampsia, anemia, postpartum hemorrhaging, and miscarriage, while her babies have a heightened threat of cerebral palsy, blindness, retardation, and preterm birth. Preterm births, in turn, place newborns in greater jeopardy of death, neurological disabilities, and a variety of other health challenges causing, on top of everything else, extended stays in hospitals.7 Extended stays in a hospital present not only an inordinate expense for a family to bear, but also cost the US health-care system more than $26 billion per year.8
Paula and Derrick experienced this firsthand. When they turned to surrogacy after five miscarriages, their surrogate, Amy, carrying twins, went into labor at twenty-six weeks and four days. Their son was born first, their daughter three minutes later, in a breech position and with a brain bleed. The family’s three-month neonatal intensive and intermediate care experience began. In addition to repeated blood transfusions for both babies, their daughter underwent heart surgery at two weeks old while their son endured four hernia operations in his first couple of months of life. Both lived on oxygen tanks for months.
Although many women and couples enter fertility clinics with a stated aim of having twins, an understandable goal given the expense and difficulties of IVF, they often have no understanding of these risks, which are largely preventable, and studies have shown that when patients are better informed, their desire for multiples sharply declines.9 Yet despite the risks to mother and baby, the incidence of twins has risen by more than 75 percent over the last twenty years. In 2017, nearly four in ten children conceived through IVF were twins.10 While some doctors defend the decision to transfer multiples by claiming that they are giving patients what they want, Dr. George Annas, a bioethicist and director of the Center for Health Law, Ethics & Human Rights at the Boston University School of Public Health, rejects the justification of accommodating patients as a reason for transferring multiple embryos: “(In) no other field of medicine would the excuse for not doing good medicine be ‘the patients demand it.’ That’s ridiculous.”11
Patients likewise are often not apprised of the risks associated with medicines or specific treatments that are prescribed for them. In my case, when IVF failed repeatedly, several doctors increased my hormone levels. In taking the higher dosages, was I risking ovarian cancer? Cervical cancer? Some unforeseen risk from the immunological suppression I was undergoing? Largely uninformed of potential fetal risks, I never worried about the long-term effects the treatments might have on my embryo, or baby. Unwarned, I never dreamed that the treatments I believed were helping might actually be hurting my own tiny eggs.
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It is not only IVF and the number of embryos transferred that goes unregulated in the United States. Procedures involving controlled ovarian stimulation and IUI are likewise unregulated. Relationships with surrogates are unregulated. Sales of sperm, eggs, and embryos are unregulated. The number and location of offspring from donors is not tracked or regulated.
Long-standing industry guidelines regarding egg donor compensation—stating that payment to an egg donor in an amount over $5,000 requires “appropriate justification” and in an amount over $10,000 is “not appropriate”—have been riddled with criticism and are often disregarded.12 This is particularly troubling, as the $80 million US egg-donation market is exploding, with older moms, gay couples using surrogates, and cancer survivors entering the marketplace like never before, in addition to the ever-increasing number of traditional heterosexual couples facing unexplained infertility. Donor eggs were used in nearly twenty thousand monthly cycles in 2012, compared with fewer than twelve thousand a decade earlier.13
The commercial nature of egg and sperm donation is obfuscated somewhat by the terminology that is used. Payments for egg and sperm are a notoriously long-ignored subject in this country, with the women and men providing the genetic material to babies born through ART known as “donors” rather than “sellers,” and the payment to them intended to reflect the time and inconvenience—and, for women, potential health risks—involved in the process of obtaining the eggs and sperm, rather than buying the actual eggs and sperm. Yet the compensation guidelines for egg donors—originally keyed off a multiple of sperm donor compensation, to reflect the greater time spent, plus an uptick for the misery of the process—have, since their inception, been perceived by many as an injustice. Harvesting eggs requires injections, ultrasounds, an invasive procedure, and potential health risks, while harvesting sperm requires one trip to a clinic and a few magazines.
In theory, the egg donor guidelines, intended to protect low-income younger women from being lured into d
onating their eggs for high pay, also aimed to keep the price of fertility low, benefiting intended parents.14 However, as the clinics that sell the eggs to the intended parents are not similarly regulated, they are left free to reap profits. And to top it all off, it turns out that the guidelines are largely ignored by a clientele that includes future parents who are willing to pay whatever it takes to have their desired children, as well as women who are willing to help out for a sum that they feel adequately compensates them for the pain and the risk.
“The guidelines are a joke,” according to Andrew Vorzimer, a lawyer and law professor who specializes in reproductive law. “I’ve drafted contracts for egg donors in the six figures.”15 Demand for quality egg donors, or egg donors with specific traits, has helped shape a landscape in which certain donor profiles command higher fees: Asians, Jews, and Ivy Leaguers top the charts, and repeat donors can be paid in the range of $40,000 to $50,000 per harvest.16
Equally, or perhaps even more concerning, the ceiling imposed by the guidelines has not diminished the practice of “luring,” which continues to flourish in ads, on the Internet, and in other arenas. While strolling through a large summer festival recently, complete with the expected Ferris wheel, whirling teacups, cotton candy, and frozen custard, I saw, wedged between the handmade alpaca sweater and bath-bomb booths, a table with free giveaways—lip gloss, nail files, tote bags, pens in cute colors. The promotion? Recruiting egg donors. As is common on college campuses today, young women flocked to spin the prize wheel, receiving, along with their jumbo nail groomer, pamphlets on the benefits—including payment of $6,000—of sharing their sought-after eggs with those in need.
Donors themselves recognize the commercial nature of the industry. In 2011, four named plaintiffs,17 representing potentially thousands of similarly situated donors, joined together to bring a class action suit against the reproductive technology professional associations (ASRM and SART), their fertility clinic members, and all egg donation agencies that agreed to abide by the ASRM and SART egg donor compensation guidelines, claiming that the compensation guidelines constituted an illegal price-fixing agreement in violation of US antitrust laws.18 After nearly five years working its way through the court system, the parties reached a settlement agreement in 2016, with the ASRM agreeing to drop the language restricting financial compensation from its egg donor guidelines.19
“Our whole system makes no sense,” said Debora L. Spar, author of The Baby Business, which presents a thorough and thoughtful investigation of the subject. Referring to the “yuck factor of commodifying human eggs,” Dr. Spar believes that “we should either say, ‘Egg-selling is bad and we forbid it,’ as some countries do, or ‘Egg-selling is OK, and the horse is out of the barn, but we’re going to regulate the market for safety.’ ”20
But we don’t. We don’t forbid it. And we don’t regulate it.
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The absence of regulation not only affects pricing in what is essentially a commercial market, it may also leave patients struggling to assess the health risks as well as the odds of success of desired procedures. Is controlled ovarian stimulation the best protocol for a certain patient? Is a patient better served by IVF? How many embryos should be transferred in a given IVF cycle? How much follicle stimulation hormone (FSH) is too much? Is there any link whatsoever between IVF cycles and cancer risk?
It is common practice in many fertility clinics, for example, for patients to undergo a fairly standard progression of treatments on the road toward IVF. First, a woman will undergo treatment using controlled ovarian stimulation, which involves following a hormone protocol designed to encourage the body to produce as many eggs as possible using clomiphene citrate (Clomid), letrozole (Femara), or FSH, in conjunction with trying the old-fashioned way or through IUI. Generally, it is only after six cycles of some type of controlled ovarian stimulation that a patient then moves on to IVF. Research trials, however, have shown that women who followed a fast-track protocol, skipping three cycles of controlled ovarian stimulation and progressing quickly to IVF had higher rates of pregnancy and live births and lower costs.21 In other words, in many cases it would make sense for a woman who does not succeed within two or three cycles of mild ovarian stimulation to go straight to IVF, preferably with a single or double embryo transfer to limit the risk of multiples. Unfortunately, there is no requirement for fertility clinics to convey this information to patients, and no central repository of information that makes it easy for them to find it.
Similarly, questions surrounding the safety of fertility drugs and hormones are rarely discussed or examined. While all the drugs and medical devices used in infertility clinics are approved by the FDA, some, such as Lupron, are prescribed as an “off label” use, meaning that it is not approved for the use in question, and some are used in dosages considered unwise in other countries. The linkage between fertility drugs and cancer, rarely whispered in the halls of a fertility clinic, remains unclear. Yet many of the women I interviewed mentioned the low-grade anxiety that provides constant background noise throughout their fertility journey. “You just know those drugs are bad for you,” Jessica reflects. “You worry, but you keep going.” I know I worried, and my husband worried. But in the absence of concrete evidence, we chose to disregard our niggling concerns, and we forged on.
Scientists have found that women who take Clomid for longer than one year may have an increased risk for developing ovarian tumors, particularly among those who did not get pregnant while on the drug.22 Research on the possible correlations between fertility drugs and breast cancer is all over the map, with some studies showing an increased rate of breast cancer among women who took fertility drugs, some studies finding no impact, and a third group indicating a lower risk of breast cancer specifically among women who took Clomid, which is in the same drug family as the chemotherapy drug Tamoxifen. For every study that finds a cancerous connection, there is a countervailing one that says there is nothing to worry about. While the research findings at this stage are conflicting and inconclusive, one thing is clear: no one is out there policing this for patients, who are left to themselves to get educated on the latest findings and consider the unknowns before making treatment decisions.
How did it get to be this way?
Before and After Louise Brown
Having children is the most basic of human functions, and there is an unspoken assumption that it is something any woman should be able to do. On average, approximately 360,000 babies are born each day worldwide; that’s 15,000 births per hour and 250 babies born in a single minute. So it is easy to comprehend why the more than eight million women in the United States each year who have trouble conceiving or maintaining a pregnancy are not only devastated but are often truly shocked by the news.
When they are shocked and desperate, and often feeling inadequate, prospective mothers typically turn to doctors for assistance. And for decades, doctors, particularly infertility specialists, have been inventively and increasingly successfully helping women conceive. But they have been doing so on a playing field with limited knowledge and without an umpire; a field, as described by Arthur Caplan, founding head of the division of medical ethics at NYU School of Medicine, “characterized by strong antiregulatory sentiment because it evolved as a business, not a research enterprise.”23 To understand this unique situation, we must go back to the beginning.
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The healthy birth of Louise Brown on July 25, 1978, in England—on the 104th IVF attempt by Dr. Patrick Steptoe and Dr. Robert Edwards—forever changed the fertility landscape. Her birth came after decades of innovative, yet unsuccessful, procedures—such as attempted surgical cures on the ovaries and cervix, gland transplants, extracting testosterone from bulls’ testicles and estrogen from the ovaries of cows.24 Born more than thirty years after Harvard Medical School professor John Rock fertilized a human egg in a glass tube, Louise, the world’s first successful “test tube baby,” set off both a medical and media frenzy. For her parent
s, Lesley and John Brown, who had been trying for nine years to have a baby, and the uncountable number of similarly situated couples facing previously insurmountable infertility, Louise’s birth was a modern miracle, a cause for celebration and great hope. For fertility specialists, such as Drs. Steptoe and Edwards, who “conceived” Louise, it was both the culmination of decades’ long work and the signaling of greater progress to come.
But for many others, particularly religious leaders and political conservatives, it was a sin, a dangerous and troubling intervention by mankind into the natural world, or God’s domain. The Roman Catholic Church, steadfast in its opposition to any form of assisted reproduction, declared that “from a moral point of view, procreation is deprived of its proper perfection when it is not desired as the fruit of the conjugal act, that is to say of the specific act of the spouses’ union.” Protestants shared this view: “Men ought not to play God before they learn to be men, and after they learn to be men they will not play God.”25
Faced with a conflicted public, the government in the United Kingdom launched a comprehensive evaluation of the medical and ethical implications of IVF that led, years later, to the regulation of in vitro fertilization, including the freezing and donation of embryos. After nearly a decade of inquiry and debate, the Human Fertilisation and Embryology Authority (HFEA) was eventually established in the United Kingdom in 1991 with the mandate to regulate not only the provision of fertility services to families in need but also the fertility research and policies to be implemented as the science evolved. In other words, the HFEA was tasked with dealing with the medical, ethical, and policy issues surrounding fertility, balancing the needs of individual families with society at large.