I was 15 in 1978 when Louise Joy Brown’s birth captured the world’s attention. Still new to monthly menstrual cycles, I had just begun to believe that one day my womb would be at the center of human creation. It was a wonderful dream while it lasted.
Two decades later, I sat nervously in my ob-gyn’s exam room covered only by a paper gown. No one could tell me why I hadn’t been able to get pregnant, so I was preparing to turn to the bright promise of in vitro fertilization (IVF).
I didn’t know then that it would become a frustrating, fruitless, and expensive odyssey. Nor did I know anything about the dark side of assisted reproduction, a highly profitable industry that operates largely under the radar of regulators.
After several years of pumping my body full of hormones for monitored cycles and treatments, my husband and I had spent nearly $50,000 without the joy of having a child. Unlike the pictures of smiling parents and their new babies posted on clinic websites and social media feeds, I came away from IVF at 40 with a battered heart and bloated body, a biohazard container full of spent syringes, and a folder containing fuzzy black and white images of embryos that were never to blossom into children.
I spent the next decade researching IVF, writing about it, and getting to know women and men around the world who were also traumatized by their experiences with IVF. Not surprisingly, they have not sought the spotlight, as reliving the experience can be excruciating. Some have been barred from speaking publicly because of lawsuit settlements.
Only recently did I learn that Dr. Sam Thatcher, who was the director of the Center for Applied Reproductive Science in Johnson City, Tennessee, wrote a damning assessment of the growing IVF field about the same time as I was having my first IVF consult. Twenty-one years after Brown’s birth, he raised concerns about the woeful lack of industry self-regulation and the creep toward profits over patient care. He noted that by the mid-1980s, more than half of the 100 assisted reproductive technology programs that existed at the time had not yet reported a pregnancy, even though they were making a great deal of money in the process. Before he passed away in 2009, Thatcher laid bare not only how clinics manipulated data to compete for new patients, but also the increasingly aggressive sales techniques fueling growth in this for-profit medical field.
Investigators and writers have begun shining some light on the dark side of IVF. It started early.
One of the inventors of the procedure, Nobel Prize winner Robert G. Edwards, was an active member of Britain’s Eugenics Society. He once wrote, “Soon it will be a sin of parents to have a child that carries the heavy burden of genetic disease. We are entering a world where we have to consider the quality of our children.” Edwards and IVF co-inventor Patrick Steptoe conducted experiments on hundreds of women between 1969 and 1978 in Oldham, England. The Oldham Evening Chronicle is now seeking the stories of 282 women who underwent 495 failed IVF cycles. One former patient, Sandra Crashley, has written that Steptoe removed all of one ovary and half of the other, shocking her body into early menopause and rapid aging.
The industry’s commercially-driven focus and lack of independent oversight continue to raise questions and concerns. Earlier this year, two assisted reproduction clinics — one in Cleveland and one in San Francisco — had catastrophic equipment malfunctions that jeopardized frozen embryos and eggs. Whether other devastating clinic failures have occurred over the years is anyone’s guess. NBC News revealed that clinics are not required to report problems unless there is a complaint filed or a negative news media report.
In its reporting, NBC reached the College of American Pathologists, which accredits more than 400 fertility laboratories affiliated with clinics performing IVF and related procedures. Only member clinics of the Society for Assisted Reproductive Technology, an organization of ART providers, get a visit from an inspector every two years.
A spokeswoman for the College of American Pathologists told NBC it “was not contacted by the fertility clinics until after news reports alerted the public about the possibility that thousands of eggs and embryos may no longer be viable because of equipment malfunctions.”
This, sadly, is what the industry deems acceptable self-regulation. Rather than demand accountability or impose a sense of urgency, the American Society of Reproductive Medicine, a trade association for the assisted reproduction industry, issued a tepid statement and referred to what was lost in the malfunction as “reproductive tissues.” The women and their partners who were clients of these clinics lost dreams and possibly even the reality of having babies, not “reproductive tissues.”
The global IVF market is valued at around $15 billion. Many clinics emphasize commercial promotion of IVF and egg freezing, and offer their patients poorly tested “add-ons” like endometrial scratching and embryo glue. In the United Kingdom, new rules will go into effect later this year requiring IVF clinics to give patients full information about any add-on services being offered to them. Meanwhile, the same procedures continue to be sold in the U.S with little or no oversight. Public policy efforts aimed at more stringent government inspection and consumer protections have never gotten traction due to the lack of an organized constituency.
Often lost in the shuffle are efforts at dispensing safer, more responsible treatments and providing patients with clear descriptions of procedural risks and outcomes.
In the U.S. today, the CDC monitors data from the more than 440 clinics that provide services to patients seeking to overcome infertility. Each year it publishes the ART Success Rates Report. This narrowly focused document relies on clinics’ reporting of the outcomes of IVF cycles. It does not provide any information on clinic operations or failures.
Beyond more comprehensive monitoring of clinic practices and facilities, consumers could use more plain talk about the drugs and chemicals used in IVF labs and clinics. There may be a link with cancer in women who have undergone IVF, but there’s no way to know definitively because a cohort of women who have undergone IVF isn’t easy to assemble or follow for epidemiologic research. The few studies that exist evaluated the effects of fertility drugs used in the past, and tend to have limitations that hamper interpretation of their results. In short, there are many impediments to evaluating the role of assisted reproduction factors that influence gynecological and breast cancer risk. However, you don’t hear clinic operators demanding more clarity. So much for informed consent.
Currently, there are about 20 commercially available culture media used to grow embryos for IVF. The makeup of culture media isn’t a trivial matter, as the culture medium is essential for embryonic development. A Cochrane review of culture media concluded this: “None of the studies reported on the health of offspring. Most studies (22 of 32) failed to report their source of funding and none described their methodology in adequate detail.”
In other words, no one really knows how the fuel for early development affects a future child’s life because clinics are not required to track or disclose this important lab operation.
In the U.S., comprehensive longitudinal studies on women who undergo IVF or the children conceived by it are hard to come by. Unlike in Scandinavia or Israel, which have a long-term tracking system complete with patient identification numbers, there is no easy way to track and reach American IVF patients. As a researcher at the National Cancer Institute told me, the fact that women who don’t have success with IVF don’t want to talk about it, coupled with the lack of clinic interest in participation, and the complexity of factors — age, biology, and the changing cocktail of drugs used by clinics — make it impossible to have a clear view into the risks of IVF.
Women and their partners can learn more today from a fast food menu than they can from a clinic selling expensive and life-altering assisted reproduction procedures. Consumers must rely on their own unwieldy research to get through the maze of protocols and pharmaceuticals that might work for their individual conditions. In my experience, which has been validated by others, clinics do a woefully poor job of explaining the options. Consumers must also hope that the labs and clinics they are using are well staffed by experts and carefully maintained.
But it doesn’t have to be this way over the next 40 years. Better oversight, stronger patient safeguards — including more compassionate care for those coping with failed IVF cycles — and more transparency about the risks and limitations of assisted reproductive technology are needed. Better education, more comprehensive reporting, and consumer protections could bring assisted reproduction to the next level.
Pamela Mahoney Tsigdinos is the author of “Silent Sorority” (BookSurge Publishing, 2009) and co-founder of ReproTechTruths.org, a grassroots initiative dedicated to greater transparency and public health information on the full spectrum of IVF and related practices, risks, and outcomes.