On Friday, March 13, the management of the large hospital in Sacramento, California, where Kate works as a nurse anesthetist announced the cancellation of all elective surgeries. Kate and her husband had been pursuing fertility treatments for nearly a year. She had an appointment the following Monday at a private clinic to prepare for her sixth egg retrieval. That weekend, Kate told her husband she was sure the appointment would be canceled, given what was happening at work.
“It just wouldn’t make sense, if they’re canceling elective surgeries,” Kate recalls.
Editor’s note: This reporting was supported by The McGraw Center for Business Journalism at the Newmark Graduate School of Journalism at the City University of New York and The Fuller Project. Two patients mentioned in the story are identified by forenames only to protect their privacy.
When Monday arrived, Kate’s appointment, to her surprise, was still on. “It was quick,” she says. Since she’d been through the process several times before, there wasn’t a lot for the nurse to show her. Kate planned to start taking medication at the end of March to stimulate the growth of her eggs. But the day after her appointment, her clinic sent her an email: the American Society for Reproductive Medicine (ASRM), the fertility industry’s principal professional body, had recommended suspending all new treatment cycles in light of the rapidly spreading virus. Her egg retrieval was canceled.
“I still haven’t quite been able to articulate how it feels,” Kate told me in early April. She is 41 years old, and feels her chances of having children are diminishing with each month that goes by.
Kate is one of tens of thousands of patients whose fertility treatments have been disrupted by the coronavirus pandemic. These treatments can be emotionally fraught at the best of times: a triangulation of risks and probabilities, girded by hope and desperation. The stakes are inherently high: thousands if not tens of thousands of dollars in costs, and invasive hormone treatments with potentially severe side effects, all for the hope of a much-wanted baby.
The pandemic confronts patients and health-care providers with new ethical dilemmas. Is it too risky to pursue a fertility procedure when there’s a deadly virus going around? And might it divert medical resources from urgent covid-19 care? In a fast-growing and increasingly lucrative industry, those questions are now creating a schism that could last long after the crisis is over.
Covid-19 arrived as the fertility industry was undergoing a rapid expansion and change in structure. More and more people are attempting to have children later in life. In 1972, the average age of a first-time mother was 21. By 2016, it was 26. And women with college degrees—who tend to have higher incomes—don’t have a child, on average, until they are over 30. The ASRM lifted the “experimental” label on egg freezing in 2012. Two years later, Apple and Facebook were among the first large firms to announce that their insurance plans would cover the procedure. In 2018, American fertility clinics carried out nearly 18,000 egg-freezing or embryo-freezing procedures for the purposes of “fertility preservation,” according to the Society for Assisted Reproductive Technology (SART), a subsidiary organization of the ASRM.
“You have no margin if you’re not seeing new patients.”
David Sable, former fertility doctor
Before egg retrieval a woman must inject hormones, typically over the course of one to three weeks. These hormones stimulate her ovaries to grow more eggs to maturity than the usual one per month. Besides taking hormones, she visits a clinic every other day for blood tests and ultrasounds to track the eggs’ growth. Once the eggs are extracted, they can be frozen unfertilized, or they can be fertilized with sperm in an incubator to make embryos, which can then be either frozen or transferred to the uterus straight away. Fewer than half of IVF embryo transfers are successful—and under 10% for women older 40 using their own, fresh embryos. That is why a growing number of women are “banking” eggs or embryos before they intend to get pregnant, in order to accumulate a surplus of younger, healthier eggs.
Private equity and venture capital investors anticipate that the confluence of these two trends—increased insurance coverage and older parents—will cause demand for egg freezing, IVF (in vitro fertilization), and other fertility services to keep increasing. Until recently, most fertility clinics in the United States operated as independent entities, but they are now being acquired by investors who are turning them into outposts of national and global chains. McDermott, Will, and Emery, a prominent law firm, estimates that the global marlet for fertility services will reach about $31 billion annually by 2023, nearly doubling from $16.8 billion in 2016.
Fertility clinics are very profitable and have high margins, says David Sable, a former fertility doctor who now oversees a fund investing in innovative fertility technology. “But,” he adds, “you have no margin if you’re not seeing new patients.”
As the US went into lockdown in mid-March, it seemed logical that fertility patients would be asked to hold off on having treatment. But the ASRM’s initial cautious approach prompted an outcry from patients. A Change.org petition asking it to reconsider its recommendations, started by Beverly Reed, a Dallas-based fertility doctor, has garnered more than 20,000 signatures since it launched on March 20. Women on fertility forums around the web said they were crushed and devastated.
Protest came from another corner too. TJ Farnsworth, a Houston-based health-care entrepreneur, swiftly founded the Fertility Providers Alliance (FPA), a new professional body, to lobby against the suspension of fertility treatments. Within a week, 400 fertility specialists joined, accounting for nearly one-third of those practicing in the US today (as of early May, the membership had grown to around 500).
Farnsworth is the founder and CEO of Inception Fertility. After it merged with Prelude Fertility in March 2019, Inception became one of the country’s largest providers of fertility services; it performs around 10% of the IVF cycles in the US, in dozens of clinics. The business is personal for Farnsworth—he and his wife had their son, Wyatt, through IVF. The experience prompted him to pivot to the fertility business after he had spent six years building a nationwide network of radiation oncology centers.
The FPA quickly established its own covid-19 task force. In a letter that was leaked to a fertility activist and posted on LinkedIn, the task force’s members said they “refuse to acknowledge these treatments as ‘elective’ or ‘non-urgent’ for our patients.” Furthermore, the letter argued, freestanding fertility clinics “do not divert clinical resources or reduce hospital capacity that could otherwise be used to care for COVID-19 patients.”
Farnsworth says that despite his personal views and the FPA letter, the majority of clinics in the Prelude Fertility network (which continues to operate under that name) followed the ASRM’s recommendations, both in response to local conditions such as shelter-in-place ordinances and for the safety and health of patients and staff. So did Beverly Reed, who started the Change.org petition.
“If there’s rules out there, I’m gonna follow them,” she says. “But I also don’t agree with them, and my patients don’’t agree with them.” The petition was a chance to “see if our voices are going to be heard.” Farnsworth, too, says he and the FPA members were simply seeking more transparency and dialogue between the society and its members. He wishes that clinics around the country had been given more time to digest the recommendations and communicate with patients.
On one level, doctors, patients, and investors share the same goal: healthy babies. Long before the coronavirus appeared, doctors, patients, and their advocates fought to have infertility recognized as a disease (the World Health Organization has classified it as such since 2009) and to get its treatment covered by insurance, pushing back against the idea that family building is “elective.” Farnsworth is one of many from the field who lobby state legislatures, employers, and insurers to try to get more coverage for fertility treatment, putting it within reach of people who would otherwise have to pay out of pocket.
In an ideal world, the questions that arise in the course of this treatment would be addressed solely by patients and their providers. Should we try another cycle? What if we used this drug instead of that one? If we transfer two embryos, what is the chance of having twins? Cost, though, is frequently a factor: even though more insurance plans now cover IVF, fewer than one-fourth of American companies with 500 or more workers have such plans, according to a 2019 survey by Mercer, a human resources consultancy.
And in the formation of the FPA, some see an attempt to introduce a new party to the conversation: investors, namely the private equity firms whose business model typically aims for returns within a set time frame. This investor-backed, growth-oriented model stands in contrast to the way infertility care is delivered in Israel and a number of European countries, where it is covered by the public health system.
The dilemma “highlights the unique interests of private equity in the field of reproductive medicine.”
Eve Feinberg, ASRM covid task force
“I think it highlights the unique interests of private equity in the field of reproductive medicine,” says Eve Feinberg, an associate professor of obstetrics and gynecology at Northwestern University, and a member of the ASRM’s covid task force. She pointed to studies demonstrating that delays of six, eight, or even 12 weeks in starting IVF cycles do not make pregnancy any less likely. But, she notes, a month or two of delays hurt clinics financially. The sums involved are not insignificant, especially for superstar doctors with well-regarded clinics. Take just one example: James Grifo, now program director at the NYU Langone Prelude Fertility Center and chief executive physician of Inception Fertility, was New York University’s third-highest-paid employee in 2017, the most recent year for which figures have been publicly disclosed, taking home over $3.5 million.
If the FPA were, like the ASRM, to begin to issue guidelines for the fertility industry, it would create a fissure—two would-be authoritative bodies that might reach different conclusions. As Feinberg points out, it is possible that investor-backed IVF centers and academically affiliated practices have divergent interests. In the case of the coronavirus threat, the two bodies’ communiqués crystallized their contrasting approaches. The ASRM’s covid-19 task force was focused first and foremost on public health. The FPA, in its letter, emphasized the physician-patient relationship.
Although the practical ramifications have thus far been limited, since most clinics around the country suspended new procedures anyway, having two separate bodies worries Norbert Gleicher, the founder and medical director of the Center for Human Reproduction (CHR), a fertility clinic on New York’s Upper East Side. A unified forum for scientific debate, as the ASRM has been, helps the scientific community form a consensus about what works and what doesn’t. The harm of a fissure won’t be apparent overnight, but in the long term, dueling professional organizations could leave patients confused, and worse off for their confusion. “When you become an official body that can issue guidelines, you have the power to direct practice,” Gleicher says.
Gleicher fears that the FPA’s formation is an attempt by investors to dictate to doctors how IVF should be practiced. In this, he sees echoes of preimplantation genetic testing, which has become widely used in part because of a new professional body that was formed in order to advocate for its use. In Gleicher’s view, such genetic testing is a costly boondoggle, which harms patients’ chances at pregnancy by encouraging them to throw away perfectly good embryos.
If the influx of private equity money changed the conversation around fertility by increasing the emphasis on profitability, the pandemic is forcing us to reckon with age-old questions in a new way. To treat or not to treat? What is urgent? What is essential? And who, in the end, decides?
As a frontline medical worker, Kate felt abundantly qualified to answer these questions as she weighed the risks and rewards of moving forward with fertility treatment (“I intubate people for a living,” she notes). In mid-February, she had worked a 48-hour weekend shift as an independent contractor at a Napa-area hospital where two patients, fresh off the Diamond Princess cruise ship, later tested positive for coronavirus. Her own hospital in Sacramento has had an average of five to six coronavirus cases on any given day since early March. Despite all that, she ached to move forward with egg retrieval, though she was less rushed to transfer embryos and potentially get pregnant, given her high risk of catching the coronavirus at work.
“I might be having my first kid at 42 and a half now, versus 41,” she says, of wanting to delay the embryo transfer. “It’s still going to happen; we’re just going to be older.” Egg retrieval, on the other hand, “is something I’m feeling very, very pressured about, because I want that done now—I want the eggs out.”
Kate is not unique; in many cases, patients want to continue their treatment, irrespective of the risks to themselves or other people that are inherent in making repeated visits to a clinic. Gleicher interpreted the ASRM recommendations, which counsel continuing treatment in “urgent” cases, to mean that his clinic should stay open, because its clients’ average age is 43, compared with the American average of 35, according to the SART. (Another example of an “urgent” case could be a cancer patient who wants to freeze sperm or eggs before chemotherapy.)
“There are distinct patient groups where a delay of three months can make a lot of difference, and I think for those patients … it’s almost irresponsible [to close]”.
Norbert Gleicher, Center for Human Reproduction
“There are distinct patient groups where a delay of three months can make a lot of difference, and I think for those patients … it’s almost irresponsible [to close],” Gleicher says. His patients, he says, weren’t worried he was jeopardizing public health—on the contrary. “I hear nothing but amazing gratefulness that we are open. They literally pray for our health.”
A heightened sense of urgency has trailed Lauren, who is now 40, since she was 35, when she found out she had severely diminished ovarian reserve—that is, she produces a low number of eggs for her age. She was single at the time, and pursued IVF on her own. She racked up so many cycles that she lost count—somewhere between 10 and 15, she guesses. She is now engaged to a woman, and they began a third round of IVF at CHR in late February, with donor embryos. On the advice of a reproductive immunologist, she paid $3,500 apiece for three doses of an additional therapy, not covered by insurance, to modulate her immune response, whose activity might have caused the two previous attempts to fail.
Although Lauren proceeded with the embryo transfer, it wasn’t an easy choice. She works as a supervisor of mental health counselors in group homes for the intellectually and developmentally disabled in New York City, and residents of the homes she works in have been dying.
“It was such a hard decision, but I had already done so many time-sensitive and expensive things in preparation for it,” she says.
When we spoke in mid-April, Lauren was one month pregnant. She had started experiencing light vaginal bleeding, which during previous pregnancies had signaled something was amiss. During her first pregnancy, she went to the emergency room within an hour after seeing blood. This time around, she is waiting it out, hoping it’s not a sign of miscarriage.
“That would be the last place I would go right now, the emergency room,” Lauren says. Instead, she makes the 45-minute drive up to CHR every four or five days from her home in Sheepshead Bay, Brooklyn, avoiding public transport. When she arrives at the clinic, she wears a mask and gloves; everyone there is wearing personal protective equipment. She and her fiancée take the pregnancy one day at a time, and they are grateful to have had the chance to do the embryo transfer. But she worries about what could happen next.
“You just keep thinking: I’ve come this far. Am I making the right decision to pursue this? Am I just worrying about money and timing and having to redo everything again? What happens if I get sick?” she asks. “What happens if I go this far and get pregnant and the baby has coronavirus?”
The question of what happens to babies born during the pandemic will be answered over the coming months, as more of them come into the world. Already, some clinics are reassessing their initial responses to the coronavirus. The ASRM revised its guidelines in late April: it now recommends that clinics consider reopening only after local coronavirus cases are in a sustained decline, and that they have “risk mitigation” plans in place.
Lucky Sekhon, a reproductive endocrinologist and infertility specialist at Reproductive Medicine Associates of New York, stopped seeing patients in person once the ASRM published its original recommendations in March. She began holding consultations by Zoom from her home instead. (She prefers it, she says, since she doesn’t have to wear a mask and can see her patients’ faces.) The week before, she had already contacted her existing patients to prepare them for the idea that treatments could be suspended as New York emerged as an epicenter of infection.
“I was really a proponent of stopping and evaluating everything, because I felt New York City was in a wartime environment, where every effort and everything that was happening needed to go towards the front line,” Sekhon says.
Now, a month on, she feels comfortable moving ahead with her more urgent cases, especially given that in recent months a number of women with covid-19 have given birth to healthy babies, and the disease does not appear be especially dangerous to pregnant women. But the clinic now prioritizes safety and social distancing. Patients come in at pre-scheduled intervals or can take a walk outside and wait for a text message when the exam room is ready, so there are never more than one or two people in the waiting room at any given time. They can’t bring a friend or partner to appointments. There’s less furniture in the waiting room. And perhaps the biggest difference is the drop in volume. When we spoke in April, Sekhon and the other 11 doctors were each starting only one new patient per day on an IVF cycle.
“We were a very, very busy high-volume practice. But I think anyone who survives this pandemic and finds a way to move forward, it’s going to be because they’re adaptable, and they’re willing to innovate,” she says. “It’s going to look different for a really long time.”
In the fertility industry as much as any other, there are many unknowns. Surely some people will be less eager or able to start a family, especially if they’ve lost their jobs and thus their health insurance. Others, however, will be eager to resume or begin treatments that had been delayed. Farnsworth, the Inception CEO, anticipates a surge in business as clinics open their doors again. Many clinics around the country, he expects, will begin a first phase of opening by mid-May.
Among those in the process of reopening is the private clinic in Sacramento treating Kate and her husband. Shortly after we spoke in mid-April, she got a call from her IVF nurse, whom she had last seen on March 16, right before her cycle was canceled. The clinic’s staff had looked at their caseload and decided to move forward with a handful of urgent cases, Kate’s among them.
“I am over the moon about being able to do our retrieval,” Kate says, but “I do have some conflicting feelings … [I] feel really sad for those ladies and couples who still have to wait.”
from MIT Technology Review https://ift.tt/2SJOxqs
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