We welcome our readers to the October issue of the VOICE, we hope again packed with interesting and relevant information for patients, colleagues, and any other party interested in reproductive sciences and clinical infertility. October is ...
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[This article deals with a rapidly developing situation. It was written by Norbert Gleicher, MD, on March 31, 2020 and published on April 2, 2020. For a list of all COVID-19 articles, scroll to the bottom.]
We hope our readers have been following CHR’s COVID-19 bulletins, where we have attempted to comment on matters of importance and provide much-needed updates in a timely manner. Whether fertility centers should remain open under current conditions has become an especially controversial issue within the IVF provider community after the American Society for Reproductive Medicine (ASRM) published a Position Statement, whose summary we reprinted in our COVID-19 Bulletin on March 17, 2020.
In contrast to many colleagues, CHR, in principle, concurred with ASRM’s statement, as CHR’s interpretation of the ASRM document somewhat differed from how many of our colleagues read it. Many colleagues concluded that _ASRM _basically left them with no choice but to close down their fertility centers. This is, however, where CHR disagreed, with the main difference in interpretation relating to one important summary point in the _ASRM _statement:
With this statement, ASRM _acknowledged the obvious: Like all medical services, fertility treatments can be “urgent”or “non-urgent.”In usual times, most IVF centers typically avoid urgent cases because, as national registries clearly demonstrate, they do not treat older women with autologous oocytes (most centers move women above age 42-43 rather automatically into egg donation) or do not make themselves available to be on call for emergency ovarian stimulations or ovarian tissue cryopreservation for younger women diagnosed with cancer. **What other _urgent circumstances are there in infertility treatments except for old age, low ovarian reserve and the threat of imminently losing ovarian or testes function to iatrogenic assaults?**
Dr. Gleicher explains the different responsibilities of IVF centers, based on the treatment urgency of their patients.
The average age of women undergoing IVF in the U.S. has for years been at around 36 years. This means that half of all patients in an average IVF center are under age 36 and the other half between 36 and 42-43 years old. How many women in such centers are urgent cases who would experience losses in pregnancy chances if their cycles are delayed by a few months? At best, only a small minority. Things are, however, quite different at IVF centers like the CHR. CHR’s median patient age over the last three years has not been 36, but 43 years.This means that a full half of all of CHR’s female patients are above age 43. Moreover, virtually all of CHR’s younger patients suffer from premature ovarian aging (POA), and present with abnormally high FSH and abnormally low AMH levels. Consequently, almost all of CHR’s patients, whether older or younger, are facing a ticking time clock and, often, really cannot afford to lose 3 months or more of fertility attempts.
Most services offered by most IVF centers, therefore, cannot be viewed as urgent, and within such a context it becomes difficult to argue with the ASRM Position Statement. Which raises the question, why, for the first time ever, are there so many rather aggressive attacks being launched against the _ASRM _leadership? The answer is simple: we are witnessing the beginning of the second stage of the industrialization of IVF.
Something rather unprecedented recently happened in the infertility field: The American Society for Reproductive Medicine (ASRM), for decades the official professional representative of all service providers in reproductive medicine, found itself challenged by a very powerful group of leading fertility centers (mostly IVF centers) with creation of a new special interest group under the name of the Fertility Provider’s Alliance (FPA).
Whether the idea for this name came from the Star Wars movies or the Alliance for Fertility Preservation, founded in 2011, is unclear and, actually, does not matter much. What matters is who stands behind this alliance and this is summarized by Lisa Ditkowsky, CFP, from PLLUSH Capital in Chicago, who in a “breaking news” press release announced the creation of FPA as follows:
BREAKING NEWS: PIONEERS IN HUMAN REPRODUCTION & FERTILITY MEDICINE BAND TOGETHER TO CREATE “FERTILITY PROVIDER’S ALLIANCE”
Today, a brand-new authority in global human reproductive medicine was created – The Fertility Provider’s Alliance
FPA created its own COVID-19 Task Force to counter ASRM Guidelines set forth last week and give ASRM the opportunity to rethink its guidelines with input from the private, non-hospital-based sector of fertility healthcare.
The Board of Directors includes:
Who is T. J. Farnsworth and who is this alleged “think tank?” It took some research to figure it all out, but when the list of Board Directors is carefully studied, it becomes very apparent who really created the FPA: This organization, in principle, represents IVF centers, all almost exclusively owned by outside financial interests, who over the last decade have made increasing inroads into ownership of private IVF centers. T. .J. Farnsworth is a perfect representative of these “investors.” He, indeed, is one of those entrepreneurs who, based on their own alleged personal experiences with infertility treatments, reached the conclusion that they knew better how to manage infertility. Martin Varsavsky is another such serial entrepreneur who, as we previously reported in these pages, based on the fact that his wife conceived with IVF and preimplantation genetic testing for aneuploidy (PGT-A), started advocating gamete cryopreservation for _all _females and males at young ages (at what he called their “peak fertility”) and then proposed a business model under which individuals at more advance ages would routinely use IVF, of course in association with PGT-A, to conceive—rather than have fun in their bedrooms.
Farnsworth founded Aspire Fertility and Inception Fertility, and Varsavsky, after buying RBA in Atlanta and an affiliated frozen egg bank, founded Prelude. Both of these entrepreneurs went on a purchasing binge of IVF centers, with Farnsworth concentrating on smaller start-ups and basically unknown (and, therefore, likely less costly) providers, while Varsavsky acquired start-ups but also more prominent centers. The feather in his cap, likely, was the inclusion of the academic IVF center of New York University, NYU Langone Infertility.
Somewhat surprisingly, in March 2019, both entrepreneurs announced the merger of their two quickly growing IVF networks into what they advertised as the “the largest provider of comprehensive fertility services in the U.S.” (quoting their press release from March 28, 2019). Farnsworth has since been the CEO of the combined entity and Jamie Grifo, MD, PhD, the head of NYU Langone Infertility program, is listed on the website as the Chief Executive Physician.
COVID-19 crisis has investor-led IVF centers openly opposing our professional association in the US, the ASRM. Image by Rick Tap via Unsplash.
Where the idea of FPA is coming from is, therefore, well defined: The point of contact for the Alliance is Farnsworth and the list of board members noted in the above-reprinted press release speaks for itself: 6 out of 12 (Inception, Aspire, Prelude, NYU Langone _and _RBA) are entities under the control of Farnsworth/Varsavsky. RMA-NJ/IVI is widely described as the largest IVF company in the world, closely followed by Shady Grove Fertilit_y, which has a somewhat unclear relationship with _IntegraMed, which claims to be the largest physician practice management company in the IVF field in the U.S., and is majority-owned by Canadian oil interests. IntegraMed, in turn, manages and, at least partially, appears to own FCI. Which leaves among board members only Spring and CCRM, both of which are also investor-financed and controlled. In short, FPA is purely a product of the investment class, which has been industrializing IVF in the U.S.
This must be understood as background to further comprehend the undated letter the FPA sent to the new CEO of ASRM, Ricardo Azziz, MBA, MD, PhD, and the ASRM COVID-19 Task Force. Furthermore, it is worthwhile noting that the letter, including physicians from the above-noted board member organizations, claimed 445 undersigned physicians from 43 fertility centers, many with multiple locations. In other words, FPA claimed in the letter to represent almost one-third of U.S. reproductive endocrinologists and IVF centers.
What conveys content better than the original? Here is the undated public letter:
To Ricardo Azziz and the ASRM COVID-19 Task Force,
The international healthcare crisis created by the COVID-19 pandemic is unprecedented in our lifetime. As the clinical community – nationally and internationally – recalibrates to deliver care in this new reality, the reproductive endocrinology and infertility community must collaborate to do the same.
We appreciate the guidelines presented in the New Guidance on Fertility Care During COVID-19 Pandemic press release issued by ASRM on March 17th, 2020. In the spirit of public health, these guidelines recommend suspending most fertility treatments effective immediately, halting the initiation of all new treatment cycles, delaying non-urgent diagnostic procedures, and cancelling embryo transfers and other attempted pregnancies using assisted reproductive technologies. These recommendations are currently in place for an indeterminate period of time, as the epidemiology of the COVID-19 pandemic remains uncertain.
In conversations with hundreds of reproductive endocrinologists across the country, we’ve learned that there was little input sought from active providers in the development of these current guidelines. On behalf of the tens of thousands of patients we serve, we, the Fertility Providers Alliance (“FPA”), hereby request to engage with you to revisit and reshape ASRM’s recommendations to the reproductive endocrinology community. We hope to meet as soon as possible to establish a rational, balanced position on managing public health and infection risks while promoting the best interests of our patients by providing access to fertility care.
As we review these guidelines, there are three critical issues we hope to explore further with the ASRM team: first, the actual public health burden created by the continuation of fertility care; second, the classification of infertility treatment as ‘non-urgent’ or elective; and third, the harmful consequences of an indeterminate delay in access to care.
Hospital Resource Conservation & Public Health Considerations
As physicians, we unequivocally support the effort, initiated by Surgeon General Jerome Adams, MD, to halt elective procedures throughout our nation’s hospital systems to conserve critical resources for COVID-19 patients. We fully agree with ASRM President Catherine Racowsky’s statement that “our healthcare system is about to be stressed in a way it has never been stressed before.” We understand and admire ASRM’s commitment to this endeavor and agree to suspend all elective procedures in hospital settings.
With that said, the vast majority of fertility centers across the United States are free-standing medical facilities that operate without hospital affiliation. Private fertility clinics utilizing specialized ambulatory surgery centers do not divert clinical resources or reduce hospital capacity that could otherwise be used to care for COVID-19 patients. Even in the extreme situation of hospital __systems reaching full capacity and seeking alternate care environments, the procedure suites and recovery bays of most fertility centers would not be commandeered to provide lifesaving care for COVID-19 patients. Guidelines to stop fertility treatment in centers who depend upon hospital operating rooms or hospital staff that would otherwise be called upon to combat the COVID-19 crisis are prudent, but those guidelines do not apply to the overwhelming majority of fertility clinics in the United States today
With regard to disease transmission risk amongst our patients, our staff, and the general public, we urge ASRM to consider both the industrial-grade sanitization protocols required for routine fertility clinic operations and the aggressive social distancing policies deployed immediately by fertility centers across the country in response to COVID-19.
The stringent sanitary procedures, sterile protocols, and quality assurance processes that form the standard of care in the fertility industry have been augmented in centers across the country with additional infection control measures to provide the safest possible environment for our patients and staff. Patients visiting our fertility clinics participate in mandatory health screenings at entry including temperature checks, compulsory hand hygiene, and 6-foot social distancing policies in shared spaces, while staff comply with extremely rigorous sanitization practices and utilization of PPE and isolation of febrile patients as necessary to provide patient care. All of these measures are designed to maximize our observance of all CDC guidelines for infection prevention and control, and to reduce or eliminate the risk of virus transmission between individuals.
To further reduce disease transmission risk and to observe public social distancing policies, clinics across the country – and particularly those in the hardest hit cities to date – have acted quickly to limit non-critical travel and/or non-critical interactions between patients and their fertility care providers. Measures taken to limit individuals onsite – including telemedicine, distributing urgent in-clinic appointments throughout the workday, enabling staff to work from home, and more – have been quickly implemented and highly effective. As medical professionals, we recognized immediately that “business as usual” was not possible in the COVID-19 climate, and we acted swiftly to ensure patient and staff safety in this new, hyper-conscious containment environment.
The CDC and various government agencies have issued national guidelines for ‘flattening the curve.’ It has been communicated that they trust city and state officials to implement these guidelines in the way that best serves the local community based on their knowledge of their constituents. We urge the ASRM Coronavirus Task Force to demonstrate a similar display of trust to the fertility provider community, whose goal – now and always – is the safety and wellbeing of our patients and staff.
Human Reproduction & Infertility Treatment
Infertility is a disease. The reproductive health community has fought diligently to recognize infertility for what it is: a disease state that includes many diverse medical conditions, all of which generate tremendous pain and suffering for individuals seeking to build or expand their families, now or in the future.
The guidelines delivered in the March 17th press release urging physicians, embryologists, and mental health professionals to suspend “non-urgent” treatment is difficult to understand in light of ASRM’s decades of commitment to the advancement of the science and practice of reproductive medicine. If we interpret this statement to indicate that all ovulation induction, intrauterine insemination, in vitro fertilization, embryo transfer, and gamete cryopreservation cycles are ‘elective,’ we immediately forfeit the very definition of infertility as a disease. We therefore refuse to acknowledge these treatments as ‘elective’ or ‘non-urgent’ for our patients, and this is a position that may be difficult to walk back in the future. We implore ASRM to honor the physician-patient relationship, and empower physicians directly caring for patients to determine whether or not an infertility treatment cycle can be safely delayed due to concerns related to the COVID-19 pandemic
We trust ASRM is aligned with the physician community on the definition of infertility, and we will therefore assume in good faith that the March 17th guidelines are intended to (1) protect patients and staff from potential disease exposure, which we have addressed above, and (2) protect the health of embryos and/or individuals who become pregnant as a result of the treatment processes described herein.
If the true spirit of ASRM’s guidelines is risk mitigation related to fetal development and maternal health, we will know precious little more on March 30th than we did on March 17th. The unfortunate reality of the COVID-19 pandemic is that we will soon have data on COVID-19 exposure during the third trimester of pregnancy, however we will need to wait at least nine months before we have information about the effect of first trimester exposure.
With regard to maternal health and fetal development, we share ASRM’s deep concern for the wellbeing of both parent and child, and fully support ASRM’s statement that data on COVID-19’s impact on pregnancy and reproduction remains limited for the present. We do, however, urge ASRM to recognize that human reproduction cannot be cancelled or suspended. Individuals who do not suffer from infertility can – and will – proceed with pregnancies in the midst of this pandemic. Unless it is ASRM or ACOG’s intent to issue a national guideline urging fertile individuals to abstain from pregnancy, the fertility community’s current compliance with ASRM guidelines to suspend patients’ treatment cycles creates a profound and troubling inequality for our infertility patients, who are currently denied the freedom of choice to pursue family-building with reproductive technologies.
As clinicians, we know that pregnant patients are routinely exposed to viral infection. Some, like varicella and influenza, can be devastating during pregnancy. Others appear to manifest similarly in pregnant patients and nonpregnant individuals. We are acutely aware of the adverse outcomes that have been observed in cases of infection with other related coronaviruses (SARS-CoV and MERS-CoV) during pregnancy, and the risks posed by high fevers during the first trimester of pregnancy. We take our responsibility to communicate these risks – and the current lack of data on COVID-19 pregnancy outcomes – extremely seriously. We have fought long and hard alongside each of our patients for each and every embryo, and we are absolutely committed to safeguarding the health of our patients and the families we help them to create. We again implore ASRM to trust and honor the physician-patient relationship, our transparency with regard to the risks of attempted pregnancy during the COVID-19 pandemic, and the decisions of our patients as they seek to build or expand their families under our care
Access to Fertility Care
The Fertility Providers Alliance represents over 400 fertility specialists who provide care to tens of thousands of patients per year in the United States. Every day, we look into the eyes of patients who do not know what the future holds. For these patients, “revisiting guidelines periodically as the pandemic evolves” creates an anguishing and indeterminate state of reproductive limbo. We are cancelling, delaying, or suspending a family for people wishing to become parents.
As an alliance of fertility providers, on behalf of the thousands of patients we serve, we feel it is critical that ASRM give voice to patient perspectives and patient autonomy during this time of crisis.
We, the Fertility Providers Alliance, are amongst the strongest proponents of ASRM’s leadership in the field of reproductive medicine. We look forward to collaborating with ASRM, as public health servants, active fertility providers, and patient health advocates, to recalibrate the fertility community’s response to the current COVID-19 pandemic. We look forward to your response. Please contact TJ Farnsworth of Inception Fertility (713-817-2223, email@example.com) on our behalf.
Yours in partnership,
The Fertility Provider Alliance
Let us remind you what the original press release announcing the creation of the FPA very clearly expressed: “FPA created its own COVID-19 Task Force to counter ASRM guidelines set forth last week and give ASRM the opportunity to rethink its guidelines with input from the private, non-hospital-based, sector of fertility health care.”
In other words, the FPA was established on short notice with the specific intent to give the ASRM the “opportunity” to rethink its guidelines with input from the FPA. The last time we heard so bluntly of such a publicly presented “opportunity” was in the Godfather movies!
Despite the overreaching oozing politeness of the letter, the message delivered was loud and clear: Play ball with us, the community of IVF investors, who have poured hundreds of millions of dollars into the IVF field over the last decade—or else face the consequences. And what could those consequences be? Here, too, the letter left little to the imagination: As already noted, with 480 practicing physicians, the FPA organizers were able to round up support from almost one-third of all reproductive endocrinologists and probably a similar percentage of IVF centers in the U.S. within one week. (One wonders how many knew who really stands behind FPA when signing on). The economic threat to the ASRM leadership is only too obvious.
Reproductive medicine, in quite a number of countries, is represented by competing professional organizations. Why should the U.S. be different? Though we would recommend a different logo, the name, FPA, actually, sounds fine but would benefit from a tagline, like, The Society of Investor-controlled IVF Centers.
The whole letter is, of course, a scam. Per the press release, the FPA created a COVID-19 task force to counter ASRM’s COVID-19 task force. That task force (listed in the letter), we are certain, must have met days and nights in the week between establishment of the FPA and release of the letter in order to formulate a contradictory opinion to the ASRM guidelines. (we wonder whether, out of a desire for transparency, the FPA would make the minutes of these meetings public). More interestingly, however, the letter does not refer to any specific conclusion the FPA task force of nine—all prominent leaders of board member organizations listed above—reached. So, where is then the counterproposal the FPA is supposedly ready to discuss with the ASRM leadership? Why, indeed, is there even a need for a task force if, as per press release, the whole purpose of creating the FPA was to counteract the ASRM’s task force recommendations?
It is, indeed, a quite frightening scam the investor-driven IVF-world is trying to pull off here; this is not the first time that this investor community in IVF attempts to dictate how IVF should be practiced. What is happening here not only involves the same group of players who, for years, have been promoting preimplantation genetic testing for aneuploidy (PGT-A) but who, a number of years ago, brilliantly recognized that controlling the policy process regarding PGT-A offered them the ultimate power over marketing PGT-A to IVF centers and the public. This is when they, for the first time, took a policy decision making process away from ASRM (where it should have been) and moved it to a small upstart society, consisting almost exclusively only of individuals with strong economic interests in the performance of PGT-A. This society is the Preimplantation Genetic Diagnosis International Society (PGDIS), which since 2016, forinexplicable reasons, has become the worldwide authority in establishing formal practice guidelines for preimplantation genetic testing for aneuploidy (PGT-A). And for even more inexplicable reasons, the ASRM_and its European counterpart, _ESHRE, allowed this to happen.
We all know where that has led us! Like the PGDIS never revealed how the guidelines the society published in 2016 and again in 2019 came about, and on what data they were based on, we are witnessing here the same non-process all over again with the alleged creation of the FPA COVID-19 task force. What all of this is really about, is not what is right or wrong in how the _ASRM_leadership responded to the COVID-19 crisis, but to repeat the previously highly successful process with PGT-A of taking over the policy process in the IVF practice community in order to project authority and credibility when fostering practice patterns in the IVF field that, ultimately, have only one main purpose: to enhance the income stream for the industry and, therefore, its investors.
Not satisfied with the power they already have been exerting over the IVF community for a good number of years from within the ASRM(they, for example, exert considerable editorial control over Fertility & Sterility, the official medical journal of the ASRM and over other medical journals in the field), this investor-driven interest group formally challenged the ASRM leadership with the above-reprinted letter to grant them even more power or face a competing organization. They want to be the deciding force, either inside or outside of the ASRM, when it comes to determining fertility treatment guidelines because those guidelines, ultimately, determine revenue at their IVF centers.
Once again, PGT-A is a good example: If it wasn’t a cash cow for IVF centers and the genetic testing industry, neither the PGDIS nor the procedure of PGT-A would still exist because, in 20 years, PGT-A has been unable to demonstrate any clinical benefit for IVF and, indeed, reduced pregnancy chances for many patients due to unnecessary discarding of many viable embryos. The same argument also applies to the many other useless add-ons that have characterized IVF over the last decade and often are driven by exactly the same interested parties represented on the FPA board. Many of these add-ons, indeed, are likely responsible for worldwide dramatically declining live birth rates in fresh IVF cycles over the last decade.
As finances at ASRM have been tight for some years (and likely are getting tighter by the minute, considering the current COVID-19 crisis in the world), the threat of a takeover of the ASRM by these forces must be taken seriously. The current dispute over whether IVF centers should remain open or not during the current COVID-19 epidemic is, therefore, not the real issue. The FPA crowd could have, simply, called up Catherine Racowsky, PhD, the current President of ASRM and/or Riccardo Azziz, MBA, MD, PhD, the relatively new CEO of ASRM, to discuss the matter. Instead, they chose to go public with here reprinted letter, revealing that the argument over staying open is just a ruse: What we are really facing is an attempted power grab of the IVF specialty by commercial interests. We have entered phase II of the industrialization of IVF.
Which brings us to the obvious question: what to do next? As already noted above, a potential split in the U.S. IVF community is CHR’s opinion would be deplorable and, likely, create a very difficult financial situation for the ASRM. With the financial power of the investor community and the genetic testing industry behind them, FPA, at least initially, would be a formidable competing force to ASRM. But in the long run, investment interests cannot help themselves because they are defined by how successful their financial results are, rather than their clinical, performance. The long-term, in our opinion, would, therefore, belong to the ASRM, as long as the organization remains guided by its primary responsibility toward the best clinical care and not the highest revenue of part of its membership. Avoiding a breakup, of course, remains the best of all solutions, but only if it does not occur as a consequence of a compromise that gives through the FPA additional decision-making power within ASRM _to investor interests. There has been too much of such influence in the past already. It is our hope that the new CEO of _ASRM _is aware of this fact. This, indeed, may be a good time to reduce the already existing excessive influence of FPA board members on the _ASRM, now that they have revealed their likely ultimate motives. To start with cleaning up the self-serving leadership of Fertility & Sterility, would be a good beginning.
This is a part of the April 2020 CHR VOICE.
Norbert Gleicher, MD, leads CHR’s clinical and research efforts as Medical Director and Chief Scientist. A world-renowned specialist in reproductive endocrinology, Dr. Gleicher has published hundreds of peer-reviewed papers and lectured globally while keeping an active clinical career focused on ovarian aging, immunological issues and other difficult cases of infertility.
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