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Thank you for the opportunity to contribute to this critical discourse on assisted reproduction, bioethical considerations and the regulatory environment. As executive director of one of the preeminent national advocacy organizations for the infertile, I feel privileged to help articulate the concerns of the estimated six million Americans who struggle against the private and public ravages of the disease. Some of these concerns are common to everyone in the field – researchers, medical practitioners, psychologists, sociologists, lawyers and state and federal oversight bodies. Some are unique to us. It’s my intention to make our perspective on these issues as clear as possible to you.

The Background

Let me begin by dispelling the unfortunate stereotypes that plague the infertile community. We have been variously caricatured as wild-eyed monomaniacs driven to ludicrous extremes and sitcom behavior to produce progeny or as bloodless fashionistas who crave infants as must-have accessories. Are there such people? Of course there are and they snag the limelight precisely because of their beyond-the-fringe turns.

Overwhelmingly, the infertile are educated, astute and reasonable people who want what other people want, children of their own. We are renowned – or notorious, depending on you point of view – for ferreting out information about every aspect of infertility. We fine comb the Internet, read almost everything in print including fairly abstruse technical material and freely exchange the knowledge we gather. We think and plan carefully before we undertake treatment. We have no other alternative. One wrong move could bankrupt us. Or worse, it could leave our futures and those of any children we might have in ruins.

In other words, the infertile in this country are in large measure a formidable, sophisticated lot precisely because of our vulnerabilities. As ART matures and evolves, so do the patients.

In that vein, we are increasingly sensitive to what is becoming common parlance among regulators and politicians when discussing established and experimental technologies. We take exception to referring to our eggs, sperm and embryos as potentially patentable manufactured reproductive goods and products. What is on the table is the patentability of technologies to help bring about life. As the end-users, we are not hapless innocents unaware that some renegades have and inevitably will misuse these technologies. Put in the historical context of all technological development, it’s evident that abuses occur regardless of how many regulations are promulgated in the name of safety. The underlying assumption that millions of infertile would choose to custom-design a vanity baby or that the preponderance ART practitioners would offer such menu options, is unacceptable. It flies in the face of more than two decades of our in-the-trenches experience.

The evidence we have is a population of more than 1,000,000 IVF children born worldwide who are indistinguishable from the general population. Those are the kind of children that the whole of everyday infertile people are seeking.

When we are lucky enough to have these children and complete our families, or when the current technologies don’t succeed, we are sometimes left with embryos. The number of frozen embryos in storage not designated for use by the infertile people who created them is much smaller than some would have us believe. The percentage that do remain after medical treatments are completed belong to us. What we choose to do with them is a most private matter that will differ from one person to the next depending on religious, cultural, philosophical and moral convictions. The American Fertility Association is adamant that for any governmental committee to even contemplate deciding what is “right” for us to do with the embryos we struggled to create, would be a gross violation of our most cherished and traditional personal liberties.

The Climate and The Burden

That said, we are advocates of the rigorous oversight of the development and application of assisted reproductive technologies. Indeed, we demand mechanisms that protect the infertile, their realized and their potential offspring.

We do not a priori oppose regulation and in fact have paid richly for the federal and state rules already in place.

However, it has yet to be demonstrated that heaping on more regulation would improve the ethical landscape.

Ever since its inception almost 25 years yeas ago, ART has provoked a dilemma over the limits of human experimentation. Infertility treatments, as with treatments in other disease groups from acne to high cholesterol, sometimes have unintended consequences.

People battling infertility have an obligation to find out how tried and true a procedure is and about the known risks. They have the right to ask and receive full disclosure about possible risks inasmuch as they can be envisioned. If patients are not satisfied with the responses, they have a responsibility to seek treatment elsewhere.

We have always had to deal with the dicey but personal question of our willingness to be on the frontlines of the testing grounds and at what level. Ultimately, it’s the patients providing the data on what works and what doesn’t in humans.

There have been eloquent arguments for more animal models. Certainly we would feel more comfortable if longer term animal studies were used, were reliable and the results translatable to us. But in matters of reproduction, animal models do not always translate to the human experience. For example, there are great success rates with Intracytoplasmic Sperm Injections (ICSI) in cows; they’re dismal among monkeys. How do we interpret that for our own understanding and use when the ICSI fertilization rate among humans is between 60 – 70%? What are our options? How many children would not be alive today if our researchers were forced to continue with unsuccessful primate models.

The latest noise has been generated by a small handful of studies of ART outcomes, leading some to conclude that practices created and implemented without increased government oversight “may” jeopardize the health of IVF children. These few existing reports have been roundly criticized by peers in the scientific community for their creaky methodology and lack of appropriate controls. Other than a good scare, they have yielded little else. We would first urge that we have credible, longitudinal analyses of IVF outcomes before any governmental body consider another layer of regulation.

Because the only thing we do know with relative certainty is that without a concomitant commitment of federal research dollars, more statutes are bound to further slow and or halt compromised laboratory and clinical progress. As it stands, it is the infertile who underwrite the lion’s share of the scientific investigation on top of bearing the brunt of the costs of compliance. As you know, having an ART child is a staggering out-of-pocket expense that precludes hundreds of thousands from even considering treatment. Insurance coverage (which, in itself, would supply another line of control) is mandated in only 14 states and, for the most part, is quite limited. Under the circumstances, we’re at a loss as to how already strapped infertile patients can be expected to finance a greater regulatory framework. Despite reassurances from regulators that costs do not get passed down to the patients, our pocketbooks have shown us otherwise.

What Is Done Can Be Done Better

As noted, there are significant state and federal regulations and laws governing assisted reproduction. In addition, there is self-regulation by professional organizations dedicated to maintaining practice and ethical standards. Although we believe best intentions, concern for the public welfare and self-interest motivate earnest vigilance, patients do not really know how well or stringently the rules, laws and regulations are enforced.

The question is, are these provisions enough? The American Fertility Association believes they could be but aren’t yet. But they represent a much more appealing opportunity for us to cooperatively deal head-on with the open-ended ethical questions of ART rather than superimposing cumbersome and possibly unenforceable regulations on top of those already in place.

There are two areas in particular that we believe offer the best potential for oversight without sacrificing the research we desperately need and the personal choice we take as our fundamental right.

The first is informed patient consent. At this moment, many physicians regard this as a moving target, referring to it as a process rather than a document. It’s true that things do change. We agree that patients and their doctors must be in constant communication about new procedures and findings every step of the way. The AFA has been told that because details of practices vary from state to state, informed consent cannot be standardized.

But there comes a time when a patient signs on the dotted line. We would like to see a joint committee of government regulators, physicians, psychologists, lawyers, other professionals and patients draft a plain-language standardized consent form that at a minimum requires each clinic to outline its safeguards and procedures; that discloses the number of such procedures (e.g., PDG or ICSI) done and the outcomes; expected outcomes and those that fall into the murkier realm “reasonable surprise;” and whether or not there have been useful studies. Once it is conceived, the document essentially becomes about filling in the blanks and updating the information on regular basis. All the rhetoric about patient protections aside, the most essential element we patients need before we willingly offer ourselves on the alter of scientific experimentation, is information. We would argue that the role of government and self-regulators is to insure that consent forms are as clear and precise as possible.

Second, we would urge minimum, uniform standards for Internal Review Boards for all institutions involved with experimental infertility protocols. Right now, only research facilities receiving government funding must adhere to federally promulgated rules. Privately funded, free-standing clinics are not held to those benchmarks even though some do have their own review boards. While the American Society for Reproductive Medicine will not publish non-IRB approved work in its journal, The AFA believes that is not sufficient motivation to guarantee patient safety. Certainly patients have an opportunity to ask the ASRM if a procedure is experimental and if it is an IRB-approved protocol somewhere before they agree to participate, assuming that a new patient even knows about the existence of IRBs or their function. That, too, falls short of the mark. Patients deserve the guarantee that a research institution, regardless of its funding source, is adhering to best practices and that the protocol under investigation is systematically reviewed by an accountable internal body. Regular periodic reports on the progress or lack thereof should be more than available to patients, they should be actively distributed.

These options simply improve on what is already in place. We acknowledge that they require more effort from infertility researchers and medical specialists, regulators and patients, but only marginally more. Stringent informed consent and uniform IRBs could provide the matrix of important ethical guidelines for both research and practice and can only put us on the right course. We do not want to play catch up when we find that our scientific breakthroughs have outpaced our sociological responsibilities. Certainly, this would be less onerous than a new stratum of complex, expensive legislation or regulation that would most assuredly tighten the noose around our individual reproductive rights. We are sure that restricting the rights of the infertile to have children is not the intent of this committee and should become “an unintended consequence.”

Conclusion

We are not naïve. The American Fertility Association understands full well that reproductive medicine is unique precisely because the outcomes are not limited to just our bodies. They may have an impact on the sons and daughters we have or hope to have as well as future generations. We want to be as careful as possible without inhibiting progress.

This disease profoundly affects those afflicted with it. It erodes self-esteem as it breeds shame and resentment. Infertility is a vortex that sucks in potential grandparents, aunts and uncles, cousins, friends and even employers. The struggle to overcome it can drain bank accounts, divide families, erode social and emotional security and good-will.

The last thing we want is yet more obstacles to finding reliable and efficacious treatments. We want to retain control of our reproductive lives. We want to empower researchers to follow promising leads and physicians to pursue and refine clinical technologies. We want medical and therapeutic decisions to remain a private matter between patient and doctor.

The AFA has more than 1,000,000 contacts every year with infertile men and women. I can assure you, this overwhelmed and over-burdened population is dismayed, to say the least, that the government’s interest isn’t first to help us conquer the disease by reducing risk with adequately federally sponsored research.

For decades the United States has been a leading light in treating the infertile. We have a brilliant track record that offers hope. It’s just that we have so far to go. Yes, we have witnessed the horrors that the rare villain visits upon us. But rare is the operative word here. Those who behave irresponsibly or even criminally do so regardless of regulation. It is far more significant that the stunning majority of patients, researchers or physicians are responsible, moral people who work within the realm of our societal norms.

It would be unfair and unwise to make the door to infertility treatment even harder to open for the millions who need it with unwieldy regulation that jeopardizes our chances to have the families we deserve when other alternatives have yet to be explored.