INSTITUTE Q&A

Q&A: Bioethics at the Institute July 2010

Bioethics at the Institute: Regulating ART

An Interview with James W. Fossett and Michelle N. Meyer

James W. Fossett and Michelle N. Meyer

Q: What is ART, or Assisted Reproductive Technologies?



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The Institute occasionally posts Q&As that are lightly edited transcripts of conversations with our researchers. This is the fourth part in a series with the Institute’s experts on bioethics. Previous Q&As in this series offered background on bioethics topics being examined at the Institute and a look at the ethical and political issues in the debate over the use of human embryonic stem cells in medical research.

James W. Fossett directs the Institute’s research program in bioethics and federalism, and is associate professor of public administration and public health at the Rockefeller College of Public Affairs and Policy, University at Albany. Institute Fellow Michelle N. Meyer is also an academic fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Her report, States' Regulation of Assisted Reproductive Technologies, was published last year.

Michelle Meyer: I’m not sure there is any official definition. Like the term bioethics, it’s probably more broad than narrow. The term itself suggests that it’s limited to technology-based ways of helping people reproduce, but some practices typically included under the rubric “ART” are low- or no-tech and have been around a long time, while others don’t so much enable infertile people to reproduce as enable fertile people to control the kinds of children they have.

For example, artificial insemination (AI) is generally included in the term, but this is pretty low-tech — think turkey basters — and has been around a long time. The woman might be inseminated with her partner’s sperm, or with the sperm of a third party, who might or might not be anonymous and might or might not have been paid.

Similarly, surrogacy is usually listed as an ART, but one type of surrogacy — traditional surrogacy— has been around at least since biblical times, and probably earlier than that. A man inseminates a woman, either the usual way or via AI, and she acts as both the egg provider and the gestator. But after she gives birth, the intent of the parties is that the genetic and gestational mother will not parent the child. Instead, the man will raise the baby with his wife or partner. What’s relatively new, because it depends on technology, is gestational surrogacy. Here, an embryo is created outside the body — using in vitro fertilization (IVF), which is itself one of the most commonly used ARTs — and then transferred into a woman’s uterus to gestate and birth. Typically, the gamete providers are also the intentional parents — by “intentional,” we mean someone who intends to parent the resulting child but who usually has no biological connection to that child — and the surrogate’s role is limited to gestation. But it’s also possible for a different person to serve each role in this process: an intentional mother, an intentional father a sperm provider, an egg provider, and a gestational surrogate. These children arguably have as many as five parents — not counting the spouses of some of these people, who might be legally presumed to be a parent. Generally speaking, ARTs have wreaked havoc with the way the law has traditionally understood parenthood.

Then there are various technologies that enable us to have more control over the types of children we have, but don’t assist infertile people in accomplishing reproduction, per se. Take genetic testing. I can test myself or my partner for what is now a very long list of genetic conditions, and on the basis of that knowledge make reproductive decisions, like forgoing reproduction or using another ART to reproduce without passing on certain traits, like donor gametes or PGD. PGD refers to preimplantation genetic diagnosis, which is used in combination with IVF. After the embryos have been created, one cell is removed from each embryo and tested for a particular genetic trait. Only the desired embryos are then transferred into the woman’s uterus. PGD is used primarily by people who want to avoid passing serious genetic diseases on to their children. But it can also be used for sex selection, and for what some people call genetic enhancement, although the line between treatment and enhancement is a fuzzy one. For instance, enhancement might include selecting embryos whose genes suggest the child might be more athletic or taller or smarter or have a certain complexion. Aside from the ethical issues with this, most of these traits almost certainly involve multiple genes as well as complex interactions between those genes and the environment, so selecting for these traits isn’t as easy as it sounds. Moving forward in time from preimplantation to pregnancy, amniocentesis and chorionic villus sampling (CVS) are of course familiar examples of genetic testing that are done at various points during the pregnancy. Very occasionally these tests reveal a condition that can be treated either in utero or shortly after birth, but mostly these tests either allow parents to terminate the pregnancy or to prepare, perhaps, to have a special-needs child.

Other ARTs may be on the horizon. I mentioned genetic enhancement using PGD, which is a sort of passive enhancement. Parents are still limited to choosing the “best” embryos that their own combination of genes can yield, whatever “best” means to them. But in the future, we might be able to actively genetically modify a sperm, egg or embryo by replacing a defective (or undesirable) gene with another one. This is called germline genetic modification. The resulting child would have at least one gene that neither of its parents has, and because the new gene is introduced very early, every cell in the child’s body would carry the genetic modification, including the germ cells (that is, the gametes), so that genetic modification would be passed on to the child’s own offspring. This has been done in animals, but not in humans — yet. As with PGD, genetic modification can be used to correct “diseased” genes — sometimes called gene therapy — or to enhance them.

Finally, as far as we know, human reproductive cloning hasn’t been done yet, but that would certainly be included as an Assisted Reproductive Technology — although some argue that cloning is replication, not reproduction.

So that’s a non-exhaustive list of ARTs, past, present and maybe future.

Q: How are all of these procedures or therapies regulated in the United States?

Michelle Meyer: Because there are so many of them, there’s not an easy answer. But the best short answer is that they aren’t, much.

At the federal level, clinical applications of genetic modification are subject to review by the Food and Drug Administration as a biological drug — but only for safety and efficacy, not for any broader ethical concerns. Genetic modification is also subject to review by the Recombinant DNA Advisory Committee of the National Institutes of Health — but only by federally funded institutions.

With respect to the more common ARTs, at the federal level, there’s really only one statute — the Fertility Clinic Success Rate and Certification Act — and it’s very limited. First, it only applies to ARTs that involve a clinician handling both sperm and eggs — basically, IVF. It doesn’t cover AI, and it doesn’t cover situations where a woman is receiving potentially dangerous fertility drugs but there’s no plan to retrieve the eggs.

Second, the act requires fertility clinics to report their success rates to the Centers for Disease Control and Prevention, but doesn't impose any standards on clinics.

There was a big problem when these fertility clinics started springing up. There is a phenomenon of, frankly, desperation among a lot of infertile people. And these fertility clinics would promise you a baby. One of the simple ways they would do this is they’d have bulletin boards with all these shiny pictures of happy, rosy-cheeked infants. They would sometimes literally use multiple pictures of the same baby, and put it on the same bulletin board, to show prospective parents that they had this great success rate. In fact, the success rate for in vitro fertilization is not that great across the board.

So the statute was really a consumer-protection piece of legislation. The thought was, it’s very expensive, it’s invasive and people sometimes go into debt to try to do this, and they ought to know what the odds are.

But it’s not clear that the act does well at even this limited role. The CDC reports only a portion of the information it collects from clinics — in particular, the number of live births per cycle of IVF. However, the CDC collects — but doesn’t report — adverse outcomes like high-order multiple births that may result in fetal death or disabilities, for example. You would think that would be part of a consumer-protection platform, but it’s not.

And even with respect to births-per-cycle, this number can be rigged. For example, clinics can select patients who are more likely to be successful — for example, lesbian couples, or couples who have a genetic predisposition that they want to screen for but who have no fertility problems per se.

The other way of skewing the numbers is to transfer more embryos into a uterus at one time than you might otherwise, since the success rate is reported as the total live births divided by the number of cycles. For example, in the case of Nadya Suleman, a.k.a. Octomom, her doctor had one of the lowest success rates in the country — an abysmally low success rate. And it was only as marginally high as it was in the last year of reporting because Suleman had actually had twins at his clinic. So with respect to the IVF cycle that ended up making headlines, he had a very large incentive to transfer all six remaining embryos for her — two of which spontaneously twinned, giving Suleman octuplets. High-order pregnancies are very dangerous to both women and the resulting children, but this is not the kind of information, unfortunately, that the CDC is releasing.

Finally, compliance with the act’s reporting “requirement” is entirely voluntary. If a fertility clinic doesn’t want to — say, because it doesn’t have a great success rate — the only consequence is that when this report is issued, that clinic is listed as “nonreporting.” Savvy consumers may understand this as a red flag and avoid that clinic, but others may be less savvy, and even some of the savvy ones may be willing to patronize nonreporting clinics if the price is right.

Q: Is it surprising to you that these technologies, at least from the federal government perspective, are so minimally regulated?

Jim Fossett: Not at all. We’ve traditionally in this country not regulated the practice of medicine at all. You’ve had various medical groups that have been absolutely adamant — not just the fertility doctors but going back a long way — that the practice of medicine is a matter for regulation by professionals. So states don’t accredit medical schools really, except on a very minimal level. They don’t regulate residency training programs, for example. Those are all certified by the appropriate specialty society. And we’ve had this longstanding tradition of the individual patient and the individual doctor as the judge of what’s appropriate for a particular patient. Unlike other countries — and the one that keeps getting mentioned is England, where there’s a national government board, the Human Fertilisation and Embryology Authority (HFEA) that sets binding standards for how many embryos you can implant. And they’ve got a very detailed set of regulations. And that’s what the English do.

Q: For all of medicine?

Jim Fossett: Across the board, yeah. They also have a thing called NICE (National Institute for Health and Clinical Excellence). What NICE does is review evidence on all kinds of new health treatments, and essentially tell the National Health Service, we pay for this but not for this. And that’s the way they do things.

Q: Some of the issues we’ve discussed (throughout the series of Q&As) then, are more the exception than the rule where regulation is concerned — the fact that stem cell research, for instance, has gotten a lot of (regulatory) attention.

Michelle Meyer: Well, research is actually heavily regulated. That is the distinction. There’s some slipperiness in terms of the word research, and what constitutes research and what doesn’t, and you could make a decent argument that some of the newer reproductive technologies are research. But they’re not viewed that way; they’re viewed as elective medicine.

And of course they’re also viewed as reproductive medicine, which adds a second layer of incentive for the government to be laissez faire about these things. In America, we have a very strong sense that reproductive issues are private, and the individual, her doctor and her God are essentially the stakeholders that get a say.

Q: So how have the states dealt with ART — with the same laissez faire attitude, generally, or is there a wide range of how states have regulated this?

Michelle Meyer: Some states have passed legislation regulating some ARTs while other states haven’t. Of those states that have regulated, the regulation is all over the map. Because it’s fairly easy to travel to a nonregulating or less-regulating state for reproductive services — so-called medical tourism — the net effect is that there’s very little stopping patients and clinicians from reaching private agreements about the use of ARTs.

Q: Can the states go further if they want? Is that within their jurisdiction?

Michelle Meyer: This is really an interesting question, as far as I’m concerned. The primary federal obstacle to states regulating — since there’s really no federal legislation that would pre-empt them — would be the U.S. Constitution, and specifically the constitutional right to privacy that undergirds the right to abortion in Roe v. Wade and subsequent cases. That case and some other cases are certainly relevant, but decisions about whether or not to have an abortion are just factually very different than some of these other questions.

So I don’t think that the answer that the Supreme Court gave in Roe v. Wade necessarily forecloses a different answer in some of these other contexts. And the fact is the Court has not dealt with any of these technologies. Very few lower federal courts have even dealt with them. To the extent that they have, and in many of the conversations among legal academics and others about regulating ARTs, there is sometimes a tendency to lump all reproductive decisions together. And having already decided that decisions about whether to use contraception and decisions about whether to have an abortion pre-viability are very much private matters for individuals to make, free from government interference, there’s sometimes a tendency to just assume all these other kinds of decisions would follow suit.

But I think that conceptually there is room to make a lot of distinctions.


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