The whole world of assisted reproduction has been described aptly as kind of Wild West. But I'd go further than that. I think it's the Wild West kind of mated with American commerce and modern marketing. What you see is a number of very highly successful clinics viciously competing for patients. And the patients describe themselves and the clinics describe them as being desperate to get a baby.

So you have a variety of highly professional, in most cases, individuals out there pitching their wares, their success rates, their new technologies, their cutting edge technology to this highly susceptible group of infertile couples who are almost willing to try anything, and almost pay any price to get a baby.

How does that effect the medicine?

It's almost like the medicine is secondary. I mean, commerce has overwhelmed this whole industry. Although, there is medicine in it, of course, you have to be licensed physician to be involved in assisted reproduction. The medicine usually takes a second place for lots of reasons.

One reason is, historically, we haven't been able to get federal funding for assisted reproduction research. So there is no standard set in the profession. There hasn't been what you have in cancer, for example, or other major diseases where you have long periods of people doing experimentation, looking at protocol, developing protocols. Finally, finding something that works and then standardizing it, so other physicians can follow it. Nothing like that in assisted reproduction. Basically, it's individual. It's developing their own techniques and then marketing them.

You emphasized the lack of federal funding. Why does that make a difference?

Historically, federal funding has paid for research; usually, through the NIH [National Institute of Health]. And research has developed specific standardized protocols that have success rates and that we can tell people about. We know if we do x, y and z, we're going to have x-percentage of getting a baby, for example. There's been nothing like that in the reproductive technologies. They've come over almost directly from Australia and animal husbandry, and then been applied immediately to patients who could pay out of pocket, because there was, again, no money available for research.

Does that mean it's bad medicine?

It means we don't know what medicine it is. It would be very interesting, and we should have done this, to do a randomized clinical trial of in vitro fertilization, for example. Kind of the gold standard in assisted reproduction versus nothing ... we know that we get some babies out of in vitro fertilization; 20 to 30% of couples ultimately get a baby, but how many of those couples would have gotten a baby without in vitro fertilization?

When you talk to patients going through it, they certainly feel like they've tried everything ... hormones, money, all of that. And many are still not getting pregnant ...

Actually, the majority of patients who undergo assisted reproduction through the clinics do not become pregnant, do not get a baby. Most of them do become pregnant, ultimately, but most of them do not get a baby. And I don't know if they know that. I think on one level, they know that. On another level, you always think you're going to be the one. Just like if you're in cancer chemotherapy, you think you're going to be the one to get a remission or get saved. You're not going to be like most people who don't benefit from the treatment.

So it's hard to explain that to couples, but it's definitely true. They know it if you push them ... they know the statistics. They know that the majority of couples will not get a baby from these procedures. Yet, they don't think there is any other way they are going to get a baby, so whatever the percentage is, 10%, 20%, 30%, from their point of view, it's better than 0%, which is what they think their odds of getting a baby is.

You say the majority will not get a baby.

That's correct.

But the statistics are that the success rate on average nationally is 23% per cycle. So the odds are if you do a few cycles, you'll get pregnant, right?

No, the odds aren't that ... If you think that if you have 23% per cycle, if you do five cycles, you have a 125% chance of getting a baby. Well, that's just not true, cause they're not independent events.

The truth of the matter is all of the statistics that have been gathered is that, ultimately, about 40% of couples, if they do three cycles or more will wind up with ... a baby at home. It is not the case that if you just keep doing it over and over and over again, someday you're going to get a baby.

You said that medicine in this field is frequently second to the marketing. What do you mean?

I guess the [doctors would say] you can't do the medicine without the patients. The truth of the matter is, there's a limited number of patients out there who both want a baby and can afford the $20,000 to $50,000 necessary to approach assisted reproduction.

So, if you are a clinic, you want those patients bad. To get them, you have to market. You have to go put ads in newspapers, ads in magazines and run seminars ... educational seminars where you explain essentially what you do ... infertility news about recent advances in infertility, for example. That brings your services to the attention of people who might be able to pay for them.

What's wrong with it?

Well, it's kind of the American way. You can certainly argue that medicine as a whole has gone to market medicine, and we have. But I think my best guess is that it's ultimately going to be a failure, because mostly disease is not something that is your fault. We mostly see in this society that health care should be a right not a privilege. We should take care of sick people because they are sick, not because they're rich or because they have enough money to afford to be taken care of.

Infertility falls in almost a separate category, though. We don't pay for it by insurance because we think it's elective--and it is. It's a disease, but a strange kind of disease. It's one that usually only one member of a couple has. It can be cured by divorce or remarriage. It's a strange kind of ... it doesn't fit the categories right. Nobody is dying. People are very upset. There's no question it's psychologically traumatic not to have a child. But it's not like a disease where you're sick. You can't work or you're going to die. It's got ... none of those characteristics. So for all of these reasons, we treat it separately.

And it makes it a candidate for market medicine, but it doesn't make the market the right model to regulate it, because the market simply asks how much can you pay? Or actually, how much are you willing to pay through supply and demand? That's the wrong question. But we've been asking that question, in all sorts of categories, from surrogate motherhood to sperm donation to egg sales to just putting a price on in vitro fertilization or other assisted reproductive technologies.

You hear a lot about success rates and certainly the clinics have improved their success rates pretty significantly over the last 10 or 20 years. Isn't it a good thing that the consumer can easily find out what the success rate of a clinic is ...

It's just in the last two years that we've started to keep national statistics on comparative success rates among clinics. It's absolutely a good thing, but it's something that clinics had to be dragged kicking and screaming into. They didn't want to do that either. It took an act of Congress, and strong pressure to get the CDC [Center for Disease Control] to finally collect that information and publish it so consumers could use it ... The industry has been there for 20 years. The fact that they've, just now, under strong federal mandate, been required to publish their success rates. It tells you something about the industry that they have no interest in doing this.

But, at the same time, you hear that the success rates lead the clinics to be more aggressive than maybe they should be ...

It's hard to know what the success rates ... though, you're right. Sometimes you could say that if the only issue is success rates, then you're going to try to implant a large number of embryos, and hope that one or two make it, to try to increase your pregnancy rate. Or are you going to use more drugs then you would like to use to try to hyperstimulate patients on fertility drugs. There is probably some truth to that.

In the other areas of medicine, where success rates have been published for years and years, people worry that you don't take the most iffy patients, the most dangerous patients, the patients who have the least likelihood of surviving a heart transplant, for example. Or more likely, just an open heart procedure. There is certainly some truth to that.

On the other hand, the counter argument to that is if the success rates are very low in this particular population, or with this particular procedure, it probably shouldn't be used. Not that you should try to push harder for it. You know that there is some level.

We've never even had this discussion publicly. What should the success rate be? What is a successful program? We can compare programs now and say, "This one is twice as good as that one." And some of them have very high success rates in the 40% range. But what about a program that's got a 10% success rate? Should that be shut down? What does one below the national mean? Should we then say they're a sub-standard program? Should they either have to change, put them on probation, or shut them down? We haven't started doing any of that stuff yet. But it seems to be that if the success rates matter to quality, it's time we do that, too.

Are you concerned about the way new procedures are developed, tested and put into place?

In general, when you want to do a new procedure in assisted reproduction, you just do it. You could have a bad dream one night, and wake up the next day and say, "I'm going to try that ... Fuse two eggs. Let me try to take the cytoplasm from one egg and put it in the nucleus of another egg. Or let me try to clone a human being. Let me do that." There's nothing to prevent any of that from going on right now.

Although, we know that 90% of Americans think cloning is wrong, it's still not against the law. It's against the law to have federal funding for it. But Congress has never passed their statute even with a moratorium on human cloning. So from human cloning on down, essentially, with private money in a private clinic, physicians can do virtually whatever they want to do as long as they have the consent of the gamete donors as well. There is no regulation. There are no limits. And that's a problem not a solution.

We haven't heard the horror stories that one would expect if this experimentation issue were a real problem. We seem to have tens of thousands of happy, healthy babies and satisfied parents.

Well, it depends what you mean by horror stories, right? We have had a child delivered to a single person from a surrogate mother, who later went on to kill that child-- abuse it and kill it. We've had a doctor stealing eggs and stealing embryos and giving them to couples that he thought "deserved" to have these embryos. We've had experiments that have been kept secret and only released in press releases or press reports. So it's hard to say that there haven't been any problems. But even if there were problems, there's no way we'd know about it. There's no inspection. There's no mandatory reporting. This is all done voluntarily.

Aside from the horror stories ... what are the problems with the way that these techniques are developed? In general, there seems to be a lot of happy, healthy babies.

Yes, and the major problem with the way the techniques are developed is we have no data. There are no protocols. There's no comparison. The only way we know how they work or whether they work is strictly on the basis of outcome. How many take home babies do you get?

... Lots of decisions are made about screening couples, embryos, surrogate mothers, sperm--where there's no standards for any of this stuff. The idea that there can be--with 200 clinics--200 different standards is ludicrous. There should be one standard. If you're going to deviate from that standard, you should have to explain it the way you have to do in every other area of medicine.

The doctors say, for instance, in surgery, you don't have that kind of controlled experiment before it's implemented.

Well, that's a problem in surgery. In general, they are correct about that. But everybody knows that's a problem. Surgeons still do publish their protocols. Surgeons always have somebody staring right over their shoulder. The operating room is essentially a public place in a hospital. But they're correct that surgery is not well controlled. We control drugs and medical devices in this country. We haven't figured out a way to regulate surgery yet and we haven't even tried to regulate assisted reproduction.

From a patient's point of view, what does that mean--the medicine is not controlled and replicated?

From a patient's point of view, what it means is that it's very difficult to get a good handle on what's going on in the industry. What are my choices in terms of informed consent? Everyone would concede the patient has an absolute right to know what the alternatives are out there. What the success rates for those alternatives are. What the cost is. What the likely side effects are. This information is extraordinarily impossible to get, because the data simply isn't there. The data hasn't been kept, so, on one level, you can't give informed consent as we normally think about it in surgery or with drug treatment.

And on another level, we just don't know where this industry is going. We just know that whatever it is today, it's going to be different tomorrow. And it'll be different the day after. We also know that we're not going to have a paper trail.

It's time that we put some standardization, some national standards in place, so that we could meaningfully compare one program to another, and that patients could be told, openly and honesty, exactly what is going on here. What they can expect. What the likely results are going to be. What records are going to be kept. What screening techniques are going to be used. What diseases they or their children will or will not be exposed to, etc.

You talk to the doctors in the field and they say, "Listen, we're heavily regulated. There's probably no area of medicine that is as transparent in terms of what it's doing and it's success rates as we are. We have to report an enormous amount about that."

It's very funny to hear the doctors in assisted reproduction argue that they are over regulated or highly regulated. I mean, there is virtually no regulation. You wonder what's the base line?

Two years ago all the national organizations--the American Society of Reproductive Medicine, for example--were arguing, "We need more regulation. It's time we had national standards." More recently, they have pulled back. They said, "Oh my god! I guess we were wrong. We're over- regulated. You know, we have to be licensed doctors ... sometimes people come in and look at our lab. Congress makes us report our success rates to the CDC."

That's not regulation. I mean regulation is ... look at what the Food and Drug Administration does for new drugs and new medical devices, for example. By requiring the sponsors of those new products to actually engage in randomized controlled studies to show whether or not they work. To show what their success rates are. To show what the risks are. What the benefits are, etc.

There is no standardization in consent forms. No standardization in counseling. No standardization in screening eggs, embryos or sperm. No standardization in terms of reporting success rates in anything but in vitro fertilization. We now have, in the United States, a viciously competing market in eggs. We have prices ranging from $2,000 to $55,000. Probably, it's going to go higher. The idea that anything but the market is ruling this industry is ludicrous.

But ultimately, it is a market ... The public policy decisions have been to take it out of the public realm and let it exist as a private industry.

No, actually the private decisions have been to try to keep it out of the public realm. The industry has consistently resisted regulation, because it likes it just the way it is. The model the industry has adopted is a contract model. That is, as long as an agreement is made between the physician and the couple, and they can pay for that agreement, then it's the contract that should rule, not public policy.

In fact, the argument of the industry is public policy should have nothing to do with this. This is a private decision between infertile couples and their physicians to do whatever the physician can help them do to have a baby, and the public should have nothing to with that. That's the industry's position.

And that position, I think, is untenable, because we're doing lots more than contracts here. We're having children. We're deciding who the mother is. Who the father is. Who's responsible for this child. What information this child is going to find about its mother and its father. All issues that are hard-core public policy issues, in addition, to the standard medical issues of informed consent, confidentiality, counseling, record-keeping and screening.

You sit on one of the industry's oversight boards. From the insider's perspective ... How significant is the oversight?

I'm on the ethics committee of the American Society of Reproductive medicine--ethics committee--to call that an oversight committee is quite funny. Our job is to come up with so-called ethical standards, and ethical standards are just what they say. They're ethical standards that physicians can follow or not follow as they see fit. They're not even guidelines ... they certainly are not procedural requirements, or even standards for the industry. So it's very important that they have an ethics committee. I'm obviously on it, so I don't think it's totally useless.

On the other hand, it's got to be recognized for what it is. It's the industry's attempt to shield itself from governmental regulation. It's the industry's attempt to say. "Don't worry. We're taking care of this." And the answer is we're talking about it. But I would never go so far as to say the industry is taking care of it.

Give me an example.

... so far the ethics committee--I've only been on it for a few years--but over more than a decade that it has existed, it's come up with approximately 40 ethical statements or ethical standards on a variety of issues from: how you collect sperm and store sperm; to egg donation; to surrogate motherhood; to what the industry should look like.

But the committee has never, nor has the American Society of Reproductive Medicine or SART, (the Society for Assisted Reproductive Techniques), ever taken a position on children. Never said anything about children. In fact, if you go through the ethics statements of both organizations, and you didn't know anything about what they were doing, you would probably be shocked to learn that they are helping people make babies, because the interests of the children never ever have been considered by either organization. And that strikes me as just being the real Achilles' heel.

... It's not that they do bad things for children. It's that they're literally indifferent to the welfare of children. That's why there is no record keeping requirements. That's why many children can never find out who their genetic mother is or who the genetic father is. That's why we've had cases like the California case where you had five people involved in an infertility treatment, and a child that the court said had no parents, was an orphan. I mean, that's just ridiculous. That's unacceptable.

There's no clinic that should be in business that doesn't see as its first priority the welfare of the children that they're creating. Right now, today, I'd have to say there is no clinic that has publicly said that is their first priority. Even said if whether it is or not. And from a ethical point of view, children have to be first.

It's surprising to hear you say that, because the clinics ... all seem to be about making happy, healthy babies that the parents want. What do you mean they're not protected ...

They're indifferent to the welfare of children. For example, ... you can go from having septuplets and octuplets, in total indifference to the fact that most large multiple pregnancies are going to result in either spontaneous abortion of all the children, or in severely handicapped newborns. There is just no excuse for any infertility specialist to ever be involved in a large number multiple pregnancies. Their excuse is, "Well, that's what the couple wanted. We were just giving them babies." That's no excuse. You cannot make handicapped children for the sake of couples or for the sake of doctors, all right? Almost everyone would acknowledge that, but yet it is still being done.

In sperm donation, it used to be routine to destroy all of the records, so the child would never know who his genetic father was. That was to protect the sperm donor, certainly not to protect the child. In fact, it was in the worst interest of the child. In egg donation, that situation often happens today, even though we know it shouldn't. Egg donors are compared to sperm donors. So not only is the health of the egg donor put into risk--routinely egg donors have no physicians--they act like they're just kind of random vendors out there selling eggs. Records are not kept. No standardization of records. We're not even sure who the mother is. Is the mother the egg donor? Is the mother the egg recipient? Is the mother the woman who gives birth to the child, as I think it should always be? Who's responsible for that child? That's the question. The question is not from the mother's point of view only, but from the child's point of view when the child is born. Who is the woman that's got the rights and responsibilities to make decisions for that child? We don't know. And the industry, quite frankly, doesn't care. At least, as far--from any of their public statement has it taking steps to make sure that that child is protected when its born.

So it's literally all the way through from the indifference to large order multiples to the refusal to regulate how many embryos are implanted, how ... infertility drugs are regulated when you are using that to the refusal to have standards for record-keeping to the refusal to make sure children have a right to know who their genetic mother is or genetic father is. All the way through. Again, it's not because they don't like children or not because they don't think children might have some rights. It's because they always put the interest of infertile couples and the physicians first, and the interest of children second.

Let's talk about the issue of multiple births. How much of a problem is multiples within this industry?

... Well, multiples is a big problem. The vast majority of multiples in the United States born, and that includes twins, triplets and quadruplets, are the results of assisted reproduction. Hardly any of them happen the old fashioned way, and they happen because of in vitro fertilization. Almost routinely, clinics had been implanting five, six, seven, eight embryos, because it increases the likelihood that one embryo will implant. But it also, of course, has the possibility that many of the embryos will implant.

It's only this year, finally, that the American Society of Reproductive Medicine has said, "Well, you should step back and try to limit the number of embryos that you implant." And that's about time, I'd say. But they still haven't come and said, "Well, this is the limit. You should never implant four embryos or try to implant more than three embryos," which I think should probably be the limit. It's a giant problem for the couples. None of whom come in to have twins, triplets or quadruplets. All of whom come in to have one healthy baby. That's their goal.

So this is something that the women I've talked to say this is explained to them, but it's meaningless at the time it's explained. You really think you're going to get one. You never think you're the one who is going to get triplets. There actually have been support groups formed around the country of families who had triplets from assisted reproduction, and they need all of the support they can get. This has really changed their life in ways that they did not want or did not anticipate ...

Aside from triplets and quadruplets, where there are certainly significant medical problems, some of the couples are ultimately glad to be getting twins ... from their point of view, it's almost better. It's their choice.

Couples are very flexible and, you know, god bless it, if they have twins, they'll accept twins. And that's very nice, but that's not what they came in for. That's certainly not what they bargained for. That's not what the doctors are trying to do. I mean, you shouldn't see twins as two for the price of one, all right? You should see twins as a failure of the technology.

... We need more counseling than goes on now, because you're not really prepared for something to go wrong. That's true even for couples who wind up with no baby at all. It's very stressful on the marriage. Many marriages end in divorce after--this is a highly emotional, highly stressful, very personal experience these couples are going through. And it's not at all patronizing to them to say they should have some heavy-duty counseling throughout and know what things might happen and what things might not happen. And be prepared as much as possible for it.

Should the doctor who got them pregnant with multiples be held accountable in some way?

Well, if we're going to see infertility strictly in market terms, a market solution to large number multiples is to require the in vitro fertilization clinic to pay the costs of the neonatal intensive care unit and the extra medical bills of raising a handicapped child. If we did that in a way that they couldn't immediately pass it on to the parents, that would overnight change the complexion of the industry and you wouldn't see any more high [area] multiples.

You'd shut it down, probably.

I don't think you would shut it down, but it would make couples undergo probably more than one cycle, for sure. We wouldn't be implanting five or six embryos. You wouldn't be going in a cycle where you've created eight, 10, 12 eggs to be released at a time.

We talked to the doctor who cared for the woman through her pregnancy. He was terribly bothered by the whole situation and is by multiples, in general. He said there is something wrong with the system where we have one set of doctors who do everything they can to get a woman pregnant. Then you have another set of doctors who come in and try to do everything they can to keep the pregnancy in as long as possible ...

... Well, the question of what the role is of the infertility doctor is an old one and not well resolved. I mean, it could be one of three things. It could be that your job is just to get the woman pregnant and then hand her over to the obstetrician. Your job is to get the woman pregnant and see her through the pregnancy, and then hand her over to the obstetrician. Or your job could be get the woman pregnant, see through the pregnancy, deliver the baby and then take care of the baby until it's able to go home.

So far, most clinics operate on the first model. Your job is to get the woman pregnant, and then it's in somebody else's hands. The obstetrician's hands during the pregnancy, and certainly, after the child is born, you've got nothing to do with that. That's, again, one reason why the child is not considered primary in this infertility field.

But this is such a specialized field of medicine, the doctors have to focus in on what they do best.

Sure, they do. But the question is what are they doing? I mean, that is what they haven't focused in on. They do at what they do best is technique. But they forget what the end result of that technique is, which is a baby. You've got to bring those two together. If they can't do it, someone else has to do it. You can't disconnect conception from its ultimate goal which is childbirth. That just makes no sense.

Do you think that is being done today?

I think it is being done today. Yes. I think just the way the field has grown up. That they have put so much concentration on trying to increase pregnancy rates that they've essentially forgotten what the purpose of increasing pregnancy rates is, which is to have healthy babies, and there is a disconnect there.

One of the top researchers in the field told us with all these fancy techniques--the experimentation with nuclear transplants, the cytoplasmic transfer-- we're reengineering the egg ... the goal is somehow to get the parents to believe that they're having a genetic child. We're basically rebuilding an egg ... explain that concept to me.

The industry is actually based on either a stated or an unstated premise, that it's better to have a genetic that is genetically related to you, than to adopt. That really, as long as you can get any genetic link at all to either parent, the mother or the father, that's ideal. Obviously it would be best if you weren't infertile and could have your own child. But infertility treatment ... is close to natural conception as possible.

Historically, we have always split off one's genes from another, with sperm donation first. Obviously, the father doesn't contribute genetically to that at all. The mother contributes her egg and gestates and gives birth to the child. With surrogate motherhood, there's always been a notion that you can hire a surrogate, but it's got to be either your egg or the father's sperm, all right? The woman who gives birth to it, the so-called gestational surrogacy, if it's not her egg, we try to act like she didn't exist at all. That it's the woman who contributed the egg, she's the mother.

Although with egg donation, we act the other way around. It's the woman who was at the clinic who gets the egg from the donor and gives birth to the child. Since she is your patient, she's the mother. And you hope the father, who contributes the sperm, so they have a child--either way you have a child who has some genetic link.

It's kind of a reification of the genes that have gotten carried away it seems to be that--but without that the clinics are essentially out of business. Cause they only exist for couples who insist the child have a genetic link to them.

But surely that is the wish of most all parents, that they can somehow a genetically linked child. This is using technology to somehow assist natural reproduction.

I don't know if it's the wish of all parents that they have a genetically related child or not. Many parents have adopted children that they're perfectly happy with and the children are perfectly happy. Many people with genetic are miserable, obviously.

There may be something to that. There certainly, historically, has been something to that when we were cavemen. There may have been some natural instinct to have your own biological child. I don't know how much we want to go by natural instincts now, but it is certainly true that the industry sells that to couples. They would basically say to them, either overtly or covertly, "Our challenge is to help you to have a child that's got some genetic link to one of you." But, to me, that's pretty artificial. That's the product they are selling and they wouldn't have a product to sell if they didn't have it.

But I think we put far too much emphasis on genetics, because since the majority of those couples are not going to have a child, they label themselves as failures, even though they could adopt and have a perfectly happy family. But they've now essentially been told that's really not an option. We've got technologies that can let you have a kid that has some genetic relations to one of you two, and that's what you should have. That's the best. Everything else is second best. It maybe not even worth doing. So unfortunately, it's a wrong message, but I also think it's a socially destructive message.

They would say they're not discouraging adoption, they're just giving more options to the parents.

Of course they're discouraging adoption. I mean, they don't say, "Go adopt first and then come to us for your second child." They say, "Come to us for your first child and if you want another one we'll try again, and then you can go adopt." But I can't believe that anyone in the industry would say that they're not discouraging adoption. You really have somebody on tape saying that? I can't believe that. Of course, they don't discourage you. They know that. I've never heard that with all of my years with these people. I've never head them say that. Never. They know what they're doing.

It appears we're currently at a place where the technology is allowing us to break certain barriers as we have accepted as the natural barriers in reproduction.

That's correct. One of the things these techniques do is permit people who can never have a child before to have a child. Post-menopausal women, for example. We now have post-menopausal pregnancies. Dead people. I don't think dead people can have children, but we can now use the gametes, the sperm and eggs of dead men and dead women to produce a child. We even haven't had a discussion about so-called posthumous reproduction. Should we ever? My own view is we should never use the gametes of dead people to have children. Again, from the point of view of the children, you're setting up a situation where their parents are dead and they can never meet their parents. What possible interest could children have in being produced that way, for example. What possible interest can a 63-year-old woman have in having a baby ...

In any event, all of these technological breakthroughs essentially make you make a choice that you never had to make before. Will you take advantage of this? Will you do this? And if you don't do it, you almost have to justify why you won't do it. "Why won't you have a baby for me?" Your husband might say, if you're in your 50s, it's possible now. Whereas, prior to that, it never had been possible, so it wasn't even an issue. You didn't have to justify your decision. There was no decision.

Many women are now being asked when their husbands die tragically in an automobile accident, "Do you want us to collect their sperm?" What kind of a question is that? And then if I say no, that means I didn't love my husband enough to have his baby after he's dead? What? I mean, that's just silly. We should just have a rule: No gamete collection after death. Period.

I want to go into some of the specific cases we have. It comes up again and again, this idea of where do you draw the line and how do you have the right and who has the right to draw the line? We don't limit people who can have babies naturally, who we know would be bad parents ... So how can we do it with people that need a little help to do it?

It's true that we don't limit the way people can procreate without assistance. But that's basically because we can't. We can't figure out a way to ... We'd love to license parents if we thought we could figure out what made a good parent. But the truth is we don't know.

But we do have some ideas of what can make a bad parent and what are bad motives to having a child. If you need medical assistance, and you are going to use the medical technology, then medical professionals have an obligation to set standards. To put inclusion and exclusion criteria, as they do for every medical procedure. It's not unfair and it's not society poking their nose into some private decisions. It only is common sense and standard medicine that we take steps to protect children that we're going to help create that aren't going to be made otherwise. That without our intervention wouldn't exist.

So obviously the medical profession may want to say we don't have any responsibility for the children. But that's nonsense. Of course they have responsibility, because they are the instrument that helps create these children.

With regard to the issue of a genetic line, basically, what's happening now seems to be one could have six people involved in making one baby through egg donation, surrogacy. Does that concern you that there is this genetic new patterning going on?

In general, the genetic mixture and the multiple parents doesn't worry me, except to the extent that we don't identify who the "parents" are with the rights and responsibilities to rear children very, very specifically.

So we know when the kid is born who its mother is and who its father is. For the kid's sake now, not for the mother and father's sake, right. Someone who is there to protect them, make decisions for them, is responsible to raise them ... We have to be very clear that the woman who gives birth to the child is always the child's legal mother, and her husband is always the child's legal father. Just that's the status. They can give the child up for adoption, etc., to protect children.

Secondly, we have to keep records for people who it matters. And it matters to most people, but not all, whose genetic background matters to them. That they know who their genetic mother is and who their genetic father is. So if they want to trace back their genetics, they're not tracing back the genetics of someone who is not genetically related to them, who they think is their "social" mother, their "social" father.

For the sake of children, again, we need a very specific social identification of mother and father. We need good record keeping, so children can trace back their genealogy genetically, if they want to.

... it raises an interesting question. Ultimately, it's complex. There's an awful lot we don't know, but it's happening ...Where do you stand on it?

We can make it happen better. I'm in favor of the new reproductive technologies ... as I'm in favor of almost everything in medicine and medical research. But I think we need rules and standards to protect the people involved. In this case, primarily to protect the children, but also to protect the infertile couples from exploitation.

We need two standards. A set of national standards that deal with the commercial aspects of the new reproductive technologies. And a set of state laws--and state law really governs family law matters and medicine in this country--that deal with the technical issues of who's the mother, who's the father, what records are kept, what screening is done, etc.

If we had those and we had decent standards in the industry, openness and some real enforceable rules then I, for one, would breathe a lot easier and think that children were protected. But I, certainly, wouldn't try to shut down the industry. That's not my goal. My goal is to make it act responsibly.

Egg donation has certainly been in the headlines. One of the concerns is that we're commodifying the eggs, and tempting women into doing this just to make money. When you talk to the egg donors, to the people that are involved, you realize that there is quite a bit involved in terms of time, hormonal issues, shots and potential risks. They deserve to be paid fairly well for all of that, don't they?

Well, the problem with egg donation, the problem with the [gamete] industry is we've developed a sperm donor model. It started with sperm donation--that was where as soon you got the sperm, you burned the records. You kept everything secret. You did everything for the best interest of the sperm donor. When egg donation came around--it's only been possible in the last few years--immediately people said we've got to treat women like men. Let's use the sperm donor model. We pay sperm donors. We'll pay women. Well, how much should we pay them?

There is a lot more involved with egg donation. You've got to take hormones usually a month or more--regulate your cycle. Have actual retrieval with a laperoscopy. There are risks--long term and short term risks. Well, let's pay them $2,000. How's that, you know? For awhile, that seemed to be fine. But very quickly the price has been bid from $2,000 to $4,000 to $5,000 to $10,000, most recently to $25,000 to $50,000. So we now no longer have the illusion that we're just paying women for their inconvenience. We now know we're paying them for their eggs.

The question is whether we should be doing that or not? Whether we should be "commodifying" eggs. It's a tough question in a country that commodifies everything. But actually we have some limits in this country. We don't commodify organs. It's actually a federal crime to sell your kidney, for example, or to sell any organ in your body, except your blood, your sperm or your eggs. It's time, that we sat down and said, "Well, maybe we shouldn't permit commerce in any of those things."

Because women are not like men. There is no risk in producing sperm. Most people, it's a relatively enjoyable experience, it's over very quickly, and we have an infinite supply. There's lots of risk in producing eggs. For me, the most corrupting thing is not the price--although the price is a problem--but the fact that the woman who is the "egg donor" or "egg seller," has no physician. The physician is retrieving her eggs is the doctor to the infertile couple. She is not treated like a patient. She's just treated like a street vendor, basically. Somehow it has nothing to do with this. That, to me, is terribly corrupting to the practice of medicine.

I know of no other place in the practice of medicine where a doctor does something to a live adult human being, not for their benefit, that puts them at risk. Medicine has never done that before. Here, they've done it without discussing it, without even talking about it. So, yes, there are major problems. Again, I think the most important problem is the infertility industry's inability to actually see and acknowledge what they are doing.

But if you limit the price, ultimately, it's the donor who is most affected. The couples would be thrilled; they have to pay less. The clinics would be thrilled, because it makes it more affordable.

All you're saying is if the price is too low, donors won't do it. I think that's right. What's wrong with that? I mean, we've limited the price to zero for kidney transplants, and heart transplants, and liver transplants. People are going to die if they don't get heart or liver transplant. Nobody's dying if they don't get an egg.

We have to look at the welfare of the people who are giving these eggs. To say that we can just ignore it, because we've got desperate infertile couples and are willing to pay for them is, again, the problem with the industry.

And now we find ourselves on the cusp of cloning. Do you think the industry will be able to not clone a human being?

Well, it's very interesting. The only thing the industry has ever taken a position against is human cloning. The industry's consistent position is if a doctor wants to do it and an informed infertile couple agrees to it, you should be able to do it. The exception has been cloning. Now, that's because there was a public outcry against cloning, and the industry thought if it said it was going to clone, for sure, they were going to get heavy duty federal regulation.

On the other hand, forget motives. At least, I would say that was a responsible position. I think that because for the industry to say cloning is reproduction essentially eradicates the whole field of infertility, because everybody has got somatic cells that can be used to clone--asexual reproduction. If that was considered a cure for infertility, it would essentially put them out of business. [By] definition, at least, because nobody is infertile if asexual reproduction is reproduction. So I don't the industry is ready to talk about that yet.

Until they get a position on that, they have to be against human cloning and they are. And god bless them. Now, that doesn't mean that no one physician out there or one clinic might not go ahead and try human cloning, because again, there is no law against it. And I think that's right. It probably will be seen as just impossible to contain yourself if a couple really wants to use cloning and is willing to pay a lot for it. There certainly going to be at least one infertility clinic in the United States that would be willing to do it, if we don't pass a law against it.

Is that the place where we are most likely to see cloning is in an infertility clinic?

Yes. It's almost or sure has to be inside of an infertility clinic, cause it has to be done with someone who knows how to manipulate embryos and how to implant embryos. It has to be a physician ... for it to have any chance to work at all, it's got to be a physician who is very knowledgeable in fertility treatment.

... are the skills of the infertility doctor the necessary skills for cloning?

Yes. There's two specific skills that infertility doctors have that are necessary for cloning. One is micro-manipulation of embryos. In this case, to take a human egg, to remove the nucleus, and then to replace that nucleus with a nucleus from a somatic cell, a body cell of the person who is going to be cloned. That's a technique that infertility physicians use in manipulating embryos. They don't use that particular technique, but they use other micro-manipulations that would permit that to do that one, too.

Secondly, and as importantly, is taking that embryo and implanting in the woman's uterus. That's not as hard to do as the other, but it's a technique, again, that infertility physicians do everyday. Or if not everyday, very often. They know how to do that. And then monitoring it to see if you have a pregnancy. That's what they do.

Other doctors don't do that. It would be very hard, and certainly no non-MD could do it. It would be practicing medicine without a license. For sure, the implantation is a practice of medicine. So only physicians could do it. I think that only people who have experience with manipulating embryos are likely to have any success doing it. So if cloning is going to be done, it's going to be done in an infertility clinic by an infertility physician.

We've seen the micro manipulation of ICSI. We have talked about cytoplasmic transfer, all of that. How close is that stuff to cloning?

It's close. You can do it well, you can't even do it reliably, except perhaps in mice ... [one] experiment took 273 tries. It was inconceivable that we'd have 273 women line up to be impregnated with the clones of one person. So I don't think we're close today. Now, if you said could we do it in the next five years, the answer to that is almost definitely, yes. Is it going to be possible to do it? We'll still don't know that. It looks like it is, because we've done it in three mammals now. The mouse, the sheep and the cow. That doesn't mean it can be done in humans. But it certainly means somebody will likely try to do it in humans.

Unless there is kind of an international outrage, and we have an international ban on it, someone will almost necessarily try to do it. On the other hand, one has to ask, what's the point? I mean the best cloning can do is give you a genetic duplicate of something that already exists. And besides the question--just look, I'm going to do it, cause I'm interested to see whether it can be done.

Other than that it's pointless, as most people have pointed out ... because you can't make anything better than what you have now. It's a genetic dead end. Again, all you can do is duplicate something that already exists. It's hard to see any rationale for that.

But to the infertile couple that has tried everything else, and this would be a very small group, it seems like it could be the next logical step up in a long stairs that they have already been climbing and committed to.

Well, cloning is not ... the argument is that an infertile couple might want to use this to reproduce. The problem with that is, this has nothing to with couples. Only one person will be reproducing. Even that person won't really be reproducing, they'll be replicating. They'll be getting a genetic copy. They can get one or more genetic copies.

It has nothing to do with infertility ... no one is infertile with cloning, all right. It has nothing to do with couple, because you don't have to be a couple to do this. It's just a technique to make a genetic duplicate.

The embrace of infertility by the cloning crowd is to try to cover their tracks. To try to say there is some good can come out of this. Infertility community itself has rejected cloning ... because it's not a treatment for infertility. In fact, the argument has been made by geneticists, that the parents of the clone are not going to be the infertile couple. The parents of the clone are the parents of the person who is being cloned. So, for example, if I clone myself, I would not be the parent of my clone, rather the genetic make up of my clone would come from my mother and father.

... So what does that mean? That means if an infertile couple is trying to have a genetically related child, they can't do it through cloning. They can have their brother or sister. But, the child they're having will be the child of their parents.

Technically, that works right, but to some of these couples, it would be splitting hairs. They just want a child ... Say your husband or your wife can't contribute, why go outside the family?

Well, if they think it's splitting hairs, again, it's the ability to rationalize anything. This kind of self-deception that says, "I don't care what the geneticists say. I don't care what the facts are. I'm having my baby and it's genetically related to me." Well, it's just not true. The fact you want to believe that bad enough and are willing to pay any amount of money to believe it and for people not to tell you the truth, again, shows the problems in the industry. The desperation of couples and their willingness to do "anything."

The next question to ask them--well, let's take the embryo we make from your clone and implant in a cow and let the cow gestate and give birth to it. If all they want is a genetic connection, they could have no real objection to that. But I think most people would be horrified at that and should be horrified at that. It's got to be more than just a genetic connection at making babies.

There is something amazing with this genetic connection.

Oh, yes. This is right. We're like now fastened on. We're in the genetic age, there's no question about it. Everything is genetics, for awhile, at least ... violence is genetic, cancer is genetic, your personality is genetic. And extreme exaggeration and reification of genetics right now, which is being played out a little bit in the reproduction area, as well.

You're saying that's not true.

Well, we know it's not true. We know that the environment has at least as much influence on your personality, what you do day to day, even your diseases, as your genes do. But we can't do much about the environment, so now we're thinking, well, maybe, we can manipulate these genes. That's where basically all of the research money in medicine is now going ... try to find disease genes and turn them on or influence them or turn them off ...

It's just like the genes is all that matters. It's what genes my kid has. It is a very strange way of thinking. I mean, that's true of the egg cells, too. I want an egg from a 5'10'' intelligent woman. There is like very little chance that the baby is going to be 5' 10'' or have the same IQ. It might, but it certainly might not, too. We put way too much stock in genetics.

But the infertility industry, of course, will reinforce, because that's all they can do is try to help you have a genetically related child. So the infertility industry has to say, "Well, yes, genetics matter a lot. And you really want a genetically related child, don't you?" I don't think it's so much the couple's saying that they want a genetically related child as the industry telling them that's what they have to have to be a real couple and have a real child.

In terms of cloning, the industry says it's not interested. Do you believe them?

Yes. I believe as an industry, because there is no money in cloning. There is no payoff in cloning. There may be a couple of people in the world who want to clone themselves. But virtually every couple that wants to have a baby wants a baby better than any of them. They really ideally want to mix their genes and have a baby that's a combination of the two of them.

I mean, that's how this industry got started and they know that. That's what they first try to do with in vitro fertilization. It's only later on if it turns out one of the two couples can't produce gametes that we go to trying to get donor egg or donor sperm or try to get somebody else's genetics involved. But you still try to get two people with genetics involved.

Just having a duplicate of one of the two in the couple, again, is not something there's a market for. There won't be a market for this until you can take the genetic duplicate and make it better. Take me, for example. Make me taller, you know, or stronger. Maybe someone will want to do that, but not just to make a duplicate.

There are some people, I guess, who are so self-absorbed that they'd like to see themselves be duplicated. But, so far, this guy [Seed] from Chicago is the only person to publicly say that. He'd like to duplicate himself. He says that he would like to see himself grow up and not make the same mistakes he made growing up. But that's certainly not a rationale to create a clone.

And again, if you look at it, as I think you have to, from the child's perspective, that's a terrible thing to do to a child. To have it born to someone who wants a duplicate and is going to try to raise that kid the way he should have been raised. To do the things that he should have done. Again, if you look at it from the child's perspective, you can't clone. You can't permit it.

We're making babies better. Their odds are better. We can do pre-implantation genetic diagnosis ... making babies the old-fashioned way, but better.

Well, no. Making them a new way for people who can't make them the old-fashioned way is really what we're doing. I mean, the industry hasn't gotten quite so far as to say that everybody should be a patient. Well, there are people that think the only responsible way to have a baby is with in vitro fertilization, so you can have your embryo screened to make sure it's got no diseases.

There is no question, in the future, if we run out of infertile couples and the industry gets big enough, you'll see them trying to sell that to every couple. That you don't have to be infertile to have in vitro fertilization. This is the only way you can have your embryo screened before implantation. You won't have to have an abortion then. If you have a baby that has a serious genetic defect, we just won't implant the embryo. I mean, everybody should do that. If we make a lot of embryos, just implant the best ones. That's your responsibility as parent to have the healthiest kid you can have and that's the way you do it.

A lot of these things are obviously improvements in some ways and certainly improvements on the situation of infertility. But one of the things that scares a lot of people is that we don't know what we don't know. That we will mistakes. That these children could develop problems 20 years later. Does that concern you?

What concerns me is, of course, there are all kinds of dangers that we don't know about and risks that we don't know about. What concerns me is not so much that they might come to pass--I mean, they most definitely will--it's that we are not doing any research on this. That we're not keeping data. That we're not tracking the kids or the couples that are the result of these techniques. We're just assuming that everything is fine. And the truth of the matter is as long as you don't look for problems, we hope we don't, won't find any. Ones won't find us. That's an irresponsible thing for the industry to do.

What do you mean that we almost definitely will find problems?

... there are problems in society, in general, with children and child rearing. There have to be at least that number of problems in the infertility industry. It can't be that every couple that's had babies with IVF is happy and everything is wonderful.

We know from sperm donation, for example, case after case, where the children report it themselves. When the couple divorces, for example, and the child is in their teenage years. There's one famous case. A woman wrote about this in The New York Times magazine--when she was devastated. She was 17 when her parents divorced. Her father just got really angry with her one time and said, "What are you so upset about. I'm not your real father, anyway." And she spent like the next 15 years trying to locate her "real," her genetic father. The last time I'd heard the story she'd narrowed it down to one medical school class in California. But that kind of thing is predictable. You know that's going to happen. You know it's going to be devastating to the child.

... If you could only have a genetic link to one parent--there's a very interesting question about whose egg or whose sperm you use for the other parent. Historically, in sperm donation, we just tried to match the father. Tried to get a donor that looked like him. Actually, just matched him for looks. The trend now is to try to get sperm that's better than the father, or an egg that's better than the mother. To get someone who is taller, smarter, more athletic. You have to really wonder what's going on here?

It seems to be what's going on here is marketing of characteristics and trying to say, look, we know tall people are better than short people. Smarter people are better than stupider people. We'll try to get the best genetics your husband can possibly provide, even though it's not from him. And we're going to give a superior kid. Not just an average kid.