Making Babies

Copyright

Copyright © 2009 by Sami S. David, MD, and Jill Blakeway, LAc

All rights reserved. Except as permitted under the U.S. Copyright Act of 1976, no part of this-publication may be reproduced, distributed, or transmitted in any form or by any means, or stored in a database or retrieval system, without the prior written permission of the publisher.

Little, Brown and Company

Hachette Book Group

237 Park Avenue, New York, NY 10017

Visit our website at www.HachetteBookGroup.com

www.twitter.com/littlebrown

First eBook Edition: August 2009

The information herein is not intended to replace the services of a trained health care professional. You are advised to consult with a health care professional with regard to matters relating to your health, and in particular regarding matters that may require diagnosis or medical attention.

A complete list of references is available at www.makingbabiesprogram.com.

Little, Brown and Company is a division of Hachette Book Group, Inc. The Little, Brown name and logo are trademarks of Hachette Book Group, Inc.

ISBN: 978-0-316-05322-8

CHAPTER ONE

Modern Fertility Medicine: The Risks and Overuse of (Sometimes) Terrific Technologies

Pamela had been through ten cycles of in vitro fertilization (IVF) at three different centers but had never been pregnant. Some of the best fertility doctors in New York had told her she was too old (39) and probably had "bad eggs."

Over the course of ten years of trying to have a baby, Evelyn's doctors had pumped her up with a total of fifty cycles of fertility drugs, really strong ones. She'd made hundreds of eggs, but still she wasn't pregnant. Not one of the four doctors she'd seen had ever stopped to ask why she wasn't getting pregnant.

Stephanie took high doses of fertility drugs in preparation for her first IVF cycle at the best clinic in the city. The doctors harvested lots of eggs, made nine embryos, and discovered on testing that every single embryo was genetically abnormal. Although they'd been willing to give IVF a try with her, they now told her there was nothing more they could do because of her age (41).

The good news is that, in the end, all these women got pregnant and had babies. The bad news is that they underwent difficult, unnecessary, and futile treatments before anyone figured out why they weren't getting pregnant and what to do about it. The worse news is that these women are not exceptions to the rule. The way fertility medicine is practiced today routinely generates stories like these.

Reproductive technologies also create a lot of expanded families, and we never want to discount the blessing that can be. What we long for is a new era in which technological successes will be unadulterated blessings, because the technology will be offered and used only when it is necessary. Everyone else will be able to get the appropriate help they need to conceive and bear children as naturally as possible—because that's what's gentlest, safest, and often most effective, even in the face of some serious fertility issues.

One in 100 babies born in the United States today was conceived with the help of assisted reproductive technologies (ARTs), according to the American Society for Reproductive Medicine (ASRM). Worldwide, more than 3 million babies have been born who were conceived through IVF—more than 400,000 of them in the United States. Each year in this country, 250,000 families consider IVF, and about half of those give it a try. They do so at their pick of 461 clinics nationwide.

The numbers have skyrocketed since IVF technology was introduced three decades ago. The number of ART births more than doubled between 1996 and 2002. A Centers for Disease Control (CDC) report from 2004 counted almost 50,000 babies born after ART interventions in this country that year. Just six years earlier, the figure was 28,000—and that was announced as evidence of the rapid growth in the use of these technologies. Over time, the nature of the industry itself has changed as dramatically as the number of babies born as a result of it, with ART morphing from an option of last resort, available to only a few, to the first choice for every player in the game.

We both celebrate regularly with patients who bring home babies thanks to amazing technological interventions, and we are always glad to do so. And we are both grateful, professionally speaking, to have something to refer patients to when our areas of expertise can't address their needs. But the sad truth underlying the good news is that ARTs, and in particular IVF, are frequently misused, grossly overprescribed, and too aggressively administered. We've arrived at this place because of a culture, both in society at large and in reproductive medicine in particular, that always goes for the quick fix regardless of other options or possible consequences, emphasizes personal gain, and values technology for its own sake. Added to that grim picture are the risks and side effects of the procedures themselves.

Based on our experience with thousands of patients coming to us in various phases of fertility treatment, as well as on what we hear from our colleagues, we estimate that as many as half of all women who receive IVF could conceive naturally or with minimal medical intervention. This is not just a theoretical best-practices argument. The consequences of fertility treatment for women, couples, and families are immense—even when they succeed. When they don't succeed, that failure adds another layer of heartbreak to an experience that is already extremely stressful physically, emotionally, and financially. Proud parents of babies born thanks to ARTs will say that it was worth everything they went through. But the more important point is not whether it is ultimately worth it, but whether it was necessary.

These technologies can be miracle makers, but they must be used wisely to be used well. As a society, we are not yet applying that wisdom. There is a better way, modeled by the Making Babies program. This is it in a nutshell: use all options available in their proper place and time, with a preference always for what's closest to the way nature intended and what's best (and most likely to work) for the patient. The truth is, with careful diagnosis, basic fertility education, and simple but detailed diet and lifestyle advice, many women using ARTs could conceive much more naturally. If any drugs or other interventions turn out to be necessary, minimal doses and least invasive procedures can be used, minimizing risks as well as unpleasant side effects—all while increasing success rates.

The stories that opened this chapter ultimately illustrate the possibilities.

Pamela, who'd had ten IVF attempts and a diagnosis of "bad eggs," also had scar tissue from having fibroids removed, which was effectively keeping her eggs from getting into her fallopian tubes. She'd started IVF to get around the scar tissue—a common approach. But clearly something about the IVF wasn't working for her, even if it was circumventing the obvious roadblock. When she came to see me (Sami), I couldn't find any other issues to explain her problem, so I recommended surgery to clear away the scar tissue. (The same laparoscopic procedure can diagnose and correct this problem all at the same time.) Two months after I performed the surgery, Pamela was pregnant, with no drugs and no IVF.

Evelyn, who'd been treated with fertility drugs since before her 30th birth-day, finally became pregnant at age 40 after a single course of antibiotics cleared up a mycoplasma infection in her cervical mucus. Two years after her daughter was born, she went on to have a son with no treatment and no delay.

Stephanie, all of whose embryos had tested genetically abnormal, fit into a pattern we have seen all too often: high doses of injectable fertility drugs predisposing eggs in older women to develop chromosomal irregularities. Stephanie had been given too many fertility drugs for a woman of 41. My (Sami's) approach was to recommend a much lower dose of essentially the same drugs. This time, her eggs and embryos were perfectly normal—and so is her young son.

It is not our intention to set anyone's mind against IVF or any other ART. But we do want anyone who goes that route to do so with eyes wide open—and to know, before he or she heads down that road, that there are many other ways through the forest that are easier, safer, quicker, and cheaper. They all end up in the same place, so the difference between what exists now and the world you envision is understanding that you have a choice, including, but not limited to, ART. So before we get into the details of how to do this right, let's take a bit of time to look at what's wrong with the way it's done now.

PATIENTS WITHOUT PATIENCE

We're about to pin a lot of this on doctors and the infertility industry, but consumers of these services need to take a look at their own behavior as well. Most couples, their hearts set on having a baby and with an acute sense that time is of the essence, want the fastest solution possible. Many feel that technology is their only choice. People struggling with infertility may feel vulnerable and desperate enough to try anything that promises they'll have a child, without doing any of the due diligence and critical thinking they'd apply to making a decision in any other area of their lives. Their doctors bear much of the responsibility, of course, but lots of couples accept IVF without examining other (and usually far better) options.

There are also plenty of people treating IVF more or less as a lifestyle choice, or as just another modern convenience. No room in the schedule for well-timed sex? Let the lab take care of the details! Long-distance relationship? Ship sperm overnight! In certain populations, the culture downplays or ignores the reality of fertility diminishing with age, with an unspoken and maybe even unconscious reliance on technology to bail out those who simply wait until it is too late to conceive naturally. There are plenty of good reasons to delay child-bearing. But doing so is not without risks—the risk of never being able to conceive and/or the risks you expose yourself and your baby to in the use of technology. The plain fact is that many people who do wait (and wait, and wait) before trying to get pregnant don't really do so for hard-and-fast reasons. For too many people, when they are faced with the reality of infertility, in hindsight their reasons for waiting no longer seem compelling.

Although it is true that fertility is not an area where you want to drag your feet in finding a solution, that does not mean that everyone should jump immediately to the most drastic measures. No one should do so without knowing his or her diagnosis and options, with the pros and cons of each. Some people have more time to work with than others, but everyone can confidently take three months to explore the possibility of conceiving as naturally as possible with the Making Babies program. We've devised the program to be as efficient as it is effective. And even if the program itself is not sufficient in your case, it will thoroughly prepare you for the next steps, physically and mentally, giving you the very best odds of success as you move forward.

DOCTORS WITHOUT PATIENCE

Lest anyone think we are blaming the victim, we now want to give the medical profession its due. We've watched from inside the industry as it has experienced explosive growth over the past three decades. And we are sad to report that too often the culture of modern fertility medicine harms more than it helps.

Because infertility patients are so often vulnerable and desperate, they are also easy to persuade—and some doctors take advantage of this dynamic. Driven by patient pressure for a quick fix, financial pressures, overenthusiasm, greed, or just plain thoughtlessness, they are steering women immediately toward drastic medical interventions and unnecessarily exposing patients to the expense, stress, and risks of IVF. Doctors often fail to produce a working diagnosis for their patients and often consider even an established diagnosis as irrelevant in the face of technology. Many fail to identify, explain, explore, and evaluate all options available to couples.

Money has corrupted health care across the board, and nowhere is that plainer than in fertility medicine. It's become an industry more than a field of medicine, and a highly commercialized one at that. Highly profitable tests and procedures are performed at ridiculously high rates, at times with no proven benefit to the patient (though the financial benefit to the doctor is high). As one patient who is an advertising executive remarked to us, "Fertility doctors are masters of marketing." That's definitely not the area of expertise you most want from your health care professional.

Some fertility doctors overmedicate patients, fail to tell patients about the downsides of fertility treatments, neglect to offer other (less profitable) treatments that may work just as well and/or be less invasive, turn away candidates they perceive as more difficult cases (because they rely on their success rates as a marketing tool), and, in the rare extreme case, perpetrate outright fraud, such as the swapping of embryos.

There are plenty of talented, well-intentioned practitioners out there, of course. Yet even they reap enormous profits from the aggressive use of technology, and it's the rare one who stands against the current. Furthermore, the irresponsible practitioners among them smear the whole profession. Even if all infertility doctors were good ones, the industry itself is woefully underregulated. Indeed, the way infertility treatment is carried out today is problematic in many ways.

WHAT'S WRONG WITH YOU?

Most of the patients who come to see us have already seen at least one fertility doctor. When we ask new patients, "What's your diagnosis?" eight out of ten of them say they don't know. But what is truly appalling is, neither do their doctors. The way fertility medicine runs these days, the diagnosis is seen as almost inconsequential. Why figure out why she's not getting pregnant, the thinking goes; we're just going to give her drugs anyway. Or, I don't need to know if he's making healthy sperm in normal amounts; we'll get enough to combine with the eggs for IVF. The general attitude is that doctors are more powerful than nature and can simply force a woman's body to become pregnant.

This is not good medicine, and we find it offensive. Even if we could put those things aside, however, this approach simply makes no sense. If the sperm count is low, why not try one of the easy fixes that may be possible rather than jumping straight to serious intervention? And if the sperm aren't healthy, do you really want to use them to fertilize hardwon eggs for IVF? The only function of fertility drugs is to make more eggs release. They won't help a bit if the problem is bad sperm, an infection, or something toxic in the environment. You can pump out as many eggs as you like, but if the sperm can't get to them or penetrate them, or the body can't implant them or keep them once they're implanted, it's not going to get you any closer to having a baby. Fertility drugs can get more eggs released, but they can't make a woman more fertile.

The first order of business must always be to find out why someone is not getting pregnant. Roughly 10 percent of all infertile couples will not be able to find out why they cannot conceive. The medical profession is left to shrug its collective shoulders and explain to these people that they are something of a mystery. They are offered ARTs, but without there being a clear idea of what is being fixed, the outcome remains uncertain. It is impossible to determine the best course of treatment without the crucial insight of just what is wrong. What works for someone with blocked fallopian tubes is not going to work for someone with a bacterial infection that's preventing implantation, and what works for that person is not going to help someone who simply doesn't know when she is ovulating or how best to time intercourse.

THE MISUSE AND OVERUSE OF IVF

The culture among both doctors and patients has led fertility medicine in general astray, but the effect is most glaring when it comes to IVF. We'd argue that even in the best practices, IVF is used too often, is insufficiently considered, and is too harshly pursued.

As in all areas of medicine, fertility practices are getting more and more specialized, and so we have plenty of clinics devoted solely to IVF. Psychologist Abraham Maslow famously wrote, "If the only tool you have is a hammer, you tend to see every problem as a nail." These days, IVF doctors are pounding nails just as fast and as hard as they can.

Often women are run through IVF clinics like cattle. Doctors know their treatment strategy before they even meet a particular patient. Doctors make themselves too busy, then don't have enough time to spend with each patient. Many doctors are more concerned with their own success rates than they are with their individual patients. Most IVF doctors go all out to convince a woman that they can make her pregnant. Then, if it turns out they can't, they blame it on her, telling her that her eggs are "bad." The big guns are always drawn first; there's almost never an effort to try every basic thing that makes sense for a particular patient before proceeding to more drastic measures. It's the rare woman who walks into one of these practices and isn't told she needs IVF (at thousands of dollars per cycle). That's like everyone who consults a cardiologist being told that he or she needs heart surgery.

On the flip side, many women are turned away from IVF treatment but never presented with any other options, with the possible exception of donor eggs. The system has mostly given up on women with high levels of follicle-stimulating hormone (FSH)—levels that generally increase with age—on the theory that they probably won't respond well to the standard treatments. Imagine oncologists refusing to treat patients who "probably" won't respond to cancer treatments, picking and choosing whom they will treat based on the likelihood of quick success. Yet many fertility practices seem to have no qualms about turning away less likely prospects. They always have one eye on how they'll look on paper, focusing on the stats they have to report each year to the government, for publication. If you've already started the process of ART yourself, you know just what we're talking about. What was the first thing you did when choosing a doctor? Bet you anything it was look up the relevant batting averages.

All this despite the fact that FSH on its own is not a good indicator of fertility prospects (see page 216), although it may predict possible IVF failure. There are many other options for women with high FSH that might allow them to conceive naturally or prepare their bodies so that IVF may indeed work for them. It's become a familiar story: a woman walks into one of our offices frantic over what other doctors have said to her, panicked that she'll never have a child (often because she's been told she'll never have a child), and within months she needs to go back to her ob-gyn—for prenatal care.

PLAYING GOD

In the early 1980s, I (Sami) was the first doctor to successfully perform IVF in New York. I was working as part of a team, but I was the one who actually extracted the eggs and then implanted them once they were fertilized. I placed the cell cluster that was to become the first baby born in the city conceived outside the womb.

And I didn't like it.

I felt like I was playing God, and that just wasn't right for me. I didn't like holding life literally in my hands. It was a kind of surreal experience, still vivid in my memory: the embryologist over my left shoulder, handing me a syringe with three air bubbles in the fluid, telling me that there were four embryos between the bubbles. I just kept thinking, These are babies inside this little syringe.

I can't think of anything more satisfying than helping people who want babies to have babies, but I knew that day that this wasn't going to be the way for me to do it. I understood that I was in the middle of a major revolution for medicine—for humanity—but I also understood that I couldn't be part of it any longer. Not that way.

My professional peers by and large saw it differently. Although our training was fundamentally the same, almost all of them made a full conversion into IVF-oriented practices. And for that, I'm often grateful: they're there when I need to refer a patient, and there are a whole lot of children in the world thanks to them.

But the shift in the field of reproductive medicine to focus so intensely on IVF is a decidedly mixed blessing. It has reached an extreme of specialized practices run like fertility factories with one-size-fits-all treatment strategies, where doctors decide on treatments without knowing what they are actually treating. It's like treating a symptom with-out looking to discover the disease that's causing it. In the process of this upheaval, we've forgotten a lot of what we once knew, and we've been blind to better solutions, old and new.

In my practice today, I focus on medical and surgical treatment of infertility in women of all ages, specializing in recurrent pregnancy losses and women over the age of 39. I consider myself a traditional doctor. Some might say "old-fashioned"—I've made house calls—but I've got a number of cutting-edge techniques in my repertoire as well. I'm a surgeon, but I approach infertility first medically, then surgically if necessary. I take only about 10 percent of my patients into the operating room. The way I see it, the less invasive a treatment is, the better (of course, it still has to work). I don't put anybody on fertility drugs unless I have to, which turns out to be less than half the time. And when I do prescribe fertility drugs, I use only one-quarter of the dose most IVF docs do. Some couples I see need drugs, but not fertility drugs—they need antibiotics or steroids. Some benefit from simply taking over-the-counter cough medicine or plain old aspirin. Some of my patients simply need to douche with baking soda before intercourse.

I'll do whatever works best for the patient, even referring for IVF—but only for people who really need it. My preference is always for the gentlest option that will be effective. When the more natural ways don't work, I'm all for making use of more aggressive interventions. Almost always, good medical detective work will uncover the cause of a patient's infertility and so reveal the appropriate solution. And despite what you'd think if you walked into just about any IVF clinic in this country, the solutions don't often involve major invasive interventions.

WHAT'S THE PROBLEM?

IVF is just the most widely used—and the most widely overused—ART. Other techniques are overused as well—and patients are charged even more for them—including genetic screening and intracytoplasmic sperm injection (ICSI), both of which are discussed in chapter 25. ARTs in general have a significant physical, financial, and emotional impact on any couple. The drugs and techniques used pose short- and long-term health risks for the mother and the baby, on top of producing unpleasant (if transient) side effects. Many are not covered by health insurance. Even if they are covered, patients may bear a high proportion of the costs out of pocket. Psychological stress and emotional problems are common—even when the procedures are successful, and even more so when they aren't. That's in addition to the plain old physical stress of going through the procedures. Among other things, treatment disrupts people's personal and professional lives. Appointments (and there are a lot of them) may be made for the convenience of the doctors and staff rather than the patients. In any case, they have to be squeezed into already very full lives. If you go to a fertility clinic at six in the morning, you're likely to see women lined up there already, waiting to get their blood taken or have a sonogram. All in pursuit of a goal that's anything but a sure thing.

Even if IVF were always carefully considered and judiciously recommended, it would still be a mistake to rely on it as completely as mainstream fertility medicine does, simply because the odds are so great that it won't work. Success rates have greatly improved since the dawn of the IVF era and are inching up each year, but, even so, the chances of having a healthy full-term baby after one cycle of IVF hovers at around 30 to 40 percent (and generally varies between roughly 10 and 50 percent, depending on the age of the mother). One of the best IVF programs in the country, for example, sends about 47 percent of patients under the age of 35 home with a baby in any given IVF cycle. The best program and the most-likely-to-succeed patients—and still patients get what they came for less than half the time.

WHY RISK IT?

The possible health risks of many fertility treatments are often glossed over—and not just by doctors who don't want to emphasize them, but also by patients who don't really want to think about them. The risks are an important part of the big picture, however. They are small but real. Negative effects on both mothers and babies are seen more frequently in children of ARTs than in naturally conceived babies. If you've already tried any of these techniques, we want you to keep these risks in perspective. In fact, everyone should keep them in perspective, because there may come a time when these are