Born in the USA (18 page)

As an example of how badly misinformed some prominent obstetricians are about Cytotec and how this can lead to false information getting to the public, on May 6, 2004, the CBS affiliate in San Francisco, on its evening
news (I-Team) aired a segment on Cytotec. While preparing the segment, CBS interviewed Dr. Ben Sachs, chief of obstetrics at Beth Israel Hospital in Boston, who said that Cytotec had been approved for induction of labor at term by the FDA in 2002. Because I already had been interviewed for the same program and had told the journalist that the drug was not approved by the FDA for this purpose, CBS contacted the FDA and was told that Cytotec had never been approved by the FDA for labor induction. So the news segment begins with Dr. Sachs saying that Cytotec is approved by the FDA, and then a few minutes later in the same segment, Dr. Sachs is told that the FDA had just told CBS that it is not approved and the journalist then asks Dr. Sachs if he still thinks it is approved and he responds: “As far as I know, that is the case.” He won't back down on camera even when presented with the facts. The public should never receive such misinformation.

Because such a misunderstanding appears to be common among obstetricians, a meeting was held at the FDA offices in late 2004 (which I attended) to discuss methods the FDA might employ to more clearly inform both doctors and the public that the FDA does not approve Cytotec induction. As a result of this meeting, the FDA put an item on its Web site in May 2005 clearly explaining that it has not approved Cytotec for the induction of labor and urging any physician who uses Cytotec on a pregnant woman to fully inform her of the risks, including uterine rupture.

Try to imagine how many hours and how much money ACOG has spent trying to get the FDA to approve Cytotec for labor induction. If the FDA would only approve it, ACOG could finally recommend it and satisfy its members. All this effort, and yet there has been no carefully controlled study showing that it saves lives. On the contrary, the FDA and Searle continue to receive reports of women and babies dying from Cytotec induction. ACOG's campaign to win approval for the use of Cytotec for induction is baffling, but at least it does serve the organization's primary purpose, protecting the interests of members. (It certainly does
not
serve ACOG's secondary purpose, promoting better health for women and babies.) What is even more baffling, however, is why obstetricians would
want
to use this drug for induction. For those cases where there is a solid medical reason for inducing labor, there are several other drugs that have been adequately studied and are FDA-approved for that use. There is no urgent need to use Cytotec, and yet doctors want to use it, so ACOG must campaign to get it approved for this use.

An often overlooked issue with Cytotec induction cases that precipitate litigation is whether or not the woman has been told the whole truth about
the drug and asked to give her consent before it is administered. In the sixteen cases with which I am familiar where Cytotec induction led to an adverse outcome and litigation—cases where the outcomes included braindamaged babies, dead babies, dead mothers, or a combination of these—the day the family discovered that the drug was not approved by the FDA for labor induction was the day they picked up the phone and called a lawyer.
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On the
Dateline NBC
television program on Cytotec that aired in November 2001, when the obstetrician representing ACOG was asked: “Does the doctor tell the pregnant woman [getting the drug for induction] ‘just so you know, this drug is not FDA-approved for this purpose'?” he replied, “A doctor has to exercise his or her own discretion in deciding just how much the patient needs to know about specific approval by the FDA.” This attitude is patronizing—as your doctor, I will decide what you, the patient, need to know. This is not fully informed choice but “selective informed choice.” Legislation in nearly every state requires that informed choice in medical practice be inclusive of all known facts, and the FDA strongly recommends that patients receiving drugs be fully informed.

The decision to induce labor is not one that should be taken lightly. To quote a highly respected obstetric textbook: “
The decision to bring pregnancy to an end is one of the most drastic ways of intervening in the natural process of pregnancy and childbirth
[emphasis mine]. The reasons given for elective delivery (which may be achieved either by inducing labor or by elective cesarean section) range from the life-saving to the trivial. There has been very little methodologically sound research on the indications for elective delivery.”
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There are certain specific conditions under which inducing labor has been shown to save lives—serious intrauterine growth retardation (the baby is too small for its gestational age), documented placental malfunction (the placenta is losing its ability to adequately nourish the fetus), and deteriorating preeclampsia (a serious condition with rising blood pressure).
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“Macrosomia” (the baby is too big) has also been used as an excuse for induction, but data do not support this. Instead, research shows that more C-sections are performed when labor is induced in cases of macrosomia, with no improvement in perinatal outcomes. Indeed, induction in this situation is contraindicated, as trying to hammer out a too large baby can harm the baby.
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Having the bag of waters break before labor begins means that the baby and the womb are no longer protected from germs and infection may
occur (a condition known as premature rupture of membranes or PROM), but there is disagreement about how long it is safe to wait for spontaneous labor once the waters have broken. The consensus used to be twelve hours, then twenty-four hours, and now studies show that under certain conditions, it is safe to go forty-eight hours or longer if there are no signs of infection. (Several prospective studies have shown that practicing “expectant management”—that is, administering antibiotics immediately and waiting for labor to begin spontaneously—does not increase the risk of infection.)
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However, even if we add PROM to the list of indications for inducing labor, the indications still apply to only a small percentage of pregnancies.

The big debate today regarding inducing labor surrounds “post-term” pregnancies, or rather the point at which we can say that a pregnancy has gone too far beyond the normal due date of forty weeks' gestation. Of course, birth can never be predicted down to a specific day. Rather, an estimate is made of the expected due date (EDD), based on the last menstrual period and/or ultrasound scans during the pregnancy, and the expectation is that the birth will happen
around
that time. Spontaneous birth between thirty-eight weeks and forty-two weeks is a perfectly normal variation. There is normal variation found with all biological events. In the case of human childbirth, the normal variation is two weeks on either side of the EDD, and babies born in this time period have no increased risks.

A study published in 1963, using data from 1958, found that the number of babies who died in the uterus before birth increased slightly after forty-two weeks and then increased significantly after forty-three weeks.
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After this study, there was a trend toward inducing labor if a pregnancy went more than forty-two weeks. However, only about 3 percent of pregnancies go beyond forty-two weeks. If we add “post-term” pregnancies to the list, that brings the total of scientifically valid medical indications for labor induction up to around 10 percent. Interestingly, that is just about what the rate was in the United States until about fifteen years ago, and it is also what the induction rate is now in many industrialized countries with excellent birth outcomes.

Induction is a good example of an unfortunate characteristic of obstetric practice—a bandwagon effect whereby doctors jump on and the wagon gets going faster and faster, until everyone is afraid to get off. In 1982 and again in 1989, sound research was published that found no significant increase in neonatal mortality rates after forty-two weeks and only a slight increase after forty-three weeks, but the induction bandwagon didn't slow down at all, it just kept going faster and faster.
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In 1996, a valid study was published that looked at 1,800 postdate pregnancies (pregnancies that went beyond forty-two weeks) and found no increase in baby deaths as well as no increase in complications compared with births of babies born “on time” at between thirty-eight and forty-two weeks.
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But the bandwagon kept right on rolling. Small studies that show that inducing postdate pregnancies, rather than simply waiting for labor to begin spontaneously, resulted in slightly fewer C-sections are frequently quoted as a reason to induce, but these studies do not show that induction reduces the numbers of dead or damaged babies, only that it lowers the C-section rate slightly. (The risks of induction are generally understood to be less than the risks of C-section, so these studies are used to justify induction.)

Induction reveals another characteristic of obstetric practice as well—a fear factor that often leads to a creeping overreaction in obstetricians. There seems to be a belief that if a little bit helps, a whole lot is even better. Induction was first done only at forty-three weeks' gestation, but before long it was being done at forty-two weeks, and now it is creeping to forty-one weeks. Now we're in big trouble, because forty-one weeks is entirely within normal pregnancy limits, and when we start inducing at forty-one weeks, we put large numbers of normal pregnancies at risk with an unnecessary procedure. At this point we have a situation in which the treatment is worse than the disease.

The truth is that only about 10 percent of babies at more than forty-three weeks' gestation get into trouble, but instead of treating these cases appropriately, we now induce labor long before the pregnancy gets to forty-three weeks with a powerful drug that has serious risks for both the woman and the baby. In investigating litigated cases of a baby or a woman dying as a result of an induction, it is common to find “postdate” on the woman's chart as the indication for induction. When we look more closely at the chart, however, it is common to discover that the pregnancy was not postdate at all but was only at 41 1/2 weeks or even 4 1/2 weeks. Claiming that the pregnancy was postdate allowed the doctor to do the induction he almost certainly wanted to do anyway for his own convenience.

When an obstetrician sets out to convince a pregnant woman to consent to an induction, he is almost always successful. All he has to do is communicate his own fears by conveying directly and indirectly all that might go wrong with a natural birth. The baby might suddenly die in the uterus. The baby's heart might suddenly stop. All these tests we're doing are to make sure that the baby is okay. When the woman is finally asked to sign an informed consent form, the form is likely to list every disaster that might
happen if the induction is
not
done, but it does not list every disaster that could result from doing the induction.

So when the doctor suggests induction, the idea is appealing to the woman because it appears to end a dangerous situation for the baby—remaining in the womb. Women are rarely told that every day the baby remains in the uterus, it grows bigger and stronger and becomes less likely to develop complications during the birth. They are rarely told that a woman's body knows when the baby is ready. Women are not told that only 3 percent of pregnancies, if left alone, will go beyond forty-two weeks and that only 10 percent of those babies past forty-three weeks get into trouble—10 percent of 3 percent = 0.3 percent of babies will get into trouble.

Yet in the United States we are inducing labor in more than 40 percent of all pregnancies. It's like taking a baseball bat to a mosquito. The obstetrician's fear that a pregnancy will have trouble if it goes “too long” dovetails nicely with the great convenience of being able to schedule an induction.

As mentioned earlier, a Maternity Center Association survey found that in 2004 we were inducing labor in 44 percent of births. If we add to this the 16 percent of cases in which drugs are used to stimulate or speed up a labor that has already started (augmentation), the total number of pregnancies in which powerful and dangerous drugs are used is 60 percent, or nearly two-thirds of all births.
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It is ridiculous to think that two-thirds of American women have such lousy uteruses that they must be whipped into shape with drugs in order to have babies.

The widespread use of Cytotec for labor induction without adequate evaluation appears to be impervious to the usual methods of quality control in health care. The FDA, the pharmaceutical industry, scientific opinion, and peer review have all failed to significantly slow down, much less stop the Cytotec epidemic. That leaves two last methods of quality control—educating the public and litigation.

At this stage, it is very important to discuss Cytotec induction in the media. Women and families need to know the truth about this drug, so they can “just say no” when an obstetrician offers it.
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But there has been little or no information made available to the public, in large part owing to “tribal loyalties” among doctors. Many obstetricians are aware of the problems with Cytotec, but they will not speak out in public. Most give journalists the “party line” about how good the drug is. Investigative reporting has become essential in protecting women and babies from dangerous obstetric practices. Already one national television network in the United States has done a program on induction with Cytotec, as has a national
Canadian network, and several regional affiliates have reported on the issue. Highly critical newspaper, magazine, and Internet articles have appeared as well.
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Let's hope that our media will continue to spread the word and that eventually their efforts will result in changes.