Born in the USA (16 page)

Then, in June 1999, two more papers appeared in the same issue of the
American Journal of Obstetrics and Gynecology
, reporting alarming rates of uterine rupture when Cytotec was used for induction in women with previous C-sections.
¹⁴
In one study, 5.6 percent of women having VBACs induced with Cytotec had uterine rupture, and in the other study the rate of rupture was 3.7 percent. This is a twenty-eight-fold increase in the rate of rupture over having a VBAC without Cytotec induction. Furthermore, for one-quarter of the women who had uterine rupture, this resulted in the deaths of their babies.

Several months after these papers were published, ACOG came out with a recommendation that Cytotec not be used for induction in women who had previously had C-sections—shutting the barn door after thousands of horses were gone. It can be estimated that during the five years before ACOG finally made its recommendation, more than 25,000 women in the United States who had previously had C-sections were given Cytotec induction (see
table 5
). We can further deduce that more than 1,000 of them suffered ruptured uteruses, and between 50 and 250 ended up with dead babies. Though we do not have hard data on the number of maternal deaths caused by giving Cytotec to women with previous C-sections, we know enough about uterine rupture to know that probably ten to twenty women died from uterine rupture caused by Cytotec induction.

Strangely, obstetricians in the United States remain in denial about the tragedy Cytotec induction represents. In
chapter 2
, I mentioned a
Dateline NBC
television program on Cytotec induction of labor that aired on November 4, 2001. Alisa Goldberg appeared as a guest on the program, among other guests. She had just completed her obstetric training at a reputable hospital and was working at the National Institutes of Health. She was also the senior author of a paper on Cytotec induction published in a prestigious journal.
¹⁵
The following dialogue took place between Dr. Goldberg and the interviewer:

Interviewer: “Do you think five years ago [i.e., 1996] doctors knew enough about Cytotec?”

Dr. Goldberg is unable to give any answer. She sits twisting in her chair and smiling.

Interviewer: “Do we know enough now about Cytotec?”

Dr. Goldberg: “We are still fine-tuning. I think there is still more to be learned. That's the way medicine evolves.”

Interviewer: “But should we wait until after we learn it before we say it is safe?”

Dr. Goldberg: “It's a catch-22. If you don't use it, then you don't learn.”
¹⁶

Of course, Dr. Goldberg could not respond to the question about whether we knew enough about Cytotec five years earlier, because if she said that we did, she would have to address the fact that it was only since then that we learned that the drug must never be used on women with previous C-sections because of the extreme risk of uterine rupture and the certainty that Cytotec has caused women and babies to die. If she said that we did not know enough, she would be condemning hundreds of her fellow obstetricians who were using this drug for induction five years earlier.

In effect, this obstetrician freely admitted on television that a vast, uncontrolled experiment is taking place on unwitting women without their knowledge, much less their consent, and there was no indication she felt remorse about that fact. Apparently, she saw no problem with using women as guinea pigs, most of the time in an unscientific way, without telling them. When she said, “If you don't use it, then you don't learn” (a classic anti-precautionary position), it was as if she had never heard of officially approved, carefully designed, controlled experimental trials in which the women involved give their informed consent. In other words, it sounds as though in obstetrics, valid science is dead.

You can be sure that this obstetrician is by no means alone. In 2005, five obstetricians from a prestigious Ivy League university hospital in New England all testified in a lawsuit involving a Cytotec induction that resulted in the death of the mother. Every one of them demonstrated their anti-precautionary approach to obstetric practice by saying that unless there is data proving significant risks, it is okay to use a drug before it has been approved by the FDA for this use.

Table 6
shows reliable estimates of the risk of uterine rupture during labor. When ACOG published recommendations for labor induction saying that Cytotec should not be used on women having VBACs, the organization took an ambiguous and somewhat confusing position on whether to use the drug for vaginal birth without previous C-section, saying only that it works: “Prostaglandin E analogues [a category that includes Cytotec]
are effective in promoting cervical ripening and inducing labor.” Of course the contentious issue is not whether Cytotec works, but whether it is safe, and ACOG neither addresses safety in the bulletin nor actually recommends that Cytotec be used for induction. Contrast this to what the organization says about Pitocin (oxytocin) in the same bulletin: “Women in whom induction of labor is indicated may be appropriately managed with either a low or high dose oxytocin regimen.”
¹⁷

ACOG's position on Cytotec induction is undoubtedly a case of politics at work. The organization does not wish to explicitly recommend the use of a drug that has known serious risks and is against label, as that could make it liable, but it does want to offer ACOG members who use the drug some wiggle room. The subtlety of the organization's approach, however, appears to be lost on some obstetricians, as my conversations with them demonstrate that many of them believe that the bulletin constitutes a recommendation by ACOG of the use of Cytotec for induction with no previous C-section.

There is now good scientific evidence that inducing labor with Cytotec frequently causes the uterus to contract too fast (uterine hyperstimulation), and there is considerable anecdotal evidence that uterine hyperstimulation
during labor can lead to severe, permanent brain damage in the baby. (The only time the baby can get oxygen from the mother during labor is between uterine contractions, so if the uterus contracts too often, the baby cannot get enough oxygen.) So, in addition to the babies that have died from Cytotec induction, we know for certain that babies have suffered brain damage as a result of Cytotec induction, though we do not know how many.

Here is one real-life story. A young married couple in rural Idaho, Mr. and Ms. M, were having their first baby in 1998. They were excited, as were their family and friends in the small community where they lived. There were two obstetricians practicing in their town, a partnership, and Mr. and Ms. M signed on with them.

The pregnancy went smoothly, and when Ms. M was just about due, one of the obstetricians told her to come to the local hospital the following Monday evening. In the chart he wrote, “Cytotec induction,” though there was no medical indication for inducing labor.

Ms. and Mr. M arrived at the hospital at 5
P.M.
, and at 6
P.M.
the obstetrician came in, examined Ms. M, and ordered the nurses to “follow the Cytotec protocol.” Neither the doctor nor the nurses told the parents what drug was being used and why, nor that the drug is not approved by the FDA, nor that serious risks were involved. In other words, there was no fully informed consent.

Over the next several hours, nurses gave Ms. M three doses of Cytotec. The electronic fetal monitor began to show that her uterus was contracting too fast and the baby's heartbeat was irregular, but the nurses continued “the protocol.” Although the nurses telephoned the obstetrician once at 11
P.M.
because they were concerned about the baby's irregular heartbeat, the doctor did not visit Ms. M again until the next morning, when he came in for his regular morning rounds. It had been twelve hours since he last saw her, and several hours since she had received an epidural block due to the pain of the extreme contractions.

In the morning, the monitor was still showing uterine hyperstimulation, but the obstetrician ordered Pitocin to further stimulate labor—adding insult to injury. Though the monitor's printout strip clearly shows many hours of uterine hyperstimulation, the condition was never recorded in the patient's chart. Every time staff looked at the electronic fetal monitor strip, they recorded the baby's heart rate, but never the other line on the strip, the uterine contractions.

That evening, the obstetrician came in, cut Ms. M's vagina open with an
episiotomy, put a vacuum cup on top of the baby's head, and pulled the baby out. The baby came out completely floppy and didn't breathe for the first five minutes. The staff put the baby on a breathing machine. In the first few hours after birth, the baby developed seizures and had to be transferred to a larger hospital with an intensive care unit for newborns. There, specialists diagnosed severe brain damage due to lack of oxygen during labor and birth.

In spite of excellent care at the newborn intensive care unit and wonderful continuing care from a host of health care workers provided by the state of Idaho, the baby now has severe cerebral palsy and severe mental retardation. The family, with lots of support from the local community, provides loving care for this child, a twenty-four-hour-per-day effort. Because the family could not possibly pay for all the care required for this child, they sued the obstetrician and his partner. As is typical in Cytotec cases, they received a large settlement before the case ever came to trial. (See
chapter 7
.) It is clear that a jury would not be sympathetic to the defense after hearing that Ms. M was given a drug that says on the label that it should never be given to pregnant women, and then was not adequately monitored after the drug was administered.

This story has many elements that are common in Cytotec induction cases gone bad. The drug was used for convenience, not because of medical need. The parents were not adequately informed of the risks. The obstetrician was absent for many hours during the labor. The obstetrician and other staff failed to recognize when the uterus was hyperstimulated. The excessive painful contractions led to an epidural block. And then Pitocin was added to the mix. Finally, the baby was pulled out by vacuum extraction.

Another undesirable consequence of drug-induced labor is a higher chance that a C-section will be performed.
¹⁸
As we saw in
chapter 3
, all such “surgical” interventions have increased risks for both the woman and her baby. Scientific evidence has proven again and again that although careful, judicious, clearly medically indicated use of obstetric interventions saves a few women's lives, the increasing use of these interventions and technologies beyond this minimal optimal level is not saving more women's lives but is doing the opposite—leading to an increase in maternal mortality. The increasing induction rates in the United States partly explain the rising C-section rate, which, in turn, is partly responsible for the rising rate of maternal mortality.

One way obstetricians who use Cytotec for induction try to justify their
choice is by quoting data that scientists know to be inadequate. The studies they quote have several fatal flaws in their methodology. However, as I've said, the single greatest weakness in the evidence they cite is that not one study is large enough to have sufficient statistical power in calculating the risk rate of less common but catastrophic occurrences such as uterine rupture and death. That is why the Cochrane Library still maintains today that we do not know enough about the risks of induction with Cytotec to recommend its use.

A brief look at the two papers some obstetricians cite as evidence that Cytotec induction is safe will illustrate that the data is being misinterpreted and that the heavy bias of the authors invalidates their conclusions. The first paper is a review by Goldberg and colleagues that was published in the
New England Journal of Medicine
. As a review, it is an attempt to survey other published reports on induction with Cytotec. The first problem is that the authors greatly confuse the reader by lumping together all uses of Cytotec during pregnancy, including its use in medical abortion early in pregnancy, its use for labor induction, and its use to treat postpartum hemorrhage (bleeding after the baby is born). When the review claims that it evaluates 200 studies involving a total of more than 16,000 women, it is falsely inflating the data.
¹⁹
Each of the situations just listed has different indications, benefits, and risks, and the data should never be combined.