experience short conversations with other doctors are the most common way doctors learn about new drugs or techniques. Sadly, reading the results of scientific studies in medical journals or hearing reports of studies at professional meetings are not typically part of most obstetriciansâ practice.
With the advent of the Internet, doctors found another convenient way to exchange medical information, though for the most part it has not meant more safeguards as to the validity of that information. In the early 1990s, while surfing around in Internet chat rooms frequented by doctors, I began to read more and more about the use of Cytotec for induction of labor. One doctor wrote, âI must say I have heard some great things about Cytotec myself. Just be careful. The stuff turns the cervix to complete MUSHIE.â
Thatâs when I went to the
Physiciansâ Desk Reference
and found that using Cytotec for induction of labor was âagainst-label-contraindicated.â I went on to check obstetric journals and textbooks, and found that the only published research into inducing labor with this drug involved far too few women to draw reliable conclusions about risks. I got a cold feeling in the pit of my stomach as I sensed that this drug would result in another widespread obstetric tragedyâand it has.
In the years that followed, when I gave lectures to obstetricians aroundthe country, more and more doctors told me that they were trying Cytotec, and I had the disturbing experience of seeing how rapidly âtrying it outâ solidified into accepted dogma. I remember one obstetrician in Sioux Falls, South Dakota, who proudly told me over lunch that he was the first doctor in his community to use Cytotec for labor induction and that he now urges other doctors to use it. He justified his actions by saying, âIf we wait for the bureaucrats at the FDA to approve drugs, weâll wait forever. We must try them out ourselves if we want progress.â He admitted that he doesnât tell the women to whom he gives the drug that it is not approved for the purpose, nor does he ask for their consent. He scoffed at my observation that he is experimenting on women without their knowledge, much less their informed consent.
In 1995, when I was lecturing in Oregon, the Oregon State Health Department told me that Cytotec was the most common way of inducing labor in that state and was being used on thousands of laboring women. Around this time, a few more studies of Cytotec induction began to appear in obstetric journals, but all were still far too small to scientifically evaluate the level of risks. 8 The studies did report risk tendencies, however, such as the possibility that the drug could make the uterus contract too fast (uterine hyperstimulation); cause signs of fetal distress (such as the fetus passing meconium or a change in the babyâs heart rate); and, for a few women, cause uterine rupture. In 1999, a review of the scientific evidence for using Cytotec for labor induction was published by the Cochrane Library. The review concluded that because of the lack of sufficient scientific evaluation and the reports of serious side effects, Cytotec âcannot be recommended for routine use at this stage.â 9
These worrisome studies had no apparent effect on the spread of the drug. It can be reliably estimated, using annual total U.S. births and induction rates, that during the five years 1995 through 1999, more than a half-million women in the United States had labor induced with this drug that was (and is)
not
approved
by the FDA,
by the drug regulatory agency of any other industrialized country,
by the pharmaceutical company that makes it,
by reliable and valid scientific evidence (the Cochrane database), or
by the British Royal College of Obstetricians and Gynaecologists.
According to the Centers for Disease Control and Prevention (CDC), the rate of drug-induced labor induction in U.S. births
With the advent of the Internet, doctors found another convenient way to exchange medical information, though for the most part it has not meant more safeguards as to the validity of that information. In the early 1990s, while surfing around in Internet chat rooms frequented by doctors, I began to read more and more about the use of Cytotec for induction of labor. One doctor wrote, âI must say I have heard some great things about Cytotec myself. Just be careful. The stuff turns the cervix to complete MUSHIE.â
Thatâs when I went to the
Physiciansâ Desk Reference
and found that using Cytotec for induction of labor was âagainst-label-contraindicated.â I went on to check obstetric journals and textbooks, and found that the only published research into inducing labor with this drug involved far too few women to draw reliable conclusions about risks. I got a cold feeling in the pit of my stomach as I sensed that this drug would result in another widespread obstetric tragedyâand it has.
In the years that followed, when I gave lectures to obstetricians aroundthe country, more and more doctors told me that they were trying Cytotec, and I had the disturbing experience of seeing how rapidly âtrying it outâ solidified into accepted dogma. I remember one obstetrician in Sioux Falls, South Dakota, who proudly told me over lunch that he was the first doctor in his community to use Cytotec for labor induction and that he now urges other doctors to use it. He justified his actions by saying, âIf we wait for the bureaucrats at the FDA to approve drugs, weâll wait forever. We must try them out ourselves if we want progress.â He admitted that he doesnât tell the women to whom he gives the drug that it is not approved for the purpose, nor does he ask for their consent. He scoffed at my observation that he is experimenting on women without their knowledge, much less their informed consent.
In 1995, when I was lecturing in Oregon, the Oregon State Health Department told me that Cytotec was the most common way of inducing labor in that state and was being used on thousands of laboring women. Around this time, a few more studies of Cytotec induction began to appear in obstetric journals, but all were still far too small to scientifically evaluate the level of risks. 8 The studies did report risk tendencies, however, such as the possibility that the drug could make the uterus contract too fast (uterine hyperstimulation); cause signs of fetal distress (such as the fetus passing meconium or a change in the babyâs heart rate); and, for a few women, cause uterine rupture. In 1999, a review of the scientific evidence for using Cytotec for labor induction was published by the Cochrane Library. The review concluded that because of the lack of sufficient scientific evaluation and the reports of serious side effects, Cytotec âcannot be recommended for routine use at this stage.â 9
These worrisome studies had no apparent effect on the spread of the drug. It can be reliably estimated, using annual total U.S. births and induction rates, that during the five years 1995 through 1999, more than a half-million women in the United States had labor induced with this drug that was (and is)
not
approved
by the FDA,
by the drug regulatory agency of any other industrialized country,
by the pharmaceutical company that makes it,
by reliable and valid scientific evidence (the Cochrane database), or
by the British Royal College of Obstetricians and Gynaecologists.
According to the Centers for Disease Control and Prevention (CDC), the rate of drug-induced labor induction in U.S. births
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