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Wednesday, Nov 25, 2009
Over the past three years I have watched in increasing dismay as this once little-known ulcer medication has become a popular obstetric drug -- one with potentially horrifying side effects and a frightening lack of safety protocols. Buried in study after study, reports show that the drug has been connected to numerous cases of ruptured uteri and even a few maternal deaths, stillbirths and newborn deaths. Despite these reports, however, tales like Holly's -- in labors attended by practitioners who appear to have little understanding of the drug's potential dangers -- continued to reach me. In fact, the widespread use of Cytotec essentially amounts to a massive medical experiment carried out on thousands of unsuspecting women -- a situation, sadly, that is all too common in the world of modern obstetrics.
Most Cytotec-induced labors do not cause adverse effects like those in Holly's labor -- in fact, for a significant number of women Cytotec seems to work amazingly well. In a way, that's what scares me the most. Since it works so efficiently for a majority and can be prescribed obstetrically without Food and Drug Administration approval, there's less motivation for learning why for some women the drug has a catastrophic effect. Aside from the oft-cited though widely ignored warnings against giving it to women who have had Caesarean sections, we know very little about which women are at risk.
What we do know about Cytotec is that it is dirt cheap: A single 25-mcg dose costs roughly 13 cents; Pitocin, in contrast, necessitates hundreds of dollars in high-tech intervention. Since Cytotec is made in 100-mcg tablets to be taken orally, its quarter-tab dosages are necessarily inaccurate: Nurses or doctors have to literally cut up the pills with little knives. Furthermore, there is still no agreement as to the dosage size or interval or even most appropriate route of administration. The most common means of administration, by placing a quarter-tablet next to the cervix, is so easy that some doctors and midwives give the pills to women to take home and insert themselves. As a result, some women who experience emergency complications like Holly's do so without a hospital staff to care for them.
Unlike a Pitocin drip, which has a half-life in the body of about 10 minutes and can easily be turned off if the woman responds to it violently, once Cytotec is administered, you can't get it out and nobody knows its half-life. This gives Cytotec an unpredictable, stealthy quality. Sometimes even when it is doing serious damage to the uterus, the woman has no awareness that something's wrong; other times it creates immediate violent contractions. Moreover, the ruptures can occur many hours after a single dose in which the drug seemed to have caused no adverse effects. No one understands how this works, but it has been the subject of discussion both in the medical literature and in physician chat rooms.
Finally, in an era of managed-care obstetrics in which doctors are seeing patients in their offices at the same time that they monitor other women's labors across town in the hospital by telephone, Cytotec's great claim to fame -- prompt, timely labors -- is a phenomenal boon. In most cases an obstetrician must be present at the time the baby is born to be paid in full for a birth. So financial factors may influence some doctors to induce labor at a convenient time. Moreover, most cases of malpractice litigation involve situations in which doctors were not present and an adverse outcome occurred. Hence doctors have ulterior motives for using drugs like Cytotec, which help speed labor and thereby ensure that they won't miss the big event.
How many women are being given Cytotec? Marsden Wagner, a Washington, D.C., perinatal epidemiologist, estimates that every year at least 150,000 U.S. women (about 3 percent of all births) are given Cytotec to start labor. But based on my conversations with other doctors and nurses, I sense that the number may be much higher. Its usage is certainly growing rapidly. Wagner also notes that the Oregon State Health Department recently told him that Cytotec is now the state's most common method of induction.
How did Cytotec become so widely used and yet remain so underresearched? In 1992 and 1993 the first reports of the obstetric use of the small white tablet -- generically known as misoprostol -- indicated that it could be highly effective for starting labor in women, whether or not their cervixes were ripe. (In contrast Pitocin, the most common induction drug, often doesn't work unless the cervix is already primed and therefore affords doctors fewer choices.) Cytotec had already been used in combination with other drugs as a chemical abortive -- why not use it as an induction medicine? Lacking other information, many physicians began incorporating it into their practices.
