OT:Cytotec: Dangerous experiment or panacea?

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Important info for midwives, doctors, and pregnant women.

 

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>DATE: 14 Aug 2000 21:07:33 -000

> " Oscar " <patternmaster

>patternmaster

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>http://www.salon.com/health/feature/2000/07/11/cytotec/index.html

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>Cytotec: Dangerous experiment or panacea?

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>Doctors are prescribing an unapproved, unpredictable ulcer drug to induce

>labor in thousands of women. Why are women the last to know?

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>By Ina May Gaskin

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>July 11, 2000 | On Nov. 12, 1998, a week before her sixth baby was due,

>Holly's nurse-midwife agreed to induce her labor. While there were no

>medical reasons for induction -- one of Holly's five daughters had weighed

>9 pounds 4 ounces and had been born after only five minutes -- the

>nurse-midwife contends that Holly complained of being tired of being

>pregnant. Before consenting to the induction, Holly's midwife says, she

>asked one of the obstetricians in her group practice if Holly would be a

>good candidate to try a new induction drug. He approved the prescription.

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>Holly disputes her midwife's story, asserting that the midwife recommended

>induction against Holly's better judgment. " My body was made to have

>babies, " she told me. With five vaginal births to her credit, Holly had

>confidence in her ability to labor.

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>Whatever the truth, both parties agree that over the next several hours the

>nurse-midwife gave Holly three 25-microgram doses of Cytotec. (Because of

>legal considerations, both parties requested anonymity.) What Holly didn't

>know and the midwife never told her was that it was an unapproved drug with

>potentially disastrous side effects.

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>One hour after the third dose, labor began, with contractions every two and

>a half minutes. According to Holly's 19-year-old daughter, Ann, who was

>present throughout labor, Holly handled herself very well.

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>Thirty hours later, her cervix not yet fully open, Holly stood up and

>walked around. Then her bag of water broke. A little later she heard a

>popping sound from her body. The midwife monitoring her labor noticed that

>the baby's heart rate had dived from a normal 130-140 beats to a

>frightening 40 beats per minute.

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>She exhorted Holly to push, and within five minutes, Holly's 8-pound,

>13-ounce daughter was born, followed by a huge gush of blood. The baby was

>blue and didn't breathe on her own, so the resuscitation team intubated

>her.

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>Holly, meanwhile, continued to bleed. Frightened, she told her midwife that

>something was wrong. The midwife assured her that her blood loss was not

>enough to warrant a doctor's presence. Later, realizing that Holly was

>bleeding excessively, the midwife removed several huge clots from her

>vagina, gave her medication to stop the bleeding and left her in the care

>of nurses.

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>Ann and Darryl, Holly's husband, were far from reassured. By this time,

>Holly lay unconscious, white as a ghost. They helplessly watched her

>struggle for breath. Darryl begged the nurses to get a doctor and the

>midwife directed a nurse to call for a doctor on the intercom. The

>physician who entered the birth room two minutes later was shocked at

>Holly's condition. " This lady is dying, " he shouted. " I'm taking her to the

>O.R.! "

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>Holly's heart stopped twice during the surgery. At one point, the doctor

>told Darryl that he did not expect her to survive. Her uterus had ruptured

>from the top down through the cervix. This kind of wound is characteristic

>of Cytotec-related ruptures, according to obstetricians I've since spoken

>to. (One doctor described them to me as " totally exploding. " ) Surgeons

>removed Holly's uterus along with one of her ovaries and a fallopian tube.

>Thirty-seven units of blood, plasma and platelets were required to replace

>the blood lost during her ordeal. Gone forever was her chance to have

>another baby.

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>Was Holly's labor a nightmare fated to happen, with or without

>intervention? Or did Cytotec cause her uterine rupture, thereby threatening

>her and her daughter's life? As with so many forms of obstetric

>intervention, even hindsight isn't 20/20. Every birth is unique, and the

>influences on labor are far more numerous than most studies can account

>for. And even with large, long-term, controlled studies, it is sometimes

>complicated to ferret out the facts about the efficacy or safety of a given

>medical procedure.

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>Cytotec, however, doesn't have the benefit of such scientific debate,

>because it is still essentially an experimental birth drug that is being

>tested ad hoc by trial and error. But most patients are never informed of

>this fact.

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>As a midwife of 30 years and one of the founders of the natural childbirth

>movement, I have overseen more than 2,000 births at my birthing center in

>Summertown, Tenn. Over the years I've listened to innumerable anecdotes

>about the dangers of medical intervention. But the stories I was hearing

>about Cytotec I found especially unsettling.

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>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.

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>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.

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>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.

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>

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>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.

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>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.

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>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.

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>

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>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.

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>A few years passed before the first published reports appeared detailing

>Cytotec's adverse effects on labor induction. By then, word of mouth in

>medical circles had made Cytotec the new darling of American obstetrics.

>Cost-effective, quick and easy to administer, Cytotec was fast becoming a

>popular alternative to Pitocin, which requires a full high-tech approach,

>including I.V., continual fetal monitoring and often (because of its

>reputation for triggering especially painful contractions) an epidural.

>Cytotec, in contrast, can be administered (though it shouldn't be) in

>virtually any setting.

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>Just how many women have been hurt by Cytotec? The question is nearly

>impossible to answer. No one has done large-scale studies of the drug, and

>the doctors and midwives who administer it do so with such vastly different

>protocols that mixing and matching results from various studies would not

>render reliable data. The most rigorous scientific authority in English on

>the effects of healthcare, the Cochrane Library, cautions that too few

>well-designed studies have been carried out to assess the risk factors

>associated with using Cytotec for labor induction. While conceding that

>Cytotec is more effective than conventional methods of cervical ripening

>and labor induction, it cautions that " the apparent increase in uterine

>hyperstimulation is of concern. "

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>Unable to find large-scale, comprehensive reporting on obstetric use of the

>drug, I decided to do a little statistical sleuthing (however unscientific)

>on my own. My research, and my gut sense, based on years of experience as a

>midwife, indicate that there are significant risks associated with Cytotec,

>certainly higher risks than those associated with other forms of induction

>like Pitocin. Combining the results in 20 studies of Cytotec-induced labors

>published in peer-reviewed journals and papers presented at professional

>meetings -- a total of 1,958 births -- I discovered a total of two maternal

>deaths, 16 baby deaths, 19 uterine ruptures and two life-threatening

>hysterectomies.

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>

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>To make sense of these figures, consider the normal incidence of uterine

>rupture, the most common serious side effect of Cytotec. Uterine rupture

>virtually never occurs in spontaneous (unaugmented) labor in women who've

>had no previous uterine surgery. Probably because of differing practices

>surrounding labor induction and augmentation, the rate of uterine rupture

>varies widely from hospital to hospital. Uterine rupture is less likely to

>happen in an out-of-hospital birth. Most midwives providing these services

>do not use drugs to augment labor. The complication has been reported as

>frequently as one in every 100 births and as rarely as one in every 11,000

>births. In my own group practice at the Farm Midwifery Center in

>Summertown, Tenn., in approximately 2,100 births we have had no uterine

>ruptures.

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>By contrast, approximately one in 100 Cytotec-induced births in the 20

>studies I looked at resulted in uterine rupture. About half occurred in

>women having vaginal birth after Caesarean, the others among women who had

>had no previous uterine surgery.

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>

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>In fact, it is women who have had Caesareans who are at greatest risk from

>Cytotec. An article published in 1999 in the American Journal of Obstetrics

>and Gynecology reported that uterine rupture occurred in five of 89 women

>with previous Caesarean delivery whose labors were induced with Cytotec --

>about one out of 16, a shockingly high figure, representing a more than

>28-fold increase over those who did not have Cytotec induction for VBAC

>(vaginal birth after Caesarean). One of the five ruptures also caused a

>baby to die.

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>According to epidemiologist Wagner, " It can be reliably estimated that

>between 1990 and 1999, as a result of the widespread off-label use of

>Cytotec for vaginal birth after Caesarean section, well over 3,000 women in

>the United States suffered a ruptured uterus, resulting in at least 100

>dead newborn babies. "

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>Amniotic fluid embolism, or AFE, is perhaps the most frightening

>complication associated with powerful labor-inducing drugs like Cytotec and

>Pitocin. AFE, which occurs when the amniotic fluid enters the mother's

>bloodstream, is one of the most dangerous complications that can happen in

>birth. More than 60 percent of women and their babies die when it occurs,

>with survivors usually suffering neurological impairment.

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>The rate of occurrence of AFE, once thought to occur only once in 80,000

>births, seems to be rising in the United States. Chicago writer Deanna

>Isaacs, whose daughter died from AFE in 1994, found that the incidence of

>AFE at the Phoenix, Ariz., hospital where her daughter died in labor was 1

>in only 6,500 births. AFE is now one of the leading causes of maternal

>death in the United States. Two cases of fatal AFE are associated in the

>medical literature with the use of Cytotec; a midwife told me about a

>third.

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>Alarmingly high as these figures are, they almost certainly don't reflect

>all of the adverse outcomes associated with Cytotec. I also gathered

>information -- much of it hair-raising -- from Internet chat-room

>discussions involving physicians who signed their names to their comments,

>as well as from obstetricians and midwives. This is anecdotal evidence,

>yes. But we can't afford to ignore anecdotes because current medical

>studies are inadequate, the drug has not been subject to FDA approval and

>mothers' and infants' lives are at stake.

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>The enthusiastic discussion of Cytotec in medical chat rooms sheds light on

>why the drug has become so popular in the United States. " You can almost

>count on a delivery 12 hours after inserting the Cytotec tablet, " said one

>doctor. Another doctor added a cautionary note: " I must say that I have

>heard some great things about Cytotec myself. I know some people who have

>used it and say that they have pretty good luck with it. It sounds like

>your ladies are pretty happy with its effects -- two-hour labors and such.

>Just be careful. I would have to say that the biggest danger is leaving the

>woman alone. The stuff turns the cervix to complete MUSHIE [emphasis in

>original] and opens it with a couple of contractions. So whatever you do,

>remember that you must not stay gone too long. "

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>Over the past 30 years, I have watched as wave after wave of medical fads

>have washed over the institution of modern childbirth. But one thing,

>unfortunately, hasn't changed: The push to discover a panacea to cure the

>pain and inconvenience of childbirth drives doctors to experiment -- and

>the women are usually the last to know.

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>In this case, to be sure, the demands of the women themselves are part of

>the problem. The Cytotec controversy is inextricably tied up with the

>increasing rate of induced labor in the U.S. Until fairly recently, induced

>labors were fairly rare: Now, one birth in five is induced, with only a

>small percentage of these inductions being medically necessary. Harried

>doctors in the HMO age are driving some of this, but women, too, are

>demanding faster labors. (This is not surprising, considering that the

>United States has the shortest maternity leave in the industrialized

>world.) If this trend increases, we can expect to see an accompanying rise

>in the medical problems that result when the strongest muscle in the human

>body -- which is also paper thin -- is stimulated to contract violently.

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>How was it that Cytotec came to be used as an obstetric drug in the first

>place? Misoprostol was originally developed by G.D. Searle & Co. of Chicago

>to prevent gastric ulcers in people who take anti-inflammatory drugs such

>as aspirin for arthritis pain. In 1988, it was approved by the FDA solely

>for this use. Yet it is quite legal for physicians to prescribe drugs for

>indications other than those for which the drug has received FDA approval.

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>This common practice, known as " off-label " use, usually involves

>prescribing one drug for another purpose. (Incidentally, no such loopholes

>exist for the use of pharmaceutical drugs in most Western European

>countries.) With misoprostol the practice seems particularly egregious:

>taking a medication meant for oral ingestion and inserting it vaginally.

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>According to Claudia Kovitz, public affairs specialist for Searle, the

>company does not intend to apply for FDA approval of Cytotec's use in

>starting labor. Indeed, why should it? At 13 cents a dose, with women

>taking no more than three doses per birth, the drug is too cost-effective

>to waste a heap of money on research whose primary result might only be to

>make the drug illegal to prescribe.

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>So what protection do pregnant women have when it comes to drugs that are

>prescribed for another purpose? Very little, according to Laura Bradbard,

>spokeswoman for the FDA. " People think we have more authority than we have.

>We approve a product for a particular indication, based on the data we

>receive. A physician is free to use a drug for any use he or she feels will

>benefit a patient. There are no safe drugs. You need to do your homework,

>ask a lot of questions and speak with your physician about your case and

>the medications, " Bradbard said.

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>

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>And even when the FDA approves a drug, there are no guarantees. " Once a

>drug reaches the marketplace, that's when we find out all the adverse

>events, because we have only seen it in 3,000 to 6,000 people perhaps, "

>said Bradbard. " Then it goes into the marketplace, where you have a million

>prescriptions. Then a reporter will say to me, 'You are approving things

>too fast. You didn't find it.' Well, we can't find it. It's mathematically

>impossible. We have to have it in the marketplace and then we have to make

>warnings. "

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>But Holly and her husband, like most patients who receive Cytotec, never

>received any warning. " We didn't know it wasn't FDA approved, " she said.

> " We would have never let them use me or my baby as guinea pigs. "

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>The end is in the means as the tree is in the seed.

>

>- Mahatma Ghandi

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>Abraham Lincoln, letter to Wm. F. Elkins Nov. 21 1864

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>Arthur Shaw ed. The Lincoln Encyclopedia 40 {1950}

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> " We may congratulate ourselves that this cruel war is nearing

>

>it's end. It has cost a vast amount of treasure and

>

>blood.........It has indeed been a trying hour for the

>

>Republic, but I see in the near future a crisis approaching

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>that unnerves me and causes me to tremble for the safety

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>of my country. As a result of the war, corporations have been

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>enthroned and an era of corruption in high places will

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>follow, and the money power of the country will endeavor to

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>prolong it's reign by working on the prejudices of the

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>people until all wealth is aggregated in a few hands and the

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>Republic is destroyed. I feel at this moment more anxiety

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>for the safety of my country than ever before, even in the

>

>midst of war. "

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