Re: Mother Jones Article
From: art fougner, md (evsono@pipeline.com)
Fri Dec 22 07:33:09 2000
Dan -
you grinch you! why let facts and reason interfere with yellow
journalism.
art
At Fri, 22 Dec 2000, Braun, R. Daniel wrote:
>
>Several big issues with this entire article.
>1. Induction of labor at 41 weeks is a standard of care with medical
>literature to back it up as decreaseing perinatal mortality and decreasing
>cesarean section rates.
>2. What most laypersons don't know is that half the drugs used on pregnant
>mothers are not approved for use in pregnancy, because it is too expensive
>for the studies to be done by the drug companies. They are done by the
>medical community, but are not considered by the FDA when approving a drug
>because that can only be done through a drug companies request.
>
>Sorry, I had to vent a little.
>Dan
>
>R. Daniel Braun, MD FACOG
>Clinical Professor
>Department of Obstetrics and Gynecology
>Indiana U. School of Medicine
>Indianapolis, IN 46202
>
>OBGYN.net
>International Representative for United States
>
>Certified AllExperts Expert
>Check out my bio/ratings page!
>http://www.allexperts.com/displayExpert.asp?Expert=1236
>
>-----Original Message-----
>From: Theresa333@aol.com [mailto:Theresa333@aol.com]
>Sent: Thursday, December 21, 2000 7:30 PM
>To: Multiple recipients of list OB-GYN-L
>Subject: Mother Jones Article
>
>Did you get to read the article in MJ? See below:
>
>or check out the web site:
>
>http://www.motherjones.com/mother_jones/JF01/labor.html
>
>Forced Labor
>Why are obstetricians speeding deliveries with an ulcer drug that endangers
>mothers and their babies?
>
>by David Goodman
>January/February 2000
>
>Like any expectant mother, Suzanne Altomare was excited about the imminent
>birth of her second child. But eight days after her due date in November
>1995, the 34-year-old was informed by her obstetrician, Dr. Thomas Kahan,
>that he wanted to induce labor. There is typically no medical necessity to
>induce healthy moms until they are at least two weeks overdue, but Kahan
>considered it the safer course. Altomare trusted her doctor, and she went
>along with his recommendation.
>
>February 2001 issue
>Table of Contents
>
>To jump-start her labor, Altomare was given two doses of Cytotec, a drug
>known to soften the cervix and cause uterine contractions that are more
>frequent and powerful than normal labor. What Altomare did not know was that
>
>Cytotec has not been approved by the Food and Drug Administration (FDA) for
>use in pregnant women. The drug, made by G.D. Searle Corporation, is
>approved
>only for treating peptic ulcers. Its package insert explicitly warned that
>"Cytotec may cause the uterus to rupture (tear) during pregnancy if it is
>used to bring on (induce) labor." Uterine rupture, the insert added, "may
>result in severe bleeding, hospitalization, surgery, infertility, or death."
>
>According to court records and sources familiar with the case, Altomare soon
>
>went into very active labor. But several hours later, a delivery nurse at
>the
>hospital in Salem, Oregon, was no longer able to detect a fetal heart tone
>or
>find the baby's head on a vaginal exam. Altomare's uterus had ruptured,
>causing internal bleeding in the mother and leaving the baby without oxygen.
>
>The nurses called Dr. Kahan, who was at home. By the time he arrived and
>mobilized an emergency cesarean section, the infant was brain-dead. Kahan
>then performed an emergency hysterectomy. When Altomare awoke, she learned
>that she would never again be able to bear a child. Her newborn daughter
>died
>three days later.
>
>Contraindications
>Download the Cytotec package insert.
>
>Since Cytotec was introduced in 1988, a growing number of obstetricians have
>
>embraced it as a "miracle" drug -- in spite of data that leave serious
>doubts
>about its safety. Lacking FDA approval and scientific consensus on how to
>use
>it on pregnant women, doctors have taken it upon themselves to administer
>Cytotec to their patients -- often without the women's informed consent.
>This
>"off-label" use is legal, thanks to an FDA loophole: Once a drug is approved
>
>for one purpose, it can be used by physicians to treat anything.
>(Misoprostol, the generic name for Cytotec, is also used in combination with
>
>RU-486: The abortion drug ends the pregnancy; misoprostol causes the uterus
>to expel its contents.)
>
>Clinical trials suggest that Cytotec is remarkably effective at softening
>the
>cervix, a precursor to inducing labor. In a recent survey of 44 studies of
>the drug, Dr. Luis Sanchez-Ramos, professor of obstetrics and gynecology at
>the University of Florida in Jacksonville, concluded that women given
>Cytotec
>are more likely to have a vaginal delivery within 24 hours -- and no more
>likely to require cesarean sections -- than women who receive no medication
>or another labor-inducing drug. Cytotec is now "the predominant agent of
>choice" for inducing labor, according to Dr. Charles Lockwood, chairman of
>obstetrical practices for the American College of Obstetricians and
>Gynecologists (ACOG).
>
>The drug's appeal is twofold. Cytotec is much cheaper to use than other
>drugs: A dose costs less than 25 cents, compared with hundreds of dollars
>for
>other labor-inducing agents. It has also enabled doctors to induce more
>labors than ever before: Over the past decade, the induction rate has
>doubled
>-- 1 in 5 women now has her labor induced -- as doctors increasingly opt for
>
>additional medical intervention in childbirth. Speeding delivery can be
>medically necessary when the mother is overdue or at risk because of high
>blood pressure or diabetes, but critics charge that doctors often rely on
>Cytotec for "convenience inductions," using the drug to induce labor during
>office hours rather than letting nature take its course.
>
>"Cytotec enables doctors to practice daylight obstetrics," says Dr. Marsden
>Wagner, a neonatologist who served for 15 years as a director of women's and
>
>children's health in industrialized countries for the World Health
>Organization. "It means that as a doctor, I can come in at 9 a.m., give you
>the pill, and by 6 p.m. I've delivered a baby and am home having dinner."
>
>But studies highlight alarming risks associated with Cytotec. The Cochrane
>Collaboration, an international body of independent analysts and physicians
>that publishes widely respected assessments of drug efficacy, cites numerous
>
>reports of uterine rupture and fetal distress involving the drug. "It cannot
>
>be recommended for routine use at this stage," the group concluded last
>year.
>After another study revealed a 28-fold increase in the risk of uterine
>rupture among women with prior cesarean sections, ACOG issued guidelines in
>1999 discouraging the use of Cytotec in such cases. The organization
>continues to recommend Cytotec for use in routine cases, however, insisting
>the drug is safe at low doses.
>
>With many doctors still regularly using Cytotec to induce labor, the toll on
>
>pregnant women and their babies is mounting. Mother Jones has learned
>through
>a Freedom of Information Act request to the FDA that in the last three years
>
>alone, the agency has received reports of 30 cases of uterine rupture in
>connection with the use of Cytotec, and eight cases in which the fetus died
>in utero.
>
>Cytotec's impact has now become the subject of lawsuits. In Oregon, Suzanne
>Altomare sued her doctor and won $2 million in a confidential settlement
>last
>year. In Texas, Lauren Carroll was awarded $1 million in 1999 after she
>suffered a uterine tear, lost her newborn son, and underwent an emergency
>hysterectomy. In Connecticut, a mother died at Yale-New Haven Hospital in
>1998 after being given Cytotec. Doctors delivered a severely impaired boy
>from her lifeless body, but the boy died last year.
>
>"For the drug company, off-label use allows for potentially massive sales of
>
>the drug without making any warranties for its efficacy or safety," says
>Michael Koskoff, an attorney representing the Connecticut woman's husband.
>"It is equally advantageous for medical professionals, since it allows them
>to use a drug in essentially an unregulated manner."
>
>Searle, the maker of Cytotec, was recently named as a defendant for the
>first
>time in a lawsuit brought by a man in Portland, Oregon, whose wife died in
>childbirth after being induced with the drug. Last August, Searle sent a
>letter to 200,000 health care providers warning them that "Cytotec
>administration by any route is contraindicated in women who are pregnant
>because it can cause abortion." The company noted that the off-label use of
>Cytotec has resulted in reports of uterine rupture, hysterectomy, and the
>death of mothers and infants.
>
>Related articles
>Prozac.org
>
>Selling the Cure for Shopaholism
>
>Migraine Killer
>
>If There Are No Side Effects, This Must Be Honduras
>
>The Charge: Gynocide
>
>Rather than heed Searle's warning, however, many obstetricians reacted
>angrily to the letter. "I think it's a great setback to women's health,"
>fumes Dr. Steven Clark, a professor of obstetrics and gynecology at the
>University of Utah School of Medicine. "What this letter means is that if
>anything bad should happen during labor and delivery, this is going to be
>blown up in great big huge letters in front of the jury. Do doctors want to
>take the risk of using a drug that is expressly forbidden for this use by
>the
>manufacturer?"
>
>But experts say such legal consequences are inherent in off-label use. If
>doctors insist on prescribing a drug for a nonapproved use, observes former
>FDA Commissioner David Kessler, "they are going to have to make sure that it
>
>is the standard of care. Otherwise they face great risks."
>
>According to one informal poll, at least one-third of hospitals have
>restricted the use of Cytotec in response to the Searle letter. "It has
>certainly had a chilling effect on the use of this drug," says Lockwood, the
>
>ACOG committee chairman. But many physicians say they are disregarding the
>warning. "It hasn't impacted us at all," says Sanchez-Ramos of the
>University
>of Florida, who insists Cytotec is safe.
>
>Whatever the drug's dangers, most women who receive it have no idea that it
>is not approved for use during pregnancy. Alicia Balassa-Clark, a
>35-year-old
>artist in Vancouver, Washington, planned to have her baby in a birthing
>center where she could be attended by midwives. But her insurance covered
>only births attended by a physician, and she was referred to a local
>obstetrician. To help induce labor, Balassa-Clark recalls, the doctor
>inserted Cytotec into her vagina, assuring her that she would have "a
>completely natural labor."
>
>After 14 hours of labor, Balassa-Clark says, the doctor told her that she
>was
>"almost there." Suddenly, a nurse said that she could not detect fetal heart
>
>sounds. "My doctor's face went ashen as the monitor readings registered that
>
>my baby was in fetal distress," Balassa-Clark recalls. (The doctor did not
>respond to requests for comment.) An emergency cesarean section was
>performed, but the baby was not breathing when she was born. Twenty-four
>hours later, Balassa-Clark and her husband made the agonizing decision to
>remove the small girl they had named Isabella Marie from life support. "I
>held her in my arms as she took a few tiny little breaths and then passed
>away," she recounts.
>
>Without informed consent, say some medical experts, patients are being
>treated as little more than human guinea pigs. Wagner, the former official
>with the World Health Organization, notes that Cytotec is not used to induce
>
>labor in Europe, and chides American obstetricians for what he calls
>"vigilante obstetrics."
>
>"Vigilante justice is: We're not gonna wait for the judge, we're gonna just
>hang 'em," he says. Using Cytotec on women "is saying we're not gonna wait
>for the judge -- the FDA and scientists -- we're gonna just go ahead and use
>
>it."
--
art fougner, md
A series of 1000 cases begins with but a single anecdote.
