The Abortion Cocktail
Bernard N. Nathanson
In April 1970, in the pages of the <Obstetrical and Gynecological Review>, I reviewed
the history of attempts to control population growth by means of medical�i.e.,
nonsurgical�abortion. Starting in antiquity, I found that the ancient Greeks did not
generally approve of abortion, while their Roman counterparts favored the use of
thaumaturgy and incantations. Cultures in Africa and the Middle East tried concoctions
of camel or goat dung. In the medical lore of Europe during the Middle Ages, pastes,
emetics, purgatives, emmenagogues, sternutators, convulsants, clysters, physical
maneuvers, and pessaries are mentioned. The Enlightenment had a vast pharmacopeia
with dazzling names and no abortifacient effect whatever: aloes, colocynth, apioline,
pennyroyal, tansy, pulegium oil, caulophyllia, cardomon, and cimicifuge.
Toward the end of the paper I discussed a newly emerging class of drugs known as
folic acid antagonists and antimetabolites. These drugs were used primarily to treat
cancer but they were also reasonably effective in producing medical abortion, at least
up to eight weeks gestation. The enormous toxicity of these drugs to the pregnant
woman, however, and the fact that they produced massive congenital deformities in the
fetuses who somehow survived the pharmacological assault, virtually precluded their
use as abortifacients.
In 1995, twenty-five years after my review, the <New England Journal of Medicine>
carried a report that the combination of a powerful anticancer agent (methotrexate) and
a relatively innocuous drug used primarily to treat gastric ulcer (misoprostol) will
effect medical abortion in 96 percent of women pregnant less than nine completed
weeks, with no currently identifiable damage to the pregnant woman.
Some thoughtful analysts, including some pro-life advocates, have suggested that the
legal battle to end abortion has at last ended in defeat with this report of an apparently
effective and safe medical form of abortion. An "abortion cocktail" that women take in
the privacy of their homes would eliminate the clearly specifiable abortionists against
whom the pro-life movement has been able to focus its efforts. In the event of a ban on
legal abortion, it would force prosecutors into the difficult position of seeking
convictions against individual women rather than against the abortionists. Any attempt
to pursue the doctors prescribing the "cocktail" would likely result merely in the
emergence of a black market or of a charade in which women seeking abortions would
report the symptoms of the diseases for which the ingredients are currently and legally
prescribed.
The legal battle to ban abortion, however, is not by any means defeated with this report
of a medical abortifacient, and it may in fact be helped. The unprofessional and
unethical means by which the procedure was tested, the unknown long-term medical
effects on women of the drugs involved, and the extreme dangers to the human gene
pool posed by partially completed medical abortions all suggest a strong societal
interest in banning the "abortion cocktail." And the falsity of claims that medical
abortions will 'demedicalize" and "empower" women by granting "at-home" abortions
will soon become apparent�allowing the pro-life movement to continue to focus its
efforts on the offices of abortionists.
Methotrexate, the first drug used in the "abortion cocktail," is an unusually potent and
dangerous drug. <The Physician's Desk Reference> (PDR), an encyclopedic
compendium of prescription drugs marketed in the U.S., devotes six pages to a
description of the powers and hazards of this drug, its uses and abuses. (The average
entry for drugs runs about one-half page.) The entry opens with a black-bordered box
reading, in part: "Methotrexate should be used only by physicians whose knowledge
and experience includes the use of antimetabolite therapy.... Because of the possibility
of serious toxic reactions the patient should be informed by the physician of the risks
involved, and should be under a physician's constant supervision."
The <PDR> goes on to specify in excruciating detail the toxic potential of this drug:
liver damage, kidney destruction, heart muscle compromise, pulmonary failure,
gastrointestinal pathology, and bone marrow suppression. It has also been reported to
cause loss of speech function, strokes, and convulsions. It is, in other words, one of the
most toxic, dangerous, and potentially fatal drugs in the entire <PDR>, and it has been
approved for use by the FDA only for the treatment of cancer�which is to say, the
dangers of this drug are so massive that they are outweighed only by the benefit of
abating or curing cancer.
There is a considerable literature concerning the use of methotrexate in ectopic, or
tubal, pregnancies. In the past, ectopic pregnancy had been managed by surgical
means, i.e., by removal of the tube containing the pregnancy. Moral theologians
generally sanctioned this approach since, although it did effect abortion, the primary
intention of the surgery was to preserve the life of the mother and the abortion was a
regrettable side effect.
However, beginning in 1987, increasing numbers of gynecologists were reporting the
successful management of ectopic pregnancy by the use of laparoscopy (the
introduction of an optical system into the abdomen through a small incision in the
umbilicus) and the delivery of a dose of methotrexate through the scope into the
amniotic sac of the fetus developing in the tube. No longer was there a "double-effect"
rationale to exonerate the surgeon; we now had a direct lethal assault on the
developing child (albeit developing in the wrong place). The moral consequences of
this "momentous advance" in gynecologic technology provided a bridge to the use of
methotrexate to destroy the child developing in the <correct> place, the womb.
In normative bioethics the use of a drug such as methotrexate would require a
sufficient benefit to outweigh the risks: the disease being treated must be of such
gravity as to justify the use of the drug. Pregnancy, however, falls comfortably into
none of the usual definitions of disease: it is <not> a state inimical to the way one is
supposed to feel; it is <not> a condition in which body components and systems are
acting inharmoniously (to the contrary, infertility would more likely fall within that
definition); it is not a state of abnormality�for the pregnant woman functions
satisfactorily within society, and the social and physical environment tolerates the
pregnant woman perfectly. Pregnancy, then, is not a disease by any normative
definition, and the administration of a drug as potent and as toxic as methotrexate
cannot be justified within the traditional framework of medical risk benefit analysts.
Richard Hausknecht, the author of the article in the <New England Journal of
Medicine>, acknowledged that the "abortion cocktail" was indeed an experiment when
he stated in his report that "the protocol [of the experiment] was approved by the
investigative review board of the Mount Sinai Medical Center." The Code of Federal
Regulations (49 CFR Part II) sets forth federal policy for the protection of human
subjects in medical experimentation, mandating the establishment of an institutional
review board (IRB) in each hospital in which human subjects are used for
experimentation. The Code further stipulates how many members each IRB should
have, from what disciplines the membership should be drawn, and precisely how each
IRB should function. The language of the Code is explicit: each IRB is charged with the
responsibility to assure that "risks to subjects are minimized by using procedures which
are consistent with sound research design and which do not unnecessarily expose
subjects to risk." The Code requires periodic reports from the experimenters and
specifies the language and nature of the informed consent presented to each subject.
(The explanation of the risks is so detailed that these consents often run to ten or fifteen
pages.)
In the Hausknecht report there is no indication of the nature and content of the
informed consent. There is no mention of periodic reports to the Mount Sinai Hospital's
IRB. There were no precautions or measures designed to minimize the risk
accompanying this experimentation. Where was the constant medical supervision the
<PDR> recommends when using the drug methotrexate? Hausknecht, in the protocol
section of the report, speaks of each subject receiving an intramuscular injection of
methotrexate, then going home, to return five to seven days later for the administration
of the second drug misoprostol; who was supervising the patient in those five to seven
days? Where were the blood tests to assure that the subject was not reacting adversely
to the methotrexate? Where were the liver and kidney function tests, the tests for
pulmonary function, the tests to assure that the bone marrow was functioning
normally, the neurological assessments?
Another section of the Code of Federal Regulations (Title 45, Part 46) directs that the
Department of Health and Human Services through the National Institutes of Health
establish and maintain an Office for Protection from Research Risks. Even if an
experiment is not federally funded it falls within the purview of this Office in that
human subjects are involved in the experimentation. This Office is responsible for
overseeing the functioning of IRBs. Subpart B of this section of the Code deals with
"research, development, and related activities involving fetuses, pregnant women, and
in vitro fertilization" and requires that each institution conducting research on such
human subjects establish, in addition to the IRB, an Ethical Advisory Board consisting
of research scientists, physicians, psychologists, educators, lawyers, and ethicists�as
well as representatives of the general public. Nowhere in the Hausknecht report is an
ethical advisory board even mentioned.
It is customary and even ethically mandatory that experimentation that carries with it a
substantial degree of risk to human subjects first be tested in an animal laboratory or, at
the very least, on a computer model. There is no mention of any such preliminary
testing in the Hausknecht report, probably because no such testing was done. Women
were once again used as laboratory rats, much as they had been used in the early days
of oral contraceptives, IUDs, silicone breast implants, and the Norplant contraceptive.
Two doctors, Creinin and Vitinghoff, carried out a similar and equally odious
experiment on pregnant women using methotrexate and misoprostol at the San
Francisco General Hospital and reported their results in the <Journal of the American
Medical Association> in October 1994. They at least had the minimal decency to
provide a group of controls (women to whom only misoprostol was given) but their
experiment was otherwise every bit as ethically shabby as the Hausknecht fiasco.
Many troubling questions arise from these two experiments. How could the IRBs of
two prestigious university teaching centers have sanctioned such an experiment,
despite the multiple strictures, restraints, and codes regarding experimentation on
pregnant women and human fetuses? Was there no concern for those women who,
having been given the methotrexate, might wish to back out of the experiment with the
fetus still alive but lethally afflicted with the well-recognized teratogenic effects of the
drug? Where were the preliminary animal testing and computer models establishing
some parameters of safety and efficacy for these experiments? Where were the ethical
advisory boards mandated by the Office for Protection from Research Risks? How
many equally invidious experiments of this sort are now ongoing�and how many are
federally funded? Where was the elaborate bureaucratic multitiered machinery
designed to scrutinize such experiments? Where were the usual whistle-blowers while
these squalid experiments were going on? For that matter, where was the pro-life
movement, and why has the public response been so muted?
Hausknecht and company make much of the increased privacy flowing from the
"abortion cocktail." This is, to be charitable, a delusion fostered largely by dishonest
reporting and slovenly procedure. In their book <RU-486: Misconceptions, Myths, and
Morals>, the feminists Janice G. Raymond, Renate Klein, and Lynette J. Dumble point
out that all medical abortions, far from being purely private affairs between women
and their physicians, are even more public than the conventional surgical (suction)
abortions. A woman seeking a medical abortion of any sort must submit to a general
physical examination (to assure she is an apt candidate for the drugs in question) as
well as to a pelvic examination. She must have a blood test to confirm the pregnancy
and an ultrasound examination to assure that the pregnancy is within the established
limits of gestation for such an abortion. A legally mandated waiting period may follow,
after which the woman must return to be given an injection by a physician or nurse.
She must return a third time for the ingestion of the second drug (misoprostol, used
both in KU-486 and the new "abortion cocktail"), whereupon she is subjected to a
second pelvic examination as well as to an elaborate mix of blood tests. Only then does
the woman go home. "To call this an at-home abortion is deceptive," Raymond, Klein,
and Dumble noted about medical abortions in general, "since most treatment transpires
in the clinic, hospital, or office, and is extremely medicalized."
Moreover, with either RU-486 or with the "cocktail," the ordeal is still not complete.
"What actually happens at home can be an excruciatingly long wait for the embryo to
be expelled from the uterus, accompanied by pain, bleeding, vomiting, and nausea and
other complications that are drawn out over a substantially lengthy period of time."
Following the miscarriage the woman must return a fourth time for an examination to
ascertain whether the abortion is complete; this usually entails another ultrasound
examination as well as a quantitative blood pregnancy test and another pelvic
examination. Despite the rhetoric of "privacy," "women in control," and
"demedicalization," there have been four office/clinic visits (in the ideal uncomplicated
case), two ultrasound examinations, multiple blood tests, and strict medical
supervision.
A group of investigators at the University of Edinburgh questioned women who had
undergone medical abortion. In their report <What Do Women Want During Medical
Abortion>, they found that only 24 percent of the women interviewed preferred to have
the actual miscarriage at home; fully three-quarters of the women desired the hospital
ambience with physicians, nurses, other women undergoing the identical experience,
and support partners present. The miscarriage of a fetus at home is a lonely, physically
trying, frightening, and demoralizing experience�one that culminates in the woman
viewing her own dead child in a terrifying mass of blood, clot, and tissue between her
legs.
The public must be made aware of the deceptions, the ethically deeply flawed
experiments, the conscienceless exploitation of women, and the potentially dire
consequences to both mother and (surviving) fetus. The long-term transgenerational
consequences to humanity itself must be examined: methotrexate is a drug known to be
capable of damage to the human DNA, and as such may induce mutations so grotesque
as to be virtually unimaginable.
If there is one ray of light in all this for pro-life forces, it is the prospect of the surgical
abortionists crossing rhetorical swords with the medical abortionists�competing with
each other for the obscene commercial traffic and trashing each other's methods with
abandon. Regardless, by no means does this intolerably unethical and immoral
technology spell the end of the legal battle to ban abortion. That battle has only begun.
BERNARD N. NATHANSON, M.D., the author of Aborting America, is a bioethicist at
the Center for Research and Clinical Ethics ar Vanderbilt University.
This article appeared in the January 1996 issue of "First Things." To subscribe write
First Things, Dept. FT, P.O. Box 3000, Denville, NJ 07834-9847, 1-800-783-4903.
Published monthly except bimonthly June/July and August/September for $29.00 per
year.
-------------------------------------------------------------------
Provided courtesy of:
Eternal Word Television Network
PO Box 3610
Manassas, VA 22110
Voice: 703-791-2576
Fax: 703-791-4250
Data: 703-791-4336
FTP: EWTN.COM
Telnet: EWTN.COM
Email address: SYSOP@ EWTN.COM
EWTN provides a Catholic online
information and service system.
-------------------------------------------------------------------
