by Sarah E. Hinlicky
It looks so nice and gentle. The "Early Option Pill" is what they call it, and you can tell from the picture on the website 1 of the brave and noble woman who’s looking out at the world thoughtfully that she’s making a smart and responsible choice. "It’s what women have wanted for years," the site tells us, "a safe, effective and innovative way to end pregnancy — taken orally, without surgery — early on." Kind of like having your adenoids removed so you can breathe more easily, I guess. But more pleasant than that since, after all, you avoid surgery with the pill. "Mifeprex is safe and effective," the text goes on to say. "Taken orally, it is non-invasive, avoiding surgery or anesthesia in most cases. Some women feel it is a more private option. When women choose the early option pill, they will receive counseling and support throughout the process." And all thanks to the FDA’s approval of mifepristone on September 24th of this year.
"Safe, effective, and innovative," they say. Let’s take a closer look at those claims.
We’ll start out with safe. Mifepristone — known to most of the world as RU-486, now marketed as Mifeprex, the miscarriage-inducing drug that France gave to the world, merci beaucoups — is safe only under very specific circumstances. (Well, safe for the mother. It’s not very safe for the fetus.) It should not be taken by women who: have high blood pressure, are obese, smoke more than 10 cigarettes a day, have diabetes or other cardiovascular risks, suffer from asthma or bronchitis, are over 35 or under 18, experience menstrual irregularities, fibroids, or endometriosis, have used IUDs or oral contraceptives less than 3 months before conception, have a history of problematic pregnancies or pelvic inflammatory disease, have an ectopic pregnancy, suffer from allergies, epilepsy, or adrenal insufficiency, have recently used steroids or anti-inflammatory medications, have taken cortisone or similar drugs for long periods of time, or have a history of liver, stomach, intestinal, or kidney disease. Got all that? Bear in mind that in France, where the use of this drug has gone on the longest, the government requires, even when perfectly healthy women are given RU-486, that the clinic have an electrocardiograph and emergency resuscitative equipment on hand. Just in case, of course. Remember, the website told us that mifepristone is safe.
Then there’s effective. Let’s take a look at the FDA trial report. The total sample group of women pregnant forty-nine days or less (now the official cut-off date for mifepristone use) was 827 test subjects. Of those, nearly 7.9% needed to have surgical abortions performed anyway, which is part of the deal when you take the drug. (After all, if you don’t surgically abort after a failed bout with mifepristone, the child will most likely be deformed — and then you really won’t want it.) 1.6% of these were "medically indicated interventions during the study period, mostly for excessive bleeding." 0.6% came at the patient’s request, 4.7% had incomplete abortions from the drug and therefore needed the surgery to finish the job, and 1% were still pregnant, despite the efforts of the drug, at the end of the trial. The FDA notes that mifepristone treatment should be denied to any woman who "does not have adequate access to medical facilities equipped to provide emergency treatment of incomplete abortion, blood transfusions, and emergency resuscitation during the period from the first visit until discharged by the administering physician." Under such circumstances, it’s a little surprising that some groups advocate making mifepristone available for women to administer to themselves in the unsupervised privacy of their own homes.
On to innovative. If we take the meaning of innovative to be simply "brand new," then we have to agree that there is something quite novel about women willingly inflicting upon themselves heavy vaginal bleeding and cramps so severe that they require opiates or other injectable painkillers over the course of two or more weeks, all in the name of having a more "private" or "natural" experience, like a miscarriage. (And don’t forget that this "innovative" experience will not necessarily accomplish what it’s supposed to do if you’re in that unlucky 8%.) It’s innovative to market a drug whose carcinogenic potential has not been studied for any significant duration of time, and which has caused abnormalities in the sexual development and behavior of rats, and which may or may not be excreted in human breastmilk (they don’t know for sure yet). Probably most innovative of all is the great wealth to be gained from women who lack the "emotional and financial resources" to keep their children, by capitalizing on their panic. Danco, the company to market Mifeprex, "picked the brand name Early Option for the drug, based on women’s responses in focus-group surveys," according to the Wall Street Journal on Sept. 5, and the company expects to have sales of $34.2 million by 2004. One imagines that their profits will be especially high since the pills are going to be manufactured by a factory owned and operated by the People’s Republic of China, a country known for its impure drugs and atrocious enforced-abortion policy, but that gets us back into the realm of safety again. For now let us simply marvel at the extraordinary innovation shown in the development of this pill.
Perhaps we ought to take a look at what actually happens when a pregnant woman chooses the "early option pill" — or, rather, "pills." If she’s been pregnant for 49 days or less, counting from the beginning of her last menstrual period, she can go to her doctor and talk about the "medical abortion" option. ("Medical abortion" doesn’t mean "medically necessary," it means "abortion by medicine." Important distinction.) If she decides that this is what she wants, she has to sign an agreement stating that she understands exactly what’s going to happen to her. Then she takes her first dosage, 600 milligrams of mifepristone. If she doesn’t abort immediately, which is the majority of the time, she comes back two days later to take 400 micrograms of misoprostol, a prostaglandin. (Misoprostol is marketed by Searle to treat ulcers. Searle has protested the use of its drug for abortions.) Then she goes home and waits it out, returning 12 days later for the doctor to verify that her pregnancy has ended, since heavy bleeding isn’t necessarily a sign of success. (If you call that success.) Where exactly the "counseling and support" that the Mifeprex website promises comes into play is not entirely clear.
While she’s waiting for the abortion to take place, the woman can expect ongoing abdominal pain as her uterus cramps up, expelling the "products of conception." This is called by the FDA an "adverse event." The study report notes that "the majority of adverse events were of mild or moderate severity. Approximately 23% of the adverse events in each gestational age group were judged to be severe." (Mifepristone was tested on women farther along in their pregnancy — up to 63 days — and they tended to have much lower rates of "success," so the statistics that are reported to the public refer only to the abortions of 49 days or less.) In the process, the woman will lose on average 70 ml of blood, which is a blood loss four times greater than that of a suction curettage abortion, putting it beyond the normal "heavy" period. Surgical intervention is necessary 1 in 100 times to stop the bleeding, and though the bleeding usually lasts only two weeks, there are records of it going on for two months. For the most part the bleeding and cramping happen at home, away from the doctor’s supervision. Nausea, headaches, vomiting, and diarrhea are fairly common side effects too, and in a few cases more exotic symptoms are exhibited as well: dizziness, fatigue, back pain, uterine hemorrhage, fever, viral infections, vaginitis, rigors, dyspepsia, insomnia, asthenia, leg pain, anxiety, anemia, leukorrhea, sinusitis, and syncope. The FDA notes that "adverse event rates were highest at Planned Parenthood clinics and lowest at Free-Standing clinics, with university hospital clinics in the middle." There’s one more pretty severe side effect. It stops a beating heart — that of the baby. By the time a medical abortion takes place, the embryo has already implanted itself. It dies because the drugs cut off its nourishment and cause cramping that expels it.
Now after learning all of this, one starts to wonder why there was such pressure on the FDA to approve mifepristone. It’s hard to imagine why any woman would voluntarily undergo such prolonged pain and bleeding (unless you consider the panic factor — by the time she knows she’s pregnant, she’ll have only about three weeks to go for the "early option," and at the outset a pill sounds less terrifying than surgery). Furthermore, an ABCNEWS.com poll of early September discovered that 47% of Americans think the abortion pill should remain illegal, while only 45% wanted it legal. So what’s the driving force behind all this?
Well, the FDA cites another study done on mifepristone/misoprostol from 1991 to 1993 in urban clinics in China, Cuba, and India — all poor, allegedly overpopulated countries. The treatment was identical to that given in the U.S. However, according to this study, "the medical regimen had more adverse events, particularly bleeding, than did surgical abortion. Failure rates for medical abortion exceeded those for surgical abortion (8.6% versus 0.4% in China, 16.0% versus 4.0% in Cuba, and 5.2% versus 0% in India). There is a serious potential disadvantage of the medical method. On the whole, medical abortion patients reported significantly more blood loss than did surgical abortion patients. Slightly higher proportions of medical than surgical patients were dissatisfied (8.8% versus 3.8%). Despite the bleeding pattern and the failure rate of the medical abortion method, particularly in China, medical abortion by the mifepristone and misoprostol regimen was said by the authors of this published study to be safe, efficacious, and highly desired by and acceptable to women in developing countries." This is a little confusing. An abortion method that not only takes a human life but subjects its mother to excruciating pain, frequently to no purpose at all, and yet it is highly desirable? Who thinks that?
The Population Council does. It’s an organization established in 1952 by John D. Rockefeller III whose mission is "to improve the wellbeing and reproductive health of current and future generations and to help achieve a humane, equitable, and sustainable balance between people and resources." What this really means is developing contraceptives and abortion methods to keep the human population down — particularly in countries considered to be overpopulated, like, for instance, China, Cuba, and India. And so the Population Council, wanting this abortion option to be available in the U.S., sponsored the FDA trials of mifepristone out of its annual budget, which this year totals $76 million. Perhaps this betrays an unacceptable lack of long-term vision on my part, but I can’t help wondering how many hungry children they could feed with all that money.