Dangers inherent in this method of abortion are evident in precautions used in other countries, for example France. The Food and Drug Administration based its 1996 finding that drug-induced abortion using mifepristone and misoprostol (“M/M”) was “safe and effective” on results involving a subgroup of women (1,681) in French trials. M/M abortions in France are performed at government-operated hospitals and clinics, typically with or adjacent to emergency room facilities. Women are screened for numerous medical conditions that rule out use of the two drugs.
Ultrasound is used to determine gestational age and to rule out tubal pregnancy. After women are given prostaglandin (e. g. , misoprostol), they are monitored on site for approximately four hours so that allergic reactions, cardiopulmonary “events,” hemorrhaging and the like can be treated promptly before they become life-threatening. A 1990 directive jointly signed by the French Republic’s Director General of Health, Director of Hospitals and Director of Pharmacy and Medication, states that whenever prostaglandins are given “in association with RU 486” the “following technical conditions … e indispensable and are to be followed:
… b) The doctor must ensure that diagnostic instruments and machines are close by, such as electrocardiogram equipment and particularly resuscitative cardiopulmonary equipment (including nitrous oxide and injectable calcium antagonists and a fibrillator).
… c) [C]linical observations and blood-pressure readings every half hour are indispensable for several hours following the administration of these drugs. Whenever there is chest pain, an electrocardiogram should be taken on the suspicion of rhythm troubles and in case of significant lowering of blood pressure” (“Letter”). In Sweden, women are “supervised by the midwife for 4 to 6 hours at the outpatient clinic” (Bygdeman). In China “the emphasis on close medical supervision is well accepted. … It is stressed that misoprostol should be taken in the clinic and followed by several hours of observation” (Wu).
The long observation is one reason that staffs in some large hospitals in China are growing reluctant to prescribe the drug combination: “The number of medical abortions has decreased recently in some of the large hospitals. The staffs were too busy to handle the procedure (more counseling, more visits, and observation), and they also have to manage the referred cases with serious side effects and complications” (Wu 199). Searle, which manufactures misoprostol under the brand name Cytotec, has consistently opposed the use of Cytotec for labor induction and for abortion.
An August 23, 2000 letter from Searle, posted on the FDA’s website, reiterates its opposition to these off-label uses and lists “serious adverse events” that have been reported: “maternal and fetal death; uterine hyperstimulation, rupture or perforation requiring uterine surgical repair, hysterectomy or salpingo-oophorectomy; amniotic fluid embolism; severe vaginal bleeding, retained placenta, shock, fetal bradycardia and pelvic pain. ” The Cytotec patent expired in July 2000.
The FDA proposed modest precautions. The private, less regulated health care system of the U. S. cannot offer women taking M/M the same level of safety unless the drugs are given, and women monitored, in settings like hospital out-patient facilities. It was widely reported in June 2000 that, nodding to these safety concerns, the FDA proposed making mifepristone available only to licensed physicians trained in surgical abortion, trained and certified in ultrasonography and in the use of M/M under an FDA-approved curriculum.
Prescribing doctors also would need to maintain admitting privileges at a hospital no more than one hour from their main office (“Release”). Inexplicably, the FDA-proposed protocol did not mandate on-site observation after taking misoprostol, although this protocol is followed in France, China, Sweden, and in the United Kingdom and is the common practice virtually everywhere the drug combination is used. Final approval by the FDA ignored safety concerns: Between June and September 2000, something caused the FDA to relax even these modest precautions.
Under the final approval issued September 28, 2000, prescribing doctors need only sign an agreement with a distributor of mifepristone that he/she can do the following: assess pregnancy duration accurately; diagnose tubal pregnancy; provide surgical intervention OR have a referral arrangement with an abortion provider; assure patients access to medical facilities equipped to provide blood transfusions and resuscitation. Additionally, doctors must see patients at 14 days and report all on-going pregnancies, serious adverse events, hospitalizations and transfusions.