Jettisoned Ultrasound and Training Requirements May Have Prevented Tragedies

Deaths, Ruptured Tubes, Heart Attacks
Among RU486 Users, Distributor Reports

By Randall K. O'Bannon, Ph.D.
NRL-ETF Director of Education & Research

For years, pro-lifers have warned that the approval of RU486, the French abortion pill, would mean not only the cruel death of innocent, yet-to-be-born children, but that their mothers could well be endangered. Sadly, on April 18, 2002, the Washington Post and the U.S. Food & Drug Administration (FDA) provided confirmation that those warnings were valid.

Two women who used the two-drug abortion technique are dead and others have been injured. Yet rather than call for tighter controls in the face of these tragedies, the U.S. patent holder has actually called for relaxed standards in administering the drug.

According to the Post, at least six women suffered serious " illnesses" after taking the drug. Two died!

Three women with ectopic pregnancies had their tubes rupture after receiving the abortion pill and a prostaglandin, misoprostol, which is used to stimulate powerful uterine contractions to expel the dead or dying child. One of those women hemorrhaged so badly she bled to death.

Two other women developed serious bacterial infections, which proved fatal in one case. The sixth woman, a 21-year-old, had a heart attack three days after taking the two-drug combination. She recovered, but questions remain about the connection of the drugs to the incident.

Danco Laboratories, the firm distributing the drug in the U.S., issued a carefully worded letter dated April 19. Danco downplayed the "illnesses," but reminded doctors that the two-drug abortion technique was not effective in situations of ectopic pregnancy and that they should follow protocol and monitor risks.

According to the Post, the FDA, which approved the drug in 2000 during the last year of the Clinton Administration, helped to craft the letter. The FDA reproduced the letter on its website, along with a series of its own questions and answers about the incidents and FDA policy.

Repeatedly, Danco and the FDA tried to assert there was no established causal link between RU486 and the medical crises that followed. However, for anyone who understands the chemical abortion process and the properties of the drugs involved, this seems disingenuous.

No one is saying that either RU486 or the prostaglandin caused the ectopic pregnancies, which happen when the embryo implants in the fallopian tube instead of the uterus. But the real question is whether these drugs or the way they were administered led to the tubal ruptures and the hemorrhaging that took at least one woman's life.

For example, misoprostol (the prostaglandin used as the second drug in the chemical abortion process) stimulates powerful uterine contractions to dislodge and force out the developing child. Whether misoprostol's chemical actions caused or contributed to the tubal rupture, or whether the fallopian tube simply ruptured as a result of the child's outgrowing the space, neither Danco nor the FDA says.

They may not know. It may be correct under such circumstances to say that no causal link has been established, but hardly right to say there is any clear exoneration of the abortion drugs.

What is undeniable, however, is that these women's situations wouldn't have reached this dangerous point if the FDA had required doctors to give ultrasound examinations prior to dispensing any drugs. As late as the summer before giving the drug final marketing approval, the FDA planned to require ultrasounds to guard against just such outcomes. But the drug's sponsor and its sympathizers in the medical establishment talked the FDA out of it.

An ultrasound would not only have given an accurate date of the pregnancy (which is important, since the drug's "effectiveness" diminishes as the baby grows and develops), but would also have given a clear indication of the child's location, i.e., whether or not this was an ectopic pregnancy. Had the FDA stuck to its original policy, if the pill's promoters hadn't objected to that policy, these three women probably wouldn't have been injured and one of those women probably wouldn't have died.

Danco and the FDA are right to point out that infection is a possibility whenever there is bleeding, whether from menstruation, childbirth, or abortion. What they don't mention, however, is that the unique conditions of chemical abortions using drugs such as RU486 and the contraction-inducing prostaglandin (PG) mean that there is extended and extensive bleeding, prolonging the time of exposure.

On average, women who have RU486/PG abortions lose four times more blood than they would from a standard suction curettage abortion. Bleeding that goes on for 10-12 days is normal, but some women bleed for a month or more. (For further details, see Dr. Joel Brind's article in the December 2000 issue of NRL News, or the NRL Educational Trust Fund's fact sheet on RU486.)

RU486 and misoprostol may not cause the infection, in the strictest sense of the term, but they create conditions that may cause doctors to overlook the signs of infection before it is too late. Nausea, vomiting, diarrhea, abdominal pain - - symptoms that normally might prompt a doctor to investigate - - are expected side effects of chemical abortions, and so are not recognized as anything remarkable.

While infections usually prompt fevers, this is not always the case, making it even more difficult, from a casual physical examination, to distinguish between a bacterial reaction and the common course of the chemical abortion.

While we do not know many details about the second woman who suffered an infection, we do know that the Canadian woman who died from a Clostridium infection after her chemical abortion in August 2001 had a strain that did not produce a fever, but mimicked the standard sequelae of a "successful" RU486/PG abortion (see NRL News, October 2001). Whether the special training requirement that the FDA also jettisoned along with the ultrasound requirement would have helped these doctors better recognize the signs of these infections, or whether this is an unavoidable risk associated with this type of abortion, is unknown.

Misoprostol was originally prescribed for the treatment of ulcers among those who take a large quantity of non-steroidal anti-inflammatory drugs (NSAIDs, in medical lingo), such as aspirin. Like other prostaglandins, however, misoprostol also stimulates the contraction of smooth muscles, such as those found in the uterus and stomach. This is why it has been used for abortion and also why it often prompts nausea, diarrhea, and vomiting.

Heart muscle has some of the properties of smooth muscle, and there is some evidence that prostaglandins have effects there as well.

Two prostaglandins used early on in conjunction with RU486 in France, gemeprost and sulprostone, were largely abandoned after one of the four women suffering heart attacks died in 1992. Most abortionists turned to misoprostol, because it was believed to be milder and safer.

While misoprostol may be milder than the stronger prostaglandins, it is not clear that this in itself prevents it from prompting similar cardiac difficulties. Despite the fact that those with signs of cardiovascular disease or high blood pressure were excluded from the trials, about a third of the women participating in U.S. trials of the RU486/ misoprostol combination saw their heart rate decrease (18.2%-21.3%) or increase (11.8%-14.1%) by more than 20% after taking the prostaglandin. Some 1.5%-1.7% of these carefully screened research subjects recorded high blood pressure readings after taking the misoprostol while a few reported heart palpitations.

While transient, these results suggest that misoprostol, like other prostaglandins, does affect the cardiovascular system. There may not be reason to think that misoprostol induces heart attacks in normal, healthy women, but both current evidence with misoprostol and recent history with prostaglandins as a class do seem to call for special caution with women who may have any personal or family history of cardiac or blood pressure issues. The more drastic consequences may not have been recorded in the trials simply because more susceptible patients were excluded.

Heart disease or a family history of cardiac problems is not listed as a contraindication (conditions that indicate a patient should not take a given drug) on current U.S. labeling, though the "Precautions" section says there is "no data on safety and efficacy in women with chronic medical conditions such as cardiovascular, hypertensive, hepatic, respiratory, or renal disease." Abortionists who prescribe the two-drug combination are required to sign an agreement certifying that they have "read and understood" prescribing information which contains this precaution, but it is unclear what guidance physicians would be expected to draw from this noncommittal language.

One major unanswered question is why the FDA or the drug's sponsor originally thought it advisable to exclude those with cardiac or blood pressure problems from the trial but, once the abortifacient combination was approved, decided not to put such women on the list for which the drug was contraindicated. If it was thought to be safe, there should have been no reason to exclude those women from the trials. If it was not safe, then data from the clinical trials, which was supposed to have excluded such patients, should not have been able to establish that it was safe. (And, as mentioned above, there was some evidence that the caution was warranted.)

Even with the decision to drop the formal exclusion of those with a history of cardiac problems, these women might have been afforded some measure of protection had the FDA gone ahead and instituted its planned requirement that those offering these chemical abortions undergo special training. While one can only speculate about what this training might have entailed, it seems reasonable to think it might have addressed the possible cardiovascular effects of prostaglandins more directly, and thereby made abortionists more cautious about prescribing the drugs to patients with this type of medical history. Again, the training requirement proposed by the FDA was dropped after the Population Council and its pro-abortion allies in the medical community objected.

An objective observer might think these incidents would cause the FDA and RU486's distributor to at least rethink the decision to jettison the ultrasound and training requirements that were initially proposed, if not to question the original decision approving the drug. However, researchers for the Population Council (the U.S. patent holders for the drug) have recently called on government authorities to drop some of the few real safeguards that remain, even going as far as arguing that the whole procedure might be done at home.

What these incidents show, however, is that the chemical abortion process is inherently a risky one. A doctor who does not do an ultrasound may miss an ectopic pregnancy until a tube ruptures and a woman hemorrhages. An abortionist expecting to see a woman in severe pain, with cramping, nausea, vomiting, and diarrhea, may not immediately recognize the signs of infection.
A screener who does not understand the activity of prostaglandins on heart muscle may not know to check for a family history of cardiac disease. And women, who've been told the process is simple and safe, may end up fighting for their lives.