Right-wingers have been beside themselves over a small cluster of deaths from toxic-shock-like syndrome, caused by infection by certain specific microorganisms, in patients who had obtained medical abortions using RU-486 or a similar preparation. Specifically, there have been 4 such deaths from 2003 - 2005, plus one previously; the most recent 4 all involved women in California who had been given an “off-label” vaginal suppository for Mifepristone Misoprostol (one of the two drugs used in the most-common medical abortion procedure), as opposed to taking it orally. These similarities prompted concern among health officials; the American College of Gynecology, which had endorsed the off-label usage, convened a study panel on the issue, and Planned Parenthood stopped using the vaginal-delivery method (which is otherwise more comfortable, easier, and more effective than oral delivery). The anti-choice contingent, however, of course began trumpeting the incidents as “proof” that all medical abortion was “unsafe”.

This “proof” suffers somewhat from certain facts: (a) no clear cause of the toxic syndrome in these cases has ever been determined; (b) the medication has been used safely, orally and vaginally, by over half a million women, as compared with only 5 deaths; (c) the death rate for medical abortion - as for every other form of early- to mid-term therapeutic abortion - is lower than that for childbirth, making abortion in general, and RU-486 in particular, the best choice for women from a safety perspective. Now, the results of ACOG’s review of the situation show that this safety differential favors RU-486 even more than was previously known.

From a summary of the report:

Between 1977 and 2001, C. sordellii genital tract infections and toxic shock-like syndrome were reported in 10 women, among whom the preceding events were childbirth (8) and medical abortion (1), reported from Canada in 2001. Another four cases were identified between 2003 and 2005, all involving women who had undergone medical abortions using the common “off-label” regimen of 200 mg oral mifepristone followed by 800 mcg vaginal misoprostol, said Dr. Fischer, who was the lead author of the published report of those four cases (N. Engl. J. Med. 2005;353:2352–60). . . .

Dr. L. Clifford McDonald, also of the CDC, reported that three additional cases of fatal toxic shock-like syndrome following medical abortion are currently under investigation by the CDC. Each of these differs in various ways from the previous five: One, in a woman who had taken oral mifepristone followed by vaginal misoprostol, was associated with C. perfringens, not C. sordellii. A second case, also of C. perfringens, involved the use of misoprostol with the cervical dilator Laminaria, not mifepristone. The third, although initially reported as being associated with a medical abortion, could not be confirmed as such. Moreover, investigation has shown pathologic findings consistent with appendicitis, serositis, and pneumonia, he noted.

Meanwhile, there have been three reported cases of toxic shock-like syndrome following spontaneous abortion, all involving C. sordellii. One of these patients was coinfected with C. perfringens. Another patient, in whom the C. sordellii did not possess the genes encoding the lethal toxin, was the only one who survived.

In other words, there have been 10 known deaths of this type in patients who either miscarried spontaneously or gave birth (plus one infection that would likely have been fatal if it had not involved a luckily mutant strain of bacteria); there have been only 5 in patients who had medical abortions (and three more deaths of patients who had medical abortions but where the cause of death is not yet known to be the toxic-shock-like syndrome and where other conditions may be present). Interestingly, the very next article in the ACOG newsletter from which this information comes warns about a “rising tide” of infections in the general public - not abortion patients - by organisms of the type implicated in these deaths.

Death rates (per 100,000 women at risk) in these cases are hard to establish, since the deaths in pregnancy run back as far as 1977 and include data from Canada. However, a total of about 560,000 medical abortions has been performed since 2000, with only 5 known deaths by this mechanism, giving it a risk of death of about 0.9 per 100,000 (about 1.6 per 100,000 if all three unknown cases are attributed to the abortions). The CDC’s estimate of abortion deaths overall is less than 1 per 100,000 pregnancies. The CDC gives the overall risk of maternal death in childbirth in the US, from all causes, not only Clostridium infection, as 7-8 deaths per 100,000 live births (varying tremendously by ethnic group). That is to say, medical abortion using RU-486 or its components has a death rate 5 to 8 times lower than pregnancy itself, and abortion by all methods is about the same. More to the point, there have been more deaths by Clostridial infection in women who did not have abortions than there have been in women who did. (This by itself does not establish relative risk, since we do not know the exact rate of death during pregnancy by toxic-shock-like syndrome separately, but since the anti-choicers never present the relative risk in abortion cases - constantly going on about “five deaths!” without ever mentioning “560,000 safe abortions!” - I gather this doesn’t matter to them.)

The bottom line, as ACOG itself concludes:

“None of it is common. Clearly there are cases related to pregnancy that have nothing to do with pregnancy termination, and then there is the smaller group of nonpregnant cases. It’s hard to find cause and effect here,” Dr. Ault said in an interview following a 1-day meeting on emerging clostridial disease sponsored by the Centers for Disease Control and Prevention that he attended on behalf of ACOG.

Beyond this, it is safe to say that there are no data indicating that medical abortion, even by off-label vaginal use of mifepristone Misoprostol, is more likely to cause death than other forms of abortion, and it may actually be safer; the only available data indicate that oral mifepristone is actually much safer than other forms of abortion; and medical abortion is vastly safer than pregnancy or childbirth. The most recent study only confirms these facts, which were obvious from the original data. Rather than indicating a clear risk, it leaves open the question whether there actually is any risk from medical abortion at all (given that Clostridium spp. infections have occurred more often in non-aborted pregnancies than aborted ones, and are widespread in the population at large, the cluster of 4 deaths in California women using vaginal mifepristone could be just a fluke - and this latest review does not prove otherwise).

Right-wing squawking on the issue is clearly a made-up scare; there simply is no factual evidence that mifepristone Misoprostol is unsafe no matter how it is used, and clear evidence that in some forms at least it is safer than any alternative. That is the message that needs to get out, and it is being deliberately distorted.

Hat tip: The Well-Timed Period, who has a good analysis.

UPDATE: Corrected the references to vaginal Misoprostol. Just to be clear: the standard, FDA-approved preparation for “RU-486″ involves two drugs, Mifepristone and Misoprostol, both given orally, in that order. Some providers found that giving Mifepristone orally, followed by a larger dose of Misoprostol as a vaginal suppository, worked better and had fewer side effects; ACOG officially endorsed this usage, and Planned Parenthood - the largest single provider of abortions - implemented it in its clinics. The vaginal administration, however, has not been officially certified by the FDA (not only the drug, but the precise method of its administration and the conditions for which it is used, are covered by FDA certification); once a drug has been declared legal for prescription, there is nothing to stop doctors from using it in ways it has not been tested for, and this sort of thing is common practice with many drugs, but such “off-label” uses are not validated by FDA testing. It’s the off-label vaginal administration of Misoprostol that has been implicated in the deaths noted above, not Mifepristone; I originally had the reference backwards. My apologies.