Sunday, March 19, 2006

Deaths Following Medical Abortion: AP, AFP, and Reuters Get The Story Wrong

Reporting on deaths in women who underwent medical abortions, three major news organizations--AP, AFP, and Reuters--get the central, and most basic, facts wrong.

Here's a bit of background. One of the early medical termination regimens involves taking two drugs--mifepristone (RU-486, Mifeprex) and misoprostol. According to its manufacturer, ~ 560,000 women have taken RU-486 since its approval in September 2000. A total of 7 deaths have been reported in women using these two drugs. [AP reports one was a ruptured ectopic, but I haven't been able to verify that.] Of these, 4 were caused by sepsis (generalized infection), and the cause of death for the most recent 2 isn't known yet. All these deaths, and this is the key piece of information, occurred in women who used the drugs in an off-label manner.

Moving on, let's look at what the major news organizations are telling you.

First, from the AP article:

In a cluster of four cases in California, the women died from an infection of the bloodstream, or sepsis. Those women did not follow FDA-approved instructions for the pill-triggered abortion, which requires swallowing three tablets of one drug, followed by two of another two days later.

Instead of swallowing the final two tablets, the second course of pills was inserted vaginally in the four women, a so-called "off-label" use of the drug....

If you even manage to catch the fact that two different drugs are mentioned--the "abortion pill" (RU-486, mifepristone), and the another drug (misoprostol)--the article tells you that the FDA-approved regimen is swallowing (oral) three tablets of RU-486, followed by oral administration of two misoprostol tablets two days later. That is correct. However, what follows isn't. Namely, that the four women who died used an off-label regimen consisting of swallowing three RU-486 tablets, followed by intravaginal (PV) administration of two misoprostol tablets.

Second, the AFP article:

The FDA said that four women had died from bacterial infections 2003-2005 after so-called off-label use of the misoprostol, inserted vaginally, rather than orally, as indicated. The mifeprex drug in the regime was given orally, as directed.

The good news is that AFP makes it clear we are discussing a two-drug regimen. The bad news is that the information about what regimen was used--three RU-486 (mifeprex) tablets given orally, followed by two misoprostol tablets PV--is incorrect.

Finally, from Reuters:

Officials cautioned against unapproved dosing regimens. The four earlier deaths occurred after women were given misoprostol vaginally, rather than orally. The approved regimen calls for oral administration of both drugs.

"The safety and effectiveness of other Mifeprex dosing regimens, including use of oral misoprostol tablets intravaginally, has not been established by the FDA," the agency said.

Again, the regimen information is reported incorrectly. [Bonus points if you can spot the problem. Hint: read the FDA quote carefully.]

Now, it's clear that all the articles are based on this FDA press release.

This is what the FDA release says is the approved two-drug regimen for early medical termination:

The approved Mifeprex regimen for a medical abortion through 49 days' pregnancy is:

  • Day One: Mifeprex Administration: 3 tablets of 200 mg of Mifeprex orally at once

  • Day Three: Misoprostol Administration: 2 tablets of 200 mcg of misoprostol orally at once.

  • So, the FDA-approved regimen is 3 tablets of RU-486 (Mifeprex), or 600 mg, orally, followed by 2 tablets of misoprostol, or 400 mcg, orally.

    The AP article reported this one correctly; the other articles didn't go into details.

    Continuing, from the *same* release, this is what the FDA says was the [off-label] regimen used in all four cases of fatal infection:

    All four cases involved the off-label dosing regimen consisting of 200 mg of oral Mifeprex followed by 800 mcg of intra-vaginally placed misoprostol.

    So, the off-label regimen used was 1 tablet of RU-486 (Mifeprex), or 200 mg, orally, followed by 4 tablets of misoprostol, or 800 mcg, PV.

    One more time: The FDA-approved regimen is 600 mg of RU-486 (Mifeprex) orally, followed by 400 mcg of misoprostol orally. The off-label regimen used was 200 mg of RU-486 (Mifeprex) orally, followed by 800 mcg of misoprostol PV.

    All three articles correctly report that the off-label regimen involved a different route of administration for one of the drugs, misoprostol (PV vs. orally). What none of the articles mention is that the off-label regimen involved significantly different doses of both drugs. In fact, they all mistakenly report that, for both drugs, the approved dosage was used.

    If you think drug dosage is not essential information, go ahead and take an entire bottle of aspirin for a headache, or take antibiotics for only one day of a seven day course and see what happens. [WARNING! This was a (possibly bad) joke, not an actual suggestion. Don't exceed the recommended daily dose of aspirin, and always finish a full course of antibiotics. And, yes, I do know I'm belaboring the point.]

    When it comes to reports of deaths in women using RU-486 and misoprostol for medical abortions, what we should be discussing is if either one of these drugs, or both, could be a contributing factor. [So far there is no evidence for that.] But you tell me how we can be informed discussants when AP, AFP, and Reuters can't even get simple information, like dosage regimens, right. Nothing more than reading comprehension was involved in reporting this correctly. The information is clearly spelled out in the FDA press release. How can we expect accurate reporting of truly complex issues (how do we determine if the drugs are involved? What would a hypothetical mechanism of action be?) when the basics are misreported?


    At 4:24 AM, Anonymous Anonymous said...

    Here's Jane Galt's thoughts on

    "Should the FDA ban RU-486?

    Jeffrey Alan Miron says no.

    Obviously, if you don't think that the FDA should exist, the answer is no. But assuming, arguendo, the validity of the FDA, I might be willing to argue that the answer is "yes". Not because of some abortion thing, but because in the course of researching the question "Could RU-486 be used to undetectably induce abortion were it made illegal?" I realized, to my great surprise, that the evidence seems to indicate that RU-486 is a poor alternative to surgical abortion.

    Women who have used RU-486 report much less satisfaction with the experience than women who have surgical abortions--particularly those who have had surgical abortions before. Over 10% of them have to have a surgical abortion anyway, and there's a substantial risk that the abortion won't work, at which point there is a high risk of birth defects (hence all the follow-up abortions). It's more painful, more bloody, lasts longer, and is apparently more psychologically traumatic. It takes more doctor's visits, and costs more.

    There are only two potential benefits. One is that nurses can be used instead of doctors to monitor much of the proceedings (women have to sit in the doctor's office for hours waiting for the thing to take)--but the FDA is hardly supposed to be in the business of approving drugs because they're better for the prescribing physicians. And the other is the political aspect in the US. RU-486 doesn't need a special surgical clinic, meaning that individual doctors can prescribe the stuff, circumventing Operation Rescue's theatrics.

    But in practice, apparently almost no one does . . . some because they don't want to be in the abortion business, some undoubtedly out of fear of reprisal, but most apparently just don't want to mess with it. It's tedious, requires somewhere to stash patients while you wait for the drugs to have their effects, and involves rather more emotional freight than most procedures performed by GPs. So while in theory, RU-486 may be a way to do an end run around the pro-life movement, in practice, it doesn't seem to be working very well.

    Of course, the FDA's investigation of deaths may well be--even probably is--at least in part politically motivated. But that doesn't necessarily mean they're making the wrong decision."

    I wonder what you think of the argument.

    At 4:25 AM, Anonymous Anonymous said...

    Sorry, I forgot that I had to tell you who I am: Liz from I Speak of Dreams

    At 6:01 AM, Blogger Unknown said...

    There are a couple of things that should be made note of...

    1. Doctors are allowed to prescribe medications for off label uses and in off label quantities; for instance, certain medications are sometimes used to induce labor although the manufacturer has not approved them for that use.

    2. There has been plenty of misinformation about how and when RU-486 is supposed to be used. Planned Parenthood changed their directions of usage for this drug several times on their site.Check out the link below; they are still telling women that the drug can be taken up to 56 days after conception when the manufacturer says 49 days according to your information.

    The real question here is when will doctors and specifically Planned Parenthood get their information straight before they give it out to women seeking abortions?

    At 3:23 PM, Blogger Emily said...

    I actually heard someone on CNN call RU-486 the "morning after pill."

    Come on, is a little fact-checking too much to ask?

    At 9:12 PM, Anonymous Anonymous said...

    Hi - Liz/Anonymous. Can you please clarify if those are your comments or someone else's? Maybe I'm just dense, but it's hard for me to tell if that's your argument or someone elses. Want to make sure before replying.


    At 11:53 PM, Blogger ema said...


    Do you have a link to Jane Galt's post? She mentions that she researched RU-486, but there are so many mistakes in her post that, before I respond, I need to make sure the misinformation comes from her sources, not from her.


    There is only one FDA-approved regimen (up to 49 days), but there are several other regimens in use (up to 56 days, or 63 days). These have been studied and proven safe and effective. [Of course, drugs/dosages/regimens also vary, but we're just focusing on timing now.]

    Doctors and PP already have their information straight. The real question is when [and how] will the public get correct medical information? Don't have the answer to that one, but I'm working on it.


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