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abortion, abortion pill

The new “study” on medical abortion reversal is total b.s. Here’s why.

There is a new study on “abortion pill reversal” and it is bullshit.

It’s a terrible study, but as it advances a forced-birth agenda we can expect forced-birth politicians to salivate and cackle and use it to brew more laws that amount to experimenting on women.

I was made aware of the study because it was reported by MedPage.

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Why a medical site would report on such a low quality piece of drivel is unknown, unless they have a secret anti-abortion agenda or they are using the plight of women to troll for page clicks? Anyway, MedPage made sure the quotes from the horrible people at The American Association of Pro-Life Obstetricians & Gynecologists, who make it their business to spread lies about abortion and to report women with miscarriages for suspected murder, were up front and the quote from ACOG, whose business is to spread facts about abortion, is buried at the end. Hey, everyone reads to the end of an article, right?

For fucks sake MedPage. I mean really.

The “study” was published in that anti-abortion shit aggregator called Issues in Law and Medicine. I’ve written about this “journal” previously. This is basically a hate journal that exists solely to publish shitty studies to advance extreme-right conservative agendas. Here are their winners from Spring 2018.

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Or these treats. Note how they publish the American College of Pediatricians who are essentially a hate group of pediatricians?

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Sadly, Issues in Law & Medicine is indexed in the National Library of Medicine, which imparts an air of respectability. I don’t think hate journals should get that privilege, but hey, that’s me. I’m not saying don’t publish your drivel, but a journal that exists to push  anti-science agendas (they love the anti vaccine screed too) by publishing bogus studies is not a journal, it is propaganda. The obvious bias should lead to exclusion.

OK, back to the “study”

It’s called A Case Series Detailing the Successful Reversal of the Effects of Mifepristone Using Progesterone and claims a 64% success rate at reversing the medical abortion regimen when given after the first part of the regimen, the oral medication mifepristone. That sounds promising, until of course you actually read the study.

The authors used data from women from the United States and “several other countries” who called an “informational hotline” about abortion reversal. We are not told which countries.

After hearing some kind of information (not detailed in the paper) but I am sure was totally fact based (inside sarcasm emoji) the women who chose to proceed were referred to “physicians and mid-level practitioners” for treatment. The women apparently gave “written informed consent for treatment to their respective treating medical professionals that included permission to track their data,” but the study also had an IRB “waiver” from the University of San Diego.

I am struggling to make sense of this.

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The authors obtained consent for giving the medication, not something normally done. Medical consent to take a drug is not consent to do reserach. They also used this medical consent to get consent to access identifable information, which seems unethical if you are promising to “save” a now wanted pregnancy with your experimental therapy. If they could get consent to take the medication and consent to collect data then why could they not get formal IRB consent to collect the data?

An IRB waiver also generally means there is minimal risk, but this is an experimental drug regimen on a vulnerable popluation (pregnant women and fetuses are considered a vulnerable research population). And an IRB waiver for a study with 325 providers from multiple countries? That is just not something that is done.

I have communicated with three different people who sit on Institutional Review Boards. All three found this sketchy.

I am struggling to understand how a observational study of a highly experimental regimen on a vulnerable popluation from  multiple countries that collects sensitive personal information could be elgible for an IRB waiver. If they were getting consent to give the medication why not get consent to be in the study? Except, of course, study consents would have to be reviewed and any inflammatory anti-abortion information would not be allowed.

If you were doing abortion reversal out of the goodness of your pro-life heart you wouldn’t be documenting all this data so well. Do the authors really expect us to believe that 325 different providers somehow all decided to tract data just cuz? Honestly, this reads like a non randomized clinical trial that used some smoke and miorrors to get around consent. At the very least it is a data base on a vulnerable population in multiple countries at multiple centers with highly sensitive information that somehow didn’t require formal IRB consent.

The Protocol

A total hodgepodge of progesterone administration that included “intramuscular injection of progesterone in oil, oral administration of micronized progesterone, vaginal use of oral micronized progesterone capsules, compounded micronized progesterone vaginal suppositories, progesterone vaginal gel and progesterone vaginal suppositories.”

There were a significant number of women lost of follow-up (27%) including 57 women who changed their minds and once again took mifepristone.

There is no basic demographic data beyond gestational age, mode of delivery of progesterone, amount of progesterone administered, “birth defects” and gestational age at delivery. We don’t know maternal age, race, country, pregnancy history, smoking history, body mass index, or really anything about these women, meaning we can’t actually draw any conclusions.

The Outcome

The data, such as it is, is no shocker. When just oral mifepristone is administered and there is no misoprostol given the mifepristone fails 25-50% of the time, which is what the “study” shows. The failure rate at 5-7 weeks is well within what is expected if you do absolutely nothing after giving oral mifepristone.

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Hard to comment on the rates at 8 and 9 weeks given the ethics issues, the drop out rates, the lack of basic demograhic data, and the fact that mifepristone alone is more successful earlier on the in the pregnancy.

This Study Adds…

Fuck all.

Mifepristone alone fails 25-50% of the time. This paper adds nothing to what we know and offers no proof that progesterone does anything. While the idea is not bioloigically unsound, testing it outside of an IRB approved protocol without informed consent is unethical.

If a patient starts a medical abortion and changes her mind before she takes her misoprostol the recommendation is still to simply do nothing and to watch and wait.

 

 

Discussion

14 thoughts on “The new “study” on medical abortion reversal is total b.s. Here’s why.

  1. Hey doc, love your writing. Your spell check is prob the culprit, but I’m sure you will want to correct this one: “Here are there winners from Spring 2018.”

    Nienke Gul

    Sent from my iPhone

    >

    Posted by Nienke Gul | April 7, 2018, 6:59 pm
  2. Thanks a lot. I really needed another reason to get pissed off tonight. 🙂 That being said, I am glad you brought this to light. I can’t understand why they actually didnt get more demographic data – other than the reason you stated regarding inflammatory anti-abortion information. ( aka: Facts)

    Posted by akbright | April 7, 2018, 8:09 pm
  3. Reblogged this on Dead Wild Roses and commented:
    Latest “science” from the anti-female forces…

    Posted by The Arbourist | April 8, 2018, 6:58 am
  4. testing

    Posted by Ted | April 8, 2018, 12:54 pm
  5. Here’s an interesting tidbit: the article mentions a 1989 study in rats which it claims “suggests” that the abortion-reversal should work. Rats were given progesterone along with RU486; none of their pregnancies aborted, so the authors of this new study claim this supports the reversal-idea.

    BUT in the rat study, the rats were given the progesterone AT THE SAME TIME as the RU486, and they were given FIFTY TIMES as much progesterone as RU-486. So, the RU-486 likely never bound to its receptor–the progesterone likely blocked it. This is VERY DIFFERENT from trying to use progesterone to REVERSE the abortifacient effect of RU486 AFTER the RU486 has already bound to the receptor.

    Which raises an interesting question: WHY are the right-to-lifers not doing animal studies to validate the reversal regimen??? We understand that human trials would be slow, since it’s hard to find subjects, and no one would want to be in the control group. But if the abortion-reversal pushers were serious, they would be doing animal studies already.

    Posted by Ted | April 8, 2018, 1:01 pm
  6. Wow! This literally makes me sick to my stomach. 😦

    Posted by madmegsblog | April 8, 2018, 2:34 pm
  7. While these anti abortion extremists carry on this absurd agenda, the government and big pharma cause millions to slowly die by no access to medical, dental care, poor nutrition, or easy access to addictive painkillers. Simple minds love the sound of this anti abortion propaganda. They refuse to see the larger efforts of big money to depopulate this country

    Posted by Flora Marr | April 8, 2018, 4:35 pm
  8. Also, the elephant in the room and the underlying true problem with all this – there is essentially no demand for “abortion reversal”. No respectable abortion provider – which is 99%of abortion providers in the US, stereotypes and the horrid Kermit Gosnell aside – will provide an abortion to a woman who seems to have a doubts. I’ve provided literally thousands of abortions over the last decade, and I have only seen 4 women return after starting the process with cervical dilators having changed their mind. I have never had a woman come back after taking the mifepristone saying she changed her mind. I have had sessions with women who seemed unsure, and in those cases sent them away without starting the abortion to spend more time thinking before doing anything. The fiction that there is a need to have a method for reversing abortion as though this is a common thing makes me furious.

    Posted by rebajea | April 9, 2018, 9:39 am
  9. I’m a medical librarian, writer, and editor. I’ve spent almost forty years distinguishing good science from crap. This “journal” is known to be junk, and these people are getting craftier all the time about simulating real research in ways that the public generally can’t detect. As the above commenter mentioned, these partisan anti-reproductive freedom fanatics are taking lessons from the tobacco industry in obfuscation, confusing the public, and outright deception. This is only going to get worse as the public gets convinced that anything published in a peer-reviewed medical journal must have been vetted for accuracy. No. Just….no.

    Posted by Sara | April 12, 2018, 7:02 pm
    • Peer review is only as good as the peers who do the reviewing.

      Posted by Ted | April 13, 2018, 3:09 am
      • It’s not nearly that simple anymore with the rise of crappy open-access journals that use their own staffs for “peer review” and create phony front groups to give the deceptive impression that they are outside reviewers.

        Posted by Sara | April 15, 2018, 11:59 am

Trackbacks/Pingbacks

  1. Pingback: The new “study” on medical abortion reversal is total b.s. Here’s why. | Dr. Jen Gunter | Second Hand Outrage - April 9, 2018

  2. Pingback: Links 4/11/18 | Mike the Mad Biologist - April 11, 2018

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