Anti-Abortion Folks Pretty Sure FDA Hiding Pile Of Dead Abortion Pill Patients Somewhere

Abortion
Anti-Abortion Folks Pretty Sure FDA Hiding Pile Of Dead Abortion Pill Patients Somewhere
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Medication abortions are safe. Really, really safe. They are safer than Penicillin and Viagra, and a lot of other medications we take. This is not a narrative those who oppose abortion are very happy about. They would like medication abortions to be incredibly dangerous and likely to result in death or severe illness or injury, so that people will not take them and the government will not allow them to be prescribed over the internet.

But unfortunately for them, and fortunately for the rest of us, this is not the case. Again, medication abortions are extremely safe, and pretty much every statistic you can find anywhere will tell you so. The incidence of adverse events with the pills are so low, in fact, that in order to dispute them, a bunch of anti-abortion people got together and did a study on the "discrepancies" between the numbers of adverse events reported by various sources for2009 and 2010.


The gist of what they told Fox News (natch) is that the data the FDA used to determine that the abortion pill was safe enough to prescribe via telemedicine is flawed because its data from 2009 doesn't match up with another study done that year, or reports obtained through the Freedom of Information Act. Of course, all the incident numbers were incredibly low.

Researchers were able to compare 2009-2010 data from the FDA's online reporting system, actual AE reports obtained via the Freedom of Information Act, and those uncovered by a previous study by Kelly Cleland and others utilizing data from Planned Parenthood.

"There are significant discrepancies in the number of AEs and total AERs reported for 2009 and 2010 mifepristone abortions identified by Planned Parenthood as reported by Cleland, those in FAERS [FDA Adverse Event Reporting System], and those provided by FOIA, impugning the reliability of FAERS to evaluate the safety or efficacy of mifepristone abortions at a time when the FDA is under pressure to eliminate REMS [Risk Evaluation and Mitigation Strategy] on mifepristone," the authors concluded.

Out of all of the data sources, the Cleland study reported the highest number of adverse events that year (1530), while FAERS reported 664 and the FOIA report gave them 330. There are a variety of reasons for this, starting with the fact that FAERS is really only meant to track unusual side effects. Oddly enough, however, they looked at this data and decided the thing that concerned them was the FDA and others continuing to use the numbers from the Cleland study to show that medication abortion is safe, because that study only reported adverse events that were actually reported to someone, rather than tracking every one of the individual 200,000 abortion-havers down to see if they maybe had some side effects they didn't tell their doctor about.

From the study, "Mifepristone Adverse Events Identified by Planned Parenthood in 2009 and 2010 Compared to Those in the FDA Adverse Event Reporting System and Those Obtained Through the Freedom of Information Act":

We are concerned that FDA and others will continue to rely on Cleland's statement, “significant adverse events or outcomes were reported in 1530 (0.65%) cases” to claim that the complication rate for the abortion pill regimen is low. Although Cleland's paper is a study of over 200 000 abortions and is cited extensively in support of the safety of medical abortion the analysis excludes the most common adverse events (retained products of conception and hemorrhage not requiring transfusion). Additionally, Cleland's reported complication rate of 0.65% is only a report of the complications known to Planned Parenthood. Cleland does not report the percent of patients lost to follow-up.

So they're saying there are discrepancies, and the issue is with the source providing the highest number of adverse events, because the mere existence of these discrepancies means the number of adverse events could hypothetically be higher than that.

Absolutely none of this makes any sense, as the American College of Obstetrics and Gynecology explained to Fox News:

"ACOG supports the FDA’s recent removal of specific restrictions on mifepristone, a decision that was based on careful review of the extensive data. This study contains potential methodological flaws and likely inappropriately drawn conclusions that contradict the decades of science and practice demonstrating the safety of medication abortion in the US."

ACOG did not respond when asked for specifics on potential flaws in the study. Dr. Mitchell Creinin, who co-authored the Cleland study, cautioned against gleaning too much from the study.

"FAERS is a passive reporting system primarily meant to catch rare outcomes," said Creinin, who currently serves as director of family planning at UC-Davis.

"With such large numbers of medical abortions, small differences in numbers means nothing. FAERS did not identify any volume of unexpected outcomes, which is really the main goal of reviewing that data source.
[...] The findings from the Cleland study are very much in line with the rest of the peer-reviewed medical literature. For this and other reasons, I am confident that even if small differences exist, they are not massive as the paper attempts to suggest."

One of the co-authors of the study was Dr. Donna Harrison. This is not her first time to the Let's Make Shit Up About Abortion Rodeo. Harrison is the executive director of the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG), a small group of anti-abortion obstetricians and gynecologists who think forcing people to have babies against their will is a swell idea. She has been the source of a lot of misinformation about both abortion and birth control, notably claiming the morning after pill causes abortions, which it does not.

The purpose of the article and the study, however, was not to provide a glimpse into a serious issue with adverse event reporting, but rather to cause confusion about whether or not the data is reliable, allowing people to claim the statistics showing medication abortion is safe are flawed and give them leverage and credibility to try to make telehealth abortions illegal again.

[FOX]

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Robyn Pennacchia

Robyn Pennacchia is a brilliant, fabulously talented and visually stunning angel of a human being, who shrugged off what she is pretty sure would have been a Tony Award-winning career in musical theater in order to write about stuff on the internet. Follow her on Twitter at @RobynElyse

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