Intent to deceive: The “Invent-Your-Own-Facts Approach”

PART III: Mifepristone lawsuit

🔆This is Part III of a multi-part series examining the mifepristone lawsuit to be heard by the Supreme Court of the United States. Read the rest of the series here.

In the 23 years since the U.S. Food and Drug Administration (FDA) first approved mifepristone, the drug “has become more common worldwide.” [1] We now have research from across the globe showing that mifepristone is “extremely safe and highly effective.” [2] There have been “hundreds of clinical trials using mifepristone over two decades,” and of these, “more than 400 were randomized controlled studies, which are considered the gold standard of research design.” [3]

Inexplicably, the anti-abortion plaintiffs, who sued the FDA in order to restrict or eliminate legal access to mifepristone, claim that there is a “lack of accurate information on adverse events.” [4] In the lawsuit, one plaintiff group, the Association of Pro-Life Obstetricians and Gynecologists (AAPLOG), curiously claims to have had “to compensate for this lack of information by conducting their own studies and analyses.” [5] The group claims that the “diversion of time, energy, and resources” in order to conduct their own research “comes to the detriment of other advocacy and educational efforts of Plaintiff AAPLOG, including their efforts about the dangers of surgical abortion, the conscience rights of doctors, and the sanctity of life at all stages.” [6] The claims are not reality-based. Lacking evidentiary support for their claims against mifepristone’s long-established record of safety, the AAPLOG is merely attempting to cast doubt on the breadth of evidence that exists, and create a legal standing to sue the FDA by claiming that the AAPLOG’s regular practice of generating ideologically-engineered, pseudoscientific “evidence” is a “hardship” in the case of mifepristone. [7]

The anti-abortion movement “has recognized that research plays a critical role in framing the national conversation about abortion and has thus invested heavily in giving pseudoscience and other intentionally misleading content the veneer of respectability.’” [8] “Creating pseudoscientific bases for restricting or outlawing reproductive healthcare allows abortion opponents to create confusion that conceals their ideologically driven goals—values that are not shared by most Americans. A solid majority believe that abortion should be legal in all or most cases.” [9] The Brennan Center for Justice calls this tactic the “Invent-Your-Own-Facts Approach.” [10]

Research conducted by anti-abortion groups and their affiliated doctors/researchers is known to be flawed, unreliable, and agenda-driven. [11] [12] [13] [14] [15] These groups and their affiliated doctors/researchers are also known to overtly misrepresent others’ research, as well as the results of their own research. [16] [17] [18] [19] [20] [21] [22] [23] The ways in which the anti-abortion movement “twists medical science to restrict a woman’s freedom are part of a long history of women’s health being used as a justification for women’s oppression. Periods were once an illness necessitating seclusion; working outside the home increased women’s risk of coronary heart disease; a woman’s raging hormones made her unfit to be president.” [24]

Plaintiff group AAPLOG pushes its pseudoscience-backed campaign “through research and publishing, notably in the peer-reviewed medical journal Issues in Law & Medicine and by the Watson Bowes Research Institute, which co-publishes the journal. Yet Watson Bowes, Issues in Law & Medicine, and AAPLOG operate in a complicated and sometimes-obscured web of co-dependence.” [25] In 2020 report, Marisa Endicott explained:

The institute, which advocates anti-abortion (and anti-vaccine) science based on questionable data and provides grants for research into “life issues,” publishes studies, legal reviews, and think pieces in Issues in Law & Medicine without disclosing they are essentially the same entity. The Watson Bowes website doesn’t mention it, but tax filings indicate it is “located within AAPLOG.” The business is registered to Harrison, who is also the associate editor of the journal, and half the listed directors and officers of Watson Bowes are AAPLOG board members. Christina Francis, AAPLOG’s board chair, is Watson Bowes’ president. 

Issues in Law & Medicine is not a mainstream journal, but it has been cited in more than 1,100 law review articles and in at least 14 state and federal courts of appeal opinions, including two US Supreme Court and seven state supreme court rulings, according to its website. Justice Clarence Thomas cited Issues in Law & Medicine in his dissent when the Supreme Court ruled in 2000 that a Nebraska statute banning “partial birth abortion” without medical exception was unconstitutional. And in 2018, according to a report in Newsweek, Idaho used research published in Issues in Law & Medicine as a basis for passing laws requiring doctors to tell patients an abortion could be reversed. (Abortion reversal, a widely criticized idea, is the brainchild of Dr. George Delgado, an AAPLOG board member.) [26]

In the mifepristone lawsuit, the anti-abortion plaintiffs made apocalyptic claims about patients’ health— claims based on speculation and “deeply flawed evidence that largely rests on cherry-picked studies and a handful of anecdotes from a handful of anti-abortion doctors.” [27] It was this “deeply flawed evidence” that U.S. District Judge Matthew Kacsmaryk, a one-time anti-abortion activist, used to justify his April 2023 ruling in favor of the plaintiffs, demonstrating that the “Invent-Your-Own-Facts Approach” has real legal consequences. [28] [29] “The impact is not simply theoretical. When AAPLOG and its ideological peers argue emergency contraception and IUDs are abortifacients, that life begins at the moment of fertilization, and that there is a “symbiotic relationship among pornography, sex-trafficking and abortion”—and lawmakers, federal officials, and judges believe it, or at least hide behind it—it’s ultimately patients and their families who will suffer.” [30] 

A 2021 study cited by Kacsmaryk in his April ruling typifies the “Invent-Your-Own Facts Approach.” The study, focused on Medicaid recipients, claimed that “between 2002 and 2015, there was a 500% increase in emergency room visits from people who had had a medication abortion within 30 days.” [31] Pharmaceutical sciences professor Chris Adkins, who used to be a professional journal peer reviewer, thoroughly dissected this paper. Adkins found that the authors of that 2021 study “exaggerated their findings and visually misrepresented them in ways that are ‘grossly misleading.’” [32] “They’re misrepresenting its conclusions to begin with. That’s my frustration...” [33] He added, “To go out and say this drug needs to be, you know, removed from the market, it’s not honestly paying tribute to what the true science really is saying.” [34]

The 2021 study was funded by the Charlotte Lozier Institute (CLI). [35] In Part I, I noted that CLI is the “research and education” arm of the powerful anti-abortion lobbying group SBA Pro-life America. CLI pushes “alarmist narratives about abortion, publishing annual reports applauding state-level abortion restrictions, spreading lies about research employing fetal tissue and advocating for deceptive anti-abortion centers. Its ‘experts’ also do [SBA Pro-life America’s] bidding by testifying before Congress and speaking on panels at other extremist anti-abortion organizations.” [36] “[D]espite being founded as the ‘anti-abortion counter’ to the well-established Guttmacher Institute, it still relies on Guttmacher for data that health centers won’t give to CLI.” [37] CLI publishes lies claiming emergency contraception is an “abortifacient” and a “shrewd marketing scheme.” [38]  — Such claims are false. CLI is known for producing biased and flawed studies, including studies submitted as “evidence” in the mifepristone lawsuit. [39] “The study was published in November 2021, exactly one year before plaintiffs filed in the Amarillo court. Charlotte Lozier filed a “friend of the court brief,” citing its research.” [40] 

All but one of the 2021 study’s eight authors “are affiliated with the Charlotte Lozier Institute, including principal author James Studnicki, who is the [CLI’s] vice president and director of data analytics.” [41] Another author, Dr. Donna Harrison, was until recently the CEO of the AAPLOG (discussed above). [42] “Another author is longtime anti-abortion activist David Reardon, who has a record of criticized research that tries to directly link abortion to depression and suicide.” [43] 

According to Adkins and other researchers, the 2021 study’s “findings are missing important context, and that the study’s major flaws are related to methodology and in how they communicate their findings.” [44] [45] For example, “the study captures emergency room visits broadly and does not distinguish between routine medical care and adverse events. The codes they use lump in issues like ectopic and molar pregnancies, which are medical emergencies” and are “not related to having taken abortion drugs.” [46] Furthermore, according to Adkins, the ways that “the Charlotte Lozier team presented their data visually lends for judges to be misled about the significance of the paper’s findings. For example, Figure 3 showed about 800 emergency room visits in 2015 within 30 days of a medication abortion, out of more than 5,000 abortion-related visits, but the authors inexplicably used two different y axes to plot these numbers, making it possible to conclude that medication-abortion-related visits were numbered in the thousands.” [47]

That 2021 study has since received an Expression of Concern from the publisher and is under investigation. The Expression of Concern says: 

“The Editor and SAGE were alerted to potential issues regarding the representation of data in the article and author conflicts of interest. SAGE has contacted the authors of this article and an investigation is underway.”

“I can’t prove that there was intent to deceive, but I struggled to find an alternative reason to present your data in such a way that exaggerates the magnitude,” Adkins said. [48]

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Citations:

[1] Janiak, E. (2023a, April 11). Mifepristone is safe. A court ruling reducing access to it is dangerous. Scientific American. https://www.scientificamerican.com/article/mifepristone-is-safe-a-court-ruling-reducing-access-to-it-is-dangerous/ 

[2] Ibid. 1

[3] Weber, L., McGinley, L., Ovalle, D., & Sellers, F. S. (2023, April 13). Abortion pill ruling cited flawed science - The Washington Post. Washington Post. https://www.washingtonpost.com/health/2023/04/13/abortion-pill-safety/ 

[4] Alliance For Hippocratic Medicine v. FDA. ¶ 309, p. 89. https://storage.courtlistener.com/recap/gov.uscourts.txnd.370067/gov.uscourts.txnd.370067.1.0.pdf

[5] Ibid. 4, ¶ 316, p. 91

[6] Ibid. 4, ¶ 316, p. 91

[7] Endicott, M. (2020, June 4). They’re doctors. they’re also incredibly effective-and dangerous-anti-abortion activists. Mother Jones. https://www.motherjones.com/politics/2020/06/american-association-pro-life-obstetricians-gynecologists-aaplog-anti-abortion-doctors-june-medical-supreme-court-decision/ 

[8] Ibid. 7

[9] Kinsella, M., & Boland, J. (2021, November 9). The “invent-your-own-facts approach”: Many abortion laws use medically incorrect language. Brennan Center for Justice. https://www.brennancenter.org/our-work/analysis-opinion/invent-your-own-facts-approach-many-abortion-laws-use-medically-incorrect 

[10] Ibid. 9

[11] Farley, R. (2022, July 12). Noem’s misleading claim about safety of medication abortion. FactCheck.org. https://www.factcheck.org/2022/07/noems-misleading-claim-about-safety-of-medication-abortion/ 

[12] Resnick, S. (2023c, August 2). Study cited by Texas judge in abortion-pill case under investigation. New Jersey Monitor. https://newjerseymonitor.com/2023/08/02/study-cited-by-texas-judge-in-abortion-pill-case-under-investigation/ 

[13] Kinsella, M., & Boland, J. (2021, November 9). The “invent-your-own-facts approach”: Many abortion laws use medically incorrect language. Brennan Center for Justice. https://www.brennancenter.org/our-work/analysis-opinion/invent-your-own-facts-approach-many-abortion-laws-use-medically-incorrect 

[14] Baran, N. M., Goldman, G., & Zelikova, J. (2019, August 21). Abortion bans based on so-called “Science” are fraudulent. Scientific American Blog Network. https://blogs.scientificamerican.com/observations/abortion-bans-based-on-so-called-science-are-fraudulent/ 

[15] Kincaid, E. (2022, December 29). Article that critiqued high-profile abortion study retracted. Retraction Watch. https://retractionwatch.com/2022/12/29/article-that-critiqued-high-profile-abortion-study-retracted/ 

[16] Resnick, S. (2023b, February 12). Suspect science and claims at center of abortion-pill lawsuit. Georgia Recorder. https://georgiarecorder.com/2023/02/12/suspect-science-and-claims-at-center-of-abortion-pill-lawsuit/ 

[17] Fazackerley, A. (2022, May 8). British scientist says us anti-abortion lawyers misused his work to attack Roe v Wade. The Guardian. https://www.theguardian.com/us-news/2022/may/08/british-scientist-says-us-anti-abortion-lawyers-misused-his-work-to-attack-roe-v-wade 

[18] Baran, N. M., Goldman, G., & Zelikova, J. (2019, August 21). Abortion bans based on so-called “Science” are fraudulent. Scientific American Blog Network. https://blogs.scientificamerican.com/observations/abortion-bans-based-on-so-called-science-are-fraudulent/ 

[19] Grimes, D. R. (2015, August 12). A scientist weighs up the five main anti-abortion arguments. The Guardian. https://www.theguardian.com/science/blog/2015/aug/12/five-main-anti-abortion-arguments-examined 

[20] Kincaid, E. (2022, December 29). Article that critiqued high-profile abortion study retracted. Retraction Watch. https://retractionwatch.com/2022/12/29/article-that-critiqued-high-profile-abortion-study-retracted/ 

[21] Steinberg, J. R., & Finer, L. B. (2012, March). Coleman, Coyle, Shuping, and rue make false statements and draw erroneous conclusions in analyses of abortion and mental health using the National Comorbidity Survey. Journal of psychiatric research. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3699180/ 

[22] Steinberg, J. R., & Finer, L. B. (2012a, March). Coleman, Coyle, Shuping, and rue make false statements and draw erroneous conclusions in analyses of abortion and mental health using the National Comorbidity Survey. Journal of psychiatric research. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3699180/ 

[23] Resnick, S. (2023c, August 2). Study cited by Texas judge in abortion-pill case under investigation. New Jersey Monitor. https://newjerseymonitor.com/2023/08/02/study-cited-by-texas-judge-in-abortion-pill-case-under-investigation/ 

[24] Endicott, M. (2020, June 4). They’re doctors. they’re also incredibly effective-and dangerous-anti-abortion activists. Mother Jones. https://www.motherjones.com/politics/2020/06/american-association-pro-life-obstetricians-gynecologists-aaplog-anti-abortion-doctors-june-medical-supreme-court-decision/ 

[25] Ibid. 24

[26] Ibid. 24

[27] Resnick, S. (2023b, February 12). Suspect science and claims at center of abortion-pill lawsuit. Georgia Recorder. https://georgiarecorder.com/2023/02/12/suspect-science-and-claims-at-center-of-abortion-pill-lawsuit/

[28] Totenberg, N., & Gersh, A. (2023, December 13). Supreme Court to hear abortion pill case. NPR. https://www.npr.org/2023/12/13/1218332935/mifepristone-abortion-pill-supreme-court 

[29] Kinsella, M., & Boland, J. (2021, November 9). The “invent-your-own-facts approach”: Many abortion laws use medically incorrect language. Brennan Center for Justice. https://www.brennancenter.org/our-work/analysis-opinion/invent-your-own-facts-approach-many-abortion-laws-use-medically-incorrect 

[30] Endicott, M. (2020, June 4). They’re doctors. they’re also incredibly effective-and dangerous-anti-abortion activists. Mother Jones. https://www.motherjones.com/politics/2020/06/american-association-pro-life-obstetricians-gynecologists-aaplog-anti-abortion-doctors-june-medical-supreme-court-decision/ 

[31] Resnick, S. (2023c, August 2). Study cited by Texas judge in abortion-pill case under investigation. New Jersey Monitor. https://newjerseymonitor.com/2023/08/02/study-cited-by-texas-judge-in-abortion-pill-case-under-investigation/ 

[32] Ibid. 31

[33] Ibid. 31

[34] Ibid. 31

[35] Ibid. 31

[36] Charlotte Lozier Institute - Pro-Lies.org: Extreme. toxic. out of touch. Pro-Lies. (n.d.-c). https://pro-lies.org/charlotte-lozier-institute/ 

[37] Ibid. 36

[38] Ibid. 36

[39] Resnick, S. (2023c, August 2). Study cited by Texas judge in abortion-pill case under investigation. New Jersey Monitor. https://newjerseymonitor.com/2023/08/02/study-cited-by-texas-judge-in-abortion-pill-case-under-investigation/

[40] Ibid. 39

[41] Ibid. 39

[42] Ibid. 39

[43] Ibid. 39

[44] Ibid. 39

[45] Farley, R. (2022, July 12). Noem’s misleading claim about safety of medication abortion. FactCheck.org. https://www.factcheck.org/2022/07/noems-misleading-claim-about-safety-of-medication-abortion/ 

[46] Resnick, S. (2023c, August 2). Study cited by Texas judge in abortion-pill case under investigation. New Jersey Monitor. https://newjerseymonitor.com/2023/08/02/study-cited-by-texas-judge-in-abortion-pill-case-under-investigation/

[47] Ibid. 46

[48] Ibid. 46