🔆This is Part II 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.
Outline:
Introduction
The anti-abortion plaintiffs who sued the U.S. Food and Drug Administration (FDA) to eliminate/severely restrict access to mifepristone - one of the drugs used in a two-drug regimen for medication abortion - insist that mifepristone is a dangerous drug that is wreaking havoc on women and girls and hospital emergency departments. “Emergency rooms across America are teeming with women and girls bleeding from abortion drugs in such copious amounts that it’s exacerbating the national blood shortage. Or, at least, that’s the grim – but false – narrative” painted by the anti-abortion plaintiffs in their initiating lawsuit. [1] Plaintiffs’ “mountain of evidence, they say, shows abortion via a specific drug regimen is incredibly dangerous and should never have been approved by the Food and Drug Administration more than 20 years ago.” [2]
Facts and evidence do not support the plaintiffs’ claims.
Mifepristone is a competitive glucocorticoid (GR) and progesterone receptor (PR) antagonist. It is often referred to as “the abortion pill” because it is the first drug in a two-drug regimen used to terminate pregnancy. The drug was first approved for use in the United States in the year 2000, after a four-year long evaluation process by the U.S. Food and Drug Administration. “Overwhelming evidence [demonstrates] that mifepristone—which has undergone rigorous testing and review and has been safely used in the United States for 23 years—is conclusively safe and effective.” [3] Over this time period, mifepristone has come to be used to treat patients with a variety of conditions not related to pregnancy termination.
The Many Uses of Mifepristone
Mifepristone is a competitive glucocorticoid (GR) and progesterone receptor (PR) antagonist. It is a versatile drug for which there are many uses.
🟩 Medication abortion: Mifepristone is a drug “used in a regimen together with misoprostol to end a pregnancy that is less than 70 days in duration (10 weeks),” dating from the first day of a person's last menstrual period. [4] Mifepristone “works by stopping the supply of hormones that maintains the interior of the uterus. Without these hormones, the uterus cannot support the pregnancy.” [5] The current medication abortion regimen is “200 mg of mifepristone-oral-route,” followed by “800 mcg of misoprostol taken buccally (in the cheek pouch).” [6]
🟩 Miscarriage management: Mifepristone, together with misoprostol, is also used to manage miscarriages (spontaneous abortions). According to the American Academy of Family Physicians, “The most effective regimen for medication management of early pregnancy loss is 200 mg of oral mifepristone followed by 800 mcg of misoprostol administered vaginally 24 to 48 hours later.” [7] While “misoprostol alone can be used if mifepristone is not available… rates of effectiveness are lower.” [8] For this reason, miscarriage patients “should be offered mifepristone pretreatment before misoprostol to increase the chance of successful miscarriage management, while reducing the need for miscarriage surgery.” [9]
🟩 Cushing’s syndrome: Additionally, because mifepristone is a glucocorticoid receptor antagonist, it is used to “control hyperglycemia secondary to hypercortisolism in patients with endogenous hypercortisolism (Cushing syndrome) who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery.” [10] “Cushing’s syndrome is a rare endocrine disease that causes elevated cortisol levels and can be life-threatening in certain cases.” [11] In April 2023, the Endocrine Society released a statement warning that a “decision to overrule the FDA’s approval of mifepristone could restrict access to treatment for Cushing’s syndrome and has broader implications on drug approvals.” [12]
🟩 Cancer treatment and research: Mifepristone is used in the treatment of a variety of cancer types, and the drug’s anti-cancer properties is being used in the development of cancer treatments. [13] [14] [15] [16] [17] [18] [19] Because of the drug’s safety, efficacy, resistance to tumor mutation, etc., “mifepristone may be the best single pharmaceutical agent for treatment of a variety of advanced cancers.” [20] (In a bizarre twist, one of the individual doctors who are also plaintiffs in the lawsuit against the FDA with the goal of having mifepristone pulled from the market nationwide, George Delgado, is “now consulting on the development of a breast cancer treatment that involves the same drug: mifepristone.” [21])
🟩 Other: The American Medical Association also notes that mifepristone is important for patients “experiencing bleeding or hemorrhaging during certain serious pregnancy complications,” as well as “other existing and growing treatments not related to pregnancy” [22] such as uterine fibroids. [23]
The Safety Record of Mifepristone
Yes, “mifepristone is safe when used as indicated and directed.” [24]
The Alliance for Hippocratic Medicine (AHM), the “antiabortion group founded for the purpose of bringing this lawsuit, argued that the way FDA initially approved the drug for sale in the U.S. in the year 2000 did not allow for enough research and testing. This is not true; approval took four years, and the drug was thoroughly tested in the U.S and in France, where it was originally developed.” [25] “The FDA approved Mifeprex more than 20 years ago based on a thorough and comprehensive review of the scientific evidence presented and determined that it was safe and effective for its indicated use. As of 2016, it can be used for medical termination of pregnancy up to 70 days of gestation. The FDA’s periodic reviews of the postmarketing data for Mifeprex and its approved generic have not identified any new safety concerns with the use of mifepristone for medical termination of pregnancy through 70 days gestation. As with all drugs, the FDA continues to closely monitor the postmarketing safety data on mifepristone for the medical termination of pregnancy.” [26]
As with other medications, the medication abortion regimen is contraindicated for some people, [27] and adverse events are possible with the use of mifepristone. [28] However, adverse events are exceedingly rare. [29] According to KFF, an independent source for health policy research, the two-drug regimen of mifepristone and misoprostol “terminates pregnancies successfully 99.6% of the time, with a 0.4% risk of major complications, and an associated mortality rate of less than 0.001 percent (0.00064%).” [30]
The FDA investigates deaths associated with mifepristone. *It’s important to note that, “[b]y definition, a death associated with a drug does not mean (it was) caused by that drug.” [31] According to the FDA, 5.9 million women in the United States have used the medication abortion regimen since mifepristone was first approved in September 2000. [32] In that time, there have been 32 reported deaths associated with, but not necessarily caused by, the use of mifepristone, according to the FDA's latest report. [33] These deaths “cannot with certainty be causally attributed to mifepristone because of information gaps about patient health status, clinical management of the patient, concurrent drug use, and other possible medical or surgical treatments and conditions.” [34] The causes of the 32 deaths include cases of sepsis, ruptured ectopic pregnancies, homicides, suicides, substance abuse/drug overdoses, pulmonary embolisms, emphysema, etc. [35]
“In the 23 years since its initial approval in the United States, mifepristone has become more common worldwide. We now have research from tens of thousands of patients who received mifepristone in England and Canada showing it is extremely safe and highly effective.” [36] “Among the hundreds of clinical trials using mifepristone over two decades, more than 400 were randomized controlled studies, which are considered the gold standard of research design.” [37]
Mifepristone is “not medically controversial at all,” explained Elizabeth Raymond, an OB-GYN and scientist, adding that “It’s been used for 23 years in this country and even longer around the world, and the incidence of serious complications is extremely, extremely low.” [38] According to Carrie Cwiak, an OB-GYN at Emory University School of Medicine in Atlanta, “Every time mifepristone is in a study, it’s shown to have the same safety profile, the same efficacy, the same high rates of satisfaction with people using it. It’s beyond reproach,” said Cwaik (emphasis mine). [39]
The American Medical Association, the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine, the American Academy of Family Physicians, the American Gynecological & Obstetrical Society, the American Society for Reproductive Medicine, and a half dozen other organizations jointly filed a brief attesting to the safety of mifepristone. [40] [41] These groups note that the “plaintiffs have taken a position that is fundamentally ideological, not scientific,” adding that the plaintiffs’ requests to restrict or ban mifepristone are “not based on rigorous scientific review and analysis but on speculation and… personal opinions.” [42] Despite the anti-abortion plaintiffs’ claims to the contrary, the overwhelming evidence conclusively shows that mifepristone is safe and effective. [43] “Worldwide, scientists, doctors, health authorities, and patients have agreed on this simple fact, over and over again.” [44]
Citations
[1] 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/
[2] Ibid. 1
[3] American College of Obstetricians and Gynecologists . (2023, February 10). ACOG leads amicus brief calling mifepristone conclusively safe and effective. American College of Obstetricians and Gynecologists . https://www.acog.org/news/news-releases/2023/02/acog-leads-amicus-brief-calling-mifepristone-conclusively-safe-and-effective
[4] Mayo Foundation for Medical Education and Research. (2024, January 1). Mifepristone (oral route) description and brand names. Mayo Clinic. https://www.mayoclinic.org/drugs-supplements/mifepristone-oral-route/description/drg-20067123
[5] Ibid. 4
[6] Center for Drug Evaluation and Research. (2023, September 1). Questions and answers on mifeprex. U.S. Food and Drug Administration. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation
[7] MacNaughton, H., Nothnagle, M., & Early, J. (2021a, April 15). Mifepristone and Misoprostol for early pregnancy loss and medication abortion. American Family Physician. https://www.aafp.org/pubs/afp/issues/2021/0415/p473.html
[8] Ibid. 7
[9] Chu, J. J., Devall, A. J., Beeson, L. E., Hardy, P., Cheed, V., Sun, Y., Roberts, T. E., Ogwulu, C. O., Williams, E., Jones, L. L., La Fontaine Papadopoulos, J. H., Bender-Atik, R., Brewin, J., Hinshaw, K., Choudhary, M., Ahmed, A., Naftalin, J., Nunes, N., Oliver, A., … Coomarasamy, A. (2020, September 12). Mifepristone and Misoprostol versus Misoprostol alone for the management of missed miscarriage (MifeMiso): A randomised, double-blind, placebo-controlled trial. Lancet (London, England). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7493715/
[10] Brown, D. R., East, H. E., Eilerman, B. S., Gordon, M. B., King, E. E., Knecht, L. A., Salke, B., Samson, S. L., Yuen, K. C. J., & Yau, H. (2020, October 29). Clinical management of patients with Cushing syndrome treated with mifepristone: Consensus recommendations. Clinical diabetes and endocrinology. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7596972/#:~:text=Mifepristone%20is%20a%20competitive%20GR,mellitus%20or%20glucose%20intolerance%20and
[11] Endocrine Society. (2023, April 10). Endocrine society alarmed by Texas Court ruling banning mifepristone. https://www.endocrine.org/news-and-advocacy/news-room/2023/endocrine-society-alarmed-by-texas-court-ruling-banning-mifepristone
[12] Ibid. 11
[13] Llaguno-Munive, M., Vazquez-Lopez, M. I., Jurado, R., & Garcia-Lopez, P. (2021, January 5). Mifepristone repurposing in treatment of high-grade gliomas. Frontiers. https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2021.606907/full
[14] Alvarez, P. B., Laskaris, A., Goyeneche, A. A., Chen, Y., Telleria, C. M., & Burnier, J. V. (2021, November 17). Anticancer effects of mifepristone on human uveal melanoma cells - cancer cell international. BioMed Central. https://cancerci.biomedcentral.com/articles/10.1186/s12935-021-02306-y
[15] Ritch, S. J., Noman, A. S. M., Goyeneche, A. A., & Telleria, C. M. (2022, December 9). The metastatic capacity of high-grade serous ovarian cancer cells changes along disease progression: Inhibition by mifepristone - Cancer Cell International. BioMed Central. https://cancerci.biomedcentral.com/articles/10.1186/s12935-022-02822-5
[16] Facebook. National Cancer Institute. (n.d.). https://www.cancer.gov/research/participate/clinical-trials/intervention/mifepristone
[17] Elía, A., Saldain, L., Vanzulli, S. I., Helguero, L. A., Lamb, C. A., Fabris, V., Pataccini, G., Martínez-Vazquez, P., Burruchaga, J., Caillet-Bois, I., Spengler, E., Acosta Haab, G., Liguori, M., Castets, A., Lovisi, S., Abascal, M. F., Novaro, V., Sánchez, J., Muñoz, J., … Lanari, C. (2023, March 1). Beneficial effects of mifepristone treatment in patients with breast cancer selected by the progesterone receptor isoform ratio: Results from the MIPRA trial. American Association for Cancer Research. https://aacrjournals.org/clincancerres/article/29/5/866/716609/Beneficial-Effects-of-Mifepristone-Treatment-in
[18] Dunham, W. (2007, April 9). Abortion pill compound fights breast cancer: Study | reuters. Reuters. https://www.reuters.com/article/idUSN29377119/
[19] tMifepristone (RU486) is a chemical contraceptive marketed in more than 55 countries and used by hundreds of millions of women worldwide. Current studies reported its uses by both genders for a safe and long-term psychotic depression and particular, Ottow, E., Gao, Y., Jang, G. R., Lahteenmaki, P., Arora, V. K., Ligr, M., Holley, A. K., Rao, S., Yazawa, H., Seaborn, T., Nathan, N., Zheng, G., Wang, J. C., … Check, J. H. (2022, April 26). Similarities and differences between embryonic implantation and CTC invasion: Exploring the roles of abortifacients in cancer metastasis chemoprevention. European Journal of Medicinal Chemistry. https://www.sciencedirect.com/science/article/abs/pii/S022352342200318X
[20] Check JH, Check D. Mifepristone May Be the Best Single Pharmaceutical Agent for Treatment of a Variety of Advanced Cancers. Cancer Sci Res. 2021; 4(2): 1-6. https://scivisionpub.com/pdfs/mifepristone-may-be-the-best-single-pharmaceutical-agent-for-treatment-of-a-variety-of-advanced-cancers-1734.pdf
[21] Resnick, S. (2023d, October 25). Doctor suing FDA recruited to Scientific Advisory Board to “repurpose” abortion pill. Kansas Reflector. https://kansasreflector.com/2023/10/25/doctor-suing-fda-recruited-to-scientific-advisory-board-to-repurpose-abortion-pill/
[22] Henry, T. A. (2023, March 14). Ama to court: Don’t overturn FDA approval of Mifepristone. American Medical Association. https://www.ama-assn.org/delivering-care/public-health/ama-court-don-t-overturn-fda-approval-mifepristone
[23] Walling, A. D. (2003, September 1). Low-dose mifepristone shrinks uterine fibroids. American Family Physician. https://www.aafp.org/pubs/afp/issues/2003/0901/p956a.html
[24] Center for Drug Evaluation and Research. (2023a, September 1). Questions and answers on mifeprex. U.S. Food and Drug Administration. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation
[25] 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/
[26] Center for Drug Evaluation and Research. (2023a, September 1). Questions and answers on mifeprex. U.S. Food and Drug Administration. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation
[27] Ibid. 26
[28] Mifeprex label - food and drug administration. U.S. Food and Drug Administration. (n.d.). https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020687Orig1s025Lbl.pdf
[29] TTT # 2022-2468 NDA 020687 ANDA 091178 mifepristone U.S. post-marketing ... U.S. Food and Drug Administration. (n.d.). https://www.fda.gov/media/164331/download?attachment
[30] Salganicoff, A., & Sobel, L. (2023, March 14). Legal Challenges to the FDA Approval of Medication Abortion Pills - Key Findings - 10110. KFF. https://www.kff.org/report-section/legal-challenges-to-the-fda-approval-of-medication-abortion-pills-key-findings/#:~:text=The%20FDA%20approved%20the%20generic,during%20the%20public%20health%20emergency
[31] Putterman, S. (2023, April 12). An anti-abortion group claimed 28 deaths were linked to mifepristone. here’s why that’s flawed. @politifact. https://www.politifact.com/factchecks/2023/apr/26/instagram-posts/an-anti-abortion-group-claimed-28-deaths-were-link/
[32] TTT # 2022-2468 NDA 020687 ANDA 091178 mifepristone U.S. post-marketing ... U.S. Food and Drug Administration. (n.d.). https://www.fda.gov/media/164331/download?attachment
[33] Ibid. 32
[34] Ibid. 32
[35] Ibid. 32
[36] 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/
[37] 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/
[38] Landman, K. (2023, April 11). Mifepristone is safe. Vox. https://www.vox.com/policy/23678597/mifepristone-safety-abortion-pill-ruling-misoprostol-kacsmaryk-fda-rems
[39] Ibid. 38
[40] Henry, T. A. (2023, March 14). Ama to court: Don’t overturn FDA approval of Mifepristone. American Medical Association. https://www.ama-assn.org/delivering-care/public-health/ama-court-don-t-overturn-fda-approval-mifepristone
[41] Resneck, J. (2023, April 12). Judge’s ruling on mifepristone has no basis in medical science. American Medical Association. https://www.ama-assn.org/about/leadership/judge-s-ruling-mifepristone-has-no-basis-medical-science
[42] Henry, T. A. (2023, March 14). Ama to court: Don’t overturn FDA approval of Mifepristone. American Medical Association. https://www.ama-assn.org/delivering-care/public-health/ama-court-don-t-overturn-fda-approval-mifepristone
[43] American College of Obstetricians and Gynecologists . (2023, February 10). ACOG leads amicus brief calling mifepristone conclusively safe and effective. American College of Obstetricians and Gynecologists . https://www.acog.org/news/news-releases/2023/02/acog-leads-amicus-brief-calling-mifepristone-conclusively-safe-and-effective
[44] Landman, K. (2023, April 11). Mifepristone is safe. Vox. https://www.vox.com/policy/23678597/mifepristone-safety-abortion-pill-ruling-misoprostol-kacsmaryk-fda-rems
These quacks will have an extremely difficult time refuting the safety record of this medication. This case should be immediately dismissed for a total and complete lack of merit. Period…but
When Trump was elected he depended on the Federalist Society and Leonard Leo to supply him with a list of right wing judges and justices to supply our courts with. Kacsmaryk knows better than this kind of stuff and for that reason he needs to be removed from the bench. If Trump is reelected there is a possibility that he could put at least a couple of new justices on SCOTUS as well as seating more on the federal judiciary. If this happens then this is what we’ve got to look forward to. Unfortunately America could be staring fascism in the face. 😔