At the cost of women’s health and safety and with a benefit to its bottom-line, Planned Parenthood has been rapidly increasing its use—and its misuse—of dangerous chemical abortions.
But when Planned Parenthood’s abuses of chemical abortions were recently highlighted by Americans United for Life’s exposé of the nation’s largest abortion provider, The Case for Investigating Planned Parenthood, the organization responded, in part, that off-label use was “common practice.” Essentially, it seems, Planned Parenthood is arguing that if other providers do something, its safety should not be questioned. “Safe” and “common,” however, are not coterminous. Women certainly deserve better than to have concerns for their health and safety dismissed because it is “common” to abuse them.
Because of its known dangers, the use of the mifepristone and misoprostol chemical abortion drug regimen (also commonly referred to as “RU-486”) has been strictly regulated by the Food and Drug Administration (FDA). On its website, the FDA notes, “Since its approval in September 2000, the [FDA] has received reports of serious adverse events, including several deaths, in the United States following medical abortion with mifepristone and misoprostol.”
A recent FDA report accounts for at least 2,207 cases of severe adverse events, including hemorrhaging, blood loss requiring transfusions, serious infection, and death.
Thousands of reported instances of serious adverse events, including death, already raises alarm. However, concern for women’s health and safety is heightened when considering the known inadequacies of what is being reported to the FDA about chemical abortions.
A 2006 review of Adverse Event Reports (AERs) related to the use of the RU-486 drug regimen, conducted by Dr. Margaret M. Gary, M.D. and Dr. Donna J. Harrison, M.D. found “AERs relied upon by the FDA to monitor mifepristone’s postmarketing safety are grossly deficient due to extremely poor quality.”
Drs. Gary and Harrison noted that the deficiency in the AER reports was widespread and consequential,
[A] majority of the AERs analyzed do not provide enough information to accurately code the severity of the adverse event in question. The deficiencies were so egregious in some instances as to preclude analysis.
What is perhaps even more disturbing than the lack of essential facts in what is reported to the FDA about chemical abortions—precluding accurate, or even any, analysis—is what is not being reported to the FDA about the dangerous drug regimen.
The limitation of the AER system was detailed by Michael F. Mangano, Principal Deputy Inspector General of the Department of Health and Human Services, in his testimony before the U.S. Senate committee,
Adverse Event Reporting systems typically detect only a small proportion of events that actually occur. They are passive systems that depend on someone linking an adverse event with the use of a product, then reporting the event … .Adverse Event Reports in and of themselves typically cannot generate conclusive evidence about the safety of a product or ingredient. Rather the system generates signals that FDA must assess to confirm if, in fact, a public health problem exists… With limited information to draw upon to generate signals, it is not surprising that FDA rarely reaches the point of knowing whether a safety action is warranted to protect consumers.
Adding to the uncomfortable fact that the FDA reports capture “only a small proportion of events that actually occur,” is that abortion-providers are openly flouting the FDA protocol and state laws designed to protect women against these dangers.
Planned Parenthood, the nation’s mega-abortion provider, violates the FDA protocol in multiple ways, putting profit ahead of women’s health and safety. And by Planned Parenthood’s own admission, off-label use of chemical abortions has come at the cost of women’s lives and “higher-than-expected” consequences to health.
According to a 2009 study produced by Planned Parenthood, “Prompted by the deaths that occurred after medical abortion and internal data that show a higher-than-expected rate of serious infection, [Planned Parenthood Federation of America] changed its medical abortion protocol at the end of March 2006.” 
Flying in the face of supposed-concern for women’s health, the same Planned Parenthood study documents another dangerous off-label use that it has not discontinued. Because of the high failure rate of and risks involved with RU-486 in later pregnancies, the FDA approved RU-486 under conditions that allowed for post-marketing restrictions and limited approval to use only in the first 49 days from the start of a woman’s last menstrual period. Planned Parenthood, by its own admission, ignores these limitations.
The Planned Parenthood study notes that between 2007 and 2008, “The only change in the regimen was an increase in the maximum gestational age at the time of medical abortion, from 56 to 63 days.” What happened when the abortion-giant offered chemical abortions for an additional week (now 2 weeks past the FDA approved use)? Planned Parenthood performed almost 11,000 more chemical abortions in the first half of 2008, than it did in the six months prior. Extending its use one week, Planned Parenthood increased its chemical abortion business by over 30%.
Providing thousands of later chemical abortions, with a higher failure rate, also enables Planned Parenthood to engage in a profit-making scheme—getting women on the hook for a second, surgical abortion when a chemical abortion fails.
According to the clinical trial submitted to the FDA for approval, the RU-486 regimen fails in 1 out of 12 women with pregnancies less than or equal to 49 days. Those failures, however, increase to 1 out of every 6 women with pregnancies just one week advanced (50-56 days), and further still to nearly 1 out of every 4 pregnancies at 57-63 days gestational age. When using RU-486, 1 out of 100 women with pregnancies less than or equal to 49 days will require emergency surgery; however, this number increases dramatically to 1 out of every 11 women with pregnancies of 57-63 days gestational age.
Though Planned Parenthood asserts its use of the “buccal administration” (where a woman holds the second drug in the abortion regimen, misoprostol, in her mouth until it absorbs through her cheeks) makes chemical abortions more effective, this method also has a known decreased efficacy as gestational age increases.
Planned Parenthood does more than “offer” a second, surgical abortion for women when a chemical abortion fails. Planned Parenthood of the Bronx’s website is explicit that women for whom the drug fails must have a second, surgical abortion. “[Y]ou must agree—before you start—that you will have an in-clinic abortion if the abortion pill does not work.”
Even using, for the sake of argument, Planned Parenthood’s low estimate that the failure rate between 57 and 63 days is only 5.2%, the numbers of second, surgical abortions would be appalling; at least 1,138 chemical abortion failures would have turned into second surgical abortions for Planned Parenthood in 2008 – just by extending its chemical abortion use one week. Considering that from 50 to 56 days the chemical abortion regimen also fails at a higher rate, even using Planned Parenthood’s preferred statistics, it is likely performing thousands of “double-abortions” each year by violating the FDAs protocol.
Moreover, the risks to women’s health and safety increase the further along a chemical abortion is performed. Medical complications, such as hemorrhaging—which require hospitalization for emergency treatment—increase with pregnancies of 57-63 days gestational age. And Planned Parenthood’s researchers acknowledged that they “do not have data available on the rates of follow-up of women after medical abortion, and it is possible that the reporting of serious infection is incomplete.”
And now Planned Parenthood is expanding its chemical abortion business in other dangerous ways.
As documented in AUL’s Report, The Case for Investigating Planned Parenthood, the use of telemedicine, or “telemed,” to distribute of RU-486 is a direct violation of FDA requirements for dispensing mifepristone, and puts a woman at grave risk. Dispensing the abortion drug regimen after videoconferencing in place of a face-to-face visit between doctor and patient, places women in greater jeopardy. At a minimum, a “virtual visit” cannot accurately assess the gestational age or rule out ectopic pregnancy.
No abortion provider, including Planned Parenthood, should be given a free-pass for the misuse of chemical abortions. And Planned Parenthood’s continued bad behavior, at the cost of women’s health and safety, should not be rewarded with taxpayer funds.
For more information, see AUL’s Report The Case for Investigating Planned Parenthood.
 Available at http://www.aul.org/aul-special-report-the-case-for-investigating-planned-parenthood/ (last visited July 14, 2011). The AUL Report is a product of AUL’s legal team reviewing over 20 years of Planned Parenthood’s public reports and promotional material, audit reports and financial statements, as well as primary source material from investigations into and charges made against Planned Parenthood and its affiliates across the nation. The AUL Report meticulously documents and sources information about the known and alleged abuses by Planned Parenthood, using information that is publicly available. (And the Report’s appendices provide copies of the original source material.)
 AUL’s analysis and point-by-point rebuttal to Planned Parenthood’s response is available at http://www.aul.org/wp-content/uploads/2011/07/AUL-Rebuttal-to-PP-7-11-11.pdf (last visited July 14, 2011).
 The FDA report documents reported serious adverse events through April 30, 2011. Obtained by the Family Research Council, the FDA report, “Mifepristone U.S. Postmarketing Adverse Events Summary through 04/30/2011,” is available at http://downloads.frc.org/EF/EF11G29.pdf. (last visited July 14, 2011).
 Analysis of Severe Adverse Events Related to the Use of Mifepristone as an Abortifacient
 Margaret M. Gary, M.D. and Donna J. Harrison, M.D., Analysis of Severe Adverse Events Related to the Use of Mifepristone as an Abortifacient, 40(2) Annals of Pharmacology 191 (2006).
 Hearing on consumer safety and weight-loss supplements. Before the Subcomm. on Oversight of Gov’t Mgmt, Restructuring, and the District of Columbia, S. Comm on Gov’t Affairs. 107th Cong. (2002) (statement of Michael F Mangano, Principal Deputy Inspector General, Office of Inspector Gen., U.S. Dep’t of Health & Human Servs.), available at http://hsgac.senate.gov/073102mangano.htm (last visited July 14, 2011).
Mary Fjerstad, N.P., M.H.S., et al, Rates of Serious Infection after Changes in Regimens for Medical Abortion, 361 New. Eng. J. Med. 145 (2009). Mrs. Fjerstad and Dr. Cullins report having been employed by Planned Parenthood Federation of America (PPFA) at the time of the study. Drs. Lichtensberg and Trussell report serving on the PPFA National Committee. “No other conflict of interest relevant to this article was reported.”
 See Spitz et al., Early pregnancy termination with mifepristone and misoprostol in the United States, 338 New Eng. J. Med. 1241 (1998).
See U.S. Food & Drug Admin., Mifeprex (mifepristone) Information (Feb. 24, 2010), available at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111323.htm (last visited July 14, 2011). In addition, the “Prescriber’s Agreement” for Mifeprex (mifepristone) states unequivocally, “you must provide Mifeprex in a manner consistent with the following guidelines.” Including,
- Under Federal law, you must fully explain the procedure to each patient, provide her with a copy of the Medication Guide. You must fully explain the procedure to each patient, provide her with a copy of the Medication Guide and PATIENT AGREEMENT, give her an opportunity to read and discuss them, obtain her signature on the PATIENT AGREEMENT, and sign it yourself.
Available at http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111364.pdf (last visited July 14, 2011).
The PATIENT AGREEMENT, requiring signature of patient and provider, states, “I believe I am no more than 49 days (7 weeks) pregnant.” Available at http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM111332.pdf (last visited July 14, 2011).
 See Fjerstad et al. supra note 7 at 149.
 Id. at Table 1. From July 1, 2007 through December 31, 2007, Planned Parenthood reported performing 35,837 chemical abortions. From January 1, 2008 to June 30, 2008, Planned Parenthood reported performing 46,777 chemical abortions.
 See Spitz et al., Early pregnancy termination with mifepristone and misoprostol in the United States, 338 New Eng. J. Med. 1241 (1998).
 In response to the AUL Report, Planned Parenthood claimed chemical abortions are 96.2% effective up to 63 days using the buccal administration. However, the study Planned Parenthood cited for its proposition notes that even the buccal administration has an increased failure rate as gestational age increases. The study claims only a 94.8% success rate for a chemical abortion at 57-63 days gestation using the buccal administration. See Beverly Winikoff et al., Two Distinct Oral Routes of Misopristol in Mifepristone Medical Abortion, 112:6 Obstet. & Gyn. 1303, 1307 (2008). In addition, the relatively small sample size of women in the later gestational age groups for the study of the buccal administration’s efficacy lowers the confidence in its findings than for its examination of RU-486 use prior to 49 days. Women were also more likely to experience unacceptable effects with the “buccal administration” of the drug. The study found women who had undergone the “buccal administration” of the abortion drug had a “statistically significant” lower “acceptability of adverse effects” than those who had the drug administered orally. Notably, the study fails to document these reported adverse side-effects by gestational age.
See Planned Parenthood, The Bronx Center – Bronx, NY, available at http://www.plannedparenthood.org/health-center/centerDetails.asp?f=2524. (last visited July 14, 2011). In contrast, the FDA approved “Patient Agreement” form notes that a woman has options, one of which is surgical abortion, “If my pregnancy continues after treatment with Mifeprex and misoprostol, I will talk with my provider about my choices, which may include a surgical procedure to end my pregnancy.” Available at http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM111332.pdf (last visited July 14, 2011). Planned Parenthood’s forcing, or coercing, women to choose a surgical abortion when a chemical abortion fails, violates the spirit, if not the letter, of the agreement form.
 See Winikoff et al., supra note 13.
 See Spitz et al., supra note 12.
 See Fjerstad et al. supra note 7 at 150. Further the study noted, “a potential concern is that serious infections may have been more likely to be underreported [after Planned Parenthood discontinued its vaginal administration of the drug] since the intense scrutiny during Period 1 (after the reports of deaths from clostridial infections) had waned.”
 Dickinson, Faraway doctors give abortion pills by video, Des Moines Register (May 16, 2010), available at http://www.9news.com/news/local/article.aspx?storyid=140688&catid=188 (last visited Mar. 26, 2011).