Planned Parenthood Exhibit 6
Planned Parenthood’s Dangerous Misuse of Chemical Abortions
When Planned Parenthood’s dangerous misuse of chemical abortions was highlighted by AUL’s The Case for Investigating Planned Parenthood, the organization responded, in part, that off-label use was “common practice.”[i] Essentially, it seems, Planned Parenthood is arguing that if other providers do something, the safety should not be questioned. “Safe” and “common,” however, do not mean the same thing. Women certainly deserve better than to have concerns for their health and safety dismissed because it is “common” to abuse them.
Unfortunately, Planned Parenthood continues to increase its use—and its misuse—of dangerous chemical abortions, with an apparent eye towards increasing its profits.
Chemical abortions are known to be dangerous.
“Since its approval in September 2000, the Food and Drug Administration has received reports of serious adverse events, including several deaths, in the United States following medical abortion with mifepristone and misoprostol,” notes the FDA website.[ii] A 2011 FDA report[iii] accounts for at least 2,207 severe adverse events associated with the use of the abortion drug regimen (also commonly referred to as “RU-486”), including hemorrhaging, blood loss requiring transfusions, serious infection, and death.
Thousands of reported instances of serious adverse events, including death, already raises alarm. The 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.”[iv] 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.[v]
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.[vi]
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 violates the FDA protocol in multiple ways, while Planned Parenthood’s own studies acknowledge that its off-label use of chemical abortions has come at the cost of women’s lives and “higher-than-expected” consequences to their health.
According to a 2009 Planned Parenthood study, only after women suffered serious infections and died did Planned Parenthood stop the vaginal use of misoprostol, an off-label practice never approved by the FDA.
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.[vii]
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 and the risks involved with RU-486 in later pregnancies,[viii] the FDA limited approval for use only in the first 49 days from the start of a woman’s last menstrual period.[ix]Planned Parenthood, by its own admission, ignores this limitation.
Using RU-486 later in pregnancy than approved by the FDA plays an enormous role in Planned Parenthood’s abortion business.
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.”[x] 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.[xi] Thus it appears that by 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.[xii]
Though Planned Parenthood asserts that 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.[xiii] No matter how the pills are ingested, Planned Parenthood cannot overcome the fact that RU-486 has a higher failure rate when administered beyond the FDA’s approved timeframe for usage.
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 failsmust 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.”[xiv]
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%,[xv] the numbers of second, surgical abortions would be significant; 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 FDA’s 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.[xvi] 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.”[xvii]
And now Planned Parenthood is expanding its chemical abortion business in other dangerous ways.
See upcoming Exhibit 7
[i] AUL’s analysis and point-by-point rebuttal to Planned Parenthood’s response is available athttp://www.aul.org/wp-content/uploads/2011/07/AUL-Rebuttal-to-PP-7-11-11.pdf (last visited Sept. 11, 2012).
[ii] Mifeprex (mifepristone) Information, U.S. Food & Drug Admin, U.S. Dep’t. of Health & Hum Servs. (Jul. 19, 2011),http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm111323.htm(last visited Sept. 25, 2012).
[iii] The FDA report, “Mifepristone U.S. Postmarketing Adverse Events Summary through 04/30/2011,” is available athttp://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM263353.pdf(last visited Sept. 11, 2012).
[iv] 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).
[vi] 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://www.hsgac.senate.gov/subcommittees/oversight-of-government-management/hearings/when-diets-turn-deadly-consumer-safety-and-weight-loss-supplements (last visited Sept. 11, 2012).
[vii]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.”
[viii] See Spitz et al., Early pregnancy termination with mifepristone and misoprostol in the United States, 338 New Eng. J. Med. 1241 (1998).
[ix]See U.S. Food & Drug Admin., Mifeprex (mifepristone) Information (Feb. 24, 2010), available athttp://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111323.htm (last visited Sept. 11, 2012). 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 athttp://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111364.pdf (last visited Sept. 11, 2012).
The PATIENT AGREEMENT, requiring signature of patient and provider, states, “I believe I am no more than 49 days (7 weeks) pregnant.” Available athttp://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM111332.pdf (last visited Sept. 11, 2012).
[x] See Fjerstad et al. supra at 149.
[xi] 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.
[xii] See Spitz et al., Early pregnancy termination with mifepristone and misoprostol in the United States, 338 New Eng. J. Med. 1241 (1998).
[xiii] 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.
[xiv]See Planned Parenthood, The Bronx Center – Bronx, NY, available athttp://www.plannedparenthood.org/health-center/centerDetails.asp?f=2524. (last visited Sept. 11, 2012). 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 athttp://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM111332.pdf (last visited Sept. 11, 2012). Planned Parenthood’s forcing, or coercing, women to choose a surgical abortion at one of their clinics when a chemical abortion fails, violates the spirit, if not the letter, of the agreement form.
[xv] See Winikoff et al., supra.
[xvi] See Spitz et al., supra.
[xvii] See Fjerstad et al. supra 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.”