(This article was originally written in 2004 but updated in 2008) In April, 2002 the FDA issued a report on Mifeprex (RU 486) associated mishaps. More than mishaps. Deaths. One woman died of sepsis, one woman died of a ruptured ectopic pregnancy. Two other women suffered ruptured ectopics, but did not die. This will be the tip of the iceberg if Mifeprex becomes as widespread as it’s advocates hope. In response to these deaths, according to the AP report of 4-17-02, an unnamed FDA official said, “the RU 486 regimen was not responsible for the two deaths. . .”. Correct. The Mifeprex WAS responsible for the two deaths of the recently conceived unborn children. But to say that the Mifeprex did not cause ectopic pregnancy death is to be more than disingenuous: If the woman who died had received a correct ectopic diagnosis before receiving Mifeprex, she would undoubtedly still be alive. The big question is: How can a doctor avoid giving Mifeprex to a patient with an ectopic pregnancy, and thus avoid this kind of disaster? The answer is: get an ultrasound to substantiate where the pregnancy is located. But ultrasound use is not required in the “FDA Qualifications” for use of Mifeprex. The FDA only requires that the doctor giving Mifeprex, “must be able to diagnose ectopic pregnancies.” So how is the abortion provider supposed to rule out an ectopic? Any way he/she thinks is adequate. Apparently this particular abortion provider “divined” that there was no ectopic pregnancy (meets FDA qualifications), but this time the provider was wrong. Result: one dead woman. How can the FDA have permitted provider qualifications that are so inept? A little background is important. The American trials used by the FDA to substantiate patient safety required ultrasound to determine pregnancy dating and location of gestational sac or fetus. Thus the FDA’s medical advisory committee was concerned that similar safety standards be a part of the Mifeprex regimen. That was certainly a logical concern: Is that not what trials are for? However, it apparently was NOT a logical concern to certain other medical powers that be. In August 2000, Vol 1, No. 8, the American Health Consultants “Contraceptive Technology lead article proclaims “Suggested FDA restrictions might curtail access to mifepristone.” “Access trumps safety standards” is the tone of the thinking. In a letter to the FDA dated July 24, 2000, ACOG objects to the restriction that the administering physician must have certification for ultrasound dating of pregnancy and detecting ectopic pregnancy. Totally ignoring the FDA’s reason for the requirement (accuracy in diagnosis for the good of the patient), and ignoring the reality of errors in both dating and sac location, the ACOG states, “Physicians and patients can quite accurately date a woman’s pregnancy” The letter simply and conveniently fails to even mention the problem of detecting ectopics (which consitiute 2% of clinical pregnancies in the US.) In the 2003 Compendium, there is mention that only 30% of the French patients get ultrasound, and that this has proven to be safe. What they do not mention is that the French socialized medicine system provides for very close monitoring of the patients by “highly experienced providers” (ACOG’s words), including a mandatory 2nd visit for in-house misoprostol administration, followed by a 4 hour observation period. In contrast, in America we are proposing varying regimens of misoprostol, and home self-administration to eliminate that inconvenient “2nd visit.” (ACOG Practice Bulletin No. 26, April 2001, page 3). Somehow the Medical Establishment is losing sight of patient safety—or at least is relegating safety to a secondary priority. The ACOG and AMA then issued a joint letter, same date, July 24, 2000, to the FDA stating, “these (FDA) requirements are not based upon scientific facts, do not follow current medical practice and impose inappropriate conditions on the practice of medicine.” (But ultrasound is the medical gold standard for dating early pregnancy and ruling out ectopic pregnancy.) The letter further states that, “It is equally imperative that the FDA’s work be based solely on evidence from the drug’s clinical trials (but the trials required ultrasound), and be entirely free from any political influence” (but the ACOG-AMA letter is certainly “political influence”). The FDA capitulated to this pressure from the “experts in obstetrics,” and they deleted the requirement that “The physician must have ‘certification’ for ultrasound dating of pregnancy and detecting ectopic pregnancy,” replacing it with “Physician providing, or supervising the provision of Mifeprex must be able to diagnose ectopic pregnancies.” And who will make sure that physicians actually have this ability? The FDA allowed, under pressures noted above, for the physicians themselves to say that they have this ability, without reference to the use of ultrasound. Thus the door was opened for the abortion providers to practically ignore the possibility of ectopic pregnancy. And thus, the maternal mortality patient mentioned above experienced cramps, abdominal pain, probably some vaginal bleeding, all expected in a Mifeprex abortion, and internally bled to death from an ectopic pregnancy. She will not be the last. But the degradation of the standard of care goes on. The February 2001 issue of Contemporary OB/GYN offered a CME article suggesting that one did not have to follow the FDA regimen to have success. The article suggested “Doses of mifepristone as low as 100mg may be as effective as 600 mg for medical abortion.” (also would incidentally result in less medicine cost and higher profit margin). The article suggests one can include gestations up to 63 days and be almost as “successful” (98% vs96% they claim). However this percent efficacy is in direct contradiction to the U.S. Clinical trials of Mifeprex, which found that the failure rate of Mifeprex jumps from 8% at less than or equal to 49 days gestation to 17% at 50 to 56 days and 23% at 57 to 63 days. (Spitz, Bardin, et.al. NEJM Vol 338[fusion_builder_container hundred_percent=”yes” overflow=”visible”][fusion_builder_row][fusion_builder_column type=”1_1″ background_position=”left top” background_color=”” border_size=”” border_color=”” border_style=”solid” spacing=”yes” background_image=”” background_repeat=”no-repeat” padding=”” margin_top=”0px” margin_bottom=”0px” class=”” id=”” animation_type=”” animation_speed=”0.3″ animation_direction=”left” hide_on_mobile=”no” center_content=”no” min_height=”none”][18]pp1241-1247) The article further counsels us that the misoprostol may be self-administered at home offering “the convenience and privacy that is available with home administration.” (Eliminates that second inconvenient office visit, too, when 49% of the women will cause significant office disturbance with bleeding and pain as they expel the fetus. Better to do that at home.) And to further demonstrate the validity of this method, they report that 96% of the involved women “would recommend it to a friend.” (AAPLOG asks, “What kind of science is that??) FDA Clinical safety trials and the French safety model are somewhat bypassed in favor of a kind of experimental approach. The clear implication is that somehow this approach will result in benefit to the pregnant woman seeking an abortion. And the degradation of standard of care doesn’t stop here. Later in 2001, the ACOG mailed to its Fellows a monograph called “Early Medical Abortion: Issues for Practice. ” This tells us that “alternative regimens are equal to or more effective than the FDA approved regimen.” It counsels us that we should “rule out ectopic pregnancy through LMP history, bi-manual exam, and ultrasound, if necessary.” (Can any doctor confirm that a seven week pregnancy is intrauterine, rather than ectopic, WITHOUT using ultrasound?) And the piece further assures us that ultrasound “is not required by the FDA.” Additionally, the use of self- administration of 800 mcg of misoprostol at home is set forth as a norm. Finally, the 2004 ACOG Compendium of Selected Publications, (page 491), while confirming that vag sono is “the most accurate means of confirming intrauterine pregnancy and gestational age,” informs us that studies “in China, Cuba, and India found that dating based on LMP closely correlated with estimates based on physical exam.” (AAPLOG does not find that statement to be particularly reassuring for the American patient taking mifeprex.) And this statement is in direct contradiction to published studies comparing sonographic estimation of gestational age with estimation by LMP. Crenin and Spitz, “Use of Various Ultrasonographic Criteria to Evaluate the Efficacy of Mifepristone and Misoprostol for Medical Abortion,” (AJOG 181 [1999]: 1419-24): “The gestational age according to the [last menstrual period] was verified by transvaginal ultrasonographic examination only 39% of the time when a gestational sac was present and 51% to 63% of the time when an embryonic pole was present.” And this was data generated during the U.S. Clinical Trials of Mifeprex, where estimation of gestational age was done by ObGyns, or experienced abortion providers. AAPLOG sees in all of this a mixed message to practitioners regarding standard of care for women seeking a medical abortion. Safety concerns are compromised in favor of ease of access, cost factors, and patient convenience (or is it doctor convenience?). The abortion provider can basically set his/her own standards for dating, locating, confirming “success,” and follow-up. It is as if the pregnant women are a kind of experimental group subject to whichever off-label protocol the individual abortion provider desires to use. We consider this a degradation of the available and acceptable standard of care. We believe the ACOG, the “guardian of women’s healthcare”, should champion the highest standards of safety, rather than be a party to such compromise, no matter what the procedure. American women deserve no less from us. (Note: AAPLOG is opposed to the use of mifeprex because it kills an innocent unborn human being. But we are also opposed to a compromised standard in the care of women for any procedure—especially an elective procedure involving the reproductive system of predominantly young women.)[/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]
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