Abortion Standards for Northern Ireland:
Deficiencies of the RCOG Guideline Pertaining to Medical Abortion


References:

1 The Care of Women Requesting Abortion, Evidence-based Clinical Guideline Number 7, Royal College of Obstetricians and Gynaecologists, September 2004. Available from: http://www.rcog.org.uk/resources/Public/pdf/induced_abortionfull.pdf (Accessed April 13, 2007). [Back]

2 Gary MM, Harrison DJ. Analysis of severe adverse events related to the use of mifepristone as an abortifacient. Annals of Pharmacotherapy 2006;40(2):191-7 (published online Dec. 27, 2005) (http://www.theannals.com). [Back]

3 The FDA and RU-486: lowering the standard for women's health. Staff report prepared for the Hon. Mark Souder, Chairman, Subcommittee on Criminal Justice, Drug Policy and Human Resources, October 2006. [Back]

4 Gacek CM. Politicized science: the manipulated approval of RU-486 and its dangers to women's health. Family Research Council 2007. [Back]

5 Ibid. [Back]

6 Mifeprex Label, FDA, Revision 2: 7/19/05. Available from: http://www.fda.gov.cder.foi/lable/2005/020687s3lbl.pdf (Accessed April 13, 2007). [Back]

7 Medication Guide, Mifeprex, FDA. Available from: http://www.fda.gov/cder/drug/infopage/mifepristone/mifeprexMedguide20050719.pdf (Accessed April 13, 2007). [Back]

8 Patient Agreement, Mifeprex (mifepristone) Tablets, FDA. Available from: http://www.fda.gov/cder/drug/infopage/mifepristone/patientAgreement20050719.pdf (Accessed April 13, 2007) [Back]

9 Mifeprex (mifepristone) Information, FDA. Available from: http://www.fda.gov/cder/drug/infopage/mifepristone/default.htm (Accessed April 13, 2007) [Back]

10 Jensen JT, Astley SJ, Morgan E, Nichols MD. Outcomes of suction curettage and mifepristone abortion in the United States: a prospective comparison study. Contraception. 1999;59:153-9. [Back]

11 Harrison, D. Statement by Donna Harrison, M.D. before the House Subcommittee on Criminal Justice, Drug Policy and Human Res., Committee on Government Reform on RU-486: Demonstrating a low standard for women's health. 109th Congress (May 17, 2006). [Back]

12 Winikoff B, Sivin I, Coyaji KJ, et al. Safety, efficacy, and acceptability of medical abortion in China, Cuba, and India: a comparative trial of mifepristone and misoprostol versus surgical abortion. Am J Obstet Gynecol 1997;176:431-7. [Back]

13 Cabezas E. Medical versus surgical abortion. Internat J Gynaecol & Obstet. 1998; 63 Supp. 1, S141-6. [Back]

14 Elul B, Ellertson C, Winikoff B, Coyaji K. Side effects of mifepristone-misoprostol abortion versus surgical abortion. Data from a trial in China, Cuba, and India. Contraception 1999;59(2):107-14. Available from: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10361625&dopt=Abstract (accessed March 31, 2007). [Back]

15 The FDA and RU-486: lowering the standard for women's health, op. cit. [Back]

16 Ibid. [Back]

17 Ibid. [Back]

18 Say L, Kulier R, Gulmezoglu M, Campana A. Medical versus surgical methods for first trimester termination of pregnancy. Cochrane Database Syst Rev 2002;(4):DC003037.202. [Back]

19 Cabezas, op. cit. [Back]

20 Elul et al., op. cit [Back]

21 Jensen et al., op. cit. [Back]

22 Medical Officer's Review of Amendments 024 and 033, Final Reports for the U.S. Clinical Trials Inducing Abortion up to 63 Days Gestational Age and Complete Responses Regarding Distribution System and Phase 4 Commitments, Finalized November 22, 1999 (dated January 27, 2000). http://www.fda.gov/cder/foi/nda/2000/20687_Mifepristone_medr_P1.pdf (accessed March 25, 2007) [Back]

23 Ibid. [Back]

24 McGregor J, FDA: Emerging Clostridial Disease Workshop, Transcript, May 11, 2006, Atlanta, GA. Available from http://www.fda.gov/cder/meeting/clostridial/meeting_transcrript.pdf (accessed April 13, 2007), citing Couzimet and Beaulieu, The New England Journal, 1986. [Apparently Couzinet B, Le Strat N, Ulmann A, Baulieu EE, Schaison G. Termination of early pregnancy by the progesterone antagonist RU 486 (mifepristone). N Engl J Med 1986;315:1565-70.] [Back]

25 Mifeprex Label, FDA, op. cit. [Back]

26 The FDA and RU-486: lowering the standard for women's health, op. cit., citing Report of the International Inquiry Commission on RU 486, April 1990, available at: http://www.trdd.org/RU486/RUCIEE.HTM (accessed on April 13, 2007). [Back]

27 Harrison, op. cit. [Back]

28 Ibid. [Back]

29 Ibid. 12 [Back]

30 Medication Guide, Mifeprex, FDA, op. cit. [Back]

31 Mifeprex Label, FDA, op. cit. [Back]

32 The Care of Women Requesting Abortion, Evidence-based Clinical Guideline Number 7, Royal College of Obstetricians and Gynaecologists, op. cit., p. 30. [Back]

33 Ibid. [Back]

34 The Care of Women Requesting Abortion, Evidence-based Clinical Guideline Number 7, Royal College of Obstetricians and Gynaecologists, op. cit., p. 46, citing Ashok PW, Templeton A, Wagaarachchi PT, Flett GMM. Factors affecting the outcome medical abortion with mifepristone and misoprostol. BJOG 2002;109:1281-9. [Back]

35 Ashok PW, Templeton A, Wagaarachchi PT, Flett GMM. Factors affecting the outcome medical abortion with mifepristone and misoprostol: a review of 4132 consecutive cases. BJOG 2002;109:1281-9. [Back]

36 The Care of Women Requesting Abortion, Evidence-based Clinical Guideline Number 7, Royal College of Obstetricians and Gynaecologists, op. cit., p. 30. [Back]

37 Ibid. [Back]

38 Harrison, op. cit., citing, Sternberg E. Proceedings of the National Academy Sciences 1989;86:2374-78. [Back]

39 McGregor J. An OB/GYN View of Early Medical Terminations and Clostridium Sordellii Infection, FDA: Emerging Clostridial Disease Workshop, Transcript, May 11, 2006, Atlanta, GA. Available from: http://www.fda.gov/cder/meeting/clostridial/meeting_transcrript.pdf (accessed April 13, 2007). [Back]

40 Report of the International Inquiry Commission on RU 486, April 1990, available at: http://www.trdd.org/RU486/RUCIEE.HTM (accessed on April 13, 2007), citing J. Clin. Endocrinol. Metab. 1989;69: 1195-1199. [Back]

41 Miech RP. Disruption of the innate immune system by mifepristone and lethal toxin of Clostridium sordellii. Journal of organ dysfunction; 2007, 1-5, i-First article. First Published on: February 19, 2007. DOI: 10.1080/17471060701200402 [Back]

42 Gacek, op. cit. [Back]

43 Harrison, op. cit. [Back]

44 Emerging Clostridial Disease Workshop, Transcript, May 11, 2006, Atlanta, GA. Available from http://www.fda.gov/cder/meeting/clostridial/meeting_transcrript.pdf (accessed April 13, 2007). [Back]

45 McDonald C. Panel 3 Discussion: FDA: Emerging Clostridial Disease Workshop, Transcript, May 11, 2006, Atlanta, GA. Available from: http://www.fda.gov/cder/meeting/clostridial/meeting_transcrript.pdf (accessed April 13, 2007). [Back]

46 Fischer M. Panel 1-Session 2: Clinical syndromes, pathophysiology and host factors of Clostridium sordellii. Clostridium Sordellii Toxic Shock Syndrome Following Medical Abortion. FDA: Emerging Clostridial Disease Workshop, Transcript, May 11, 2006, Atlanta, GA. Available from http://www.fda.gov/cder/meeting/clostridial/meeting_transcrript.pdf (accessed April 13, 2007). [Back]

47 FDA public health advisory: sepsis and medical abortion. July 19, 2005; updated July 22, 2005 and November 4, 2005. Available from: http://www.fda.gov/cder/drug/advisory/mifeprex.htm (accessed April 13, 2007). [Back]

48 Mifeprex Label, FDA, op. cit. [Back]

49 Medication Guide, Mifeprex, FDA, op. cit. [Back]

50 Patient Agreement, Mifeprex (mifepristone) Tablets, FDA, op. cit. [Back]

51 >Gacek, op. cit. [Back]

52 http://www.fda.gov/cder/drug/infopage/mifepristone/default.htm [Back]

53 Seligman P. Opening Session, FDA: Emerging Clostridial Disease Workshop, Transcript, May 11, 2006, Atlanta, GA. Available from http://www.fda.gov/cder/meeting/clostridial/meeting_transcrript.pdf (accessed April 13, 2007). [Back]

54 Gerding D. Opening Session, FDA: Emerging Clostridial Disease Workshop, Transcript, May 11, 2006, Atlanta, GA. Available from http://www.fda.gov/cder/meeting/clostridial/meeting_transcrript.pdf (accessed April 13, 2007). [Back]

55 McGregor J. An OB/GYN View of Early Medical Terminations and Clostridium Sordellii Infection, FDA: Emerging Clostridial Disease Workshop, Transcript, May 11, 2006, Atlanta, GA. Available from: http://www.fda.gov/cder/meeting/clostridial/meeting_transcrript.pdf (accessed April 13, 2007). [Back]

56 McGregor J. Panel 1, Session 2, FDA: Emerging Clostridial Disease Workshop, Transcript, May 11, 2006, Atlanta, GA. Available from http://www.fda.gov/cder/meeting/clostridial/meeting_transcrript.pdf (accessed April 13, 2007). [Back]

57 FDA public health advisory: sepsis and medical abortion, op. cit. [Back]

58 Soper D. Panel 3 Discussion, FDA: Emerging Clostridial Disease Workshop, Transcript, May 11, 2006, Atlanta, GA. Available from: http://www.fda.gov/cder/meeting/clostridial/meeting_transcrript.pdf (accessed April 13, 2007). [Back]

59 McGregor J. An OB/GYN View of Early Medical Terminations and Clostridium Sordellii Infection, FDA: Emerging Clostridial Disease Workshop, Transcript, May 11, 2006, Atlanta, GA. Available from: http://www.fda.gov/cder/meeting/clostridial/meeting_transcrript.pdf (accessed April 13, 2007). [Back]

60 Ibid. [Back]

61 Ibid. 13 [Back]

62 Kweder S. Panel 3 Discussion, FDA: Emerging Clostridial Disease Workshop, Transcript, May 11, 2006, Atlanta, GA. Available from: http://www.fda.gov/cder/meeting/clostridial/meeting_transcrript.pdf (accessed April 13, 2007). [Back]

63 Miech RP. FDA: Emerging Clostridial Disease Workshop, Transcript, May 11, 2006, Atlanta, GA. Available from: http://www.fda.gov/cder/meeting/clostridial/meeting_transcrript.pdf (accessed April 13, 2007). [Back]

64 Ibid. [Back]

65 Ibid. [Back]

66 Ibid. [Back]

67 McGregor J. An OB/GYN View of Early Medical Terminations and Clostridium Sordellii Infection, FDA: Emerging Clostridial Disease Workshop, Transcript, May 11, 2006, Atlanta, GA. Available from: http://www.fda.gov/cder/meeting/clostridial/meeting_transcrript.pdf (accessed April 13, 2007). [Back]

68 Ibid. [Back]

69 Ibid. [Back]

70 Ibid. [Back]

71 The Care of Women Requesting Abortion, Evidence-based Clinical Guideline Number 7, Royal College of Obstetricians and Gynaecologists, September 2004, Recommendation 16, p. 29. Available from: http://www.rcog.org.uk/resources/Public/pdf/induced_abortionfull.pdf (Accessed April 13, 2007). [Back]

72 Harrison, op. cit. [Back]

73 The FDA and RU-486: lowering the standard for women's health, op. cit. [Back]

74 Fischer M. Fatal toxic shock syndrome associated with Clostridium sordellii after medical abortion. N Engl J Med 2005;353:2352-60. [Back]

75 Greene MF. Fatal infections associated with mifepristone-induced abortion. N Engl J Med 2005;353(22):2317-8. [Back]

76 Harrison, op. cit. [Back]

77 McGregor J. An OB/GYN View of Early Medical Terminations and Clostridium Sordellii Infection, FDA: Emerging Clostridial Disease Workshop, Transcript, May 11, 2006, Atlanta, GA. Available from: http://www.fda.gov/cder/meeting/clostridial/meeting_transcrript.pdf (accessed April 13, 2007). [Back]

78 Ibid. [Back]

79 The Care of Women Requesting Abortion, Evidence-based Clinical Guideline Number 7, Royal College of Obstetricians and Gynaecologists, September 2004, Recommendation 16, p. 29. Available from: http://www.rcog.org.uk/resources/Public/pdf/induced_abortionfull.pdf (accessed April 13, 2007). [Back]

80 Mifeprex Label, FDA, op. cit. [Back]

81 Ibid. [Back]

82 Ibid. [Back]

83 Ibid. [Back]

84 Ibid. [Back]

85 Ibid. [Back]

86 Medical Officer's Review of Amendments 024 and 033, Final Reports for the U.S. Clinical Trials Inducing Abortion up to 63 Days Gestational Age and Complete Responses Regarding Distribution System and Phase 4 Commitments, Finalized November 22, 1999 (dated January 27, 2000). http://www.fda.gov/cder/foi/nda/2000/20687_Mifepristone_medr_P1.pdf (accessed March 25, 2007) [Back]

87 Medication Guide, Mifeprex, FDA, op. cit. [Back]

88 Mifeprex Label, FDA, op. cit. [Back]

89 Medication Guide, Mifeprex, FDA, op. cit. [Back]

90 Mifeprex Label, FDA, op. cit. [Back]

91 Ibid. [Back]

92 Spitz IM, Bardin CW, Benton L, Robbins A. Early pregnancy termination with mifepristone and misoprostol in the United States. N Engl J Med 1998:338(19):1241-7. [Back]

93 Gary, et al., op. cit. [Back]

94 Ibid. [Back]

95 Mifeprex Label, FDA, op. cit. [Back]

96 Gacek, op. cit. [Back]

97 Ibid. [Back]

98 FDA public health advisory: sepsis and medical abortion, op. cit. [Back]

99 Mifeprex Label, FDA, op. cit. 14 [Back]

100 Fischer M. Panel 1-Session 2: Clinical syndromes, pathophysiology and host factors of Clostridium sordellii. Clostridium Sordellii Toxic Shock Syndrome Following Medical Abortion. FDA: Emerging Clostridial Disease Workshop, Transcript, May 11, 2006, Atlanta, GA. Available from http://www.fda.gov/cder/meeting/clostridial/meeting_transcrript.pdf (accessed April 13, 2007). [Back]

101 Ibid. [Back]

102 FDA public health advisory: sepsis and medical abortion, op. cit. [Back]

103 Ibid. [Back]

104 McDonald C, op. cit. [Back]

105 McGregor J. An OB/GYN View of Early Medical Terminations and Clostridium Sordellii Infection, FDA: Emerging Clostridial Disease Workshop, Transcript, May 11, 2006, Atlanta, GA. Available from: http://www.fda.gov/cder/meeting/clostridial/meeting_transcrript.pdf (accessed April 13, 2007). [Back]

106 Sicard, D. Panel 3 Discussion, FDA: Emerging Clostridial Disease Workshop, Transcript, May 11, 2006, Atlanta, GA. Available from: http://www.fda.gov/cder/meeting/clostridial/meeting_transcrript.pdf (accessed April 13, 2007). [Back]

107 Gacek, op. cit. [Back]

108 Misoprostol (marketed as Cytotec) Information, FDA. Available from: http://www.fda.gov/cder/drug/infopage/misoprostol/default.htm (accessed April 13, 2007) [Back]

109 Ibid. [Back]

110 Cytotec Label, FDA. Available from: http://www.fda.ogv/cder/foi/label/ 2002/19268slr037.pdf (accessed April 13, 2007) [Back]

111 Misoprostol (marketed as Cytotec) Information, FDA, op. cit. [Back]

112 Kweder S. Panel 1, Session 2 Discussion, FDA: Emerging Clostridial Disease Workshop, Transcript, May 11, 2006, Atlanta, GA. Available from: http://www.fda.gov/cder/meeting/clostridial/meeting_transcrript.pdf (accessed April 13, 2007). [Back]

113 Ibid. [Back]

114 Ibid. [Back]

115 McGregor J. Panel 1, Session 2 Discussion, FDA: Emerging Clostridial Disease Workshop, Transcript, May 11, 2006, Atlanta, GA. Available from: http://www.fda.gov/cder/meeting/clostridial/meeting_transcrript.pdf (accessed April 13, 2007). [Back]

116 Ibid. [Back]

117 Cytotec (Misoprostol) Label, FDA. Available from: http://www.fda.gov/cder/foi/label/2002/19268slr037.pdf (accessed April 13, 2007). [Back]

118 Spitz IM, et al., op. cit. [Back]

119 Ibid. [Back]

120 Ashok PW, Templeton A, Wagarrachchi PT, Flett GMM. Factors affecting the outcome of early medical abortion: a review of 4132 consecutive cases. BJOG 2002;109:1281-89. [Back]

121 Report of the International Inquiry Commission on RU 486, April 1990, available at: http://www.trdd.org/RU486/RUCIEE.HTM (accessed on April 13, 2007). [Back]

122 The Care of Women Requesting Abortion, Evidence-based Clinical Guideline Number 7, Royal College of Obstetricians and Gynaecologists, September 2004, op. cit., p. 12. [Back]

123 Ibid. [Back]

124 Ibid. [Back]

125 Ashok PW, Templeton A, Wagarrachchi PT, Flett GMM. Factors affecting the outcome of early medical abortion: a review of 4132 consecutive cases. BJOG 2002;109:1281-89. [Back]

126 Ibid. [Back]

127 Kweder S. Panel 1, Session 2 Discussion, FDA: Emerging Clostridial Disease Workshop, Transcript, May 11, 2006, Atlanta, GA. Available from: http://www.fda.gov/cder/meeting/clostridial/meeting_transcrript.pdf (accessed April 13, 2007). [Back]

128 Fischer M, Panel 1, Session 2, Pathophysiology and host factors of Clostridium sordellii, Clostridium Sordellii Toxic Shock Syndrome Following Medical Abortion. FDA: Emerging Clostridial Disease Workshop, Transcript, May 11, 2006 [Back]

129 Ibid. [Back]

130 Ibid. [Back]

13

1 Ibid. [Back]

132 Ibid. 15 [Back]

133 McGregor J. An OB/GYN View of Early Medical Terminations and Clostridium Sordellii Infection, FDA: Emerging Clostridial Disease Workshop, Transcript, May 11, 2006, Atlanta, GA. Available from: http://www.fda.gov/cder/meeting/clostridial/meeting_transcrript.pdf (accessed April 13, 2007). [Back]

134 The Care of Women Requesting Abortion, Evidence-based Clinical Guideline Number 7, Royal College of Obstetricians and Gynaecologists, op. cit., p. 12. [Back]

135 Cytotec Label, FDA, op. cit. [Back]

136 Spitz, IM, et al., op. cit. [Back]

137 Ibid. [Back]

138 Mifepristone: Expanding Women's Options for Early Abortion, Planned Parenthood Federation of America, First Published May 1, 2006, Updated August 24, 2006. Available at: http:www.ppgmv.org/news-articles-press/politics-policy-issues/abortion-access/mifepristone-6128.htm (Accessed April 7, 2007). [Back]

139 The FDA and RU-486: lowering the standard for women's health. Staff report prepared for the Hon. Mark Souder, Chairman, Subcommittee on Criminal Justice, Drug Policy and Human Resources, October 2006. [Back]

140 The Care of Women Requesting Abortion, Evidence-based Clinical Guideline Number 7, Royal College of Obstetricians and Gynaecologists, op. cit., p. 49, citing Autrey AM, Hayes EC, Jacobson GF, Kirby RS. A comparison of medical induction and dilation and evacuation for second-trimester abortion. Am J Obstet Gynecol 2002;187:393-7. [Back]

141 The Care of Women Requesting Abortion, Evidence-based Clinical Guideline Number 7, Royal College of Obstetricians and Gynaecologists, op. cit., p. 49-50. [Back]

142 Ibid. [Back]

143 Ibid. [Back]

144 Autrey AM, Hayes EC, Jacobson GF, Kirby RS. A comparison of medical induction and dilation and evacuation for second-trimester abortion. Am J Obstet Gynecol 2002;187:393-7. [Back]

145 Ibid. [Back]

146 Ibid. [Back]

147 Kahn JG, Becker BJ, MacIsaac L, Amory JK, Neuhaus J, Olkin I, et al. The efficacy of medical abortion: a meta- analysis. Contraception 2000;61:29-40. [Back]

148 Ibid. [Back]

149 Ibid. [Back]

150 The Care of Women Requesting Abortion, Evidence-based Clinical Guideline Number 7, Royal College of Obstetricians and Gynaecologists, op. cit., p. 31. [Back]

151 Jensen JT, et. al., op. cit. [Back]

152 Winikoff, et al., op. cit. [Back]

153 Medical Officer's Review of Amendments 024 and 033, Final Reports for the U.S. Clinical Trials Inducing Abortion up to 63 Days Gestational Age and Complete Responses Regarding Distribution System and Phase 4 Commitments, op. cit. [Back]

154 Cabezas op. cit. [Back]

155 The FDA and RU-486: lowering the standard for women's health, op cit. [Back]

156 Ashok PW, Penney GC, Flett GMM, Templeton A. An effective regimen for early medical abortion: a report of 2000 consecutive cases. Hum Reprod 1998;13:2962-5. [Back]

157 Ashok PW, Templeton A, Wagaarachchi PT, Flett GMM. Factors affecting the outcome of early medical abortion: a review of 4132 consecutive cases. BJOG 2002;109:1281-9. [Back]

158 Ibid. [Back]

159 Kahn JG, Becker BJ, MacIsaa L, Amory JK, Neuhaus J, Olkin I, Creinin MD. The efficacy of medical abortion: a meta-analysis. [Back]

2000;61(1):29-40.

160 Ashok PW, Judd A, Flett GMM, Fitzmaurice A, Graham W, Templeton A. A randomized comparison of medical abortion and surgical vacuum aspiration at 10-13 weeks gestation. 2002;17(1):92-98. [Back]

161 Ibid. [Back]

162 Medical Officer's Review of Amendments 024 and 033, Final Reports for the U.S. Clinical Trials Inducing Abortion up to 63 Days Gestational Age and Complete Responses Regarding Distribution System and Phase 4 Commitments, op. cit. [Back]

163 FDA and RU-486: lowering the standard for women's health, op cit. [Back]

164 FDA: Emerging Clostridial Disease Workshop, Transcript, May 11, 2006, Atlanta, GA. Available from: http://www.fda.gov/cder/meeting/clostridial/meeting_transcrript.pdf (accessed April 13, 2007). [Back]

165 Winikoff B, et. al., op. cit [Back]

166 B, et. al., op. cit [Back]

167 Cabezas E., op. cit. 16 [Back]

168 Elul B, et. al., op. cit. [Back]

169 Medical Officer's Review of Amendments 024 and 033, Final Reports for the U.S. Clinical Trials Inducing Abortion up to 63 Days Gestational Age and Complete Responses Regarding Distribution System and Phase 4 Commitments, op. cit. [Back]

170 FDA and RU-486: lowering the standard for women's health, op cit. [Back]

1

71 Jensen JT, et. al., op. cit. [Back]

172 Darton N. Surprising journey for abortion drug. New York Times. March 23, 1994, p. C12. [Back]

1, 2, 3,