784
replacement is necessary, as can the 20g/day levonorgestrel IUD. 5 years is recommended for the
before
Nova T because the pregnancy
rate
increases
subsequently. 12 For multiparous women and nulliparous women in low-risk groups, there seems to be little if any risk of getting PID with modern copper-releasing IUDs and the 20 fig/day levonorgestrel IUD. If a patient in a high-risk group needs to use an IUD, a copperreleasing or a levonorgestrel-releasing device can be prescribed, after counselling. The levonorgestrel IUD will offer some protection against PID: the rate, at 5 years of use, is less than 1 per 100 woman-years. In all cases medicated devices releasing copper or levonorgestrel are preferable to the older nonmedicated devices. 1. WHO Scientific Group. Mechanism of action safety and efficacy of IUDs. Geneva: WHO, 1987. 2. WHO. IUDs: physiological and clinical aspects. WHO Tech Rep Ser 1968; 397: 21. 3. Advisory Committee on Obstetrics and Gynecology. Report on IUDs. Washington, DC: US Food and Drug Administration, 1968. 4. American College of Obstetricians and Gynecologists. The IUD. ACOG Tech Bull 1968; 10. 5. Kessel E. PID with IUD use: a reassessment. Fertil Steril 1989; 51: 1-11. 6. Westrom L. PID bacteriology and sequelae. Contraception 1987; 36: 111-28. 7. Westrom L. PID and other STDs. Curr Sci 1989; 1: 5-10. 8. Wright NH, Leemmle P. Acute PID in an indigent population. Am J Obstet Gynecol 1968; 101: 979-90. 9. Westrom L, Bengtsson LP, Mardh DA. The nsk of pelvic inflammatory disease in women using intrauterine contraceptive devices as compared to non-users. Lancet 1976; ii: 221-24. 10. Grimes DA. IUD and PID: recent developments. Contraception 1987; 36: 97-109. 11. Struthers B. IUDs, PID and fertility in nulliparous women. Adv Contraception 1990; 7: 211-30. 12. WHO Task Force Report: The T Cu 380A, Multiload 250 and Nova T IUDs at 3, 5, and 7 years of use. Contraception 1990; 42: 142-58. 13. Cramer D, Schiff I, Schoenbaum SC, et al. Tubal infertility and IUDs. N Engl J Med 1985; 312: 941-47. 14. Daling JR, Weiss NS, Metch BJ, et al. Primary tubal infertility in relation to IUD use. N Engl J Med 1985; 312: 937-41. 15. Wilson JC. A prospective New Zealand study of fertility after removal of copper IUDs: a four year study. Am J Obstet Gynecol 1989; 160: 391-96. 16. Sandmire HF. Fertility after IUD discontinuation. Adv Contraception 1986; 2: 327-35. 17. Newton JR, Tacchi D. Long-term use of IUDs. Lancet 1990; 335: 1322-23.
Protecting individuals; preserving data information technology led to widespread public concern about privacy and data protection. Soon we were awash with publications and consultative documents containing numerous recommendations for standards of practice. The content and style of these pronouncements depended on their derivation, whether from a professional or government body, or from a medical or non-medical background. Naturally they tended to relate to prevailing national mores. Many specifically considered the questions raised by the need for the public good, particularly for medical research, whether clinical or epidemiological. Perhaps the most scholarly was the report of a working party set up by Advances
in
the Commission of the European Communities chaired by E. G. Knox.’ It is therefore especially unfortunate that a draft EC directive2 currently circulating for consultation should be formulated in such a way that it could, if implemented, lead to the rapid demise of much of the epidemiological (and social science) research in the Community.3This draft directive is proposed despite the Commission’s endorsement of the 1981 Data Protection Convention of the Council of Europe, the justification given being that only seven members (including the UK) have ratified it and passed domestic legislation. The Commission concludes that, without a further directive, equivalent protection between member states is insufficient. The dangers in the document stem from its heavy legal overtones. Standards concerning the use of personal data are based on the levels prevailing in the most restrictive states. Moreover, the authors seem to have totally ignored the needs of the public health for epidemiological and much other research. Take this sweeping general caveat: "member states shall prohibit the automatic processing of data revealing ethnic or racial origin ... and of data regarding health or sexual life, without the express and written consent, freely given, of the data subject". An important and damaging principle sets out that personal data should be "kept in a form which permits identification of the data subjects for no longer than is necessary for the purpose for which the data were stored.". The restrictive nature of these proposals could rule out the release of cancer information to regional cancer registries and thus effectively sabotage the large body of research they generate into causes of cancer and evaluation of the effectiveness and safety of treatment. This would be in line with with the prevailing policy in Germany, for example, where cancer registration is severely restricted. It would also render impossible retrospective studies of health records. Those who are consulted must point out the real dangers in these proposals and insist on a reformulation that permits the continuation of epidemiological research. A study of the wording suggests that this could be readily achieved by exempting medical research that is conducted under strict ethical safeguards. Medical communities in member states are already conscious of the need to safeguard both privacy and confidentiality. In the UK a group set up by the Royal College of Physicians is preparing a report on ethical safeguards; we hope this will provide guidelines to help exempt medical research from the damaging proposals in the directive. 1. Knox EG. The
2.
3.
confidentiality of medical records: the principles and practice of protection in a research-dependent environment. Report of working party of Advisory Panel for Social Medicine and Epidemiology in European Economic Community. Luxembourg: Commission of the European Communities, 1984. Proposal for an EC Council Directive concerning the protection of individuals in relation to the processing of personal data. Syn 287. Brussels, 1992. Knox EG. Confidential medical records and epidemiological research. Br Med J 1992; 304: 727-28.
replacement is necessary, as can the 20g/day levonorgestrel IUD. 5 years is recommended for the
before
Nova T because the pregnancy
rate
increases
subsequently. 12 For multiparous women and nulliparous women in low-risk groups, there seems to be little if any risk of getting PID with modern copper-releasing IUDs and the 20 fig/day levonorgestrel IUD. If a patient in a high-risk group needs to use an IUD, a copperreleasing or a levonorgestrel-releasing device can be prescribed, after counselling. The levonorgestrel IUD will offer some protection against PID: the rate, at 5 years of use, is less than 1 per 100 woman-years. In all cases medicated devices releasing copper or levonorgestrel are preferable to the older nonmedicated devices. 1. WHO Scientific Group. Mechanism of action safety and efficacy of IUDs. Geneva: WHO, 1987. 2. WHO. IUDs: physiological and clinical aspects. WHO Tech Rep Ser 1968; 397: 21. 3. Advisory Committee on Obstetrics and Gynecology. Report on IUDs. Washington, DC: US Food and Drug Administration, 1968. 4. American College of Obstetricians and Gynecologists. The IUD. ACOG Tech Bull 1968; 10. 5. Kessel E. PID with IUD use: a reassessment. Fertil Steril 1989; 51: 1-11. 6. Westrom L. PID bacteriology and sequelae. Contraception 1987; 36: 111-28. 7. Westrom L. PID and other STDs. Curr Sci 1989; 1: 5-10. 8. Wright NH, Leemmle P. Acute PID in an indigent population. Am J Obstet Gynecol 1968; 101: 979-90. 9. Westrom L, Bengtsson LP, Mardh DA. The nsk of pelvic inflammatory disease in women using intrauterine contraceptive devices as compared to non-users. Lancet 1976; ii: 221-24. 10. Grimes DA. IUD and PID: recent developments. Contraception 1987; 36: 97-109. 11. Struthers B. IUDs, PID and fertility in nulliparous women. Adv Contraception 1990; 7: 211-30. 12. WHO Task Force Report: The T Cu 380A, Multiload 250 and Nova T IUDs at 3, 5, and 7 years of use. Contraception 1990; 42: 142-58. 13. Cramer D, Schiff I, Schoenbaum SC, et al. Tubal infertility and IUDs. N Engl J Med 1985; 312: 941-47. 14. Daling JR, Weiss NS, Metch BJ, et al. Primary tubal infertility in relation to IUD use. N Engl J Med 1985; 312: 937-41. 15. Wilson JC. A prospective New Zealand study of fertility after removal of copper IUDs: a four year study. Am J Obstet Gynecol 1989; 160: 391-96. 16. Sandmire HF. Fertility after IUD discontinuation. Adv Contraception 1986; 2: 327-35. 17. Newton JR, Tacchi D. Long-term use of IUDs. Lancet 1990; 335: 1322-23.
Protecting individuals; preserving data information technology led to widespread public concern about privacy and data protection. Soon we were awash with publications and consultative documents containing numerous recommendations for standards of practice. The content and style of these pronouncements depended on their derivation, whether from a professional or government body, or from a medical or non-medical background. Naturally they tended to relate to prevailing national mores. Many specifically considered the questions raised by the need for the public good, particularly for medical research, whether clinical or epidemiological. Perhaps the most scholarly was the report of a working party set up by Advances
in
the Commission of the European Communities chaired by E. G. Knox.’ It is therefore especially unfortunate that a draft EC directive2 currently circulating for consultation should be formulated in such a way that it could, if implemented, lead to the rapid demise of much of the epidemiological (and social science) research in the Community.3This draft directive is proposed despite the Commission’s endorsement of the 1981 Data Protection Convention of the Council of Europe, the justification given being that only seven members (including the UK) have ratified it and passed domestic legislation. The Commission concludes that, without a further directive, equivalent protection between member states is insufficient. The dangers in the document stem from its heavy legal overtones. Standards concerning the use of personal data are based on the levels prevailing in the most restrictive states. Moreover, the authors seem to have totally ignored the needs of the public health for epidemiological and much other research. Take this sweeping general caveat: "member states shall prohibit the automatic processing of data revealing ethnic or racial origin ... and of data regarding health or sexual life, without the express and written consent, freely given, of the data subject". An important and damaging principle sets out that personal data should be "kept in a form which permits identification of the data subjects for no longer than is necessary for the purpose for which the data were stored.". The restrictive nature of these proposals could rule out the release of cancer information to regional cancer registries and thus effectively sabotage the large body of research they generate into causes of cancer and evaluation of the effectiveness and safety of treatment. This would be in line with with the prevailing policy in Germany, for example, where cancer registration is severely restricted. It would also render impossible retrospective studies of health records. Those who are consulted must point out the real dangers in these proposals and insist on a reformulation that permits the continuation of epidemiological research. A study of the wording suggests that this could be readily achieved by exempting medical research that is conducted under strict ethical safeguards. Medical communities in member states are already conscious of the need to safeguard both privacy and confidentiality. In the UK a group set up by the Royal College of Physicians is preparing a report on ethical safeguards; we hope this will provide guidelines to help exempt medical research from the damaging proposals in the directive. 1. Knox EG. The
2.
3.
confidentiality of medical records: the principles and practice of protection in a research-dependent environment. Report of working party of Advisory Panel for Social Medicine and Epidemiology in European Economic Community. Luxembourg: Commission of the European Communities, 1984. Proposal for an EC Council Directive concerning the protection of individuals in relation to the processing of personal data. Syn 287. Brussels, 1992. Knox EG. Confidential medical records and epidemiological research. Br Med J 1992; 304: 727-28.
