Contraceptive Research, Introduction, and Use Lessons From Norplant (1998) / Chapter Skim
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3 Workshop Summary and Analysis
3 Workshop Summary and Analysis
Pages 37-56
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From page 37... ...
The workshop had three objectives: to review newly available data on Norplant's efficacy, safety, and use; to extract lessons from diverse aspects of the method's development, introduction, use, and market experience; and to explore approaches to developing and introducing, new contraceptives based on learning Mom the Norplant market experience. The workshop consisted of these elements: 17 formal presentations; two organized dialogues, one on consumer perspectives, the other on strategies for developing and introducing new contraceptive technologies; and extensive discussion among subcommittee members, presenters, and invited participants on the information presented and its implications.
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From page 38... ...
DATA REVIEW Efficacy Data were presented from two 5-year-long studies of major short- to medium-term side effects of implant contraceptives not identified in clir~ical trials: the Postmarketing Surveillance of Norplant led by WHO and pre-introductory studies led by the Population Council. The evidence from those studies was that both Norplant and the two-rod levonorgestrel implant system are highly efficacious, with failure rates under 1 percent per year, thus providing reversible contraceptive protection essentially equal to that of permanent methods, that is, tubal ligation and vasectomy.
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From page 39... ...
Discontinuation rates associated with nonmenstrual side effects seem higher than those for menstrual side effects but no single side effect, menstrual or nonmenstrual, is consistently associated with decisions to discontinue use. Continuation and Discontinuation In studies to compare method use, implant continuation rates tend to be high relative to those of other reversible contraceptives.
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From page 40... ...
Postmarketing Surveillance The report from the 5-year Postmarketing Surveillance of Norplant confirmed its value not only as a source of knowledge on adverse effects that cannot be identified in clinical trials, but as evidence that large-scale, longer-term surveillance studies using cohort methodology can now be considered feasible in developing countries.
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From page 41... ...
The Fill committee's extensive analysis of the field of contraceptive research and development, which culminated in its 1996 report, led to some conclusions that are appropriately repeated here as preface to this report's closing sections. First, while contraception is frequently used and new contraceptive technologies seem to be much needed and desired, as an area of human health it has certain intrinsic complexities.
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From page 42... ...
The great preponderance of the method's difficulties were those that have to do with larger, systemic difficulties in assuring provider training and evidence of competency, delivery system capacity for assuring the quality of all required services, the adequacy and appropriateness of counseling arid communication, and the character and timing of consumer involvement. Providing and Receiving Training in New Contraceptive Methods Are Equally Critical Complicated implant removals were the basis, in 1994, of the first lawsuit involving Norplant and the subsequent flood of media coverage and litigation.
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From page 43... ...
Taking Context into Careful Account Is Essential Experience with Norplant highlighted the fact that long-acting, provider-dependent contraceptive methods require special regard to ensure that decisions for their election and continued use are freely made and well informed. Failures in this respect not only have ethical implications but more broadly affect the proper utilization of the technology in question and its reputation.
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From page 44... ...
Areas for Strengthening or Expansion 1. Clinical Research Data reported at the workshop pointed to two areas where more fundamental research is needed to strengthen the position of implantable contraceptives in the array of contraceptive options: research on vaginal response to hormones, including cyclic hormonal effects, and on the use of progestins in contraceptives on the incidence of sexually transmitted disease, importantly including HIV; and research on the causes of hormonal side effects that, in addition to their implications for the users of hormonal methods, also affect the ability of providers to manage and treat those events clinically.
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From page 45... ...
"Introduction" was thoughtfully utilized by the Population Council as a bridge from research and development and from the successful completion of clinical trials, to Norplant's entry into national family planning, programs. The key mechanism was introductory trials in a limited set of facilities that then became centers for extension of training after national product registration; their purpose was to identify management and technical issues affecting method delivery and to develop and refine guidelines, standards, counseling materials, and training, programs for clinical management.
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From page 46... ...
The questions the workshop participants flagged as of greatest concern were: how mechanisms for informed decision-making are to be developed and by whom; the distinctions and connections among the kinds of information needed in the experimental stages of product development, compared to what is needed in the introductory phases and in routine clinic settings; the purposes and practical implications of labeling,, informed consent documents, and clinical guidelines for informational and decision-making purposes; what is essential as opposed to discretionary information; and the impact of all the above on participation in contraceptive research and development. If and when new long-acting, provider-dependent contraceptive products are developed and introduced, each of these concerr~s would ideally be part of a systematic strategy for informed decision-making, to then be tested and refined ill the product's clinical trial and preintroductory phases.
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From page 47... ...
Credentialing A significantly problematic aspect to Norplant's introduction derived from the fact that requirements for reasonable competence in surgical procedure are uneven across clinical facilities worldwide. This is especially problematic when new technologies are introduced rapidly, as was the case with Norplant despite major investment in provider training.
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From page 48... ...
9. Product Liability The Norplant experience provides further grounds for the perception that product liability, or simply the anticipation of liability, stifles industrial investment in development of new contraceptives.
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From page 49... ...
The subcommittee and workshop participants again voiced support for the conclusion of the 1990 and 1996 Institute of Medicine committees concerning the potential importance of enactment of a product liability statute. Broadly stated, such a statute would make FDA approval of contraceptive drugs and devices available to manufacturers as a defense against punitive damages, assuming proper compliance with FDA regulatory requirements.
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From page 50... ...
conditions occurring with a frequency of 5 percent or more during the first year of use in clinical trials and judged to have possibly been associated with its use; and (d) conditions observed in Norplant users postmarketing but for which there is no basis for judging a causal relationship (Food and Drug Administration.
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From page 51... ...
Plasma levels of levonorgestrel and free levonorgestrel index in women using NORPLANT implants or two covered rods (NORPLANT 2~. Contraception 35:215-228, 1987.
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From page 52... ...
1 1. The 1995 cycle of the NSFG gathered data between .lanuary and October 1995 on a national probability sample of women aged 15~4 selected from households followed by the National Health Interview Survey, a continuous multistage household survey.
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From page 53... ...
14. The term "menstrual changes" is meant to express alterations in previous patterns and includes as most significant heavier menstrual flow, greater cycle irregularity increased spotting, longer periods, and more painful periods.
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From page 54... ...
20. Just as this report was going to press, the following results, highly germane to this report, became available from a Population Council study of a representative sample of 2,979 current and former Norplant users in 14 Indonesian provinces: (1.)
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From page 55... ...
medical/community-based organization whose primary focus is the development of culturally proficient health intervention and research models. Its Women of Color Reproductive Health Forum held two workshops in 1996 that were pertinent to the won lo of the "Boom and Bust Initiative": Finding Common Ground Lmpo~'erment v.s.
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