The objective of this paper is to describe secrecy in drug regulation in Finland, by recording and reporting our experience in obtaining Norplant® licensing documentation. The materials used are the documents, phone calls and other contacts recorded in a research diary that were produced while relevant authorities considered our application to obtain the documents and the publication of our manuscript. The application process was complicated, and it took three years to obtain the licensing documentation and two years to try, unsuccessfully, to get permission to publish the manuscript. In the course of these procedures we made 188 active contacts, and the authorities wrote several memoranda. The drug regulatory authority and the manufacturer wanted to categorise the whole licensing process as a trade secret, and to have the manufacturer define what a trade secret is and when trade secrets could be released, while the Ministry for Social Affairs and Health valued more open regulation. The process is still not complete because the manufacturer has sued the ministry in court about their decision to grant dispensation. It can be concluded that to enable independent research on drugs and drug regulation, the publicity status of documents must be clear, and trade secrecy must be defined narrowly. Decisions on dispensation to give access to classified documents should consider the interests of public health and should be made by authorities other than the drug regulatory authority.

The discourses of the female body in rural Bangladesh illustrate gender relations in rural society and the degree to which village ideologies of shame, purity, and pollution affect women's attitudes toward contraceptive practices. Women's understanding of their body and perception of flow, buildup, and blockage related to Norplant use reveal a belief in the disruption of the internal state of the body. Humeral notions underlie descriptions of Norplant use, which are understood to agree with women differently. Bengalis believe that blockage in the body can endanger the wider social and moral sphere. Culturally promoted fears of illnesses motivate individuals to conform to social norms. Some rural women chose to ignore their health problems, some dropped out, and some preferred Norplant.

Norplant® is the brand name of the world's first registered subdermal hormonal contraceptive implant, developed by the laboratories of the Population Council, an international organisation working in the area of fertility and population growth. The article revisits the trajectory of this contraceptive in Brazil from its arrival through clinical trials to its eventual ban in 1986 by the Brazilian regulatory agency responsible for approving medications at the time. Its circulation generated controversies related to research practices, side effects and political uses of the drug as a birth control method. This article focuses its analysis on the divergences related to research practices. It uses a controversy analysis technique, reviewing the versions of those involved, investigating their understandings and the effects that this object generated in their networks. Norplant® provoked displacements and associations between civil society groups, State authorities, scientists and physicians, industry, pharmaceutical products, research procedures, bureaucratic instruments, and the female users of the contraceptives. Scientific styles of medical thought were shaken up and new forms of thinking about scientific autonomy began to be discussed in the country.

OBJECTIVE

To make an assessment of the acceptability and cost of subdermal implants, a new method in Turkey, in a free-choice environment.

METHODS

The records of women attending a university well-woman clinic in Istanbul, Turkey, were analyzed retrospectively. Among other contraceptives registered in the country, the women were offered subdermal contraceptive implants (Norplant) during counselling sessions. The women who chose implants were invited to attend for follow-up three times during the first 12 months and were advised to return annually thereafter. An estimation of cost was performed for Norplant, using the government price of the implant and the wage rates of public-sector staff. An estimation of cost was also performed for oral contraceptives.

RESULTS

Among the 5650 women who applied to the Clinic for contraception between 1 January 1995 and 31 December 1998, 274 women decided to use implants, giving an initial acceptance rate of 5.1%. Continuation rates were 91.8%, 71.6% and 42.5% at 12 months, 24 months and 36 months, respectively. There were no pregnancies within the study period. The only demographic characteristic that was positively related to the acceptability of Norplant was younger age. The cost of contraception with Norplant was found to be lower than that for oral contraceptives.

CONCLUSIONS

The high initial acceptance and continuation rates, combined with its high efficacy, make Norplant a valuable tool for Turkey's National Family Planning Program. Contraception with Norplant is also a cost-effective method, at least for the public sector.

OBJECTIVE

Norplant implants have been used for long-lasting contraception in Senegal since 1986. The purpose of this work was to assess tolerance and acceptability of the method among Senegalese women.

METHODS

A prospective non-comparative study including 300 women was undertaken in the Obstetrics and Gynecology Clinic at the University Teaching Hospital A Le Dantec of Dakar between December 1986 and July 1991. Women meeting inclusion criteria were seen at 1 month, 3 months, and 6 months after insertion then every 6-month until device removal.

RESULTS

The mean age of women was 31.3+/-5.45 years and mean parity was 4.7+/-2.45. Almost half of the women no longer desired pregnancy and 67.6% of the women who had not used contraceptive method the month before admission decided to use Norplant. During follow-up visits, 45.2% had menstrual side effects mainly amenorrhea 23.4% and irregular bleeding 12.5%. Non-menstrual side effects were local reactions at the implant site (19.9%). The other side effects were dizziness, asthenia, insomnia, anemia, and high blood pressure and weight change. Overall, 58.8% of the women kept their implants and had them removed after 5 years of use. The failure rate was 3.3+/-1.25. At the end of five years of use, satisfaction was 84.8% and nearly two-thirds of the women decided to recommend Norplant to a friend or relative or to use it again.

CONCLUSIONS

Norplant is a method of choice among the range of contraceptive methods available in Senegal. Because of its advantages and its ease of use, Norplant could be a widely used method in Senegal.

A longitudinal study of women using Norplant(R) was conducted to determine the effects of levonorgestrel implants on menstrual and haematological indices among the acceptors. Packed cell volume (PCV), white blood cell (WBC) concentrations (total and differential), and platelet concentration were performed at pre-insertion and at the 12-month follow-up. Each acceptor received a menstrual calendar to chart all bleeding, and spotting events. The mean PCV was 40.5 +/- 2. 4 at insertion and had a statistically significant (p <0.01) rise to a mean value of 42.2 +/- 2.6 at 12 months. The mean WBC concentration had a significant decrease at 12 months (p <0.001) when compared with the pre-insertion value. Similarly, the neutrophil and lymphocyte concentration had a statistically significant decrease (p <0.05 and p <0.01, respectively) at 12 months of use. The reduced values in the concentrations of monocytes, eosinophils and basophils did not reach significant levels. The mean value of the platelet concentrations had a significant decline at 12 months of use (p <0.001). Reduced bleeding patterns were more commonly reported compared to increased bleeding episodes. This pattern was associated with increased PCV, a change that may prevent anaemia in developing countries. The decline in the platelet concentration at 12 months of study was, however, a source of concern that will require follow-up.

The purpose of the study was to understand the family planning administrators' knowledge of Norplant and their fluence on the spread of Norplant in countryside of Sichuan. 156 administratoras were surveyed. It was found that most of the administrators worked hard on education, propagation, organization and management of using Norplant, and they recognized the contraceptive efficacy of Norplant. However, the educational level of the administrators was generally low. They were short of the training on Norplant related knowledge(training rate was only 36.5%). The degree of the users' satisfaction and the administrators' knowledge on Norplant varied between areas. The result indicated that the basic quality of the administrators and their knowledge of Norplant were influences on the spread of Norplant in the countryside of Sichuan. Soit is very important to improve the basic quality and knowledge of the administrators of family planning.

BACKGROUND

Barrier methods of contraception do not have systemic effects and allow the user complete control over their use. For women, the ease of use of a contraceptive is often more important than its efficacy. Hence, barrier methods could be offered as a useful alternative method of contraception. Nonoxynol-9 (a spermicide) is a locally acting, non-hormonal method free from systemic side-efforts. It is a woman-controlled, reversible method which is to be used before intercourse. There are little data available on its efficacy, side-effects and acceptability among Indian women.

METHODS

The vaginal pessary nonoxynol-9 was offered as a contraceptive option to 3200 women attending the Family Planning clinics at 31 Human Reproduction Research Centres (HRRCs) of the Indian Council of Medical Research. The other contraceptives offered included an intrauterine device, oral pills, condoms, Norplant, tubal sterilization and vasectomy using the cafeteria approach. Those who accepted nonoxynol-9 were followed up to assess the rates of continuation, failure and side-effects.

RESULTS

The nonoxynol-9 pessary was accepted by 541 women who were followed up for 3470 woman-months of use. The reasons given for acceptance were that it was user-controlled and/or they did not wish to use other methods because of the side-effects or contraindications of these methods. The overall continuation rates were 41.2% and 33% at 9 and 12 months of use, respectively. Most women (31.3%) discontinued its use due to personal reasons such as husband dissatisfaction, desire for further pregnancy, irregular use of pessary and difficulty in insertion. Twenty-nine women became pregnant during the study period (15 due to method failure and 14 due to user failure) giving a use-effectiveness of 8.8% at 12 months. The method failure rate was 4.3% at 12 months of use. The failure rates were lower compared with the reported failure rates of barrier contraceptives (1%-30% at 1 year of use) and the side-effects were minimal.

CONCLUSIONS

Nonoxynol-9 had low acceptability (16.9%) and overall continuation rates--41.2% and 33% at 9 and 12 months of use. It could be offered to women looking for a short term, user-controlled contraceptive.

OBJECTIVE

To determine whether a profile can be developed to indicate which clients are the best candidates for Norplant by describing the characteristics of clients who use this contraceptive for 5 years and those who have it removed early.

METHODS

A descriptive study of data collected from a convenience sample. SELLING: A state-supported university hospital's obstetric and gynecology outpatient clinic serving primarily indigent clients in the southern United States.

METHODS

Women (N = 256), primarily with low incomes, being seen for removal of Norplant contraceptive capsules. Of these, 166 women had completed the recommended 5 years.

METHODS

Characteristics of the clients who retained the contraceptive for the recommended 5 years and characteristics of clients who came for early removal.

RESULTS

Clients who retained the contraceptive for 5 years differed from those who did not on only three characteristics: race, age, and parity. No significant differences were found in education or marital status.

CONCLUSIONS

No clear profile of successful Norplant users emerged. Instead, thorough counseling of each individual is essential to the client's completion of 5 years with Norplant. Advantages and disadvantages must be explained and the client's tolerance of possible side effects must be assessed, thereby helping the client to make an informed choice.

Subdermal contraceptive implants have only recently been approved for use in the United States. At present, only one subdermal contraceptive implant, Norplant, is approved in the United States. This article describes the development of Norplant, its efficacy and safety, a description of the system, education for clients, side effects, indications and contraindications, insertion and removal, incorporation into midwifery practice, and education for health professionals regarding its use.