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GENERAL ARTICLES Quinacrine acceptance spreads at NAVSFWI meeting. A. Aggarwal (Deputy Editor, New Delhi, India). The 11th Indian Conference on Family Welfare and Voluntary Sterilisation and Family Welfare of India: Newsletter Report Oct. 30, 1996; pp. 1-2. *NOTE: If you are unfamiliar working with PDF files Summary: 11th Indian Conference on Family Welfare and Voluntary Sterilisation and Family Welfare of India (NAVSFWI) in Agra attended by governor of Uttar Pradesh and addressed by U. K. Nanda, outgoing President, who reminded his audience that the mortality of women due to pregnancy related causes globally was around one half million annually, 99% of them in developing countries. R. V. Bhatt, newly elected President of the NAVSFWI, stressed the need for quinacrine sterilization as an alternative to the surgical approach. The P. D. Baveja Oration was given by E. Kessel, his subject: 100,000 quinacrine sterilizations. The conference expressed wide acceptance of the quinacrine nonsurgical method.The quinacrine imperative. T. Black (MSI, London), Unpublished report. Marie Stopes International 1995; . *NOTE: If you are unfamiliar working with PDF files Summary: The developing world is experiencing a family planning revolution. Most couples in many of these countries know of at least the Pill or sterilization. Because the majority of them complete their families after 6 to 10 years, they will have to contracept for 25 to 30 years. Access to safe, affordable abortion, legal or illegal, is improving. Poverty is not a barrier to family planning, nor is religion at the programming level, as distinct from policy, or is it even at times of high infant mortality. The private sector is now an important source of contraception. the Demographic Health Survey and others indicate the couples' desires for but lack of contraceptive services. There is a tremendous unmet need for terminal methods. Surgical sterilization is expensive and not readily available, necessitating operating theaters, medical and nursing staff. There is an urgent need for safe, effective inexpensive methods of sterilization that can be delivered by paramedical personnel in rural areas. For men -- vasectomy is available. Transcervical quinacrine sterilization offers this possibility for women. It is the only realistic, practical, affordable prospect of making the health, maternal and infant death, and abortion preventing benefits of terminal contraception readily available, accessible, affordable and acceptable to all women who have completed their families in rural and urban areas alike.Quinacrine pellets have potenial for simple, low-cost female sterilizations . CTU Staff article. Contraceptive Technology Update. (A monthly newsletter) April 1994; . *NOTE: If you are unfamiliar working with PDF files Summary: Special report on quinacrine pellets as potential for simple low-cost female sterilizations. The issue includes results of foreign study of the QS method that has led to debate. There is a description of quinacrine and its extensive use as an anti-malarial and treatment for giardia, tapeworm and lung cancer. The history of its development by J. Zipper, MD to block the Fallopian tubes is recounted, as are the toxicology studies carried out since the 1970s. Opposition by J. Norsigian of the Boston Women's Health Book Collective and Dr. Pollack of the AVSC is included, as well as a response to their concerns by E. Kessel, MD of the International Federation of Family Health.Large quinacrine study comes under fire from family planners . CTU Staff article. Contraceptive Technology Update. (A monthly newsletter) April 1994; . *NOTE: If you are unfamiliar working with PDF files Summary: Special report on quinacrine pellets as potential for simple low-cost female sterilizations. The issue includes results of foreign study of the QS method that has led to debate. The matter of skill of insertion technique vs. the experience of the technician is taken up by S. Mumford, of the Center for Research on Population and Security. Failure rates of the method are discussed by G.K. Stewart, MD of the Planned Parenthood Association of Sacramento, California, and his arguments are refuted by P. Bhiwandiwala, MD, former medical director of Family Health International. Ectopic pregnancies and the data collection process of the Vietnam report were of concern to I. Sivin of the Population Council.Will American women want Quinacrine?. CTU Staff article. Contraceptive Technology Update. (A monthly newsletter) April 1994; . *NOTE: If you are unfamiliar working with PDF files Summary: Special report on quinacrine pellets as potential for simple low-cost female sterilizations. Foreign women like quinacrine, but will American women want it?Quinacrine controversy separates rich and poor nations . CTU Staff article. Contraceptive Technology Update (a monthly newsletter) August, 1994; . *NOTE: If you are unfamiliar working with PDF files Summary: Quinacrine controversy separates rich and poor nations. Article in Lancet reporting on Vietnamese trials of the QS method has become center of a debate in that journal. Both WHO and AVSC have been accused of bringing the trials in Vietnam to a halt by issuing statements without the participation of researchers in Hanoi. Advocates of the method claim it to be safer than surgical sterilization, costing less than $1 per woman.***In response to fears that it may be carcinogenic, researchers at Family Health International (FHI) who have been following nearly 1500 users in Chile for 15 years stated that "no evidence was found of excess cancer risk associated with quinacrine pellet transcervical sterilization." A delegation of mostly American family planning experts visited Vietnam recently. They talked with women and providers of the QS method. The women said they were not coerced and they liked the method. M. Potts, MD and M. Hanson, MD were among the group sponsored by the International Services Assistance Fund. Hanson, a private practitioner in Minneapolis, plans to investigate possibility of starting a similar program in the U.S. Risks and rewards: family planners weigh quinacrine. J. M. Diconsiglio, Editor. Family Planning World 1994; January/February, pp. 19-20. *NOTE: If you are unfamiliar working with PDF files Summary: This nonsurgical chemical method of female sterilization has divided the reproductive community. Already used by 100,000 in reported clinical trials, it is remarkably inexpensive and safe. It moves sterilization, for which there is a great unmet worldwide need, to a supply method like condoms or pills, according to one expert.Sterile arguments. Economist Staff article. The Economist: Science and Technology March 19, 1994; pp. 99-100. *NOTE: If you are unfamiliar working with PDF files Summary: Irreversible female sterilization is the most widely practiced form of birth control across the world. Quinacrine method may make it safer and much easier. Discussion of the antimalarial use of the drug since the 1930s. No long term effects have ever been reported in the thousands of troops who ingested large quantities of the drug. Female sterilization using a small amount of the drug is now available, safe and very inexpensive. Women are not only not coerced, but sometimes will pay to enter the trials. Author urges the technique be taken up, instead of waiting for tests that rich countries insist on but are not willing to pay for.Anatomic and physiologic factors affecting the development of transcervical sterilization techniques . C.A. Eddy, C.J. Pauerstein. In: Female Transcervical Sterilization: Zatuchni GI, Shelton JD, Goldsmith A, Sciarra JJ, eds., Philadelphia, Harper and Row 1983; p 7-23. *NOTE: If you are unfamiliar working with PDF files Summary: Quinacrine sterilization method found effective among women in Vietnam. S. Edwards, editor. International Family Planning Perspectives 1993; 19:157-8. *NOTE: If you are unfamiliar working with PDF files Summary: To evaluate the safety, effectiveness, acceptance and delivery of quinacrine as a sterilization method, researchers conducted trials of the drug at rural health centers in 24 provinces in Vietnam from 1989 to 1992. Participation in the study was voluntary. Women who were at least aged 30 and who had at least two living children aged three or older were eligible to use the method. All participants in the study were sexually active, were not using another contraceptive method and were at least six weeks beyond pregnancy termination. The investigators advise that quinacrine sterilization, which appears to be safe, effective and easy to deliver, could increase contraceptive prevalence in developing countries among women who do not want more children. They also view it as a way to reduce maternal mortality, which is at a level of 380 deaths per 100,000 live births in Vietnam. The researchers estimate that 242 maternal deaths were prevented as a result of these 31,781 sterilizations. Considering the cost of two insertions of quinacrine, which is less than US $1.00, they conclude that "this procedure represents our most cost-effective way of lowering maternal mortality."Family Health International's role in quinacrine female sterilization research. FHI Staff article. Contraceptive Update May 1994; Vol. 14, p. 27. *NOTE: If you are unfamiliar working with PDF files Summary: 1976 -- At the request of Chilean scientist Dr. Jaime Zipper, FHI begins transcribing and analyzing data from a clinical trial of quinacrine administered in a slurry solution to 200 Chilean women. High pregnancy rates (9.9 per 100 women after 12 months) and toxicity prompt FHI research on a new method of administration. 1977 -- FHI researchers develop 10-minute releasing quinacrine pellets and works with Dr. Zipper to initiate clinical trials of these pellets administered with thiopental sodium to 165 Chilean women. The 12-month pregnancy rate after three insertions is 4.3 per 100 women. 1979 -- FHI initiates clinical trials of these pellets without thiopental sodium among 81 women in Baroda, India; 151 women in Valdivia, Chile; and 143 women in Santiago, Chile. After three insertions, 12-month pregnancy rates are 0.0 per 100 women in Baroda; 0.7 in Valdivia; and 3.3 in Santiago. 1981 -- Following FHI-sponsored animal studies in the United States on mutagenicity and teratogenicity, FHI receives an exception for an Investigational New Drug (IND) application from the U.S. Food and Drug Administration and develops 100-minute releasing pellets. In 1984 -- FHI initiates clinical trial of these new pellets on 112 women in Santiago, Chile. Pregnancy rates at 12 and 24 months are 2.0 per 100 women. That year, FHI begins a Phase I clinical trial of quinacrine in the United States, investigating the effects of 10-minute releasing quinacrine pellets on 10 women 24 hours before hysterectomy. In 1985 -- FHI conducts a Phase I clinical trial in the United States, investigating the effects of 10- and 100-minute releasing quinacrine on 11 women 30 days before hysterectomy. Four years later, FHI identifies 8 cancer cases during long-term follow-up of women who received quinacrine pellet sterilizations in FHI-sponsored clinical trials in Chile. In 1990 -- FHI chooses to withdraw the IND, discontinues its funding for prospective studies in Chile, and initiates a retrospective cohort study on Chilean women who had received quinacrine pellets. In 1992 -- the Vietnamese government, which had begun an introductory program of quinacrine sterilization in 1989, requests data. 1993 -- Through the retrospective study in Chile, FHI documents 17 cancer cases among 1492 quinacrine sterilizations performed from 1977 through 1989. FHI finds no evidence that quinacrine increases the risk of cancer above the normal risks for women in age-specific groups, but recommends continued surveillance of this cohort. 1994 -- The request of the Vietnamese government asks FHI to begin a retrospective study of 31,781 quinacrine procedures carried out by the Ministry of Health in Vietnam. FHI starts to analyze sociodemographic data from all procedures, plus a survey of a sample of 1800 quinacrine users in three provinces. That year FHI also convenes a toxicology expert meeting on quinacrine. The participants conclude that further research is needed on toxicity, teratogenicity and potential carcinogenicity. FHI makes plans to apply for a new IND in order to conduct further testing on quinacrine safety. FHI quinacrine studies. FHI Staff article. Contraceptive Update. September 1995; Vol. 16, p. 27. *NOTE: If you are unfamiliar working with PDF files Summary: Family Health International will not proceed with new animal studies on the safety of quinacrine, a drug that has been used in nonsurgical female sterilizations. Lack of long-term funding for this project prompted the decision. It is estimated that the work could take eight years and $8 million to complete.Discussion: Research and clinical experience with quinacrine. A. Goldsmith (Program for Applied Research on Fertility Regulation (PARFR), Northwestern University Medical School, Chicago, Illinois); L.E. Laufe (The University of Texas, Health Sciences Center at San Antonio, San Antonio, Texas); T.M. King (The Johns Hopkins University School of Medicine, Baltimore, Maryland). In: Female Transcervical Sterilization: Zatuchni GI, Shelton JD, Goldsmith A, Sciarra JJ, eds., Philadelphia, Harper and Row 1983; p 141. *NOTE: If you are unfamiliar working with PDF files Summary: Question and Answer format. Queries are: Are there any histologic clues as to the mechanism of action of quinacrine? Do the "skip" lesions suggest that the quinacrine does not act directly on the epithelium during intrauterine administration but as a local vascular transport mechanism, finding its way through the various layers of the tube to the epithelium? Have attempts been made to radiolabel the quinacrine to determine if its effect is a surface phenomenon, and whether there is local microcirculation or intrinsic vascular regulation? Will increasing the length of the quinacrine lesion improve the occlusion rate? Does quinacrine produce a lesion that is histologically unique? Does the method of quinacrine instillation affect the rate of absorption? Have species differences in the effects of quinacrine been confirmed, and if so, do they provide any clues as to the mechanism of action? Have any studies confirmed that estrogen can affect recanalization of quinacrine-induced lesions? Have any serious side-effects occurred with the quinacrine IUD, and can the closure rates be considered reliable? Is the hysterosalpingogram (HSG) justified as a part of the sterilization protocol, considering the variable results in predicting tubal closure, the risks with the method, and the possibility that injecting the dye might itself open some tubes? Do the same blood levels occur with pellets as with other delivery vehicles? Would combining a quick and acute insult of the tube with a long insult improve the effectiveness of the quinacrine? With a slow-releasing dosage, might the resorption effect be avoided and therefore a higher number of malformations be seen? When quinacrine was used as an antimalarial drug, and was taken by pregnant women, did it affect fetal growth and development? What blood levels of quinacrine are associated with central nervous system excitation, heart block, and other serious complications? Have any deaths been attributed directly to quinacrine use? What is the danger of ectopic pregnancies in quinacrine-treated women, if the tubes are not sufficiently damaged? What treatment was given to the Chilean patients experiencing CNS effects following quinacrine instillation? Did these patients experience other side-effects? Has any work been done on the effects on neonates of the passage of quinacrine in breast milk? If the quinacrine IUDs become widely available in developing countries, or in the developed world, what will the consequences be if the quinacrine device is mistaken for a regular IUD and accidentally inserted in a woman? What is the Mexican experience with quinacrine? What is the experience in India with the quinacrine pellets? Clinical Report: Quinacrine-Fused Pellets . R. Guzman-Serani (Austral University of Chile, Valdivia, Chile), A. Bernales, L.P. Cole. In: Female Transcervical Sterilization: Zatuchni GI, Shelton JD, Goldsmith A, Sciarra JJ, eds., Philadelphia, Harper and Row 1983; p 100-04. *NOTE: If you are unfamiliar working with PDF files Summary: bodyQuinacrine nonsurgical female sterilization. D. T. Hieu, D. N. Tan (Department of Mother and Child Health and Family Planning, Ministry of Health, Hanoi, Vietnam). Current Science 1994; 67:706-9. *NOTE: If you are unfamiliar working with PDF files Summary: Major complications of the quinacrine method reported in a large field trial in Vietnam of 0.03% are remarkably lower than the 1.7% for laparoscopic sterilization. Smaller clinical trials of the quinacrine method support its safety as far as early major complications are concerned. Side effects of this method are also reported as mild and transient in these studies. There have been no deaths reported in 80,000 quinacrine method procedures whereas in Bangladesh and in Gujarat State, India, case fatality rates of 19 and 20 per 100,000 female surgical sterilizations, respectively, have been reported. The greatest benefit of the quinacrine method is its ability to raise contraceptive prevalence among high risk women of developing countries with their high maternal mortality. Many expensive but needed interventions are being considered to lower maternal mortality, but the quinacrine method is the most cost-effective.Potential demand for voluntary female sterilization in the 1980s: the compelling need for a nonsurgical method. E. Kessel, S.D. Mumford (International Fertility Research Program, Research Triangle Park, North Carolina). Fertility and Sterility 1982; 37:725-33. *NOTE: If you are unfamiliar working with PDF files Summary: Sterilization has become the world's most prevalent method of fertility regulation. Its health and socioeconomic benefits, especially in developing countries, are achieved by eliminating high-parity births and contributing to slower population growth. An estimate of voluntary sterilization needs in the 1980s in developing countries, excluding China, indicates a demand for approximately 180 million procedures. This represents a 5-fold increase over the number presently performed and could mean a 20-fold increase in rural areas. The current state of female sterilization technology has been reviewed. Because of the fragile condition of health care delivery systems in the developing world and the rural residence of the population, it is unlikely that surgical sterilization can meet the projected need. Progress has been made in the development of the intrauterine administration of quinacrine pellets for nonsurgical female sterilization. Despite the estimated lifetime failure rate of 3 per 100 women, it is seen as a safe and deliverable method that has potential to meet the expected demand for sterilization in the 1980s.Quinacrine nonsurgical female sterilization: a reassessment of safety and efficacy. E. Kessel (International Federation for Family Health, Chapel Hill, North Carolina); J. Zipper (Hospital Sotero del Rio, Puente Alto, Chile); S.D. Mumford (Center for Research on Population and Security, Research Triangle Park, North Carolina). Fertility and Sterility 1985; 44:293-8. *NOTE: If you are unfamiliar working with PDF files Summary: The relative safety and efficacy of surgical and nonsurgical quinacrine pellet methods of female sterilization have been reassessed. Although experience with the quinacrine pellet method is limited, it appears to have advantages for both developing and industrialized countries. Its failure rate at 3 years after three transcervical insertions of 250 mg of quinacrine in pellets is approximately 5%, compared with 0.5% for surgical sterilization. But the method can be delivered in any clinical setting capable of performing an intrauterine device insertion. The absence of increased risk of ectopic pregnancy among quinacrine pellet method failures has been noted. It is estimated that ectopic pregnancy accounts for one third of surgical sterilization mortality in a country like Bangladesh, compared with < 5% in the United States. The need for multiple insertions of quinacrine pellets to achieve acceptable efficacy has not been demonstrated clinically. A single insertion trial is a high priority for fertility research.Prospects for nonsurgical female sterilization. (Editorial). E. Kessel (Department of Public Health and Preventive Medicine, Oregon Health Sciences University, Portland, Oregon). International Journal of Gynecology and Obstetrics 1989; 29:1-4. *NOTE: If you are unfamiliar working with PDF files Summary: For the last twenty years the increase in couples controlling their fertility through sterilization has been dramatic. Now estimated at over 100 million, it reflects growth of relevant services and outpatient surgical methods. A considerable unmet need exists, as evidenced in the World Fertility Survey. A simple method of nonsurgical female sterilization has been developed by Dr. Jaime Zipper in Chile. It consists of two transcervical applications of 250 mg of quinacrine as pellets, using an IUD inserter. The cost is minimal, compared to surgical sterilization, and would save the lives of countless women. The World Health Organization and the United States Food and Drug Administration are not interested in encouraging this method. But developing countries, with their limited resources, should initiate trials as a high priority in fertility research.Surgical vs. nonsurgical female sterilization. E. Kessel (International Federation for Family Health, Chapel Hill, North Carolina); J. Zipper (Hospital Sotero del Rio, Puente Alto, Chile); S.D. Mumford (Center for Research on Population and Security, Research Triangle Park, North Carolina). MCI newsletter January 1991; No. 16 pp. 1-2. *NOTE: If you are unfamiliar working with PDF files Summary: Report of over 10,000 cases using intrauterine quinacrine pellets in studies, primarily in Chile, India and Vietnam. No serious complications, a 3% failure rate at one year and 5% after 10 years. For developing countries, the method's main advantage is its effect on the prevalence of sterilization and the saving of many lives, at an extremely modest cost. The personnel trained in IUD insertions are already available for this procedure.Laparoscopic sterilization: an obsolete procedure?. E. Kessel (Department of Public Health and Preventive Medicine, Oregon Health Sciences University, Portland, Oregon). In: Proceedings of The World Congress of Gynaecological Endoscopy, Bombay, India 2-5 December 1993; pp. 34-6. *NOTE: If you are unfamiliar working with PDF files Summary: On the basis of need, safety, efficacy, cost and acceptability, the quinacrine pellet method of nonsurgical female sterilization should be offered by all gynecological endoscopists to their well informed patients. The need for laparoscopic sterilization will rapidly decline if this is done.Cost-effectiveness of interventions to lower maternal mortality: the role of quinacrine pellet nonsurgical female sterilization. E. Kessel. (International Federation for Family Health. Leasburg, North Carolina). Pan African Maternal and Child Health International Conference, Cairo May 25-27, 1994; . *NOTE: If you are unfamiliar working with PDF files Summary: A history of the method's development and a description of its present form. There is a tremendous need, world-wide for such an effective, low-cost contraceptive. It could help reduce the devastating high rates of maternal mortality in Africa and Asia.Quinacrine pellet method of non-surgical female sterilization. E. Kessel, J. Zipper, D. T. Hieu, B. Mullick, S. D. Mumford. In: Advances in Human Reproduction. Proceedings of the VIIIth World Congress on Human Reproduction and IVth World Conference on Falloppian Tube in Health and Disease, Bali, Indonesia. April 1993, The Parthenon Publishing Group London 1995; pp. 501-512. *NOTE: If you are unfamiliar working with PDF files Summary: Both surgical and non-surgical quinacrine pellet methods of female sterilization are relatively safe and effective methods of permanent fertility control. Surgical methods have the advantage of known high efficacy and can be provided postpartum and post-abortion. The main advantage of the quinacrine pellet is its ease of delivery, resulting in higher contraceptive prevalence among high risk women. From present knowledge it also appears somewhat safer than surgical sterilization, especially for women at higher risk of surgical complications. Neither method should be thought of as reversible, although there is some success in the case of the surgical method, especially with clip or ring occlusive devices. There is no experience with reversibility of the quinacrine method. Both methods should be widely available as options to well-informed women who desire no more children.100,000 quinacrine sterilizations. E. Kessel (Department of Public Health and Preventive Medicine, Oregon Health Sciences University, Portland, Oregon). Advances in Contraception 1996; 12:69-76. *NOTE: If you are unfamiliar working with PDF files Summary: 100,000 quinacrine nonsurgical female sterilizations have been completed over the past decade involving transcervical insertion of quinacrine (252 mg) as pellets by one, two or three monthly insertions. No deaths have been reported and serious complications are far fewer than for surgical sterilization. Side effects are mild and transient. Efficacy has improved from 3 pregnancy failures per 100 women at 1 year to approximately one by improved insertion technique and use of adjuvants. Long-term follow-up of early cases in Chile shows no increased risk of cancer for this method. The main advantage of quinacrine sterilization is its ability to raise contraceptive prevalence and thereby reduce maternal mortality and morbidity, especially in rural and urban slum areas of developing countries. It should be made available as an option to well informed women everywhere as an economical and safe permanent family planning method.GENERAL ARTICLES (Continued on Next Page) |