RESEARCH ARCHIVE PDF FILES - TOC
ON THIS SITE Introduction and Overview |
| QS FAQ's |
| Research Archive Table of Contents |
| Ask the experts on the method |
Contact: Elton Kessel MD Stephen Mumford Dr Ph |
 Table of Contents for the QS Research Archive Index and Publication Summaries We have assembled what we believe to be a complete record of the published findings of researchers of the quinacrine nonsurgical female sterilization method and this collection is continuously updated. We offer this collection of literature to interested researchers, potential investigators of this method and other decision makers in order to facilitate their efforts. The materials have been divided into fourteen sections.GENERAL ARTICLES The general articles offer overviews of the state of nonsurgical female sterilization and the quinacrine method. THE QUINACRINE NEWSLETTER Articles of interest from the last two issues of the Quinacrine Newsletter, featuring summaries of the current work and emerging issues from investigators around the world.QUINACRINE AS AN ANTIMALARIAL Summaries of the findings of the extensive research effort undertaken to develop quinacrine as an antimalarial, helvetica. This literature offered early quinacrine pellet researchers much reassurance with regard to the safety of the drug.FDA PHASE I REPORTS AND RELATED PUBLICATIONS Published papers based on reports of studies used by the FDA to approve Phase II clinical trials of this method and related publications. ANIMAL STUDIES Publications regarding animal studies undertaken to examine the safety of placing quinacrine in the uterus.PREHYSTERECTOMY STUDIES Prehysterectomy studies have been performed both out of safety concerns and to examine the mode of action of the method.THE QUINACRINE SLURRY METHOD Published papers on the quinacrine slurry method, although it was abandoned a decade ago. The findings of these studies are useful.THE PAP (PHENOL-ATABRINE [QUINACRINE]-BILIGRAPHINE PASTE) METHOD Research on the PAP method which involves the use of quinacrine. These PAP studies offer further reassurance with regard to the drug's safety when applied to the Fallopian tubes. The PAP (Phenol Atabrine[quinacrine] Biligraphine Paste) technique involves the blind transcervical introduction of 0.1 ml to 0.15 ml of the PAP paste into each Fallopian tube. The formulation of the paste is noted and the total dose of quinacrine delivered to the tubes is estimated to be 70 mg to 105 mg. In well trained hands, the technical failure rate is 5% 12%; however, some investigators have reported much higher rates. Among the technical successes, this method is highly effective (greater than 99%). More than 500,000 procedures have been performed since the late 1950s and no deaths have been reported, which suggests that the use of the drug quinacrine in this manner is manifestly safe.QUINACRINE PELLET METHOD CLINICAL TRIALS Clinical trial reports on the quinacrine pellet method that have been published thus far.MISCELLANEOUS QUINACRINE PUBLICATIONS This section offers a wide variety of publications. These papers are responses to questions we are frequently asked about the method. The first two discuss the mode of action of the quinacrine pellet method (pate77 and pate79). The third attests to the legal use of the quinacrine pellet method in the U.S. today (arch84, kess89a). The fourth offers general information on the drug quinacrine in simple terms, while the fifth, sixth and seventh contain a more detailed treatment. The eighth is a recent review of the use of quinacrine in another application as a sclerosing agent--causing the lung to adhere to the chest wall (bjor89). The ninth describes the mode of action of quinacrine as a powerful disinfectant (ciak67). The tenth is an overview of the many actions and uses of this drug in the United States (wall89). The eleventh is a paper on reversal of QS using transcervical tubal catheterization (thur95). The twelfth compares ectopic pregnancy in QS and surgical sterilization (kess96). The thirteenth is the pharmacological basis of quinacrine in Goodman and Gilman (c). The fourteenth reports quinacrine as the most effective and best tolerated drug for giardiasis (hand94). The death rate for surgical sterilization in a developing country is described in fifteen QUINACRINE AND CANCER IN HUMANS This section includes the available literature on this topic. An assessment of the carcinogenic risk from quinacrine undertaken by a team of toxicologists for FHI concluded that the risk may be, at the very worst, quite small (tice90). The only long-term follow-up of QS patients reported thus far found no increased risk of cancer after 14 years (soka95).WHO AND QS The World Health Organization (WHO) undertook a vicious attack on QS almost at the very moment that the method achieved international recognition for its enormous fertility control potential with the publication of the Hieu et al. (hieu93b) paper in The Lancet. When this patently unscientific approach of WHO was brought to the attention of its editors (lanc94), The Lancet responded by describing WHO's behavior as "reprehensible" (lanc95). During 1994, the British Medical Journal published a series of eight articles describing in great detail the corruption and incompetence at WHO. In 1995, the editors of The Lancet concluded that WHO had lost its "coherence, credibility, and relevance" and that there were "obvious sources of corruption within the Organization" (lanc95). A former assistant director general of WHO of 24 years describes one of the most powerful sources of corruption at WHO which is also the world's leading opponent of family planning (sieg93).THE OPPONENTS OF QS AND WHAT THEY ARE SAYING This section offers all published reports from opponents of QS whom we have been able to identify. We intend to offer on this WEB site all attacks on this method so that all concerned can see exactly what the opposition is saying. Thus far, the scientific case for QS has easily withstood all criticisms leveled against it. Much, if not most, of the criticism of QS is motivated by religious opposition to family planning supported by individuals who wish to protect their own interests. INSTRUCTIONAL MANUALS, CLIENT AND PROVIDER BROCHURES, STUDY PROTOCOLS, AND DATA COLLECTION FORMS AND MANUALS An excellent training package on QS for clinicians is available. It clearly describes the procedure and counseling session. Accompanying the video is an instruction manual as an aid to achieve proficiency in the provision of QS. A record system recommended by the International Federation for Family Health is included in the manual. Patient and provider brochures describing the procedure complete this service. They are available in English, Chinese (Mandarin), Bangla and Spanish.The IFFH has developed a set of study protocols, standard data collection forms and manuals that standardize the completion of these forms. These materials will be useful in the conduct of each of the types of research identified above. Their use is encouraged because they assure comparability of studies. Five basic data collection forms for evaluation of safety and effectiveness of the quinacrine pellet method have been designed and used by IFFH (see Appendix 1). The Chemical Nonsurgical Female Sterilization Study Record, the Follow up Record and the Pregnancy Confirmation Form, with their Instruction Manual, are the basic records to be used in research protocols to test hypotheses for improvement of the safety and effectiveness of the quinacrine pellet method. The Female Nonsurgical Sterilization Register is an abbreviated record for monitoring acceptability studies. From a research point of view, this data will provide use effectiveness rates in service programs and greatly expand our data base on the immediate side effects of quinacrine pellet insertions. This Register can be used for confirming studies investigated with the Chemical Nonsurgical Female Sterilization Study Record. The Quinacrine Pellet Study Register for Evaluation of Pregnancy Failures is used for retrospective evaluation of effectiveness of any acceptability study or service program. | ||