Large quinacrine study comes under fire from family planners.

A large study among 31,781 women, in 24 provinces of Vietnam, who underwent nonsurgical female sterilization via insertion of 2 doses of quinacrine 30 days apart has various flaws, according to many family planning specialists and researchers. The authors of the study based their findings on just 11,686 women and then extrapolated the results to all 31,781 women. Study providers did not follow a standard protocol. They used data from just 1 province (Namha) to determine the ectopic pregnancy rate (0.89/1000 woman years of use). Study authors are in the process of doing a separate analysis of ectopic pregnancy rates among all 24 provinces. Yet, it may not represent true rates because of the other inconsistencies in the study. Women may have died from ectopic pregnancy, but the researchers would not know this, since the women lived in rural areas. The medical director of the Association for Voluntary Surgical Contraception objects to the study because quinacrine has not gone through an acceptable and thorough regulatory review process. The study authors said that since the least skilled and experienced clinicians had the highest failure rate, and the most skilled and experienced clinicians had the lowest failure rate (17.2% vs. 5.3%), improved skills and more experience of inserting by clinicians would reduce the failure rate. Later analysis of the data by another group found, however, that failures continued despite the size of the series of women, suggesting that the clinician is consistently not performing the procedure correctly. The group attributes failures to other causes (e.g., in utero blood interfering with the action of quinacrine). Other experts attribute the failures to the technology. Since Vietnam has had an aggressive national population program, and a provider secretly inserted quinacrine in a woman in Vietnam recently during a routine exam, family planners fear that women may be forced to accept the quinacrine method.