Controversy over Quinacrine Sterlization Pellet

Date Published: July 17, 2006

In a recent report, dated September 1993, the Association for Voluntary Surgical Contraception discusses the safety and efficacy of Quninacrine pellets (QP) for nonsurgical sterilization and raises issues about how its use could affect the rights of family planning clients, especially in the area of free and informed choice. Developed in the 1920's the drug quinacrine was used to treat malaria during World War II. Subsequently, it has been used to treat conditions as widely disparate as tapeworm and lupus. Because it is a simply manufactured and low cost intrauterine drug that is easily inserted, there is great potential for providers to abuse the trust of clients undergoing pelvic examinations. Inserted into the womb, the QP dissolves annd results in a scar tissue forming at the ends of the fallopian tubes. This blocks the passage of the egg into the uterus.

AVSC documents some of the problematic areas in the clinical trials and testing of nonsurgical QP, especially the early problematic results from toxicological tests. As yet, large scale controlled clinical trials have not been conducted. Family Health International (FHI) began clinical trials in Chile in the late 1970's and has continued its follow-up of Chilean women without arriving at any clear conclusions about QP's safety.

In its July 24, 1993 issue The Lancet reported on a field trial from Vietnam covering 31,781 cases of nonsurgical sterilization with quinacrine between 1989 and 1992. Of the eight types of major complications documented during the trials, two were severe pain and PID. Carried out in 24 provinces of Vietnam the trials violated sampling inclusion criteria by including women under the age of 30 as well as some who were breastfeeding. Also noteworthy is the bias created by excluding a large number of cases from the statistical analysis, especially for examining side effects. AVSC concludes that until more carefully designed studies are conducted to assess safety and mechanisms are established to ensure free and informed choice the risks posed by QP cannot be underestimated.

In 1991 WHO's Toxicology Review Panel recommended against the study of QP for female sterilization:

"Quinacrine is a positive mutagenic agent in bacterial systems and there is inconclusive evidence in mammalian systems. There is a lack of carcinogenicity assessment in animal systems, but limited evidence that there may be carcinogenesis in humans.

"---Pharmacokinetic studies indicate that intrauterine administration of quinacrine in pregnant monkeys resulted in much greater absorption than in non-pregnant animals, and similar or greater absorption than by intravascular injection. Lethality occurred after intrauterine administration in monkeys. Mild liver and cardiovascular toxicity were also reported in the monkey studies and there have been cases of "toxic psychosis" in humans to whom a quinacrine slurry was given by the intrauterine route...." (WHO/HRP; April 1991).

The Panel also advised against the use of potentiating agents (ampicillin, ergolamine and ibuprofen) in combination with QP. Its recommendations, however, have not been heeded. The Center for Research on Population and Security has been supplying QP at no cost to researchers and government health agencies. Field trials are underway in eleven countries: Bangladesh, Chile, Costa Rica, Croatia, Egypt, India, Indonesia, Iran, Pakistan, Venezuela, and Vietnam. A Vietnamese publication, Women, said that more than a hundred female rubber plant workers had visited a doctor for routine pelvic examination when the doctor inserted the QP (obviously without their consent).{Fawn Vrazo, "Sterilization Method raises Hope, Fear," (Philadelphia Inquirer, December 2, 1993).

For a more thorough report on QP from AVSC, please contact the following address: Amy E. Pollack, M.D., M.P.H., Medical Director, Association for Voluntary Surgical Contraception, 79 Madison Avenue, New York, NY 10016, phone 212-561-8083 fax 212-779-9439.