FHI quinacrine studies
Network 16(1): 27
1995
ISSN/ISBN: 0270-3637 PMID: 12290470 Document Number: 292969
Scarcity of long-term funding has influenced Family Health International (FHI) to stop new animal studies on the safety of quinacrine pellets that are used in nonsurgical female sterilizations. These studies would have lasted 8 years and cost $8 million. FHI planned to examine quinacrine's potential toxicity, including life-time carcinogenicity in rodents. In the early 1980s, it sponsored toxicology studies but the US requirements for evaluating toxicity were different then. In 1994, a meeting of experts evaluated quinacrine research and FHI then decided to conduct short-term genetic toxicity tests on quinacrine. These tests proved that quinacrine causes genetic damage in vitro. FHI sent both the World Health Organization (WHO) and the US Agency for International Development (USAID) these results. FHI is presently conducting follow-up of two clinical studies in Chile (USAID-funded) and in Vietnam (Mellon Foundation-funded). A small cancer cluster promoted the follow-up study of 1492 women in Chile. One woman had developed the rare form of uterine cancer called uterine leiomyosarcoma. Data up to 1991 reveal that quinacrine did not increase the risk of cancer, but the sample size was too small to confirm quinacrine's safety relative to cancer. The Vietnamese government asked FHI to conduct a follow-up study that includes more than 2000 quinacrine acceptors and about 1500 controls. Ministry of Health providers had inserted the quinacrine pellets in the cases. Based on the findings of the original study, WHO recommended that Vietnamese officials suspend quinacrine sterilizations until more toxicologic evaluation of quinacrine could be performed.