International Services Assistance Fund, June 22, 2006
FDA approves Phase III QS trial
Earlier this month, International Services Assistance Fund (ISAF), a North Carolina based non profit organization, received permission from the US Food and Drug Administration to conduct a Phase III clinical trial of a non surgical method of female sterilization known as quinacrine sterilization or QS.
ISAF has been working to expand this method since it sponsored a study group
to Vietnam in February/March of 1994 to observe the great safety and acceptability
of its use there. One member of the study team, Dr. D. Malcolm Potts, now
Bixby Professor of International Public Health at UC Berkeley, noted in a
letter to the Lancet that QS was the most important advance in contraception
since the birth control pill.
ISAF’s contract research organization (CRO), Oxford Pharmaceuticals
Resources, Inc. has notified its collaborators including Planned Parenthood
to discuss next steps in conducting this trial with the goal of completing
the trial and then obtaining FDA approval to market QS kits in the US. The
trial’s Chief Investigator is Dr. Jack Lippes, the internationally known
inventor of the Lippes Loop IUD, who has written and spoken widely about
QS in recent years. Earlier, Dr. Lippes conducted and successfully completed
an FDA approved Phase I trial of QS on US women volunteers.
He wrote this abstract for the XVIII International Federation of Gynecology and Obstetrics (FIGO) for the speech he will present at that meeting in November 2006 in Kuala Lumpur, Malaysia:
“QS has now been performed in 50 countries on more than 175,000 women. No mortality has been reported. No adverse events severe enough to require surgery has been reported. The serious complication rate has been found to be 1/50 that of surgical sterilization and the failure rate to be 1% to 2% after 2 years. The cost of QS is about 1/10 that of surgical sterilization. QS is a simple outpatient procedure that has been performed frequently by well trained nurses and midwives. Training requirements are minimal for clinicians who are experienced in performing pelvic examinations and IUD insertions, abortion or endometrial biopsies.
No other foreseeable advance in women’s reproductive health has as much potential to reduce maternal mortality and morbidity and the number of elective abortions.
Surgical sterilization has long been the leading contraceptive method worldwide. Our 29 year international experience with QS has led us to conclude that worldwide accessibility of QS is achievable such that 80% of women will have access to this method. Furthermore, we demonstrated that QS is highly acceptable and have concluded that 80% of women will accept this method before they reach the end of their reproductive years. This achievement would reduce maternal mortality and morbidity by 40%, a number of abortions performed worldwide by 40% and the number of unwanted births by more than 50%.”
With a huge number of women in every country around the world wishing now to have no more children, the potential of delivering QS, an out patient, economical, non surgical, safe to administer method, offers huge promise.
For additional information contact ISAF at 919-990-9099 or go to the web site, www.quinacrine.com