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Published in the Quinacrine Newsletter 2000 |
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 QS: The Indian Experience Krishna Jaffa, MBBS | | .JPG) |
Quinacrine (Q) has been used extensively in India for several decades to treat a host of infectious diseases. The introduction of Q for non-surgical sterilization followed a review of more than 36,000 cases at an MCH conference in Bandung, Indonesia, in 1991. Dr. JK Jain, a surgeon and member of the Indian government’s Central Family Welfare Council, brought back information on QS from this conference and presented it to the Indian Council of Medical Research and several leading Indian obstetrician/gynecologist specialists. In April 1992, Dr. Badri Saxena, then Deputy Director General of the Indian Council of Medical Research (ICMR), proposed an ICMR-supervised study on the role of Q pellets for female sterilization. ICMR’s toxicology review panel and human ethics committee reviewed the facts on QS, and the Director General of ICMR mentioned that he had successfully, and extensively, used quinacrine to treat patients with giardiasis. A draft protocol, prepared by Dr. Saxena, resulted from these meetings. The Drugs Controller of India attended a second toxicology review, and stated that a QS trial protocol could be launched safely. Baroda and Chandigarh in India were chosen as the two centers, and 8 women were enrolled in the study. Five of them were successfully sterilized; the 3 failures were attributed to violation of the recommended protocol guideline to maintain hysterosalpingographic (HSG) pressures to under 100 mm Hg during follow-up HSG. Documentation of tubal occlusion was taken as the end point. Transient adverse effects following the procedure included nausea, fever, and low back pain. Subsequently, the Lady Hardinge Medical College ethics committee gave permission to its Department of Obstetrics and Gynecology to complete a study on QS, with excellent results. As information about the ease of delivery, safety, and low cost of QS spread, more physicians asked to be taught to do the procedure. The training, under the supervision of an obstetrician/gynecologist specialist, included videos and other educational material illustrating correct insertion technique. They were also taught indications, contraindications and the importance of counseling the women. As coordinating physician for trials during 1997-1998, I placed heavy emphasis on compliance with informed consent requirements; in fact, every kit I sent out went with a consent form detailing the procedure. The need for follow-up was stressed; to facilitate this, I provided follow-up forms and guidelines to physicians. In the more than 10,000 follow-up forms I reviewed, and approximately 300 women I interviewed, I found no evidence of the serious allegations that were to follow. All I saw were minor side effects: transient nausea, low back pain, occasional spotting and amenorrhea lasting up to several months. In 1997, ‘The Yellow Haze,’ a documentary on QS, received widespread media attention. It alleged that the two women interviewed by the producers had not given their consent for the QS procedures they underwent. This appeared to be contrary to the facts as I knew them, and I was deeply concerned. As part of my preparation for the public interest litigation that followed, I approached Dr. Maya Sood of Lady Harding Medical College and asked her how the ethics committee, and the entire Department of Obstetrics and Gynecology of the College, could have overlooked this alleged violation of a patient’s rights. She pulled out the file on the QS study, and showed me the signed consent forms. The two women who alleged they hadn’t given consent had signed the forms; in fact, their signatures were clearly legible. Dr. Sood has not been given the chance to bring this to light. Following rapidly on the heels of ‘The Yellow Haze,’ several articles condemning QS as carcinogenic, and its proponents as coercive, appeared in the Indian press. Ms. Brinda Karat, of the All India Democratic Women’s Association, and also a member of the Communist Party of India, started speaking out against QS. Her key concerns: cancer and coercion. Women’s organizations picketed our work premises in New Delhi; any attempts to reply to their allegations were drowned by heckling. And so a promising method went the way of Norplant, which, incidentally, was also banned following a public interest litigation filed by the All India Democratic Women’s Association. And in this way Depo Provera, which Ms. Karat lobbied against, was removed from the Indian government’s family planning program. Why a person with no formal medical training should take it upon herself to condemn several proven safe methods of family planning is best known to her. Ms. Karat has also gone on record to state that Indian women are being used as “guinea pigs” by QS researchers. Would this then imply that we Indians benefited from women in the USA being used as guinea pigs for the oral contraceptive pill? It follows from Ms. Karat’s argument that there should be no clinical trials, whatever. During this entire period, not a single physician went on record to state that QS was harmful; on the contrary, India’s most eminent clinicians have insisted that QS is an ideal sterilization option in India. From the press, the matter passed into the hands of the very people who agreed QS was safe enough for a clinical trial in ethics committee meetings. However, this time the Drugs Controller cited articles that appeared in the lay press as the reason for his office’s recommendation that QS be banned. Dr. Saxena, who drafted the initial ICMR protocol, said their study was a failure. The All India Democratic Women’s Association filed a public interest litigation in the Supreme Court of India, asking for a ban on QS in India. Repeated written petitions from Dr. JK Jain went unanswered; the proponents of QS requested ICMR and the Drugs Controller to provide reasons for recommending the ban. No answers were forthcoming. No interviews were granted. This silence followed the Drug Technical Advisory Board’s recommendation that QS be banned; not a single obstetrician/gynecologist was on that Board. And a few months later, we had a ban order in effect.  | ||
Why US Women Deserve Mildred Hanson, MD | |  |
Dr. Jack Lippes has reviewed the major risks of surgical sterilization by laparoscopy. Most deaths from this procedure in the USA are attributed to the use of general anesthesia. Although it is possible to perform laparoscopic sterilization using local anesthesia and sedation, the majority of these procedures in the USA use general anesthesia. Deaths due to perforation of a large blood vessel are rare in the United States because of the availability of a vascular surgeon in the institutions performing laparoscopic sterilization. In developing countries vascular injuries may be lethal. In our own hospital, I have seen this lifesaving procedure in two dramatic cases. The prevalence of vascular injury is not really known. Another risk avoided by quinacrine sterilization (QS) is the hospital environment where the more antibiotic resistant strains of bacteria reside. Besides the comparative safety of QS to surgical sterilization, there are other reasons to support the QS option. One is minimal discomfort. Among women I interviewed in rural Vietnam who chose quinacrine sterilization, most rode their bicycles home the day of the procedure and were able to attend to their children’s needs also on the same day. But the major advantage of QS in the USA and elsewhere is its increased access for women who cannot afford surgical sterilization. QS costs about 10% of the charge for surgical sterilization. It can be performed by trained nurse practitioners who are already skilled in IUD insertion and sterilization counseling. I strongly recommend that QS become an option for American women now. Spreading the Word |
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