Quinacrine Non-surgical Method of Voluntary Female Sterilization: Current News  
 
   
  

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WHO AND QS (Continued)

WHO fellowships -- what do they achieve?.
F. Godlee, assistant editor. British Medical Journal 1995; 310:110-2.
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Summary: Training health professionals is one of WHO's major strategies for improving health care in the developing world. The aim, to strengthen a country's own capacity rather than injecting expertise from outside, is in the best tradition of sustainable development. But how effective is this so called "capacity building in human resources"? Since it accounted for $43m of WHO's budget in 1992-3 and is considered by WHO to be a major contribution to health in individual countries, it deserves detailed examination.

WHO's special programmes: undermining from above.
F. Godlee, assistant editor. British Medical Journal 1995; 310:178-82.
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Summary: Despite the World Health Organization's spoken commitment to developing integrated primary health care, its most visible and successful activities are not integrated within countries; they are its disease specific intervention programmes, such as the Global Programme on AIDS and the programmes for the control of diarrheal and acute respiratory diseases. The 10 or so special programmes, all but one of which (the onchocerciasis control programme) are based in Geneva, have found increasing favour among donors, but critics say that they undermine WHO's attempts to integrate its activities at country level and discourage countries from developing their own capacity.

WHO in Europe: does it have a role?.
F. Godlee, assistant editor. British Medical Journal 1995; 310:389-93.
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Summary: WHO is under pressure from all sides to justify its existence. Donors want to know what they are getting for their money, and health professionals question the relevance of the organization's work. The pressure to justify itself is perhaps strongest of all in Europe, where most member countries have fully fledged health infrastructures and high overall levels of health. Now there is the additional threat of encroachment into the field of public health by the European Union. The disintegration of the Soviet bloc has given WHO's regional office in Europe a new sense of purpose and led to a major shift in resources towards the countries of central and eastern Europe. But WHO's critics are calling for a different shift in the way its European office works: from its current concentration on broad based policy issues to the nitty-gritty of health care management and delivery.

Interview with the director general.
F. Godlee, assistant editor. British Medical Journal 1995; 310:583-6.
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Summary: Dr. Hiroshi Nakajima was elected director general of WHO in 1988. Born in Japan, he trained as a psychiatrist before joining WHO in 1973. He was WHO's regional director for the Western Pacific from 1979 to 1988. His term of office has been marked by criticism of his management style and allegations of misuse of WHO's funds. I spoke to him at WHO's headquarters in Geneva in July. I have presented the interview in the form of questions and answers. It would be misleading, however, not to make clear that in doing so I have transcribed conversation which was at times extremely difficult to follow. I feel that it is important to emphasize this in the context of an interview with an international leader, one of whose primary tasks must be to communicate his views on health to people across the world. The interview gave me first hand experience of the difficulties in communication that staff, diplomats, and others, including Japanese leaders, have consistently commented on since Dr. Nakajima took office.*********

Quinacrine method of family planning. (Letter).
D.T. Hieu (Ministry of Health, Hanoi, Vietnam). Lancet 1994; 343:1040.
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Summary: Hieu asserts: We were both surprised and disappointed by the treatment given by the scientific community with respect to our Lancet report. Scientific debate should be out in the open. Unsubstantiated opinions of unidentified WHO experts and FDA officials should not be accepted by the scientific community in this attempt to undermine our decision to proceed with this method; nor should these opinions be allowed to obstruct the international evaluation of this most promising family planning method.

Quinacrine sterilization revisited. (Commentary) (A critique of the WHO position on the quinacrine method).
E. Kessel (Department of Public Health and Preventive Medicine, Oregon Health Sciences University, Portland, Oregon). Lancet 1994; 344-698.
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Summary: Kessel, taking exception to the Geneva meeting, observed: The HRP consultation in Geneva closed without a consensus among the participants as to the next steps for the quinacrine pellet method. WHO insisted that no clinical trial should be conducted until there had been more laboratory and animal toxicology studies. Other participants thought that clinical trials should continue concurrently with toxicology studies; they reasoned that the long-term risks will eventually be determined by epidemiological studies involving many women who have used the method for a long time. And that was what happened for most contraceptives in use today.

Death of a Study: WHO, what, and why.
Lancet Editorial. Lancet 1994; 343:987.
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Summary: Editorial takes strong exception to manner in which the World Health Organization (WHO) and the Association for Voluntary Contraception (AVSC) dealt with Hieu study of 30,000 women using QS. Despite Lancet efforts to elicit response from WHO, there has been none. Editor observes: This is no way to evaluate research. That WHO should resort to anecdote and misinformation and then try to duck the question is reprehensible. Maybe now, with the publication of Hieu's letter, WHO--and AVSC--will have the courtesy, and the courage of their convictions, to air their criticisms properly for the first time. Meanwhile, as Prof. Malcolm Potts commented on a follow-up visit to Vietnam as a member of a team from International Projects Assistance Fund, "international agencies now find themselves in the embarrassing position of pontificating according to Northern standards on a much needed South-South technology they failed to support in a timely manner earlier." At this juncture Hieu surely deserves the last word: "Unsubstantiated opinions of unidentified WHO experts and Food and Drug Administration (FDA) officials should not be accepted by the scientific community in this attempt to undermine our decision to move forward with this method."

Fortress WHO: breaching the ramparts for health's sake.
Lancet Editorial. Lancet 1995, Jan. 28; Vol. 345, pp. 203-4.
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Summary: This highly critical editorial concludes that WHO has lost its way -- its coherence, credibility and relevance. States that there are obvious sources of corruption and mismanagement within WHO and that this organization must now be reinvented.

Vatican control of world health organization population policy: an interview with Milton P. Siegel.
S.D. Mumford (Center for Research on Population and Security, Research Triangle Park, North Carolina). The Humanist 1993; 53:21-25.
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Summary: Milton P. Siegel, who for 24 years was the assistant director general of the World Health Organization, speaks out. The unchecked growth in world population has strained the life-support systems on the planet, resulting in misery for countless millions of human beings. The source of this calamity is to be found in the early days of the UN organization. Western democracies that controlled its agenda, such as WHO, caved into the political pressure of the Vatican with its influence on Catholic voters. This power is multidimensional but offset by fundamentalist Protestantism in the US and fundamentalist Islam internationally. Some of the delegates shaping UN health policy in the 1940s recognized that overpopulation would be a major and preventable cause of death. Prof. Milton P. Siegel joined WHO in 1946. He said that the basis of opposition to discussion of population and its problems was that family planning was not a health issue and shouldn't be debated. Most of the delegates disagreed. But the few countries dominated by the Vatican didn't want this. If you introduce anything under the rubric of health, it is hard to argue against it. The opposition insisted that these were political considerations only. Pressure was brought to bear at every relevant meeting -- World Health Assemblies -- and in the interims on the officers and country representatives who were intimidated by the Holy See. The Belgium and Irish delegations threatened to withdraw from WHO and take steps to destroy the organization during the third World Assembly; India's minister of health, Rajkumari Amret Kaur, was a converted Catholic who refused to support any kind of family planning program. Ceylon and the Scandinavian countries proposed a resolution to establish an expert committee to learn about spacing of children and birth control problems. They were defeated after a heated debate when the resolution was withdrawn. The UN, disappointed in WHO's miserable performance, established the UNFPA. But the Vatican's influence is still considerable, according to Prof. Siegel.

Out of the public's view: the battle for quinacrine.
M. Weld (Chairman of Global Population Concerns, Ottawa, Canada). Humanist in Canada 1996, Autumn; pp. 31-2.
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Summary: In the developing world, sterilization accounts for 45% of all contraceptive use. Over the next 10 years, UN Family Planning Agency estimates 200 million procedures will be needed to achieve population goals of 12 billion people by the end of the 21st century. Quinacrine method would appear an excellent solution to the problem. Opposition by the Catholic Church has prevented its widespread use despite its record of safety and efficacy in clinical trials in many countries.

THE OPPONENTS OF QS AND WHAT THEY ARE SAYING


Quinacrine family planning method: Letters to the Editor.
R. Abdullah (Asian-Pacific Resource & Research Centre for Women, Kuala Lumpur, Malaysia):. Lancet 1994; 343:1425-7.
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Summary: The writer is concerned that women in developing countries may not understand full implications of the permanence of the method or its application. Worried about long-term physiological effects and risk of abuse or coercion.

The quinacrine controversy one year on.
M. Berer, Editor. Reproductive Health Matters 1994; 4:99-106.
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Summary: Following the report of a study of the use of quinacrine as a nonsurgical method of sterilization in more than 31,000 women in Vietnam, Reproductive Health Matters published a critical analysis of the Vietnamese data. Since then, a consensus has been reached that toxicological testing of quinacrine in animals should be done before there are any further clinical trials or any other provision of the method to women. Yet a number of people are continuing to promote and perform quinacrine sterilizations. This paper looks at what is known about the safety and efficacy of this method and gives examples of who is currently providing it. It asks what should be done when consensus views are ignored or rejected by individual providers.

The quinacrine controversy continues.
M. Berer, Editor. Reproductive Health Matters, No. 6 November 1995; pp. 42-6.
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Summary: Quinacrine is a non-surgical method of female sterilization. It has not been approved by the drug regulatory authority in any country as studies have not yet shown whether it is safe or effective. A small number of individual doctors are continuing to provide this method to poor women in developing countries, in spite of international advice by WHO, IPPF and other medical and scientific experts in the field. This report includes: 1) a summary of events in the past year, most importantly the finding of mutagenicity in three of the four pre-clinical toxicology tests on the drug and the issues these results raise for further research; 2) a paper by Lezak Shallat on the continuing provision of quinacrine sterilization to women in Santiago, Chile.

The Quinacrine Method of Nonsurgical Sterilization: Report of an Experts' Meeting.
C.S. Carignan, D. Rogow, A.E. Pollack (Association for Voluntary Surgical Contraception (AVSC), New York, New York). Advances in Contraception July 1994; AVSC Working Paper No. 6.
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Summary: In July 1993, Lancet published a report by Hieu et al. (1) of 31,781 cases in Vietnam in which quinacrine hydrochloride pellets were used for nonsurgical female sterilization. The report raised a number of substantial issues for professionals in the fields of family planning, women's health, and contraceptive research. On December 2, 1993, the Association for Voluntary Surgical Contraception (AVSC) held a meeting of experts in New York to air these issues and to assemble the latest information and thinking about this method of sterilization. AVSC invited representatives of institutions working with quinacrine and organizations concerned about the issues raised about the drug to participate in the meeting. Many participants made presentations on issues related to the quinacrine method of sterilization (see page 5). In this paper, the authors summarize the opinions voiced and recommendations made at that meeting. It does not represent a consensus of the group; it is a representation of many points of view on a complex subject.

Multiply and perish.
R. Dasgupta (and G. S. Mudur, investigative reporter). Insight, Calcutta Sunday, January 19, 1997; .
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Summary: According to this journalist, quinacrine is being used by doctors for sterilizing women in the Third World, despite strong medical evidence against the drug. There follows a description of Dr. Mullick's office as being an unsanitary, shabby room, and the treatment of the women who seek this inexpensive method, insensitive. The author roughly describes the method and there is a list of other doctors who do agree with the proponents, Kessel and Mumford, from whom they receive supplies to perform the method. There is further criticism from various sources.

Quinacrine sterilization: Letter to Editor.
H. Hoogenboom (Association for Voluntary Surgical Contraception). Lancet October 22, 1994; 344:1160.
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Summary: Defends attack on the method.

Response to AVSC Technical Statement concerning Quinacrine pellets for nonsurgical female sterilization.
E. Kessel, MD.. Memorandum Nov. 5, 1993; .
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Summary: Author finds the statement flawed on several counts. Among them: (1) the Lancet article was misinterpreted; (2) AVSC failed to make a reasonable risk/benefit assessment of the method. Kessel corrects and clarifies the statements by page and paragraph. In his general comment he observes that it is not the role of American organizations to decide whether the QS method should be studied or used in service programs of other countries. They should do this for themselves, according to local needs and assessments. Their efforts should be supported by U.S. research organizations. Excellent counseling is needed for all family planning methods, especially for permanent ones, to rule out possibility of coercion. The Vietnamese physicians reporting on their experience in Lancet concluded that: "This procedure represents our most cost-effective way of lowering maternal mortality."

Quinacrine sterilization: Letters to the Editor.
E. Kessel. Lancet November 19, 1994; 344:1434.
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Summary: Response to Hoogenboom accusation that Kessel had misrepresented AVSC role in the quinacrine sterilization controversy. His commentary was only concerned with errors and misinterpretations of the Vietnamese field-trial report (see Lancet 1993, Vol. 342, pp. 213-17.)

Women are guinea pigs in contraceptive trial.
S. Y. Khan (Times of India News Service). Times of India Sunday, March 16, 1997; .
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Summary: Third World women are being used as guinea pigs for new types of contraceptives. Pioneer in new quinacrine method is B. Mullick, whose clinic in Calcutta serves women seeking this non-surgical sterilization by means of this antimalarial drug. Other physicians throughout India are also performing the method. Article quotes a number of people with no knowledge of the method who criticize it severely. Also characterizes Mumford and Kessel as right-wing anti-immigration lobbyists who are main sponsors of this method.

Cheap but deadly contraceptive is on 'trial'.
S.Y. Khan. Times of India 1997; March 16.
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Summary: The author accuses doctors in India of using the quinacrine method, which he characterizes as being very dangerous. He quotes several doctors both in India and elsewhere who describe it as crude and imprecise. Khan claims that the method has been banned in a number of countries and is being used without the knowledge of drug authorities in India. He names Mumford and Kessel as sponsors, who are being supported by right-wing anti-immigration lobbies in the USA.

Quinacrine sterilization: Letters to the Editor.
S. Mumford. Lancet November 19, 1994; 344:1434.
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Summary: S. D. Mumford: Response to Hoogenboom letter of Oct. 22, p. 1160, protesting that the Association of Voluntary Surgical Contraception (AVSC) intended only to encourage discussion of the quinacrine pellet method of female sterilization when it prepared its report of September 1993. Mumford cites lack of consultation with professionals having first-hand knowledge of the method. Refers to AVSC's hidden agenda.

The use of quinacrine pellets for non-surgical female sterilization.
A. E. Pollack, C. S. Carignan (Association for Voluntary Surgical Contraception). Reproductive Health Matters 1993; 2:119-22.
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Summary: Considering the current data, including the Lancet article, it is not possible to conclude that quinacrine pellets are a safe and effective non-surgical method of female sterilization. If the questions regarding safety and efficacy can be satisfactorily answered, the low cost and ease of insertion would make quinacrine a promising method. However, further carefully designed studies that specifically address short- and long-term safety are needed. A standard protocol of insertion, with studies evaluating efficacy, must be established. Until the outstanding questions have been answered, the use of quinacrine pellets for female sterilization should continue to be considered an experimental procedure. (Note of intention to convene a small group of experts to address issues mentioned. A summary report will be published.)

Contraception: a technical statement on quinacrine pellets for nonsurgical female sterilization.
A.E. Pollack, C.S. Carignan (Association for Voluntary Surgical Contraception). Advances in Contraception 1994; 10:43-50.
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Summary: For many years, researchers have been seeking nonsurgical methods for female sterilization because these methods may be safer, simpler, cheaper, and quicker than conventional techniques, and may require a lower level of skill to deliver. Various investigators have explored using intrauterine instillation of quinacrine for tubal occlusion. Until recently, reports of quinacrine use for nonsurgical sterilization have been scarce and limited to data sets involving small numbers with very short-term follow-up. The July 24, 1993 issue of the Lancet reports on 31 781 cases of nonsurgical sterilization with quinacrine in a field trail from Vietnam. The present paper is written as a background review to assist family planning providers in the dialogue regarding the introduction and use of quinacrine. It attempts to answer questions regarding what is currently known about the safety and efficacy of quinacrine, and what the recent article published in the Lancet adds to our knowledge. It also raises the question of how quinacrine sterilization affects free and informed choice and the other interests of family planning clients.

Business as usual for quinacrine sterilization in Chile.
L. Shallat. Reproductive Health Matters Nov. 1995; No. 6: pp. 144-6.
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Summary: Quinacrine is a nonsurgical method of female sterilization. It has not yet been approved by the regulatory pharmaceutical authorities of any country, since studies have not demonstrated its safety and efficacy. At the individual level, a small number of physicians have continued to apply the method to poor women in developing countries, against the advice of WHO, IPPF, and other medical and scientific experts in this field. This article includes: 1) a summary of the events of the past year, the most important of which is the presence of mutations caused by the drug in three of the four preclinical test cases and what those results imply for future research; 2) a document on the continued provision of sterilization by this method in women in Santiago, Chile.

The drug peddlers -- the quick fix method.
S. Sirohi (Washington, DC correspondent of Insight.). Insight, Calcutta Sunday, January 19, 1997; .
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Summary: The reporter insists that behind Kessel and Mumford are foundations, anti-immigrant groups and private individuals with a common belief -- the population bomb can explode and consume our (U.S.) resources, overrun our borders and ultimately cause a crisis in our country. He gives an account of past misuse of women in experiments and equates the quinacrine method with these heinous crimes. According to him, Kessel and Mumford are concerned only with numbers and dollars.

Contraception crisis.
Editorial. Times of India Tuesday, March 18, 1997; .
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Summary: A barrage of unsubstantiated criticism of the quinacrine method. Why is the focus on women alone in the matter of family planning? The government is accused of political maneuvering to deflect accusations that the men are being spared their responsibility in these matters.

Quinacrine: tests find genetic damage.
Women's Health Journal Staff article. New Technologies, Women's Health Journal, Latin American and Caribbean Women's Health Network 3-4/95; p. 24.
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Summary: Report on the Family Health International (FHI) announcement that its recent in vitro toxicology tests link quinacrine to genetic damage. Proponents of the sterilization method introduced it at the Fourth World Conference on Women NGO Forum in China. FHI lacks funding to continue the 8-year $8 million study. They are continuing retrospective studies in Chile and Vietnam. The new training video on quinacrine sterilization with accompanying manual and brochures for service providers and potential clients were offered at the Forum at Huairou. Data from a clinical study in India were presented by Dr. Kessel and views were exchanged with opponents on safety and ethical issues.

In Chile, QS studies continue.
Women's Health Journal Staff article. New Technologies, Women's Health Journal, Latin American and Caribbean Women's Health Network 3-4/95; .
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Summary: Meetings were held for discussion between feminists and quinacrine researchers, led by Zipper. Report of controversy when the method was offered by the Chilean Ministry of Health as an alternative to surgical sterilization in some of its clinics because unmet need is high. Health ministry officials still view quinacrine as a promising option. The Open Forum for Reproductive Health Rights met with proponents of the method to clarify consent procedures and improve access to hospital ethics committees who review these research decisions in Chile's decentralized public health care system.
  
         
 
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