EDITION 2 ~ JUNE 2009 (Updated 7/6/11)

Bruce Sundquist

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Prior Editions: Edition 1 of January 2007 


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Oral Use of Quinacrine


Transcervical Use of Quinacrine


Cancer and QS




Pressures on PPFA


Power Politics in the WHO


History of FDA-approved Clinical Testing of QS *


Other Tests of QS *


Opposition to Use of QS *


Usefulness of FDA Phase III Clinical Testing of QS *

( C)



The Tubal Ligation Alternative to QS


The Abortion Alternative to QS


The IUD Alternative to QS

( D)



Risks Associated with QS


Comparison of QS and its Alternatives 


Misuse of QS


The Link Between Clinical Testing of QS and Misuse of QS


Failure Rates of QS *





Table E-1

Global-Scale Maternity-Related Data for the Year 2000 (02D1)

Table E-2

Effect of population growth rate on probability of civil conflict (04P1) 

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Note 1: * In the interests of brevity, the term "Quinacrine Sterilization" is replaced by the abbreviation "QS" throughout this document.

Note 2: A reference citation e.g. (98C2) signifies the second document cited that was published in 1998 and having a lead author whose last name begins with "C". The final integer is just a running index.

An exciting, but largely unnoticed, recent development is the International Service Assistance Fund's (ISAF) Phase III clinical trial of a non-surgical method of female sterilization known as QS (quinacrine sterilization). QS has been performed in 50 countries on more than 175,000 women (06I1). It is so simple and so low-cost that it can be performed by nurses instead of doctors (06B1). It can even be done in peoples' homes (even in the developing world) using a simple, inexpensive, plastic, disposable tool (06B1).

QS costs about a tenth as much as a normal laparoscopic surgical sterilization, a procedure that has long been the leading contraceptive method worldwide. QS has 1/50th the complication rate of laparoscopic surgical sterilization (03B2). In the developing world, the cost of a QS is about $2.50 (03B2) (06B1). In the U.S., the cost of a QS is about $100 (03B2). In the U.S. the cost of a laparoscopic surgical sterilization is $4,000 to $6,000 (03B2). So with approximately 600,000 laparoscopic surgical sterilizations per year in the U.S., the savings to the U.S. health care system from converting laparoscopic surgical sterilizations to QS could reach $2 billion/ year (02L1). The popularity of surgical sterilization and the potential of QS is all the more impressive when one considers that most developing world women lack access to surgical contraception, since it is either physically non-existent, or it costs far more than all but a fraction of developing world women can afford. They are not likely to have such access for the foreseeable future. (http://www.quinacrine.com) QS could revolutionize contraceptive provision worldwide.

Let us expand on "revolutionize," but only as it pertains to the developing world. The number of women aged 15-49 years married or in union in 2005 was 947 million in the less developed regions of the world (05U1). Some 59% of these 947 million women use any method of contraception, and 53% use modern methods of contraception. Some 22.3% of these 947 million women use female sterilization. Only the IUD (14.5%) comes anywhere close to sterilization (05U1). If these developing world women had access to QS ($2.50) in addition to surgical contraception ($25 in developing nations), this 22.3% would increase significantly - perhaps to 25%. Less than half of the women in the developing world have access to sterilization. So if QS were to be introduced into the half of the developing world without any access to sterilization, the percent of developing world women using sterilization would at least double to 50%. This would increase the percent of developing world women using modern methods of contraception from 53% to 81% (53% + (25%-22.3%) +25%).

A common rule-of-thumb says that total fertility rates can drop to replacement level only after the percentage of women using modern contraceptives reaches 70%. This suggests that the population growth rate in the developing world could drop to replacement level or below after momentum effects wear off as a result of broad-scale introduction of QS. Maternal death rates and abortion rates would see huge declines in developing nations. A stable developing world population would eliminate the $1.2 trillion need for infrastructure growth required to accommodate population growth and eliminate the desperate shortage of financial capital and human capital that now plagues the developing world. (See Section E below.)

Despite all the potential benefits alluded to above, and in Section E (below), some harsh realities must be faced. A Phase III clinical test of QS is going to cost about $8 million. This is a large sum when quinacrine is off-patent (because it is already an anti-malarial drug) and costs only pennies for the quinacrine pellets needed for a QS procedure - not a high-profit-margin drug. Currently about $1 million has been raised. Another harsh reality is the fact that a number of politically active organizations oppose any contraceptive that works. For these organizations, an inexpensive, simple, safe contraceptive that even the poorest of developing world women can afford has got to be their worst nightmare. The prospect for QS to eliminate population growth in the developing world, as noted above, makes that nightmare even worse. One must expect, then, that these organizations will become extremely active in the arenas of public discourse and federal legislation when the time is right. Some of their past activities aimed at slowing, or halting, introduction of QS into common usage in developing nations are described below. When financier Warren Buffett funded Phase II clinical tests of QS, he incurred much nasty criticism from religious fundamentalists who tend to oppose any means of contraception that works. The potential benefits of a Phase III clinical test of QS vastly outweigh the test's costs as noted above. So what seems to be needed most now is a greater public understanding of QS, its history (that spans more than half a century), its science, its politics and its potential benefits to developing world women and to mankind in general in terms of large-scale reductions in maternal death rates, abortion rates and developing world poverty. One should be aware, however, that all this could only be achieved after a no-holds-bared struggle with the Vatican (that has won the bulk of such struggles in the past). This is the purpose of this document.

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Part [A-1] ~ Oral use of Quinacrine ~

Part [A-2] ~ Transcervical Use of Quinacrine ~
Quinacrine causes sterilization by scarring the fallopian tubes shut. It has also been used to intentionally scar sensitive abdominal cavity tissue in cancer patients, thus preventing dangerous fluid buildup (00M1). Dr. Jaime Zipper, who discovered QS, has records of 1500 QS cases performed in his clinic in Chile. He followed these cases for 20 years. No increase in the incidence of cancers and no serious problems were observed (99L1). In a review of the development and utilization of the QS procedure by Zipper and Kessel (03Z1) the main conclusion was that QS is ready for widespread use, especially where surgical sterilization is not safely available, or when women are poor candidates for surgery, or when women have such a fear of surgery that they will not seek surgical sterilization.

Part [A-3] ~ Cancer and QS ~

The uterus is known only to produce three cancers. (1) Cancer of the cervix we now consider a sexually transmitted disease related to the papilloma virus. (2) Cancer of the endometrium usually occurs after, and around, the time of menopause; in women of reproductive age, it is found in conjunction with a functioning ovarian tumor where estrogen is produced unopposed by progesterone. (3) Uterine sarcoma, a very rare malignancy representing 1% to 3% of uterine cancers, occurs at a mean age of 55 years. It is associated with obesity, hypertension and diabetes. None of the factors associated with uterine cancers can be related to quinacrine (02L1).

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Part [B-1] ~ Pressures on PPFA ~
The Planned Parenthood Federation of America (PPFA) Board met in El Paso on 11/13/99 to consider a recommendation of the PPFA National Medical Committee (NMC). It called for PPFA to undertake a clinical trial under FDA supervision in PPFA clinics. The NMC recommendation was made after the NMC's Ad Hoc Committee on QS had carefully studied the matter for a year. This study included considering the arguments of the opponents of a clinical trial - opponents who offered no evidence to support their claims. A group of four individuals, each with a long history of attacking other methods of contraception, such as the pill, IUDs, Depo Provera and Norplant, prepared a petition to the PPFA Board. This petition was sent by e-mail on 11/6/99 to thousands of individuals with a request that they co-sign it and respond by 11/11/99. No offer was made of site addresses where information on QS could be obtained. Individuals were asked to accept, on faith, the many criticisms of QS, as the four authors offered absolutely no substantiating evidence supporting these criticisms. The petition was circulated at the 11/13/99 PPFA meeting. Acceptance of this petition by PPFA would have been tragic because it would have delayed, by at least two years, access to QS everywhere. PPFA wound up speaking out in defense of the QS method, and indicated a conditional willingness to test it in patients (00M1).

Part [B-2] ~ Power Politics in the WHO ~
Professor Milton P. Siegel detailed how the Vatican seized control of World Health Organization (WHO) family-planning/ contraception-related policy-making right from its earliest stages (Ref. 304 of Ref. (96M1)). Siegel was the Assistant Director-General of WHO for its first 24 years. He is considered among the world's foremost authorities on the development of WHO policy. During the third World Health Assembly (1950), the Vatican threatened to kill WHO and start their own organization if the director general did not stand up before the Assembly and specifically state that WHO would not get involved with family planning. He did. WHO did not get involved at all for more than a decade. In its 45-year history, WHO has had a deplorable record in family planning. Its commitment has been minuscule. Even today, family planning accounts for only a tiny fraction of the WHO budget. The Vatican continues to have considerable influence at WHO. For example, in the mid-1990s it succeeded in having appointed as director of WHO's Human Reproduction Program a professor from a Catholic University in Rome, Dr. Giuseppe Benagiano, the son of Pope John Paul II's dentist. Benagiano promptly set out to kill any further clinical studies of the quinacrine pellet method of non-surgical female sterilization (Ref. 305 of Ref. (96M1)).

In 1993, strong evidence for the safety of quinacrine-induced tubal sclerosis was provided when Dr. Troug Hieu reported on over 31,000 Vietnamese women who had undergone quinacrine sterilization (Ref. (3) of Ref. (02L1)). There were no deaths, and serious adverse effects were estimated to occur at 1/50th the rate at which they occurred during laparoscopic sterilization (an option not available to most, or all, Vietnamese women). Dr. Hieu's clinical trial was cut short when the WHO, Special Programme, Development and Research Training on Human Reproduction complained that toxicology data "were not adequate to justify large-scale field studies." The British Medical Journal Lancet challenged the WHO to explain its negative position on QS, calling the WHO's action "reprehensible." The WHO reason for cutting the clinical trial short is probably false. In 1942, the Winthrop Corporation published a 40-page bibliography that listed 171 references on the toxicology of quinacrine, including data from clinical trials (Ref. (6) of Ref. (02L1)). Some feminist groups have also argued that clinical trials of QS should not start, based on logic suggesting that they were unaware of the Winthrop Corporation's bibliography (02L1).

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Part [B-3] ~ History of FDA-approved clinical testing of QS ~
Phase I:
Researchers at Family Health International set out on the US FDA approval track in 1981 (00M1). Their research was stymied by Third World controversies, funding droughts, and ever-tougher FDA requirements. The US FDA granted approval for a Phase I clinical trial to be carried out at the Children's Hospital in Buffalo, New York. The Investigative Review Board of the Children's Hospital unanimously approved of this clinical trial twice, once in 2000 and again in 2001 (02L1). The FDA approved a Phase I trial of QS that was completed as of April 30, 2003 (03B1). That trial involved a study of QS procedures performed on 10 women (03B1).

Phase II: Warren Buffett revived the approval process in the late 1990s with a $2 million donation to Family Health International. This donation apparently financed the FDA - approved Phase II testing of QS. Phase II testing was apparently successful and approved in mid-2006.

Phase III: Around mid 2006 the International Service Assistance Fund (ISAF) announced Phase III clinical trials of QS (06I1). At this point the financial barriers escalate dramatically. Phase III clinical trials are expected to require 8 years and cost about $8 million (05F1). Thus far, about $1 million have been raised (06B1). Quinacrine is no longer protected by a patent. (Quinacrine is an FDA-approved medication as an anti-malarial - a process involving far greater amounts of quinacrine being passed into the blood stream than a QS procedure.) Quinacrine is now available for only pennies for a QS procedure (an "off-label" use of quinacrine). So clearly, the potential profitability of quinacrine for use in QS is extremely low relative to the estimated $8 million cost of FDA-approved Phase III clinical trials.

The fear of litigation associated with the testing and development of any contraceptive raises the reluctance to get involved in clinical trials of QS even further. Part of the problem is that the anticipated benefits to the developing world are not widely recognized. Full approval of QS as a result of passing the FDA-approved Phase III clinical testing process would be expected to win worldwide acceptance of the QS procedure. The potential benefits of this are described in Section E of this document. Further evidence will require decades of post-marketing surveillance of many thousands of QS acceptors, as was done for oral contraceptives (02L1).

Part [B-4] ~ Other Tests of QS ~
Suhadi, Soejoenoes, Bhatt, Sokol and others have conducted studies that monitored patients for periods varying from 6 months to over 19 years following the QS procedure - and that published their results (03B1). Some of these studies reported a success rate of 97% (03B1). All these studies concluded that QS was a safe, effective, non-surgical from of female sterilization (98M1) (96S1) (00S1). A paper by Jaffa (00J1) notes a review of more than 36,000 QS procedures in Indonesia in 1991, and a study of about 10,000 QS procedures conducted in India during 1997-1998.

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Part [B-5] ~ Opposition to Use of QS ~
Politics of QS in India
The experiences of India over the past decade as documented by Jaffa (00J1) provide insights on the nature and tactics of the opponents of QS. Interest in establishing a QS program in India resulted from a review of more than 36,000 QS cases in Indonesia in 1991. Trials were run in India during 1997-1998 following an extensive planning process. Great attention was paid to pre-procedure interviews with patients, explaining the process, and obtaining signed consent forms from patients. This was motivated by the success of an Indian anti-contraceptive organization in banning Norplant and Depo-Provera, two popular contraceptives used widely throughout much of the world. About 10,000 follow-up forms were studied, and 300 personal interviews were conducted. Only minor problems were found (00J1).

In 1997 a documentary on QS, 'The Yellow Haze,' received widespread media attention in India. It alleged that two women interviewed by the producers had not given their consent for the QS procedures they underwent. This was in spite of the fact that the consent forms signed by these two women were available. Following rapidly after 'The Yellow Haze,' several articles condemning QS as carcinogenic, and the proponents of QS as coercive, appeared in the Indian press.  This was in spite of the fact that many tens of thousands of follow-ups to QS procedures showed no evidence of higher incidences of cancer, and no scientific studies existed that suggested a QS-cancer link. Evidence of coerciveness also did not exist. The leaders of the anti-QS movement had no formal medical training and were part of the organization that had previously gotten Norplant and Depo-Provera banned in India. 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. The anti-contraception group filed public-interest litigation in the Supreme Court of India, asking for a ban on QS in India. The Drug Technical Advisory Board recommended that QS be banned, though not a single obstetrician/ gynecologist was on that Board.  Instead of expert testimony, the Drugs Controller cited articles that appeared in the lay press as the reason for his office's recommendation that QS be banned. A few months later a ban order went into effect (00J1).

The Characteristics of Opposition to Contraceptives with Potentials similar to QS
In the mid-1990s, the first conceptually new development in contraceptives in 20 years - anti-fertility vaccines - was developed. It was attacked by several feminist organizations in much the same way that QS has often been attacked. No science is used in such attacks (as is normally the case in attacks on QS). The comment that there was a scientific consensus that the world was overpopulated was met with a comment that it was scientists who brought us the atomic bomb. In response to questions pertaining to how we will solve the problems that we now have, feminists responded with statements laying the blame for everything bad on the West. Any concerns expressed about population issues generally were seen by feminists as being genocidal toward people of other races. The bulk of the testimony by feminists consisted of rants against genocide, eugenics and racism. Those concerned with population-related problems were accused of being racist, anti-woman and anti-poor. These same feminists were instrumental in the near-total elimination of the IUD option for American women. They were also able to withhold Depo Provera from American women for 20 years.

Part [B-6] ~ Usefulness of FDA Phase III Testing of QS ~
It appears that global-scale use of QS procedures awaits the US FDA's approval of QS at the Phase III level - a process that would take about 8 years to complete, once the necessary funding (about $8 million) has been raised. Some have pointed out that, while such a level of testing is an appropriate standard for using QS in the developed world, it is simply wrong to apply that standard in the developing world (where the process is most badly needed). Others have reacted to this view by suggesting that it is tantamount to supporting two different standards of health care, and have expressed outrage at the very idea (03B1). If one examines the controversy a bit more closely, it is easy to see the fallacy of the latter argument.

What is crucial here is to ask what criteria ought to define any standard of safety for a medical procedure or drug. Consider the following example. In some regions of Southeast Asia the probability of dying as a result of an abortion is about one in two. Yet women still seek out abortions in a desperate attempt to avoid worsening the already extreme wretchedness born of earning a dollar or two per day and feeding an already unaffordable number of children. A tubal ligation surgery is likely unavailable, and unaffordable if it were available. Failure to get a QS means another one or two abortions at least, and hence a chance of dying during an abortion of well over 50%.

All those tens of thousands of follow-ups done on past QS recipients possibly were not done with all the scientific rigor required of FDA Phase III clinical studies. So when these earlier studies report no risks of cancer and other deadly ailments as a result of a QS, a risk as high as perhaps 10% of some deadly ailment might have slipped through the cracks. Had a Phase III clinical study been done, the uncertainty of the conclusions would be far smaller. The question for the developing world woman faced with a one-out-of-two chance of dying during an abortion is not whether a Phase III study on QS has been done, but whether the risks of a QS procedure exceed the risks of another abortion or two. We already know the answer to that question, so what possible sense is there in Southeast Asian country demanding a FDA Phase III clinical study before it legalizes QS procedures?

In the developed world, the risks associated with an abortion or two is one in several thousand, so it is perfectly reasonable then to demand an FDA Phase III clinical study of QS, since that is the only way of making sure that the risks associated with a QS procedure are less that the risks of the various alternatives to a QS. So the answer to the question raised above as to what criteria ought to define any standard of safety for a medical procedure or drug is simply a question of balancing risks. The risks inherent in the alternatives to a QS procedure in the developing world are far higher than in the developed world. Hence an FDA Phase I or II clinical study of QS is all that can be logically justified for the developing world, while an FDA Phase III clinical study is needed to do the risk-balancing in the developed world. All this has nothing to do with callously setting two different standards. The difference in risks inherent in alternatives to QS are much different in the two worlds, and this alone is all that is needed to decide on the appropriate and justifiable level of clinical study to be required. The tragedy is that holding off approval of QS until Phase III has been completed (a delay of a decade or more) achieves nothing but a huge increase in maternal deaths, a huge increase in motherless children, and a huge increase in abortion rates among the poorest, and most powerless, of developing world women.

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Part [C-1] ~ The Tubal Ligation Alternative to QS ~
No country has successfully reduced its population growth rate below 1%/ year without widespread use of sterilization (96K1). Female surgical sterilization has, for years, been the most popular birth-control method in the world (06I1) and in the US. About 28% of American women have had their "tubes tied" (00M1). American women are usually sterilized by tubal ligation that is usually done by laparoscopy (popularly known as "band-aid surgery)". The only alternative is opening the abdomen. The incision(s) in a tubal ligation are 4-5 mm, and can be covered by a band-aid. The death rate from laparoscopic sterilization is extremely low -about two deaths per 100,000 cases (99L1). In a number of developing world countries the issue of the safety of tubal ligation is largely irrelevant. Religious and political influences often make it impossible for government hospitals to accommodate the demand for an elective procedure such as surgical sterilization, i.e. tubal ligation. Some countries for which this is true include Chile, Indonesia, Vietnam and Egypt. This is despite the fact that all of these countries have well-developed family planning programs (03Z1). This problem increases the urgency of finding a less invasive method of female sterilization, especially one that could be safely performed in rural areas of developing countries at an affordable cost (03Z1).

There are also the risks of serious complications inherent in tubal ligation being a surgical procedure:

Since QS is a non-surgical procedure, the risks of death and serious complications as a result of QS are believed to be essentially zero (99L1). Currently only Phase I and II clinical trials of QS have been completed under FDA supervision, so until Phase III clinical trials can be completed under FDA supervision, American women must choose between surgery (tubal ligation) or an indefinite number of abortions, or an indefinite number of children. These last two options involve a small element of risk in the U.S. However in developing world settings, the corresponding risks can be much larger.

Part [C-2] ~ The Abortion Alternative to QS
Almost 600,000 women die annually of pregnancy-related causes according to the WHO. (See Table (E-1) below.) Of the estimated 46 million abortions performed annually around the world, 20 million are considered unsafe - and 78,000 are fatal, according to the population information program at Johns Hopkins University in Baltimore (00M1). Successful completion of the Phase III trial of QS would be expected to reduce maternal mortality and morbidity worldwide by 40% (06I1). It would also be expected to reduce the number of abortions worldwide by 40% (06I1).

Abortion in the developing world (where surgical female sterilization is usually not available, or too expensive if it is available) is typically a risky, messy business that most of us in the developed world have little understanding of. Some research published in the Lancet (06U1) provides some useful insights. Unsafe abortion methods that occur primarily in the developing world can be divided into several classes: oral and injectable medicines, vaginal preparations, intrauterine foreign bodies, and trauma to the abdomen. Women in developing countries rely on teas and decoctions made from products. Foreign bodies inserted into the uterus often damage the uterus and internal organs. In the South Pacific and Africa, abortion by abdominal massage is still used. These primitive methods show the desperation of the women. Surveys before the legalization of abortion on request documented the techniques in common use. Of 899 women, 74 had attempted to abort one or more pregnancies; 338 said one of their friends, relatives, or acquaintances had done so. About 80 tried to abort themselves. Nearly 40 used a combination of approaches. The more invasive the technique, the more likely it was to disrupt the pregnancy. Insertion of tubes or liquids into the uterus, were more successful than other approaches. Another method was to place a flexible rubber catheter into the uterus to stimulate labor. In diverse regions such as the South Pacific and equatorial Africa, abortion by abdominal massage is still used by traditional practitioners. The pummeling of the woman's lower abdomen is designed to disrupt the pregnancy but sometimes bursts the uterus and kills the woman instead. Miscellaneous methods and oral medications, such as laundry bleach, turpentine, and doses of quinine, were commonly used in New York - before abortion was legal. Injection of toxic solutions with douche bags or turkey basters was common. Absorption of soap solutions into the woman's circulation could cause renal toxicity and death. Potassium permanganate tablets placed in the vagina were also common; these did not induce abortion but could cause chemical burns, sometimes eroding through to the bowel.

This is the sort of thing that QS in developing nations would be, in essence, competing against. It is hard to imagine that QS could be more dangerous than any of these alternative procedures. Yet, for some reason, the developing world is waiting for an FDA Phase III clinical test procedure to prove that QS is not just safe, but ultra-safe, as if to say that the current alternatives to QS are so safe as to set the bar for QS at an extremely high level. Yet none of these alternative procedures have undergone even a FDA Phase I clinical test, and if they were it is doubtful that any of these procedures would receive FDA approval. This astounding degree of irrationality is hard to understand. It could just reflect a heel-dragging strategy by religious fundamentalists hoping to delay widespread use of QS for the several decades required for completion of FDA's Phase III testing. In the meantime they can work to prevent the initiation of Phase III, and developing nations can pretend that Phase III completion is essential for widespread use of QS even though maternal death rates and death rates from illegal abortions are extremely high in these same nations.

Part [C-3] ~ The IUD Alternative to QS ~
In the 1999 edition of the Physician's Desk Reference, combined data from the Population Council and WHO to reveal that the Copper T380A IUD is discontinued by patients for a variety of reasons such as expulsions, pain, backaches, and personal reasons and (most often) because of bleeding. At the end of three years, only 23% of women who started with the Copper T were still using it. After 10 years the continuation rate had dropped to 5% (99L1). Of course, the IUD is reversible, while QS is not.

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Part [D-1] ~ Risks Associated with QS ~
The second-most serious risk is that the inserter may perforate the uterus and deposit quinacrine in the peritoneal cavity. It is an uncommon accident, unique to QS. Once the quinacrine is absorbed the pain diminishes and nothing else happens. This is not life threatening (99L1). The most serious risk is that of pregnancy.

Post-QS Studies of Risks: For over 20 years, Dr. J. Zipper followed more than 1500 women who had QS. No excess risk of cervical cancer was found when these women were compared with a control group who were not exposed to quinacrine. Nor was any increase in endometrial cancer found over those same 20 years. In general, QS patients showed no excess risk of cancer compared with a control group who were not exposed to quinacrine (02L1).

In 2000, Steven Mumford contended that, after more than 100,000 QSs in 25 countries over the past 20 years, not one woman has died from the quinacrine pellet method (00M1). However the World Health Organization (WHO) and the US FDA take issue with Dr. Mumford, even though they believe that QS holds promise. They contend that past studies of QS are too varied and flawed to reliably conclude that QS is safe and effective (00M1). By 2003, QS had been used by more than 150,000 women in 35 nations - some for over 25 years - with no reported deaths or life-threatening complications (04C1).

The obvious conclusion from all this is that clinical studies supervised by the FDA out through Phase III are required for broad acceptance of QS in the US, the developed world, and the developing world in general. Presently only FDA-supervised clinical tests of QS through Phase II have been conducted (06I1). The problem is now financial. A phase III clinical study would cost about $8 million - a huge barrier for a non-patented drug that costs only pennies per sterilization. (See Section (B-2) on the huge influence of the Vatican on family planning policies of the WHO. This offers compelling evidence that the opinion of the WHO regarding QS, or any other contraceptive, is far from objective.)

Possibility of Coercive uses of QS: Another concern often expressed is that QS might be performed coercively or without the patient's knowledge. Those expressing this concern often point out this concern as their reason why an FDA clinical trial of QS should not be done. The logic here seems muddled however. If a government or a non-governmental organization or an individual is bent on performing QSs coercively or without the patient's knowledge, it has absolutely no need for an FDA-supervised clinical trial of QS to carry out their illegal acts. Successful completion of a Phase III FDA-supervised clinical trial of QS can hardly increase or decrease the number of such illegal acts. Proponents of QS have devised very detailed procedures for informing potential patients of all the ins and outs and risks of QS. These procedures require that the patient sign a form signifying what they want and stating that they are fully aware of the risks and permanent nature of a QS. This is essential in a world full of individuals and organizations that oppose any and all means of contraception, and who might see lawsuits as potential weapons for reducing the frequency of QS - or abolishing QS.

Part [D-2] ~ Comparison of QS and its Alternatives ~ (Updated 7/6/11)

Most people don’t realize that various technologies that have been (and are being) developed for averting births (and enabling couples to control the number of children they have) also reduce the cost of averting a birth to a few dollars in developing world settings. (The cost was about $600 a decade or so ago.) This suggests that the dire poverty of the developing world could be eliminated for a small fraction of the cost of the development- and humanitarian aid that developed nations give to developing nations every year (roughly $60 billion/ year). So next time your congressman complains that he doesn’t see any benefits from development and humanitarian foreign aid, tell him to look in the mirror for the source of that problem. Despite that, foreign aid for family planning programs has been cut drastically in recent decades because (1) Much of the funding has been transferred to HIV/AIDS and (2) Family planning is too frequently, and erroneously, linked to abortion.

UN data (03U1) show that by far the most popular contraceptive is female sterilization. This is in spite of the fact that over half of the women in developing nations lack, physically and/or financially, access to female sterilization so they must often resort to often-dangerous illegal abortions. This perhaps explains why two of the four processes described below are processes for low-cost female sterilization.

Note that all four processes described below for better matching a family’s desired number of children to the actual number of children they have significantly reduces abortion rates and maternal death rates from illegal abortions. Despite this, those opposed to abortion tend to oppose most or all of the processes described below.

The QS Process: The cost of QS in the US would be the charge for two office visits plus the cost of the quinacrine pellets – $300-$400 (99L1). Another source (00M1) notes that the QS procedure costs about $2/ patient, and that it is so low-tech that it can be performed without anesthesia, by midwives or nurses. (This $2 figure probably pertains to QS procedures done in developing nations.) Laparoscopic sterilizations in the US can cost $3000 to $4000 (99L1). Another source indicates $2000 (00M1). Another source indicates $4,000 - $6,000 (03B2). Thus QS could offer an attractive alternative to poor women in the US. The cost issue is far more important in the developing world where the median wage is about $2/ day and a significant fraction of the population barely survives on $1/ day. In developing nations, the cost of a QS is about $5, while the cost of a surgical laparoscopic sterilization is $30-$50. In the poorest nations of the developing world surgical laparoscopic sterilizations tend to be simply not available (like most other surgeries). Lists of the 50 or so poorest nations tend to correlate well with lists of nations with the highest total fertility rates – typically 5-7 children per woman.

Surgery-free quinacrine sterilization has been done on several hundred thousand women with generally good results. Religious fundamentalists have, thus far, blocked large-scale use of quinacrine sterilization in South and Southeast Asia. They have also opposed the Essure process. (See below.) Millions of people have been exposed to doses of quinacrine far greater than what sterilization involves. Quinacrine sterilization would compete with the developing world’s version of the Essure process.

There is also the issue of time costs. Surgical sterilization requires some time to recover. For QS the recovery time is insignificant. Among the women interviewed in rural Vietnam who chose QS, most rode their bicycles home the day of the procedure, and were also able to attend to their children’s needs on the same day (00H1).

The Essure Process: In the developed world the cost of a surgery-free female sterilization via the "Essure" process is on the order of $500. This is too expensive for developing nations in most cases. However, one Essure retiree has pointed out that the cost of an Essure process could be reduced, in a developing world setting, to the cost of two mass-produced plugs for the fallopian tubes (a few cents) plus the cost of ten minutes in a trained nurse’s office.

A little math using the same UN data (03U1) as mentioned above shows that such a process would increase the "contraceptive prevalence" for modern contraceptives in developing nations to well above 70 percent. A prevalence of 70 percent or more produces population decline. This would eliminate the $1.4 trillion cost of infrastructure expansion in developing nations; eliminate their dire scarcity of financial capital and the countless other problems that result from financial capital scarcity. It would also bring populations down closer to the earth’s carrying capacity. All this would enable developing nations to move closer toward developed nation status, as has been demonstrated by the eight nations mentioned above.

The Mass-Media Approach: The third low-cost technology for averting births is a mass media (radio and/or TV) approach that is also applicable to dealing with numerous other issues that degrade the quality of life in developing nations. Examples include adult- and female education, the rights of women to control their sex lives, benefits of smaller families, wider spacing between births, and other social issues that effectively, though indirectly, influence population growth.

These mass media approached weave their social messages into what are called "Social Content Serial Dramas" a.k.a. "soap operas" or, in Latin America, "telenovelas." In one study the cost of selling family planning was found to be 80 US cents per new adapter. This probably translates to a cost of less than $10 per birth averted. TV-Globo's "telenovelas" have been found to be the principle force driving Brazil's total fertility rate down from 3.4 children per woman in 1989 to 2.3 in 1996.

The leading, and most sophisticated, creator of social content serial dramas has been the Population Media Center (PMC). Its results have been attracting funding from large foundations and even from developing nation governments. PMC is active in dozens of developing nations, and is expanding to many more.

Misoprostol: The fourth low-cost technology for averting births is the drug Misoprostol. It is often taken together with Mifepristone (RU-486) to cause abortions. Misoprostol can also be used by itself to cause abortions. Women wanting an abortion take the pills and go to a hospital where a nurse performs vacuum aspiration to complete the abortion. Used by itself Misoprostol has a success rate of about 85 - 90%. This is adequate for developing nations where other abortion alternatives are worse or too expensive. It is approved as a treatment for stomach ulcers and other medical problems in most countries. Misoprostol has been shown to prevent excessive bleeding after childbirth. That bleeding is the leading cause of maternal death in the developing world. The WHO has added misoprostol to its core list of essential medicines for preventing postpartum hemorrhage. Misoprostol’s big advantage in developing nations is its low cost – a few cents in India or Mozambique for example. Also Misoprostol cannot be outlawed because of the other medical uses for it. It is usually available over-the-counter at drug stores. It has the advantage over its alternative oxytocin in that oxytocin is given as a shot, and it requires refrigeration. (Also see http://en.wikipedia.org/wiki/Misoprostol) Some data here are from IPPF/WHR. Other data are from an article by Melissa Block in a 6/29/11 article in National Public Radio.

Part [D-3] ~ Misuse of QS ~
In 1993 a positive article about Vietnam's quinacrine program appeared in the prominent British journal, the Lancet. Western reproductive health experts were surprised and alarmed by its scale - nearly 32,000 women. Tens of thousands more women had been sterilized in Malaysia, India, India, Bangladesh, Costa Rica, Croatia, Egypt, Indonesia, Iran, Pakistan and Venezuela (00M1). The Vietnamese study declared that the quinacrine program was "safe and acceptably effective" and had averted an anticipated 242 pregnancy-related deaths. However Vietnamese government officials later acknowledged that the program grew so fast that training of sterilization workers often was inadequate. These officials also admitted that supervision was minimal. Even worse, Vietnamese news media reported that 107 rubber plantation workers who went for a routine gynecological exam said they were sterilized without their consent. Vietnamese government officials denied that charge. Despite that denial, Vietnam's quinacrine program was suspended in 1993 as a result of pressures from the WHO (00M1). (Note however that strong Vatican influences in the WHO date back to 1950, so the objectivity of WHO pressures is questionable at best. (See Section (B-2))

In February of 1994, a family planning expert, Donald Collins, led a group of 14 family planning experts to Vietnam to study the QS program (04C1). At that time, more than 50,000 Vietnamese women had accepted QS voluntarily. No deaths or life-threatening complications were reported. Quinacrine sterilizations were offered in clinical settings all over Vietnam. Women were offered a choice between QS and surgical contraception, and both choices were offered free of charge. Even under those conditions, Vietnamese women choose QS over surgical contraception by a ratio of 11 to 1 (04C1). The cost of QS was low, something that a poor nation like Vietnam could afford, and which its women (many of which were interviewed personally by Collins' group) desperately needed. In December of 2003, the Vietnamese government received a letter from the WHO stating: "WHO experts and FDA officials have said that they would be surprised if quinacrine did not turn out to be carcinogenic." This surmise appears to have little or no basis (See Part (A-3)). Further, there was a threat to cut off Vietnam's financial aid from several international aid agencies if the highly successful QS program was continued (04C1).

Remember that, in the mid-1990s, the Vatican succeeded in having appointed as director of WHO's Human Reproduction Program (HRP) a professor from a Catholic University in Rome, Dr. Giuseppe Benagiano, the son of Pope John Paul II's dentist. Upon his appointment, Benagiano promptly set out to kill any further clinical studies of QS (Ref. 305 of Ref. (96M1)). The Vietnamese QS program was apparently one of those programs caught in the WHO's HPR's crosshairs. Under the threat of a financial aid cutoff, the Vietnamese Ministry of Health decided not to resume its popular QS program. As a result, a principal method of birth control became abortion. Despite this, Vietnam still managed to achieve a total fertility rate of 2.3 children per woman, but to achieve this goal Vietnam had to resort to an abortion rate 3.5 times that in the US (04C1). Other nations caught in the crosshairs of the WHO's HPR's efforts against QS and other contraceptive methods included China, India, Indonesia, and several Latin American countries. These efforts by the HPR would, over time, cost the lives of more than 40,000 Vietnamese women and over 115,000 Indonesian women (04C1). By February of 1994 the Vietnamese Ministry of Health found that the HPR's suggestion of suspicions that quinacrine might be carcinogenic (See above) could not be substantiated (04C1). Benagiano also undertook a major effort to keep a highly favorable collection of 25 QS studies from 14 countries covering more than 40,000 QS users from reaching the November 1994 meeting of the International Federation of Gynecology and Obstetrics World Congress in Santiago Chile. His effort failed (04C1). Knowledgeable officials from the International Planned Parenthood Federation, and the Population Council, told the Collins group that the WHO's HRP attacks on new family planning advances had been ongoing for decades (04C1).

In India there were also disputed reports of coercive sterilizations. As a result, women's-health advocates succeeded in getting QS banned in 1998 (00M1). Also in 1998 Chile banned QS shortly after a Wall Street Journal account of ethical breaches in various countries. Stephen Mumford called the account "horribly dishonest," but the Journal stands by its account (00M1).

It is interesting to note that, in every case of breach of ethics that have been bought to public attention, regardless of the truth of the charges, the net effect of the alleged breach of ethics was the exact opposite of what the initial intent was (assuming all breaches of ethics were deliberate as charged). This result, plus the risk of extremely expensive lawsuits, suggests that the frequency of deliberate breaches of ethics is likely to diminish with the passage of time. Over the past decade or more, practitioners of QS have been developing increasingly elaborate consent forms and procedures for their patients to sign as a means of reducing the risk that QS will be banned, or the risk that they will be drawn into expensive lawsuits. However there still remain organizations that are opposed to contraception of any kind. These entities are likely to grow increasingly alarmed by future successes of QS procedures. As a result, they are likely to work harder to develop strategies for bringing false charges at every opportunity as a means of eliminating their worst nightmare - inexpensive sterilizations that even the poorest and least technologically advanced of developing world folk can afford.

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Part [D-4] ~ The Link Between Clinical Testing of QS and Misuse of QS ~
Opponents of QS argue that the potential for abuse of QS is simply too overwhelming to allow its use (See References 8-10 of Ref. (03B1)). Since FDA clinical tests of QS would probably lead to FDA approval of QS, and since this approval would probably lead to widespread (and worldwide) use of QS, one might argue that there should be no FDA clinical tests of QS (03B1). This logic needs closer examination.

There have been forced sterilizations in the past, invariably by governments attempting to avoid the social, economic, political and military instabilities, wretchedness, and hope-deprivation that rapid population growth and over-population tend to produce (08S1). These efforts have almost invariably backfired and produced results that were the opposite of the intended results. For this reason, it seems likely that widespread forced sterilizations are a problem that will end up fixing itself if it has not done so already. But more to the point, a government intent on administering a program of forced sterilizations does not need (nor would it in any way benefit from) FDA Phase III clinical trials of QS to carry out its clandestine program. There is therefore no logical linkage between FDA trials of, or FDA approval of, QS procedures and the frequency of government-sponsored sterilization programs.

There may also have been instances of QS being used to perform female sterilizations under the guise of performing a routing gynecological examination. Such a procedure might be motivated by a desire to sterilize a woman who is mentally retarded and who therefore is unable to control her sexual activities and unable to care for the resultant children. But here again, an individual or organization intent on administering a sterilization under false pretenses does not need (nor would they in any way benefit from) FDA Phase III clinical trials of QS to carry out such a sterilization. There is therefore no logical linkage between FDA trials of, or FDA approval of, QS procedures and the frequency of such clandestine sterilizations. Also, it would be virtually impossible for anyone to get away with such a procedure. Guilt is easy to prove, and lawsuits and/or jail terms are a virtually assured outcome of attempting such a procedure.

Part [D-5] ~ Failure Rates of Quinacrine Sterilization ~
Newer protocols for QS show a pregnancy rate of about 2 per 100 women after two years of use, which is about twice that of surgical sterilization (99L1). However the risk of ectopic pregnancy following failures of surgical sterilization is much higher than for QS. Using older QS data with a higher failure rate than the present, the QS risk of ectopic pregnancy in Vietnam per 1000 woman-years was found to be the same as that of surgical sterilization in the US: 0.89 vs. 0.7-0.8 respectively (99L1). In a review of the development and use of QS it was concluded that the prospects for improved efficacy (effectiveness) of QS to the point of matching the pregnancy rate of surgical sterilization appear likely (03Z1). Many clinicians now have failure (pregnancy) rates that approximate those of surgical sterilization. (See www.crinacrine.com) and some report zero rates of pregnancy (03B2). As experience is gained, the failure rate of QS can reasonably be expected to decline.

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The following table is useful in quantifying the first-order benefits that might reasonably be expected from the successful completion of an FDA Phase III clinical trial of QS and the resultant global-scale acceptance of the QS procedure.

Table E-1 ~ Global-Scale Maternity-Related Data for the Year 2000 (02D1)


Developing World

Developed World


Women Aged 15-44 (thousands)




Pregnancies (thousands)




Unintended Pregnancies (thousands)




Births (thousands)




Unintended Births (thousands)




Abortions (thousands)




Maternal abortion-related deaths




Maternal Deaths




Deaths due to Unintended Pregnancies




Note: Ref. (02D1) breaks the developing world data above down into 4 regions, and breaks the developed world down into 3 regions. That data is further broken down into national data. It does this for each of the 6 years 1995 through 2000. These more detailed data are not needed here.

Using estimates given in Ref. (06I1) and the data in Table E-1, successful completion of a FDA Phase III clinical trial would be expected to:

One major effect of 6.2 million fewer births in the developing world would be a savings in infrastructure costs to developing nations of about $101 billion/ year ($16,400/ averted birth). This is based on an analysis by economist Lester Thurow (95C1) that found that each 1% growth in population requires a capital investment of 12.5% of a nation's GNP (GDP) in infrastructure (educational-, industrial-, commercial-, and transportation- infrastructure, plus housing, land development, utilities etc.).) These savings would come largely in the form of reductions in unmet needs for new infrastructure, plus reduced wretchedness, hopelessness, warfare, terrorism, religious fundamentalism, and environmental degradation. The developing world's desperate shortage of financial capital would be reduced; the safety of financial capital, and what it is invested in would be enhanced, and the supply and productivity of human capital would increase. These are all vital steps in the progression from developing world status to developed world status. Only eight nations have made the transition from developing nation status to (or near to) developed world status in the past 100 years. All of these transitions occurred during periods of active family planning programs. These second order effects could produce a spiral of benefits that, in total, would greatly exceed the first-order benefits noted in the three bulleted statements shown above.

An example of second-order effects comes from a study by Population Action International (04P1) that has made the relationship between population growth rate and the probability of civil conflict fairly quantitative. The results of their study are summarized in Table E-2 below.

Table E-2 - Effect of population growth rate on probability of civil conflict (04P1)

Births per 1000 per year






Probability of Conflict*






*Likelihood of an outbreak of a civil conflict in a given decade

Even QS in the US could also provide significant benefits to the nation's poor women. About 76% of pregnancies to poor women in the US are unintended (95G1). The Title X program (the federal program that provides family planning to poor women in the US) has seen its funding drop (in inflation-corrected terms) by 55% during the period 1980-2000 (01D2). This was in spite of the fact that every public (Title X) dollar spent for family planning services saves $4.40 - over $3 in medical costs alone -that otherwise would be spent over the next two years to provide medical care, welfare benefits and other social services to poor pregnant women (99A2). Further benefits would result from reducing the poverty caused by families having more children than they can afford, reduced crime rates, and similar benefits. A 90% reduction in the cost of female sterilization would make badly stretched Title X funding go farther.

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Joel E. Cohen, How Many People Can the Earth Support? W.W. Norton., New York (1995).
95F1 Family Health International, "FHI Quinacrine Studies," Contraceptive Update (1995) 16:27.
Alan Guttmacher Institute, "The Cairo Consensus: Challenges For US Policy at Home and Abroad" (1995).

96K1 E. Kessel. Newsletter report of the 11th Indian Conference on Family Welfare and Voluntary Sterilization and Family Welfare of India (10/30/96) p. 2.
Stephen D. Mumford, "The Life and Death of NSSM 200", Center for Research on Population and Security. P.O. Box 13067, Research Triangle Park NC 27709; 919-933-7491 (1996) http://www.kzpg.com/Lib/Pages/Books/NSSM-200/index.html.
96S1 A. Suhadi, A. Soejoenoes, "One year experience using quinacrine pellets for non-surgical female sterilization," Indonesian Journal of Obstetrics and Gynaecology 20 (1996) pp. 39-43.

97P1 David Poindexter, "Population Realities and Economic Growth," Population Press, 4(2) (November /December 1997). http://www.popco.org/irc/essays/essay-poindexter.html.

98M1 Stephen D. Mumford, "A response to Alix Freedman's Wall Street Journal article on QS," Downloaded from http://www.quinacrine.com/news6.htm#n1962 (October 16, 1998).

99A2 Alan Guttmacher Institute report of January, 1999.
99L1 Jack Lippes, "Quinacrine Sterilization (QS) Safety and Efficacy," a workshop presentation at the American Public Health Association Annual Meeting in Chicago, IL, on 11/8/99.

00H1 Mildred Hanson, MD, "Why US Women Deserve QS as an Option," An article published in the Quinacrine Newsletter in 2000.
Krishna Jaffa, "QS:  The Indian Experience," Published in the Quinacrine Newsletter (2000).
Marie McCullough, "Non-Surgical Sterilization: Miracle or Menace?" Buffalo News (3/7/00).
00S1 D.C. Sokol, A. Dabancens, R. Guzman-Serani, "Cancer risk among women sterilized with transcervical quinacrine in Chile: update through 1996," Fertil Steril 74 (2000) pp. 169-171.

01D2 Cynthia Dailard, "Challenges Facing Family Planning Clinics and Title X", The Guttmacher Report on Public Policy (April 2001).

02D1 "Promises to keep: The Toll of Unintended Pregnancies on Women's Lives in the Developing World," Global Health Council, 1701 K Street, Suite 600, Washington, DC (20006), 202-833-5900, www.globalhealth.org (2002) Authors: Nils Daulaire, M.D., M.P.H., Pat Leidl, M.A., Laura Stark, M.Sc. Ph.D. et al http://www.globalhealth.org/assets/publications/PromisesToKeep.pdf
02L1 Jack Lippes, "Quinacrine Sterilization: the imperative need for American clinical trials," Fertility and Sterility 77(6) (June 2002) pp. 1106-1109.

03B1 S. Bhattacharyya, "Quinacrine sterilization (QS): the ethical issues," International Journal of Gynecology and Obstetrics 83 Suppl. 2 (2003) pp. S13-S21.
03B2 Mandeep Brar, Ida Campagna et al, "Quinacrine Sterilization," a presentation at the triennial FOGO meeting in Santiago Chile (11/4/03).
03U1 United Nations, "World Contraceptive Use 2003," United Nations Population Division, Department of Economic Affairs.
03Z1 J. Zipper and E. Kessel, "Quinacrine sterilization: a retrospective," International Journal of Gynecology and Obstetrics, 83 Suppliment 2 (2003) pp. S7-S11.

04C1 Donald Collins, "WHO creates demand for more abortions," Pittsburgh Tribune Review (1/28/04).
04P1 Population Action International, "How Demographic Transition Reduces Countries' Vulnerability to Civil Conflict" in PAI's publication The Security Demographic: Population and Civil Conflict After the Cold War (2/11/04). http://www.populationaction.org/resources/factsheets/factsheet_23_securityDemog.html.

05U1 United Nations Department of Economic & Social Affairs, World Contraceptive Use 2005," (2005) http://www.un.org/esa/population/publications/contraceptive2005/2005_World_Contraceptive_files/WallChart_WCU2005.pdf (Last visited 5/19/09).

06B1 Dr. Tim Black, Chief Executive of Marie Stopes International, in a personal communication to this author of 11/23/06.
06I1 International Service Assistance Fund, press release of 6/22/06. (Contact ISAF at 919-990-9099 or visit www.quinacrine.com)
06K2 June Kronholz, John Lyons, "Smaller Families in Mexico May Stir U.S. Job Market," Wall Street Journal (4/28/06) p. A1.
06U1 (Unknown) "Abortion: Traditional Methods," Lancet (a UK medical journal) (11/25/06).

08S1 Bruce Sundquist, "Could Family Planning Cure Terrorism?" Edition 7 (September 2008) 

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