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~ TABLE OF CONTENTS: ~

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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.

~ INTRODUCTION ~
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 1/50^th 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 ~

• More than 100,000,000 people in the world have taken quinacrine over the past 5 decades to prevent, or treat, malaria (99L1). This number includes children and pregnant women (99L1). After 50 years of follow-up, no clusters of cancer have been reported. No abnormalities of newborns have been observed (99L1). (Quinacrine was first synthesized in the 1920s (00M1).)
• Quinacrine is the only FDA-approved drug for giardia, caused by an intestinal parasite (00M1). Currently, quinacrine is also used to treat rheumatoid arthritis, lupus, tapeworm, and amebiasis infections (02L1).
• During World War II, 3,000,000 American soldiers took this drug daily while serving in the South Pacific. Fifty-four years later no Veterans Administration Hospital has reported any long-term serious side effects or any increase in cancer among the personnel (02L1) (99L1) as compared with those who served in Europe and did not take quinacrine. This vast amount of experience indicates that ingesting quinacrine on a daily basis for long periods of time has minimal toxicity. There are very few drugs that have been used so extensively for so long a time, studied so thoroughly, and whose safety remains unquestioned (99L1).
• When quinacrine is inserted into the uterus it is absorbed rapidly into the blood stream - just as it is when it is taken orally. Based on plasma-levels after transcervical insertion, quinacrine levels fall rapidly after 3 hours. In the prevention of malaria and the treatment of lupus, 100 mg. of quinacrine is the prescribed daily dose, meaning a yearly dose of 36,500 mg. When quinacrine is used in female contraception, two doses of 252 mg. each are prescribed a month apart for a total dose of 504 mg. Such doses are miniscule relative to the doses prescribed for malaria and lupus. Repeated daily doses are also necessary for treatment of malaria and giardiasis, and these doses produce far higher tissue concentrations than the one or two doses required for a QS (99L1).

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.

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 1/50^th 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:

• The complications characteristic of any general anesthesia (99L1). (Tubal ligation is considered to be unsuitable for women with any health problem that makes anesthesia dangerous (00M1).)
• The needle used in laparoscopy can perforate a blood vessel resulting in a huge quantity of carbon dioxide being injected into the bloodstream, creating a gas embolism. A gas embolism can also occur if the abdomen is over-distended with carbon dioxide (99L1).
• The sharp tool used for making the 4-5 mm. incision can puncture the bowel, requiring a bowel resection (99L1).
• The cauterization used in laparoscopic sterilization may also burn the bowel. Some days later that burned area ruptures and the intestinal contents spill into the peritoneal cavity, requiring a bowel resection and the management of a severe peritonitis (99L1).
• In a hospital environment the more antibiotic resistant strains of bacteria reside (00H1).
• Deaths due to perforation of a large blood vessel are rare in the US because of the availability of a vascular surgeon in the institutions performing laparoscopic sterilization.  But in developing countries vascular injuries may be lethal (00H1).  

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)