A method of sterilizing women by burning their fallopian tubes and upper uterus with acid is the latest procedure to find favor with certain prominent worldwide population control advocates.
The procedure, called quinacrine sterilization, uses a modified intrauterine device (IUD) applicator to introduce quinacrine pellets to within about .5 centimeters of the top, or fundus, of the uterus. There they dissolve, filling the upper womb and the nearby fallopian tubes with quinacrine hydrochloride, a strong acid. The resulting chemical burns, particularly to the sensitive fallopian tissues, are intended to provoke the growth of scar tissue thus blocking the tubes and preventing conception.
The data about quinacrine’s safety are limited and contradictory. Some very basic questions — such as whether it might cause cancer — remain unanswered. Yet quinacrine’s proponents appear unconcerned about its possible adverse health consequences, preferring to focus their research on the so-called practicalities of the procedure (dosage, introduction method and time frame) while accelerating their effort to sterilize as many women in the developing world as possible. Unless responsible parties in the United States and other countries begin to take a more active role in the regulation of this drug, it seems likely that ever greater numbers of women will be harmed by it.
Although chemical sterilization is an idea with ancient roots, the first modern research took place in Germany in the 1920’s, where scientists began investigating the use of carbon dioxide as a sterilization tool. The method, while faster and easier than surgical procedures, killed too many patients.1 Then, as now, the desire was to find a quick, cheap and widely available means of eliminating female fertility.
The search was abandoned in the years after the war but resumed in the 1920’s. Dr. Jaime Zipper, the inventor of the Copper T IUD, developed a procedure to flood the uterus with a “quinacrine slurry.” His experiments were unsuccessful because the drug leaked from the uterus into the body cavity often. On occasion it even entered the bloodstream, allegedly causing at least three deaths.2
Zipper then turned to a hard pellet form of the drug which contained less of the compound and could be placed with greater accuracy near the fallopian tissues. Zipper’s experience with applicators enabled him to modify them to deliver quinacrine tablets to within a few millimeters of where they would do the most harm. This, with adjustments, has been the basic technique ever since.
What quinacrine does
Once quinacrine tablets are placed near a woman’s fallopian tubes and begin to dissolve into quinacrine hydrochloride, her tissue begins to undergo severe chemical damage.
In a 1995 study researchers inserted quinacrine tablets into 33 Indian women who were awaiting hysterectomy for other causes. Ten received 252 milligrams of quinacrine (7 pellets, the standard dose) and 23 others received 324 milligrams (9 pellets). Researchers examined the uteri and fallopian tubes of the women following removal and described the varying degrees of damage they found. The result was a four-stage classification scheme ranging from patent (no damage) (stage 0) to complete tubal occlusion (stage III).
Their descriptions of the damage read like a diagnosis of severe illness, made all the more bizarre because this damage was intentionally inflicted.
In stage I, the “stage of acute inflammation,” the researchers described, “damage to epithelium, with slight or no decrease in lumen. Acute inflammatory change in laminia .… often with hemorrhage .… Areas of necrosis as result of tissue damage. Heavy infiltration of submucosa and muscle by neutrophils, lymphocytes and plasma cells with vascular congestion and vasodilation.”3
Stage II was characterized by “chronic inflammation,” the researchers found, “with chronic inflammatory cellular infiltrate in lamnia propria, submucosa and inner muscle coat…”
Stage III the “stage of fibrosis and tubal occlusion,” was marked by “complete loss of mucosal lining with an absence of lumen [as well as]… marked fibrosis of inner muscle coat.”
It is interesting to note, however, that even after all this damage had been done, a few of the fallopian tubes began showing signs of reconstituting themselves. “Some stage III tubes showed a process of recanalization … however the lumen is neither lined with normal epithelium, nor continuous with the lumen in the rest of the tube of this series.”4
None of the women who received the standard quinacrine dose exhibited precisely the same stage of post-insertion damage in the same time frame. The researchers concluded that higher dosages might have to be used.
Safe and effective?
The finding that fallopian tubes scar at different rates has further inflamed the ongoing debate within the population control movement itself about the merits of this method. Marge Berer, writing in Reproductive Health Matters, questions whether it is worth pursuing at all:
Quinacrine is intended to achieve a sterilization. There is no inexpensive or non-invasive means of checking at follow-up whether it has worked — only a subsequent pregnancy would indicate failure. Ectopic pregnancy is life-threatening and a major cause of maternal mortality, so any increased risk of ectopic pregnancy is important. It might be higher if women did not return for a recommended second insertion and/or the method occluded the tubes partially but not completely enough to prevent fertilization.5
Available studies lend credence to Berer’s concerns. Studies of quinacrine sterilization in Chile, where two insertions of quinacrine were used, found a cumulative failure rate of 3.4 % among women over 35, and therefore less fertile. The failure rate among women under 35 was 8.7% at five years and 11.6 percent at 10 years. This compares unfavorably with surgical sterilization, which has consistently lower failure rates. The largest quinacrine study ever conducted, which involved almost 32,000 women in Vietnam, revealed a failure rate of 4.31% after 24 months.6
Quinacrine enthusiasts counter that improved data on dosage, delivery technique, optimum timing and possible use of additional drugs will bring the failure rate down. But every modification adopted to gain a greater chance of sterilization also tends to reduce quinacrine’s overall usefulness. For example, the use of specially trained technicians may increase the sterilization rate, but then what of quinacrine’s ease of application, so often touted by proponents? If paramedical staff cannot perform the procedure without special training, then one of quinacrine’s major “advantages” is lost.
Other problems abound. Studies have found that some women bleed profusely merely from having the quinacrine hydrochloride applied, flushing out the acid and thus making it unlikely that the requisite damage to their tubes will be done. Unsuccessful attempts at quinacrine sterilization are not evident, as Berer pointed out, until a woman becomes pregnant, with the increased risk of ectopic pregnancy that entails.
Then there is the concern that quinacrine is a carcinogen. A study of just over 800 women in Chile who had undergone quinacrine hydrochloride sterilization between 1977 and 1989 revealed an elevated incidence of cancer among women who were 40 years or older when they accepted quinacrine sterilization.
Women sterilized with quinacrine between the ages of 40–44 had a cancer rate that was almost double that expected, while women sterilized between the ages of 45–49 years had more than double the expected rate.7
A second Chilean study also yielded an increased incidence of cervical cancer, but the researchers, including Jaime Zipper, declared the increase to be “not significantly different” than that of the general population. Clearly more research needs to be done.
Dr. Ralph Heywood, a British toxicologist who has three decades of experience in assessing fertility control methods, has voiced other concerns about quinacrine and DNA:
Given the prevalence and range of cancers, tumors, sexually transmitted diseases and other injection in the upper reproductive tract in women,” [how quinacrine might impact DNA is important.] “It is concluded that the pre-clinical package of data is inadequate at this time to make a proper risk assessment. It is my position that studies in women should not be conducted until a risk-benefit assessment has been made.”8
If quinacrine is not only a suspected carcinogen but is unreliable to boot, why push it so hard? Quinacrine supporters speak of a vast and pressing need among women in the developing world for a safe means of preventing pregnancy as the primary reason.
Dr. Stephen Mumford, who is president of the Center for Research on Population and Security, is perhaps quinacrine’s foremost proponent. Mumford often cites concerns over maternal health as the reason for his interest in quinacrine, although he has frequently voiced other concerns (see sidebar on page 11).
“It would be tragic to see [opponents of quinacrine] win out,” Mumford said, “for the women around the world who die of unintended pregnancy, quinacrine offers their only hope.”9
But quinacrine opponents counter that Mumford’s approach is predicated on an unacceptable double standard for women’s health care. A woman facing a difficult pregnancy in a developed country is given medical care to help her reduce the risk; a woman in a developing country is told to burn her womb with acid to avoid that risk. Berer carries the question to its logical end:
According to the logic [that risks to maternal health justify quinacrine distribution] everyone should be sterilized so that there would be no risk of maternal deaths at all.
Even in [its] own terms, however, [this] argument is scientifically flawed. The fact is that women at risk of a maternal death are a much bigger group than those who do not want to be pregnant and who do want to be sterilized. The risks and benefits of a sterilization method should be compared with those of other sterilization methods, not with the risks of maternity. There are alternatives to pregnancy besides quinacrine sterilization, even where the skills to surgical sterilization are lacking .… The fact is, on the basis of what is currently known about it, quinacrine sterilization would not be approved and could not be provided in any country with well functioning drug regulatory mechanisms. And it is only in the poorest of rural and urban areas of certain developing countries, where women do not have access to the information that would allow them to make an informed choice, that quinacrine sterilization is being provided.10
Dr. Amy Pollack, president of the Association for Voluntary Surgical Contraception, a population control organization, also refutes Mumford’s claims: “What kills women in childbirth is horrible obstetrical services, totally inadequate services that exist around the world. Not only are they bad services, but they’re services provided for women who want to have children, and those women are not going to choose sterilization. So women who don’t choose sterilization and choose to get pregnant are not going to be saved by quinacrine. The numbers that are presented to us don’t take that into account at all.”11
If Mumford’s concern about maternal health is bogus, then why is he and others pushing this acid so hard around the world? Many suspect that a fear of population growth in the developing world, far more than a concern for women’s health, guides the quinacrine effort. This interpretation is supported by the coercion and dissembling that has surrounded quinacrine trials to date.
The largest clinical trial of the drug has taken place in Vietnam — a nation governed by a one-party dictatorship which is currently making a concerted push to lower the birth rate.12 Did Vietnamese women participate voluntarily in clinical trials, or were they coerced? There are allegations, made in a Vietnamese language publication called The Woman, that at least 100 of the participants in the Vietnamese study had quinacrine inserted without their knowledge during pelvic examinations.13 Faced with these and many other charges this study was suddenly halted in 1993.
There are also credible reports that ever-growing numbers of women are being sterilized without any standard drug trial protocol at all.
In Pakistan, for example, a Dr. Altaf Bashir of the Mother and Child Welfare Association in Faisalabad has reported sterilizing women with quinacrine at the rate of 100 a month.14 Most of the women were found in “street camps” or were otherwise tracked down and “motivated” by Bashir’s staff.
Because so many women did not return to the clinics for the second insertion of the drug Bashir took up a single insertion approach, even though much of the available research so far argues against a single insertion being sufficient to cause complete sterility. An independent nurse practitioner who observed Bashir’s work had this to say about it:
Some patients are recruited at ‘street camps’ and given little information or time to fully understand and think about the implications of this type of procedure. Patients receiving treatment at regular clinic facilities receive a bit more information, but are not informed that this method has not been formally sanctioned for use in Pakistan. Insertions are primarily conducted by lady health workers (not doctors) with limited clinical skills necessary to rule out any underlying pathology. Essentially no follow up of these patients is conducted. The patient is told to ‘return if she has any problems.’ Those that don’t return are assumed to have no problems, no pregnancies, etc. There is no mechanism established for follow up of these patients.15
Another critic wrote: ‘“Dr. Bashir claimed that she has a very low failure rate with the method but she never seemed to see the women again to confirm this, except for those who returned one month after the insertion. Dr. Bashir claimed that the women don’t return because they have no problems. But in this part of the world it is much more likely that woman who has experienced problems would simply not be permitted by her family to return to the same clinic, precisely because she had problems…”
Concerns increase as well when it becomes clear who directs and funds quinacrine’s distribution.
As part of its investigation into the use of human subjects in contraceptive research, the British Broadcasting Company’s Horizon series found links between the Leland Fikes Foundation, a private American group, Stephen Mumord’s quinacrine effort,16 and the Federation for American Immigration Reform, an organization known to be strongly anti-immigrant.
It is also known that Family Health International, an organization founded by Mumford’s friend, Dr. Elton Kessel, is directly involved in supplying quinacrine to India,17 where an estimated 10,000 women have been sterilized.
Mumford and Kessel reportedly direct much of the campaign out of Mumford’s basement in Chapel Hill, North Carolina.18 Further, Family Health International is the organization which was in charge of at least one trial of Norplant in Haiti from which observers in Haiti reported horrific instances of brutality.19
The weight of the evidence leads observers to strongly doubt if improving women’s health is the primary motivating factor behind the worldwide quinacrine effort and to question whether racial fears and prejudice might play more of a role. But no matter what the motivations, in the absence of some concerted international effort, it seems likely that the push to advance quinacrine use will likely continue unabated.
1 Robert Proctor, Racial Hygiene: Medicine under the Nazis (Cambridge, Mass., 1988), as quoted in “Phantom Sterilizations: The Quinacrine Story,” Baobab Press, Vol. 3:23 found at http://www.africa2000.com/BNDX/BAO323.htm.
2 Charles S. Carigan, et al, “The Quinacrine method of nonsurgical sterilization: report of an experts meeting,” AVSC Working Paper, July 1994.
3 RN Merchant et al. “Clinicopathologic study of fallopian tube closure after single transcerivcal insertion of quinacrine,” International Journal of Fertility and Menopausal Studies, Vol. 4-: 1: 47–54.
5 Marge Berer, “The quinacrine controversy, one year on,” Reproductive Health Matters, November 1994.
6 Cheri Pies, et al., “Quinacrine Pellets: an examination of non-surgical sterilization,” International Family Planning Perspectives, Volume 20, Number 4, December 1994.
7 David Sokal, et al., “Cancer risk among women sterilized with transcervical quinacrine hydrochloride pellets, 1977–1991,” Fertility and Sterility, Vol. 64:2, August 1995.
8 Berer, ibid.
9 John Consiglio, “Risks and rewards: family planners weigh quinacrine,” Family Planning World, January/February 1994, p. 20.
10 Berer, ibid.
11 Amy Pollack, quoted in The Human Laboratory, a videotape produced by the British Broadcasting Service under the Horizon series and aired on 8 November 1995.
12 MT Feuerstein, “Family planning in Vietnam: a vigorous approach,” World Population Studies, Vol. 47: 1, p. 36.
13 Consiglio, op. cit.
14 Berer, op. cit.
15 Berer, op. cit.
16 The Human Laboratory, op. cit.
17 Berer, op. cit
18 The Human Laboratory, op. cit.