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Date: Mon, 23 Nov 1998 03:05:56 +1100
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To: PROGRESSIVE POPULATION NETWORK <ppn@csf.colorado.edu>
Subject: more on quinacrine
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SURREPTITIOUS STERLIZATIONS: AN ENDANGERING PROCESS
  O tempora! O mores! This cri de coeur will perhaps be evoked in
those reading the spate of reports lately, on surreptitious "trials"
on the non-surgical sterilization of women with quinacrine, being
carried out by NGOs and private doctors in a host of places in the
country. Many aspects of our socio-economy have come together in this
scandalous "trial" of contraceptives now coming into India. These
include the invidious nature of the efforts of international financial
institutions to undermine the institution of the state in Third World
countries indebted to them, the hypocrisy of the neo-liberal discourse
on rights and the international euphoria on reproductive health as the
solution to the health problems of women, accompanying the sustained
propaganda, over the years, that population growth lies at the heart
of all social problems in these countries.

A Legacy from the Past
Non-surgical sterilization of this sort has a tragic and indeed brutal
history. Ridding ourselves of euphemisms, this is nothing but chemical
sterilization pioneered in the Nazi concentration camps. The victims
in that grand design were jews, gypsies, communists and the
eugenically unfit. Now the victims, subject to these covert "trials",
are poor Third World women, as the Neo-Malthusian chicken comes home
to roost. Worldwide, the "trials" have been conducted in 15 countries
including Chile, Indonesia and Vietnam. Currently all countries in
South Asia are sites of this scandal.

Quinacrine over the Years
Quinacrine, a synthetic anti-malarial, was used in the treatment of
malaria during the thirties and forties, till it was replaced by
better drugs such as chloroquine. Current interest in the drug stems
from its novel use discovered about two decades ago. But issues of
safety, efficacy and ethics have since trailed the "trails" around the
globe.
The method was developed in Chile by Dr. Jaime Zipper in the
seventies. Dr. Zipper had earlier experimented with chemicals like
formaldehyde and sulphuric acid to block the fallopian tubes of
laboratory animals. Assisted soon by two American doctors, Dr. Elton
Kessel and Dr. Steven Mumford, who were to become the lions of the
quinacrine sterilization movement, Dr. Zipper, over the next decade
and a half, tried out quinacrine sterilization in three public
hospitals involving more than a thousand women.

Methods of Applications
The procedure involves the trans-cervical introduction of pellets of
quinacrine into the fundus of the uterus in the early proliferative
phase of the menstrual cycle, using a modified copper T IUD inserter.
While various schedules have been tried out, the most common involves
the insertion of seven pellets of 36 milligrams of quinacrine
performed either once or twice. The insertion of quinacrine into the
fundus of the uterus is followed by local inflammation. The scar
tissue that follows the inflammation leads to tubal occlusion and
hence irreversible sterilization.

Inherent Risks
The quinacrine insertions do not require anaesthesia or trained
personnel and can be performed in areas with no access to health
facilities. While these are held out as some of its operational
advantages, given the nature of family planning programmes and the
poor development of public health infrastructure in these countries,
it is precisely these features which endow the method with an
extremely high potential for abuse as indeed is obvious from the
conduct of the "trials" in India.

Global Trials
In Vietnam, more than 31,000 women underwent quinacrine sterilization
between 1989 and 1993. The Ministry of Health subsequently called off
the trials following the WHO’s recommendations. A retrospective study
of more than 1600 of the women was carried out in 1994. The findings
of this study, however, has not yet been published.

In June 1994, the WHO ‘Consultation on Female Sterilization Methods’
called for the conduct of four pre-clinical toxicology studies on
quinacrine before approval of the drug for clinical testing on women.

It categorically stated that human clinical trials should be stopped
forthwith pending the outcome of these toxicology studies.
Family Health International, an NGO in the United States, which had
earlier assisted Dr. Zipper in his studies and had been involved with
equally questionable trials with Norplant in Bangladesh, decided to
carry out these studies with financial assistance from USAID. The
rationale adduced was that a safe and non-surgical method of
sterilization would be cheaper than surgical methods of sterilization.

The September 1995 issue of FHI’s newsletter Network reported that
three out of four studies on quinacrine were positive, that is to say
that quinacrine was mutagenic. Mutagenicity, the capacity to induce
changes in cells, is indicative of possible carcinogenicity or cancer
causation. While not all mutagenic substances are carcinogenic,
laboratory studies on rodents are necessary to exclude
carcinogenicity. In view of this, the USAID decided to stop the
funding of these studies. Further, problems developed with the next
step involving trials on female rodents, with the route of insertion,
the dosage, the number of insertions required, and above all, the
heavy mortality among rodents which had to be subjected to repeated
anaesthesia during the course of the trials.
In Chile, meanwhile, there was an uproar following the receipt of a
September 1994 memo from the Centre for Research on Population and
Security, an NGO run by Kessel and Mumford in North Carolina. The memo
stated that the Chilean government was considering replacing surgical
sterilization with quinacrine sterilization in the country’s two most
populous regions. It jubilantly proclaimed that the Chilean
government’s plans vindicated the efforts of the pioneers of the
quinacrine method of sterilization in the face of the WHO’s
"ridiculous" position. The memo turned out to be propagating an
untruth; it nevertheless provided an impetus to activists to probe the
entire issue of the conduct of these trials.

Concern and Resistance
A broad-based coalition called "Open Forum for Reproductive Health and
Rights" voiced the following four main concerns as they agitated for a
halt to the "trials".

Unresolved issues of safety, for in addition to possible toxicity and
carcinogenicity, quinacrine should also be tested for embryotoxicity
in the event of failure of the method;
The WHO recommendation that human clinical trials not to be conducted
till toxicology trials are satisfactorily carried out;
The need for scrutiny of the trial documents by an ethics committee,
to assess both safety and ethical standards that had been followed.
The Chilean Ministry of Health withdrew its support to the trial in
December 1994 while the public hospitals were asked to review their
internal ethical procedures. However, Dr. Zipper and his team are
reportedly continuing the trials in private clinics with the financial
support of the Centre for Research on Population and Security.

Trials in India
In India, quinacrine sterilization is being carried out with "hundreds
of doctors involved" according to an early convert to the cause, Dr.
Barrel Mullick. He claimed that he himself has trained over 200
village health workers, from all over the country, in quinacrine
sterilization even as he frankly admits that there has been no
follow-up of the women who were sterilized. Further, as happened in
Chile, none of the women were aware that they were part of a trial.
Perhaps more ominously, it was stated that this method was most
suitable for the surreptitious sterilization of oppressed women from
minority communities who would otherwise require their husbands’
permission.
Dr. Mumford gushed in a documentary telecast on BBC, entitled The
Human Laboratory, claimed that it would cost merely 10,000 dollars to
sterilize 70,000 women. The Indian converts to their cause mention a
figure of Rupees 35 per women.
Mumford, Kessel and Mullick also state in a paper that "not to be
ignored is the most important role that sterilization must play in
maintaining peace and security, given the disastrous nature of the
world’s overpopulation".
What Kessel and Mumford ruthlessly exploit is the "space" created by
current efforts to roll back the state in Third World nations under
the aegis of the Breton Woods Financial Institutions. Central to these
efforts is a systematic effort to increase the role of NGOs and
private agencies as it is seen that public agencies, reeling under
mandatory budget cuts, are unable to perform their regulatory roles.
We are thus witness to agencies like the ICMR, hitherto mandated to
regulate, monitor and evaluate clinical trials on human populations,
getting reduced to impotent bodies, unable to keep track of the
proliferating "research" being carried out by a host of NGOs and
private institutions. We are also witness to foreign funding agencies
bypassing national regulatory channels to fund such research, being
carried out in utter disregard of international norms and ethics.

Real Issues at Stake
The rhetoric of "choice" and "reproductive health" that surrounds much
of such research is beguiling to those uninitiated in public health
issues. Thus we are told that quinacrine sterilization can liberate
Third World women from the horrendous toll of maternal deaths. What is
ignored is the entirely fallacious nature of the argument. What causes
maternal deaths is the appalling health status of women in these
countries and the absence of emergency obstetric care in the event of
complications of pregnancy. Quinacrine - or for that matter, other
methods of contraception - do nothing to address these fundamental
issues. Indeed, in India, mortality data indicate that even within the
reproductive age group of women, causes due to reproduction account
for merely 12 per cent of all deaths. The major causes of death remain
infectious diseases and undernutrition.
While the motives of Kessle, Mumford and the likes are easy enough to
understand, what is less explicable is the scores of Indian doctors
who are pawns in this international nexus of demographic fascists.
This could only be the consequence of the sustained propaganda, over
the years, that population growth among the poor is the chief cause of
all the social evils that bedevil the country.
In Bangladesh, meanwhile, leading editorials in newspapers have called
forcefully for a ban on these covert trials as they urge the most
stringent punishments to the doctors responsible for carrying them
out. What they poignantly ask is for how long will Third World women
continue to be treated as guinea pigs in the contraceptive industry.
While the Government of India and its regulatory agencies turn a
Nelson’s eye to these violations of human rights in the name of
"reproductive choice", it is the poor women who, denied of all other
choices in life, pay the price in morbidity and mortality for
exercising their right to contraception.


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A report released by the Delhi-based women’s organisation, Saheli,
highlights what it terms as the ‘unethical, unscientific, and in most
cases illegal’ manner in which trials for chemical sterilisation using
Quinacrine drug are being conducted in India.
Quinacrine was used orally for treating malaria, but it fell into
disuse as malaria parasites developed resistance to it. In the late
1960s, its potential for tubal blockage was publicised by a Chilean
scientist. It was later promoted as a cheap and easy way to sterilise
women.
The Saheli report points to an acute lack of scientific information
guiding a procedure that is known to have numerous negative short and
long-term effects. These range from high failure rate to perforation
of the uterine wall and the increased risk of ectopic pregnancies. In
fact, the ICMR had abandoned clinical trials of the drug precisely
because of the high incidence of ectopic pregnancies that came to its
notice. There is also the added risk of cancer. Taking all these
factors into consideration, the report concludes that the large scale
use of Quinacrine sterilisation in India has frightening potential for
women’s lives and health.
In Bangalore, an organisation known as Contraceptive and Health
Innovations Project (CHIP Trust) has, according to Saheli, recruited
around 400 doctors from different parts of Karnataka to conduct
sterilisations using the drug and to monitor its effects.
A documentary video, The Yellow Haze, made by a young team of
film-makers from the Mass Communication Research Centre of Jamia
Millia Islamia University, Delhi highlighted the clinical trials for
Quinacrine conducted on 32 women for an MD thesis by a student of Lady
Hardinge Medical College, Delhi under the supervision of a senior
doctor. The women experimented on came from underprivileged
backgrounds. Six of these women spoken to also revealed that they were
not told anything about the Quinacrine or its potential short and
long-term side-effects.
The Saheli report states that conducting of such trials clearly flouts
established medical and ethical norms and Indian laws. It called for
an immediate end to them.

Source: Express News Service 11 July 1997.


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