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Date: Mon, 23 Nov 1998 03:06:06 +1100
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To: PROGRESSIVE POPULATION NETWORK <ppn@csf.colorado.edu>
Subject: more on quinacrine
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Quinacrine Sterilization: An Unsafe Method of Female Sterilization?


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Quinacrine sterilization is a non-surgical method of female
sterilization that was invented in Chile by Jamie Zipper in the early
1970's. The procedure involves inserting a quinacrine pellet into a
woman's uterus where it "inflicts injury- something similar to a
chemical burn- that causes scar tissue to form. The scar tissue in
turn blocks reproductive processes."[1] Although the method has been
used by doctors (especially in developing and third world countries)
for over thirty years, questions about its safety and its
effectiveness remain unanswered. Quinacrine is used for sterilization
purposes today despite the fact that it has not been adequately
tested. If a non-surgical method could be deemed both safe and
effective it could become a very important part of women's health care
world wide, especially in places where surgical forms of sterilization
are necessary but unsafe. Unfortunately the quinacrine method does not
yet fill this void in female reproductive methods.

Toxicology Studies were not done on quinacrine until thirty years
after it was introduced as an anti malarial drug. Toxicology studies
are a major step in drug testing, a step required by most of the
world's drug administrations. The Federations of Gynecology and
Obstetrics states that "no experimental method should be tested in
humans before adequate toxicology studies [are done] in animals to
clarify questions of safety."[2] Studies done by the WHO toxicology
panel in 1991 found that "the evidence concerning mutagenicity was
inconclusive" and that "further toxicological studies... were
required."[3] There were additional questions raised by the WHO
toxicology panel with regards to the fact that quinacrine is often
given with ibuprofen, ampicillin or ergotamine. They noted that there
is no scientific evidence to support using these drugs in conjunction
with quinacrine and that toxicology studies should be done on all the
drugs to see how they interact together.

Another set of toxicology studies was done in 1995 by Family Health
International (FHI). FHI discovered that three of the four studies
showed mutagenicity, which can indicate that something is carcinogenic
or cancer causing. Although not everything that is mutagenetic is
carcinogenic, the results of these tests indicate that more direct
carcinogenic studies need to be done in order to discover how safe
quinacrine is. To date, these studies have not been done; the
quinacrine sterilization method continues to be used.

Beyond the testing, little is known about the actual physical affects
that this procedure can have on women. Quinacrine, in high doses, has
been known to cause toxic psychosis (a form of chemical insanity), as
well as nervousness, hallucinations and psychotic episodes. The fact
that these reactions are known to come from high doses of quinacrine
make finding an accurate dosage imperitive. Some women, after having
had the procedure, have reported "unexplained bleeding, a sensation of
burning internally and pain after insertion." [4] Data collection on
this procedure is difficult; this process of sterilization is not
legal or medically accepted so there are few records.

Data on pregnancy after the insertion of the quinacrine pellet has
been kept more accurately. In Chile the rate of pregnancy in women
under thirty five was 8.7 percent after five years and 11.7 percent
after ten years. The rate of pregnancy for women over thirty five is
slightly lower, probably due to the fact that fertility decreases
after the age of thirty five. The rate of pregnancy is absurdly high
for a method that is professes to sterilize women. Dr. Lisa Rarick,
Medical Officer at the USFDA thinks that "the failure rate [of
quinacrine sterilizations should not] be too far off that for surgical
sterilization, especially since it is sterilization - not a form of
contraception that is being offered... five percent would be too
high."[5] If five percent is considered too high to be considered
"effective" then quinacrine should not be used as a method of
sterilization. People have raised concerns over a possible rise in the
rate of ectopic pregnancies in women who become pregnant after being
"sterilized" by the quinacrine method. Any rise in ectopic pregnancies
must be carefully considered because ectopic pregnancies are very
dangerous to the mother. In addition, the effects that the quinacrine
method has on pregnancies that do occur has not yet been studied even
though the method inherently damages the female reproductive organs.

The last concern raised about quinacrine is the fact that women may be
participating in this method of sterilization without knowing that it
is still "experimental" and that they are a part of a clinical test
group. There is concern that some of the women are being sterlized
with quinacrine without full knowledge of the possible risks. Reports
from an independent nurse practitioner in Pakistan is that "patients
are recruited... and given little information or time to fully
understand and think about the implications of this type of
procedure."[6] This attitude seems to be prevalent elsewhere as well.
In promotion of quinacrine, a drug without adequate testing, some
supporters seem to "use the fact that women's lives in developing
countries are more at risk for pregnancy to justify why a
sterilization method need not be a safe or effective for them as for
women in developed countries"[7] This attitude encourages the
continued used of quinacrine among women as a viable method in
developing and third world countries despite the fact that there are
huge risks involved for these women.

If a non-surgical method of female sterilization could be discovered,
tested properly and determined to be safe and effective, the benefits
would be huge. As of now, quinacrine is not that drug and the
quinacrine method is not the answer.

Mistakes have been made in the past regarding inadequate drug testing
before drugs are used on a widespread scale. DES, breast implants, and
other poorly tested drugs and medical procedures have cost women their
fertility, their health and their lives. Drugs need to be tested
properly. Time , money and resources are all things that can be worked
around if a product is needed. There is no excuse for risking lives,
health and fertility simply for the convenience of putting a drug out
which has not been properly tested. It is too late to repair the
damage that has already been done with quinacrine, but it is not too
late to continue with the necessary testing and go forward from here.


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Notes
1 Taken from BAOBAB Press, Vol.3, Num. 23
(http:www.//africa2000com/BNDX)

2 Berer, Marge; The quinacrine Controversy One Year ON, p.105,
Reproductive Health Matters, No.4, November 1994

3 ibid. 2 p101

4 Berer, Marge; The Quinacrine Controversy Continues, p.144,
Reproductive Health Matters, No.6, November 1995

5 ibid 2. p.102

6 ibid 2, p104

7 ibid 2, p.100


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