E-DRUG: Norgestrel and combined contraceptive pills (cont'd)

[Barbara Mintzes <bmintzes@compuserve.com>]

E-drug: Norgestrel and combined contraceptive pills (cont'd)
---------------------------------------------

John Urquhart praises Norplant's delivery system as the reason for
the contraceptive's high effectiveness. It is a continuous release
system, but as I mentioned before it is also releases a higher dose of
levonorgestrel than the available oral alternatives. Norplant is less
effective in women who weigh >70kg than in smaller lighter women so
presumably the dose as well as the delivery system have some
relationship to its effectiveness.

The delivery system of this contraceptive has been subject to much
discussion and controversy. Many women's organizations -- in
countries as diverse as Zimbabwe, India, Bangladesh, Thailand, Brazil
the US, UK, Finland and Canada, to name a few -- have raised serious
concerns from a human rights perspective. The problem is that the
contraceptive must be removed in a minor surgical procedure, so a
woman must find a specially trained doctor or other health worker to
remove it. A number of case reports and results of focus group
discussions in four countries [Zimmerman et al, Studies in Family
Planning, 1990] attest that it is not always easy for women to have the
contraceptive removed when they want, either because of changed life
circumstances, or for what the health worker considers to be "minor"
adverse effects, particularly the menstrual cycle disturbances which
60-80% of women experience, or effects such as headaches, both of
which can have a large negative impact on daily life. Menstrual
disturbances can be extreme, including what is called "menstrual
chaos" in the literature, semi-continuous or random light bleeding for
months on end. Some women joke that the contraceptive is very
effective because you're bleeding all the time anyway, in societies
where there is a strong taboo against intercourse during menstruation.

Another problem with the delivery system is that Norplant is often
much more problematic to remove than insert. Injuries related to
removal difficulties have been the subject of many lawsuits in the
United States and the labelling now includes warnings about these
potential problems. 

A more fundamental question is whether long-acting contraceptives
should be designed in a way which explicitly removes control over
decisions to start and stop using the method from the woman herself.
The decision to pursue a subcutaneous delivery system for Norplant
was made in the late 1960's or around 1970, as phase I trials were
carried out from 1970 to 1975. Whether a similar method would be
developed today is an open question; however, there has been a shift
in family planning and population policies, highlighted at the Cairo
Conference, towards a more woman-centred reproductive health
approach, which recognizes the need for steps to foster women's social
and economic equality. Hopefully this will also lead to some changes in
technological innovation and design. 

Leaving aside discussions of whether or not methods such as condoms
which protect simultaneously against pregnancy and STD transmission
should be promoted more heavily as first-line options for family
planning, it is possible to design a continuous delivery system so it
can be removed at will if the user desires, such as patches or hormone
releasing vaginal rings. 

Another question raised was the cost of Norplant. I am not sure how
much of the $25 charged per set in developing countries is related to
the use of levonorgestrel rather than another form of norgestrel,
versus the silica capsules etc, or how much this cost would go down
with a different active ingredient. In assessments of relative
contraceptive costs, part of the high cost allocated to this method has
been related not so much to the cost of each set of capsules as the
infrastructure needs for safe use as compared to some other
contraceptives: specialized training and sterile conditions for insertion
and removal, record-keeping and follow up of women for five years to
remove the capsules when they are no longer effective. This follow-up
is crucial because the capsules release gradually decreasing levels of
levonorgestrel after the five year period, which is associated both with
a higher risk of ectopic pregnancy -- potentially life threatening --
and fetal exposure to levonorgestrel with continuing pregnancies.

This is a diversion from isomers, but I thought it was worth adding
some of the critical discussion which has surrounded the introduction
and use of this contraceptive.

With best regards,

Barbara Mintzes
bmintzes@compuserve.com

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