E-drug: Indian women's group protest at new contraceptive trial
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[BMJ has an editorial this week on safety of third generation
contraceptices, URL below, a research article on the safety, a
newsbit about a new trial in India and a piece giving websites of
interest. Copied as fair use. KM]
BMJ 2001;323:119-120 (21 July 2001)
<http://www.bmj.com/cgi/content/full/323/7305/119>
Editorial: The third generation pill controversy ("continued")
The risks are still small compared with those of pregnancy.
BMJ 2001;323:130 ( 21 July )
http://www.bmj.com/cgi/content/full/323/7305/130/c
News extra
Indian women's groups protest at new contraceptive trial
Rohit Sharma Mumbai
India's leading women's groups held a noisy demonstration outside
the health ministry on World Population day last week against the
introduction of contraceptives that they considered hazardous. They
also demanded the withdrawal of "coercive" population policies in
several states.It followed the announcement last month by the
health minister, C P Thakur, that the long acting injectable
contraceptive norethisterone would be introduced on a trial basis in
12 medical college hospitals across India.
But Brinda Karat, general secretary of All India Democratic
Women's Organisation, is concerned at the proposals. "The Indian
Council of Medical Research had done some trials [of
norethisterone] in the early 1980s which were withdrawn precisely
because it was found that it was not suitable for Indian conditions,"
she said.
Women's groups say that the long acting hormonal contraceptive
has many side effects, such as disturbances in the menstrual cycle,
abnormal blood clotting, depression, severe headaches, and
abdominal cramps. Use of the contraceptive requires ruling out
contraindications such as heart disease, liver dysfunction, diabetes,
and genital cancers, making their introduction highly problematic in
Indian conditions.
"There will be women who will be doing a 10 hour working day,
and, if you have side effects such as irregular or heavy bleeding or
severe headaches or abdominal cramps, it is going to affect your
whole lifestyle and even your right to work," said Ms Karat.
Women's groups say that while hormonal contraceptives would
demand regular monitoring of the woman, this is not possible under
Indian conditions. Even in the case of trials of Norplant
(levonorgestrel-releasing implant system), failure to follow up was
as high as a third in some cases, she said.
"What is going to happen is that funding agencies which are
concerned about the health-not of Indian women but of
multinational companies-will be giving money to the Indian
government, which will use it to buy the injections," said Ms Karat.
"So Indian women's bodies will become a conduit for international
funding to multinational companies."
Women's groups have also opposed population policies of several
states of India that have shown zeal in controlling the population.
Whereas the National Population Policy respects "voluntary and
informed choice" and the target-free approach, population policies
of the state governments of Uttar Pradesh, Madhya Pradesh,
Rajasthan, Maharashtra, and Andhra Pradesh violated the letter and
spirit of the national policy, the women's groups said.
"Contraception is practically a universal demand for women," said
Laksmi Murthi of Saheli, the non-governmental Women's Resource
Centre, "but it needs to be safe and based on informed consent.
What we are demanding is birth control and not population control.
It is a way of looking at the issue from a user's perspective rather
than a demographic perspective."
But India's Family Welfare Secretary A.R. Nanda told the BMJ that
the government was not introducing the long acting injectable
contraceptive norethisterone into India's national family planning
programme at this stage. "We are only going to do operational
research to find out whether the product is suitable for Indian
conditions or not from the point of view of safety, efficacy and
acceptability."
Nanda claimed the backing of India's Supreme Court in conducting
the research and denied that the Indian health delivery system was
too poor to be able to monitor the trial participants properly.
The Indian Council of Medical Research (ICMR) was very much in
the picture, Nanda said. The new research would take over from
where earlier research got stalled due to a legal case involving
contraceptives in the Supreme Court a few years back.
On the question of state population policies, Nanda conceded that
some state governments had introduced disincentives to control
their population growth. "We don't advocate disincentives and we
are trying to impress upon state governments to change their
stand," he added.
BMJ 2001;323:172 (21 July 2001)
http://www.bmj.com/cgi/content/full/323/7305/172/a
The debate over third generation oral contraceptives and venous
thromboembolism has frequently surfaced in the BMJ in recent
years, and the central dilemma has been how best to explain risk.
James Drife's editorial (p 119) makes it all sound rather simple, and
his analysis is about the clearest beacon in an ocean of confused
risk assessment.
The choppiest waters are inevitably found on the web. It seems
that the 1995 Lancet paper that set tongues wagging about the
third generation pill spawned multiple interpretations. Seek
information on Google (www.google.com) and you find that the
first link points to Human Life International
(www.hli.org/hli/main.html) whose mission is to promote and
defend the sanctity of life and family around the world. Human Life
International has embarked on a culture war, defending God's law
against the ills of the sexual revolution ignited "in large measure by
the birth control pill." This moral rigour facilitates an alarming
interpretation of risk. A factsheet on contraceptive pill side effects
(www.hli.org/issues/contraception/other/side-effects.html) warns
that among users of third generation progestagen pills there is an
increased risk of deep vein thrombosis of 600-900%, compared
with non-users. Worrying figures, but official guidance is hard to
find.
The United Kingdom Department of Health decided in 1999 that the
"absolute risk of venous thromboembolism in women taking third
generation combined oral contraceptives is very small and is much
less than the risk in pregnancy"
(www.doh.gov.uk/cmo/cmo99_02.htm). The World Health
Organization also offers advice at
http://who.int/hrp/progress/46/06.html. Even so, presenting this
information in a way that is of use to consumers appears to be
beyond everyone's capability.
Kamran Abbasi.
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