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Kathmandu Sunday August 12, 2001 Shrawan 28, 2058.
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Interrogating Depo Provera
By Madhura Lahokare
This book, authored by renowned health activist
Dr.C.Sathyamala, is in the form of a monograph, which contains a review of literature on
the various aspects of the indictable contraceptive Depo-Provera. Depo-Provera has had a
controversial history since its introduction in the U.S. by Upjohn Co. (USA). Initially it
was used for the treatment of renal and endometrial cancers and for preventing spontaneous
abortions. However, right since 1967, Upjohn’s application to the U.S. Food and Drug
Administration (USFDA) for approval for its use as a contraceptive had been repeatedly
rejected till 1992 when the USFDA approved its contraceptive, following the results of a
multi-national study which showed no association between use of Depo and risk of breast
cancer. Clinical trials with Depo-Provera had been initiated by the Indian Council of
Medical Research (ICMR) in the 70s in India as well, though these were discontinued due to
a high rate of bleeding disorders in the women who were given Depo. But in June 1993, on
the heels of the approval granted by the USFDA, the Drugs Controller of India granted
permission to Upjohn Co. to market Depo in the private sector. Though the contraceptive is
yet to be introduced into the Government’s Family Programme, a decision will be made
regarding the same on the basis of the results of Phase IV trials ( pre-programme
introduction study).
It is against this background that this review acquires
significance. The review is a comprehensive one, covering a wide range of aspects
regarding the side effects of Depo. For the uninitiated, it would actually be startling to
discover the range of possible risks that are associated with the use of this injectable
contraceptive, being promoted as a safe method by it’s manufacturers.
Some of the more significant ones among these are bleeding
disorders, risk of osteoporosis, increased risk of breast and cervical cancer, delay in
return of fertility and hazardous effects on the progeny as well. It is now a proven fact
that Depo causes unpredictable menstrual disturbances like irregular, prolonged or heavy
bleeding or amenorrhoea (absence of menstruation). In spite of the known effect of
bleeding disorders on women’s health, they continue to be dismissed as minor side
effects; the attitude has been to minimise it’s importance and be more concerned
about the possibility of discontinuation of the contraceptive by the user.
Depo-Provera also induces hypo-estrogenic (estrogen
deficient) state in users which leads to a range of side effects including decreased
libido, dizziness, depression and other symptoms akin to menopausal ones like hot flashes,
loss of energy, etc. It also causes osteoporotic (weakening of bone) changes through
demineralization of bones – this increases the lifetime risk of fracture for the
users and has serious implication for Indian women who are underweight and show a high
prevalence of calcium deficiency.
Studies further show that return of fertility is delayed
after discontinuing the contraceptive and in subgroups of women it may lead to permanent
infertility due to irreversible atrophy and fibrosis of the ovaries. Evidence from studies
reviewed also demonstrated a positive association between use of Depo and an increased
risk of breast cancer and cervical cancer in young women, the latter being of public
health importance in India and other developing countries.
Besides this, Depo causes serious adverse reaction, which
could lead to life long disability. Infants exposed to Depo in utero have an increased
perinatal and neonatal mortality risk. More serious effect of in utero exposure to Depo is
the increased risk of giving birth to children with chromosomal anomalies including
Down’s Syndrome. It also affects birth weight adversely and alters the fat
composition of breast milk, which could have a serious effect on breast-fed infants in
developing countries.
In spite of such serious risks, the author laments that
published literature on the safety aspects of this drug is very sketchy. The available
studies suffer from methodological flaws, inappropriate study designs, inadequate sample
size and failure to follow up. However, the review sufficiently shows up Depo as a
systemic, long term, invasive contraceptive, posing serious hazards for the health of the
users as well as their progeny. But this issue is ignored and the high maternal mortality
in developing countries is cited as a reason for deferring any kind of risk-benefit
assessment of use in these countries. The author, however, rightly points out that whether
high contraceptive prevalence alone as the only measure would reduce mortality and
morbidity posed by pregnancy related causes in developing countries is highly debatable.
Given the long list of possible side effects on users as well
as progeny, the question of this drug being used by a large number of women acquires great
public health significance. Being a contraceptive, this drug would be targeted towards
women in all reproductive ages viz. 15-45 – which also constitutes the most
productive, healthy time of an individual’s life. When used by large population, even
a small health hazard can assume great public health importance, since the sheer numbers
affected by or subjected to these risks would be high. The hazardous side effects assume
extra danger when considered in the context of Indian women – a majority of whom are
anaemic, malnourished and suffer from all kinds of micronutrient deficiencies.
This book thus becomes very pertinent in the current debate
between those for and against introduction of Depo. It is also an eye-opener for all those
making well-intentioned arguments for the promotion of Depo use to ‘empower’
women to exercise their choice. At a broader level, it again demonstrates that it is not
the pure concern for the health and safety of users, which dictate the promotion and
introduction of contraceptives, or any other drugs or medical technology for that matter,
but the political-economic concerns, involved. This painfully researched book is thus a
significant contribution in this contentious area of contraceptive technology and
it’s implications.
The only possible shortcoming is that it is not really clear
for whom the book is intended – for doctors and practitioners, policy planners,
activists, lay people or users themselves. Pertinent as it is, the book is at times
exceedingly technical in its review and analysis of the various studies. This is perhaps
necessary for the purpose of the book; but it becomes very difficult for a non-medical
person to understand all the implications clearly.
(M. Lahokare is currently pursuing M.Phil at Jawaharlal
Nehru University’s Centre of Social Medicine and Community Health where she is
researching on political economy of increased medicalization in our society.)
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