Memorandum

Copy of the memo submitted to Health Minister Dr A Ramadoss explaining why women’s groups oppose injectable contraceptives along with a list of 55 signatories.

To

Shri A Ramadoss,

Union Minister for Health and Family Welfare,

Nirman Bhawan,

New Delhi

26 October 2004

Sub: Why Women’s Groups Oppose Injectable Contraceptives

Hon’ble Minister,

We would like to begin by saying that we as concerned scientists, women's groups, and health activists are firm advocates of voluntary birth control and the right of a woman to control her fertility. We firmly believe that families, and women in particular, should have the choice to decide the number of children they want and access to safe and affordable contraception. We are convinced that women want and need safe contraceptive choices, which are user controlled and which carry no risks to their health and well-being. With this conviction, for the last two decades we have opposed the introduction of injectable contraceptives in the family planning programme for very specific reasons.

In this context, we view with concern the workshop in Manesar (27-29 Oct 04), organized and co-ordinated by Parivar Seva Sanstha (a National level NGO), in collaboration with Government of India, UNFPA and Packard Foundation through Population Foundation of India to “expand choices of contraception” by the introduction of injectables, which are hazardous to women’s health.

In the bid to meet unrealistic population control targets and as part of the liberalisation policies, the Indian authorities have in the past few years relaxed drug regulations in order to expedite the introduction of long acting, invasive, hazardous contraceptives into India. Unchecked over-the-counter sales, ill-informed doctors and inadequate Post Marketing Studies are the harsh realities of this strategy which is poised to subject millions of Indian women to long-acting hormonal contraceptives such as the injectables (Net En and Depo Provera) and sub-dermal implants (Norplant), that is likely to cause irreversible damage to their own and their progeny's health.

The injectable contraceptive Depo-Provera was approved for marketing in India in 1993 without the mandatory Phase 3 trials. Upjohn, the American multinational, thus gained access to one of the largest markets for contraceptives without following the mandatory requirements.

Women's groups, health groups and human rights groups throughout the country have opposed the introduction of this injectable given the potential for abuse, non-completion of mandatory trials and the lack of accountability of pharmaceutical agencies. Conclusion from analysis of major studies from all over the world have compelled a call for a complete ban on injectable contraceptives and particularly its introduction in the public (National Family Welfare Programme) sphere. Significantly, Depo- Provera [DMPA - Depot Medroxyprogesterone Acetate] has been listed as a last resort drug, particularly in Europe. The specific grounds on which injectable contraceptives are opposed are as follows:

Short term and Long term Adverse Health Impact

Severe side-effects of Net-En and Depo- Provera are well documented, including menstrual disorders, cessation of the monthly cycle or irregular bleeding, general weakness, migraine headaches, and severe abdominal cramps. In a country where a large percentage of women in the reproductive age suffer from anaemia, irregular and heavy bleeding can have catastrophic consequences. Moreover studies have shown that injectable contraceptives like Depo-Provera can also lead to osteoporosis. This is again fraught with grave consequences for poor women who have low bone density due to poor nutritional status. Irrefutably, Depo-Provera has been indicted for:

• climacteric-like syndrome (pre-mature menopause)

• irreversible atrophy of the ovaries and endometrium leading to permanent sterility

• deaths due to spontaneous formation of clots inside blood vessels (thrombo-embolism)

• two fold increase in acquiring HIV infection from an infected partner as well as increased transmission from an infected woman to a non-infected partner

• ten-fold increase in the birth of a Down Syndrome baby in women users

• increased chances of death in children born to women users.

• increase in the risk of breast cancer, cervical cancer including carcinoma-in-situ

• return of fertility after discontinuation of the drug has not been established

• unanswered questions regarding the health of babies born after cessation of the drug.

Concerns on Inadequate Infrastructure and Accountability for Administration, Follow up and Care:

It must be remembered that in the case against the injectable Net En, filed in the Supreme Court in 1986 against the Union of India, ICMR, DCI and others by Saheli and other women’s groups (many of whom are signatory to this memorandum), the government’s admission at the close of the case in 2000 that mass use of Net En in the FP programme is not advisable is a recognition of the potential risks and need for close monitoring and follow up.

Depo-Provera is hazardous for women in all circumstances. Moreover, administration of injectable contraceptives requires ruling out of contra-indications and close monitoring, not just for a few months but over long periods. However, such monitoring is totally absent in this country. Since it is mainly poor women who visit Government hospitals, once again it is they who are treated as 'living laboratories'.

Even when women access the health services provided by the NGO sector, many of these concerns remain. To date, the Government of India has not evolved any definitive mechanisms / standards for NGOs in the sector – in terms of care, follow up or accountability. Hence, our core concerns on women’s health and safety remain unaddressed.

Dubious Post Marketing Surveillance in India

The five year post marketing surveillance (PMS) study was supposed to have been done in place of the final stage of clinical trials and its results have as yet been neither made public or published. According to the highest authority, the Drugs Controller of India, any decision to introduce DMPA even for private marketing should be taken after the results of the post marketing surveillance are satisfactory. In this case, the post marketing surveillance has in fact translated into the private marketing of the drug. This is hardly surprising given that PMS was conducted by Upjohn, the pharmaceutical company which directly stands to profit from the results of the research. This raises serious doubts regarding the “scientific objectivity” of the data collected and its analysis. Close scrutiny of the PMS data would reveal that each woman user is included in the study only for 5 injections each for a duration of 3 months. Thus, the study covers each woman user for a period of 15 months only. There is no logic for this short period, since the intended duration of DMPA is as a spacing method for at least 2 to 3 years. Further, the period of 15 months is not adequate to assess long-term effects. Thus, it is unscientific to declare Depo Provera as ‘safe’ on the basis of inadequate data.

Following are issues of specific serious concerns unaddressed in the PMS:

• The potential side-effect of loss of bone density and subsequent increased risk of osteoporosis has not been studied, despite the fact that there was a separate budget in the PMS to monitor bones by densitometry. This issue is of great significance in India where bone density among women is likely to be low, and a 7 to 10 percent risk -as reported in a New Zealand study- may increase the incidence of fractures.

• Significantly, cancer risk has not been studied, though long-term studies in other countries show that increased risk of breast cancer -especially in younger women-- cannot be ruled out. Assessment of return of fertility has not been incorporated in the study design - a serious lacuna in a contraceptive being promoted as a spacing method. Similarly, the effect of DMPA on progeny conceived accidentally or immediately on cessation of use of DMPA has also not been studied.

• The classification of "non-serious medical events" is problematic. Problems such as amenorrhoea, irregular bleeding, generalised weakness and lethargy, migraine headaches, pain in the abdomen and severe abdominal cramps have been considered by the researchers to be "non-serious". From a woman user perspective, these side-effects could be debilitating and hamper daily activities and affect one's well-being. It is important to remember that contraceptives are targeted at healthy women in the prime of their lives, and such debilitating side-effects cannot be side-lined as "non-serious". Similarly, the study does not even look into possible side-effects like mood changes, loss of hair or loss of libido which are also of concern to women users.

• Breast feeding is a contra-indication for DMPA. The administration of DMPA during lactation could have a serious adverse effect on the health of the breast feeding women because of its association with demineralization of bone. This is in violation of international norms and ethics as put down by WHO and CIOMS guideline number 11.

Many other research studies often quoted in favour of Depo-Provera have also been similarly scrutinised and challenged for their veracity, and hence we believe there is no scientific/medical justification for the introduction of injectable contraceptives like Depo-Provera or Net-En.

Dr. C. Sathyamala in her monograph titled “An Epidemiological Review of the Injectable Contraceptive Depo-Provera” (Publishers: Medico friend Circle & Forum for Women’s Health, 2000 & 2001), clearly articulates the problems associated with DMPA and concludes that Depo-Provera is hazardous to the health of the women and her progeny. The contraceptive is not suitable for nulliparous women, adolescents, breast-feeding women, women who have completed their family, and women in the reproductive age group. There are numerous other studies which states the Depo-Provera is hazardous for women and the evidence available is already too damning and it would in fact be unethical to subject more women to clinical trials with these contraceptives.

Jagori, New Delhi and Kalpana Mehta, New Delhi had submitted a petition in the Supreme Court of India I. A. no of 1994 in Writ Petition No 698 of 1993

Drugs Technical Advisory Board Recommendation Against Depo Provera

The recommendations made at the Drugs Technical Advisory Board meeting held on 16th February 1995 clearly state that: "Depo-Provera is not recommended for inclusion in the Family Planning Programme."

N.H. Antia, one of the members of the DTAB in a separate note states the following as reasons why it should not be included.

The target based approach of the government program may lead public health personnel to impose DMPA on women without checking for contra indications and without explaining properly other possible hazards including permanent sterility.

The almost superstitious belief in the power of injections, "gullible women would be more than willing to use this injection thus rendering themselves vulnerable to misuse of DMPA".

The health of the DMPA user has to be monitored to watch for the array of disturbing side effects of DMPA. The Indian public health system is too inadequate, inefficient and indifferent to do this work properly.

Up to 2/3 of women on DMPA experience menstrual chaos, which may be culturally unacceptable to the women.

Lack of Informed consent:

Right from the experience in Patancheru in Andhra Pradesh in 1985 (leading to the filing of a writ petition in the Supreme Court), where poor, illiterate women were recruited in clinical trials and administered the Net En injectable without informed consent, women’s groups have monitored the violations of informed consent while administering contraceptives. "Unveiled Reality - A Study on Women's Experiences with Depo-Provera, an injectable contraceptive" conducted by Sama (2000) reveals that women in Delhi were put on injectable contraceptives in a Public Health set-up without informed consent. Vital information regarding the safety and adverse effects of the contraceptive are withheld from women, thereby depriving them of the right to make an informed choice.

More recently, in a series of state-wise public hearings on the Right to Health initiated jointly by the National Human Rights Commission (NHRC) and Jan Swasthya Abhiyan (JSA), testimonies of women’s experiences with Depo-Provera were collected and presented by Sama before the NHRC and health officials from different states. NHRC panel was surprised that a public health establishment was administering Depo-Provera and subsequently has demanded an explanation from the officials for the same.

The empowerment of women is not simply a matter of offering them more contraceptive technologies without providing sufficient and complete information, proper screening and follow-up. The attempt to justify the introduction of injectable contraceptives on the specious plea that it would provide women with a wider range of contraceptive "choice" is making a mockery of the concept of "choice" given that an overwhelming majority of women are denied their basic rights and have no choice regarding access to health, education or employment.

We hope that the “precautionary principle” will prevail, where questions such as: How much risk to women’s health can be avoided? What are the alternatives to this product and are they safer? Is this particular contraceptive even necessary? are considered with the rights and well-being of women in mind, rather than the interests of pharmaceutical companies.

In short:

• Our position on injectables is very clear. There is enough scientific evidence to show that these are hazardous for women under any circumstances. The risks far outweigh the benefits of convenience of administration and use.

• The public health system is particularly ill-equipped to administer injectables, and NGOs and private practitioners are currently out of the ambit of practically all mechanisms of accountability. This scenario is not conducive to entry of injectables.

• We do not believe that women's "choices" are enhanced by adding yet another hazardous contraceptive to the "basket". User satisfaction of a hazardous drug has to be viewed from a different lens.

We urge you to consider these issues very seriously before considering any proposals that recommend the inclusion of injectable contraceptives in the National Family Planning Programme. We hope you will reject the interests of private profit and work instead, to formulate a policy that ensures the overall good for the health of women and their progeny.

Sincerely Yours,

Sarojini NB               Laxmi Murthy

(Sama)                     (Saheli)

This memorandum has been endorsed by the following organisations and individuals:

1. Aalochana Documentation and Research Centre, Pune: Simrita Gopal Singh

2. AIDS Awareness Group, Delhi: Elizabeth Vatsayan

3. Akshara, Mumbai: Nandita Gandhi

4. All India Democratic Women’s Association (AIDWA): Brinda Karat

5. All India Progressive Women's Association (AIPWA): Srilata Swaminathan

6. Anandi, Gujarat: Neeta Hardikar

7. Catholic Medical Association of India

8. CEHAT, Pune: Sunita Bandewar

9. Centre for Social Medicine and Community Health, JNU: Dr Mohan Rao

10. Chetna, Ahmedabad:

11. Community Health Cell, Bangalore: Thelma Narayan

12. Delhi Science Forum: Dr Amit Sengupta

13. Dr. Amar Jesani

14. Dr. Anant Bhan

15. Dr. Anant Phadke

16. Dr Dhruv Mankad

17. Dr Mira Sadgopal

18. Dr Navsharan Singh, Independent Researcher

19. Dr Vandana Prasad

20. Dr Veena Shatrughna

21. Eklavya, Dewas: Anu Gupta

22. Ekta, Madurai: Bimla

23. Explorations, Mumbai: Jaya Velankar

24. Forum Against Oppression of Women, Mumbai: Sandhya Gokhale

25. Forum for Women's Health, Mumbai: Meena Gopal

26. Gramya Resource Centre for Women: Ashima Roy Choudhury

27. Hanif Lakdawala:

28. Health Watch U.P., Bihar:

29. Jagori, Delhi: Abha Bhaiya,

30. Jan Swasthya Abhiyan, Madhya Pradesh:

31. Maati, Munsiari, Uttaranchal: Malika Virdi

32. Madhya Pradesh Mahila Manch: Lorry Benjamin

33. Majlis, Mumbai: Flavia Agnes

34. Medico Friend Circle:

35. MPVS: Dr Ajay Kumar Khare

36. National Federation of Indian Women: Sehba Farooqi

37. Nirantar, Delhi: Jaya Sharma

38. OLAVA and Muslim Women's Rights Network: Sabah Khan

39. Padma Prakash

40. People’s Health Movement: Dr.B.Ekbal

41. Prabir Purkayastha

42. Prayas, Rajasthan:

43. Rahi, New Delhi: Anuja Gupta

44. Renu Khanna

45. Sachetana, Kolkata: Rajashri Dasgupta

46. Saheli, Delhi: Laxmi Murthy

47. Sahiyar, Baroda: Trupti Shah

48. Sama, Delhi: Sarojini N.B

49. Sangram, Sangli: Meena Seshu

50. Stree Adhikar Sanghata, Delhi: Anjali Sinha

51. Sunil

52. Tamil Nadu Women's Collective: Sheelu,

53. Vacha, Mumbai: Sonal Shukla

54. Vimochana, Bangalore: Donna Fernandes

55. Women's Centre, Mumbai: Ammu Abraham