FAMILY PLANNING: AT WHO’S COST?

 FAMILY PLANNING: AT WHO’S COST?

Newsletter September 1986

For the tint time in India, the attempts of the Health Ministry and the ICMR to push a hazardous contraceptive fur women has been challenged through a writ petition filed in the Supreme Court on the 7th of April 1986.

On 1st May 1986, the court issued notice to the respondents to show cause as to why the petition should not be admitted and stay order granted on further trials of the contraceptive. In addition to the Health Ministry, the ICMR, and the State of Andhra Pradesh, the Drug Controller of India was also impleaded as a respondent. The notice was returnable on July 15,1986, but the hearing has been postponed to the first week of September.

The contraceptive in question is Norethisterone Oenanthate (Net-Oen), an injectable form of the female hormone, progesterone, similar to the controversial drug Depo-Provera. Produced by Schering, a West German firm, it was first marketed in Peru in 1967. In 1971, it was withdrawn, as rats tested with this drug developed pituitary and breast nodules. Thereafter, it was put back on the market and is now being propagated as the ideal contraceptive for third world women.

The ICMR is currently engaged in the last stage of trials and the government plans to introduce it into the mass Family Planning programme in a big way. Far from sharing the optimism of the government and the ICMR, we contend that there are several reasons for grave concern.

THE CASE AGAINST NET-EN

The case against NET-EN rests on the following grounds:

1. Disruption of Bodily Functions

NET-EN is a synthetic hormone, similar in structure to the natural female hormone progesterone.

When a high dose of this one hormone is injected into the body, a disruption is caused in the finely tuned hormonal system.

Further, since NET-EN supresses the natural production of progesterone and other hormones, there is the possibility that irreversible damage may take place and the body become unused to producing these hormones on its own.

2. Many serious effects unknown

• The rate at which contraceptive hormones such as NET-EN are metabolised (broken down in the body) is not well understood. Different populations metabolize the drug at different rates.

• Some amount of the drug accumulates in the body with subsequent injections. The reason for this or the significance of this is not known.

• Little is known about why bleeding disturbances take place.

• There is no satisfactory approach to the management of bleeding problems.

• If by chance a woman is pregnant when she gets the injection or she becomes pregnant inspite of the injection (failure of contraception) there is no information as to whether she will produce a normal or abnormal child.

• Small quantities of the drug pass through the milk of breast-feeding mothers. The effects of such exposure to the drug by the infant are not known.

• Although animal studies have raised concern about the risk of cancer, no human studies have been done to rule out this risk with NET-EN.

3. NET-EN does not fulfill criteria of a spacing method

Characteristics of a good spacing method

Method should be acceptable to women as a contraceptive for 2-3 years.

After discontinuing the method, if she so desires, a woman should be able to become pregnant and bear a normal child.

Method should be safe for breast feeding mothers and their infants.

Method should not have serious contra-indications which would need specialised skills to diagnose.

Method should not cause long term irreversible damage to the health of women or their progeny.

Results found with NET-EN

In a study done by ICMR, 70% of the women had dropped out by the end of two years.

This aspect of the contraceptive has not been adequately studied.

Since the drug passes through breast milk, the safety of the drug for breast feeding children has not been demonstrated.

There are several contra-indications such as pregnancy, liver disease, which can be positively detected at all times only by using special tests.

Long-term safety has not been proved e.g., cancer risk.

4. Ethical considerations are not being taken into account

According to the ethics of medical research, whenever a new drug is tested on humans, the participants of the trials must be given full information about the known benefits and dangers of the drug and their consent taken to participate in the tests. The women who are recruited for the NET-EN trials are not being told that a new drug is being tested on them. Their consent for participating in a trial is therefore not being taken.

For NET-EN trials, the researchers are supposed to recruit women who

• request a method of family planning.

• choose NET-EN after being told about the advantages and disadvantages of all the methods of contraception available.

However, women are being recruited for NET-EN trials when they go for abortions or for some other gynaecological complaint and are not offered a choice of method even if they do want a contraceptive.

Women are not being told the harmful effects of the injection.

The phase IV trials are being conducted in the form of family planning camps and women are being lured for these by publicity material (posters and pamphlets) which give incomplete and biased information about the injection and other F.P. methods.

5. Should not be introduced into the mass F.P programme

•  Considering that women need to be carefully screened before being advised to take the injection (pregnancy and liver disease must be ruled out, a vaginal examination and breast examination is recommended);

• The injection itself must be administered in a very careful manner (the drug needs to be injected deep into the muscle; care must be taken to expel the entire drug from the syringe, the injection site should not be massaged, because all this can alter effectiveness of the injection);

• and that regular follow-up of acceptors is needed (the first injection should be given during the first five days of the menstrual cycle and subsequent injections after every 60 days);

Considering all this, the injectable is not suitable for our mass family planning programme.

The primary health centres and sub-centres are not equipped to screen women for contra-indications or to deal with complications due to the drug.

6. Potential for abuse

There is a grave possibility that the injection can be widely misused once introduced into the mass F.P. programme. The F.P staff are so pressurized to meet targets that the injection may be given indiscriminately to fulfil quotas. Besides, because of the injection culture that exists in rural areas, women can easily be given the injection without being told that it is a contraceptive.

7. Questions related to Family Planning Policy

The Indian Council for Medical Research is presently experimenting with several hormonal preparations such as vaginal rings, sub-dermal implants, anti-pregnancy vaccine. All these are female methods of birth control. Why are no male methods of contraception being developed?

Why is research being done in long-acting invasive methods of contraception and no attempt being made to improve the already existing and simpler methods such as condom, diaphragm, cervical caps, spermicidal jelly, foam tablets. Is it because the long-acting methods enable the State to have greater control?

Besides, if women's health is really the concern of the policy makers, as they consistently claim it is, then why do we have a target-oriented F.P. programme which leads to so much abuse of F.P. methods?

The Indian government is currently conducting more and more research on long-acting hormonal contraceptives in the form of injectables, sub-dermal implants, vaginal rings etc., which are to be progressively introduced in the 7th Plan period. We consider this emphasis on long-acting invasive contraceptives as a dangerous trend because:

•  Little information exists on the long-term effects of hormonal contraception.

• Invasive methods cause a series of health problems which we consider an unjustifiable risk for women wanting contraception.

• The health services in our country, specially in rural areas, are not adequate to screen acceptors properly, or to deal with complications as and when they do arise.

• Given the target-oriented, high pressured F.P. Programme in our country, there is far greater potential of abuse with these methods.

• The effects of these long-acting methods of contraception will have to be borne by the women for longer periods of time, as the drug cannot be withdrawn at will.

• Such methods leave women with less and less control over their reproduction.

Another cause for grave concern is that several thousand women, mostly from the poorer classes are being recruited for testing these contraceptives without being told that they are being experimented upon. We consider this to be a gross violation of human rights.

We therefore feel an urgent need to campaign against the government's oppressive population policy and its plans to introduce all such hazardous contraceptives NET-EN being the first long-acting, dangerous contraceptive which is in the final stages of testing.

We feel it is important to:

1.    Inform women about all aspects of these hazardous contraceptives so that they are not misled by slogans such as ‘Injection le lo, baccha nahi hoga’ using a variety of methods.

2.    Question the basis on which contraceptives are approved for testing and general marketing in the country, and to form a pressure group to prevent the government from promoting hazardous methods.

3.    Create a debate on the ethics of human experimentation, specially on women who are the targets of contraceptive research.

Needless to say the campaign can be a success only with the involvement of several groups and organizations. We therefore hope that you will join this campaign and send us your ideas about how to make it a success.

FOR THOSE NOT FROM INDIA:

We appeal to you to join this campaign by:

1.    Sending us letters of support to the petition.

2.    Getting information on the testing and use of Net-EN in your country.

3.    Product information sheets given by Schering, the manufacturer of Net-EN. (Brand names are Norigest, Noristerat).

4.    Details of your Government's policy with regard to Net-EN.

5.    Testimony of women who have used or been exposed to the drug.

6.    Statements by medical practitioners for and against use of Net-EN.

7.    Any other information which could help our case.

COUNTRIES WHERE NET-EN IS AVAILABLE

In 1983, Schering provided a list of 34 countries where Net-EN (Noristerat) was available:

1.    AUSTRALIA

2.    BAHAMAS

3.    BARBADOS

4.    BELIZE

5.    BERMUDA

6.    CARACAO

7.    CENTRAL AFRICAN REPUBLIC

8.    CENTRAL AMERICA

9.    DENMARK

10.  FRANCE

11.  DOMINICAN REPUBLIC

12.  GERMANY (FED. REP.)

13.  HAITI

14.  GAUTEMALA

15.  INDONESIA

16.  KENYA

17.  LIBERIA

18.  PAKISTAN

19.  PERU

20.  PHILLIPINES

21.  PORTUGAL

22.  SINGAPORE

23.  SIERRA LEONE

24.  SOUTH AFRICA

25.  SURINAM

26.  THAILAND

27.  TRINIDAD

28.  ZAIRE

29.  ZAMBIA

It is also being used in field studies in:

30.  BANGLADESH

31.  CUBA

32.  EGYPT

33.  PEOPLE'S REP. OF CHINA

34.  TUNISIA

35.  INDIA

36.  IRELAND

37.  SWITZERLAND

38.  SWEDEN

This List may not be Exhaustive.