WHY THE CONCERN NOW?

Why the Concern Now?

Newsletter April 1987

India prides itself as the first country in the world to have a national programme of family welfare and planning. It became an integral part of economic planning right from the first Five-Year Plan, 1951-56. In the beginning a ‘clinic approach’ was adopted, i.e. services were provided to those who sought them on their own. When this did not reduce birth rate to a targeted level, the clinic approach was changed into an ‘extension approach’. Here, female health workers were recruited to actively canvass for the adoption of contraceptives by married couples, Incentives in the form of cash rewards were used and the health workers in the government service were pressurized by the target system to `motivate` couples. Utilization of force to compel people to adopt F .P. methods reached an unprecedented height in 1976-77 (during the emergency). The end result of this period was the overthrow of the ruling party of the time. Because of this, the pressure was let off to an extent during the sixth Five Year Plan and no overt force was used on the people. However, from the policies and programmes outlined in the current Five Year Plan (Seventh Plan Period), it is clear the effort is to reduce birth rate at all casts, reminiscent of the period of the emergency.

In this plan period, the emphasis of the government is to be on

(a) long-acting invasive methods of contraception,

(b) speedy introduction of contraceptives approved in other countries without conducting the necessary clinical trials in India, and

From this it seems that the national goal of population control is likely to overrule all considerations of the health of women, who are the primary targets of these methods and policies.

Implications of Emphasizing Long-Acting Invasive Contraceptives

The methods of preventing pregnancy can be broadly classified into 4 categories 1

1. methods that do not interfere with the reproductive system·- abstinence, withdrawal, rhythm, mucus method (natural methods) and condom, diaphragm, cervical cap (barrier methods).

2. methods that prevent conception by acting locally on the reproductive organs—intra-uterine contraceptive device (Copper—T, Lippe’s loop).

3. methods that prevent conception by acting on the entire reproductive system—oral pills, injectables, subcutaneous dermal implants, etc.

4. methods that surgically and permanently block conception—vasectomy, tubectomy.

The first three categories are considered spacing methods which are used to control the interval between two successive births while the fourth category is of terminal methods.

Since all methods of contraception are designed to prevent/block/disrupt the normal reproductive process in healthy individuals, safety and effectiveness are the two most important criteria for evaluating a contraceptive. Considerations such as control over reproduction and contraception, potential for abuse, and health service implications also need to be taken into account. These considerations will have to be applied to each of the spacing methods available.

Safety

In contrast to therapeutic agents used to treat physical and mental ill11ess, contraceptive agents are directed to interfere with normal body processes in individuals in good health.

* they are used potentially over long periods of time

* require a rapid and complete reversibility of action

* are employed on a continuous basis by considerably larger number of women

* are frequently administered with less supervision than any other therapeutic agent.

Another consideration is that interference with the reproductive process may theoretically at least affect the health of future generations and the future fertility of the woman herself.

Because of the above factors, all effects other than the contraceptive effect experienced by the use of a contraceptive, assume far greater significance. Unlike therapeutic agents which could potentially leave the user in an overall state of better health, complications due to contraceptives can potentially leave the user in a comparative state of ill health.

The harmful effects of the three categories of spacing methods depend on the level at which they act, i.e. the level at which they disrupt the reproductive process. Natural and barrier methods do not interfere with the reproductive system as such, and therefore there is no question as to their not being safe.

IUCD’s act locally and the problems due to their use are generally limited to the reproductive organs, i.e. pelvic inflammatory disease, excessive menstrual bleeding and sometimes septic abortions and ectopic pregnancies. Invasive methods (those that enter the blood stream) such as oral pills and injectables act systemically. They act not just on the reproductive organs but on the other organs also which are not involved with reproduction. Thus oral pills can affect the clotting mechanism leading to the formation of blood clots in the veins, which can result in myocardial infarction (heart attack).

It is obvious that the systemically acting invasive contraceptive agents are far more hazardous than the locally acting, natural or barrier methods.

Effectiveness

It is generally argued that invasive methods have much lower failure rates than the other spacing methods.

For every contraceptive method there are two kinds of effectiveness: theoretical effectiveness and use effectiveness.

Theoretical effectiveness refers to the anti-fertility action of the contraceptive agent under ideal conditions without errors or omission in technique. Theoretical effectiveness can vary from population to population because of disease pattern, height, weight, etc. Use effectiveness reflects the level of protection achieved by a population using the method in a given place, time, and under given conditions. Use effectiveness also varies from population to population because of social and cultural factors. To a considerable extent use effectiveness is determined by continuation of use and consistent practice of method adopted by the user. In turn, continuation and regularity of use reflect, among other things, the frequency of "side effects" experienced with the method.

In order to promote invasive methods of contraception, generally their theoretical effectiveness is compared with the use effectiveness of barrier methods. For instance, condom with spermicidal agent has similar theoretical and use effectiveness as the oral pill. However, the oral pill is pushed on the argument that its theoretical effectiveness is greater than the use effectiveness of condoms with spermicidal agent. This is a gross misrepresentation of facts.

Approximate number of pregnancies during the first year of use per 100 non-sterile women*

*Source: Contraceptive Technology, 1976-77.

With regard to injectable contraceptives, till now only their theoretical effectiveness is known. Their use effectiveness remains to be seen. However, since frequency of side effects influences continuation rates, and continuation rates determine use effectiveness; it is possible to predict their use effectiveness on the basis of information we already have. In India, continuation rates with the injectable NET-EN have been found to be considerably lower (31.4) than with IUCD (52.6 for Copper T) by the end of two years.

As with this injectable, complications due to other invasive methods will be higher than with other spacing methods. Therefore continuation rates due to complications and lack of health facilities are likely to be lower, thereby making them less effective in practice.

Thus, both from the point of view of safety and effectiveness, invasive methods are not likely to offer any advantage to the user.

Why then this emphasis on invasive methods? This is where the social and cultural aspects of reproduction and its control, and health service implications come into play.

Control over Reproduction and Contraception

Unless left completely to the choice and desire of users, people have to be motivated to use contraceptives, and more importantly, to continue using them. This is where long acting invasive methods offer a particular advantage. Unlike the pill which needs to be taken daily, and thus requires daily motivation on the part of the user, or the condom which also requires constant motivation, long-acting invasive methods offer the potential of protecting the user for much longer periods of time after just one shot of motivation. For example, one injection can protect a user for two months or more. This same logic applies in the desire to produce sub-dermal implants which, once inserted, can protect the user for two years or more. IUD’s, once inserted, can also protect a user for 2-3 years. However, IUD’s can be pulled out by the user herself if she so desires, whereas long-acting invasive methods do not leave this control in the hands of the user. A woman can decide not to take another injection but can do nothing about the injection and its effects for the duration of its action, i.e. two months or more. Similarly, implants can be removed surgically, but only by a medical practitioner. Instead of the user having the power to decide when to discontinue a method, the power new shifts into the hands of the medical and F.P. practitioners.

Potential for Abuse

Invasive methods also carry a high potential for abuse. While nobody can force a person to use a condom, swallow a pill or keep an IUD in place, an injection can he given to a woman without her knowledge of receiving a contraceptive. Just the way IUD’s are known to have been inserted into women after undergoing abortion or delivery, without their knowledge, sub dermal implants, or vaginal rings can also be inserted without the knowledge of the woman, when she is in the hands of the health and F.P. system.

Implications for Health Services

Long-acting methods are also propagated on the grounds that they are beneficial in countries with poor health services. The logic is that long-acting methods require less contact with the health and F.P. service since one time motivation offers long term protection. In terms of ‘fitting’ the user with a contraceptive this logic holds true; however, it breaks down completely when we consider that long-acting methods create far more complications and therefore create the need for greater medical supervision and better health services.

The particular characteristics of long-acting invasive methods therefore create advantages for the government and the F.P. programme, but not for the woman herself. To focus on the peace and comfort of taking one injection and relaxing for 2 months, or taking an implant and being worry-free for 2 years, is to overshadow the crucial issues of safety and effectiveness.

Implications of Introducing Contraceptive Agents which have been found Safe and Effective Elsewhere, without Conducting Clinical Trials in India.

Every new drug or contraceptive agent goes through a series of animal and human trials before it is approved for marketing. These tests are done to determine the efficacy, dosage, short-term/long-term effects and effect on progeny, of the drug or contraceptive agent. When all these factors have been established, operational research studies are conducted to see how the logistical problems of supply, requirement of health services and training requirements of health and F.P. personnel to deliver the contraceptive can be met. It is mandatory for a drug company to conduct animal and human studies to establish safety and efficacy before applying for permission to market a drug or contraceptive agent. Countries wishing to use the drug or contraceptive agent in their own country make their decision on the basis of this data. However, clinical trials on humans (phase I,II,III) are also conducted in each country, depending on the drug regulations in that country.

Some countries may conduct all the phases of human trials while other countries may conduct only phase III and then go on to operational research. The reasons for conducting clinical trials in the country are:

(a) The physiological norms of the people (height, weight, etc.) differ significantly from one part of the globe to the other, with the result that dosage alterations are sometimes necessary.

(b) In India, a great majority or people have had tropical diseases with the result that the functioning of liver or spleen is affected which, in turn, may alter the pattern of bio-transformation of these drugs in the liver.

(c) Finally, we know that there is what is known as the ‘genetic variability of enzymes’ which affects drug responses. In recent years it has been realized that drugs may affect the rates of enzyme formation. The activity of drug inactivating enzymes in human liver is also known to be under hereditary control*

(*Source : ICMR Technical Report Series No. I2)

The new recommendation of approving contraceptive agents on the basis of results found elsewhere, and only conducting operational research studies in the country is therefore a dangerous trend. While such a policy would no doubt expedite the introduction of new contraceptive agents, it will leave Indian women open to all kinds of unforeseen harmful effects of these contraceptives, with little help provided by the inadequate health services in the country. A country like ours also does not have any mechanism for conducting post-marketing surveillance to document and monitor unforeseen effects. Further, once the drug is in the market, the .Indian Drug Regulatory Authority is not powerful enough to withstand the multinational and national drug lobby and withdraw a hazardous drug or contraceptive from the market. (The history of high-fixed-dose oestro-genprogesterone combination drugs is a classic example where even though the Drug Controller banned these combination drugs, the drug companies were able to get a stay order against the ban. These drugs are still sold in the country over the counter).

Implications of Adopting Social Marketing Techniques to Promote Contraceptive Use.

The government is at great pains to make us (and the world) believe that our F.P. programme is a voluntary programme, a people’s movement, based on the cafeteria approach. In this context using social marketing techniques appears to be no more dangerous or harmful than using high pressured advertising to sell a variety of soaps. The government and F .P. planners also counter arguments against the promotion of hazardous contraceptives by stating that there is no harm in including them in the "contraceptive cafeteria". After all, different users may find different contraceptives more acceptable.

However, this approach requires certain preconditions which do not exist in our country. To choose freely women need:

- unbiased information regarding the advantages and disadvantages of the different contraceptives.

- the freedom to choose contraceptive best suited to them

- constant supply of all contraceptives.

It is a well known fact that voluntary acceptance of a contraceptive method is a myth in our country. Reliant on medical and F.P. personnel for their information about contraceptives, women are usually given incomplete and/or biased information. The F.P. worker may not be aware of the complications and risks associated with a method. Because of the targets each worker has to meet, they may hesitate to give information even if they have it, thinking that women may get unnecessarily put off. Often motivators recommend their own favourite method. Contraceptives are also recommended on the basis of what is available with that particular motivator, or the contraceptive which is being tested. For instance, barrier methods like cervical cap and diaphragm are not available in the country.

Government propaganda, in the form of leaflets and pamphlets, is no less biased and social marketing techniques are not going to help the user in any way. Advertising has never been associated with complete and accurate information, and using non-conventional outlets for sale of contraceptives ensures less rather than more information. The experience of Bangladesh is a clear indicator of what will ensue. A few years ago, Bangladesh adopted an inundation programme using social marketing techniques to promote oral contraceptives- These pills were to be distributed through unconventional outlets such as paan and cigarette shops as well as through family planning workers. Funded by USAID, the programme turned out to be expensive for both the women and the funders. Instead of reducing fertility this programme ended up by increasing the fertility rate by more than 10% (a common occurrence if women miss one or more pills in the cycle). Another consequence was that many women continued to take the pill even after they had become pregnant because the pill often masked the indications of pregnancy. As the pill often produces symptoms similar to pregnancy, the village women confused the symptoms of pregnancy with the effects of the pill. Even USAID’s trained family planning workers could not answer most of the basic questions about the pill. After3 years of experience with the inundation programme, these workers could not say how many days after the onset of menstruation a woman should start taking the pill; did not know what advice to give to a woman who missed taking the pill on five consecutive days; and could not say what type of side effects might be anticipated by women on the pill.

When combined with the fact that long-acting invasive methods tend to leave women with less control over contraceptive choice, and that contraceptive availability is determined by a complex relationship between drug companies, Aid agencies and the government, it is obvious that social marketing is not going to be in the interests of women. They will only be the victims of high doses of subtle pressure to conform to the behaviour desired by the F.P. planners and the government.

Conclusion

The new trends in the F.P. policy pose a serious threat to the health and personal liberty of women, who are the targets of F.P.

We need to understand and expose the implications underlying these policies. We also need to raise the following questions:

l. Is it justifiable to introduce hazardous invasive hormonal contraceptive methods to prevent a normal physiological phenomena such as pregnancy?

2. Is it justifiable to pose contraception as an answer to the lack of adequate obstetrical facilities, nutrition and other basic requirements which cause the majority of morbidity and mortality in women in the reproductive age group?

3. Is it justifiable to snatch away from Indian women the little control they have over their fertility by promoting methods of contraception that are designed to place control in the hands of F.P. experts?

4. While it is necessary to conduct trials on human beings to test new contraceptives, is it justifiable to recruit persons who are not in a position to give informed consent in the true sense?