Is pregnancy a disease?
With the increasing importance of birth control in the national family welfare programme, contraceptive research in the country is bustling. A whole range of new contraceptives, from plant-based creams to surgical methods and vaccines, could make conventional birth-control practices such as sterilisation and condom-use obsolete. And, though they have yet to hit the market, many of them have already become controversial.
The development of new contraceptives -- especially birth-control vaccines -- has sparked protests by various organisations. But scientific institutions researching contraceptive methods are clamouring to be heard above the din of opposition to their work. Both the Indian Institute of Science (IISc) in Bangalore and the National Institute of Immunology (NII) in New Delhi claim they lead the world in research on their respective birth control vaccines.
Anti-fertility vaccines work in much the same way as other disease-fighting vaccines, using the body's immune system to prevent pregnancies. They prompt the immune system of both men and women to treat certain reproductive hormones as foreign to the body.
NII has successfully completed safety and efficacy clinical trials on an injectable vaccine for women. The vaccine induces an immune system response against the human chorionic gonadotropin (HCG) hormone, which maintains the secretion of progesterone (a hormone that prepares the inner lining of the womb for pregnancy). NII tests show the vaccine prevents pregnancy for 20 menstrual cycles after an initial 90-day lag period.
Awaiting field trials Research on HCG vaccines began in the 1970s and is going on in Mexico, Chile, Finland, the Dominican Republic, USA and Australia. NII claims it is the only lab to have finished efficacy trials of this vaccine. Says G P Talwar, professor of eminence at NII who heads the vaccine research team, "We are far ahead in this field of research." NII is now awaiting permission for field trials of the vaccine.
IISc is evaluating the clinical safety and efficacy trials of a male fertility control vaccine, which curbs the secretion of the follicle-stimulating hormone (FSH) that aids sperm production. Says team leader N R Moudgal, "As far as we are aware, this is the first vaccine of its kind in the world to be clinically tested."
Besides anti-hormone vaccines, work on other types of contraceptives is being done. NII has conducted safety trials of an intra-uterine device vaccine based on a neem seed extract that induces the immune system to destroy sperm. Says Talwar, "This vaccine, called Praneem, is simple and was originally devised to cover the 90-day lag period of the anti-HCG vaccine. We are experimenting to find if it can be used independently or for a longer duration." NII scientists are also looking at the gonadotropic hormone, which stimulates ovulation, to curb pregnancy.
The Institute for Research in Reproduction ***(where?) and IISc are experimenting on animals to prevent embryo development.
At IISc, scientists are trying to reduce the synthesis of the male sex hormone testosterone to block sperm production without affecting libido. Says Moudgal, "The method is simple and reversible, but the clinical efficacy of this procedure is yet to be determined."
Meanwhile, the Central Drug Research Institute (CDRI) in Lucknow, which released the birth control pill Centchromon that was welcomed by women's groups, has developed an intra-vaginal spermicidal cream. Called Consap, the cream consists of extracts from reetha (soapnut), a traditional household detergent. Clinical safety and efficacy trials of Consap are over and preparations are under way for field testing on 2,000 couples for about five years.
CDRI director V P Kambhoj says Consap is unique in that it kills sperms in all parts of the vagina, unlike other creams, which require a medium of a certain acidity to be effective. CDRI scientists are also trying to introduce condoms lined with Consap. Claims Kambhoj, "Because it will not be absorbed by the body, the cream will have almost no side-effects. And, it is effective against sexually transmitted diseases." The institute is also working on a pill for men and a menses regulator that can clear fertilised ovum.
However, anti-fertility vaccines have prompted protests both at home and abroad and has been the focus of discussions at various fora in the Capital recently. Women's groups argue such methods are not only dangerous but would also make them increasingly dependent on medical professionals. Says a spokesperson of Delhi women and human rights groups, "Without adequate follow-ups, these methods can pose major health risks."
At a population summit of the world's scientific academies, the importance of "improved contraceptive options for both sexes" was stressed. On November 11, officials from the department of family welfare and scientists from the Indian Council of Medical Research (ICMR) and NII held a debate with representatives of women's organisations who oppose implantable, injectable and immunological contraceptives.
Three days earlier, 16 women's and human rights groups protested outside the regional World Health Organisation (WHO) office against WHO-aided research and clinical trials on birth control vaccines. Their slogan: You can't treat pregnancy like a disease.
A notice issued by the 16 groups, which included Janwadi Mahila Samiti, Saheli and the People's Union for Democratic Rights, puts the arguments in a nutshell: "The immune power in invaluable; it is for fighting diseases; it is wrong to misuse the immune system against pregnancy. And, vaccines can be imposed on unsuspecting rural folk; even doctors cannot reverse the effect of these vaccines."
At a workshop during the seventh international women's health meeting held in September at Kampala, Uganda, a campaign was formulated to stop the development of anti-fertility vaccines worldwide. Workshop papers argue, "The risk-benefit balance will never be favourable" especially "if the real life conditions of men and women in LACAAP (Latin America, Caribbean, Africa, Asia and the Pacific) countries are considered.
However, scientists point out such fears are unfounded. NII scientists claim trials are being carried out in reputed medical centres. They also contend that side-effects are few. Says an NII scientist, "Earlier, in clinical trials (of HCG vaccines) involving 106 subjects, only seven women developed fever as a reaction. This can easily be handled clinically. Further tests show even this (reaction) can be eliminated."
More options ICMR senior deputy director general B N Saxena defends the development of the new contraceptives, saying, "Scientists are trying to provide more options that have less physiological strain. The aim is always to find more effective and safer contraceptives."
Talwar explains the significance of anti-pregnancy vaccines: "Tubectomy and vasectomy are perceived as irreversible. Condoms and pills require constant motivation and their use in rural areas is limited. Intra-uterine devices entail heavy blood loss, which can be costly for anaemic women. Norplant has not yet entered the scene. So there is a need for reversible, new methods that do not disturb menstrual regularity, increase bleeding and require daily intake." Talwar has invited the protesting women's groups for an open discussion.
-- with inputs from Sachindra in Lucknow.
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