11. the anti-fertility vaccine that never was

The Anti-Fertility Vaccine
That Never Was
Sonya Ghosh
The research on the anti-hCG vaccine consists of a part of Kulkarni PP, Patel KL et al, 1982, “Clinical controversial anti-hCG anti the hormone which induces an and Immunological Response to Pr-B-
fertility vaccine that scientists antibody reaction and blocks hCG.
Two prototypes of the anti hCG 25:421-34).
struggling to develop for the last three vaccine are being developed globally, The Anti Fertility Project
decades raises many ethical questions one by the World Health that need to be debated. Questions Organisation (WHO) HRP in Geneva Research (ICMR) launched a multi crore have been raised by women’s groups and the other by National Institute of project called “Immunological since the 1970s about compromising Immunology (NII) by Dr. G.P. Talwar Approaches to Fertility Control” (IAFC) rights of women in the name of and his colleagues.
‘population control’. Instead of giving Inconclusive Trials
The WHO Task Force guidelines to become a classic example of futile prevent pregnancy and protect on Immunological Methods for Fertility research, inexplicable delays and against AIDs and sexually transmitted Regulation attempts to limit cross- unjustified expense and needless animal
diseases, the anti fertility vaccine is reactivity. Cross-reactivity between experimentation. Initially funded by the
designed to be easily administered to hormones is a key concern because Ministry of Health and Family Welfare
large numbers of women using the hCG resembles a family of hormones with an outlay of Rs.14.63 crores (1983-
least resources. If administered to produced in the pituitary gland. A 92) it was transferred to Department of
illiterate populations the issues of user vaccine that immunises against hCG Biotechnology (DBT) in 1987. The
control and informed consent are could affect these other hormones government sanctioned Rs.5.77 crores
further cause for concern. Most of the causing other disorders. To avoid to National Institute of Immunology and
research is directed towards women cross-reaction, World Health to five other governmental institutes on
even though these vaccines can be Organisation HRP(??) decided to the controversial vaccine.
used by both men and women. develop a vaccine based on a peptide
Going Against Own Findings
However, the government has now that has no similarity to the pituitary realised that inappropriate animal hormones. However, NII under Dr. experimenting on rodents, bonnet models were used and have halted the Talwar decided that cross reactivity is monkeys and baboons, before starting not important. A prototype vaccine Phase1 clinical trials. These trials What is the Anti hCG vaccine? based hCG was carried out by showed that though all the women
A rise in the level of hormone hCG Population Council in the 1970s, All generated antibodies against hCG indicates that a woman is pregnant as India Institute of Medical Sciences above the determined efficacy level. Theit is secreted by the early embryo and tested another similarly based antibody response was variable amongtriggers release of other hormones to injectable prototype vaccine in 23 the participants, an outcome that theenable the fertilised egg to remain healthy, young women. Eight extensive animal trials were unable toimplanted in the uterus. If hCG is pregnancies occurred in this group predict. The researchers, however,blocked, the level of progesterone creating a controversy on the ethics of declared satisfaction with the vaccine,declines and the blastocyst (fertilised using fertile women in such studies and its fully reversible nature. Butegg 5 days after fertilisation) is since the effect of this vaccine on their extended Phase1 trials (completed inexpelled, terminating pregnancy. The babies is not known. (Shahani SM, September 1990) refuted these findings, Phase III trials, intended to conclude CAG report, 1994, at http:// previous trial had shown ‘encouraging’ by 1992, have not been held till date. Dr. www.cagindia.org/reports/scientific/results.
Talwar retired from NII to continue 1994_book1/index.htm) and whether Flexible Definitions
developing the vaccine at his it will indeed fund the vaccine being After Phase1 trials, key scientists independent Talwar Research developed by Dr. Talwar, and on what decided to cross-expand the parameters Foundation, which work he claims DBT grounds and to what extent.
of defining what constitutes a ‘normal’ will fund. Dr. Vinayak of DBT confirmed Explain Wasted Funding
menstrual cycle of women and defined that after two decades the vaccine was Scientists responsible for thisit as 22-35 days. On this basis they still in its developmental phase, that inconclusive research, funded byconcluded that 90 per cent of the women Phase III trials have not yet begun and government and supported by publicundergoing the trials had normal that funding to this project had been taxes cannot continue to hide behindmenstrual cycles. According to this downgraded. It remains to be seen how the myth of ‘progress of mankind’ tomode of analysis, a woman who had a DBT will phase out the anti fertility carry out what increasingly appears aregular 24-day cycle before vaccination vaccine funding so as not to attract self serving activity: accountabilitywhich changed to 32 days post- public attention to its investment of must be enforced for state fundedvaccination, would fall within the range crores together with other blunders researchers and they must explain theof normal. This enabled the scientists (already noted in detail in the lack of results. to disregard irregular cycles. Instead,insertion of IUD, irregular use ofcontraception or lactation were cited as The Ethics of it All
reasons for fluctuation in menstrualcycle length. Is The Non Human Primate Model
Ignoring Negative Reactions
Appropriate For Anti Fertility Studies?
indicated similar results with 85 per centwomen seen to have “normal” cycles.
The Rhesus monkey is a popular monkeys that have suffered from and Variation in immune response and choice for testing pregnancy been treated for tuberculosis in resulting pregnancy risk was a termination through hCG because of articles in research journals withoutproblem that emerged clearly in Phase easy availability of this animal. It is citing this fact?II clinical trials held at the AIIMS, also justified by scientists on grounds Safdarjung Hospital and the PGIMER: of alleged “monkey menace” in both which have been seriously sickeven though 80 percent of women urban and rural areas, an argument contribute to any serious research orgenerated antibodies that were used also to justify the use of stray will it simply serve to earn promotionsclearly above the safe level (revised to dogs in experiments. However, certain for the researchers?50ng/ml from 20ng/ml in Phase 1 ethical questions arise in the use of trials). One pregnancy occurred in a the rhesus monkey: The convoluted cervix of the female monkey simply because there is a data level. 26 pregnancies occurred in women rhesus makes manipulation difficult base on that monkey in terms of estruswith low antibodies. Of these, four and blastocysts have to be recovered cycles, pregnancy records,opted to deliver their babies through a difficult surgical process. reproduction records, etc. Monkeyswhich were reportedly normal and Is it ethical to subject the rhesus to languish for years in animal housesfollow-up was only done till the age successive surgeries on grounds of because researchers do not collectof three-and-a-half years, instead economy and easy availability when data on younger monkeys: one 27 yearof 10 years, as recommended by a species like the bonnet monkey old monkey has been in the animalIDRC, and WHO guidelines.
would enable non surgical recovery house of a reputed medical college of The unacceptability of this of blastocysts as it has a straight Delhi for 19 years because of ‘proven
vaccine became clear on three counts cervix?
after the Phase II trials:
• the antibodies produced were too the wild and most suffer from monkeys are not even given aseptic variable for an acceptable product. tuberculosis. Is it ethical to present post operative care, (often even anti-fertility data recovered from analgesics are denied). They are The Profile of an Illegal breeder
with other individually housedmonkeys in rooms that lack basic The family of Shashi Suri has illegally procured and sold animals for experimentation for three generations.
A CPCSEA team made a surprise visit to his top story flat in Model Town.
Initially he denied keeping animals on the premises but when we prevailedupon him to unlock the terrace, this is what we found: trays of mice were found strewn, some mice had died of cold (it was the month of December), others had eaten each other as no food or water had been given. In a tray under the water tank, a breeding rat had cannibalised her newborn babies and only the remnants could be seen. In another corner of the terrace was a bucket of stale water filled with frogs, half of which were found to have died. In other cages, rats and mice had not only died, but were left to rot Mr. Suri is a popular supplier and has sold animals to Delhi University colleges, Maulana Azad Medical College and All India Institute of Medical Sciences. For a consideration he can even supply cats, dogs and monkeys caught off the road. His frog suppliers bring frogs in gunny bags and earthen pots from Bulandshahr and Guwahati by train.
Reliable and reproducible results from animal experiments can only beobtained if laboratory bred animals with identifiable genealogies and proper health parameters are used. Yet reputed institutes do not attach Human Reproduction ed. M.Serio and any importance to this crucial scientific fact. This raises questions as to the relevance of the data collected from experiments on such animals.
Delhi University colleges continue to buy from him in violation of all baboons differ in important aspectsfrom that in humans” and raises the Early Training into Malpractices
question of whether an appropriateanimal model can be found to mimic • None of these colleges have an animal holding facility , animals for dissection days and in the rhesus it is 8-9 days.
shift graves at the back of the institute • No registers are maintained to record health and treatment.
Sonya Ghosh

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