Norplant  Sterilisation  Third world guinea pigs

BBC Television: Horizon

THE HUMAN LABORATORY

AIR DATE 5 November 1995

NARRATOR (CHARLOTTE CORNWELL): The 60s, the age of contraception, heralded a whole new era of liberation for women. But contraceptives have not always meant liberation.

SYBIL SHAINWALD: They have been used as a human laboratory. They're just expendable. Who cares if a Third World woman dies?

NARRATOR: When Norplant was released in the West recently, it seemed to be every woman's dream. Hassle-free sex, no daily pill, and extremely reliable protection. Six implants are surgically inserted under the skin of the arm, where they stay for five years, releasing a hormone to inhibit ovulation. Its developers claimed it was the most widely-studied contraceptive to arrive on the market. But some women have had problems. Patsy Smith had Norplant inserted after the birth of her second child.

PATSY SMITH: Three months after having Norplant inserted I started getting horrible headaches like gosh, it was like somebody was just grabbing my head and just squeezing it together as tight as can be squeezed like someone had put a bomb in there and it was going to go off. I'd noticed that being kind of blurry and after the months it got a little bit more blurry and things started looking like they were on top of each other and...

NARRATOR: Doctors thought there was nothing wrong at first, but over the next year her eyesight deteriorated. Her symptoms became unbearable and she was taken to hospital.

PATSY SMITH: I knew something was wrong rightaway when residents and students and people started coming in and saying can we look at your eyes, you know, can we take a look at your eyes. They did all kinds of tests and pictures and X-rays and ultra-sounds and odds and ends and, oh I was scared, I was really, really scared, and then they tell me this big word and I'm like whoa. I then asked if I would go blind and Dr. Tang told me she couldn't make any promises that she couldn't make me any guarantees at all, so we're just waiting.

NARRATOR: They found Patsy had pseudo-tumour cerebri, a condition where increased fluid pressure in the brain crushes the optic nerve. The pale circle shows a cross-section through a normal nerve, but in Patsy's case, the fuzzy white circle shows where the nerve has been crushed and permanently damaged.

DR. ROSA TANG: Patsy has blindness in one eye already, for practical purposes. What damage she has now is not going to improve. She is blind in that eye permanently and partially blind in the other. If she has another episode this may further damage the vision she has left and she could go completely blind.

NARRATOR: Could the Norplant have caused this? Dr. Tang became so concerned that she wrote to every eye specialist in Texas to find out if other women on Norplant had eyesight disorders. Out of 100 women referred to her, over 40 had blurred vision. Of these 8 had the same condition as Patsy.

ROSA TANG: It was very surprising for me because I had not seen any reports in the literature at this time of such a link between Norplant and pseudo-tumour cerebri and I was surprised of the fact that there were so many patients that seemed to be having the condition related to Norplant. I think that there is enough out there that there is a possibility of a link between the two that a larger-scale study should be done if Norplant is to be continued.

PATSY SMITH: What hurts me the most is the possibility that I may go blind and not see my children grow up. It's really scary. It's more precious to me now than it was before. I take a lot of the things that she does and I hold them near so that way I can remember them if anything happened.

NARRATOR: Eyesight disorders, strokes, persistent bleeding, problems with removal - many women have no such side-effects, but thousands are now taking legal action in the West. Norplant was studied for 20 years in the West, but mostly in developing countries. After standard clinical trials of Norplant had been completed, pre-introductory clinical trials were held to assess the drug's safety, efficacy and acceptability in local conditions. Horizon went to Bangladesh to investigate one such trial. In the mid-80s, stories had begun to emerge from women's health campaigns. In the slums of Dhaka, Farida Akhter heard of women with Norplant in their arms who were desperate to get it removed. She realised she had stumbled on a drug trial.

FARIDA AKHTER: This started with the slum woman very secretly. They just did not tell anybody, there was no announcement and these are poor women, we are not meeting them every day so nobody knew.

NARRATOR: Farida Akhter was concerned about the vulnerability of slum women and wanted to know how the tests were being run, but no-one could tell her.

FARIDA AKHTER: We found that the family planner would just come to them and say that you can't talk about these things to any outsider woman, and they were afraid to talk to us, you know. They were so afraid that sometimes they were not even sure that because we look educated woman we might be from the government, or from the family planning clinic itself, maybe we are just pretending to know them, so they were not sure what they could tell us. You know, it took us time to even get their trust to be open and they were so much afraid, you could see in their face that they were really afraid.

NARRATOR: An earlier trial had been dropped because of public outcry over the way Norplant was being promoted as a safe drug when it was still under test. While Farida Akhter was investigating this trial, her offices were raided by military government officials.

FARIDA AKHTER: They just gave me an impression that if I don't answer questions in the right way they will do something. It was like a frightening thing you know. They entered the gate, asked where is the Executive Director and you know, two men coming in you know and entered my room and sat down and there was a file and you can see the government file, you know it's a red tape and they have Ubinig written on it you know, and they said where do you get the money from, what are you doing you know. They were just frightening me, asking me look, you have the file, we have information about you.

NARRATOR: Undeterred, she continued her investigation.

FARIDA AKHTER: I really had to find out in a detective way. We went to the villages, we went to the slum areas. It was more than 100 woman we talked to.

NARRATOR: She found the side-effects were having a dramatic effect on their lives.

WOMAN [SUBTITLED]: Suddenly my body became weak, quite suddenly. I couldn't get up, couldn't take care of my children, couldn't cook. I was bedridden.

WOMAN [SUBTITLED]: It was unbearable.

INTERVIEWER: Did you feel weak?

WOMAN: Yes, my limbs felt like collapsing, as if they were being wrenched apart. I couldn't work or eat even. I had to lie in bed for three months. I couldn't do anything.

INTERVIEWER: And the bleeding?

WOMAN: I was bleeding all the time.

FARIDA AKHTER: Severe bleeding makes her so weak and she even does not have two meals a day. Many of them fainted quite often, you know which was not the case before, so these woman were telling us we were supposed to be very happy after taking this Norplant, but why our life is like hell now.

NARRATOR: Then she heard of women being coerced to stay in the trial. Once Norplant is inserted, a woman cannot remove it by herself.

WOMAN [SUBTITLED]: I went to the clinic as often as twice a week. But they said: 'This thing we put in you costs 5,000 takas. We'll not remove it unless you pay this money.' Of course I feel very angry. I went to several other doctors and offered them money to take those things out, but they all refused. I went to three or four of them and they said these can only be taken out by those who put them in. They said that, if they tried they might go to jail.

INTERVIEWER: If they ask you to take Norplant again, will you?

WOMAN: That thing! Even if 14 generations of my ancestors asked me, I shall refuse.

INTERVIEWER [SUBTITLED]: How many times did you go to the clinic and ask them to take it out?

WOMAN: In 6 months about 12 times. Yes, about 12 times. I went to the clinic and pleaded 'I'm having so many problems. I'm confined to bed most of the time. Please remove it.' My health broke down completely. I was reduced to skin and bone I had milk and eggs when I could, but that did me no good.

WOMAN [SUBTITLED]: I felt so bad, my body felt so weak, even my husband told me it was all very inconvenient.

INTERVIEWER: How is your relationship with your husband?

WOMAN: What else could it be? He says he'll get another wife tomorrow. I told the doctors, 'Please take it out, I'm having so many problems.'

INTERVIEWER: How many times did you ask to get it removed?

WOMAN: Oh, about 15 times. One day I was so desperate. I gave up hope. I felt like throwing myself under the wheels of a car.

FARIDA AKHTER: One woman when she begged to remove it, they said 'I'm dying, please help me get it out'. They said 'OK, when you die you inform us, we'll get it out of your dead body', so this is the way they were treated. In a slum area people are living in a very small, like 5ft by 7ft where at least five family members are living and these woman are working outside. The most important resource they have is their own healthy condition.

NARRATOR: In Bangladesh if a woman can't work, often her family can't eat.

FARIDA AKHTER: We have many information where these woman have told us that they have sold their cow or the goat which was the only asset they had for treatment because she had to get well, otherwise the family can't survive, so in order to save her, they had to, you know, sell the cow or if they didn't want to treat her then she suffered, so the family was suffering either way. In every sense these people were totally torn. Their economic condition were torn, their family happiness was totally gone.

NARRATOR: By now, news of the Norplant testing had spread. Nasreen Huq, who has recently represented the Bangladeshi government on women's health issues, found more disturbing aspects to the trial.

NASREEN HUQ: Participation in a clinical trial requires that the person who is participating in that trial understands that it is a trial, that the drug they are testing out is still in experimental stages. This requires informed consent. This was categorically missing.

INTERVIEWER [SUBTITLED]: When they implanted this device, did they say it was an experimental thing that they were testing?

[WOMEN RESPONDING]: No.

NARRATOR: Perhaps most worrying of all in the drug trial, potentially serious side-effects appeared to have been ignored.

NASREEN HUQ: Many of them told us that they had problem with eyesight which is not recorded by the clinics which were doing the trial on their bodies.

WOMAN [SUBTITLED]: I couldn't see. I couldn't look at things at a distance. I had trouble focusing. You know in the village we light oil lamps. I couldn't look at them. They looked like the sun, as red and large as the sun. If I looked into the distance, my eyes would water.

INTERVIEWER [SUBTITLED]: What do you mean by this dimness of the eyes?

WOMAN: If I went out of doors, my eyes became absolutely dark. I couldn't see anything at all as if my eyes had become affected by blindness.

NARRATOR: In 1993 a report of the first phase of this trial concluded: Norplant is a highly effective, safe and acceptable method among Bangladeshi women.' It stated less than three per cent of women reported significant medical problems, no mention of eyesight disorders or women being refused removal.

NASREEN HUQ: I think the Norplant trials were bad science, really shoddy science, because they were not recording the side-effects. They were scolding women when they wanted to report side-effects, they were scolding women if they came in at a time when they were not scheduled to come in for a follow-up check. Their request for removal were disregarded, were not even recorded during the trial. So how can they tell us that it was an acceptable method for women and that this has been scientifically tested out, you know? When continuation rates reflect caution, reflect refusal to remove, reflect disregard of women's concerns, reflect disregard for women's health, how can they even accept that this has been the work of scientists?

FARIDA AKHTER: If you look at the trial, it looks like as if this woman are no better than a guinea pig and a guinea pig perhaps is more expensive in the West, that's why our woman are cheaper here, so they're easily available, they can be easily controlled and their bodies can be easily tested.

NASREEN HUQ: When you conduct a trial in this sort of setting, you are simply taking advantage of them being poor. You've access, cheap access, to subjects, and you can write it up as a successful trial. You're not in any way advancing science, you're taking advantage of a situation in which women are poor and they don't want to have more children, and by providing this method, or conducting this trial, you are not in any way letting them out of their desperate situation. I mean, I have been trained in science and I'm sorry, this is not science.

NARRATOR: The trials were developed with funds from the US Agency for International Development.

DR NILS DAULAIRE: We have very strict rules at AID in terms of any experimentation that's done that certain ethical standards in terms of human subjects have to be met, and informed consent is a critical part of that. I've not been made personally aware of any serious lapses in terms of informed consent of any of the AID trials. If there are cases where women were not accorded the opportunity to have Norplant removed, that would be a very serious breech and if this was done with US aid funds, we would take that extremely seriously.

INTERVIEWER: Well it has been done with US funds it appears, and we have interviewed many women who had problems getting it removed. How can this be, with a clinical trial which you're running with American taxpayers' money?

NILS DAULAIRE: Well I can't answer that specific clinical trial because that's one that I'm not personally familiar with. I can't tell you how it can be, I can tell you that if it is, there will be severe consequences. The organisations that would be responsible for monitoring and overseeing these would have to clarify how any such activities took place under their oversight.

NARRATOR: Family Health International oversaw some of the trial for US AID. They confirmed their officials were in Bangladesh regularly, but told Horizon: we do not believe this was very poor science. The study was well designed and implemented in an ethical way. They admitted there were problems with removal, but say they acted upon them and that these were not as widespread as claimed. Yet their own data reveals that out of 1300 women from the expanded trial, over 100 reported being refused removal. And Horizon found evidence of problems with other US AID studies of Norplant. Testing was also carried out in Cité Soleil in Haiti, the poorest community in the poorest country in the western hemisphere. Since the mid-80s, there have been 14 coups d'état and 8 changes of government.

CATHERINE MATERNOWSKA: Danger's a difficult concept to define in Haiti. It can come from any direction at any moment. People who stand up and indicate that they have been abused are often punished, attacked at night, raped, hundreds of women in Cité Soleil have been raped by the para-military forces. Often entire neighbour-hoods are razed and burned down. This political instability makes the climate for doing good research absolutely impossible. For many years now I've had copious field notes on side-effects with the Norplant method, but I've had to work essentially in secret and covertly with Haitian women listening to their stories and their difficulties and unable to publish it. The participants in my study could have been in grave danger had the information been let out, the fact that they were talking to me about their woes, about their difficulties with the Family Planning Centre and the Norplant method. Many of the women that I interview come from the countryside where they've lost their land, where they've lost their income, where they've basically taken off in search of life and within months most of them tell me, the little saying (FRENCH) takes a turn and they say (FRENCH), which means in searching for life the essence of life is destroyed. They can't find food, they can't find water, they have no access to health care, so essentially they're looking for life but they find misery.

NARRATOR: It was while studying this community that Catherine Maternowska came across US AID trials of Norplant and was worried at what she found.

CATHERINE MATERNOWSKA: Side-effects in the context of Haitian women's lives are horrible. With the Norplant users they were extremely severe. Bleeding could go on for 18 months and what this means in a Haitian woman's life has enormous impact. In Haiti, women don't have cotex or tampons. That means that they have to use rags. She needs to wash them every morning. Washing is not a simple task at all in Haiti. She has to buy soap which cuts into her finances for her food. To purchase water. A woman who can't actually purchase the water needs to find the water in the nearby gutters which are filthy, polluted and used for defecation among other things. Another bad side-effect was headaches. A Haitian woman is not able to buy aspirin. They live in very noisy, active, polluted, intense communities and the headaches on top of all this were intolerable. Many women collapsed from this method in sheer exhaustion. They couldn't go to work, they felt so ill, they were unable to function.

NARRATOR: Just as in Bangladesh, a pattern emerged where it was sometimes difficult for the women to get the Norplant removed. Catherine Maternowska believed local clinics were under pressure to keep women in the trial to make the data look good.

CATHERINE MATERNOWSKA: One woman came in with an infection in her arm. She was a market woman, she carried heavy loads on her head and when she came in asking to get the insert out, the doctor complained and he complained and he looked at me and he was used to having me in the clinic and he said, 'Oh Cathy, look at this woman, she's an animal, she wants her Norplant out, she's an animal. She has to be in the study and she wants it out now. What's her problem?' They proceeded to throw her literally onto the table, lie her down so that they could do the, take the Norplant insertion out. They threw her head to the side like this and they gave her the anaesthesia but before the anaesthesia had actually taken effect in her skin they started pulling the inserts out and making incisions and pulling the inserts out. Because the infection in her arm it looked painful, it was red, it was swollen, and the muscle and sinew tissue had grown over the implants, they were pulling and she was wailing, she was why, why, and they continued calling her an animal. I think it's a sham, it's disgusting, it appalled me that this kind of research was going on. When someone's looking for help, looking for a solution to their poverty and what they find is something that just makes their poverty worse, it's a huge, huge sadness.

NARRATOR: For health workers in Cité Soleil Norplant is one of a long line of contraceptives that have been tested in Haiti over several decades.

ROSE-ANNE AUGUSTE [SUBTITLED): It is important for us to expose how women in poor countries are used as guinea pigs, especially in Haiti, so that they can test their products. Developed countries may not even use these products because the hormone levels are too high. But they use these in experiments on women in poor countries so that they can regulate the levels. Fundamentally, what appears to us in Haiti is that these people have found a laboratory here a slum laboratory - to do whatever they want. And one of the biggest laboratories for the American government is right here in Cité Soleil.

INTERVIEWER: Why would your research target the poorest and the most illiterate and the least well able to defend themselves group?

NILS DAULAIRE: You'll find that the broad portfolio of research does not target the poorest and the most illiterate and the least able to defend themselves. That in fact the research that's carried out is over a broad spectrum of society because it's important to understand the use effectiveness and the benefits, as well as the disadvantages of certain contraceptive types among a wide variety of groups.

INTERVIEWER: That maybe true for US AID as a whole, but I am talking about the clinical trials of Norplant in the Third World which were in the slums of Dhaka..

NARRATOR: At this point the interview was terminated by a State Department official who asked for further information. Later, Horizon was told: US AID categorically denies that poor Haitian women were being used as human guinea pigs by the United States. They added they were proud of their programme in Cité Soleil and that the clinic there had been widely praised for its quality of care. Norplant was studied in over 40 countries and apart from Bangladesh, there are reports of problems from Indonesia, Brazil and others, so how did the drug get approved by America's Food and Drug Administration? Sybil Shainwald attended the only public hearing in 1989.

SYBIL SHAINWALD: The FDA approve a process In the case of Norplant was ludicrous. It was not the standard approval process. The auditorium was packed and it was like a dog and pony show. There were blond women running around saying I love Norplant, I'm satisfied with Norplant. On the other hand, the advisory committee, which was hearing the testimony, took very little cognisance of the fact that there were problems that had been reported throughout the world.

NARRATOR: This application was later withdrawn due to problems with the data. It was resubmitted and approved 8 months later with no further public hearing.

SYBIL SHAINWALD: This was the fastest approval process that I know of since I have been dealing with the Food and Drug Administration and the purpose was to market this overseas to control population.

NARRATOR: Many researchers do believe that Norplant is of great benefit, but others are critical of the US government's promotion of a long-acting contraceptive overseas.

PROF. BETSY HARTMANN: At the highest levels in Washington, population growth in the Third World has long been perceived as a national security threat. During the Cold War, of course, public fear and paranoia often focused on the nuclear bomb and in the post-Cold War period we're having the population bomb re-emerging as a threat. Now we're fearing these Third World peoples. Does this mean that you promote Norplant like a weapon in the war against population growth? Colleagues and I have looked through declassified documents and have found, much to our horror, that at the highest levels of government this has been an obsession. There is a national security memorandum, for example, which talked about the great need to control population growth in places like Brazil and the big countries and how this population was a definite national security threat.

NARRATOR: Norplant is at least an officially approved contraceptive. But there are other, less regulated methods already in use.

BETSY HARTMANN: It's not just in the United States case the government, but there are also a whole range of private foundations that are funding the building of a population control movement.

NARRATOR: One private organisation is run by two doctors from America's southern states who believe they've found the answer for Third World women in a drug called Quinacrine.

DR. STEPHEN MUMFORD: Quinacrine is the most important development in contraception since the birth control pill. It has an enormous potential for preventing births and we're talking about literally billions of births.

DR. ELTON KESSEL: We have trials of the Quinacrine method going in some 17 countries like India, China, Bangladesh, and the trials are going very well. 100,000 women have had this method without a single fatality being reported.

NARRATOR: Dr. Elton Kessel was the founding director of Family Health International. He now researches Quinacrine in a worldwide operation, masterminded from Dr. Mumford's basement in Chapel Hill, North Carolina. Quinacrine is inserted into the top of the womb where it causes inflammation and scarring in the Fallopian tube, in theory blocking the tube with scar tissue and preventing the sperm from reaching the egg.

STEPHEN MUMFORD: It's a very simple procedure, takes only a few minutes. It can be done in very primitive settings by people who do not necessarily have a lot of clinical skills. Quinacrine is clearly the cheapest method available in the world and in fact the second cheapest method would probably be more than 100 times as expensive as the Quinacrine method. For $10,000's worth of Quinacrine pellets, 70,000 women can be sterilised.

INTERVIEWER: Is that a lot of women?

STEPHEN MUMFORD: That's a lot of women, and a lot of grateful women.

DR. AMY POLLACK: The story of Quinacrine is very unusual. It amazes many people that, despite the fact that this drug has not been approved by any major regulatory body for use in women, it's been used and distributed to over, you know, 80,000, maybe 100,000 women around the world who've been told that it's a safe and effective method and therefore agreed to use the method. How's it been done? Just a couple of guys out there running around with suitcases full of the drug who distribute the drug to doctors, primarily, and there's an appeal because it's inexpensive and it's easy to use.

NARRATOR: But some scientists believe the drug could put women's lives at risk - from cancer and ectopic pregnancy. And they question this entire approach to sterilisation.

PROF. SHREE MULAY: This method of producing scar tissue is extremely barbaric. to try to damage the tissue so that you produce inflammation and block the tubes that way I think is extremely crude. It is imprecise for sure because one does not know where exactly that is going to take place and it causes a tremendous amount of pain because of the inflammation. There has been a long history of chemical sterilisation research and this history is really an ugly one and it's quite a shocking one because all kinds of agents have been used - sulphuric acid, formaldehyde - all of these agents which actually burn the tissue and cause production of scar tissue. Chemical sterilisation was first tried out by the Nazis in their very first experiments in the death camps. That it has been picked up in the 60s, 70s and the 80s and been promoted as rescue for the women of the Third World I think is quite extraordinary.

STEPHEN MUMFORD: We're seeing 500,000 women die per year. Every day women die because of unwanted fertility that could be treated with this method.

INTERVIEWER: And you're going to save them?

STEPHEN MUMFORD: That's... I'm not going to save them, they're going to save themselves by electing this if the thing is made available, if the method is made available. We know these women want this method.

AMY POLLACK: What kills women in childbirth is horrible obstetrical services totally inadequate services that exist around the world. Not only are they bad services, but they're services provided for women who want to have children, and those women are not going to choose sterilisation. So women who don't choose sterilisation and choose to get pregnant are not going to be saved by Quinacrine. The numbers that are presented to us don't take that into account at all.

NARRATOR: The World Health Organisation has stated that no further Quinacrine research in women is justified until further laboratory tests have been completed.

AMY POLLACK: We don't have answers to critical questions about the long-term impact of Quinacrine on women, and until we have those answers, and we can find those answers, we should not be using this drug in women, period.

NARRATOR: So who is funding the research?

BETSY HARTMANN: A student of mine was examining who was funding the anti-immigration movement in the United States and searching through the tax records of various foundations, when she chanced upon the tax records of the Leland Fikes Foundation and found to her amazement that that Foundation was not only funding the Federation for American Immigration Reform, which is very anti-immigrant, but Mumford's work on Quinacrine. It's very scary that you have a private foundation funding both an anti-immigration group and a form of unethical contraception. I think there's a racial fear involved in this politics.

STEPHEN MUMFORD: My God this is they call this an anti-immigrant organisation. I think that the Federation of American Immigration Reform is a highly patriotic institution, that is correct. I mean very few Americans agree that we should have open borders and FAIR's position is that we should not have open borders and that has been the focus of their efforts since they were created. I'm very happy to identify with the Federation for American Immigration Reform.

ELTON KESSEL: You know, if you open the borders of the United States, the United States will become a developing country.

STEPHEN MUMFORD: That's correct. Most Americans do not want to live in these conditions, including myself.

NARRATOR: They've had sympathisers for their philosophy in high places.

STEPHEN MUMFORD: I've just completed a book and George Bush was just leaving the directorship of the CIA at that time. George Bush read the synopsis again, which said over-population is a graver threat to US security than the nuclear threat. George Bush says I agree with everything you're saying here in this synopsis and I can assure you that the people at the CIA agree with you too, so at that point I knew that at the highest levels of our government this issue was being discussed.

NARRATOR: The latest scientific research promises the ultimate in easy-to-use and safe contraception. Contraceptive vaccines are being developed. In the future, one jab may prevent reproduction for years. It offers great hope, but how could it be used, and by whom? In the Philippines women believe they have been tested with a contraceptive vaccine, secretly.

SISTER MARY PILAR VERZOSA: I first got suspicious of the vaccination programme by the way it was being carried out. The government would announce one or two days a year which they called national immunisation days. They made announcements that only women of reproductive age, that is from 14 to 45-year-old, should come to the health centres for their tetanus immunisation shots.

NARRATOR: Records show two-thirds of tetanus deaths in the Philippines are amongst men, so why would they target the women? She was even more suspicious when she discovered the jabs were to be given five times in three years, when usually a tetanus is given much less frequently.

MARY PILAR VERZOSA: That really put a lot of questions in our minds. The Department of Health would send their teams into the schools, they would just tell the teacher in charge that this was a government programme, it's a service being given, it's good for the girls.

NARRATOR: Then she started to hear disturbing reports from women when she was working in the slums.

MARY PILAR VERZOSA: The women would say why is it that the tetanus shots that we've been getting have had effects on us? Our fertility cycles are all fouled up, some of the women among us have had bleedings and miscarriages, some have lost their babies at a very early stage. The symptoms could come soon after their tetanus vaccination - some the following day, others within a week's time. For those who were pregnant on their first three or four months the miscarriage was really frightening.

NARRATOR: There are several research programmes around the world testing the contraceptive vaccine linked to tetanus which creates an immune response. The vaccine contains Beta HCG, part of a hormone necessary for pregnancy. This Beta HCG stimulates antibodies so that if a woman's egg becomes fertilised her own natural HCG will be destroyed and pregnancy will not occur.

MARY PILAR VERZOSA: I began to suspect that here in the Philippines that's exactly what's happening. They have laced the tetanus toxoid vials with the Beta HCG. The only way I could make sure that they hadn't done that was to examine the vials, and how to get a hold of those vials was going to be a problem. Who was I to collect them from the health centres?

NARRATOR: Sister Mary was helped through the Catholic network. A friend who worked in a health clinic removed the vials unnoticed. The nuns packed them with ice and sent them to an independent laboratory.

MARY PILAR VERZOSA: Oh boy that was really something when this came out of my fax machine. Report on HCG concentration in vaccine vials. Three out of those four vials registered positive for HCG, so my suspicions are affirmed that here in our country they are not only giving plain tetanus toxoid vaccination to our women, they are also giving anti-fertility.

NARRATOR: Sister Mary was not alone. Many women and doctors reported similar findings. Dr. Vilma Gonzaga became suspicious when she had two miscarriages, both times after receiving the tetanus jab. She is now suing the government since tests showed she had very high levels of antibodies to Beta HCG.

DR VILMA GONZAGA [SUBTITLED]: Women should have been told that the injection would cause miscarriage and, in the end, infertility. The Department of Health should have asked beforehand, so that only those who didn't want to have children had the injection. I really hope and pray to God that I will still have a baby and get a normal pregnancy. And I am still hoping that the Department of Health will find an antidote to the antibodies in my body.

NARRATOR: But the government has denied any contamination of the tetanus vials and their tests have led to different conclusions.

DR RAYMUNDO LO: We found insignificant traces of what the machine read us HCG and I interpreted this as plain background noise, in other words anything could have caused that signal which caused the machine to read it thus HCG, so I think the notion of tetanus toxoid being laced with HCG to cause abortions is plain hogwash.

NARRATOR: Medical practitioners in Manila do not accept this and have called for further investigations.

DR REYNALDO ECHAVEZ: We in the Philippine Medical Association doesn't believe in what the government is saying. The test that were made in both big medical centres were all positive for HCG, Beta HCG, and they claim that this is insignificant. To me this could not be insignificant because it can produce anti-HCG. At the moment there is a presence of HCG in the vaccine. It can produce anti-HCG and this can now neutralise the HCG that a woman will produce during pregnancy and abortion will set in.

NARRATOR: So are the fears genuine, or does this fit a Catholic campaign to discredit the population programme? While the science remains unresolved fewer women are accepting any vaccinations, and this could damage public health. If the claims are true, how could it have been done?

DR FAYS SCHRATER: If there is a conspiracy to immunise the women of the Philippines with chorionic gonadotropin rather than tetanus, then it requires the knowledge of some member of a government, or two. It requires the participation of a manufacturer to link the chorionic gonadotropin physically to the tetanus toxoid - you can't just throw it in the vial and expect it to do its work. And it requires that it be mislabelled and that it be shipped then to a centre who knows what's in it and who is going to distribute it in a guise of tetanus vaccine. Of course it's plausible and in fact it's probably not all that complicated. All it takes is money and desire and the willingness to lie. We have this long history, we, as women, of been either lied to or coerced in terms of contraception. We've been lied to in terms of either the dosage of hormones like in the pill, we've been lied to about the effects of Norplant, we have had Norplant coercively used and then refusal to remove it, women have been forced into sterilisation camps. There's a long history of medical science being used negatively on women's bodies and of women being lied to.

FARIDA AKHTER: We are for family planning, but this is not happening. External agencies - the government, the international aid agencies - they decide what method we should have, how many children we should have, and then they decide even what kind of contraceptive we should have, and then they dump on us all the rejected ones, new ones they test on our bodies and woman have no control over it.

NARRATOR: Every year 13 million children under five die, half a million women die in pregnancy, there are 50 million abortions worldwide. The need for family planning and new contraceptives is overwhelming.

AMY POLLACK: If we fail to recognise the human rights of women in developing countries in terms of testing contraceptives and using contraceptives, then we will lose all of the methods around. Women will deny themselves family planning methods because they will consider it all of the time an experiment, and they will never trust the support that they're getting from outside of their own country. That's a risk that we take.