REPORT and FILM on Commercial Surrogacy

Sama Resource Group for Women and Health, Delhi is happy to announce the release of,

1.‘Birthing a Market’, a report on the study on commercial surrogacy undertaken by Sama. The study analyses the perspectives of various actors, surrogates, agents, doctors and commissioning parent, involved in the industry and the arrangements to establish the position of the surrogate in the arrangement as well as the logics driving the industry. The research was conducted in Delhi and Punjab and captures the variations in the industry across the regions. The study does a careful analysis of the medical practice and the interests that influence it.

The context in which women are increasingly choosing to enter the industry as well as the various accompanying ideological tropes in practice are highlighted to better understand their choices and unearth the ways in which the arrangements embody both relations of domination as well as possible subversion. The study brings to fore a critique of the practice by raising questions regarding women’s work, the public health system in India and medical ethics in private health care. This critique is situated  within the debates of women’s autonomy and organization of care in the current political economy of a transnational industry.

 

2.“CAN WE SEE THE BABY BUMP PLEASE?” is a 43 minutefilm on commercial surrogacy in India, that explores questions and concerns through the experiences of surrogate women. The film’s narrative traces the ethical challenges, medical malpractice, and potential exploitation that can occur when surrogacy is practiced in a legal vacuum, while also highlighting and understanding the interplay of surrogate women’s choices, contexts and compulsions.

Directed by Surabhi Sharma

Produced by Sama – Resource Group for Women and Health

Executive Producer- Magic Lantern Foundation

Funded by- UNFPA, India

For more details contact:

Sama- Resource Group for Women and Health, B-45, 2nd Floor, Main Road Shivalik, Malviya Nagar, New Delhi-110017 | Email: sama.womenshealth@gmail.com | Website: http://www.samawomenshealth.org

Advancing Feminist Debates on Reproductive Technologies….A SEMINAR

The development, use, and consolidation of a wide range of reproductive technologies in today’s world pose challenges—old and new—to feminist politics. Not only is access to technologies mediated by axes of gender, sexuality, class, caste, religion, dis/ability, etc., the design and deployment of technologies occurs within regimes of power that determine their nature and use.  Both conceptive and contraceptive technologies are proliferating; along with their popularity, the implications of their use are also rising. What does this mean for progressive feminist politics that seeks to extend beyond a rights framework and address questions of structure and justice? How do we understand autonomy and choice vis-à-vis women’s bodies in the context of reproductive technologies in the contemporary moment? Do older feminist positions need to be revisited, and do newer concerns need to articulated?

A day-long seminar in April, organized by Sama- Resource Group for Women and Health, in Delhi, seeks to engage with these questions, and to build feminist discourse through collective reflection. This seminar will comprise of two sessions that follow the format of presentations followed by discussion.

• Assisted Reproductive Technologies and Sexuality

The provisioning of ARTs in India, though unregulated, has grown into a veritable fertility industry in recent years. As expensive technologies with low success rates and significant health risks that glorify motherhood, these technologies are problematic from a feminist perspective. Yet, they are also delinking biology—indeed sex—from  reproduction by making it possible for gay individuals and couples to have biologically related children. Does this constitute a subversive reworking of the heteronormative family, or does it merely reinforce the institution of family? Do ARTs challenge the ideology behind marriage and sex for procreation, by disentangling the sperm, ova and womb, or do they merely shift the contours of biology, while keeping intact the determinism at its core? This session seeks a queer feminist engagement with ARTs, including with advocacy on related provisions of the Draft ART (Regulation) Bill and Rules 2010, and with questions of adoption, and the use of ARTs by HIV positive persons.

• PCPNDT and Feminist Reflections

Against the backdrop of India’s low—and still declining—sex  ratio, feminist voices continue to uphold the ban on sex selective abortion alongside defending women’s right to abort. Yet, our own hierarchies of selection are in operation on the question of abortion. A feminist position that challenges the materiality of the body and the destiny of biology would necessarily see both gender and dis/ability as social constructs. However, feminist politics has responded differently to right to abort in these two instances. How do we understand and respond to a woman’s right over her body, vis-à-vis the rights of her “unborn child”, in a way that is both consistent and progressive? And how do we understand and define disability, including its point of origin, in a way that resonates with feminist principles we want to espouse?

The Regulation of Surrogacy in India: Questions and Complexities

While instances of commercial surrogacy have risen by leaps and bounds (a recent article in a leading national daily estimates that the cost of the surrogacy market is over 2000 crore), its regulation or rather non-regulation has been a matter of concern. Within this flourishing market, even as clinics and other players continue to make huge profits, there are several ethical concerns that arise out of the increasing commercialization of women’s bodies and bodily labour; this includes concerns about the health and rights of the surrogate and the child/children born out of surrogacy. Given such a context, the need for a comprehensive legal framework cannot be overemphasized. This is particularly evident in cases involving legal tussles about the citizenship status of children born through transnational surrogacy arrangements.

In the proposed Draft Assisted Reproductive Technology (Regulation) Bill and Rules-2010, prepared by the Indian Council of Medical Research (ICMR), a substantial section is devoted towards regulating surrogacy arrangements. Though a welcome step, significant gaps in the protection of surrogate women and children still remain. The most striking of these perhaps is the provision for payment to the surrogate woman, which appears to undermine her rights by favouring instead the intended parents. According to the present Draft, payment to the surrogate is to be made in five installments instead of three (as in Draft 2008, the only previous version). The majority, i.e. 75 per cent of the payment is to be paid as the fifth installment, following the delivery of the child. This is in complete contrast to the Draft 2008, in which there was provision for the majority of the payment (i.e. 75 per cent) to be made as the first installment. This not only shows a clear priority accorded to the intended parents, but also betrays that the worth of the surrogate’s labour, pregnancy, related emotional and physical risks etc are considered reducible to and meaningless without a tangible reproductive output, the baby. The potential health risks that a surrogate might face (as a result of undergoing IVF) do not appear to be a cause of concern at all. For instance, according to the Bill, only gestational surrogacy, i.e. through IVF, will be permitted, and genetic surrogacy, i.e. through IUI, which is the less invasive option, is ruled out. While this may be to avoid any contesting claims over the custody of the baby later, it again reveals that the ‘commercial angle’ outweighs the ‘human’, and no nuanced understanding of the surrogate’s rights, who may have voluntarily entered into a contract but may also relate to the baby in emotional ways, .

The present Draft has also increased the number of permitted successful live births for a surrogate from three (in the previous Draft) to five; this is inclusive of the surrogate’s own children. This provision inadequately addresses an aspect critical to the surrogate’s health: the number of permitted cycles she can undergo. Since the number of live births is not equivalent to the number of ART cycles, to effectively ensure that the surrogate’s health is not exploited, the maximum number of permitted cycles must also be specified.

In lieu of the recent and controversial cases of international surrogacy that have resulted in legal battles for citizenship status for the child/ren, the Bill has made provisions to address this issue. The draft Bill now makes it mandatory for foreign couples to produce a certificate from their countries declaring that the respective countries permit surrogacy, and that the child will be considered a legal citizen. As an increasing number of couples from other countries access surrogacy services in India, such a provision will be a useful legal framework. The Draft Bill should take concrete measures to address the legal needs of the surrogate women.

Therefore, it can be concluded that while a legislation to regulate the untrammeled commercialism of ARTs and surrogacy in India is a much-needed step towards checking unethical medical practice, the human rights of the surrogate and the children—legal, financial, and health-related—need to be better protected.

* This post has been published in the form of an article in the Medico Friend Circle Bulletin

Memorandum of Concerns Regarding the Interim Report of the Committee Appointed by the Government of India to Enquire into “Alleged irregularities in the conduct of studies using Human Papilloma Virus (HPV) vaccine”

To

Shri Ghulam Nabi Azad,
Union Minister for Health and Family Welfare,
Ministry of Health and Family Welfare,
Nirman Bhavan, Maulana Azad Road,

New Delhi 110011

Date: 21^st February, 2011

Subject: Concerns regarding the Interim Report of the Committee appointed by the Government of India to enquire into “Alleged irregularities in the conduct of studies using Human Papilloma Virus (HPV) vaccine” by PATH in India.

Sir,

We, the undersigned public health organizations, health networks, medical professionals, human rights groups and women’s groups write to voice our deep concerns regarding the Interim Report of the Committee appointed by the Government of India (vide notification No. V.25011/160/2010-HR dated 15^th April, 2010) to enquire into “Alleged irregularities in the conduct of studies using HPV vaccine” by PATH in India.

While identifying several deficiencies in the planning and implementation of the project, the report, submitted to the Ministry of Health and Family Welfare, has failed to fix responsibility on any individual or agency. Rather than suggesting any punitive or disciplinary measures, the report identifies ‘minor’ deficiencies as lessons for strengthening clinical research in future.

Our questions and concerns

1. The report does not contain accounts of any interaction with the participants of the study (either in Gujarat or AP), their parents, the hostel wardens, teachers, local health workers etc, or even with the parents of the girls who died post vaccination for verbal autopsies of the deaths. These do not appear to have taken place, and may be considered a significant methodological limitation of the report.

2. In marked contradiction to the official stand of both PATH and ICMR, the report states that: “It needs to be highlighted that 4 of the 5 primary outcome measures proposed in the study relate to evaluation of the safety of the vaccine.” For instance, in an update posted by PATH on their website (accessed on 15 February 2011) following the suspension of the projects, they state,
   “It should be noted that the post-licensure observational studies in Andhra Pradesh and Gujarat do not seek to evaluate the efficacy or safety of these licensed, approved HPV vaccines. No biomedical outcomes are being researched; no blood or other samples are being drawn, and no therapies are being tested. The safety and efficacy of these vaccines have been documented in numerous studies and endorsed by numerous international and national regulatory agencies.”Similarly, in the response from Mr. A.B.Ramteke, Joint Drug Controller (I) to an RTI (dated 21.07.2010), it was clearly stated that the design and purpose of the study was i) to demonstrate suitable vaccine delivery strategy ii) to raise community awareness iii) to build the evidence base of vaccine delivery strategy for future introduction of HPV in India. However, it was not mentioned that the study outcome was to evaluate the safety of the vaccine.

   Not only does this reveal the inconsistencies in the literature made available in the public domain regarding the nature, aims and outcomes of the projects, moreover, if the safety of the vaccine is in fact being studied, it may be ascertained that the projects are clinical trials. Thus, the protocols of clinical research in India have been violated. The Committee has not dispelled this ambiguity.

3. The report states, “One of the major deficiencies of the study in retrospect was inadequacy of the preparation for tackling Serious Adverse Events (SAEs) and deaths, whether related or unrelated to the vaccine. The deaths came to notice after a long gap of their occurrence, mainly when the preparations were a foot for the next round of vaccination. And then no independent body of experts analyzed the cause of deaths.” In the absence of any mention of the follow up of deaths and serious adverse events, how did the State governments and other authorities[1] approve the study design? Further, deaths and adverse events following vaccine administration were not investigated by the DIO or DRCHO.The Drugs and Cosmetics Act clearly outlines that ethics committees are responsible for review and approval of trial protocol so as to safeguard the rights and well being of trial subjects, especially those from vulnerable sections of the population. There appears to be reluctance to hold the involved ethics committees accountable for violations.
4. We welcome the recommendation for “the need for continued pharmacovigillance of the HPV vaccine” and the reiteration of rule 122-E of the Drugs and Cosmetics Act, that “all vaccines, in particular the HPV vaccine, shall be treated as new drug for four years from the date of their approval in India. All research studies (whether a clinical trial or not) involving administration of a new drug (vaccine), even after licensing, should proactively monitor and investigate all adverse events, more so the SAE and deaths irrespective of their appearing or not appearing to be related to the vaccine.”
5. Further, while the Interim Report justifies the inclusion of girls in the age group of 9-14 years in the PATH projects as bridging the Phase III trials conducted prior to the approval of the drug for marketing, sale and import for private markets in India, it completely ignores the inadequacies and shortcomings of these pre-trials themselves.
6. While the report states that “there was no specific targeting of any particular group or class except that the plan called for including a predominantly urban, rural and tribal block in each selected district”, it goes on to say that “in hindsight the veracity of this plan can be debated… … if it was impractical to take consent of parents in predominantly tribal area such an area might have been excluded from the study.”
7. The report establishes that “The legality and morality of the circular of the Government of Andhra Pradesh authorizing the Hostel Wardens and Head Masters to sign the consent on behalf of the minor girls included in the study is questionable.” This is an absolute travesty of free and informed consent, a central and inviolable tenet of research ethics, as listed in both the DCA and ICMR’s ethical guidelines for biomedical research.
8. The report states that “no provision has been made of an insurance cover for any unforeseen event (including death) or residual morbidity related to the intervention for vaccine recipients in this study which is the usual practice for trails with NCE/ INDs”. It goes on to establish that “PATH has taken an insurance cover for itself”. In this case, why were the participants not covered? Further, the absence of any mention in the study protocols of an insurance cover for participants raises concerns regarding the inadequacies of the approval processes, and the responsibilities of the approval bodies.
9. The Committee has noted that the use of the State’s health machinery for the execution of the project “might have led to blurring of the distinction between routine, national immunization programme and research nature of the HPV vaccination study”. As such, “it is important for Public Private Partnership programmes to be extra vigilant and ensure that the Authority of the State is not misrepresented.”
10. Despite stating that “the fact that the vaccine for the study was provided by manufacturers free of cost does raise the concern about undeclared conflict of interest since the results of the study may be used to influence the decision by the Government”, the Committee fails to build upon this significant and alarming aspect.
11. The section of the report on Responsibility is the weakest, as it lets off the hook all those involved in the project, by declaring the deficiencies in the project as “minor” and not “willful or fully anticipable (sic)”, and stating that “since there does not appear to be any overt mal-intention, no responsibility can be fixed”.

Our demands

1. Since violations have occurred at all levels of the project, we demand that all involved be considered culpable, and appropriate punitive action be taken. To say that responsibility cannot be fixed with any “one” individual or organization is a dereliction of duty, and a convenient excuse for irresponsible and unethical conduct, thus setting a dangerous precedent.
2. Compensation should be provided, with immediate effect, to the families who have lost their children and to the children suffering side-effects.
3. All study participants should be provided proper medical treatment and follow up
4. The Government should place in the public domain:

• All the documents pertaining to the agreement with vaccine manufacturers and all other bodies regarding the government’s plan to introduce the HPV vaccine.
• The list and design of projects planned, proposed, approved and completed, agencies involved, and donors involved, proposed locations, and all the results of the pilot phase and clinical trials.
• All details, including names and minutes of the meetings, of all ethics committees that approved or disapproved the study plan.
• The full version of the Interim Report by the Government of India inquiry committee, as soon as it is ready.

We hope you will take cognizance of our demands, and appropriate action.

Signed By:

1. Jan Swasthya Abhiyan (Indian chapter of the People’s Health Movement)

2. Sama- Resource Group for Women and Health

3. Saheli Women’s Resource Centre

4. Low Cost Standard Therapeutics

5. All India Democratic Women’s Association

6. All India People’s Science Network

7. National Federation of Indian Women

8. Jagori

9. Haq: Centre for Child Rights

10. Gramya Resource Centre for Women

11. Dr. Imrana Qadeer

12. Dr. Indira Chakravarthi

13. Rajashri Dasgupta

14. Veena Shatrugna

---

[1] 1. National Advisory Group constituted by ICMR, 2. State Advisory Group of AP and Gujarat, constituted by the State governments, 3. Health ministry’s Screening Committee of the Government of India, 4. DCGI- license for import of vaccine for trial and trial protocol, 5. Institutional Ethics Committee of NARI for Phase I study, 6. Institutional Ethics Committees, separately for AP and Gujarat, for Phase II study, and 7. Western Institutional Review Board, an independent ethics committee based in Olympia, WA, USA

*Excerpts of this memorandum have been published in the Medico Friend Circle Bulletin

New ART Bill to be Tabled Soon

A recent news report (The Times of India; June 17, 2010) states that a new draft Assisted Reproductive Technology (ART) Bill 2010 is going to be tabled in the next session of parliament. The full text of this draft Bill is available on the website of the Indian Council of Medical Research (ICMR).

Trial and Error: Ethical Violations of HPV Vaccination Trials in India

On July 9, 2009, the Andhra Pradesh Minister for Health and Family Welfare in association with the Indian Council of Medical Research (ICMR) and PATH (Programme for Appropriate Technology in Health) International a non-profit organization based in USA launched what it described as a ‘demonstration project’ for vaccination against cervical cancer. The vaccine, against the Human Papillomavirus (HPV), which is one of the most common families of viruses and the source of a common sexually transmitted infection, was administered to 14,000 girls between the ages of 10 and 14 in three mandals – Bhadrachalam, Kothagudem and Thirumalayapalem – of Khammam district in Andhra Pradesh. In Andhra Pradesh, the vaccine used was Gardasil, manufactured by Merck Sharpe and Dohme, the Indian subsidiary of Merck and Co. Inc., a US-based pharmaceutical company.

In a similar project, on August 13, 2009, the Gujarat government launched a two-year ‘Demonstration Project for Cancer of the Cervix Vaccine’ in three blocks of Vadodara District – Dabhoi, Kawant and Shinor – to administer three doses of the HPV vaccine to 16,000 girls between 10 and 14 years. There were reports of deaths of four girls from Andhra Pradesh and two girls from Gujarat following the administration of the vaccine.

During March 27-30, 2010, a team of women’s and health activists visited Bhadrachalam mandal, one of the three mandals of Khammam district where the ‘demonstration project’ was undertaken to understand the ground reality; in particular, to look at the nature and procedures of taking consent and providing information to the girls and their parents, and the availability of the health infrastructure required to support cancer screening and prevention.

The children selected to participate in this project were from four social groups with poor economic background – scheduled tribes, scheduled castes, Muslims and other backward communities. Majority were tribal children, whose parents were agricultural labourers. Some girls were from families that have been displaced by the ongoing conflict in the neighbouring state of Chhattisgarh; circumstances that serve only to compound their vulnerability.

Majority of the vaccinated girls in Bhadrachalam were residents of ashram paathshalas (boarding schools). The selection of these girls for the project is striking, given that their parents, living separately, cannot monitor and respond to any adverse developments in their children’s health. Moreover, this has allowed providers to conveniently side-step the provision of parental consent.

The vaccine was administered through a camp approach in the hostels and school campuses. In many instances, the wardens of the residential schools and hostels were asked to provide consent or permission for vaccination, while parents were not informed. The very nature of this project appears to be in violation of all ethical norms as a warden, whether a legal guardian or not, be allowed to provide consent for hundreds of children without consulting their parents, who are their natural guardians;

The ‘consent form’ was used primarily in the case of non-residential schools, and children were asked to get signatures from their parents. This violates the designated protocol for obtaining informed consent, whereby the ‘researcher’ is required to directly provide information mandatory for consent to the person(s), in this case the parents.

Selected girls were given HPV Immunization Cards, which were in English – a language that neither the girls, nor their parents, were familiar with. Further, all involved (the wardens, teachers and students) believed the project to be part of the public immunization program, and had no idea that they were in fact, part of a research study. They were not even aware that they had a choice regarding participation in the study.

Many stated that they were given to understand that the government was providing free of cost an expensive vaccine that would prevent ‘uterine’ or ‘cervical cancer’. This would otherwise be unaffordable for them. Several parents brought their daughters to the vaccination camps themselves when they heard about the project. One mother said, “Since it was a vaccine being given by the government, we all trusted it blindly and considered it reliable, like any other vaccine that is given in the immunization programme”. Participants were verbally informed that the vaccine would provide life-long protection, with no side-effects or impact on fertility. The fact that the vaccine protects against only two types of the HPV virus and that regular pap screening is required even after vaccination was mentioned at all- neither verbally, nor in the written material given to some girls. Since the long term efficacy and protection by the vaccine is unknown, it cannot be claimed that even 60-70% protection will be achieved. Currently is also unclear if, when and how booster shots will be required.

Many of the vaccinated girls continue to suffer from stomachaches, headaches, giddiness and exhaustion. There have been reports of early onset of menstruation, heavy bleeding and severe menstrual cramps, extreme mood swings, irritability, and uneasiness following the vaccination. No systematic follow up or monitoring has been carried out by the vaccine providers.

While the project was being carried out under the banner of the National Rural Health Mission (NRHM) shockingly enough the Mission’s mandate does not extend to or mention any such research project. Further, the existing health infrastructure in the region is woefully inadequate. Pap smear facilities are conspicuous by their absence in all government facilities in the area. The entire tribal mandal of Bhadrachalam does not have a single gynaecologist.

The vulnerability of this these communities are thus further compounded by of the lack of access to health care, lack of access to information and absence of mechanisms for reporting adverse effects.

The state government has claimed that the deaths of the four girls post-vaccination were unrelated to the ‘project’. However, parents of Kudumula Sarita, who died in January 2010, believe that their daughter died due to the vaccination, and not by consuming pesticide, as has been officially declared by the authorities.

The trial has been suspended temporarily by the government after a strong campaign by health networks, women’s groups and by parliamentarians. A committee has been set up by the government to conduct an inquiry, the composition of the committee leaves much to be desired and is far from representative.

The Ministry of Health and Family Welfare, on 22^nd April 2010, finally conceded that the HPV vaccination project was in fact, a “post-licensure operational research study”, which on further clarification, was confirmed to be a Phase IV, post marketing, clinical trial.

On 29^th April, the ICMR admitted that their ethical guidelines had been flouted in the course of this trial.

Meeting Health Rights by Free Treatment to All Indians: Requirements and Challenges

A day long consultation on the subject ‘Meeting Health Rights by Free Treatment to All Indians – Requirements and Challenges’ is being jointly organized by Jan Swasthya Abhiyan, Centre for Budget and Governance, Oxfam India, Centre for Legislative Research & Action, Sama, and Prayas at Dy. Speaker’s Hall, Constitution Club, New Delhi on 4^th May 2010 from 10:00 AM to 5:00 PM.

The objective of this consultation is to orient and sensitize members of parliament and other important segments of policy planners about this very vital issue and evolve an economical and social model to ensure free treatment to all citizens of India.

Background

The total health spending in India is one of the lowest in the world, and most of it is private expenditure in the form of out of pocket payments. The majority of this payment is on the purchase of drugs and diagnostics, which are priced exorbitantly when bought individually by patients from chemist shops or pharmacies of private doctors, nursing homes, and hospitals. The same medicines are available in one tenth of the cost if bought in bulk.  It is a huge challenge that these medicines at reduced costs, which are essentially the actual prices, will reach citizens. Purchase of medicines individually:

1. Causes significant rise in the overall cost of treatment
2. Increases the load of unreasonable and unnecessary drugs, which are the causes of rising drug resistance and iatrogenic morbidities
3. Leads to higher occurrence of catastrophic illnesses, which require hospitalization because large numbers of patients do not seek treatment until it gets very serious for reasons of non-availability of money
4. Causes continuing high maternal mortality ratio and child death rates because of lesser use rate of health care services

Participation is only by invitation.

Memorandum to the Health Minister on World Health Day Opposing HPV Vaccinations

7th April 2010: World Health Day

To,

Shri Ghulam Nabi Azad,
Union Minister for Health and Family Welfare,
Ministry of Health and Family Welfare,
Nirman Bhavan,

Maulana Azad Road,
New Delhi 110 011

Date: April 7^th, 2010
Subject: Opposition against the unethical nature of the ‘demonstration project’ for the Human Papilloma Virus (HPV) vaccine being conducted in Andhra Pradesh and Gujarat.

Sir,

We the undersigned public health organizations, health networks, medical professionals, human rights groups and women’s groups write to voice our intense opposition to the unethical nature of the ongoing HPV vaccination ‘projects’ being conducted in Andhra Pradesh and Gujarat by PATH International, in collaboration with ICMR and the State Governments. We also strongly stand in solidarity with the local efforts initiated by groups and Networks in Andhra Pradesh following the death of 4 young, tribal girls in Khammam district following the vaccination.

As was clearly detailed in a Memorandum, dated October 1^st, 2009, signed by over 50 groups and individuals, the efficacy of the vaccines Gardasil and Cervarix is highly suspect and a number of very serious side effects, including deaths have been observed across the world, in vaccinated girls. As per the extensive documentation by a fact finding carried out by local groups in Khammam district in Andhra Pradesh (where 14000 girls in the age group if 10 – 14 years have been vaccinated with the three doses of HPV vaccine), the adverse reactions faced by over 120 girls include epileptic seizures, severe stomach ache head aches and mood swings. There have also been reports of early onset of menstruation following the vaccination, heavy bleeding and severe menstrual cramps. Moreover, the current, ‘demonstration project’ has no follow up mechanism in place for girls who suffer from adverse events following the vaccination. As a result many of the girls have had to seek treatment in the private sector and with local quacks.

The matter has further gained grave urgency with the deaths of four tribal girls in the area. The local authorities have refused to take cognizance of their probably association with the vaccine, two of the deaths have shockingly been written off as suicides, when the evidence clearly suggests otherwise! Along with sounding extremely suspicious this has also raised valid concerns of this being a massive cover up exercise.

Above all, the very nature of this project seems to be unethical and violates all norms of conducting trials on human subjects. In many Aashram Schools, a verbal consent to vaccinate girls living in the Aashram schools has been taken from the Hostel Warden/ teacher in-charge, while parents were not even informed about it. In cases of day scholars, where consent was obtained from the parents, the form given held the nomenclature of an approval form “Angikaara Patram” and only provided minimal information with no provisions for addressing in detail the need for follow. In fact, when a lady warden of a hostel objected when she was told that the vaccine was being administered on girls in the hostel, she was informed that this vaccine is mandatory! This is a travesty of the entire concept of “informed consent.”

Consent and information, reserved for only a few, is a farce and was based on provision of wrong information. Many of the girls were told that the vaccine would prevent uterine cancer and would provide life-long protection. This information is factually incorrect and provides the recipient with a false sense of security against the “dreaded” disease. As per the claims by the pharmaceutical companies themselves, the vaccine only protects against infections caused by 2 types of HPV virus (of the 13 high risk strains of HPV) that are associated with a higher risk of cancer of the cervix. Moreover, once again as claimed by the companies themselves, the protection by the vaccines is understood to last for only 4.5 years with Gardasil and 7 years with Cervarix, while, the need for a booster has not yet been established. There are reports in developed countries that this number too is an over estimation and the protection in fact may not last for more than 3-5 years.

It is also shocking and worrying that these projects are being carried out under the NRHM banner, while the existing medical facilities in the region are extremely inadequate. While Pap smear facilities are not available in Government facilities in the area (a must for even those who have been vaccinated against HPV) the absence of a Gynaecologist in the entire tribal mandal of Bhadrachalam is absolutely appalling. It is highly irresponsible and negligent of the State and Central government that such large scale exploitation of poor and tribal populations is being carried out by subjecting them to a vaccine with a dubious track record, when even the basic public health facilities are not in place.

Although, the nomenclature suggests otherwise, the secrecy regarding the non-transparent selection criteria of the area, the girls and the aim of the project has raised undeniable fears that this is a Phase IV clinical trial being carried out under the guise of a ‘demonstration project’ Moreover, there is an inexcusable lack of clarity with regards to the role and accountability of international agencies such as PATH and Bill and Melinda Gates Foundation that appear to be funding this project. It is beyond doubt the worst case of human rights violation, where young healthy girls have to die for being part of a state-endorsed experiment, initiated by a profit making private company.

This constitutes shocking criminal negligence on the part of the authorities, who have provided permission and support to this programme within the public health system. We need immediate government intervention to prevent this. No NGO should be given such permission for clinical trials/ demonstration projects, regardless of which vaccine or drug is being administered. Financial support from the industry or from an international organization should not be the criteria to introduce any vaccine, whether in a pilot project or in the universal immunization programme.

Thus, standing in solidarity with groups, parents and the girls in Andhra Pradesh, we demand that:

1. the government should make sure that all these projects are immediately brought to a halt across the country, till concerns relating to safety, efficacy and cost effectiveness of the planned interventions are reevaluated.
2. the government should set up an  inquiry:
   1. into the deaths of the tribal girls;
   2. into the side effects of the vaccine on affected girls, so that responsibility can be fixed and action taken.
3. All agencies involved in the project need to be held accountable and culpable for any ethical, legal, medical violations that emerges in such an enquiry
4. the State Government should take immediate action, including providing compensation to the families who have lost their children and to the children suffering side-effects
5. all the sufferers should be provided proper medical treatment and follow up
6. the Government place in public domain::

• All the documents pertaining to the agreement with vaccine manufacturers and all other bodies regarding the government’s plan to introduce the HPV vaccine.
• The list of projects planned, proposed, approved and completed, agencies involved, donors involved and proposed locations. and all the results of the pilot phase and  clinical trials

7.  the Government institute a national policy on this kind of medical ‘experimentation’, and  a pro-people vaccine policy based on public health needs

Signed by

1. Jan Swasthya Abhiyan (JSA)

2. All India Democratic Women’s Association (AIDWA)

3. All India Drug Action Network (AIDAN)

4. All India Peoples’ Science Network (AIPSN)

5.  Federation of Medical and Sales Representatives’ Associations of India (FMRAI)

6. Sama- Resource Group for Women and Health, Delhi

7. Action India, Delhi

8. HAQ- Centre for Child Rights, Delhi

9. KRITI, Delhi

10. Jagori, Delhi

11. Breastfeeding Promotion Network of India, Delhi

12. Centre for Women’s Development Studies (CWDS), Delhi

13. Centre for Legislative Research and Advocacy (CLRA), Delhi

14. Delhi Forum, Delhi

15. Diverse Women for Diversity, Delhi

16. RAHI Foundation, Delhi

17. SANGRAM, Maharashtra

18. Adivasi Aikya Vedika, Andhra Pradesh

19. Anthra, Hyderabad, Andhra Pradesh

20. Yakshi, Hyderabad, Andhra Pradesh

21. Asmita Collective, Secunderabad, Andhra Pradesh

22. Adarsha Women’s Society, Khammam, Andhra Pradesh

23. Koyitur Kutuva, Khammam, Andhra Pradesh

24. Adivasi Seva Samiti, Khammam, Andhra Pradesh

25. ANKURAM, Hyderabad, Andhra Pradesh

26. Girijana Deepika, East Godavari, Andhra Pradesh

27. Tholakari Adivasi Mahila Vedika, East Godavari, Andhra Pradesh

28. Adiavsi Seva Sangham, West Godavari, Andhra Pradesh

29. Arunodaya Grameen Abhivridhi Sangham, Vijayanagarm, Andhra Pradesh

30. Adivasi Chaitanya Sangham, Adilabad, Andhra Pradesh

31. Chinnayya Adivasi Vikasa Sangham, Srikakulam, Andhra Pradesh

32. Manyam Girijana Seva Sangham, Vijayangaram, Andhra Pradesh

33. Adivasi Ahara Bhadrata Sangham, Visakhapatnam, Andhra Pradesh

34. Jeevam, Visakhapatnam,  Andhra Pradesh

35. Savara mahila sangham, Srikakulam, Andhra Pradesh

36. Agricultural and Social Development society (ASDS), Khammam, Andhra Pradesh

37. Natwan Sangham (Tribal Women Federation), Khammam, Andhra Pradesh

38. Rukmini Rao, Gramya Resource Centre for Women, Hyderabad, Andhra Pradesh

39. Usha Seethalakshmi, Freelance Researcher & Consultant, Hyderabad, Andhra Pradesh

40. Kalpana.Kannabiran, Hyderabad, Andhra Pradesh

41. Vasanth Kannabiran, Hyderabad, Andhra Pradesh

42. Lalitha Kumari, Hyderabad, Andhra Pradesh

43. BHUMIKA Magazine, Andhra Pradesh

44. Anchita Ghatak, Parichiti- A Society for Empowerment of Women, West Bengal

45. Anu Gupta, Eklavya, Madhya Pradesh

46. Bimla Chandrasekar, EKTA, Tamil Nadu

47. Dr Veena Shatrugna, Hyderabad, Andhra Pradesh

48. Chinu Srinivasan, SAHAJ, Baroda, Gujarat

49. Dr Gopal Dabade, Drug Action Forum, Karnataka

50. Jaya Velankar, Women’s Rights Activist, Delhi

51. Dr. Kaveri Rajaraman

52. K R Nayar, Jawaharlal Nehru University, Delhi

53. Manisha Gupte, MASUM, Pune, Maharashtra

54. Dr Mira Shiva, Initiative for Health Equity and Society (IHES), Delhi

55. Dr Mohan Rao, Jawaharlal Nehru University, Delhi

56. Neha Madhiwala, Centre for Studies in Ethics and Rights (CSER), Mumbai, Maharashtra

57. Prof Padmini Swaminathan, Madras Institute of Development Studies, Chennai, Tamil Nadu

58. Pallavi Sobti-Rajpal, Utthan, Gujarat

59. Rajashri Dasgupta, Kolkata, West Bengal

60. Renu Khanna, Sahaj, Baroda, Gujarat

61. Dr Vandana Prasad, Delhi

62. Ranjan De, Filmmaker, Delhi

63. Dr. Ajay Kumar Khare, Madhya Pradesh Vigyan Sabha/JSA, Bhopal, Madhya Pradesh

64. Bishakha Dutta, Filmmaker, Mumbai, Maharashtra

65. Dr. Y. Madhavi, Scientist, Council of Scientific and Industrial Research (CSIR), Delhi

66. Saheli, Delhi

67. Salai Selvam, Tamil Nadu

68. CREA, Delhi

International Consultation Concludes

An International Consultation on the commercial, economic and ethical aspects of Assisted Reproductive Technologies titled Unraveling the Fertility Industry: Challenges and Strategies for Movement Building was organized by Sama in Delhi from the 22nd to the 24th of January 2010. During this three day consultation, over 80 participants from more than 10 countries– including activists, researchers, and academics — came together to discuss issues and concerns around the growth and proliferation of what is now a veritable ART industry. Discussions began with an overview of the current global political economy context, followed by region-specific sessions that brought in local experiences from countries that are facing the implications of these technologies. Each day concluded with a discussion on the possible strategies for movement building, which were consolidated in the final session on the final day.

In addition, a Volume of Papers titled Making Babies- Birth Markets and ARTs in India was launched by Sama on the 23^rd January, in collaboration with Zubaan – a feminist publishing house. Sama also marked its tenth anniversary on this day, with an evening of music and poetry.

To see the programme schedule of the Consultation, click here: Programme