Notwithstanding the various issues that have emerged in the context of health insurance from different States of India, there are several questions to be asked What are the implications of RSBY like schemes for the health sector? Do they improve access and quality of care? What are the concerns about insurance schemes that are emerging from the country? Is health insurance, health for all?
The discussions will be in a mix of Hindi and English language. We look forward to your confirmation.
Workshop for Media Students in Delhi/ NCR
Sunday, 30th June 2013
10:00 am to 2:00 pm
Conference Room No. 2,
India Islamic Cultural Centre, Lodi Road, New Delhi
Issue in Focus: Come and participate in an interactive session on some key, topical issues vis-à-vis gender, health and rights with specific reference to gender based violence and and the role of the health system ( consent, care and medico legal issues), and Assisted Reproductive Technologies (IVF, etc.) commercial surrogacy (social, ethical and regarding regulation).
Duration and Format: This session is planned as a short introduction to these issues that we hope will contribute to your understanding and work their course of your study, research and practice or as future media professionals. It will be divided into two sessions which will include a documentary film screening, participatory exercises and discussion as the tools of learning and sharing.
For Whom: This workshop is primarily open for students of Media Studies, who are studying journalism, film making, and use of other kinds of media to tell stories, report on issues and make/ change public opinion through their work. There are some slots for other interested students also, especially students of sociology, gender studies, law, medicine, etc. Certificates of Participation will be given to all those who attend this workshop.
Please send us a paragraph expressing why this issue is important for you and how this workshop will help you. Registrations will close once we have a full house, so do send in your mails soon! We will send a confirmation of participation to selected students only due to space constraints.
Who we are: Sama has been working on issues of women’s health and rights for more than a decade, through action research, policy monitoring and advocacy, capacity building and knowledge creation and dissemination. To know more about our work please visit
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:
We would like to announce the release of the report on ‘The National Consultation on Regulation of Drug Trials.’ The Consultation held on 26-27thSeptember, 2011, was an effort towards initiating a dialogue around the existing gaps in policy and its implementation vis-à-vis the regulation of drug trials, towards developing an appropriate framework for future intervention strategies in this regard. The Consultation was organised by Sama –Resource Group for Women and Health, Centre for Studies in Ethics and Rights (CSER); Low Cost Standard Therapeutics (LOCOST), All India People’s Science Network (AIPSN),Drug Action Forum, Karnataka (DAF-K) along with Dr Amar Jesani.
Recognising the urgent need for furthering transparency in trials, protection of participant rights, and implementation of the highest standards of independent inquiry, this National-level Consultation was attended by nearly 60 participants, who mainly comprised of representatives from health networks, the medical and scientific community, research organisations, media, activists, legal experts, women’s groups and policy makers towards evolving concrete recommendations for policy and regulation on these issues.
Some of the main themes that were discussed at the Consultation include –
The new division of labour in commercialised research and the CRO industry;
Regulatory standards vis-à-vis the conduct of clinical trials in India;
Pressing dilemmas and Issues with regard to the existing systems of regulation;
Issues of public health vis-à-vis clinical trials;
Role of ethics committees and dilemmas in governance.
The concluding session facilitated a platform for collective strategizing over future interventions towards people-centric clinical research.
The speakers included Amar Jesani, Kaushik Sundar Rajan, Pushpa Bhargava, Brinda Karat, Arun Bhatt, Sandhya Srinivasan, Vasantha Muthuswamy, Sarojini, Anjali, C.M.Gulhati, Deapica, Parsottam Parmar, Rachna, Roli Mathur, Sujith Chandy and many others. The sessions were moderated by Anant Phadke, Amit SenGupta, Vineeta Bal, Satyajit Rath, Chinu Srinivasan, Jacob Puliyel, Samiran Nundy, Nandini Kumar to name a few. Discussions were also held with VM Katoch (DG ICMR), officials from MOHFW and DCGI.
The report in documenting its proceedings closely follows the structure of the Consultation. While presentations have been addressed in verbatim to maintain their authenticity the central concerns and points discussed following the presentations have been highlighted at the end of each session along with the comments from the chairs and discussants.
If you would like copies, please do write to us at email@example.com .
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?
Following ethical concerns raised by the people’s health movements, women’s groups, human rights groups, child rights groups, public health networks etc. and Smt Brinda Karat, a Member of Parliament at a press conference on April 7th, 2010, the HPV vaccine ‘demonstration projects’ were suspended by the Ministry of Health and Family Welfare. The trials were conducted by the American NGO PATH in collaboration with the ICMR and the State Governments of Andhra Pradesh and Gujarat. Later the Ministry on April 15th, 2010 constituted an Enquiry Committee. The Committee included, Prof. S.S. Agarwal, former Director Sanjay Gandhi Postgraduate Institute of Medical Sciences; Dr. S.P. Agarwal, Former DGHS and
Dr. Suneeta Mittal, Head of Obstetrics and Gynaecology Department, AIIMS. The brief before the Committee was to look into ‘the alleged irregularities in the conduct of studies using HPV vaccine by PATH in India’. An interim report by the Committee was made available to the media on February 21st, 2010 at a press conference called for by the campaign. However, the Committee’s final report remains absent in the public domain till today.
The Committee’s final report also follows the trend of the interim report in exonerating the responsible parties despite providing clear evidence of misconduct and violations. The Committee was also assisted by three expert members [Dr. Rani Kumar, Dean, AIIMS; Dr. A.K Dutta, Head of Pediatrics, Kalawati Saran Hospital and Dr. Y.K. Gupta, Head of Pharmacology, AIIMS] to look into various aspects of the projects including the linkages of the deaths with the vaccine and the ethics of the implementation of the projects. While the expert members have raised pertinent questions and ethical concerns, the Committee in its final recommendations and conclusions has in most cases chosen to ignore these findings. Some of the main issues that we would like to highlight here include:
1. Nature of the Projects - Ascertained Clinical Trials Violating the Drugs and Cosmetics Act (DCA)
PATH and ICMR have reiterated several times that the Demonstration Projects could not be classified as clinical trials: as they did not seek to evaluate the efficacy and safety of the vaccine and as no biomedical outcomes were being researched and no blood or other samples were drawn, and no therapies were tested. However, as Dr. Y. K. Gupta, observes in the Committee’s report, the nature and objectives of these projects, makes it evident that they are in fact clinical trials, wherein the projects were a “study of a pharmaceutical product carried out in human participants” and “4 of 5 primary outcome measures proposed in the study related to evaluation of the safety of the vaccine in population setting.” The very principles used to define a clinical trial by the CDSCO and the Schedule Y of the Drugs and Cosmetics Act, 1954 can be applied to the demonstration projects conducted by PATH.
Moreover, the Committee in the Section 7 of its findings [pg.73] has explicitly stated that it “is of the opinion that by whatever name you call it, the project proposal has been carried out as research on human participants. And as such it had to follow all the guidelines and statutory requirements applicable for research on human participants. Monitoring and management of Adverse Events/ Serious Adverse Events should have been more vigorously pursued.”
If the demonstration projects were indeed clinical trials, the non-compliance of the requirements of Schedule Y of the Drugs and Cosmetics Act raises grave ethical and legal concerns. Several clauses of the Act have been violated. The Ministry of Health and Family Welfare (MOHFW) therefore needs to take exemplary action on those violating the law of the land: in this case the concerned officials of the ICMR, the DCGI and the NGO PATH.
2. Selection of Study Area
Dr. Y.K. Gupta in his report to the Committee has specifically stated that the study has been carried out on “vulnerable population”. However, the report once again falls short by stating that while the stratification (urban, rural and tribal) “seems appropriate, caution is required”. The Committee in Section 7.5 (Page 75) has further stated that, “…. for better understanding of the research nature of the study and its impact on cancer prevention a higher strata/ better educated/ better aware population inclusion might have been more desirable. The tribal and more difficult areas could have been chosen in the later round. The standard of medical care in remote areas is generally not of the same level as in the urban areas. It would have been easier to provide proper medical care at urban district level for any SAE, particularly the life threatening SAE. It would have been better investigated to document the cause of the illness even if unrelated. The adequacy of existing AEFI system to measure 4 out of 5 primary endpoints also could have been better tested in the urban area first.“
It has been categorically stressed that “everyone shall desist from research on tribal population, unless of specific benefit to them” (Pg 80:8.5). The Committee’s recommendation to apply caution and safeguards while conducting trials on marginalized populations is a necessary and welcome one. However, the Committee appears to have taken too lenient a view of the violation of this very principle in the context of these demonstration projects, wherein the Committee’s only suggestion is to undertake a review of ethics if the project was to continue.
3. Process of Obtaining Consent
In her findings, with respect to the process of obtaining consent and the inspection of the informed consent forms, Dr. Rani Kumar explicitly states “… from the numerical analysis it is obvious that the team involved in conduction (sic) of the study on HPV has been very casual in its approach and has ignored many ethical issues such as signatures of parent/guardian, witness, PI and discrepancy in the date of receiving the vaccine and date of signature (page 49).” Similarly, the Committee in its findings in Section 7.1 [Page-70] has also declared, “the most significant deficiency in the implementation of the project was the obtaining of consent”. The Committee has observed (pg 72:7.1.4) that the ambivalent sentences in the consent form are tantamount to “covert inducement and indirect coercion” especially in the light of the high cost of the vaccine (~ Rs 9000 for three doses).
Also shocking in AP, is the Integrated Tribal Development Authority [ITDA] orders to the hostel wardens, headmasters and teachers to comply with the demands of the project and also facilitate the consent taking processes, particularly in the Ashram Paathshalas where these personnel were ordered to give mass consent (Page 51, Letter to Dr Kishore Chaudhury by Dr Rani Kumar dated 6th September 2010). 2763 forms (out of a total of 14253) were signed by the Hostel Wardens/ Head Master in AP/.
The Committee, in section 7.1.1 [page 70] also mentions that, “this authorization runs contrary to the basic principles of obtaining consent as students cannot be considered to have full autonomy in front of their teachers/ Head Master. There is no express approval of the Institutional Ethics Committees (Ices) of MNJIO&RCC, Hyderabad for this provision, nor is there any mention of it in the consent document.”
It is extremely alarming that despite clear evidence regarding serious lacunae in such a fundamental aspect of any form of research, no action has been recommended against those involved in the designing and implementation of these projects nor against those ethics committees who approved of such a design.
4. Issues Related to Safety, Follow-up and Reporting of Adverse Events
The lacunae in the adverse event reporting system has been an issue of concern for the experts as well as in the discussions of the Committee. The Committee in its findings in Section 7.2 [page -74] explicitly states, “there has been direct contact with the human participants, they have administered an intervention which is not part of a prescribed prevention, and have expected adverse events. The Committee is of the view that in all investigational studies (irrespective of being done with non-licensed or licensed products), particularly those that deal with administration of new entities; monitoring, reporting and investigation of all adverse events – non-serious, serious or deaths – should be an integral part of the study and responsibility of the investigator. Adequate insurance cover for participants to include unforeseen/unexpected or even probable morbidity and mortality events should be a part and parcel of such studies.
In this context rule 122-e of the Drugs and Cosmetics Rules, 1945 provide that all vaccines shall be new drugs unless certified otherwise by the licensing authorities under Rule 21, and a new drug shall continue to be considered a new drug for the period of 4 years from the date of its first approval or inclusion in the Indian Pharmacopoeia, whichever is earlier.”
Moreover, Dr. A.K. Dutta in his observations has mentioned several unacceptable and prolonged delays in the reporting of adverse events and deaths due to a lack of any independent monitoring systems. Further, although his observations state an unlikely link between the deaths of 7 girls and the vaccine, in 3 of these cases no conclusive evidence in this regard could be found. Further it is shocking that the study protocols did not include a separate component for the surveillance of adverse events with solely relying on the existing State run guidelines for the reporting of Adverse Events Following Immunization (AEFI). Particularly surprising is the lack of action taken by the DCGI and ICMR in the light of these delays.
We also welcome the Committee’s recommendation: “…besides issuing directions, an active programme needs to be evolved for training investigators and sensitization of regulatory agencies to specially look for these aspects in any study involving human subjects. There is also need for specific and separate legislation covering all aspects of biomedical and health research involving human participants which should provide statutory status to ICMR ethical guidelines and harmonize separate provisions under GCP guidelines and Schedule Y of the Drugs and Cosmetics Act.” [pg 81]
Although the Committee has quite forcefully condemned the laxity and also made sound recommendations in this regard, in their section on ‘responsibilities’ [pg 81] they once again absolve all the parties involved. Moreover, the Committee does not raise the important questions related to the number of girls who have dropped out of the study and their follow up.
5. Lack of Clarity in Finances
A lack of clarity regarding the finances and the financial contributions of the different parties involved, in the projects also reflects in the Committees observations and findings. The Committee has raised certain pertinent questions in their remark in section 7.5 [page 75] that states, “On the basis of market price of Rs. 3000 per dose the approximate cost of vaccinating 25000 girls would be aprox. Rs 250 million. What was the financial investment of ICMR and State Governments in the project is not provided. The State clearly provided the cold chain and manpower for immunization. But would it have done so if the vaccine was not free. There is concern about the hidden possibility of a hidden agenda to push this prohibitively expensive vaccine into the Indian Healthcare System. It might have been more prudent if the National Technical Advisory Group on Immunization (NTAGI) has deliberated on the study prior to its implementation and given its recommendations. The Ethics Committees should have looked into this aspect as well before approving the studies and a speaking mention should have been made in their approval.”
6. Need for Insurance Cover for Study Participants
Further the Committee states that “concerns over the Insurance No provision has been made of an insurance cover for any unforeseen event or residual, morbidity, related, or unrelated to the intervention; which is a usual practice in trials with NCE/INDs. The Committee is of the view that since the HPV vaccine is a newly developed vaccine, even though licensed, there should have been a provision of insurance coverage for study participants. The need for an Insurance cover is even more since the vaccine is administered to normal healthy individuals that too adolescent girls.” It also goes on to establish that “PATH has taken an insurance cover for itself”. The absence of any mention of such insurance cover for participants in the study protocols raises concerns regarding inadequacies of the approval process and the responsibilities of the approval bodies.
However, once again the Committee has failed to build on these concerns later in the section on ‘conclusions and recommendations’ and ‘responsibilities’.
7. Public Private Partnerships
Further, while the Committee has pointed out to the, “blurring of the distinction between the National Immunization Programme, as routine service activity versus the research nature of the HPV vaccination project” they have failed to levy any form of responsibility on either the State or PATH in this regard, merely advising caution for such partnerships in the future. Further although the Committee has commented on the role of the NRHM, it has failed to look into the other IEC material that has largely contributed to this blurring of distinction and has also in many ways mislead the parents of participants of the study.
Despite these cases of clear violations and foolproof evidence by the experts appointed, the Responsibility section of the report is the weakest with the Committee exonerating all involved in the project. Despite clearly highlighting the aspect of conflict of interest with the involvement of the two pharmaceutical companies, providing the vaccines free of cost, the Committee, fails to build upon these aspect later in the report.
In the light of the above, we demand that:
- The DCGI be held accountable for the approval and licensing of such a study that was severely lacking in several clinical trial protocols as is required by the Drugs and Cosmetics Act and the ICMR’s Ethical Guidelines on Biomedical Research on Human Participants.
- The multi-level violations particularly with regard to the selection of the study area, the lacunae in the research instruments, etc., – reflect the fact that the ICMR and its bioethics committees have been extremely lax in its role as technical supervisors and advisors. Furthermore it also casts doubts on the objectivity, seriousness and thoroughness of the members of the advisory group and ethics committees who gave their approval to these projects without critically examining the protocols. Immediate action should be taken against all members of these committees along with those ICMR officials who were responsible for and associated with these projects.
- Given the active engagement of the State governments and machinery in the implementation of the projects, immediate action must be taken against all those involved and further safeguards be put in place at the policy level to pre-empt such forms of exploitation in the future when similar projects run through public private partnerships.
- These projects should not be restarted and immediate action be taken against the PATH officials involved, with all research findings being treated as null and void.
- Bill and Melinda Gates Foundation the principal donor for these projects and the organization PATH, the principle investigator in this project, also largely responsible for its design and planning, take immediate onus of the various lacunae and provide compensation for all those affected by the vaccination.
- All the participants of the projects for atleast 4 years, as is prescribed by the Drugs and Cosmetics Act, for any adverse event, both serious and non-serious, with the immediate provision of any necessary treatment.
- Given, the earlier concerns raised regarding the safety, efficacy and prohibitive costs of the vaccine, these vaccines must not be introduced under any circumstances in the public universal immunization programme, with increased efforts instead to promote and provide for screening facilities in areas of high incidence of cervical cancer.
- A critical relook at the Drugs and Cosmetics Act and the ICMR’s Ethical Guidelines for Biomedical Research on Human Participants to ensure that such violations do not recur, particularly given the booming clinical trial industry.
Date: 9May 2011
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”
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: 21st 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.
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 15th 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
- 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.
- 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.
- 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 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.
- 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.”
- 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.
- 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.”
- 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.
- 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.
- 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.”
- 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.
- 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”.
- 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.
- Compensation should be provided, with immediate effect, to the families who have lost their children and to the children suffering side-effects.
- All study participants should be provided proper medical treatment and follow up
- 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.
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
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. 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
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).
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 22nd 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 29th April, the ICMR admitted that their ethical guidelines had been flouted in the course of this trial.