Tag Archive | health

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 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.

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 4th 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.

Press Conference on HPV Vaccines

On the occasion of World Health Day, Jan Swasthya Abhiyaan (JSA), All India Democratic Women’s Association (AIDWA), Sama – Resource Group for Women and Health and Saheli Women’s Resource Centre organised a Press Conference to highlight our concerns regarding the HPV vaccines and to voice our 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.

The safety and the efficacy of the two HPV 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 aches, headaches and mood disorders. The matter has further gained grave urgency with the deaths of four girls in the area. Moreover, the very basis of the project is in direct violation of both, the Governments own Ethical Guidelines of Research on Human Subjects and the rights of children as secured by national law as well as international conventions that India is a signatory to.

Other serious issues include the unethical licensing of the two vaccines for marketing as so-called preventives against cervical cancer, and the aggressive promotion by the manufacturers in schools, residential localities and so on through pediatricians and gynaecologists.

The key findings from a fact-finding visit to Khammam district in Andhra Pradesh were also shared at the conference.

The speakers at the conference included:

Brinda Karat – Member of Parliament

Amit Sen Gupta – Jan Swasthya Abhiyaan

Sarojini N. -  Sama Resource Group for Women and Health

Kalpana Mehta -  Saheli Women’s Resource Centre

Sudha Sundararaman – All India Democratic Women’s Association

Venue: Indian Women’s Press Corps (IWPC), 5 Windsor Place, Ashoka Road, New Delhi
Date:  April 7th, 2010
Time: 1:30 – 3:30 pm

Visit http://www.hindu.com/2010/04/08/stories/2010040857390100.htm and http://www.dnaindia.com/india/report_cancer-vaccine-programme-suspended-after-4-girls-die_1368681 to view some of the news coverage.

Press Release

April 7th, 2010 – World Health Day

Unethical Medical Intervention to prevent HPV infection by the government in collusion with drug company and foreign NGO renders poor tribal girls dead and debilitated

Protests, representations and extensive coverage in the media against PATH-ICMR project being carried out in AP and Gujarat seem to have fallen on deaf ears and the government has gone ahead with a vaccination programme with Gardasil (HPV vaccine manufactured by Merck) leading to four deaths and 120 girls suffering from debilitating new illnesses like epilepsy, headaches, stomach disorders and early menarche.

The girls, 10-14 years old, belonging to poor families, were enrolled in a study being carried out jointly by PATH (an International NGO), Indian Council of Medical Research and the respective state governments funded by Bill and Melinda Gates Foundation. The objective of this two year study is to look into acceptability and service delivery issues of Gardasil, marketed in India by MSD Pharmaceuticals Pvt. Ltd, being misleadingly promoted as a preventive for cervical cancer.

The literature circulated in the project makes outright false statements about its safety, efficacy and duration of effectiveness. The girls and their parents have been told through the project documents that the vaccine will give life long immunity, has no side effects other than minor ones like fever and rash and will not affect future fertility of the young girls.

When deaths started getting reported local groups in Andhra Pradesh were alarmed by and carried out a fact finding to discover that no consent was taken from parents and the girls and their families have been left uncared for. Post mortem reports were also not easily accessible, and in cases of death cover up was the general dictum.

We question:

  1. Why are poor girls and their families being actively misled? Who is liable for the debilitating effects of the vaccine and who will medically look after these girls and pay compensation for the damages suffered by these people?
  2. How has the government embarked on this study of giving three injections to the girls when it is also planning a massive multi-centric dose determination study to see if two doses will suffice?
  3. How has the Drugs Controller General granted approval to the vaccine without proper research in India? For a drug to be administered to children, it has to go through stages of clinical trial, including Phase 3 adult clinical trials. So far with Gardasil only one trial has been carried out with just a small sample of 110 girls which has followed them up for just one month after the completion of vaccination and that too only to look at the immune response post vaccination. The vaccine has also been approved for adult women till 27 years of age without doing any trials with them at all.
  4. Why are these studies being carried out when at various times the concerned government officials have gone on record to say that it is not feasible for the vaccine to be introduced in the Indian Public Health system given its costs? Is it not then using these poor girls as guinea pigs for a vaccine which can be used only in the private market by well to do families? Why is a two year study being carried out with no future guarantee even for the subjects of this study to keep them protected with boosters when they actually get married by when the effect of this vaccination will wear off? The effect of the vaccine seems to wear off after 4-5 years, and will require periodic booster injections to retain claimed effectiveness.

The path of licensing of the vaccine in India raises many serious questions as time and again scientific logic and the ethical guidelines have been violated at each step. Our law clearly states that no trials of drugs can be conducted among children before trials are conducted on adults. While the other HPV vaccine, Cervarix, made by GlaxoSmithKline has also been licensed in India it has been approved for use for children without any trials among them at all. It should be remembered that last year the two drug companies had engaged in massive advertisement of these vaccines in the media and are continuing with giving incentives to doctors and holding promotional camps in schools among the paying segment of the market.

All this is being done for products which have no proven value. Even the license given by US FDA has asked Merck to actually study whether there is a reduction in the incidence of cervical cancer due to vaccination.

Even as their effectiveness and usefulness remains unproven information on the adverse effects of these vaccines are pouring in from all quarters. The tally in US alone crossed the mark of 17000 adverse effects (as reported under the voluntary adverse effects reporting system); and even the US FDA gave a hearing to health advocates to present the case against the vaccines on March 12, 2010. The adverse effects include heart, immune, blood clotting, respiratory, nervous, digestive and musculoskeletal systems and occur with far greater frequency than those observed with any other vaccines. Many experts and established medical journals have already termed it the biggest public health experiment.

In the public health system of India this vaccination will prove to be an expensive and hazardous exercise. These vaccines at best protect against two sub types among 15 which are associated with cervical cancer and hence ideally women will have to undergo pap smear tests for an effective cancer control strategy along with various hygiene and nutrition related strategies. Unfortunately, there is no investment in screening which can help the adult population today.

We demand:

1. Complete suspension of all studies and trials with Gardasil and Cervarix and suspension of their licence for marketing in India till such time that a public enquiry is held on their licensing in violation to the India law.

  1. Proper enquiry in the deaths in Khammam that have been dubbed as suicides. Unless it becomes clear that the vaccine has no impact on the mental health of girls the project authorities cannot be absolved of the blame.
  2. Each vaccinated girl be examined by independent authority to assess the range and incidence of side effects. While this will provide the much needed information about vaccine safety it will also detail the care that these girls require and the compensation they and their families deserve for having been actively misled.

4. Proper long term follow up of the vaccinated girls till they get married and have children and booster doses at the right time free of cost, with full informed consent for those girls who wish to continue vaccine protection.

Unless the government details a plan for cervical cancer control, with full compliment of boosters, screening and treatment this project is sheer experimentation with innocent, vulnerable and poor people of the society who can not afford this expensive vaccine. According to us the government is constitutionally bound to take care of the life of all citizens and not subject them to new medical problems at the behest of foreign NGOs.

Sama                      All India Democratic Women’s Association                   Saheli

All India People’s Science Network                  Jan Swasthya Abhiyan

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 7th, 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 1st, 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

The Problematics of Cervical Cancer Advertisements

The recently launched (and extremely aggressive) marketing campaign against Cervical Cancer has caught Sama’s attention. This GlaxoSmithKline (GSK) sponsored “public awareness campaign” bears distinct resemblance to a previous campaign by MSD (Merck Sharp & Dohme Corp.) with the caption ‘Guard Yourself’. Interestingly, both the advertisements do not disclose the name of the vaccine. Moreover, there is no mention of contraindications or side effects.

The print ads for these campaigns invariably feature a smiling (and presumably loving) mother-daughter pair. The latest cervical cancer ad by GSK carries sub-headings giving information and prompting action. This campaign is much more aggressive than MSD’s previous one, and is running full-page ads in leading national dailies and sending smses through country-wide networks. The ad supplies a sobering statistic on cervical cancer, putting it ahead of breast cancer as a leading killer for women. It announces the ‘Good News’ that vaccination can protect ‘our daughters’ from Cervical Cancer. The dosage required is mentioned, along with urgent slogans and affirmations such as ‘Act today!’ and ‘It’s true!’ What is missing again is the name of the vaccine, contraindications, side effects etc.

The MSD advertisements would carry on in a similar vein, asking you to know, do and give, as much as you can, to protect your loved ones from cervical cancer. The ad provided information under headings like ‘It can happen to you’, ‘Know the relation between HPV and cervical cancer’ and ‘How is HPV contracted?’ The ad concluded with a message imploring the reader to consult her doctor for protection. These also appeared on TV channels. Throughout, the name of the vaccine being so obviously promoted, was conspicuous by its absence.

Concerns around HPV vaccine: A Memorandum to the Health Minister

In a Memorandum to the Ministry of Health and Family Welfare, public health activists, along with several health networks and organisations, voiced concerns around the introduction of the Human Papilloma Virus (HPV) vaccine Gardasil. The Memorandum is as follows:

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: October 1, 2009
Subject: Concerns around Human Papilloma Virus (HPV) vaccine
Sir,

We, the undersigned, public health organizations, health networks, medical professionals and women’s groups, write to express our concern with regard to the introduction of Human Papilloma Virus (HPV) vaccine, Gardasil, to young girls in the country.

On July 9th, 2009 under the demonstration project being implemented by the Union Ministry of Health and Family Welfare in association with Indian Council of Medical Research (ICMR), PATH International and State government, the Andhra Pradesh Minister for Health and Family welfare launched a pilot program for vaccination against cervical cancer. The three doses of HPV vaccine are to be administered to 16,000 girls between 10 and 14 years in the mandals of Bhadrachalam, Kothagudem and Thirumalayapalem in Khammam district in Andhra Pradesh.[1] The vaccine will be administered in 3 doses at the interval of 0, 2 and 6 months.

Similarly, 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 immunize 16000 girls between 10 and 14 years with three doses of Gardasil. The Gujarat State Minister for Health and Family Welfare claimed that this demonstration project will help the Centre to examine the possibility to introduce the vaccination project across the country [2]

We are alarmed by this decision by State and Union Governments and we oppose the introduction of the vaccine on the following grounds:

Efficacy of the Vaccine

  • Information about the efficacy of Gardasil remains uncertain. The current HPV vaccine prevents infections, resulting from just two of the HPV subtypes (16 and 18) that may cause cervical cancer, and also HPV subtypes 6 and 11 that can lead to genital warts. The subtypes 16 and 18 account for 70% of the cases of invasive cervical cancer globally.[3] But there are over 100 HPV subtypes and one of the main concerns is that if the vaccine was to work and indeed ‘block’ subtypes 16 and 18 then the other carcinogenic subtypes may become dominant.
  • There is lack of conclusive data regarding the length of immunologic protection the vaccine confers against HPV subtypes 16 and 18.[4] Studies so far have followed up with the vaccinated ‘subjects’ for 5 years and have shown that it offers protection only for 5 years. Thus it is not clear whether protection lasts longer than this time period. Since the long term efficacy and protection by the vaccine is unknown we can not claim that even 60-70% protection will be achieved. Moreover, since the highest incidence of cancer of the cervix in India is in women above 35years of age, it is not clear whether a 3-dose schedule will provide long lasting immunity or if boosters will be required.
  • If booster doses are needed, and it is not known how frequently, what will be the impact of the booster doses on the safety of the vaccine? Moreover, booster doses would certainly increase the cost of vaccination per woman as many times as the booster would be given.
  • HPV vaccination is not a substitute for cervical cancer screening. All women, including those who are vaccinated, should continue to have regular Pap test screening and also HPV test as the preventive effect of the vaccine on cervical cancer has not yet been demonstrated.
  • HPV Infection rarely leads to progression to cancer. Only a minority of infections persist for several years, and only about 10% of low-grade lesions progress to a higher grade. About 5%of high-grade lesions progress to invasive cancer.[5]

Side-effects

  1. The Federal Vaccine Adverse Event Reporting System (VAERS) in the US has logged a total of 12,424 of adverse events following HPV vaccination, according to the US Centre for Disease Control and Prevention. Between June 2006 through December 2008, more than 23 million doses were administered in the US alone. Of these, 772 were reports of serious events (6.2 % of the reports) including 32 deaths and the remaining 11652 (93.2%) were classified as non-serious.[6]

The most common events reported were, Syncope, Local reactions at the site of immunization (pain and redness), Dizziness, Nausea and Headache.[7] Venous thromboembolic events, autoimmune disorders, Guillian Barre Syndrome, motor neuron disease, anaphylaxis, transverse myelitis, pancreatitis and death were amongst the serious adverse events reported. Amongst reports of autoimmune disorders to the VAERS system, 88% were associated with the HPV vaccine alone.[8]

  1. In Australia, the rate of anaphylaxis shock after Gardasil injection has been reported as 2.6 per 100.000 doses[9].
  2. The official Gardasil website itself clearly mentions, “GARDASIL may not fully protect everyone, and does not prevent all types of cervical cancer, so it’s important to continue routine cervical cancer screenings. GARDASIL does not treat cervical cancer or genital warts”.[10] The side effects listed include, pain, swelling, itching, bruising, and redness at the injection site, headache, fever, nausea, dizziness, vomiting, and fainting. Sometimes fainting is accompanied by falling with injury, as well as shaking or stiffening and other seizure-like activity.[11]
  3. The Indian Academy of Pediatrics Committee on Immunization (IAPCOI) in their recommendations mentions that, the vaccine is contraindicated in those with history of previous hypersensitivity to any vaccine and should be avoided during pregnancy.[12] Moreover, there have been no adequate and well-controlled studies in pregnant women, and animal reproduction studies are not always predictive of human response.[13]

Moreover, while this data is mostly sourced from US based research and trials conducted in other countries, the adverse reactions in the Indian context are unknown. Thus, the approval of a vaccine that claims to prevent a sexually acquired infection that sometimes causes cancer of cervix, and that too only if vaccination is completed before exposure, is highly questionable.

Cost Effectiveness

  • The current cost of the vaccine is Rs. 3000/- per dose (approximately USD 60) per dose. So for every 10-year old girl, 3 shots initially, and 8 shots (assuming the need for a booster shot every 5 years) over the next 40 years [until she becomes 50].  This would amount to Rs. 33,000/- by present estimate. Can the Ministry afford an injection that costs Rs 9,000 for every woman in a country where we cannot give DPT (costing Rs. 3) to 50% of children of the country?
  • In a recent study from India, published in the New England Journal of Medicine (NEJM), 31,488 women (30 to 59 years old), were followed up over 8 years with no intervention (in the control group). 64 died of cervical cancer. The absolute risk of cervical cancer was 2.5/10,000/year. If we optimistically assume that every case of cervical cancer will be prevented by the vaccine, the absolute risk reduction is 0.00025 and the numbers of women needed to be vaccinated to prevent one death is 4000. So the cost per life saved is Rs. 75 million.[14]
  • A cost effectiveness study published in the NEJM in 2008 concluded that if the vaccine provided protection against HPV for only ten years, then vaccinating preadolescent girls would only provide a “2% marginal improvement in the reduction in the risk of cervical cancer as compared with screening alone.” Moreover, it would cost $144,100 for each healthy year of Life Saved, instead of the $ 43,600 estimated for a vaccine providing life-long protection. Most researchers believe that even in the US, interventions costing more than $50,000 per quality-adjusted year of life (QALY) saved, are not cost-effective, while others use a higher ceiling of $100,000.[15]
  • Looking at our public health system, no government in India can afford this expense. The average per capita annual income in India in 2009 is Rs.38 000 and, while the current per capita annual public health expenditure in India is about USD 10.
  • Given this totally unfavorable cost-efficacy in the Indian context, we see no chance that this vaccine can be included in the Indian National Immunization program. Hence conducting such a demonstration project in India would mean using Indian people as mere guinea pigs.

Aggressive Marketing

  • Merck Sharp & Dohme (MSD) India Pharmaceuticals Private Limited, which is the Indian subsidiary of Merck & Co. Inc., the manufacturers of Gardasil, has also recently started a Cervical Cancer Prevention Program that informs Indian Women to help protect them against cervical cancer and related HPV infections. The program’s tagline, “What will I do to save my daughter from cervical cancer? – Everything that I can!”[16] is uncannily similar to Gardasil’s tag line – “We chose to help protect ourselves against cervical cancer and other HPV infections: Now the choice is yours.”[17] Similarly, PATH, that supported the formative research for the HPV vaccine Gardasil in India, highlights the demand for the vaccine through quotes like “Our granddaughters’ generation should be a generation without cancer.”[18] In this way a false signal is sent out that claims that the vaccine can prevent cancer although Gardasil prevents cancer of cervix associated with just 2 types of HPV.
  • These advertisements induce fear with regard to HPV and cervical cancer and thus create an inaccurate impression of a “public health emergency”.
  • A 15-second commercial on Indian television urges parents to get their young girls inoculated with the vaccine Gardasil to protect against cervical cancer, Advertising prescription drugs on television is unethical enough, but using fear and inaccurate claims to sell them is worse.[19]

We urge that

  1. The Government should review the decision to conduct a demonstration project of HPV vaccine in the mass immunization programs in the absence of sufficient long-term evidence of its effectiveness complete and unbiased information, and without any prior public debate. The huge cost incurred in this mass immunisation even if the current price of the vaccine is reduced substantially should be seriously considered.
  1. The state initiates comprehensive access to reproductive and sexual health programs / services for adolescents, women and men.

v      The focus should be on increasing access to preventive health care services such as pap screenings, visual screening of the cervix with acetic acid (VIA) and Visual Inspection of cervix with Lugol’s Iodine (VILI).

v      Screening programs should be augmented with newer technologies such as the use of liquid based pap testing in women, who have abnormal pap test results.

v      Provide population-based outreach pap screening services for Cancer of cervix, particularly for women from the tribal and rural areas.

v      Undertake special measures towards promoting awareness among women and community so that they come forward without any inhibitions to undergo such screening tests.

v      Instead of an expensive vaccination strategy, monitoring measures should be made available to detect Cervical Cancer at a very early stage. Treatment of all women with the diagnosis of Cervical Cancer in situ is likely to cost the public health care system much less, than buying the vaccine.

v      Public health services be made available to all, with special emphasis on women’s health, by filling in the vacancies of the gynaeocologists and para- medical workers, by providing basic screening facilities.

  1. As mentioned earlier the current vaccines target only 2 oncogenic types: HPV-16 and HPV-18. Secondly, the relationship between infection at a young age and development of cancer 20-40 years later is not known. So how should a parent, physician, politician, or anyone else decide whether it is a good thing to give young girls the vaccine that partly prevents infection caused by a sexually transmitted disease that in a few cases will cause cancer 20-40 years from now?[20]
  1. It is learnt that the Union Health Ministry has signed a memorandum of understanding (MoU) with the US Company Merck, covering the entire gamut of the trial and the launch in the country. As per the MoU, the pre introductory trial will be carried out at several centres in the country, including Institute of Cytology and Preventive Oncology (ICPO) (www.icpo.org.in) for a duration of 6 months. What is the status of these trials and if they have been completed, what are the results / findings?
  1. Financial support from industry or from an international organization should not be the criteria to introduce any vaccine in pilot phase or in universal immunization program.
  1. The role of PATH is not very clear. It appears that PATH is trying to find ways of influencing policy makers through its formative research.

Our Demands;

  1. All trials and studies to be immediately brought to a halt till in an open forum questions relating to safety, efficacy and cost effectiveness of the planned intervention can be justified.
  1. To place before the public:
  • 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 all trials planned, proposed, approved and completed, the agencies involved, the donors involved and proposed locations and all the results of the pilot phase trials as well as clinical trials.
  • The status of approval accorded to the vaccine and the data which has been submitted by the company (vaccine manufacturer) for the purpose.
  • The estimated total cost, as per the government’s assessment, of purchase of the vaccine and its administration.
  1. A vaccine policy to be formulated based on public health needs.
  1. Open up the issue for public debate and the opinion of health groups, women’s groups and other civil society members to be actively sought.

We urge you to consider these demands very seriously and act upon this matter in the larger interest of the health and well-being of the women and adolescent girls of this country. We ask you to provide the information and documents that we have requested within a month of the receipt of this letter.

Yours Sincerely,

  1. Dr. Gopal Dabade, All India Drug Action Network (AIDAN)
  2. Medico Friend Circle (MFC)
  3. Jan Swasthya Abhiyan (JSA)
  4. All India Peoples Science Network (AIPSN)
  5. Centre of Social Medicine and Community Health, Jawaharlal Nehru university (JNU), Delhi
  6. Sama Resource Group for Women and Health, Delhi
  7. Dr. Y. Madhavi, National Institue of Science Technology And Development Studies (NISTADS), Delhi
  8. Jagori, Delhi
  9. Dr. Imrana Qadeer, Delhi
  10. Dr. N. Raghuram, Guru Gobind Indraprastha University, Delhi
  11. All India Democratic Women’s Association(AIDWA), Delhi
  12. Action India, Delhi
  13. Human Rights Law Network (HRLN), Delhi
  14. Delhi Forum, Delhi
  15. Centre for Women’s Development Studies (CWDS), Delhi
  16. The Other Media, Delhi
  17. TARSHI, Delhi
  18. Partners in Law and Development (PLD), Delhi
  19. MATRIKA, Delhi
  20. Indira Chakravarthy, Public Health Researcher Delhi
  21. Ranjan De, Film maker, Delhi
  22. KRITI, Delhi
  23. Dr Veena Shatrugna, Hyderabad, Andhra Pradesh
  24. Dr. Sagari Ramdas, ANTHRA, Andhra Pradesh
  25. Andhra Pradesh Adivasi Aikya Vedika, Andhra Pradesh
  26. Dr. Rukmini Rao, President, Gramya Resource Centre for Women, Hyderabad, Andhra Pradesh
  27. Yakshi, Hyderabad, Andhra Pradesh
  28. Locost, Baroda, Gujarat
  29. SAHAJ, Baroda, Gujarat
  30. Utthan, Ahmedabad, Gujarat
  31. Sahiyar, Baroda, Gujarat
  32. Dr. Hanif Lakdawala, Ahmedabad, Gujarat
  33. Dr. Hemant Shah, Deputy Director, Bhansali Trust, Radhanpur, Gujarat
  34. Mahila Sarvangeen Utkarsha Mandal(MASUM) Pune, Maharashtra
  35. Dr. Anant Phadke, Sathi-Cehat, AIDAN, Pune, Maharashtra
  36. SATHI-CEHAT, Pune, Maharashtra
  37. CEHAT, Mumbai, Maharashtra
  38. LABIA, Mumbai, Maharashtra
  39. Forum Against Oppression of Women, Mumbai, Maharashtra
  40. Ravi Duggal, Mumbai, Maharashtra
  41. Dr. Amar Jesani, Independent Consultant on Bioethics and Public Health, Mumbai, Maharashtra
  42. Dr. Lakshmi Lingam, Professor, Women’s Studies, Mumbai, Maharashtra
  43. Dr. Dhruv Mankad, Hon. Director, Vachan, Nasik, Maharashtra
  44. Amitava Guha, FMRAI, Kolkata, West Bengal
  45. Dr. Narendra Gupta, Chittorgarh, Rajasthan
  46. Drug Action Forum, Karnataka
  47. Community Health Cell (CHC), Bangalore, Karnataka
  48. Dr. Daisy Dharmaraj, TEST Foundation, Chennai, Tamilnadu
  49. Dr. Subhashri, Chennai, Tamilnadu
  50. North East Network, Assam
  51. Dr. Ajay Khare, Madhya Pradesh Vigyan Sabha, Bhopal, Madhya Pradesh
  52. Jagannath Chatterjee, Bhubaneswar, Orissa

Contact address:

Anjali and Sarojini

C/o Sama, B-45, 2nd Floor, Shivalik Main,

Malviya Nagar, New Delhi –110017.

Ph: 26692730


[1] The Hindu, (July 10, 2009), “Pilot Program for Vaccination against Cervical Cancer launched”

[2] Press Trust of India (August 13, 2009), “Gujarat Launches Cervical Cancer Vaccine.”

[3]Schiffman M, Castle PE, Jeronim J, Rodrigue AC, Wacholde S. (2007) “Human Papillomavirus and Cervical Cancer” Lancet; 310

[4] Lippman A, Melynk R et. Al (2007),”Human papillomavirus, vaccines and women’s health: questions and cautions” Canadian Medical Association Journal (CMAJ) 177

[5] Jun 2007 “Human papillomavirus: often harmless but in some cases carcinogenic.” Prescrire International, (Vol. 16, Issue 89, Pages 115-119)

[6] Centre for Disease Control and Prevention, USA, “Summary of HPV adverse events reports published by JAMA” http://www.cdc.gov/vaccinesafety/vaers/HPV_JAMA.htm Accessed on: September 10, 2009.

[7] Centre for Disease Control and Prevention, USA, “Summary of HPV adverse events reports published by JAMA” http://www.cdc.gov/vaccinesafety/vaers/HPV_JAMA.htm Accessed on: September 10, 2009.

[8] Slade B., Leidel L, et al (2009)”Post Licensure Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine” JAMA, Vol.302, No.7

[9] Brotherton, J.M, Gold. M.s., Kemp, A.S.et al. (2008). “New South Wales Health HPV Adverse Events Panel. Anaphylaxis following quadrivalent human papillomavirus vaccination” Canadian Medical Association Journal, 179(6), 525-33

[10] http://www.gardasil.com/ Accessed on September 11, 2009

[11] Ibid

[12]Indian Academy of Pediatrics Committee on Immunization(IAPCOI) (2008), “Consensus Recommendations on Immunization” Indian Pediatrics; Volume 45

[13]Slade B., Leidel L, et al (2009)”Post Licensure Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine” JAMA, Vol.302, No.7

[14] Aneja H and Pulliyel, J (2009) “Selling Vaccines: Deciding on who can afford HPV” Indian Pediatrics:

[15] Kim J and Goldie S. ( August 21, 2008) “Health and Economic Implications of HPV Vaccination in United States”, New England Journal of Medicine Volume 359:821-832

[16] Guard your self brochure by MSD

[17] http://www.gardasil.com Accessed on September 11,2009

[18] PATH, “Shaping a strategy to introduce HPV Vaccines in India”

[19] IANS December 13, 2008 “Cancer vaccine Kicks up Controversy in India”,

[20] Haug C.(2009) “The Risks and Benefits of HPV Vaccination” JAMA; 302(7):795-796.

Draft National Health Bill – A Public health and Gender Analysis

A Workshop

12th and 13th December 2009, New Delhi

Sama is organizing a two-day workshop on the draft National Health Bill, which is a critical first step towards legal recognition of the right to health and health care in India and its operationalisation, and therefore necessitates an in-depth understanding and analysis of its provisions. This workshop follows several requests that we have received from organisations and provides an opportunity to develop a comprehensive understanding of the Draft Bill based on a public health and gender analysis.

The workshop will address the following:

  • * the salient features of the bill
  • * the key thematic areas
  • * role and regulation of the private health care sector
  • * centre / state relationship under the mandate for a central law on health

The resource persons for the workshop are – Shruti Pandey [an advocate & senior consultant with the National Health Systems Resource Centre (NHSRC)], Renu Khanna (SAHAJ, Baroda) and Abhay Shukla (SATHI, Pune). This workshop will be in English and is designed primarily for Programme Co-ordinators.

Participation is only by invitation from Sama.

Welcome to our blog

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This is an effort by us at Sama to keep in touch more regularly with all of you. I hope you will visit this site regularly and keep in touch. Keep a watch on this space for new events, developments, news and information about all that we do at Sama.

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