Tag Archive for HPV vaccine

Health rights activists say NO to HPV Vaccine

HPV-Vaccine

Following the government’s decision to conduct a feasibility study to introduce a vaccine for Human Papillomavirus (HPV), public health activists and women’s groups question the vaccine’s safety and efficacy

By Team FI
Health rights activists, women’s groups and representatives of public health networks have reacted with shock and concern over the Government of India’s recently announced plan to introduce human papillomavirus (HPV) vaccine in the Universal Immunization Programme (UIP).

In a memorandum sent to the Union Minister for Health and Family Welfare, the activists state their concerns over the Government’s decision to conduct a feasibility study in order for the vaccine to be used in the country in the next three months. “We are extremely concerned about the long-term safety and efficacy of the HPV vaccines—Gardasil and Cervarix—and strongly feel that it would lead to serious adverse effects for its recipients. The Supreme Court is hearing the writ petitions (Kalpana Mehta and others vs Union of India & Others; Writ Petition Sama and others vs Union of India & Others) that have raised important questions regarding the vaccine’s safety and efficacy as well as its relevance and priority as a public health measure in India,” states the memorandum.

The Memorandum pointed out the lack of “conclusive evidence” that the vaccine would ensure protection against HPV. “These vaccines have not been in use for long enough to know the level of protection they will offer to young women when they are actually exposed to the risk of HPV infection. The impact of the vaccines on the health of adolescents is also not known,” states the memorandum.

Following is the full text of the Memorandum :

To
Shri Jagat Prakash Nadda,
Union Minister for Health and Family Welfare,
Ministry of Health and Family Welfare,
Nirman Bhavan, Maulana Azad Road,
New Delhi 110 011.

Date: 5 August 2015
Sub: Memorandum regarding the introduction of human papillomavirus (HPV) Vaccines in the Universal Immunization Programme.

Sir,

We, the concerned representatives of public health networks, women’s groups, health researchers, health and women’s rights activists and individuals are writing to you to convey our shock and concern over the Union Government’s plan (reported in Asian Age http://www.asianage.com/india/government-plans-reintroduce-hpv-vaccine-308) to introduce the human papillomavirus (HPV) vaccine in the Universal Immunization Programme (UIP). According to the newspaper report, the Government has asked the National Technical Advisory Group on Immunisation (NTAGI) to conduct a feasibility study in the next three months on the vaccine so that it can be introduced in the country. We are extremely concerned about the long-term safety and efficacy of the HPV vaccines—Gardasil and Cervarix—and strongly feel that it would lead to serious adverse effects for its recipients. The Supreme Court is hearing the writ petitions that have raised important questions regarding the vaccine’s safety and efficacy as well as its relevance and priority as a public health measure in India.

At the outset we would like to bring to your notice that the HPV will by itself not reduce the rate of cervical cancer in India. It is well documented that HPV infection is a necessary cause of cervical cancer; however, since every woman with HPV infection does not develop cervical cancer, it is not necessarily a sufficient cause. Other factors are necessary for progression from cervical HPV infection to cancer. Long-term use of hormonal contraceptives, high parity (number of times given birth), early initiation of sexual activity, multiple sex partners, tobacco smoking and co-infection with HIV have been identified as established factors; co-infection with Chlamydia trachomatis and herpes simplex virus type-2, immuno-suppression, low socioeconomic status, poor hygiene and diet low in antioxidants are other probable factors influencing the progression of cervical cancer. Genetic and immunological host factors and viral factors such as variants of type, viral load and viral integration are likely to be important, though they have not yet been clearly evaluated.

Further, there is a lot unknown about HPV vaccines even today, including whether a repeat dose is required and how long the vaccine might protect from HPV infection. There is no conclusive evidence which suggests that the vaccine will protect girls from acquiring HPV and developing cervical cancer later in their life. These vaccines have not been in use for long enough to know the level of protection they will offer to young women when they are actually exposed to the risk of HPV infection.

The impact of the vaccines on the health of adolescents is also not known. For instance, individual case reports of CRPS (Complex Regional Pain Syndrome) and POTs (Postural Orthostatic Tachycardia Syndrome) have been reported following HPV vaccinations from several countries including Australia, Germany, Japan, the US and Denmark. The Danish Health and Medicines Authority has drawn the attention of the European Medicines Agency (EMA) towards the vaccine’s safety and efficacy and the EMA is currently conducting a review of the vaccine’s safety profile.
(http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2015/07/WC500189481.pdf)

There is little evidence of the safety and efficacy of the HPV vaccine in the Indian context. These vaccines were hurriedly licensed here, on the basis of grossly insufficient research; the Cervarix trial was restricted to women and Gardasil was introduced after a trial with only 110 girls and no adult women.

Government committees have criticised both scientific and ethical aspects of the vaccines’ introduction in India. The 41st Report of the Parliamentary Standing Committee had called for an enquiry into the licensing of the products. However, no enquiry was conducted. The 72nd Parliamentary Standing Committee found gross under-reporting of adverse events in the only large scale “demonstration” study of the two vaccines, on girls between 9 and 16, carried out in Gujarat and Telangana by the US-based NGO Programme for Appropriate Technology in Health (PATH) in collaboration with the Indian Council of Medical Research (ICMR).

A number of girls experienced side effects and at least 7 died post vaccination. The Parliamentary Standing Committee concluded that the girls’ deaths were not properly investigated and that they were instead summarily dismissed as being unrelated to the vaccine. The Committee also concluded that PATH’s demonstration study violated the rights of the vaccinated girls and called for an enquiry by the National Human Rights Commission (NHRC) and the National Commission for the Protection of Child Rights (NCPCR).

Further, money and resources that would be spent on this vaccine should be spent to strengthen health services including screening for cervical cancer. These include large-scale awareness programmes (including sex education for girls) on HPV, cervical cancer, methods of preventing transmission of sexually transmitted infections, and the need for screening. This will have a far greater impact in reducing the incidence of and mortality from cervical cancer. Indeed, the Planning Commission’s working group on Non-Communicable Diseases (NCD) for the 12th Five Year Plan recommended that “at this juncture emphasis on availability of HPV vaccine at district level may not be required as simple advice on personal hygiene and early symptoms of Cervix Cancer and training of Health worker in VIA techniques will help in prevention & early detection of cervix cancers”. (Proposal for the 12th five year plan, working group on NCDs, Planning Commission, GoI, pg 100).

Finally, you are well aware that the Supreme Court is still waiting to hear from the DCGI and the ICMR on its order of 12th August 2014, calling on them to produce the files relating to the licensing and collaboration with PATH before the court in the matter of Writ Petition (civil) 558/2012 Kalpana Mehta and others vs Union of India and others and Writ Petition (civil) No.921/2013 Sama and others vs UoI and others. It is unacceptable to ask NTAGI to look into the feasibility of the vaccine when the Health Ministry has failed to comply with the order with respect to licensing that deal with safety and effectiveness of these vaccines.

We sincerely urge you to call an immediate halt to any attempts to introduce the HPV vaccines in the Universal Immunization Programme in the larger interest of the health and well-being of the adolescent girls and women of this country.

Supreme Court admits plea against cervical cancer vaccine trials

Supreme_Court_of_India

By Team FI

The supreme court of India on Monday has admitted a public interest writ petition against licensing and trials with cervical cancer vaccines in the country. The Court has asked the Government of India to file its reply in the matter immediately.

The petitioners -three health rights activists – argued that Gardasil and Cervarix are two unproven and hazardous human papillomavirus (HPV) vaccines purported to prevent cervical cancer, marketed in India by MSD Pharmaceuticals Pvt. Ltd. (subsidiary of Merck) and GlaxoSmithKline Ltd. The petition challenged their licensing for use in the private sector and attempts to introduce them in the public sector. The petition implicates the Drugs Controller for having licensed the vaccines without adequate research on safety and efficacy; the Health Ministry for not carrying out an enquiry into licensing of these vaccines as ordered by the Parliamentary Standing Committee on Health and Family Welfare in April 2010 nor taking any action on the report of the enquiry committee set up by itself despite all irregularities of PATH project being confirmed. Rather than looking at safety and efficacy of these vaccines in India, this project was meant to influence the government to adopt these vaccines for introduction in the public sector.

According to the press statement by the petitioners, PATH had initiated a project for the introduction of the two vaccines in India by signing an MoU with ICMR even before they were licensed by the Drugs Controller of India. This project was funded by Bill and Melinda Gates Foundation (BMGF) who had substantial stakes in Merck that produced the vaccine and hence there was a direct conflict of interest. PATH was helped by ICMR in carrying out large scale trials in the states of Andhra Pradesh and Gujarat unethically and without regard for health of poor tribal girls. The unethical nature of the study and deaths of girls became the subject of Governmental enquiry in 2010 when the matter was repeatedly raised by activists. This enquiry concluded that there were many gross violations in the project with respect to procedures for taking informed consent, inadequate health facilities for dealing with adverse events and medical emergencies. Yet after two years of the enquiry the government had not initiated any action to redress the situation and to punish PATH and ICMR as admitted by Ghulam Nabi Azad before the Indian Parliament in December 2011.

The petitioners have been raising the issue with the Health Ministry, the Drugs Controller, and National Commission for the Protection of Child Rights and other authorities including the government of Andhra Pradesh and have not made any headway. Hence a petition was filed under article 32 of the Constitution.

Hazards of the vaccines and unproven benefits
The vaccines are genetically engineered and their hazards are unknown even to the scientific communities. Though r-DNA has been detected in Gardasil in samples from many countries including India, in their application for licensing MSD pharmaceuticals claimed that there was no hazard because there was no r-DNA. GlaxoSmithKline uses a novel technique for producing Cervarix which involves the use of insect cells. Their product information admitted to their vaccine containing insect cells and proteins only in July 2011 though the vaccine was already in use since 2007. These residues or adventitious agents enter the blood stream when the vaccine is injected and are acknowledged to have the capacity to cause infections, tumours and cancer. What is noteworthy is that neither of these vaccines has been studied to determine their potential to cause cancer. In addition, the Drugs Controller has not even set standards of acceptable limits for such contamination in vaccines on the basis of which he could have found them safe for licensing.

Though both the vaccines are claimed to prevent cervical cancer, the truth is that cervical cancer takes twenty or more years to develop and the vaccines have just not been around that long to prove their efficacy in preventing cancer. But what is known with certainty is that if these vaccines are given to women who already are infected with the virus then they do raise the incidence of cervical cancer among those women.
Gardasil was first licensed in the USA in June 2006. This licensing was done on fast track with numerous conflicts of interests not only on the review board but also in that that the vaccine patent was held in PPP and the FDA itself as a part of the health department would benefit from the sales.

Licensing issues
Both vaccines were licensed for use among girls and women in India on the basis of very small studies that flouted even the liberalized Indian law. This law allows easy access to the Indian market for drugs and vaccines produced by multi-national companies once they are approved in the home country. In 2005 this law also made it possible for multi-national companies to hold trials for unapproved drugs in India simultaneous to international trials.

Targeting adolescents
These vaccines are supposed to work best when administered to girls in the age group of 9-14, before sexual debut. In the case of Cervarix GlaxoSmithKline did a trial with just 176 adult women and was granted a license for an age group of 10-45 year old women. This trial just looked at anti-body levels achieved and immediate side effects. No trial was done among Indian girls.

In the case of Gardasil, Merck through its subsidiary MSD signed an MOU with ICMR in 2005 but did not proceed with the studies that were envisaged involving thousands of women. But once it was licensed in the USA it did a speedy trial on its own with only 110 Indian girls 10-14 year old again to see immediate immune response. But it got a license by the DCGI to administer it to women from 9-26 years old though not a single adult woman had undergone a trial. According to the Indian law a trial on adults has to precede a trial among children and it was these violations that had been brought to the notice of the Parliamentary Committee that had asked for a proper enquiry into licensing.

Violations in PATH project
PATH on its own had decided to do studies with the HPV vaccine in four countries and India was one of them. The Indian market is substantial if a vaccine is accepted in the immunization programme. There is documentary evidence that though PATH is an NGO in this case it had entered into business agreement with Merck so that Merck had a ready market for the vaccine in the resource poor countries. In fact PATH got funding from BMGF in the very month that Gardasil was licensed in the USA. It signed an MOU with ICMR for this purpose. ICMR played along though it was clear that the vaccine was too expensive for India to afford. For each girl vaccinated the country would need to spend Rs 10,000 for three shots. The vaccines were marketed by hyping the risk of cervical cancer. Yet the fruits of this approach were not going to be reaped for 30-40 years or when the ten year olds crossed the age of forty – the age group when women are susceptible to cervical cancer. ICMR went ahead though it knew that the country is unable to meet the present needs of medicines to meet the current problems of the population like T.B. and malaria and could ill afford to spend money for these uncertain products. Further through its cancer registries it was also aware that the incidence of cervical cancer was declining and it was not a major health problem of the country.

PATH project was carried out in total disregard to scientific approach. It made false claims about the safety of vaccines and their efficacy. When the project took off there was no data to figure out the need for boosters, how the malnourished girls of India would respond to the vaccine that had so far only been administered to a healthy population. Yet a large number of girls in A.P. and Gujarat were administered a vaccine that had serious side effects including death. When four girls died in Andhra PradeshSupreme Court India women’s groups raised a hue and cry in 2010 and the government ordered an enquiry. The Government of AP, of Gujarat and PATH made depositions and provided data. The Enquiry Committee found that records of even informed consent had been fudged. The girls were not asked for their assent even though the law provides for such assent to be taken in writing. Further no arrangements were made for providing medical care to them if they suffered serious side effects.

Thus the rights of all 24,000 girls who were recruited by PATH in these trials were flouted as they were given the vaccine without a chance to make free informed choice. This assertion of women’s groups was confirmed by the enquiry. However, the Enquiry Committee had no legal expert and could not determine the liability of PATH towards the girls who were duped or forced into participation in PATH trial, those who died during the trial and those who would have suffered serious side effects.

PATH did everything to prevent the problems of the study from becoming common knowledge and sat on data on deaths despite women’s groups making a hue and cry about it at a public meeting organized by them in December 2009. The petitioners have pointed out that the data on death during the project is incomplete, illogical and full of discrepancies yet the deaths were called as being unrelated to vaccine administration. Side effects reported by the study were very rare and this was also brought out in the Enquiry. Yet there is no provision of continuing health care of these rural girls. Extrapolating from trial data of the two companies the petitioners have estimated that there are at least 1,200 girls in the two states have suffered from serious side effects or have developed auto-immune disorders who need continuing medical care and treatment.

These questions have been put before the Supreme Court with the hope that prompt justice and care would be provided to girls who are suffering as a consequence of an ill designed trial carried out by PATH with the active support of ICMR and the two state governments. By those very governments who are constitutionally bound to protect their life and health. Given the serious violations indulged by PATH, the petitioners have asked that PATH be blacklisted and no other foreign agency be allowed to have field presence.

The petitioners have also asked for the licences of the two products to be suspended and the vaccines recalled as there has been no scientific basis to allow their administration to girls in the private market either.

Health Care: Technology on Trial?

Health care India

Opposing vaccine technology and clinical trials instead of ensuring efficacy and transparency in their process is like throwing the baby out with the bathwater

By Vineeta Bal

Vaccination is one of the pillars for cost effective preventive approaches for primary health care. Following the World Health Organisation (WHO) recommendation for expanded programme of immunisation of all children to reduce child mortality, in 1978, India introduced six childhood vaccines, Bacillus Calmette-Guerin (BCG), DPT (Diphtheria, Pertussis, and Tetanus), polio and typhoid. In 1985 under universal immunisation programme, the measles vaccine was added. Subsequently there have been further additions.

Though vaccination coverage in India is only around 40-50% in children by the age of one year, considering the geographical outreach of the programme, the number of vaccines administered and the number of beneficiaries, it is one of the largest in the world. Vaccination has significantly reduced the frequency of illnesses and deaths in children due Diphtheria, Pertussis, Tetanus, Mumps, Measles, Rubella, and other such diseases. Life expectancy at birth has shown tremendous improvement even though, of the 26 million children born in the country every year, approximately 1.83 million children die before they turn 5. What is disturbing is that a majority of these deaths could have easily been prevented with improvement in sanitation facilities, timely medical care and vaccination.

There is limited awareness about vaccinations in India and therefore there are many misconceptions. There are many, including some activists, who believe in ‘nature cure’ and ‘nature therapy’ indicating no active technological intervention. They protest strongly against the government policies for compulsory childhood vaccination.  Most of these demands are based on inadequate knowledge and have somewhat individual-centric perspective of human rights as explained later.

Interactions with activists from diverse backgrounds bring out one significant point – an apprehension about technology – because technology related discourse uses specialized jargon, a large section of activists do not follow it. There are also, the all-pervasive feudal relationships apparent even in such movements, which make grassroot activists accept what is told to them by leaders as good, bad or ugly without developing an adequate information base or an understanding of technology.

The cumulative data from years of vaccination experience, in millions of children in the developed countries, has helped us evolve a better understanding of the advantages and disadvantages of the process. Some rare serious adverse effects continue to affect recipients adversely. Some others like autism, which remained controversial for a long time, were recently proven as not linked to vaccination.

For preventing the occurrence of diseases in order to improve the quality of life of the people, the development of new vaccines and clinical trials to test their efficacy are essential steps. However, these vaccine development (or for that matter, drug development) projects often become works-in-progress with no guarantee of complete success.

The Human Papilloma Virus (HPV) based vaccines to prevent cervical cancer is a good example to discuss. Cervical cancer affects uterine cervix, the lower part of the uterus, which causes an estimated  2,75,000 deaths a year. Out of this approximately 70 per cent occur in the developing world. A study published by Lancet early this year, stated that in India itself, majority of the cancer deaths in women were due to cervical cancer and breast cancer.

The HPV vaccine was undergoing development from mid-80s. Large scale trials in various phases have taken place in the developed and developing world including India to evaluate the efficacy of the HPV vaccine. From 2008 onwards, the vaccines are commercially available and millions of women (and men for infection caused by the same virus) in the developed world have completed the primary schedule of the vaccination.

After the success of two HPV vaccines in clinical trials, with their impending availability in the market, PATH initiated a process for a post-licensure observational study in some countries including India in 2006. However, following enormous criticism and campaign from health activists, government stopped the PATH study in 2010. One cannot deny the fact that there were adverse effects observed during the trials including a few deaths. There were also many irregularities in the process – concerns over ethical issues and arbitrariness, flouting rules and regulations – that this did happen in connivance with government agencies made it worse. Besides, testing it on poor tribal girls was a problem, obtaining informed consent from teachers rather than parents was another flaw, not using well-defined feedback methods which include checking and reporting adverse effects was also a major concern. There were other sticky issues like introducing vaccine where no surveillance system for cancer screening exists on the ground.

However, the development of HPV vaccine, which may help to bring down the incidence of cervical cancer does not appear unjustified in itself. The vaccine is proven to protect from HPV infections (repeat HPV infections contribute to cervical cancer). In a span of 5-7 years, no one can ensure that incidence of cancer has gone down; it will take 20-30 years of follow-up. But the logic suggests that the vaccine would have its positive impact.

Thus, should this vaccine technology itself be the primary target for criticism or should the way in which it was used in India be looked at? Do health activists and feminists understand and make this distinction when opposing clinical trials?

If this distinction is not made, it would mean that these critics are working against efforts to develop a new vaccine or a new drug, rather than criticizing the way in which technological innovations are tested.

Perceived injustice and concern for the underprivileged define the basis for the civil society activism in one form or the other. While the individual pain and suffering of the underprivileged or the victims of injustice cannot be denied, that in itself cannot and should not form the basis of activism. When a broader philosophical view is taken, it seems that considerations for the ‘greater good’ of the society with a focus on social justice and equality, define the primary basis of the activism. At times, this may entail undermining individual human rights, as mentioned above.

With the passage of time, technologies are pervading our lives more integrally and comprehensively, hence taking an informed stand on developments seemingly linked with the use of technologies is vital for the ‘greater good’ of the society.

Vineeta Bal is a member of Saheli and a scientist at the National Institute of Immunology, Delhi. The views expressed here are personal.

Original articles published on feministsindia.com can be reproduced but due acknowledgement to the website is obligatory