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.
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