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Notice (8): Undefined variable: urlPrefix [APP/Template/Layout/printlayout.ctp, line 8]latest-news-updates/politics-of-immunisation-4677021.html"/> LATEST NEWS UPDATES | Politics of Immunisation | Im4change.org
Resource centre on India's rural distress
 
 

Politics of Immunisation
-Economic and Political Weekly

The health ministry's move on HPV vaccine feasibility is ill-advised.

The union health ministry has asked the National Technical Advisory Group on Immunisation (NTAGI) to examine the feasibility of introducing the Human Papillomavirus (HPV) vaccine in the country’s universal immunisation programme. The NTAGI has been given three months for this task. The HPV vaccine, which is supposed to protect against cervical cancer in girls and women, is generally given between the ages of 9 and 14 years and is presently available in the private health services sector. However, this vaccine has been at the centre of controversies and debates for long and a large number of public health and research activists representing a number of organisations have written to the union health minister flagging issues about its safety and capability. The health ministry’s directive to the NTAGI is rather surprising in view of a parliamentary committee’s report on the alleged irregularities in a so-called clinical trial of HPV vaccines on tribal girls in 2010 and an ongoing hearing on it before the Supreme Court.

It is pertinent here to note the 72nd report of the Parliamentary Standing Committee on Health and Family Welfare. In 2010 it had delved into allegations that the trials conducted by an American body, the Program for Appropriate Technology in Health (PATH), for the HPV vaccine on tribal girls in Khammam District of the then Andhra Pradesh (they were also conducted in Gujarat) had led to seven deaths and serious side-effects in others. Not only has it strongly indicted the manner in which the trials were conducted and the roles of the Indian Council of Medical Research (ICMR) and the Drug Controller General of India (DCGI) but some of its statements have a direct bearing on the issue at hand. It says

    ...the choice of countries and population groups; the monopolistic nature, at that point of time, of the product being pushed; the unlimited market potential and opportunities in the universal immunisation progammes of the respective countries are all pointers to a well planned scheme to commercially exploit a situation. Had PATH been successful in getting the HPV vaccine included in the universal immunisation programme of the concerned countries, this would have generated windfall profit for the manufacturer(s) by way of automatic sale, year after year, without any promotional or marketing expenses. It is well known that once introduced into the immunisation programme it becomes politically impossible to stop any vaccination.

The report recommended that the government take up this subject with the other countries (Vietnam, Uganda and Peru) through diplomatic channels.

What is also noteworthy in the present context is that one of the objectives of these “observation studies” as PATH had then described them was to examine the possibility of introducing the HPV vaccine into the country’s immunisation programme. The estimated cost of three doses of Cervarix is Rs 6,000 and that of Gardasil is Rs 8,400.

The Supreme Court is hearing a case about this trial which had used the vaccines Gardasil and Cervarix. The apex court has asked for explanations from the ICMR and DCGI. It has also directed the centre to place before it the report of the parliamentary committee referred to above. This report had also censured the “shoddy investigation” into the deaths of the tribal girls by dismissing them as unrelated to the vaccines and attributing them to a number of other factors.

There is no doubt that cervical cancer deserves serious attention considering that it is the most common woman-related cancer in India and an estimated 79,000 women die of it every year. As such the “market” for drugs and vaccines related to this disease accounts, according to media reports, for a quarter of the global sales. However, the moot point here is whether a vaccine whose safety and ability are subjects of bitter controversy should be included in the universal immunisation programme when other measures should actually be stepped up. For example, in the US, it was the widespread campaign to popularise the simple pap smear test that reportedly reduced cervical cancer deaths by three-quarters in the last 50 years.

As leading public health activists have pointed out, instead of incurring heavy expenditure on the vaccines, the government should attend to increasing access to pap screenings, liquid-based cytology (LBC) tests and other visual screening methods, provide outreach pap screening services for women in tribal and rural areas, promote awareness about this disease and the screening tests available and fill vacancies in public health services which target women’s health. They have also cautioned the government about the lack of proper evidence that the HPV vaccine is safe in the Indian context, that not much is known about the requirement for a second dose and for exactly how long the vaccine’s reported protection against cervical cancer lasts. The HPV vaccine will by itself not reduce the rate of cervical cancer in India since the HPV infection is a necessary cause of cervical cancer but not every woman with HPV infection develops cervical cancer, other factors also weigh in, they pointed out.

The government’s directive to NTAGI then seems an illustration of the malady of learning nothing and forgetting everything. Leave aside taking action on the parliamentary committee’s report on the Khammam trials of the HPV vaccines, there is no evidence that it was even studied seriously.