HPV Vaccine for India - A Controversy


Cervical cancer vaccination: for Delhi and Punjab, lessons from Andhra and Gujarat


As more States decide to introduce HPV vaccination, it is important to bear in mind the lessons learnt from the HPV vaccine trial in Andhra Pradesh and Gujarat. The trial came under scrutiny following the uproar over the death of seven children. Though deaths of the children were found to be unconnected with the vaccination, investigation into the conduct of the trial exposed several ethical violations, including signing of 2,800 consent forms by a hostel warden. The trial was suspended in March 2010.
Following the uproar caused by the deaths and unethical practices during the conduct of the HPV vaccination trial, the Supreme Court in January 2013 expressed serious concerns about clinical trials in India. It said that uncontrolled clinical trials in India by multinational pharmaceutical companies was creating “havoc” and slammed the Centre for failing in its duty to stop the “rackets” that resulted in deaths of people who had participated in clinical trials.
And in September 2013, the Supreme Court stayed the approvals for 162 clinical trials already approved by the Drugs Controller General of India. It then came out with very stringent guidelines for the conduct of clinical trials.
The Indian Council of Medical Research (ICMR) has been the driving force behind the vaccination programme. “We held expert group meetings with many stakeholders, including NGOs, and looked at the scientific evidence from the World Health Organisation, the International Agency for Research on Cancer (IARC), other countries that have introduced HPV vaccine and from within India. We took into account the current global recommendations. We also looked at experiences of other countries in this region such as Nepal, Indonesia and Sri Lanka, which have introduced the vaccine,” says Dr. Soumya Swaminathan, Director-General of ICMR.
There is a lack of effective screening for cervical cancer in developing countries, India included. A 2009 study carried out in about 500 villages in Osmanabad district in Maharashtra found a “single round of HPV testing was associated with a significant reduction in the numbers of advanced cervical cancers and deaths from cervical cancer”. There were 34 cancer deaths in the HPV-testing group compared with 64 in the control group.
The WHO has made it abundantly clear that despite vaccination, screening for cervical cancer should continue. The reason: besides 16 and 18 HPV serotypes, infection with 11 other serotypes can cause cervical cancer. The HPV serotypes 16 and 18 account for only about 77% of cervical cancer in India. Hence, girls vaccinated with even a quadrivalent vaccine can be infected with other serotypes. The 9-valent HPV vaccine, which was licensed in 2015, offers greater protection against HPV-causing serotypes.
Some oncologists from the Tata Memorial Centre are of the opinion that HPV vaccine to prevent cervical cancer is not needed in India. They cite the sharp fall in the number of cervical cancer cases without any medical intervention. They attribute this fall to increased awareness particularly of personal hygiene in cities such as Mumbai, Bengaluru, Chennai, Kolkata and Delhi. Cancer registries in four rural pockets have not shown any increase in incidence in over two decades.

Courts can look into parliamentary panel reports but not rely on them: Supreme Court

Updated: Oct 12, 2017, 10.14 PM IST

Read more at:
R. Prasad
OCTOBER 04, 2017 17:57 IST