The Indian Express reports that the Indian government has decided not to introduce a cervical cancer vaccine into the universal immunisation programme. This decision has been made despite the fact that India has an unacceptably high death rate from cervical cancer.
Opposition to the vaccination programme came from Ashwani Mahajan, the national co – convener of the Swadeshi Jagran Manch who explained the party’s stance in a letter to the Prime Minister Narendra Modi:
It is our concern that this programme will divert scarce resources from more worthwhile health initiatives diverting it to this vaccine of doubtful utility and that its adverse effects will erode confidence in the national immunisation programme and thereby expose children unnecessarily to the risk of more serious vaccine-preventable disease.
Although the decision not to include the HPV vaccination in the universal immunisation programme is not final it won’t be happening in the near future. In India the vaccine is available in the private sector and can be given if there is demand on behalf of the woman and her doctor sees a need.
Cervical cancer is the second most common cancer among Indian women accounting for an astounding 67,000 deaths a year. Many developing nations such as India have no organised screening programs, with Pap smear testing only available to a small population of mainly urban women. I would hope that the RSS wing Swadeshi Jagran Manch which has argued successfully against the HPV vaccine will now press for improved health care with Pap smears programs instituted throughout India for clearly 67,000 deaths a year from cervical cancer is shocking. Contrast this with the situation in Australia where this particular cancer is a long way down the list of common female cancers – in fact it is rated the 18th most common cancer in Australian women. Clearly socio economic conditions in India need to improve in order to address this alarming death rate. Risk factors for this disease include living in poverty, dietary deficiencies, smoking and multiparity ( having given birth to more than one child).
India is no stranger to the HPV vaccines, Gardasil and Cervarix. In 2009 an unethical vaccine trial took place involving thousands of young girls. The trial was called a ‘demonstration project’ and run by the Indian unit of the Program for Appropriate Technology in Health (PATH). However the project was in reality, a Phase IV, post marketing, clinical trial.
It involved the vaccination of about 30,000 girls, aged between10–14 years. The vaccines used were Gardasil and Cervarix. Women’s health groups alarmed at the trials and rightly concerned that the HPV vaccines had not been tested for safety and efficacy in the Indian population where adolescent girls are often malnourished conducted their own investigation and found that the young girls selected for the trial — many of them poor tribal girls — came from communities lacking the necessary health infrastructure such as Pap smear facilities and gynaecologists.
These young adolescent girls had put their faith in the government, naively trusting it to do the right thing — in this case providing them with an expensive vaccine free of cost, to prevent cervical cancer. However, there was no informed consent process; they were not told that they were part of a clinical trial and that they had the right to refuse participation. In the rare cases where consent forms were used, there was no information regarding compensation, or about possible alternative treatments or risk management.
The girls were also not informed that one of the possible and significant side effects of the vaccine might be infertility. Notwithstanding the fact that at least four girls died in Andhra Pradesh and two in Gujarat and that many girls went on to suffer severe side effects (including anaphylactic shock, seizures and paralysis, motor neurone disease, and disorders of the immune system), there was no follow-up monitoring by PATH. The deaths were attributed to other causes such as malaria or suicide.
In April 2010, the Indian Council of Medical Research told the governments of Andhra Pradesh and Gujarat to immediately suspend the cervical cancer control vaccination program for girls. In the same year, due largely to the insistence of the activists, the Indian Government held an inquiry into the study which found that many violations had taken place which included a lack of informed consent, and inadequate health facilities for dealing with adverse events and medical emergencies. A further finding in April 2013 by a committee appointed by India’s parliament accused PATH of violating clinical-testing norms:
Its [PATH’s] sole aim has been to promote the commercial interests of HPV vaccine manufacturers who would have reaped windfall profits had PATH been successful in getting the HPV vaccine in the Universal Immunization Program of the country.
All of this is of course cold comfort to the parents of 13-year old Sarita Kudumula who only learnt that their daughter had taken part in a medical trial after she collapsed and died a few days after her Gardasil injection. Girls from tribal communities such as Sarita are obliged to attend government schools located away from their communities which increases their vulnerability to exploitative drug trials.
You can read more about these unethical trials in Gardasil: Fast-Tracked and Flawed
Every year in India, 122,844 women are diagnosed with cervical cancer and 67,477 die from the disease. India has a population of 432.2 million women aged 15 years and older who are at risk of developing cancer. It is the second most common cancer in women aged 15-44 years. India also has the highest age standardised incidence of cervical cancer in South Asia at 22, compared to 19.2 in Bangladesh, 13 in Sri Lanka, and 2.8 in Iran.
In light of these alarming statistics so much more needs to be done to alleviate this huge disease burden. The answer will not be found in HPV vaccines but in changes to the poor socio – economic conditions endured by women at risk of cervical cancer.