Controversy around vaccine gets muckier

The controversy surrounding vaccination for preventing cervical cancer, one of the most deadly cancers to afflict women in India, refuses to die.

A week ago, Prime Minister’s office shot a letter to Ministry of Health and Family Welfare (MoHFW) to examine the safety and efficacy of Human Papilloma Virus (HPV) vaccine for preventing Cervical Cancer.

On the other hand, Delhi state government around the same time has announced a roll-out of free HPV vaccine jabs for it’s school girls.

After receiving a complaint from Rashtriya Swayam Sevak Sangh (RSS) based organization Swadeshi Jagran Manch wrote to the PMO objecting the introduction of HPV vaccine in India, MoHFW’s office of Deputy Commissioner (Immunization) has been asked to look into the complaint.

In the meanwhile, East Delhi Municipal Corporation (EDMC) has started a drive to vaccinate up to 5,000 girls between 11 to 13 years with the controversial HPV vaccine.

“We will identify school girls who are eligible to take this vaccine, link the vaccination to their Aadhar card, train teachers to seek parents consent , arrange transport to take the girls to Delhi State Cancer Institute and get them vaccinated,” said Dr Sharda Jain, Chairperson, Delhi Gynaecology Forum.

When questioned about controversies around it’s safety and efficiency, Jain retorted, “It is absolutely safe to administer HPV vaccine to girls.”

Girls will be vaccinated in two doses within a gap of six months. Delhi government has procured the vaccines at almost half the price from private pharma companies.

While one dose of HPV vaccine costs Rs 5,000, it has cost Rs 2,300 to the state. The state has already procured 10,000 doses of vaccination. Up to 400 teachers in EDMC municipal schools have been sensitized to counsel girls and their parents to undertake vaccination.

The letter from PMO to MoHFW states, “Mahajan points out that the vaccine is very expensive. A cost-benefit study for India shows that if the cost per vaccinated girl exceeds US$3.30 (Rs 212), vaccination alone would no longer be more efficient than screening alone.” This means that introducing a vaccine without putting a holistic mechanism for preventive screening in place is not a cost-efficient option.

Dr Jacob Puliyel, member of National Technical Advisory Group on Immunization (NTAGI) said that safety data on HPV vaccine is poor at the moment and that it is not a good idea to start a free immunization drive at the moment.

“There are numerous reports of those administered with HPV vaccine to have developed chronic fatigue syndrome (CFS ) otherwise known as myalgic encephalomyelitis which is characterized by long-term fatigue that limits a person's ability to carry out ordinary daily activities.” Dr Puliyel said.

Also, The American College of Pediatrics one of the HPV vaccines could possibly be associated with the very rare but serious condition of premature ovarian failure (POF), also known as premature menopause.

“What is more shocking is that in Japan, use of the vaccine in adolescents has been associated with such serious adverse events that it has been withdrawn from the immunization programme,” Dr Puliyel added.

“There is currently no scientific study that shows the vaccine reduces cervical cancer in the women who are vaccinated. The efficacy of the vaccine against cancer is unknown.” Ashwani Mahajan, co-convenor of SJM said, “While health is a state subject, the state government should also keep in mind the safety of it’s population while administering a vaccine.”

The letter forwarded by PMO office to MoHFW stated, “It has been alleged that HPV vaccine has highest rate of adverse effect among all vaccines in use as per World Health Organization.”

After the journal 'Cancer' described how authors from Post Graduate Institute (PGI) in Chandigarh falsified science published by others, in an attempt to show that $14/child for the vaccine is cost-effective, the health minister of Punjab, Brahm Mohindra has directed that the HPV vaccination be halted until PGI evidence is reviewed.

“Recently the vaccination drives in Mansa and Bhatinda districts have however been concluded. We have urged the health minister to place all material regarding these vaccination drives in public domain like reporting of any adverse effects in girls, procedure of taking consent and availability of infrastructure to support cancer prevention and screening,”said Manmohan Sharma, co-convenor of Jan Swasthya Abhiyan, Punjab.

FACTS TO KNOW

•  Cervical cancer is the second leading cause of death for women in India. About 67, 477 deaths occur in India annually according to estimates.
• There was an allegedly unethical trial by NGO PATH of the Bill and Melinda Gates Foundation and Indian Council Medical Research (ICMR) funded by Merck Sharp and Dohme (MSD) and Glaxo Smith Kline (GSK)– the vaccine manufacturers,in Andhra Pradesh.
• The 72nd report by the Parliamentary Standing Committee castigated the Indian Council Medical Research, Drug Controller General of India, Ethics Committee members, and PATH for the unethical manner in which this clinical trial was done after calling it a demonstration project.
• The WHO report shows it is the vaccine with the highest rate of adverse effects among all vaccines in use. Some of these are seriously debilitating. They report that ‘a number of safety signals—complex regional pain syndrome (CRPS), postural orthostatic tachycardia syndrome (POTS), and chronic fatigue syndrome (CFS) have emerged with human papillomavirus (HPV) vaccines, which share a similar pattern of symptomatology’. Cluster analysis reveals additional reports of Adverse Events (AEs) following HPV vaccination that is serious in nature and describe symptoms that overlap those reported in cases from the recent safety signals (POTS, CRPS, and CFS), but which do not report explicit diagnoses.