HPV vaccinations in India: Moral and ethical questions raised by health advocacy groups

Examiner.com

April 8, 7:41 PMVaccines ExaminerNorma Erickson

Yesterday, V.M. Katoch, Director-General of the Indian Council of Medical Research, called a halt to an HPV vaccination ‘project’ being conducted in two rural Indian states, Andhra Pradesh and Gujarat. This ‘project’ was conducted by PATH International, in collaboration with the ICMR and the two respective state goverments and funded by the Bill and Melinda Gates Foundation, according to The Hindu Press.

An arrangement had been made for Merck and GlaxoSmithKline to provide the HPV vaccines (Gardasil and Cervarix) for the ‘project,’ Initially, this ‘project’ was to involve the vaccination of 32,000 Indian girls. Only 14,000 children received the shots at the time the ‘project’ abruptly ended.

58 public health organizations, health networks, medical professionals, human rights groups, and women’s groups raised some very serious moral and ethical concerns regarding the methods incorporated during this HPV vaccination ‘project’ when 4 unexplained deaths prompted them to conduct a personal fact finding mission.

  1. Why are poor girls and their families being actively misled?
  2. Who is liable for the debilitating effects of the vaccine ?
  3. Who will medically look after these girls and pay compensation for the damages suffered by these people?
  4. How has the government embarked on this study of giving three injections to the girls, when it is also planning a massive multi-centric dose determination study to see if two doses will suffice?
  5. How has the Drugs Controller General granted approval to the vaccine without proper research in India? (For a drug to be administered to children in India, it has to go through stages of clinical trials, including Phase 3 adult clinical trials. So far, with Gardasil, only one trial has been carried out with just a small sample of 110 girls with follow-up scheduled for just one month after the completion of vaccination. That was only to look at the immune response post vaccination. This vaccine has also been approved for adult women until 27 years of age without any trials in India at all.)
  6. Why are these studies being carried out, when at various times concerned government officials have gone on record to say it is not feasible for these vaccines to be introduced in the Indian Public Health system given the cost?
  7. Is it not using these poor girls as guinea pigs for a vaccine which can be used only in the private market by well to do families?
  8. Why is a two year study being carried out with no future guarantee even for the subjects of this study to keep them protected with boosters when they actually get married and the effects of the vaccine have worn off?

According to the various advocacy groups who signed off on the formal letter of protest,

…………..the secrecy regarding the non-transparent selection criteria of the area, the girls and the aim of the project has raised undeniable fears that this is a Phase IV clinical trial being carried out under the guise of a ‘demonstration project’.’  Moreover, there is an inexcusable lack of clarity with regards to the role and accountability of international agencies such as PATH (International) and Bill and Melinda Gates Foundation that appear(s) to be funding this project.

(if allegations are proven) It is beyond doubt the worst case of human rights violation………This constitutes shocking criminal negligence on the part of the authorities who have provided permission and support to this program within the public health system……Financial support from the industry, or from an international organization should not be the criteria to introduce any vaccine………

MORE…

PG

Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.