By: Mahim Pretap Singh, published in ‘The Hindu’
14 October 2010
Activists concerned over commercial ICMR investigations on side effects and ethical issues are still on.
BHOPAL: The controversial anti-cervical cancer vaccines Gardasil and Cervarix, trials of which were suspended by the Indian government earlier this year, are slowly expanding their presence in Madhya Pradesh through vaccination drives in girls’ schools. While the trials in Andhra Pradesh and Gujarat were conducted on illiterate, poor and tribal women, the vaccines have found a new target group in Madhya Pradesh in the form of girls studying at elite boarding schools.
Gardasil is manufactured and marketed by MSD Pharmaceuticals Private Ltd., an affiliate of Merck & Co. Inc., U.S., while GlaxoSmithKline Pharmaceuticals Ltd. is the manufacturer of Cervarix. Both are administered to prevent the Human Papiloma Virus from causing cervical cancer.
Vaccination drives for Cervarix are going on in a few schools in and around Indore and Bhopal, a medical representative of Glaxo told The Hindu on condition of anonymity. One such drive was recently conducted in the Scindia Kanya Vidyalaya (SKV), Gwalior. “We were approached by both Glaxo and Merck for vaccination, but we finally settled with Glaxo. Not many parents gave consent to get their daughters vaccinated, but some did and their daughters were vaccinated,” says the SKV school physician Dr. Jyoti Bindal. Another school, Daly College of Indore, was reportedly approached by both companies for initiating a similar vaccination drive. However, the school physician, Dr. Shantanu Maitra, has put the process on hold. “Both the companies have been approaching us for the last three years, but we are still reviewing the proposal. For me, what eventually matters is the safety of the students and that, I assure you will not be jeopardised,” says Dr. Maitra.
Asked about promotion, a spokesperson from GlaxoSmithKline (GSK) told The Hindu: “We do not promote vaccination drives in schools for any of our vaccines. These are marketed only to doctors directly.” And an MSD India spokesperson said: “MSD is not involved in any school based vaccination programme in Madhya Pradesh.”
There is no prohibition in law on the selling and marketing of both the vaccines. However, activists have raised concerns about the vaccines being approved for commercial purposes even while investigations pertaining to ethical issues and side-effects were still being conducted by the Indian Council of Medical Research. A senior official explained that while mass trials of these vaccines were suspended by the ICMR, private individuals could still use them. “While public trials for these vaccines were suspended by us, private individuals can opt for vaccination on prescription from a doctor. The results of our investigation will be made public soon,” ICMR Director-General Dr. V. M. Katoch told The Hindu.
However, those critical of the vaccines say that they should not be allowed to be sold in the market while investigations on the Andhra Pradesh and Gujarat episodes was still being conducted by the ICMR. The vaccination drives in Andhra Pradesh and Gujarat allegedly resulted in the deaths of four girls.
What makes the issue contentious is that the trials being conducted in Andhra Pradesh and Gujarat were post-marketing phase-IV trials, which means the vaccines used in the trials were in the same stage of production as the vaccines being administered to school girls across the State. This effectively means there is absolutely no difference between the “phase-IV state sponsored public trials” that are being investigated and the “private vaccination drives” currently going on since both involve the same product.
(Note: Article reprinted in its entirety with kind permission from the author.)