Controversial vaccine targets Indian school girls.

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Controversial vaccine drive targets M.P. school girls now

Mahim Pratap Singh

http://www.hindu.com/2010/10/14/stories/2010101464271400.htm

Activists concerned over commercial use as 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 GlaxoKline

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 GlaxoKline (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.â€

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.