In a far cry from the scene that prevailed almost a year ago, the two brands of vaccines to prevent cervical cancer are said to be gaining ground in the country.

Sales of Merck & Co's Gardasil in 2010 increased 72 per cent over 2009 and GlaxoSmithKline's Cervarix gained 60 per cent, Indian officials of these companies separately said. They are approved by the Drug Controller-General for sale and use by women aged 9-45 years.

MSD Pharmaceuticals P Ltd, Merck's domestic outfit, launched the vaccine in April 2008 to fight four strains of HPV (the human papilloma virus) that causes cervical cancer. Ms Monica Choudhari, MSD's Global Brand Leader, citing IMS said, “In 2010, we saw 72 per cent increase in the usage of Gardasil over 2009.”

So far, 70 million doses were sold with doctors prescribing it and women seeking it for themselves or for their daughters, she said.

Cervical cancer, the No. 1 killer cancer in the country, kills 74,000 women a year, or a woman every minute, according to her.

GSK product growth

GSK India, which followed with its HPV vaccine, Cervarix, in 2009, said the brand grew in volume by 60 per cent in 2010.

At their respective launches, Gardasil cost Rs 2,800 a dose and Cervarix Rs 3,300 a dose. Each is to be given as three doses. Gardasil hovers around Rs 2,500. The global market for these blockbusters was put at $10 billion in 2009.

Last year, GSK reduced its price by 40 per cent . It said, “As awareness about the need and relevance for this vaccination builds, among both doctors and consumers, further growth can be expected.”

The controversy

Last April, the two vaccines were in the eye of a storm after six tribal girls died in Andhra Pradesh and Gujarat; the girls were part of a multi-country feasibility study that was being conducted by an NGO, PATH. The Indian Council for Medical Research stopped the study after the deaths.

Ms Choudhari said only the PATH study to explore their introduction in the community – and different from clinical trials which were over – was stopped. “DCGI hasn't changed the [Gardasil] label. Though the PATH study has been put on hold temporarily we have not got any word on that. There is no directive, nothing has changed for us or [the sale of] Gardasil. We employees, our children have taken the vaccine and we at MSD feel very strongly about its safety and efficacy,” Ms Choudhari told Business Line during an interaction in Bangalore recently.

In Bangalore, the monthly sales of these vaccines, according to one source, was topping 5,000 doses. It could not be ascertained.

EXPERT's view

On the growing use of the vaccines, Dr S.G. Kasi, one of Bangalore's leading paediatricians and past President of the Indian Academy of Paediatrics Bangalore branch, said studies have been halted, not its use. “We have no data [to say] the deaths of the tribal girls were related to the vaccine, though they happened during the study, in what doctors call ‘a temporal association'.

Causal [or safety] relationship has not been proven.”

GSK said the number of doctors using its vaccine had doubled in the second year of launch. “While the PATH-related controversy did set the entire category of cervical cancer vaccination back a few paces, doctors are convinced that this vaccination is safe and is needed to protect Indian women from cervical cancer. Cervarix has demonstrated a favourable safety profile through a number of its clinical trials globally and a trial conducted in India.

“We are sure that the investigations by the committee set up to investigate the PATH trials will validate the safety and efficacy of the vaccine which has been approved in 110 countries and which is being used in the public immunisation programmes of the UK, Japan, the Netherlands, Sweden, Panama and Malaysia. This will provide the necessary impetus once again."

Meanwhile, those watching the HPV vaccines scene also await the long-term decade study of their use in Europe in a few months, Dr Kasi said.

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