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Diarrhoea vaccine raises a storm

New Delhi, Dec. 15: A children’s vaccine against a stomach infection has triggered controversy with some doctors claiming there is not enough data to show it is effective in India and accusing a leading drug company of using a misleading advertisement to promote the vaccine.

GlaxoSmithKline Pharmaceuticals (GSK) has stopped the advertisement for the vaccine intended to protect children from potentially life-threatening rotavirus infections after the advertising industry’s self-regulating body upheld a doctor’s complaint that it was misleading.

A New Delhi-based physician, Nalini Abraham, had complained to the Advertising Standards Council of India that GSK’s advertisement shown on two television channels had wrongly claimed that the vaccine is the only way to reduce the incidence of rotavirus infections. She said the virus is ingested through contaminated food, and hygiene can reduce the spread of the infection.

“The vaccine is expensive... (people) are being fooled into spending... money for a vaccine that has not been proven to be effective in reducing the overall incidence or the numbers of deaths from diarrhoea in India,” Abraham said.

The ASCI examined the complaint and the company’s response and ruled that the claim in the advertisement was “inadequately substantiated” and “misleading”. GSK has told the ASCI it would discontinue the advertisement.

Sections of paediatricians have also expressed concern at what they say is insufficient data from India to establish the efficacy and cost-effectiveness of rotavirus vaccines available through the private sector in India over the past four years.

The vaccines are typically given to infants in two doses. Each dose is available for about Rs 980 in India, according to a paediatrician in New Delhi.

The World Health Organisation has recommended the introduction of rotavirus vaccines into national immunisation programmes of countries such as India where deaths from diarrhoea make up more than 10 per cent of child mortality.

But doctors are locked in an intense debate with some arguing for its speedy introduction into the government’s immunisation programme, and others cautioning that it is being promoted through inappropriate extrapolations and faulty cost-benefit arguments.

“Vaccination is the best method to prevent deaths and morbidity (illness),” Umesh Parashar and Johnie Rose, two US-based physicians wrote last week in a debate published in the British Medical Journal.

They cited a study published three years ago that had extrapolated laboratory-confirmed infections to estimate that rotaviruses may be causing nearly 1,47,000 deaths across India each year.

But two Indian paediatricians have, in the same issue of the journal, said the true burden of rotavirus deaths in India has not been established and that deaths from rotavirus infection can be prevented through “simple measures to correct dehydration”.

“No studies have looked at the efficacy of the vaccine in India,” paediatricians Jacob Puliyel at the St Stephen’s Hospital in New Delhi and Joseph Mathew at the Post-Graduate Institute of Medical Education and Research in Chandigarh wrote. “But studies from Bangladesh and Vietnam show vaccine efficacy against rotavirus diarrhoea is 48 per cent. This is much lower than in the West where it is 90 per cent.”

Two government paediatricians have also questioned the decision by India’s drug regulators to grant marketing approval to the rotavirus vaccines in India without adequate data in support of its efficacy within the country.

“It is surprising the (rotavirus) vaccines have been approved for marketing despite insufficient immunogenicity and absent efficacy data in Indian children,” Rakesh Lodha at the All India Institute of Medical Sciences and Dheeraj Shah at the University College of Medical Sciences in New Delhi wrote earlier this year in the journal Indian Pediatrics.

A GSK spokesperson told The Telegraph the company would need “more time” to respond to such concerns raised by sections of India’s paediatricians.

One government paediatrician who requested not to be named said combating diarrhoea is likely to demand multiple interventions. “Things like handwashing, hygiene, and oral rehydration therapy can make a difference, but there isn’t as much focus on these as there should be,” the doctor said. “A vaccine too could play a role, but it has to be first proven as cost-effective.”

Abraham said that while parents could take informed decisions about whether to accept the vaccines available in the private sector, the national immunisation programme needs to focus on achieving “maximum good for maximum numbers”.

“India should first ensure that the well-established life-saving vaccines against diphtheria, measles, and tetanus already in the immunisation programme reach out to 100 per cent children,” Puliyel said.