Thursday, April 22, 2010

Anti-cervical cancer vaccines - Indian girls as guinea pigs? Deaths related?

Anti-cervical cancer vaccines are a rage now in India - with hefty advertising budgets, effective medical executives convincing doctors and doctors themselves turning advocates! The vaccine is usually administered to girls as they enter their teenage years. And it is estimated that as much as 70 per cent of reported cervical cancers are believed to be caused by the human papilloma virus. The vaccine claims to prevent infection with certain species of HPV.

After coming under fire in Rajya Sabha on April 22, 2010, the government put on hold clinical trials of anti-cervical cancer vaccine HPV in Andhra Pradesh and Gujarat, even while stating that death of six vaccine-administered tribal girls in the two states could not be attributed to the medicine. The health ministry on April 22, forcefully denied the allegation levelled by the opposition that Indian girls are being used as guinea pigs for anti-cervical cancer vaccines!

Four of the 14,091 girls given the vaccine in Andhra Pradesh had died, while two of the 10,686 vaccinated girls died in Gujarat, Health Minister Mr Azad said but added prima facie no connection between these deaths and vaccination had been established.

Defending the large-scale clinical trial under which 24,000 girls in the age group of 10-14 years were permitted to be given human papilloma virus(HPV) vaccine in the two states, Health Minister Ghulam Nabi Azad said it had become imperative as 76,000 of the 1,32,000 girls suffering from the cervical cancer had died in the country in 2006 alone, fearing the number of sufferers would go up by a lakh every year. Secondly, the permission for phase IV clinical trial of the HPV vaccine was given only after phase III trials had been conducted in more than 100 countries, he added.But at the same time the Minister said Andhra Pradesh and Gujarat governments had been advised not to carry out further vaccination until a committee set up by the Union Government to probe alleged ethical violations in the trials submitted its report.

Marxist leader Brinda Karat, who raised the issue of death of six tribal girls during the clinical trials through a calling attention motion in the House today, demanded that the government induct experts in the panel set up by it to probe ethical violation, if any, in the allowing the clinical trials by a US-based non-governmental organisation(NGO) -- PATH. She strongly objected to the government allowing the phase IV trial based on a study carried out on just 110 children by foreign pharma companies not registered in India.

The two HPV vaccines (GARDASIL) were allowed for clinical trial in the country in accordance with the Drugs and Cosmetics Act, 1940, and these are available in the market. However, a US-based NGO, PATH, was granted permission to carry out an operational research on these vaccinations in Khammam district of Andhra Pradesh and Vadodara in Gujarat.

Theoretical excitation and Medical Conspiracies
Two common instances even you would have experienced: It is a common observation that most of the commerce graduates are inspired of theoretical business gains and setup business establishments soon after studies, but get to reality with their hands burned, from real experiences different from theory! Another case is, most of my doctor(english medicine) friends, advocate/subscribe to anti-pregnancy tablets in the initial years of marriage, especially important for doctors to complete their studies etc and later we had seen that they are bound to have problems with normal pregnancy later on! 

You also know, how pharma companies made money with WHO(World Health Organisation) over rating the criticality level for the disease! Now its upto you to relate the story!

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