462 deaths related to testing of experimental drugs on patients in India till mid-2010 alone, show health ministry figures

Dance with Shadows

From India Express

Monday, August 9, 2010, 18:44 This news item was posted in Clinical Trials,

Deaths related to drug testing in humans are going exponentially high in India as the country is becoming a choice destination for pharmaceutical giants to conducts clinical studies of experimental drugs on real-time patients.

The number of deaths during clinical studies has been steadily increasing and as many as 462 people, who were a part of clinical trials, died in the year 2010 alone till June, according to figures available with the Union Health Ministry.

There were 132 deaths in year 2007, 288 deaths in the year 2008 and 637 deaths in year 2009 , say the data.

In April, Indian government suspended Merck’s cervical cancer vaccine Gardasil study in two states following reports of deaths of 4 girls and several complications.

Gardasil was to be tested for its “acceptability and service delivery issues” in about 32,000 girls aged 10-14 in the southern Indian state of Andhra Pradesh and Western state of Gujarat.

Gardasil vaccination programme is being conducted jointly with PATH, a Seattle-based NGO, the Indian Council of Medical Research (ICMR) and the two state governments. The vaccination drive is funded by the Bill and Melinda Gates Foundation

PATH-International, which is conducting the study for the maker of Gardasil Merck, an American pharmaceutical company since July 2009, has described the study as a “demonstration project.”

The human papilloma virus (HP) vaccine HPV vaccine Gardasil, meant to prevent cervical cancer among women, has been alleged to have led to the death of the four girls who were administered the dose in Khammam district of Andhra Pradesh.

Besides the death, more than 120 girls, who were given the vaccination, have complained severe adverse reactions of stomach disorders, epilepsy, headaches and early menarche.

Though officials say that deaths occurring due to negligence of the company during trials is rare, such instances have come to light. The most recent case being the trial of a human papilloma virus (HPV) vaccine in Andhra Pradesh, where four girls died after being vaccinated. While, the Indian Council of Medical Research (ICMR) halted the trials, experts are still investigating the cause of the deaths.



Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.