Clinical trial deaths and compensation in India

By Ed Silverman // May 5th, 2011

An investigation by India’s health ministry has found that drugmakers running clinical trials in the country have not compensated survivors of most volunteers who died during their studies. Of 671 deaths that were reported last year, there is evidence that compensation was given in just three cases, The Business Standard writes.

And so, the health ministry has asked 44 drugmakers to explain why they have not provided compensation, which is mandatory under the current law. Among those queried were Eli Lilly, Novartis, Pfizer, Bayer, Merck, Johnson & Johnson and Sanofi-Aventis. For instance, data compiled by the ministry show there were 152 deaths reported during Sanofi trials and 138 took place in Bayer trials.

A Novartis spokesperson tells the paper that its clinical trial investigator insisted any deaths were not caused by a medication, but instead due to the progression of underlying diseases. And compensation is not required in such cases. Other drugmakers offered a similar argument. Ministry officials also say that most deaths, which were attributed to cancer or cardiovascular and cerebrovascular disorders, seemed to have occurred due to the advanced stage of illness among volunteers. (How can they be so sure that the medication did not weaken the individual)

However, there were 26 deaths that went unexplained. These occurred during trials run for or by Lilly, Amgen, Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Sanofi and Pfizer. Quintiles, the contract research organization, was also on the list. And some members of the Committee on Government Assurances, which conducted the probe, are not satisfied with the explanations provided.

“Of the 671 deaths they (ministry) have mentioned, 26 are directly related to the administration of the experimental medicine. But they are not sure about the other cases as they use terms like ‘could be’ and ‘may be’, instead of outright rejection. They need to be more specific,” Maneka Gandhi, a member of Parliament from the Bharatiya Janata Party, tells the paper.

The committee began its probe because the ministry did not have records on the number of deaths and the socioeconomic status of the clinical trial subjects who died. According to Gandhi, the growing number of clinical trial deaths – 137 deaths registered in 2007, 288 in 2008 and 637 in 2009 – prompted the review.

These companies are so filthy rich yet seem so wretchedly POOR because they cannot even bring themselves to part with a miniscule percentage of profit they make thanks to  millions of such guineapigs.

 


The ugly face of Casteism

I love India, the country of my birth. However the disease of casteism still needs weeding out from the roots as the below clip shows.


Toxic Tears- The evils of the so called “green revolution” and Globalisation

So many farmers all over the world are committing suicide because of the way those in control exercise their power over them.  (Monsanto being one of them…)

All my life I have heard how science is going to help make the world a better place. Well, I am sure it could but the faceless, cowardly, few in power over most scientists have mainly used science to actually trample over most of humanity.

The evidence is there bleeding all over the place… no one need look too far.. Some of you may disagree at which point I would like to share the following:

Bertrand Russell wrote in his  book entitled The Impact of Science on Society (1952)  that:

“It is to be expected that advances in physiology and psychology will give governments much more control over individual mentality than they now have even in totalitarian countries.

Fichte laid it down that, education should aim at destroying free will, so that, after pupils have left school, they shall be incapable, throughout the rest of their lives, of thinking or acting otherwise than as their schoolmasters would have wished. (Bear in mind “school masters” teach the curriculum that is set by the governments who are heavily influenced by the corporate world). But in his day this was an unattainable ideal: what he regarded as the best system in existence produced Karl Marx. In future such failures are not likely to occur where there is dictatorship.

Diet, injections, and injunctions will combine, from a very early age, to produce the sort of character and the sort of beliefs that the authorities consider desirable, and any serious criticism of the powers that be will become psychologically impossible.

Even if all are miserable, all will believe themselves happy, because the government will tell them that they are so.

The below article is nothing new.. just another jolt to try and move those of us asleep to WAKE UP.
CHANDIGARH: It is a juxtaposition of contraries that has now become ironic. Even though Punjab government has found a negligible number of farmers who merit Rs 2 lakh compensation, given to those who are driven to suicide because of debt, a Dutch researcher has been overwhelmed by the tragedy which has almost become an every house tale in the villages.

Tom Deiters, who had come to India six years ago to carry out research on farmer suicides in Lehragaga area, as an academic exercise, was moved by the destruction that the pesticides were wreaking that he decided to stay-on for a longer time.

His documentary “Toxic Tears” profiles the heart-broken men and women in Punjab’s villages who had lost their sons to the faulty farming practices. An old woman, her face heavily creased with age, in Chottian village, broke down as she narrated how her eldest son had drunk the very pesticide, which had trapped him in a debt, to end his life four years ago.

A year later, her younger son, unable to tolerate a failed crop and more debt, followed suit. Tom, whose thesis was for doing Masters in International Relations, a part of political science, at the University of Amsterdam in Holland, is now using the Punjab model, to highlight how globalization is far removed from reality. “The evils of so called “green revolution” are so stark in Punjab,” said Tom Deiters, while talking to TOI.

“I want to use Punjab’s example to show how the policy makers are not connected to the reality. This is important because other states in India like Bihar want to follow Punjab’s footsteps,” he said. Frustrated by the pattern of the vicious trap that he had seen replicated across the villages, Toxic Tears, highlights how motivated people, especially commission agents, are taking pains to deny the very existence of farmers’ suicides.

“Farmers are borrowing money at outrageous rates from agents, many of whom are doubling up as agents of pesticides and fertilizers. There is a strong bias at work, “said Tom, who is now more focused on solutions. Punjab government too had been in a state of denial regarding the suicides and had maintained that these were only isolated cases.

“Organic farming, free of chemicals, is a way out, though it has own set of problems. But, there are farmers who are waking up to this fact. I am trying to map organic farmers in Punjab and start a self help group. The organic farmers can get together, learn from each others’ experience, market their produce together and watch the community’s interests, ” said Tom Deiters who has travelled extensively to Europe to study organic farming.

Read more: Toxic Tears: A tale of many Punjab villages – The Times of India http://timesofindia.indiatimes.com/india/Toxic-Tears-A-tale-of-many-Punjab-villages/articleshow/7584358.cms#ixzz1F7RkX5V6


KAVITHA KURUGANTI
Alliance for Sustainable & Holistic Agriculture (ASHA)
A-124/6, First Floor
Katwaria Sarai, New Delhi 110 016

http://www.kisanswaraj.in
http://www.indiagminfo.org &
http://www.iamnolabrat.com

Phone: +91-9393001550

http://timesofindia.indiatimes.com/india/Toxic-Tears-A-tale-of-many-Punjab-villages/articleshow/7584358.cms
Printed from
Toxic Tears: A tale of many Punjab villages
Priya Yadav, TNN, Feb 27, 2011, 06.12am IST


Some of my favourite bollywood dances


Rekha


Ash1

Ash2

Mughal E Azam


Banjara gypsy children song and dance from the Thar desert, India

The clip is from “Latcho Drom” a Tony Gatlif movie, traces the movement of gypsies from the subcontinent of India to Andalusia, Spain!

Este clip es de la pelicula de Tony Gatlif  “Latcho Drom”. Este pelicula investiga el moviemiento de los Gitanos de India a Andalucia Espana!


Gandhi’s speech to the Truthers

The mahatma was an atma (soul), maha (spiritually evolved) in many ways.. I like what he said in this speech. I love the last words written on this clip.


When a big tree falls, the earth shakes

http://www.tehelka.com/story_main41.asp?filename=Ne250409coverstory.asp

Above article shows how far India has got as far as accountability for these events is concerned even with a Sikh PM..

“SOMETIMES, WORDS can haunt even decades later and become a powerful leitmotif. Rajiv Gandhi’s infamous words — when a big tree falls, the earth shakes — during the brutal massacre of Sikhs in 1984 is one such sentence. It has peppered discussions and debates for 25 long years and it is this chilling cold analogy that still records a high nine on the emotional Richter scale, so powerful is its recall.”

“Till the day the journalist flung his shoe, it was all about winnability, not accountability;”

“No one could afford to overlook the negative impact of fielding Jagdish Tytler and Sajjan Kumar, the two most prominent and maligned faces of 1984 from the Capital city of Delhi where Sikhs were slaughtered in the worst massacre.”

“THE TRUTH often lies buried in small details and it is often hard to find.”

“‘The riots negated the concept of nationhood,’ said the PM in an emotional speech. Strong words from a Sikh PM acted as balm then, but what happened subsequently was a shame.”

“The orphans of politics lie in wait.”