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Third world guinea pigs?
A detailed analysis on the recent case of the death of 49 babies from clinical trials. Despite this, foreign press organisations, have taken the liberty to unearth and expose the dark sides of clinical trials.
THIRD WORLD nations have always been the favourite laboratory for clinical trials. And some of the reasons, why drug companies, choose these nations is because defence mechanisms are at its lowest and violations is at its highest.

Considering the most recent case in India where 49 babies died due to clinical trials and the mixed reactions by the general public reported in the media, one can simply gauge the actual value of human life, in these nations. Moreover, it is also sad to note that people cannot open their eyes to the criminal nexus between the drug cartel, hospitals and politicians. However, India has always been one of the favourite hot beds for clinical trials and the failed results have not really been reported accurately, in the press for obvious reasons. Despite this fact, foreign press organisations, have taken the liberty to unearth and expose the dark sides of clinical trials. One such example was the BBC’s investigative report, "Dark side of Clinical Trials" reported some years ago, which exposed the total apathy of the medical fraternity and the lapses in clinical trials and its impact on the patients.

I also would like to cite a case, which took place during the 1996 meningitis epidemic in Kano, Nigeria, where Pfizer, a leading United State (US) pharmaceutical, conducted a trial of an unapproved drug, "Trovan" on children suffering from the outbreak. This resulted in the death of 11 children and rendering nearly 200, permanently brain damaged. However, the Nigerian government charged Pfizer with criminal conspiracy and is suing them for two billion dollars, as damages. Despite the court hearings, Pfizer is trying to make an out of court settlement, while at the same time their claims of proper "informed consent" remain the same as that of the All Indian Institute of Medical Sciences (AIIMS).

Several organisations, across the world have voiced their concern about the unethical clinical trials and its disastrous impact on patients. But time and again, government agencies have failed to rectify this disaster. In the case of India, Rahul Verma, rightly pointed out the fact that all this is due to the corruption at its highest levels, but some educated fools, believe that the number of deaths in clinical trials, are not alarming and there is no reason to worry. Worst ever, is the Health minister Anbumani Ramadoss, who forms a very biased committee by appointing the same doctors from AIIMS on the panel and within a span of 48 hours, he decides to give a thumbs up for the hospital and forgot about the babies, who died due to the trials. Moreover, investigations by activists, advocating the case has also revealed that two of the drugs, tested on the babies, were not meant for infants at all. And they were actually stress related drugs.

Why the Helsinki Declaration?

Though the World Medical Council (WMC) knew the relevance of clinical trials, yet they forged the Helsinki Declaration in 1964. This declaration was created and revised over and over again, in view of the blatant human rights violations, by clinical trial investigators. And it was apart from the international Nuremberg code, created in 1947. But my question is, have doctors really bothered to read the text of the declaration, which binds the doctor with the words, "The health of my patient will be my first consideration."

If India claims to be an upcoming super power, are its physicians not bound by the International Code of Medical Ethics, which declares that, "A physician shall act only in the patient’s interest when providing medical care, which might have the effect of weakening the physical and mental condition of the patient."

Dr Arthur Caplan of the center of Bioethics at the University of Pennsylvania once questioned, "Are too many poor people disproportionately recruited for research? Who knows? Are the elderly in nursing homes underrepresented in clinical trials? Who can tell? Should more children be involved in studies of new drugs? Cannot say. Is it more likely that people get injured in for-profit test centers than in academic research settings? No data is available to answer that question. He further adds, "Bodies are not the same as Coca-Cola cans. And when you’re talking deaths in clinical trials, mistakes are not an option. It’s just an area where we have to have absolute, foolproof reporting in place."

The Indian case demonstrates how doctors from AIIMS and the Health minister, Anbumani Ramadoss have blatantly violated the ethical principles laid down by the international Nuremberg Code and the Helsinki declaration. They are guilty for violating the international fundamental right to good health by altering all ethical principles for their own good and to increase profits in the name of medical development.
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