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The clinical business of illegal drug trials

Apr 05, 2012

Unethical drug trials by Western pharmaceutical companies are killing poor people in Africa and India. The sad part of such trials, says health activist Mira Shiva, is that many of these drugs being tried and tested on the vulnerable people are unnecessary and irrational.

Recently, a bench of the Supreme Court of India expressed grave concern over an ongoing illegal clinical trial of untested drugs while responding to a public interest litigation (PIL) filed by a group of doctors. The petitioners alleged that multinational corporations have used poor people including juveniles, adivasis and dalits as guinea pigs for various drug and vaccine trials.

"Over 3,300 patients were tested. Clinical trials were conducted on 233 mentally-ill patients, 1,833 children in the age group of one day to 15 years. In 2008, there were 288 deaths, in 2009, there were 637 deaths, and in 2010, there were 597 deaths," the PIL had said.

The court has sought an explanation from the government and the Medical Council of India, a statutory body with the responsibility of establishing and maintaining high standards of medical education and recognition of medical qualifications in the country.

“An extremely ethical trial for a nonsensical drug, does that make it great?”
Dr. Mira Shiva, Head of the Public Policy, VHAI

The hearing has once again stirred a debate on drug trials on vulnerable people in developing countries which, according to many, is a big business these days. India and Africa offer the most suitable environment for global clinical trials, therefore, the maximum number of unabated illegal drug trial cases emerge from these regions.

Trials on ‘subjects’

Before introducing a new drug for use by humans, companies carry out clinical trials to study the effects of that drug on people. These trials are carried out on ‘subjects’, after their ‘informed consent’ is taken. The ‘informed consent’ means that the participant not only agrees for the trial but is also aware of its repercussions.

The subject’s safety is ensured in the United States but not in India. There are guidelines by the Indian Council of Medical Research (ICMR), the apex body in India for the formulation, coordination and promotion of biomedical research, which are never inacted.

Clinical trials or aggressive marketing of drugs? 

A Gurgaon-based clinical trial consulting firm, Ziven Consulting, reveals that the global clinical trial industry is worth Rs 1,56,870 crore and clinical trials conducted in India in 2008 were worth Rs 1,345 crore.  The data clearly reflects that mushrooming of clinical trials in India started after 2005.

Mira Shiva, Head of the Public Policy, Voluntary Health Association of India (VHAI), and coordinator of the All India Drug Action Network, told OneWorld that these trials are done totally from a market point of view and that too for Western markets.

“An extremely ethical trial for a nonsensical drug, does that make it great?” argued Shiva.

There are drugs in the market which are safer, cheaper and more receptive. Therefore, the testing of newer and similar drugs is irrational and part of excessive marketing. Huge amounts are pumped into such practices in the name of R&D that indirectly go from the exchequer's pocket. So, the idea that all clinical trials are great, and all drugs in the market are necessary is a farce, reasons Shiva.

Lack of health literacy

“We don’t have minimal health literacy as part of education. People are clueless about their systems, clueless about their medicines and clueless about their rights as patients,” said Shiva. The participants (or subjects) of these trials are poor and vulnerable people because they are the ones who risk their health, and ultimately their lives, for small chunks of money. The subjects don’t even know how the trial process works.

It is a known fact that the poor in developing nations even sell their blood and kidneys for money. Many kidney donors suffer from complications throughout their lives and it is a similar fate for the victims of unethical clinical trials who either die or suffer severe health complications for the rest of their lives. Most do not even get adequate compensation.

In developing countries, pharmaceutical companies outsource these trials to research organisations but in case of complications, nobody is held accountable. 

Ironically, even the educated people are not aware of their rights. The issue of drug trials should raise the bar of what the general public should know as patients or as a 'subject' undergoing a random drug trial.

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