:: REVIEW ::


Drug Trials: The Dark Side

BBC documentary, reviewed by Vikram Popat

Hindu Voice UK, May 2006

'Outsourcing' of jobs is an important phenomenon affecting the way that business is done today. Many large companies in the West are moving jobs to developing countries, where the workforce is much cheaper. In this way, the companies make huge savings on the amount paid as wages. The main country to which jobs are being outsourced is India, because it has a larger English-speaking workforce than any other country.

Whereas Western countries have often expressed apprehension about the loss of jobs to another country, outsourcing has generally been welcomed in India because it provides an increase in employment. The most popular type of outsourced jobs is the 'call-centre', but there are other types of outsourced services too.

But jobs are not the only thing being outsourced to India. Recently concern has been expressed at the way in which medical trials are being outsourced to India to allow unethical trials on poorly informed patients to take place that would never be allowed to take place on Western populations.

Scientists in Nazi Germany used prisoners in concentration camps to carry out a wide range of medical trials, with no regard to the rights or consent of the individuals on who these trials were carried out. These scientists were subsequently tried and many of them convicted in the Nuremberg Trials for crimes against humanity. This led to the 'Nuremberg Code', a set of rules to which every clinical trial must adhere. 'Informed consent' is a key principle of the Nuremberg Code. All patients taking part in medical trials must be fully informed of the potential risks of the trials.

Currently, there are hundreds of thousands of Indian patients on clinical trials, and the number is likely to grow to a staggering 2 million by 2010. Many of these patients are very poor, and are given insufficient or even false information regarding the trials.

Most of the world's largest pharmaceutical companies have a presence in India, but there is concern about how the country achieves its exceptional recruitment rates and questions about fully informed consent.

'Drug Trials: The Dark Side', a programme recently broadcast on BBC Two was the best exposure of this phenomenon to date. The programme showed how six years ago, an experimental drug from the US called M4N was injected into cancer patients in India without being properly tested on animals first. Later it was discovered that several patients had not known they were part of a clinical trial. Most of the patients are now dead. The family of one surviving patient was interviewed, showing conclusively that he had been fooled into taking part in the trial thinking they were getting high quality Western medicines.

One doctor based in Mumbai, Dr Shashank Joshi, says the idea of all patients giving informed consent in India is "a myth according to me... because I do not think it's truly informed in the language the patient understands.

"Most of the patients sign on the dotted line without understanding the nature and the consequences of what is being administered to them."

Another trial that was scrutinised was that which led to the creation of the now popular anti-psychotic drug, 'Risperidone'. The drug is very expensive, 60 tablets of Risperidone 2mg is listed as costing £103.96 in the May 2006 Drug Tariff.

Parshottam Parmar was one of the patients on the trial. He and his wife were told that his chronic psychiatric condition would disappear by this new American medicine. In fact, as British psychiatrist Dr Vikram Patel pointed out, that is misleading and impossible. There is no absolute cure to the condition that Parshottam Parmar was suffering - some maintenance medicine would always have to be taken. After the trial was over, Parshottam was denied access to the drug, because he couldn't afford it. He was moved back to his previous medication. This shows the contemptuous disregard for the health of the actual patients who take part in these trials. Most new drugs are very expensive upon their initial appearance on the market. The poor patients who take part in these trials are NOT going to be able to afford them, and the drug companies running these trials are not decent enough to offer the patients in these trials a continuation of the trial medication if it was successful in improving their condition.

This shows that these trials are in no way intended to benefit those individuals who the tests are carried out on. They are intended to benefit patients (customers) in rich Western countries. The poor Indian patients on whom these trials are carried out are just guinea pigs, who big drug companies see as an intermediate stage between animal testing and humans living in the West.

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