Clinical Trials
Clinical Trials ‘All patients should receive the best possible therapy AND the well-being of the individual research subject must take precedence over all other interests.’ Says article 11.3 of the ‘Declaration of Helsinki’, the Holy Grail for biomedical research on humans. With more and more clinical trials being conducted in developing countries, the question naturally arises…while outsourcing these trials, are the pharmaceutical companies growing to disregard this declaration? To be able to answer my question, first let us evaluate the problems being faced by developing countries while conducting clinical trials! Well, for a starter, developing countries lack effective regulatory mechanisms for overlooking these trials. Then for the main course, the crisis is worsened by corruption in the social institutions of the Sub-Saharan countries and countries like India, including health care. And then finally for desert, with the number of ethical violations in clinical trials in developing countries increasing day by day, what more do we need to say that regulations have been “failing to keep up with these countries’ trials boom” No matter which angle we look at it from, we just find faults and more faults.
YOU SAY, clinical trials will bring about improved infrastructure. I SAY, of what use is that infrastructure to the general public if it is only going to be used by the pharmaceutical companies to reap more profits.
YOU SAY, the patients have to sign on a consent form if they are to be tested on. I SAY, consent is just for the paper as many patients who sign up for trials are illiterate, and do as the doctor recommends.
YOU SAY, they are helping the financially backward get state of the art medical treatment. I SAY, your package also comes bundled free with exploitation by providing the trial drug free of cost and hence luring the patients into signing the consent form.
And then comes the worst part – NONE of the countries classified as ‘developing’ by