Drug Trials - the Dark Side11th May 2006
The recent disastrous trial of the monoclonal antibody TGN 1412 at Northwick Park Hospital has heightened the public's interest in clinical drug studies. And the long term result may be increased scepticism such that fewer people in the United Kingdom will be willing to participate in clinical research.
Clinical trials are increasingly being conducted in developing countries that offer a rich source of suitable and apparently willing patients. Drug Trials - the Dark Side was a compelling documentary on how drug companies are targeting India for this purpose, says Ike Iheanacho in the BMJ.
Kenyon set out to discover just why so many people are ready to take part in clinical studies, even though they receive no financial reward.
Through interviews, case studies, and on the spot reporting, Kenyon showed how the rapid recruitment commonly relies on insufficient regard for ensuring that patients give informed consent. Patients too poor to afford standard therapy, and with little or no understanding of clinical research, are only too happy to accept what appears to be 'free' treatment from doctors they revere. In such circumstances, the notion of truly informed and freely given consent becomes highly questionable as the documentary made clear.
Testimony to how little some patients really knew was their thumbprints (rather than signatures) on consent forms written in English, a foreign language. In an unusual move, one drug company allowed Kenyon to film the recruitment of a patient to a study of a drug for rheumatoid arthritis. Even in this heavily stage-managed setting it was obvious the patient had 'consented' to enter the trial without really knowing he was agreeing to an experiment; he also appeared to believe that the treatment would cure his arthritis.
Whatever the faults in how participants are recruited, the boom in India's clinical trial industry is set to continue. What is more, Western countries may find it convenient to have such treatments tested elsewhere. Drug Trials - The Dark Side should help to ensure that such delegation of risk does not blind us to the costs borne on our behalf by others far away.
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Title: Drug Trials - the Dark Side
Author: Sue Knights
Article Id: 358
Date Added: 11th May 2006