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Vishal Agrawal, Specialist Registrar in Psychiatry South Essex Partnership NHS Foundation Trust
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vishalagraw{at}gmail.com Vishal Agrawal
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The editorial by Adams et al makes for interesting reading. However, it raises a few conflicting and worrying issues. Population in rich countries do tend to end up being unofficial participants in post licensing trials and the author’s suggestion that these trials take place before licensing, are very valid. Of course, in a market driven society, commercial interests sadly often override other issues. Drug companies are in the business of making money and it is true that most new, and often beneficial, drugs would not have been developed without the financial backing of these big pharmaceutical giants. Also, one should spare a thought for the relatively poorer nations and where they stand in this battle. The regulatory set up around drug trials in much more sophisticated in richer nations. This is not the case in poorer countries. The BBC reported what it called ‘outsourcing’ of patients to India. It estimates that by 2010, there will be 2 million patients on drug trials in India. BBC Two documentary, ‘Drug Trials: The Dark Side’, illustrated trial misconducts in a number of cases. It reported that in one instance an experimental drug from the US called M4N was injected into cancer patients in India without being properly tested on animals first. Informed consent is not clearly understood in countries like India. The absolute faith in doctors is often not challenged, with sometimes, disastrous consequences. Therefore, protection and regulation in pre licensing trials is something, which should be looked into urgently. More needs to be done globally to prevent humans becoming unsuspecting guinea pigs in drug trials, whatever the stage of the trial. Another point the authors make in the original article is about patents and availability of new drugs. Even with the loophole of process patent, new treatments are not freely available to the most needy population. With the closure of this loophole, is it not going to cause even more distress? The population that could afford it due the loophole will also be deprived of the drugs. The principle of process patent may be wrong, but with its abolition, what alternative will the residents of poor countries have but not to suffer more? As far as guilt is concerned, I think the guilt is more about not being able to use newer, and sometime supposedly better treatments, rather than the guilt of having to resort to older tried and tested methods. One can only hope that a concerted effort is made to help patients, irrespective of the economic status of their place of residence. Reference:http://news.bbc.co.uk/1/hi/world/south_asia/4932188.stm Declaration of Interest: The author has consulted for Janssen-Cilag and spoken for AstraZeneca. |
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