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Prasoon S Majumdar
Editor, Economic Affairs - The Sunday Indian
Dean Academics (All India), The Indian Institute of Planning and Management
Drug abuse or child abuse
US companies test drugs on children in developing world
T he United States of America never fails to live up to its image. And in the same line they have added another feather in their cap. Recently, in order to fasten the development of drug meant for American children, the 1997 Pediatric Exclusivity Provision directed the trials of the drugs on children of Third World countries. It has been reported that these companies carried out more than 30 per cent of medical trials in countries like Uganda and India. This approval by the US legislature not only stinks of their discriminatory policy but also questions the American government’s developmental policies towards the Third World nations – especially those aimed at improving the lives of children.
This Pediatric Exclusivity Provision which actually falls under a decade old law incentivises the companies to test their drugs in poorer nations. And top it up, these medicines are not meant for Third World nations as they will never be made available. As per reports, of 174 trials that were carried out in these nations, most of them were meant for infectious diseases and a few for heart, allergy and arthritis ailments. Moreover, the pediatric provision allocates extra funds and extra patent life to companies who test these drugs on children rather than adult! Furthermore, since the cost of conducting research in these nations is hugely less, the companies feel attracted in making these countries as their laboratories. Moreover, weak regulatory requirements, illiteracy, blind trust on doctors and lack of knowledge about clinical trials make the execution of these trials smoother and faster along with making the forging the consent forms an easy task, which is largely written in English. Almost a decade back Pfizer illegally tested an unapproved drug on children in Nigeria, with brain infections which resulted in deaths of children and occurrence of arthritis in many. This multinational company took advantage of consent form (written in English) signed by the parents of children who at large were uneducated.
In the same lines, the State Government of Madhya Pradesh, in a Rajya Sabha session, admitted that 2,365 people had undergone clinical trials, for pulmonary disease, asthma, cancer etc, out of which around 70 per cent were children. As a result of this, scores of these children adopted serious health problems, including deaths. This not only speaks about double standards of the US health policy but also reveals fissures within the Indian policy framework. Where we have in place mechanism for cosmetic trials under the Drug and Cosmetic Act, the government is still to consider Bio-medical Research on Human Subjects, Promotion and Regulation Bill 2006, which despite ministry level clearance is still unimplemented.
On the outset, whether its children or adults, no clinical trials should be done on human, especially for infectious diseases. And if the tests have to be carried out, it must not be done in developing countries, where the children are already vulnerable to number of diseases on account of malnourished — which further makes them susceptible to infections and diseases. It makes no sense to carry out tests on children of poor nations for drugs especially for diseases that rarely occurs there. This is an all out breach of ethics and protocol in clinical trials and shows the need of global regulations. A drug approved in one country should not be tested in another country. Along with WHO’s intervention, the local government and medical associations need to take this matter as priority. It is insane to lose children on tests for diseases and medication – either of which are not meant for them!
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