Around the world, in both developed and emerging economies, clinical trials are testing new and promising drugs to treat cancer, diabetes, TB, HIV and other serious conditions. However, in India, only a handful of new clinical trials of major experimental drugs have been initiated on patients, either using public or private industry funds, since early 2013. This is a worrying statistic for a country comprising one-seventh of the world�s population. The current state of affairs needs to be addressed in order to prevent a humanitarian, public health and economic development disaster.
In the medical sphere, India represents both a developing and a developed country, with a large part of the population served by overburdened, poorly-equipped public clinics and others (mostly the upper middle class and the wealthy) seeking care at private medical centres whose expertise and equipment rival those of the best hospitals in the US. The socio-economic transformation that the country has seen in the past decade has led to a surge in the incidence of lifestyle disorders, while the traditional diseases of a developing economy persist. Because of its huge population and serious health problems�diabetes, TB, HIV, malaria, cardiovascular diseases, among others�and because it has a significant cohort of physicians who are experienced in conducting clinical trials, India was, until early 2013, a favoured destination for industry and medical academics who were seeking locations for clinical trials. The clinical trial industry in India was robust, with a number of high-tech industries such as clinical research organisations and data processing firms�many of them India-based and India-owned�springing up to service the research enterprise. Until these recent regulatory changes, clinical trials had been offering new hope to patients and represented opportunities for medical, scientific and social advancement for the country.
In 2012, an Indian NGO filed a lawsuit against the Indian government, alleging that thousands of Indians had been injured or had died while enrolled in clinical trials in India, with inadequate informed consent, and that the Indian government�s regulatory framework for approving and regulating clinical trials was inadequate.
The lawsuit�s allegations were, unfortunately, partially correct, in that the Indian drug safety agency has been historically underfunded and inadequate to its tasks. But the lawsuit appeared to have ignored the fact that just because an injury or death occurs during a clinical trial does not mean that the injury or death was caused by participation in the trial. For example, end-stage cancer patients
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