Clinical trials without ethical review in the foreground
A recent series of ethics, and higher in some cases, illegal experiments, studies in India is fueling concern about the impact of clinical studies without ethical approval in other countries where legislation may be insufficient or no is not implemented. In a series of articles last year, shed Dr. Chandra Gulhati, editor of the independent magazine of drugs, the monthly index of medical specialties in India, light on the illegal trials and illegal promotion of drugs for cancer, letrozole as a fertility symbol of medicine in India.More than 400 women who had tried in vain to understand, is registered to participate without their consent in clinical trials in India, to see if the drug induced ovulation. The drug is a copy of a patented Novartis product, Letrozole received by
the generic pharmaceutical company Mumbaibased Sun in the wake of women expensive fertility treatment. Letrozole is known worldwide for the treatment of breast cancer in postmenopausal women allowed, but not for any other use in any country, including one adopted in India.Since then, India has a huge public outcry about the lack of regulatory authorities to end a recent series of clinical trials, legal and illegal, but unethical. An NGO based in Delhi is filing a complaint about the Letrozole case to Indias Supreme Court last month, the Government of India pledged to push harder, more effective legislation to solve the problem this year. Dr Gulhati contends that although the company and the doctors who conducted the tests violated the law has not been subjected to a
criminal investigation by Indian authorities.Letrozole trials are a prime example of a widespread phenomenon throughout the world. A recent study of more than 200 health researchers concluded that one quarter of clinical trials in developing countries do not undergo ethical review. The survey was commissioned by the former National Bioethics Advisory Commission and published in the February issue of the Journal of Medical
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