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Bhopal Memorial Hospital turns hot spot for clinical trials on untested drugs by MNCs
The Bhopal Memorial Hospital and Research Centre (BMHRC), set up to provide super-speciality treatment to the Bhopal gas tragedy survivors and also to carry out research on long term effects of methyl-iso-cyanate (MIC), has become a hot spot for conducting clinical trials on untested drugs by the multinational pharma companies, it is reliably learnt.
According to sources, instead of concentrating on MIC-related issues, the hospital has over the years become a hot spot for conducting clinical trials on untested drugs that were primarily designed to help pharma companies. Drugs in the trials included telavancin (patented by US company Theravance), tigecycline (Wyeth), prasugrel, fondaparinux (GlaxoSmithKline) and fixed-dose combination of cefoperazone with sulbactum (Magnex) sold by Pfizer in India.
While cefoperazone is no longer marketed either in the US or other advanced countries, its fixed dose combination with sulbactum was never approved in the US, the home base of Pfizer though it is sold in some developing countries like India (annual sales Rs 70 crore), Chile, Colombia, Peru and Vietnam, sources said.
“Except for fondaparinux, other agents tested in Bhopal were all new chemical entities (NCEs) or investigational new drugs not approved for human use anywhere. Consequently their side effects were not fully known when the trials started in Bhopal. The morbidity and mortality caused by these NCEs on unfortunate, unsuspecting victims in the Bhopal trials is not known,” said Dr CM Gulhati, a medical expert and editor, Monthly Index of Medical Specialities (MIMS), a medical journal.
Dr Gulhati said that people with 'reduced autonomy' should not be subjected to trials as per the ICMR code of conduct for drug trials. But, Bhopal gas victims have zero autonomy since they are totally dependent on treatment provided by the BMHRC. Can a patient refuse to take a drug prescribed by the attending doctor at the only hospital in the country meant for gas victims?, he asks.
As per the ICMR code, trials are not normally mixed with medical care. If the investigator is serving both as a researcher and the patient's physician, this fact should be told to the subject. In such cases the informed consent should be sought by a third party (eg. by a neutral, independent physician or in the presence of an NGO). In disaster areas, the research should be aimed at effectively dealing with similar events in future and not on non-specific drug trials.
Besides, ethical standards applied in a host country (such as India) should not be less stringent than they would be for the same trials conducted in the country of innovation (such as United States or Britain). Can any hospital in the West dare to conduct clinical trials on victims of disasters like the one in Bhopal?, asks Dr Gulhati.
The government-funded BMHRC was set up in the year 2000 after the 1984 Bhopal gas disaster to provide super-speciality treatment and to carry out research on long term effects of MIC, the chemical that caused the holocaust.
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