Are Indians supposed to be guinea pigs for doing medical research by multinational companies
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Author: Sanjeev Roy
Research requires constant analysis with existing facts and formulate a hypothesis. Testing the hypothesis to prove or disprove the new fact which came out from existing one, is the goal for each researcher.
Medical research involves several step but one of the most criticisized is when it comes to human model. Medical research pertaining to drug discovery starts with various in-vitro and in-vivo models and finally ends with human species. Experiments done on animals cannot be projected accurately for patient use, and therefore needs validation on healthy human subjects. Ethically and regulatory wise, for certain diseases like AIDS, and Cancer it is not permitted to conduct any research involving healthy human subjects. For new drugs to be available to the patients for their treatment, one of the earlier step is to test the drug in disease free subjects to know how it is absorbed from gastro-intestinal system, how is it distributed in the body, how long it remains in the body, how is it metabolized and excreted from from the system. Doing such kind of preliminary research, does not necessarily require a diseased patient whose body system is already compromized. The question that arises whether healthy human subjects are also not compromized in whom a new drug would be introduced whose safety is unknown for human species. The answer might be yes, but how will a new drug come to the market unless it is tested in healthy subjects.
In past and also recently, such drugs have been tested in US and european countries and launced in market. The only reason why such studies are successful without any controversy, is the quality of care given to the subjects during the study. The ethics committee to approve the studies are vigilant to see that the rights and safety of such subjects are not compromised. The regulations are strict enough to allow conducting such studies only in presence of medically qualified person. The medically qualified person should be available throghout the study with the subject and there should be availability of an ICU set-up where the subject would be monitored continously.
Majority of the mulinational companies started seting up centres in India to conduct such studies in healthy subjects. The idea is not to put the Indians at risk, but to explore the way an Indian would behave to the drug. The genetic makeup of an Indian is totally different from a Caucasian, and so the drug absorption and metabolism would also be expected to differ. The regulations in US mentions that data from different ethnic population has to be submitted for proper evaluation of safety issues with new drug. And as the drug would be made available worldwide, it is also more necessary to collect such preliminary information from healthy subjects throughout the globe rather than exploring a group of compromized patients.
Conducting such studies would not make us guinea-pig unless it is ethically approved and conducted under continous medical supervision. Rather we would contribute globally for the cure of many ailing patients waiting for some miracle drug.
Research needs to be supported from various sections in society to keep it ongoing for new valuable things, to be delivered ultimately to the same society for the better of mankind.
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