OPV : A phase IV clinical trial going on in India?

October 17, 2006

http://www.imanational.com/Hepatitis/ImaDiscussion.htm Minutes of Indian Medical Association meeting on the OPV Dr Verma (NPSP)• Response by NPSP to the paper will be circulated• The only option is to aim for eradication collectively. NPSP available to disseminate any information required.• MOPV has been used for 40 years and is not an experimental vaccine. Current use considered as phase IV trials• Strengthening of routine immunization not a part of PEI- GOI paying due attention as a separate project Response (Dr SK Mittal- If use of

mOPV is a phase IV clinical trial has the consent been taken by the parents and childrenDr Wenger – Issue may be taken up with the GOI) Dr Raju Shah, Past President, IAP1. There is already a India Expert Advisory Group to suggest ways and means of interrupting transmission of wild poliovirus in the country. This group should be expanded adding more National experts.2. It is alarming that the same is being done as phase IV clinical trial without following the established national guidelines for such trials. (We need to confirm this from authorities)3. There is a need for Expanded IEAG to

consider future strategies, including newer strategy of combined use of IPV and OPV. "Our ideal is not the spirituality that withdraws from life but the conquest of life by the power of the spirit." - Aurobindo.

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