FIAR Director's Report - 2004
Fight fire with FIAR
Second Gandeepam Site Visit March, 2004
During the week of March 16, 2004, FIAR's director, George Carter, undertook a second site visit to Gandeepam in Tamil Nadu, India for the NIH-funded, 2-year planning grant FIAR is undertaking. He was joined by Debbie Indyk, PhD of Mt. Sinai Medical Center. This project is collaboration between Gandeepam, Mt. Sinai and FIAR. We felt the absence of our friend, Henry Sacks, MD, PhD, who is the Principal Investigator on the project on the United States side.
Dr.Sacks had joined Mr. Carter during the first site visit and for the Conference on HIV/AIDS and Siddha Medicine that was held in December, 2003. Both visits were very productive and encouraging, though some bureaucratic hurdles remain. For more on the December conference, an International Meet on the Prevention, Care and Control of HIV/AIDS under the Time-Tested Siddha Traditional Medicine System. It was held December 4-6, 2003. Please see the Gandeepam website (http://www.gandeepam.org) for a report of that meeting and other information.
Part of the Planning Grant was the development of an Institutional Review Board (IRB) in order to assure patient safety. In the process of developing the IRB, Gandeepam must also undertake to pass a written test in order to satisfy the legal requirements of the Mt. Sinai partner. In addition, the constituted IRB must be approved by the NIH. The IRB membership has been developed and these tasks are underway.
A major issue has been awaiting the receipt of the permission from the Indian government, specifically from the Indian Council of Medical Research (ICMR) to conduct the study in human participants. To date, our efforts have been delayed by this bureaucratic necessity and thus we have been unable to release funds to the Indian side of the grant for the purposes of evaluating their treatment in patients. It becomes a sort of Catch 22.
However, there is hope on this front as well. The lok sabha (or elections) are coming in May and the fiscal year is ending, so it appears that the necessary approvals will be received by early May at the latest. This approval is then sent to the U.S. State Department for their approval.
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