FIAR begins Spring Break study!
The good news!! FIAR and the Mount Sinai Medical Center have received approval from the National Institutes of Health (NIH), the National Center of Complementary and Alternative Medicine (NCCAM), to utilize funds to help both develop FIAR's capacity and begin the development of a clinical study to evaluate what we refer to informally as the "Spring Break" formula. As explained below, this is sadly a salvage of a grant that was killed by bureaucratic indifference.
Spring Break is a formula of some 25 Chinese herbs, developed by FIAR's Mark Kuebel, Lic. Ac. and Fred Blair, Lic. Ac. The formula is designed for individuals who either have not yet begun antiretroviral therapy (ARV) or who have decided to take a break (a treatment interruption). Recent data suggest that such interruptions may have attendant risks. However, other studies suggest methods to minimize these risks. And the reality is that, whether due to ARV toxicities or other reasons, people do decide to take breaks.
The Spring Break formula is designed to reduce viral load while either stabilizing or increased CD4 counts. The herbs selected to be in the formula were picked based on an understanding of:
Spring Break is not designed to replace ARV. It is hoped, however, that the use of the formula may help to provide individuals with some extra time and healing time and recovery from ARV side effects. This grant will enable FIAR to develop this project into a rigorous, controlled clinical trial to evaluate the potential of Spring Break to help individuals not currently on ARV--which still is something like 90% of HIV+ on the planet today!
The grant is specifically to help develop the capacity of both FIAR and the traditional medicine practitioners to understand the elements of clinical trial design. This includes elements such as appropriate patient intake, the role of the institutional review board, human subjects research protection, clinical trial design and other elements. In addition, a full and complete evaluation of the formula's constituents will be undertaken in order to develop an R21 grant application and have a head start on an Investigational New Drug application for the FDA. Review of the clinical practice experience will be undertaken. And, as with the original study, the options in relation to intellectual property will be explored. One of the key features of the original grant in India was to assure that if there was any evidence of efficacy or a commercial value to the formulas developed by the traditional mediicine practitioners, those rights would remain with THEM, not FIAR or Mount Sinai.
So there is unfortunate news. FIAR, working in conjunction with partners at Mount Sinai Medical Center in New York, NY and Gandeepam in Tamil Nadu, India, had received a capacity development grant to evaluate the Siddha approach to managing HIV disease. Half the money from the grant was to be spent in India to help this remarkable group develop the capacity to conduct clinical studies and to undertake an initial observational study. This was to be followed by application for a five-year clinical trial proposal, if warranted. What was required was only that the Indian Council of Medical Research (ICMR) either approve the grant or deny it. After three years, ICMR failed to take any action on the request. Neither the ICMR constituted under the BJP nor the Congress governments were able to give a formal response, creating a sense of deep disappointment and sadness among all partners and most especially, local people living with HIV.