F I A R
The Foundation for Integrative AIDS Research .
Fight fire with FIAR
On March 26, 2004, FIAR met with community and NGO leaders at the offices of the Blue Diamond Society (BDS) in Kathmandu, Nepal. The meeting was organized by BDS director, Sunil Pant and Director of Communications, Salina. Salina also acted as translator for Mr. Carter so that each statement was translated from English to Nepali.
Part I: Background and Suggested Study Design
George Carter, FIAR's director, began with a review of the proposed project to undertake a clinical evaluation of the treatment of HIV disease by traditional systems of medicines, such as Ayurveda and Tibetan medicine.He noted that part of the background rationale for botanical medicine is simply that so many use it. Even in the United States, where there is access to antiretroviral therapy (ARV), studies show 50-60% use "alternative" medicine. Other areas, where ARV is unavailable, have similarly high levels of use.
He reviewed some of the evidence, including the recent study of multivitamins and antioxidants for managing neuropathy. While it did not appear to benefit the neuropathy, a statistically significant increase in CD4 count was noted. Other studies on botanical agents such as Curcuma longa, Glycyrrhiza glabra as well as Cannabis sativa (for neuropathy) were also reviewed.
Finally, it was noted that strategically, positive evidence for a beneficial effect of such therapy could help reduce costs associated with the use of diagnostic evaluations as well as potentially delay the need for ARV. However, of course, more evidence is needed to evaluate these types of interventions, which is the basis for the current proposal.
Evidence-based medicine can help us to begin defining what is helpful and what is not. He reviewed the studies being conducted by FIAR so far, including the efforts in Gandeepam, Tamil Nadu as well as the milk thistle study in people with HIV and hepatitis C co-infection. He also reviewed some of the history of FIAR's association with Blue Diamond Society. (For more information on this, please see the FIAR website or contact Mr. Carter).
In order to conduct a study in Nepal, certain needs must be met. The first is to set up a site which has access to CD4 counting and viral load technology. A handout was provided that reviewed on the first two pages some of the different strengths, weaknesses and costs of various extant technologies for the evaluation of CD4 counts. In addition, Mr. Carter referred to the work of Schupbach et al., to improve the heat-dissociated p24 antigen test as a much less costly means of evaluating viral load. The costs of individual CD4 tests may be reduced to approximately $4-6 per test while the dissociated p24 test may be as little as $8 or as much as $30 per test (compared to $75-167 for the per test cost of the Roche Monitor).
He then reviewed a preliminary trial design where participants would be evaluated both by a Vaidya (who would be assisted in maintaining meticulous patient records) as well as an allopathic physician for bloodwork evaluation. Patients with approximately 250 CD4+ cells or higher would be eligible for the study. They would be then provided the treatment. Dr. Kamdev Jha has the most specific ideas about treatment and it is hoped that he will be able to participate in the study (he was in attendance). People with lower CD4 counts would be given the option to take ARV, Ayurvedic treatment, both or neither, but would be encouraged to use ARV.
The primary aim of the study would be to evaluate the safety of the intervention. Preliminary evidence of efficacy over the three or six months (to be determined) of the evaluation period would be a secondary aim. The study would be open label, initially.
In addition, some time was spent on discussing issues such as informed consent (or understood consent) as well as the need for organizations such as an Institutional Review Board (IRB). These mechanisms are to assure patient safety, confidentiality and autonomy. Participants in the study must be informed of any risks the study may pose. They must rest assured that any data collected on them remains confidential. (In future discussions, we will explore the idea of using a "unique identifier" system to separate patient identity from the data to further assure confidentiality; this is crucial where stigma and discrimination can put individuals lives in jeopardy.)
Finally, there was a brief discussion of intellectual property rights. Assuring that local practitioners retain their IP rights and any benefit that may accrue is retained locally is critical to the success fo the project. These options will be explored as the project develops.
The floor was opened to questions and discussion.
Part II: Community Input
Mr. Carter quizzed the audience regarding their use of Ayurvedic or other types of medicine. At first, the response was limited. However, when common products were noted as being used, about a third of hands were raised. It would be interesting to explore to what degree individuals actually see a vaidya. It was disappointing that there were no HIV+ individuals identified (or groups who were aware of such) who were currently using Ayurvedic medicine. It is hoped that some preliminary data on whether people use traditional medicine will be identified and their experiences to date recorded.
Some questions were raised about the study design and stakeholders in developing and implementing the study. It was noted that the design is only preliminary. The ideas presented seemed like the best approach, however, it is deeply desired that the protocol for the study be developed on a community level. Some clarifications were made about who the participants would be in the study. It is anticipated that people at earlier stages of disease will participate. People with lower CD4 counts will also be followed, particularly if they choose to use the Ayurvedic/Tibetan interventions, however, they will not be formally considered participants in the study.
Dr. Jha spoke at length regarding the need for a rigorous methodological study. He was enthusiastic about the possibility of utilizing allopathic methods to establish the efficacy of his approach to managing HIV. From his experience, he He noted that there are different stages recognized within the Ayurvedic tradition, including infection (first stage), spreading (second stage) and the often fatal "end" stage (third stage). Treatment is most effective at the earlier stages.
He also noted that he has proposed a protocol for evaluation. He had been promised some patients from the blood bank, however, they withdrew from the offer.
At the end of the day, perhaps the most helpful thing was gathering these different groups together for discussion and evaluation of the proposal. The connections and networks that may arise from the meeting of the NGOs, community members and vaidyas may create the type of synergy needed to develop this project further.
In addition, it is clear that there is a pressing need for diagnostic tools. We are deeply hopeful that, rather than having to send bloodwork to India at great cost (and potentially deterioration of the sample en route), local facilities can be utilized to provide HIV+ Nepalis with better data.
FIAR is deeply grateful for the help and input of BDS in developing this forum. We look forward to working with the groups and people who were able to attend the meeting, as well as others who have expressed an interest in the past and new partners. This project will be successful with the input and participation of all relevant stakeholders.
FIAR anticipates a return visit in September/October and will continue to develop the program and seek appropriate funding and relevant approvals from the Ministry of Health for undertaking this research.