The Foundation for Integrative AIDS Research .

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 a 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.

Currently, Gandeepam has been using a formula consisting of some 27 herbs (Main Formula). All new patients receive this, usually as a fresh juice. (It can also be provided as a powder or in capsules, however these are not as thought to be as potent as the fresh juice.) In addition, the patient's clinical condition is evaluated and recorded. They may then be given additional treatment (in the form of combinations of botanicals, minerals and other Siddha medicines) to a) strengthen immune responses and b) manage and diminish opportunistic or other infections.

Dr. Ramani has informed us that the Main Formula is being evaluated for medical licensure by companies in both Tamil Nadu and in Andhra Pradesh. This is in preparation for also submitting an application for a patent to protect their intellectual property rights (a key feature of this grant).

The majority of HIV+ patients are being treated at their site in Namakkal. There are other clinic sites (besides the main garden in Sivagangai District) located in Pudukkotai and Bangalore (just opened). At the Namakkal site, there are two physicians and five outreach workers. The outreach workers does outreach to nearby villages; each of the five covers 5-7 villages (approximately 30 villages), and patients are followed-up during these visits. In addition, awareness of the project is sustained.

At this point, we also developed the concept for an intensive review of some 30 new patients. The primary aim is to assure the safety of the interventions Gandeepam is using. In addition, this open label evaluation will underscore Gandeepam's capacity to document, monitor, follow-up and develop/maintain inclusion/exclusion criteria for a clinical study. In addition, all efforts to assure patient safety and informed consent will be undertaken, as per the improvement upon the current informed consent as well as the utilization of the relevant IRBs (at Gandeepam and Mt. Sinai). Finally, patient records are kept in a locked room. A file cabinet with a lock will be obtained to further assure patient confidentiality. The current informed consent they have been using is being reviewed and strengthened. In addition, practitioners have already developed a simple unique identifier system to follow patients. This effort will also be further evaluated.

Such a study should enroll rapidly. They see approximately 8-15 new patients per week. Very often, the patients arrive on Sunday. One Sunday, 30 people showed up! It is anticipated that the 30 individuals who will receive intensive review may be recruited within three weeks. Field staff may be utilized if there is a particularly heavy Sunday that enrolls a large batch to catch any information that may be missed if there should be a particularly heavy patient load day.

A brief review of patient records was also undertaken. This supplemented a more complete review of all records last December. In that review and the current more cursory one, it appeared that many patients were seeing clinical improvements in terms of increased weight, resolution of fever, improved energy and diminution of infections. However, many had only data regarding the treatments being provided with little additional clinical information. Only a few, due to the costs, had bloodwork of any kind. All had at least had HIV testing that indicated their positive status, though these were probably not confirmed with Western blot follow-up (which costs about $20 per test and is, for most, an onerous expense of 900+ rupees).

Finally, we had the opportunity to visit different individuals who had been treated with the Siddha protocol. First was a patient who came to the Namakkal center for further treatment. He appeared to have suffered some weight loss and had large, papular lesions on his face, arms and legs. It appeared to Mr. Carter to be Kaposi's sarcoma, however he is not a clinician. Dr. Bubhaneshwar felt it was a form of eczema due to the well-defined borders on the lesions. On the legs, there appeared to be some weeping of lesions but this is not inconsistent with KS in more advanced, fulminant stages. It was noted that these lesions had been more serious at the prior visit, however a photo of that earlier visit was not located.

Second, we drove to the village where a young woman (about 43) who had been a sex worker and flower seller lived with her family (daughter, son and mother). She felt that the Siddha medicine had considerably imporoved her condition. Her strength and energy had returned. She appeared to be in good condition and good spirits.

Another patient we met last December also had seen significant improvement. She is part of Gandeepam's IRB.

Please contact us (fiar@verizon.net) for information on further developments. At this time, Mt. Sinai is planning to send 2-3 medical students to undertake an internship at Gandeepam this summer and provide additional technical assistance. We plan a site visit for this September/October to further the research objectives.