Banerji Protocol Meeting 07 March 2013 In Attendance: Dr. Iris R Bell Khadija Ben-Aissa Anil Srivastava Peter Gold Dr. Pratip Banerjee Dr. Leanna J Standish: Not in Attendence: Dr. Shankar Gupta Charles Maynard Dr. Shantaram Kane Rubayi Srivastava Professor, Department of Family and Community Medicine, Research Professor, College of Nursing, University of Arizona. Scientific Program Coordinator, Open Health Systems Laboratory, Maryland. President, Open Health Systems Laboratory, Maryland. expert on media and publicity for the homeopathic community in the US The Prasanta Banerji Homeopathic Research Foundation PhD, Program Director, Pharmaceutical Resources (PBHRF), Kolkata. Executive Dir., Open Health Systems Laboratory, Maryland. Chemical Engineer, Independent Researcher in Ayurveda and Adjunct Prof at IITBombay PPP Project Manager, Open Health Systems Laboratory, California. Dr. Barbara Sarter Associate Professor, Hahn School of Nursing and Health Sciences, University of San Diego, California. Branch, NCI, National Institute of Health, Maryland. Topics of Discussion Peter Gold will provide a bio. Khadija will update the potential collaborators on the wiki OHSL will connect with potential collaborators Invite Dr. Leanna Standish for our next meeting Meeting with Barbra and Koumatsoulis to discuss the new Form. Barbara will try to get an answer from MD Anderson investigator about trying some remedies on cell lines. Discussion: Introductions Petre: Alison Teitelbaum (National center for Homeopathy Exsecutive Director) would like to have permission to join the BP discussions. Dr. Leanna (http://www.bastyr.edu/people/alumni-facultyresearcher/leanna-j-standish-phd-nd-lac-fabno) had a continuous interest in the BP way back (~15 years). She is a neuroscientist who had an interest in Natural medicine combined to chemotherapy and shares a particular interest with Dr. Iris Bell on the nanoparticle concept of Homeopathic remedies. She is treating patient and tried using the BP for some of her patients:~12 GM patients accepted to be treated by the BP and have a survival rate of 25 months. She is practicing in the University of Washington. Dr. Peter Gold is treating patients but on limited base From 2005 he communicate with homeopaths in all over the world except in Latin America (Group coordination, social media…) Lotte And John Hecht Memorial Foundation and NCCAM is funding Dr. Leanna project on Breast cancer integrative oncology Prospective Matched Controlled Outcomes Study within Bastyr University. Hecht foundation supports Global advancement. Banerji Protocol outcome: Dr. Leanna: Do the Banerjis have a database of patient treatmet and outcome? Publishing a formal outcome analysis of the Banerji clinic is a good start. Iris: they have a good online review on Ruta but I don’t know where is it published. The Banerjis are very committed and open to share data. Peter: what does the data show? Iris: the outcomes are quiet strong and they helped many people from India as well as many foreigners. In India it is very common to see patients combining homeopathy with allo-medicines. The Banerjis say that the outcome is better with the patients who did not succeed to overcome the illness with allo-medicine alone. Applying resources: Peter has relationships with multi social media publishers. There are a lot of ways for exposure to social media but t is preferential to have a scientific publication first. Iris would be better placed for that. Iris: may be we focus our next conference call on data mining_ publishing reports of clinic outcome. Iris/Barbra paper is in the process of review might bring more attention to this subject once it is published. The focus of the paper is nanoparticles and will be published in a nanomedecine journal rather that a homeopathy journal. Clinical testing depends on dose, size, nanoparticles. We need to be able to do Bioassays, clinical studies… Iris thinks that it will be possible to publish in a nanomedecine journal, they will find the topic very interesting. How to proceed: Dr. Leanne How to proceed here: 1. Retrospective outcome, Preliminary a. Specific focus on Glioblastoma multiform: GBM b. Publish 2. Find fund for clinical Trial: The Hecht foundation, they will fund a clinical trial in the United Sates to replicate the Banerjis finding. a. Dr. Leanna Q: Are the Banerjis open to have a trial here in US b. Iris: From our discussion when I met him they are very open. 3. Dr. Leanna a. I already have done a lot of research on GBM b. I know how to establish the protocol c. And I have expertise to do imaging for phase 1 and phase 2 trial d. Did you already have any discussion regarding FDA approval? 4. Critical: how to evaluate the actual material used in the remedies a. Multiple technology: i. TEM ii. Laser based microscopy iii. Nanoparticle tracking methods. Estimate concentration. The advantage is that the NP in the homeopathic remedies are dispersed (variable sizes) iv. Physical characterization (what are the criteria we are looking for) 5. Now we can have a chance to prove the mechanism of action of homeopathic remedies used in a protocol and in response to diagnosis. a. Before the nanotechnology emergence we did not have any way to characterize the remedies. b. Where are the remedies from:Iris: Barbara gets some from the Banerjis Leanna: do you have sample from them. c. Looking for nanotechnology experts who can help charachterizing the nanoparticles in the remedies. Iris tried to contact Dr. Shena Kelly (http://biochemistry.utoronto.ca/kelley/kelley.html) but did not get any reply. d. Iris: commercial vendors: 300$/ sample. San Diego vendor, it takes from 1h to few days to see results. e. Peter: we can identify a handful of academic institution to characterize the core remedies of the BP (Harvard Nanomedecine department…). f. Confirm the presence of the NP in the remedies. g. Iris: Scorpion venom nanoparticle slow down Brain cancer cells h. Demonstrate that such remedy is active by looking at size and structure, surface charge… i. Iris will send a short description the correlations. Points collected from Khadija discussions with Dr. Barbara Sarter and DR. Pratip Banerji: Patient clinical reports and Banerjis database: The Banerji clinics keep clinical record using Oracle medical. Dr. Barbara was analyzing subsets of the data The Indian statistical Institute is analyzing subsets of the Banerji’s clinical data. Although all patient records are kept, not all of the records were digital. The staff in the clinics are overloaded and not very well trained which influences the accuracy of the collected patient reports: Lack of correct terminology and missing information. Dr. Barbara spent some time in the clinics and succeeded in converting a complicated clinical record form provided by NCI to a more friendly, which can be easily used by the clinic staff. This intake sheet (of 1-2 pages) will help the Staff in such very busy clinical environment to collect more accurate data without loosing accuracy of the information. Dr. Barbara believes that if the Banerjis implement the use of such form within one year we will have very accurate clinical reports to analyze. Dr. Banerji worked with Dr. Sushanta Banerjee and Dr. Srater on statistical analyses of \ Brain cancer patient outcomes. The statistical analysis showed that the best rate of success was observed with the GBM patients treated with the Banerji protocol. Dr. Barbara compared these results to the outcome of patients treated by the best conventional medicine using the SEER database and found that the BP outcomes are superior. The manuscript is being reviewed and corrected by DR. Sushanta. Banerji Protocol homeopathic remedies Origin: Dr. Sarter doe not have GBM remedies from the Banerji clinics. Dr. Banerji is getting his remedies from an Indian manufacture SBL: http://www.sblglobal.com For research purpose we can have an agreement to get remedies distributed to the US. Action items for next meeting: 1. The group will focus on data mining_ publishing reports of clinic outcome. 2. The group decides for Mrs. Alison Teitelbaum (National center for Homeopathy Executive Director http://www.nationalcenterforhomeopathy.org/hta/meet-new-nchexecutive-director-alison-teitelbaum-ms-mph) to join the BP discussions. 3. Iris will send a description of correlation between size, surface charge and nanoparticle characterization 4. Khadija will send to Dr. Banerji the list mail of all the participants of the BP. He will send his Book by mail. 5. Khadija will contact Dr. Sushanta Banerjee and get and update about the Banerji protocol and GBM manuscript. 6. Dr. Barbara will write a draft of summary paper about converting a complicated clinical record form provided by NCI to a more friendly form used by the clinic staff in a very busy clinical environment without loosing accuracy of the information and allowing more accurate scientific analysis. 7. Dr. Banerji will ask SBL if they distribute in the United State.