Re: Quick question Subject: Re: Quick question From: Kevin Murphy Date: 12/22/19, 10G12 AM To: Brad Racino CC: Jill Castellano , Diana Shapiro Brad, first of all…it is the weekend and vacation for me and my family, so let’s end this til after the Holiday please….I will not be responding until after the New Year…see my answers below…k From: Brad Racino Date: Sunday, December 22, 2019 at 6:29 AM To: Kevin Murphy Cc: Jill Castellano , Diana Shapiro Subject: Re: Quick question Ok, I'm going to summarize so that I make sure I'm understanding this correctly: Please review the copy of the slide I gave you on your first visit that summarizes standard rTMS, vs modified rTMS (MRT), vs our version of rTMS, PrTMSTM. MRT at that time, was representative of the middle column. -The research you cited in that VA proposal was performed and published by BTC using MRT. -MRT, you've told us many times, is an entirely different treatment than PrTMS, since it uses its own proprietary algorithm and method. That's part of the basis of your lawsuit with them. True, MRT comes up with it’s frequency using their own algorithm….they still ultimately deliver rTMS, with the exact same machine, so no, it is not an entirely different treatment….it is rTMS treatment using a modified prescription….their algorithm that creates their frequency is part of their prescription, it is 1 of 6 or more parameters possible to adjust, but the treatment is always rTMS. We didn’t know then (or to this day) what frequency their algorithm calculated…it was hidden from the investigators, users and technicians. This was the only portion of their treatment protocol that could have been considered proprietary, and it’s why they hid it. The rest of the treatment protocol is nearly identical to standard rTMS. Their frequency algorithm has now been published (patented) and it is completely different from what PeakLogic Inc. uses in our frequency algorithm. Again, calling it MRT at that time, the other treatment parameters were the same as standard rTMS, except in some cases, a slight reduction in amplitude was used. I walked you and Jill through this at my clinic, showing you the machine, and showing you standard rTMS settings, and how what MRT (as I understood it) was mostly doing was making one minor (0.1 of a Hz) frequency change adjustment…they were not changing the other parameters…At the Del Mar Neuro Center, I was in my own space, but in the same suite, practicing medicine by making further parameter adjustments (changing parameters and looking for better results). This is what happens in science. The two technologies have continued to diverge to this day. Clinicians and Investigators disagree, or decide to go off on their own path and pursue their own ideas and interests. During my time with them, I consistently gave NBRL recommendations on how to improve their protocols, which largely were not adopted. That’s their prerogative. It’s also my prerogative to move on and practice medicine on my own. Nearly every piece of scientific work is built upon the knowledge of our predecessors. The computer you’re staring at was built on countless iterations by various people over time. MRT was built on making a minor deviation frequency change from standard rTMS, and would be a predecessor to what they have now, called MeRT, and a predecessor to what we have now, trademarked PrTMS. MRT and MeRT are brand names they chose to use to try and differentiate themselves from standard rTMS. As a note, NBRL previously filed for the use of PrTMS as their name, which made sense, and which I supported…they later chose to go with MeRT and abandon PrTMS, which I told them was a bad idea. When the PrTMS acronym was released by them, PeakLogic Inc picked it up and trademarked it. I still disagree with the notion of MRT or MeRT being described as something other than a personalized form of rTMS…. -You submitted this to the VA on Aug. 5, 2016, after you broke off from BTC. -You were seeking IRB approval to study PrTMS, not MRT or MeRT. Yes I no longer affiliated with NBRL after the end of 2015. The issues why are well documented in my countersuit. I'm struggling to understand how this could be interpreted as anything other than you passing off MRT as PrTMS? Sorry you’re struggling with this Brad, but that’s not correct. I was moving on, advancing the science, ultimately changing multiple parameters (eeg type & frequency [taking wireless eeg’s every day to every fifth day], creating a new frequency every 5th day or less vs every 3-4 weeks, changing and adding treatment locations [treating 4-5 locations vs 1], giving different frequencies with different amplitudes at different treatment locations during the same treatment, changing amplitude [adjusting amplitude based upon the patient’s personalized real-time FFT], adjusting the number of trains, train length, and train interval), using a clinical response to stimulation and a dose response curve to modulate protocol parameters… ALL of these changes were different than MRT (at that time), and have served to advance the science….. Anecdotally, at Del Mar Neuro center, my staff and I were treating different indications as well, again, in the same suite, but in a different location, and seeing different (better clinical results) with my evolving version of PrTMS, now trademarked PrTMSTM. I was involved with the VA submission because I sponsored the study location, and could anecdotally testify to their results. I was a reviewer of their results towards the end of the study, hence, I was put on the paper. I was not a final reviewer before submission, as would have generally been requested. 1 of 5 1/30/20, 11:16 AM Re: Quick question And you just wrote, "in those days, initial submissions to the VA were done in conjunction with the Brain Treatment Center." However you said in your answer to the NBRL lawsuit, "Dr. Murphy did not collaborate with NBRL on clinical trials" and "NBRL was conducting a clinical trial on patients in its separate offices at Del Mar Neuro Center. Dr. Murphy was not involved in the clinical trials ..." See above. I was not officially part of the clinical trial and/or an official member of NBRL/BTC, I was not MD of record, did not treat or formally consult the patients, and was limited throughout the study to viewing the interim analysis. I sponsored the study location and was a reviewer, and an author on the paper. As an author, I have rights to discuss the data, and use the data in my lectures, or as unpublished “proof of concept” or “pilot data” or “interim analysis” in IRB submissions. You can quote or reference preliminary data in an IRB that is or isn’t your own…in other words, the message to the IRB is “someone (maybe even us) has done some preliminary work in this area, and we now want to formally test it in an original or larger trial….” Last, I also found this graphic online: https://gsof.org/unique-treatment-for-veteran-tbi/ And here is your graphic from your VA submission: 2 of 5 1/30/20, 11:16 AM Re: Quick question It appears to be the same study you are citing (double-blind, sham-controlled). However your VA submission switched the colors (and made it appear as if PrTMS worked worse than placebos (?)). The sham and treatment group marque names are reversed...this is an error. This would have been caught if this submission continued. It is the same study, showing an interim report I believe on the first 36 patients….at the end, another analysis was made of the final data, which was over 100 pts if I’m not mistaken. At the time we first wrote and submitted this to the VA (2015), I was representing BTC’s data to the VA. Being on faculty at UCSD, I was the one who suggested that we go to the VA, got the meeting, and gave the presentation on this data to the VA, in an effort to get a more formal trial done at the VA. NBRL/BTC had done their own in-house data analysis, so third party validation and independent verification via a trial was necessary. I spent a good part of the lecture, explaining to the VA committee that “MRT was a personalized form of rTMS”….I remember a comment made in the meeting “why don’t you just call this personalized rTMS then….” After I dissociated with BTC, I chose to resubmit this study proposal to the VA, with the intent to study my own version of PrTMS, and used the descriptive acronym of PrTMS as suggested. The work and experience I had learned from the MRT study still remained a predicate experience for further investigation of our own form of PrTMS. Brad, I don’t claim to be perfect, and I’m sure with the number of documents Diana and I have given you and Jill, you’ll be able to find some errors, like in the graph above. Maybe it’s your tone or personality, but I have to wonder if your goals are to really understand this…or is it just an attempt to do a “I gotcha” article…? The bottom line is PeakLogic Inc. is promoting a very disruptive science, that is antithetical to drug therapies, and is showing promise in a number of orphan neurocognitive disorders, like autism and cerebral palsy. It is going to continue to rub people and groups the wrong way, as it is disruptive to a number of industries and professions. That is why more formalized randomized trials are needed. I successfully raised 10M to this end… Regardless of what you feel like focusing on, the bigger story of what really happened here will get out. The University, through academic jealously, incompetence, and retaliation, chose to squander a 10M gift, specifically donated to scientifically test the outcomes seen in my clinic using a personalized form of rTMS. Btw, I’ve signed a settlement agreement with NBRL. Of course, I cannot tell you the details, but I’m very satisfied with the outcome. k 3 of 5 1/30/20, 11:16 AM Re: Quick question Please help me understand this better. Thank you, -Brad Kevin Murphy December 21, 2019 at 7:01 PM Brad, PrTMS is descriptive acronym, like SCUBA…it has been, and continues to be used by many to describe the process of personalizing rTMS…each group/competitor personalizes rTMS differently, and has their own process, software code etc, and sometimes their own acronym….we decided a few years back to trademark the PrTMS acronym itself since it was available, and descriptive of the generalized process, and makes it clear, that the treatment we are ultimately providing is rTMS…so PeakLogic now owns the TM….as time goes on, PeakLogic will enforce the use of the acronym if necessary… Im not sure what version of the PTSD study I gave you, but in those days, initial submissions to the VA were done in conjunction with the Brain Treatment Center (BTC) and used PrTMS to describe the data from the MRT study done at my clinic in 2015 (Taghva, et al)… the VA and IRB understood rTMS, but not MRT….I sponsored the study by providing the clinic to do the study…this was research with a “R” covered by Western IRB, performed by the Brain Treatment Center, and published by them… “MRT” was a brandname for their version of PrTMS, that then evolved to “MeRT”….in all cases, the process involves delivering rTMS with each group trying to differentiate themselves… So it can be confusing, but research evolves, and names and brands evolve… K Kevin T. Murphy, MD kevin@prtms.com 619-804-3359 Chief of Staff Diana Shapiro 858-774-8440 diana@prtms.com www.PrTMS.com From: Brad Racino Date: Saturday, December 21, 2019 at 10:00 AM To: Kevin Murphy Subject: Quick question Dr. Murphy, I noticed in your VMRF protocol for the PTSD study that page four has a section titled "Progress Report" and it describes preliminary data from a preliminary study. It details 36 combat veterans in a double-blind, open label prTMS trial and includes graphs of "Change in PCL-M Scores Post-PrTMS." I'm confused because you told us you hadn't done any Research (with a capital R) for prTMS. So what is this? Thanks, -Brad -- BRAD RACINO Senior Reporter & Assistant Director inewsource.org c. (845) 553-4170 t. @bradracino P.S. We want to hear from you! 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Brad Racino December 21, 2019 at 1:00 PM Dr. Murphy, I noticed in your VMRF protocol for the PTSD study that page four has a section titled "Progress Report" and it describes preliminary data from a preliminary study. It details 36 combat veterans in a double-blind, open label prTMS trial and includes graphs of "Change in PCL-M Scores Post-PrTMS." I'm confused because you told us you hadn't done any Research (with a capital R) for prTMS. So what is this? Thanks, -Brad -- BRAD RACINO Senior Reporter & Assistant Director inewsource.org c. (845) 553-4170 t. @bradracino P.S. We want to hear from you! Take a brief survey to help us get to know you and the topics you want us to look into. ----------------------------------------------------------------------------- PLEASE TAKE NOTICE: The information transmitted is intended only for the person or entity to which it is addressed and may contain information that is confidential, privileged and/or otherwise exempt from disclosure under applicable state and federal law, including, but not limited to, privacy standards imposed pursuant to the Federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). Any review, retransmission, dissemination or other use of, or taking of any action in reliance upon this information by persons or entities other than the intended recipient is prohibited. If you receive this transmission in error, please contact the sender immediately and delete the material from any computer. Thank you. Attachments: image001.png image002.png 5 of 5 0 bytes 0 bytes 1/30/20, 11:16 AM