Ed Harris - Background (Revised 1/25/16)

Transcription

1 Ed Harris - Background (Revised 1/25/16) Contact: eharris@sclerodermainfo.org Personal, Professional, and Academic Background Age: 68, currently retired Academic background: o BS Mathematics 1967 o MS Computer Science 1969 and 1976 o MS Clinical Psychology 1983 (PhD coursework completed) Two publications in research journals 51 years experience as software developer, consultant, and successful serial entrepreneur. A major part of this career was spent in medical software development, including developing comprehensive software for medical laboratories, pharmacies, and early development of electronic medical record software. Personal Medical History Started to develop unusual symptom (Raynaud's) in 1985 at age 38. Formally diagnosed with limited scleroderma in early Developed major symptom progression over next several years and by early 1993 had severe reflux, decreased lung functioning, and chronic chilling in addition to increased Raynaud's attacks. Hearth arrhythmias were detected the following year. In early 1993 obtained access to comprehensive medical search library on CD ROM thanks to the generous gift from the CEO of a company that sold this product to libraries for several thousand dollars. Developed a new disease model based on extensive review of all of the medical research to date, proposed a trial experimental treatment plan based on this research, and submitted it to my doctors in April

2 Obtained approval in September 1993 for a one-year trial that would be covered by my health insurance. The treatment approach was regular plasmapheresis treatments. Treatments began in November The treatment regimen used was one treatment a week for four weeks followed by two months of rest before repeating the cycle (16 treatments per year). At the end of one year, major objective improvement in all symptoms was observed, resulting in an additional one-year extension of the trial. At the end of year two, all symptoms were gone except for very mild residual Raynaud's symptoms. Lung functioning returned to the normal range in follow up testing. Heart arrhythmias that developed in 1994 disappeared the following year. Regular plasmapheresis treatments have been continued on a regular basis as the sole systemic treatment since November 1993 and I remain in perfect health. In 1998, a short experiment was conducted to see what would happen if these treatments stopped was tried. Symptoms began to return after six months so regular treatments were resumed at that point. These symptoms completely disappeared again over the next year once treatments were restarted. Scleroderma Patient Educator / Consultant 1996 to Present Scleroderma FAQ 1996 to 2014 In 1995, as the Internet was in its infancy, I searched and discovered that there was essentially no information available online for scleroderma patients that could be readily understood by someone without a medical background. I was able to obtain an update to the Medline CD ROM library that I had originally obtained in 1993, researched all new studies since 1993, and wrote and published online the first edition of a patient education document on scleroderma titled the Scleroderma FAQ. The updated Scleroderma FAQ won two patient education awards and was translated into Spanish over the next few years. The last major update to the Scleroderma FAQ was done in 2009 as good patient education information was finally becoming available from a number of sources, e.g., the Scleroderma Research Foundation, Scleroderma Foundation, Johns Hopkins, Mayo Clinic, etc. Scleroderma Education Project October 2013 to Present (Website: SclerodermaInfo.org) Background In October 2013, I decided to do an update to the Scleroderma FAQ as a prequel to updating the Wikipedia article on scleroderma, which is not very good. I assumed this would just take a couple of weeks since doing literature review research is much easier 2

3 and faster than it was when I had originally researched and wrote the FAQ 18 years earlier. I started the project by reviewing current major scleroderma websites, e.g., Scleroderma Foundation, Mayo Clinic, Johns Hopkins. I found that there was a lot of useful information but it was not very detailed. I then started reviewing the research literature directly and realized that there was a huge amount of information that was not being included on any existing website. A lot of this information was fairly technical but also important for people that wanted to learn as much about the disease as possible in order to work more effectively with their doctors. I decided that I needed to start over by reviewing all of the major research and try to produce a comprehensive document that would bridge the gap between technical and medical jargon found in research papers by explaining everything in a way that patients without a medical background could understand. The first draft of a completely rewritten Scleroderma FAQ was completed on November 21, 2013 after about 200 hours of research and writing. This initial draft of the updated FAQ was 34 pages long (the existing version was about 8 pages long). Between November 2013 and July 2014, I received feedback on the FAQ from a number of reviewers, including the Scleroderma Foundation and a scleroderma expert/ researcher and revised the FAQ in accordance with their feedback. In April 2014 I researched and wrote a companion document to the FAQ titled the Guide for New and Future Patients. I also realized at this point that in addition to these initial two documents, there were a number of other articles that I wanted to write, including additional patient education documents but also a series of Technical Articles that would cover certain topics in more detail and include selective research citations. Some of these technical articles would be targeted at physicians and researchers in addition to more sophisticated patients. As a result, in May 2014, I made the decision to launch a complete new website called the Scleroderma Education Project which would house all of these documents. The new website the Scleroderma Education Project - located at SclerodermaInfo.org, was launched on July 23, While the website has only been live for about a year and I have not done a lot of PR yet, it has regular traffic from 104 countries at this point. Currently about 25% of the visits are from countries other than the US. Scleroderma Patient Consultant 1996 to Present Once the original version of the Scleroderma FAQ was published online in 1996, I almost immediately began to receive s with follow up questions from patients around the world (my address was included in the FAQ). Most of the questions were follow-up questions to information in asking for information the FAQ. I would usually work one-on-one with these patients either by but on occasion I also communicated with them by phone. If the patient asked me for specific advice, I would first make sure that they knew that I was not a physician and could not offer medical advice. However, I was often able to propose questions or options for the patient to 3

4 discuss with their doctors. For the most part, these types of queries were limited to a few times a year during the period 1996 to October As I began researching and writing the new version of the Scleroderma FAQ in October 2013, I realized that in addition to reviewing the research directly, I would be able to improve the document by listening to the questions and comments that scleroderma patients were posting in online patient forums. I joined the largest scleroderma patient forum that I could find the Inspire forums that are run by the Scleroderma Foundation. Over the next year I became increasingly active in working with patients on the Inspire forums, both by posting research-based answers to questions or sometimes through direct communication with individual patients that contacted me privately through the messaging system built into the Inspire forums. Once the website went live in July 2014, I also started working with new patients from around the world that contacted me through the website. By September 2014, I was spending a significant amount of time in this role as patient consultant in addition to continuing to research and write new content for the website. In October 2014, I joined a number of Facebook scleroderma groups and have become a very active member of these groups. I spend a significant amount of my time each day in one-to-one patient interactions, frequently helping to educate patients on ways to work more effectively with their physicians in order to get quickly and correctly diagnosed. Recently (September 2015) I became an active member of the Inspire patient support forums run by the Scleroderma Foundation. This is the largest scleroderma support community in the world. Current and Future Technical Scleroderma-Related Publications Patient Education Series Scleroderma FAQ - The Scleroderma FAQ is a comprehensive document that covers systemic scleroderma diagnosis and treatment. It is written in a language that patients can understand but also includes medical terminology that patients will encounter when working with their physicians. All information contained in the FAQ is based on current medical research and includes up-to-date information on new diagnostic criteria and treatments for systemic Scleroderma. Guide for New and Future Patients (Available in Spanish) This document is a companion document to the Scleroderma FAQ. Think of the main Scleroderma FAQ as the 50-page User Manual that came with your shiny new 65-inch ultra high definition TV. This Guide is the equivalent of the Getting Started Guide that also came with the TV. While this Guide includes some basic information extracted from the Scleroderma FAQ, it has a very different focus. In addition to giving a basic overview of 4

5 Scleroderma, it is designed to help patients get diagnosed as quickly and accurately as possible. It helps you to be better prepared for your doctor visits and also includes information about tests and procedures that are commonly ordered for patients with Scleroderma. Guide for Family and Friends (in Process) One of the challenges that scleroderma patients face is explaining their disease to family and friends. This document is designed to be a short handout that gives some basic information about this very rare disease that should help your family members better understand what you, as a scleroderma patient, are going through, and how they can best be supportive. ANA and Antibody Series How to Do Scleroderma ANA and Antibody Testing Correctly This document is a bullet point summary of my technical article on ANA and Antibody Testing that is written as a physician education document. It was vetted by one of the leading US scleroderma clinician / researchers before publication on the website and has since been also reviewed by the medical director of one of the leading US reference labs - Dr. Alan Metzger, RDL Laboratories. Dr. Metzger is a rheumatologist, which is unusual for the medical director of a reference lab. RDL has indicated that they are interested in publishing a version of this article on their website as a resource for physicians. Changes in ANA and Antibody Levels Over Time This article was prompted by a question on a patient through my website. It discusses the research on when and how ANA and antibody levels change over time and the clinical significance of these changes. I was also able to work closely with Dr. Metzger on this article. The Puzzle of ANA Negative Systemic Scleroderma Depending on the research study, between 5% and 10% of patients with clear scleroderma symptoms repeatedly test negative for ANA when done correctly by indirect immunofluorescence (IFA). This paper explores some of the research on the clinical aspects of negative ANA scleroderma as well as speculates on what might be going on in these rare cases. The Diagnostic Challenge of False Positive anti-scl70 Results (in Process) Historically, testing for the anti-scl70 antibody (one of the two main antibodies associated with diffuse variants of systemic scleroderma) was done using a time consuming method called double immunodiffusion. Modern antibody testing methods such as ELISA and Multiplex offer a much faster and less expensive testing method for anti-scl70 antibodies that is generally very accurate. However, research suggests that there is a significant problem with false-positive results especially when the results are in the low positive range. Technical Article Series Understanding Medical Research (in Process) I am currently writing a 3-part series that will teach patients about medical research. The series will cover: Testimonial, Anecdotal Reports, and Case Studies one patient at a time Observational Studies lots of people, lots of problems 5

6 Formal Clinical Research Studies from open label pilot studies to the "gold standard" (double blind, placebo control, randomized trials) Part 1 of the series is completed and posted on my website. This will eventually be turned into a combined technical article on my website. A version of the final article that is not focused on scleroderma will be made available to many other online patient medical websites and support groups as a general education document. Scleroderma Mortality Trends and Risk Factors (in Process) - This article will discuss research that has examined changes in scleroderma survival rates over the past forty years. The research clearly shows that survival rates for all forms of systemic Scleroderma have definitely improved during this time period. However, a careful analysis of the research data suggests that when improvements in Scleroderma patient survival rates are compared to improvements in survival rates in the general population, there appears to be little evidence (with a few clear exceptions) that current Scleroderma treatments are leading to improved survival times. This article will also review the research literature that analyzes how specific symptoms and disease subsets affect Scleroderma patient longevity. Scleroderma and Antibiotic Protocol Therapy - The usage of antibiotics to treat Scleroderma patients is probably one of the most controversial treatment approaches that patients often learn about through Internet searches when they are first diagnosed with Scleroderma. The general view of the medical community is that while some early research showed promise, a later research study did not demonstrate that the particular antibiotic used in the study lead to any significant symptom improvement in a group of Scleroderma patients. While this was a limited study without a normal control group, researchers and clinicians frequently cite it as evidence that antibiotic protocol (AP) therapy is ineffective. On the other hand, there are a number of anecdotal reports of patients that report major improvement in their symptoms, sometimes to the point of complete and long-term remission of most of their disease symptoms. This technical article will explore the controversy in some detail and suggest a hypothesis that may account for the discrepancy between these two divergent points of view. Research Article Series Scleroderma Blood Hyperviscosity: Implications for Research and Treatment This paper discusses the research behind my successful treatment protocol. There is a significant body of research that documents blood hyperviscosity (thickness) in scleroderma patients that appears to be caused by red blood cell hyperaggregation (clumping). The article discusses the potential implications for this as a possible trigger for the cascade of symptoms that develop in scleroderma patients. It suggests several possible research studies that can test the validity and significance of this disease pathogenesis hypothesis. The article also reviews several treatment approaches that can potentially break up the red blood cell clumping and may lead to the development of drugs or other treatment approaches that target a different part of the Scleroderma disease process than is targeted by current treatments. 6

7 Long-Term (22 Year) Successful Treatment of Limited Systemic Scleroderma Using Plasmapheresis (in Process) The initial draft of this case study has been completed and it is now in review. I now have three co-authors for this study, including experts on blood rheology and plasmapheresis. It is my hope that this case study will encourage physicians to try this treatment approach as well as re-open interest in looking at scleroderma blood hyperviscosity as a possible mechanism for scleroderma disease pathogenesis and as a potential avenue for developing new treatments that can be more effective and less toxic than current treatment options. Benefit of Long-Term Therapeutic Plasma Exchange Treatment in a Patient with CREST Syndrome (Limited Systemic Scleroderma): A 21-Year Success Story This abstract was presented at the AABB conference in October This is basically a condensed version of the longer case study. The abstract is published in the September 2015 issue of the research journal Transfusion in conjunction with the conference. Publications Harris ES, Meiselman H, Poriarty PM. Therapeutic Plasma Exchange for the Treatment of Systemic Scleroderma: A Comprehensive Review and Analysis. Accepted as an abstract/poster for the American Society for Apheresis Meeting at Palm Springs, CA May Weiss J, Roy M, Harris ES. Benefit of Long-Term Therapeutic Plasma Exchange Treatment in a Patient with CREST Syndrome (Limited Systemic Scleroderma): A 21- year Success Story. Transfusion September (S3): 103A. Presented as a poster at the AABB Annual Meeting Anaheim, CA, October Kirschenbaum DS, Harris ES, Tomarken AJ. Effects of parental involvement in behavioral weight loss therapy for preadolescents. Behavior Therapy 1984;15: Hobbies and Other Personal Interests Skilled amateur musician (principal bassoonist in Madison, WI community orchestra) Composer of classical music for orchestra, band, and chamber groups (in training) Avid tennis player (I play about 10 times a week, year around) Gourmet chef 7