This is a report first sent to the Friends of MPNforum, a group that is closely engaged in supporting and contributing to the magazine and its projects. We were asked to make it more widely available since the report expands a bit on the Patient Advocate project and announces several appointments and changes. Since we’re all part of the MPN community, we’re happy to publish this brief report. Your comments or questions are always welcome.
There’s a balance between assaulting friends with e-mail and being so discreet as to let significant developments go unreported. As our latest project moves to its conclusion, I realized I hadn’t informed you of other, equally important, events.
We’ve been busy. Last month, driven by the Sanofi fedratinib clinical trial meltdown, we published two Special Issues of MPNforum, filed two Freedom of Information Act requests with the FDA (and one appeal) and launched an initiative to increase MPN patient security in clinical trials.
MPNforum is a collective effort and you’re integral to its success. Most of you follow MPNforum in one form or another but some of you cannot. We have to do a better job to keep all our friends in the loop. Here’s the delayed update.
The Fatigue Project – First results of our Fatigue Project were presented by Dr. Robyn Emanuel in December at ASH-New Orleans. Since that time there have been several revisions of the on-line survey tool developed by the Mayo Clinic team. The final version is in production now and will be launched in a week or two. This is a project of primary importance to MPN patients for whom fatigue is the single most debilitating effect of our disease.
New Board of Editors — I plan to step down as Editor of MPNforum at the end of this year. The first step in building continuity has been the appointment of a Board of Associate Editors, experienced writers deeply engaged in our MPN community: Ann Haehn, Jamie Strause, Kathy Dubin Flynn, Mary Cotter, and Richard Baumeister. Other volunteers, like Ellen Jacquardt (List of Hematologists) and Mary Morochnick (MPNclinic) will continue on.
The Index Project – One of the most valuable libraries of practical MPN medical advice is buried within the archives of the MPNclinic: The answers to over 100 questions sent to this panel in 2013. The organization and cross-referencing of a crude index will be done by an MPN volunteer, Sherrill Farnstrom, experienced in cataloging. Together with the MPNforumQuarterly Journal’s “How I diagnose…” and “How I treat….” Series this Index will serve the needs of patients, physicians and students worldwide.
The Zebra Coalition – A group of patients, caregivers and physicians have helped field an initial petition to the FDA to mandate a Patient Advocate on every clinical trial. A few words on that are probably in order.
For now, all we are trying to do is establish the principle that patients need a voice in the Clinical Trial process… and start the discussion with patients, doctors, institutions, FDA, sponsors. The basic idea is to provide a person to whom a patient can turn to voice concerns and fears, a person with some shared experience, to help provide support and monitor his or her progress. The added safety level is this same person would track local adverse events from occurrence to reporting and receive trial-wide SAE reports along with investigators.
The benefits to IRBs, Sponsors, and Investigators seem to me considerable: Safety, compliance, perseverance, recruitment. Working with patients, the PA can help encourage, compliance with the study protocol, funnel problem issues that arise in the trial – whether unresolved patient complaints, environmental concerns, etc. – to trial managers, help convey information to patients in the trial and enhance trial recruitment efforts by allaying patient fears of isolation.
The benefit to patients: A patient goes into clinical trial in a vulnerable and isolated state. Compliance rather than active participation is required of a patient in clinical trial . In the process patients lose their voice and sometimes their will. In some cases this results in suffering and early trial withdrawal.
Finally, MPNforum operations — As many of you likely know, MPNforum logged its 250,000th visitor to its pages about a month ago. It’s a tribute to your support and to all working on this on-line magazine that so many of our fellow patients and caregivers worldwide can depend on us to report the news, analyze the science, present the stories and advocate for the MPN community. Without you, it couldn’t happen.
Thank you for your friendship and support, please let me know if you have any questions or concerns about any of this…
Comments on: "MPNforum Operational Report" (4)
Thank you for all the information. It has armed me with questions for my doctors, understanding of what they say and the followups to my treatments. As more people know about these rare diseases, more donations and research can be done. YAY!
Just a couple of comments on the Zebra Coalition:
1) Bless everyone who was involved in starting this process as I was on the SAR302503 trial and asked Mayo to get off in mid Sept prior to the end of the trial.
2) The petition seems to only allow one person/email address to sign up which is disappointing as my wife is on the list but not me.
3) Through family & friends, especially at our winter home in Palm Desert, CA, we have logged 39 sign ups through yesterday.
Thanks for all you do.
Fred Chadwick, patient and husband of Laurie Chadwick
From all of us, thank you Fred! So glad you got off the trial in time. Have you had your thiamine levels checked? Please feel free to contact me privately, email@example.com, if you’d rather keep some comments private for now.
Thanks to all for the great work. The information gained is invaluable!