After four weeks of intense work, a group of advocates has submitted forty pages of comments on the P2P systematic evidence review. We published a summary of our comments last week. If you want to read the full document, you can view it in two pieces:
Part One addresses the issues with the Evidence Review’s base assumption that all CFS and ME definitions represent the same disease or set of closely related diseases, and the analysis and conclusions drawn regarding diagnostic methods, accuracy and concordance of definitions, subgroups and diagnostic harms.
Part Two addresses the analysis and conclusions drawn regarding treatment effects and harms; and issues related to applicability, reliability and future research directions.
I was proud to work with the following advocates who join me in making these comments:
- Mary Dimmock
- Claudia Goodell, M.S.
- Denise Lopez-Majano, Speak Up About ME
- Lori Chapo Kroger, R.N., PANDORA Org CEO and President
- Pat Fero, MEPD, President, Wisconsin ME & CFS Association, INC.
- Darlene Fentner
- Leonard Goodell, Jr.
- Alan Gurwitt, M.D.
- Wilhelmina D. Jenkins
- Joseph Landson, M.S.
- Margaret Lauritson-Lada
- Jadwiga Lopez-Majano
- Mike Munoz, PANDORA Org Board of Directors
- Matina Nicholson
- Charmian Proskauer
- Mary M. Schweitzer, Ph.D.
- Amy L. Squires, MPA
- Susan Thomas
- Erica Verrillo, Author
There is still time for you to submit your own comments. Feel free to draw inspiration from the work we publish here today, or the other posts I’ve published over the last several weeks.
Pingback: Evidence Review Comments Due Monday October 20th | Speak Up About ME
BRAVO!!! And a huge thank you. You have brilliantly outlined the state of affairs and the position of ME patients everywhere.
Thank you, Sandra!
You all are true heroes. Congratulations on your spectacular work.
Thank you, Deborah!
I cannot thank you enough for this.
You are very welcome.
Jennie, a thousand thanks to you and your group for having produced in such a short time such a remarkable document on behalf of all of us. It politely but clearly and firmly tears that document to shreds with patient documentation and clear reasoning; in fact, it should be used to replace the document, or the NIH should pay you all to produce a replacement version. Just plain superb!
Chris
Thank you, Chris! It would be lovely for knowledgeable people to produce a replacement version. I’ve heard many researchers are extremely unhappy about the review.
Congratulations to all involved in submitting your comments. I appreciate your collective effort. The information that you have shared over the past several months has been very helpful to me in framing my own comments.
Excellent, Jim! Thank you for taking the time to submit comments! Hard work no matter how you slice it.
I just sent my comments in! Thanks to Jenni and all of those who worked together on the 40 page response document. Also the others who sent comments in. I fully oppose the P2P process and it’s many serious flaws. I fully support all the advocates who are working so hard to make sure that they get things right for patients. -Toby Vokal
Thanks, Toby. Thank you for submitting comments, too. I hope they internalize everything we are saying.
you’ve done an absolutely AMAZING job, ladies! thanks a million, infinitely appreciated! and thank you so much for making your comments available to us too, it was a huge help for me when writing my own comments.
Thank you, Magdalena! And thank you for submitting your own comments!
My suggestion for everyone who agrees with the document put together by Jennie and her hardworking colleagues: send in a comment, even if one sentence, to the effect of:
I agree with and fully endorse the joint comment sent in by Jennie Spotila, Mary Dimmock, and their colleagues.
It’s nice to put your comment here but get it also to the people who need to hear about it:
http://effectivehealthcare.ahrq.gov/research-available-for-comment/comment-draft-reports/?pageaction=displayDraftCommentForm&topicid=586&productID=1976
(Use the “general comments” box — scroll down. There is no need to put down your contact info or name unless you want NIH to be able to contact you if they need clarification on something.)
Thank you, Anonymous. I’m not sure how much an endorsement will matter to AHRQ, but it certainly can’t hurt.
Thank you, all.
Thank you thank you thank you thank you thank you thank you thank you thank you thank you!
My husband, Blake, submitted comments on our behalf, referencing your document–“echoing and endorsing” the term ME rather than CFS or ME/CFS. Your work allowed us/him to write a personal narrative illustrating potential harms (and past ones to be sure too because so many doctors still think this is a form of depression or a psycho-social illness). Also, we felt that coming from him it had more strength because he works for a federally-fundedn on-profit corporation that oversees the SAFE research, development, and launching of satellites, and he could use language of data mining and scientific reviews to say that you really can stop and change this process. In rocket launches, anyone in the chain of command can shout HOLD! HOLD! HOLD!, even in the last seconds of final countdown if any one system of dozens looks slightly not right, and it stops the launch. (You can actually listen in to this at Spaceflight Now http://www.spaceflightnow.com/ . It’s quite exciting!)
Hmmmm. HOLD! HOLD! HOLD! could be the perfect chant in December….
Carollynn, we really need someone at NIH willing to yell HOLD! HOLD! HOLD! Great analogy.
Want to send another thanks for Jennie and all who helped review the Draft AHRQ report and who helped compile the response. I managed to get my 11 pages of comments to them today, I used a lot of the information presented on this blog site for the basis of my reponse. I can’t tell you how helpful it was!
Thanks for sending comments, Cathy! This is exactly what we hoped – that our comments would help others with theirs.
Got my comments in just before the deadline last night! I want to say thank you to Jennie, Mary, and all who worked together and submitted a world-class response to the agency’s dangerously flawed review. I can only imagine how upset the M.E. clinicians and researchers must be to have their groundbreaking work that required sweat, tears, and sacrifice by the doctors and patients just flippantly dismissed away by the agency in this farce of a review.
I agree with the commenter above who said Mary et al’s 40 page rebuttal document should be adopted as the official Evidence Review instead. That is the truth!
I want to share my opening paragraph to my 4 pages of comments. I hope the IOM listens to our public comments and asks for a re-do on the Evidence Review.
“I want to state in the strongest terms possible that I vehemently oppose and protest the acceptance of this Draft Report. This Draft Report is devastating to M.E. patients and effectively winds the clock backwards 30 years in terms of scientific advancement and understanding of the disease M.E.
The entire premise of this review is deeply flawed and it can be summed up by quoting page ES-30 as follows: “Given the breadth of symptoms in ME/CFS, we a priori elected to not review symptom related outcomes except for fatigue. Some interventions may have revealed benefit for other characteristics of ME/CFS and this review would not have identified these outcomes.” Are you serious? Who gave you the authority to decide that you could focus solely on fatigue and ignore every other symptom related outcome? Speaking with the authority of someone who has M.E., I can tell you that M.E. is not about fatigue!”
Thanks to you all forworking so hard on this.
@Tom Jarrett
‘File’ ME/CFS patients into broad-based fatigue — has always been the name of the game–rigged game.