My Correspondance with Beth Collins Sharp RN of ARHQ

 

 

My Correspondance with Beth Collins Sharp RN of ARHQ Regarding The NIH Pathways To Prevention Systematic Review for ME and CFS.

May 2nd, 2014,  The NIH Pathways To Prevention Systematic Review for ME and CFS was published.  When I heard it had been published, I went to the ARHQ website where it was published to take a look at it.

When I read that document, the nurses cap automatically went back on my head and I started thinking like an R.N. I say this because as soon as I read that document, I saw right away that it was clearly negligent and thought, the medical people with this illness need to really start speaking up and I must contact someone regarding this.

I looked for the link on the website to where I could contact the authors regarding this, I found the link and I sent them a message, which started my correspondence with ARHQ and Beth Collins Sharp RN.

Below are copy and pastes of the actual email communications with ARHQ and Beth Collins Sharp.

May 2nd:

The correspondence starts May 2th with my comment via the feedback to the authors:

Discussion Thread
—————————————————————
Customer By Web Form (Name Not Given) – 05/02/2014 02:48 PM Hello, Im writing in regards to the systematic review that is planned for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome that was just published and put on this site yesterday,  Its very very bad, the evidence to be reviewed, more than 1/2 of it is biased and incorrect evidence for the reveiwers to review!!  I would really like someone to contact me back at my email above about this.

Response from AHRQ on May 5th:

—– Forwarded Message —–
From: AHRQ Effectivehealthcare

To: “Me
Cc: “Ramage, Kathryn (AHRQ) (AHRQ Contractors)”

AHRQ Effectivehealthcare
Sent: Monday, May 5, 2014 2:32 PM
Subject: RE: Site Feedback [systematic review for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome ]

Thank you for your recent inquiry to the Agency for Healthcare Research and Quality (AHRQ).

The protocol for this project was posted on the Effective Health Care (EHC) Program website, however, the research review itself is still in progress.  The draft version of this report will be posted for public comment on the EHC website, and we welcome any comments and feedback that you have regarding this topic at that time.  The key questions for this topic were also posted for public comment, however, that time period has closed.

Please feel free to visit the following link to join the EHC email list to learn about recently released products for public comment and final posting:  http://www.effectivehealthcare.ahrq.gov/index.cfm/join-the-email-list1/

We appreciate your interest in AHRQ’s Effective Health Care Program and the resources that we produce.

Sincerely,

The AHRQ Effective Health Care Program

 

 

My Reply to ARHQ on May 5th:

From: Me
Sent: Monday, May 05, 2014 3:33 PM
To: Ramage, Kathryn (AHRQ) (AHRQ Contractors)
Subject: Fw: Site Feedback [systematic review for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome ]

Dear Kathryn,

The email states you forwarded my feedback.
I didn’t send feedback to be placed on an email list, I send feedback to be directed to a person.
I and other patients would rather talk to a specific person than get our legal team involved.

Thankyou,

 Me

(I figured the mention of the “Legal Team” would get a faster response)

 

 

Response from Beth Collins Sharp on May 7th:

From: “Collins Sharp, Beth (AHRQ)”
To: Me
Cc: “Ramage, Kathryn (AHRQ) (AHRQ Contractors)”
Sent: Wednesday, May 7, 2014 12:07 PM
Subject: RE: Site Feedback [systematic review for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome ]

Hello Ms,

First, I am sorry it was difficult to be referred to me. The staff working with the general e-mail addresses have been given new routing directions.

More to the point, I am happy to try and answer your questions and respond to your concerns as it relates to the systematic review process and AHRQs role in this project. If your questions bump up against confidentiality or policies where I cant share information, I will be up front about that and when possible, explain why. As you probably know, I am AHRQs ex-Officio to the CFSAC and have past experience with the EPC program.

Thank you for contacting us. I’ll look forward to another e-mail from you and try to help where I can.

Thank you, Beth
___________________________________________

Beth A. Collins Sharp, PhD, RN, FAAN
Senior Advisor, Women’s Health and Gender Research
Senior Advisor for Nursing
Agency for Healthcare Research and Quality

 

 

My Reply to Beth Collins Sharp June 7th

From: Me
Sent: Saturday, June 07, 2014 4:12 AM
To: Collins Sharp, Beth (AHRQ)
Subject: Re: Site Feedback [systematic review for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome ]

Hello Beth,

It thought the original response was from one of those automated systems when I received a response from from my feedback. I have to be honest, im surprised to see your email. Thankyou for writing me back.

Because of this illness, I could not write you back sooner. I am writing you now. I may register to speak over the phone during the CFSAC meeting and repeat the words im saying here to you.

My name is Anne LiConti. Im a long time patient with this illness. Before I became a long time patient, I was an active Registered Nurse almost 10 years, my employment included working at a very large well known medical center in New York City where I am originally from. I know you are an RN too, as you know, after working in one of those medical centers, you can work anywhere and you learn early on how things work, like this review that is planned to be done.

The NIH Systematic Review for the P2P program has a clear Bioethics violation in it.
There is outdated information in this review, that is harmful to patients if it is allowed to be used in the evidence review.

There has been multiple studies, with proven evidence, by 3 different research groups, that was known before this review was written. Therefore, this review is an unethical, bioethics violation and must be stopped!

It is obvious, that the authors who wrote this review, do not have any type of expertise in the care of the ME patient. If they did, they would know that evidence that is being used in this review will cause irreversible harm, disability and has even been fatal to patients. If they do have expertise, then they are negligent.

There is nothing in this review that proves disclosure of the issue. The non medical lay people who are going to be involved in this process, they do not have knowledge of the inaccurate evidence because not only are they not practitioners, they are non medical lay people.

Beth Maier made a statement, which I heard while I was watching the video where the process of this P2P review was being explained, or should I say, that she was attempting to explain.

Beth mentioned “The Jury Model.”

Quite frankly, patients are not criminals that sit in front of a jury for the jury to decide whether or not that they receive correct or incorrect care. This “Jury Model” is a disgrace to medicine. There is no other way to word that.

I have been a patient in this community for 20 years. While I was active in the RN field, I would’ve never dreamed of being treated the way the patients in this community have been treated. I never saw anything like this in my life. I cant believe I am actually a patient in this patient community where we are dealing with a situation that is far beyond unethical in the year 2014. This is a disgrace, has been a disgrace, and continues to be a disgrace.

Because of the bioethical issues regarding evidence in this review, it would be of all due conscience, in other words, because of the oath that was promised by all of the practitioners involved, and that is “Do No Harm”, thus, this review must be stopped!

Thankyou,

 

 

Response from Beth Collins Sharp June 11th

On Wednesday, June 11, 2014 4:23 PM, “Collins Sharp, Beth (AHRQ)”
wrote:

Hello Anne,

When I didn’t hear from you before, I assumed that the ME/CFS was hitting you hard. I’m glad you were able to write back.

I agree that it’s hard to be a nurse and see how little progress has been made over the years. That’s why, in my role as Ex-Officio for AHRQ, I’m trying to listen carefully to patients and apply it to what I know about the systematic review process. There is a clear message from patients and advocates that they are concerned about harms from specific treatments. The protocol for the systematic review includes looking at harms so the manuscripts that document the harms should be considered also. That is a routine in these reviews and the researchers are used to considering the harms.

I cant comment about the non-experts on the Panel. AHRQ is not involved in the selection of the Panel. I will say that the members of the panel are recommended by experts and the P2P has a long history of doing very well at putting together a responsive panel.

I recognize that we feel differently about this. My past experience with the P2P program and the AHRQ systematic reviews influences my more positive outlook. Just as your experience with ME/CFS influences your view. More importantly, even though our views are different, I would like to say that I respect your opinions and will keep them in mind in our CFSAC work.

I will listen for your voice on the phone next week during public testimony.

Sincerely, Beth
___________________________________________

Beth A. Collins Sharp, PhD, RN, FAAN
Senior Advisor, Women’s Health and Gender Research
Senior Advisor for Nursing
Agency for Healthcare Research and Quality

 

 

My  Reply to Beth Collins Sharp June 13th

This reply is where I told Beth SPECIFICALLY WHY the Systematic Review for the NIH Pathways to Prevention for ME and CFS is Negligent and has Bioethical Violations!

To Collins Sharp, Beth (AHRQ)

Jun 13 at 2:03 AM

Hello Beth,

I was not able to get my request in on time to be heard via phone call during the CFSAC meeting.

I will be more specific in this letter why the Systematic Review for the P2P for ME and CFS is in error.

The authors who were paid to write that review, obviously did not have M.E. expertise, because they wrote a negligent document,  recommending unsafe non medical treatment that is harmful to M.E. patients.

Here are the reasons why:

NIH P2P Systematic Review For ME published online 5/2/2014.

The NIH P2P systematic review was supposed to be designed to further research.

This review will not further research as it contains non medical therapy which is harmful to M.E. patients.

The authors of this review did not exclude non-medical therapy GET/Grade Exercise Therapy which is harmful to ME and CFS patients.

The authors were negligent in not excluding the non-medical therapy of GET/Graded Exercise Therapy from the NIH P2P review for ME and CFS patients as the results of the 3 different research groups were known before publishing date of May 2nd, 2014.

Evidence used for the NIH P2P Systematic Review cited 6 defintions for ME and CFS:
-Centers for Disease Control and Prevention Fukuda et al., 1994
-Canadian Carruthers et al., 2003
-Revised Canadian Jason et al., 2010
-International Consensus Statement Carruthers et al., 2011
-London Dowsett, 1994
-Oxford Sharpe, et al. 1991


All of cited defintions except the Oxford definition point out post activity exacerbation of symptoms after trivial amount of activity, physical or mental fatigue or muscle weakness after minimal exertion which may persist long after exertion ends, Post Exertional Neuro Immune Exhaustion, Post Exertional Malaise.


The authors of the NIH P2P Systematic Review for ME and CFS allowed The Oxford definition criteria of GET/Graded Exercise Therapy to “slip through the cracks” and to be included in the systematic review as one of the non-medical treatments for ME and CFS. This was NEGLIGENCE of the authors, because it does not include that key piece of data in the definition which states that GET or Graded Exercise Therapy causes a post activity, whether physical or cognitive, exacerbation symptoms, long after exertion ends, Post Exertional Neuro-Immune Exhaustion, or Post Exertional Malaise.


This NIH P2P Review for ME and CFS was published on May 2nd, 2014, which was after 3 CPET VO2 Max Studies, that were completed by 3 different research teams stated below:


Dr. Enlander of the Mt Sinai Medical Center in NYC: November 20th, 2013: “Incorrect Govt Criteria Hurts Chronic Fatigue Syndrome Patients:
http://bit.ly/1hX7MFm



Dr. Snell and Dr VanNess of the Workwell Foundation in California: June 23rd, 2013 http://ptjournal.apta.org/content/early/2013/06/26/ptj.20110368.short

http://www.workwellfoundation.org/research-and-latest-news/


Dr. Betsy Keller in Ithaca NY: September 17, 2013 http://beforeitsnews.com/health/2013/10/exercise-physiologist-prof-betsy-keller-mecfs-patients-will-respond-abnormally-to-2-day-cardiopulmonary-exercise-tests-2-2508464.html


All 3 different research groups, in 3 different centers, where CPET VO2 Max testing using the Stevens Protocol was performed, all resulted in the same findings!

Findings:


-Abnormal Recovery Response to Aerobic Exercise- up to 7 days


-Decreased Functional Capacity or a drop in VO2 Max during test #2, 24 hours after test #1 due to metabolic abnormalities, thus causing post activity or exercise exacerbation of symptoms, PEM, PENE


-ME/CFS participants were unable to reproduce most physiological measures at both maximal and yentilatory threshold intensities during a CPET performed 24 hours after a prior maximal exercise test.


.-Decrease in anaerobic threshold from test 1 to test 2 causing a decrease or lower threshold for physical activity.


-Results from the second test indicate the presence of a CFS related post-exertional fatigue


-Significant Post Exertional Amplification of Symptoms.

-Ability to generate energy from the aerobic system is significantly impaired.

These results correlate with Dr. Enlander’s statement- INCORRECT GOVERNMENT CRITERIA IS HARMFUL TO ME AND CFS PATIENTS, NEW RESEARCH FINDS!

These results correlated with what patients have said for the last 30 years.

THE RESULTS OF THE 3 CPET VO2 MAX STUDIES PERFORMED BY THE 3 DIFFERENT RESEARCH GROUPS, SHOW THAT THE 1991 OXFORD DEFINTION FOR CFS IS OUT OF DATE, OBSOLETE, DOES NOT APPLY TO ME OR CFS, AND IS HARMFUL TO PATIENTS WITH ME AND CFS!

Because of these results, there is no way that Oxford Definition criteria can be used in good conscience at this point, because of clear bioethical issues, negligence by the authors, and if allowed to be used will be a bioethical violation and negligence by the P2P Panel knowing that the non medical therapy of GET is in fact harmful to ME and CFS patients.

There was also noted that there is no disclosure to non-medical lay people who will be participating in this process that the non-medical therapy of GET is harmful to ME and CFS patients.

The Non-Medical Therapy of GET or Graded Exercise Therapy will not advance research via the NIH P2P Study for ME and CFS as it is a therapy that is harmful to ME and CFS patients.

This NIH P2P Systematic Review for ME and CFS patients MUST be retracted and MUST be canceled as it will not advance research as explained above, has bioethical violations, is negligent, and is harmful to ME and CFS patients.

Beth, the error in the treatment recommendation can be equated to a medication error that results in permanent harm and disability to the M.E. patient, as this particular treatment has resulted in permanent disability to the M.E. patients for the last 30 years. In no way, will this review advance research.

This review was not checked and proof read properly before it was published online.  If so, the authors would’ve noted those 3 studies and included disclosure to the Non Medical lay people.  That document is clearly negligent.

In addition, an M.D. named Dr. Larry Baldwin, who is a Vascular Surgeon, disabled by M.E. 20 years, just wrote  a guest post called: “Post Exertional Debility” that was surprisingly posted on the Solve CFS Initiative website (formerly known as the CAA).

http://solvecfs.org/guest-post-dr-larry-baldwin-on-post-exertional-debility-in-mecfs/


It was posted on May 14th 2014 but there is still plenty of time to stop the P2P study as it is harmful and negligent to M.E. patients.

M.E. patients and patient advocates will be protesting this. M.E. patients are tired of unethical and negligent treatment recommendations. Its obvious that no one has listened to this patient group at all.


I myself, see this not just as a patient, I see it through R.N eyes, and this is unacceptable, and there is no excuse for this.


If we as RN’s, were employed by a center where GET therapy was done, and we didn’t double check this, questions this, refuse to allow the patient to go forth with this,  we would be sued because this therapy permanently disabled patients. This is the reason patients are unseen, because they are homebound because of this.


The 1994 Fukuda Definition, the way it was written in 1994, the Symptom “Post Exertional Malaise” was on the bottom of the list of symptoms.  The CDC changed it and put that symptom on the top.


“Post Exertional Malaise” is the incorrect wording of this symptom because the symptom isn’t “Malaise”, its severe muscle weakness. Malaise is not weakness, and fatigue is not weakness. Its the same symptom that Post Polio Syndrome patients get.


I know what you are going to say, so I will correct you first, only 1-3% of polio patient suffered paralysis, 7-9% who were diagnosed did not, the other 90% did not know that their “summer flu” was a polio infection.


The wording “Post Exertional Malaise” was deceiving, because doctors did not pay attention, they had no idea what it was, that’s why for 30 years, patients have been saying “I get worse after activity, exercise, reading, and the practitioners, had no idea what the patients were talking about because of the way that was written.

The 1994 Fukuda Defintion was a negligent document, just like this P2P for ME is negligent.


Like I said, the patients and patient advocates will continue to the protesting since before the IOM studied commenced.

Thankyou for your time,

Anne LiConti

 

 

Response from Beth Collins Sharp June 13th

Collins Sharp, Beth (AHRQ) Thank you Anne, The information that you provided is very informative. I will look at the links that you provided. I hope you have a nice weekend,

Beth
___________________________________________

Beth A. Collins Sharp, PhD, RN, FAAN
Senior Advisor, Women’s Health and Gender Research
Senior Advisor for Nursing
Agency for Healthcare Research and Quality

 

 

My  Reply to Beth Collins Sharp June 15th

 

To Collins Sharp, Beth (AHRQ),Me
Jun 15 at 12:54 PM

Beth,

Thankyou very much for replying to my emails and reading what I put in the emails.  I know you are busy, just a few more words.

This patient group has suffered unnecessarily. For this patient group to continuously suffer because of faulty and negligent illness criteria and non medical therapy, is getting beyond negligent and is becoming a crime.

The patients have suffered actually by the actions of a key person in the world of “CFS”, who was employed by the NIH, no longer with us anymore.

You probably know who I am talking about, there are also documents that were retrieved by an advocate, via FOIA, with the mans own words pretty much saying what he did.

His own words prove his actions to be intentional.

What that man did was a crime to millions of patients who are disabled and not here with us anymore. The people who aren’t here are not are all victims of self euthanasia/suicide.

That man, whose painting happens to be hanging in the NIH as some distinguished researcher,  manipulated the name of an illness that is a horrible illness to have to live with, this illness is torture!! He downplayed this illness by changing the name (which caused the patients harm and abuse by the name alone) and downplayed it more by changing the key hallmark symptom of the illness by downplaying it, to something that would not be considered something that disabled the patients.

Because of what was done, there is a whole community of patients, that we dont even know the numbers of, CDC’s numbers are wrong, who are disabled and homebound now for the last 20 years, and im one of them, because of the actions of that individual.

This illness is a life thief!!

I just want to point out why I said what I said about the 1994 Fukuda Definition for “CFS” being a negligent document.  Any saavy malpractice attorney, could prove that definition negligent with a Websters dictionary.

They would not even need any type of medical book, or a 140 on the Stanford Benet IQ test,  all they would need is a Webster’s dictionary.

This patient community is owed a serious apology, a serious apology!

There have been deaths because of GET or Graded Exercise.  Here is one of them:  http://en.wikipedia.org/wiki/Brynmor_John

Brynmor John.  He actually dropped as he was walking out of the doors of the gym at the House of Commons in England right after he did his GET session.

What makes it more negligent- is because he probably didn’t have a previous stress test to see if it was safe for him to do that GET because this illness is treated as a psych disease in England.  Because of “CFS” he probably didn’t even get a physical exam.   I know that because it happens over here to many patients.

I also know that because I was a cardiac rehab nurse in 2 different cardiac rehab centers. Patients didn’t exercise on any type of machines until they had a stress test to see if it was safe.

Brynmor John’s Case made the news because he was some type of politician over there.

Another example of  a patient who died because of no physical exam Casey Fero, 23 years old.
http://www.investinme.org/Article%20011-Casey%20Fero.htm

I know you have heard the name. His mother is an advocate.  If Casey got a proper physical exam, any doctor who listened to his heart, would’ve heard abnormal heart sounds. I know, I was a CCU nurse at NY Hospital/Cornell Medical Center (now New York Presbyterian Hospital, etc..)

I also know this, because of what the condition of what heart was in on that autopsy that was done,  that kid was having arrythmia’s for a long time and they never knew. I his heart condition was picked up like it should’ve been, he would’ve been a candidate for a heart transplant and still possibly be here.

***Casey died of myocarditis that is, his heart was infected with disease. There was inflammation, and the tissue was full of viral infection. Casey also had old fibrosis, indicating that the viral infection was not of a new onset.**”

When I heard about and read what the results of his autopsy was, I was outraged, I couldn’t believe it. I thought, how the heck could anyone miss that.  You know why it was missed, because when he said “CFS”, no one took him seriously, they either said to him “there is no such thing’ or “he was depressed.”

There have also been deaths because patients need IVIG. A patient named Irene Romano, wrote a blog called “Laughing from my Sick Bed”, died in January.  Irene said she had bronchitis, was on antibiotics and strict bedrest, she said she had 3 previous life threatening episodes of pneumonia.

She was only 61, 61 is still too young to die from that, if she was 80, I would agree with everyone, not 61. She should’ve been getting IVIG.

http://laughingfrommysickbed.blogspot.com/
http://www.kepnerfuneral.com/obituaries/Irene-Romano/

One more example, but this one is about disability, and
a very sad case. Jessica Taylor.  You may have heard her name.

Here is a video of her:

You never saw kids in the condition she was in unless they were going to die soon.

Jessica Taylor just stood up for the first time in 8 years.

She could not get out of her bed for 8 years!  That could be your daughter or my daughter.

She and many other children are the same condtion, because of this exercise issue!!!

This is beyond negligent!

There was a promise made, an even by me because im an RN and that was “Do No Harm.”  “Do No Harm” went out of the window 20-30 years ago in regards to the patients who were diagnosed with “CFS.”

Thankyou again Beth for reading my email. I do hope to be able to get to the next CFSAC or another related meeting, and say everything that I said to you in these emails.

Im actually available by phone, if for some reason, some of the people who are scheduled to speak, are unable to speak during the meeting.  If so, send me an email and I will send you my phone number.

Thankyou,
Anne LiConti

 

“The Other Side Of The Stretcher” (c) 2014

This blog is not for medical advice.
For medical advice, you must speak with your physician!

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About The Other Side Of The Stretcher

Nurse turned patient, but not by choice. I was became a Registered Nurse in 1985 when I was 21 years old. That career was cut short the end of 1994 when I was unable to work anymore because of the illness M.E. or Myalgic Encephalomyelitis. I have 3 adult children including twins, A daughter and 2 sons. View all posts by The Other Side Of The Stretcher

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