Why The NIH Pathways To Prevention Systematic Review For M.E. and CFS Is Negligent!

Why The NIH Pathways To Prevention Systematic Review For M.E. and CFS Is Negligent!

An Explanation!

 

First I want to say, I became an Registered Nurse in 1985. So my point of view is not of a patient, it is as of an R.N.

When I decided to take a look at the Pathways to Prevention Systematic Review for M.E. I saw right away that it was clearly negligent and harmful to M.E. patients.

I then thought the medical people who have this illness need to start speaking up about the negligence we have witnessed the last 20+ years. What I wrote below is also part of the letters that I also have written Beth Collins Sharpe AHRQ, and Dr. Francis Collins.

The authors who were paid to write the NIH Pathways To Prevention (P2P) Systematic For M.E. 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.

Proof of Negligence, Bioethics Violations, and Harm associated with the NIH P2P Study For M.E. and CFS!

NIH P2P Systematic Review For M.E. 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 M.E. 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 M.E. 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 definitions for M.E. 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 definitions 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 M.E. 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 M.E. and CFS.

Allowing Oxford criteria or recommendations 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.

The NIH P2P Review for M.E. 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, New Research Finds:” 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
“A FOREIGN & ILLOGICAL RESULT” DR. B KELLER ON EXERCISE TESTING IN ME CFS”
http://www.prohealth.com/library/showarticle.cfm?libid=18349
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

-M.E. and CFS participants were unable to reproduce most physiological measures at both maximal and ventilatory 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 CHRONIC FATIGUE SYNDROME 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.

No where on the NIH Pathways To Prevention Systematic Review
For ME and CFS does it make any reference in regards to “Informed Consent.” The goal of Informed Consent is for the patient to be an informed participant in their health care decisions including information of all of the available treatments including the benefits and the risks, so the patient can make an informed judgement or decision in regards to the treatment including whether or not to participate.

Further Info regarding Informed Consent:

https://research.uncc.edu/departments/office-research-compliance-orc/human-subjects/informed-consent

https://depts.washington.edu/bioethx/topics/consent.html

I searched even further to see what the requirements are for authors writing a systematic review in regards to informed consent.

The Journal Of Physical Therapy which endorces the ICMJE guidelines has a page about “Information for Authors: Requirements for Systematic Reviews” which gives very easy to understand instructions in how to format a systematic review.  Proof that the principles outlined in the Declaration of Helsinki were followed are to be included in the “Methods” section of the systematic review.

If we take a look at the actual systematic review, which is the research protocol, no where in the ‘Methods Section” do I even see a mention of informed consent or the Declaration of Helsinki which is the “Ethical Principles for Medical Research Involving Human Subjects.”

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 which would be a violation of the Declaration of Helsinki

“GET” has also been known to be lethal as well. Brynmor John died immediately following Graded Exercise Therapy or GET as he was walking out of the doors of the gym at the House of Commons in England. http://en.wikipedia.org/wiki/Brynmor_John

This review was not checked and proof read properly before it was published online. If so, the authors would’ve noted those 3 studies, included the issue of informed consent, disclosure to the Non Medical lay people, as well as GET or Graded Exercise Therapy being potentially lethal to ME patients. That document is clearly negligent.

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.

Additional evidence has been recently written by an M.D. named Dr. Larry Baldwin, who is a Vascular Surgeon and disabled by M.E. for 20 years. Dr. Baldwin just wrote a guest post called: “Post Exertional Debility” which was surprisingly posted on the Solve CFS Initiative website (formerly known as the CAA). Dr Larry Baldwin explains post exertional debilitation in regards to this illness which happens to be the hallmark symptom of M.E.

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

Furthermore, if I as an R.N. was employed by a center where GET or Graded Exercise Therapy was actually done, and didn’t double check this, questions this, and refuse to allow the patient to go forth with this, I could be sued as well as the doctor, my nursing license would be revolked if the patient became permanently disabled and unable to work. This would happen because of all of the documentation and proof that GET or Graded Exercise Therapy is indeed harmful to M.E. patients. This is the reason patients are unseen, because they are homebound because of this.

Lets look at the common sense factor here.  The authors used 6 different “CFS” defintions as part of their guide to write the NIH P2P Review for ME and CFS.  Out of the 6 of the defintions, 5 of the definitions point out post activity, post cognitive, post exertional, and post exercise debilitation.

So if 5 out of the 6 defintions say that patients experience debilitation after anything that has to do with any type of activity, then why is GET or Graded Exercise Therapy being used as a non-medical therapy in the NIH P2P Study for ME when its quite clear that Graded Exercise Therapy will harm the patients?  Quite frankly, this is no different than the Tuskeegee Syphillis Experiment!

Reknown ME and CFS researcher and clinician Dr. Paul Cheney was quoted as saying at an Invest in ME conference in May of 2010: “The whole idea that you can take a disease like this and exercise your way to health is foolishness… It is insane.”

I agree with Dr. Cheney, because I know, I am a patient with this illness and I like many of the rest of us patients with this illness have tried exercising our way back to health. If we were all able to exercise our way back to health, we wouldn’t be disabled and homebound, we would’ve returned back to work years ago!

No one in their right mind would want to be in the condition that these patients are in, I can assure you. Just like Dr. Cheney said, trying to “exercise your way back to health is not only foolish, but it is insane! Thus, there you have my opinion regarding the NIH P2P Study for M.E. and CFS, its nothing less than insane!

I myself, see this not just as a patient, I see this through R.N eyes, and this is unacceptable, and there is no excuse for this. M.E. patients have suffered terribly and unnecessarily for 20-30 years and unfortunately at the hands of incompetent and non-compassionate medical professionals.

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

All health care practitioners, including myself because I made the promise of “Do No Harm.”

“Do No Harm” means we are supposed to help patients, not harm the patients.

Unfortunately, “Do No Harm” became virtually non-existent when it was thrown out of the window 20-30 years ago for patients diagnosed with M.E. or CFS.

M.E. patients will continue to suffer harm if the NIH Pathways To Prevention Systematic Review for M.E. and CFS is not retracted and the December workshop is canceled. The reason M.E. patients will continue to suffer harm is because of the lack of information regarding GET or Graded Exercise Therapy and because of the non M.E. expertise people who will be participating in the study.

 

“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

8 responses to “Why The NIH Pathways To Prevention Systematic Review For M.E. and CFS Is Negligent!

  • Anushka

    Hi Anne,
    I am very impressed!

    To us patients it is clear that what has been done to us for 20+ is a crime – we live with the results every day! But your insight presented here as a nurse, and therefore medical professional yourself, is invaluable information for us and other medical practitioners. INFORMED CONSENT! It is not only the patients who should be informed about their rights, but MD’s and nurses should be clearly informed about the harm they can do to patients diagnosed with ME or CFS following the misleading and negligent recommendations by health institutions such as the CDC webpage. Health institutions around the world have clearly harmed a whole patient community by recommending harmful non-medical treatment known to exaggerate patients condition. It is more than negligent, it is malpractice of epic proportions.

    You said it well:

    “I myself, see this not just as a patient, I see this through R.N eyes, and this is unacceptable, and there is no excuse for this. M.E. patients have suffered terribly and unnecessarily for 20-30 years and unfortunately at the hands of incompetent and non-compassionate medical professionals.

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

    All health care practitioners, including myself because I made the promise of “Do No Harm.”

    “Do No Harm” means we are supposed to help patients, not harm the patients.

    Unfortunately, “Do No Harm” became virtually non-existent when it was thrown out of the window 20-30 years ago for patients diagnosed with M.E. or CFS.”

  • TheOtherSideOfTheStretcher

    Hi Anushka and thankyou so much, I feel so humbled by your post 🙂

    I was thinking and thinking about this and I do not remember , especially in the studies with the UK people, when they have taken “Informed Consent” seriously.
    The PACE study is a good example.

    Its unfortunate that we, the patients have to keep on top of this. After all of these years, we really don’t have a choice because they are trying to slip these things in and aren’t paying attention or think the patients aren’t paying attention…..

    Now, with this case definition fight, we don’t have a choice. The good thing is, all of us are doing something, every little thing counts and adds up!

    I hoped didn’t forget anything and included everything.
    If you didn’t see on the forum yet, I did find more evidence and that will be Part 2 of this saga I guess or part of the next post! 🙂

    Thankyou so much again for stopping by and posting a comment! 🙂

  • SCIENCE ME

    Hi Anne,

    I have never thought about the issue of informed consent before and now that you raised the issue all sorts of questions pop up.

    Let’s take the cases of children or young adults being taken away and forced to undergo harmful non medical treatment such as GET. Does a “guardian” who has been appointed by the state not give an informed consent to the “treatment” the child will undergo ? Does this guardian, in such cases the state, not bear full responsibility for the treatment given under it’s supervision ? Or what about the hospital staff, such as nurses, who are supposed to administer such “treatments” or medical abuse ; aren’t they also concerned about being held responsible if the “treatment” clearly is questionable and harms this child or young adult? If a nurse is being aware of such harm being done to a patient where can she/he turn to to make a complain?

    A lot of questions to answer……you raised an important issue!

    “The good thing is, all of us are doing something, every little thing counts and adds up!”

    TRUE .

    Anushka

  • TheOtherSideOfTheStretcher

    Anushka,
    There are many journal articles about “informed Consent”, this country and International.
    We could probably have some good discussion about this on the forum, regarding national, international, the Declaration of Helsinki, etc…

    I pulled up this abstract quick (I put part of it here, the rest is on that link with the rest of the full article):
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1280103/

    THE PARAMETERS OF INFORMED CONSENT
    Edward L Raab, MD JD*§

    From the Department of Ophthalmology, Mount Sinai School of Medicine of New York University, New York.
    *Presenter
    §AOS member.
    Author information ▼ Copyright and License information ▼
    Copyright ©American Ophthalmological Society 2004
    ABSTRACT.

    “Purpose

    To describe the components of a proper informed consent; which risks must be disclosed and which need not; additional safeguards for incapacitated persons, minors, and research subjects; and where the law will imply consent that is not otherwise obtained.”

    “Results

    Lack of informed consent can reinforce a claim of medical malpractice or serve as an alternative point of attack when the case is otherwise weak. Special requirements must be met when patients are the subjects of clinical research.”

    Justina Pelletier for instance- this may be part of the malpractice case- we probably will not see it because she is under age unless the family posts the information somewhere.
    Other cases like hers where the people were over 18- its says in the full article, even if the Malpractice case is weak, the lack of informed consent is a claim that can win for the plaintiff.

  • SCIENCE ME

    …..additional safeguards for incapacitated persons, minors, and research subjects; and where the law will imply consent that is not otherwise obtained.” “Lack of informed consent can reinforce a claim of medical malpractice or serve as an alternative point of attack when the case is otherwise weak. Special requirements must be met when patients are the subjects of clinical research.”

    Well that is clear enough, is it.
    I think this is really a topic worth raising in research in general.

    In the case of Karina I am certain beyond a shadow of a doubt that they have a case against the appointed state guardian and doctors involved. The same is the case in the young girl from germany.

    Even if such cases are not won immediately and the damage done can never be undone, it will make those who initiate such terrible actions as to remove sick children forcefully from their home, incarcerate them against their and their families will and subject to torturous like “treatments”, think twice before they do such a thing again.

    Accountability !

    It does not matter what the child or young adult is suffering from , such horrible abuse of state power and mistreatment by medical practitioners is plain and simple criminal.

  • The Pathway to Prevention (P2P) for ME/CFS: A Dangerous Process

    […] Why the NIH P2P systematic review is negligent – click HERE […]

  • Debra nice

    I love All your hard truth work for ME Anne.. Thank you so much from ME. Bless you & TLC to you. 🙂 X sick of the abuse ME GET!!… 😦

  • The Other Side Of The Stretcher

    Awwww, thankyou so much Debra 🙂 God bless you xoxoxxo

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