NIH patient participation and communication: what do you want to see?

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How should patients be integrated into the NIH process?

The US National Institutes of Health has made several promising, public steps forward in recent months, announcing a new commitment to research ME/CFS, hinting at possible new drug trials, and promising to use strict criteria including the Canadian Consensus Criteria to select patients for their intramural studies.
Yet the premature publication of the study protocol and the involvement of Dr. Brian Walitt and others who have previously taken a somatoform or psychosomatic view of the disease have raised serious concerns among many patients about the NIH’s capacity to understand the patient community and execute on the findings of the IOM report and the P2P process.
In recent weeks, both Dr. Avindra Nath and Dr. Francis Collins have publicly stated that patient involvement is coming. At the CDC grand rounds last week, Nath citing the legacy of ACT UP affirmed that, “input from the patients is absolutely critical for any disease that you want to study. They’re the ones who really experience the symptoms and live it.”
Yesterday, Vicky Whittemore laid out in a conversation with Carol Head of Solve ME/CFS a few possibilities for patient involvement:

1. Include an open period during each Trans-NIH Working Group meeting in which patients can ask questions and offer their feedback;

2. Include advocates on the smaller working groups created in conjunction with the study; and

3. Hold regular teleconferences throughout the study so that community members can receive updates on progress from the investigators themselves. The first conference call is expected to be announced this week.

While they are formulating their plans, we want to know what you think about what the model for patient involvement should look like. What kind of relationship with the NIH would you like to see? What would signal to you that they are serious about working differently than the US federal government ever has with this disease?
Please leave your comments below. 

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12 thoughts on “NIH patient participation and communication: what do you want to see?”

  1. We have to see all the problems from a million miles away. We already do, but somehow we are never ahead of the curve.
    The study is too small. We would have probably asked for 100 ME/CFS patients alone.
    The cohorts are a mess and not representative of the tangle of symptoms we experience which are often much like MS, Parkinson’s, Lupus, AIDS, etc.
    We need people without bias. Psychiatrists and psychologists should not be involved just as they most likely would not be involved with MS, Parkinson’s, Lupus, AIDS studies.
    Reeves was a political move and we would have never involved it in a study. It isn’t even necessary to study the disease.
    Although we don’t design research studies for a living, how is it that I know we could have done WAY better than this?
    OPEN DATA!

  2. Also, we are pretty good at putting out the fires and often with one voice between research orgs and advocacy orgs, but can’t there be just as fast a unified message ahead of the curve?
    Key orgs need to work together and stay in touch and someone has to represent that voice and stay at the table full time. That takes someone of good health and possibly a team of healthy allies dedicated to this task. It doesn’t take a full time team tasked with this, just one that is always able to be at the table.
    What is proposed above is a good patient feedback proposal but it has to lay groundwork and not just put out the never ending fires.

  3. The NIH can show their committment to the mecfs community by the following:
    1. Assign a liasion to answer questions and provide updates to groups and individuass.
    2. Remove all researchers from the study who do not hold the belief that mecfs is anything but a physical disease.
    3. Explain why they are using lymes and nd? as controls, and the outcome expectation from this choice.
    4.Include the mecfs community in the the final design of the study.
    5. They can show committment to the mecfs community by using the current and accepted term of ME/CFS or the WHO’s recent label of Post-Viral Fatigue. By creating yet another term, it leaves the appearance they believe themselves superior to other research programs.
    It is time the NIH begins to work for us and not against us.
    Thank you,
    Heidi Maahs

  4. We should be involved in funding decisions. Severe patients desperately need help. Top scientists are ready and eager to help us but aren’t being funded. This needs to be a priority; it can’t wait. We need a triage type system so that the sickest patients get help first. I’m bedridden and have been sick for 33 years. I haven’t been well enough to participate in the type of study the NIH is now planning for most of those years. Severe patients need help NOW. We need representation, funding, research, appropriate medical care and treatments!

    1. Very good point. Several other researchers are conducting studies on severely affected PWCs. The NIH needs to mandate that funded studies include a minimum percentage of severe patients.

  5. I AM GOING TO HAVE TO TAKE A BACK SIT ON THIS .
    JUST NOT UP TO THESE TYPES OF CHALLENGES THESE DAYS .
    I THINK GOOD COMMUNICATION WITH THE CURRENT DIFFERENT SUPPORT GROUP ORGANIZATIONS WOULD BE A GOOD START .
    QUESTIONARS COULD BE POSTED WITH THE PATIENT’S INPUT SHARED .
    I WOULD NEED A MULTIPLE CHOICE .
    I TRY TO FOLLOW A VARIETY OF SOURCES OF INFO SO THAT I GET A “BALANCED ” PERSPECTIVE .
    BUT MY DAYS OF BEING A GOOD SCIENTIFIC RESEARCH READER ARE OVER .
    AT 63 , BY BRAIN NO LONGER FUNCTIONS THAT WAY.
    BRAIN DEAD ,
    PAT

  6. 1. The CDC and NIH must stop forcing ME patients and the rest of the ME/CFS community in a position of having to *react* to their significant errors (for example, Reeves criteria; Brian Walitt, MD; Fred Gill, MD; Charles Lapp MD’s medically incorrect and dangerous presentation in the February 2016 Grand Rounds). These recent errors were entirely avoidable had these agencies engaged with patients and the ME/CFS community in advance. These are but a few recent examples that illustrate the continuing lack of respect afforded to our community. Full stop.
    These agencies must work to earn our trust. We’ve read and heard their words but their actions do not match!
    2. To begin a productive dialog, let’s also ask CDC and NIH to provide us with a list of realistic opportunities for input and partnership. From there we could add, subtract and edit that list.
    3. If and When the ME/CFS community raises strong objections and/or strong concerns, We expect NIH to acknowledge our objections and concerns and not gloss over them or pretend they did not read or hear them. For example, has Dr. Francis Collins acknowledged the letter and petition (with 725 signatures, no less) delivered to him on February 15, 2016? When objections were raised to NIH about Brian Walitt, M.D.’s participation, Vicky Whitmore wrote, “…We have utmost confidence in the team…”. Well, that’s very nice that NIH has the utmost confidence in the team but her response does not even acknowledge the ME/CFS community’s concerns about Dr. Walitt. (http://meaction.net/2016/02/23/nihs-initial-response-to-article-and-comments-on-walitt/)
    4. Why is NIH not funding Dr. Ron Davis’s work????????????!

  7. I am a survivor of the 1985 Lake Tahoe Mystery Illness and prototype for Holmes et al CFS.
    Approved for ampligen.
    And was in the 1999 NIH “Original CFS cohort follow-up study” conducted by Dr Peterson for the NIH.
    So… they know what “CFS” really is.
    The question is, why do they feel the need to ignore the data they have, select a new patient group, and start the game all over again?

  8. i like carol head’s ideas. i think it’s a good start.
    patients need real power in this process however; susan g komen provides opportunities for advocates to shape the development of future clinical trials. you can read more about their role here: http://ww5.komen.org/uploadedFiles/Content/ResearchGrants/GrantPrograms/AIS%20Advocate%20Involvement%20Guidelines.pdf.
    the lack of patient input for the research done about them mirrors the lack of input we have about our medical care in general: none. we can’t be trusted, we’re exaggerating our symptoms, they’re our body’s way of expressing our strong emotions.
    agreed with others that anything so much as ressembling a nod to the psychosomatic model is out. enough of the disrespect, let’s have some serious research.

  9. This is a bit rough, but here are my initial thoughts:
    Patient involvement with NIH
    1. Have patients on all committees.
    a) TheTrans-NIH Working Group and any smaller committees developed
    b) The national clinic trial and any smaller committees developed
    c) The SEP ME/CFS funding panel
    d) Whatever body decides on RFAs
    e) CDC
    f) Are there any other bodies we should be on?
    2. Have an online mechanism where patients apply for these positions, there is an online vote by patients as to who gets each spot. The positions should have terms – perhaps 2-3 years. And when 2 or more patients are on a committee, the terms should end in different years.
    3. The patient population should have input in all work. Each body should post its minutes in a timely fashion. Patients can then submit their opinions online ahead of time. All meetings should be webinars with the investigator and decision makers present so patients can participate. These should happen at key decision times and on a regular basis – say a minimum of every 3 months. There should also be an open period during each meeting where patients can ask questions and offer their feedback realtime to build on discussions as they happen.
    4. I think patients should have some type of approval/veto power. I’m not sure how this would be achieved. Some sort of referendum process?.
    Do patients register to vote on referendums? What type of assurance is there that only ME and CFS patients register.
    Do we have a group of 3-9 representatives who have veto power that we vote for? We’re then looking for a lot of patients well enough to participate in these committees and the veto committee – are there enough able and willing people?
    Do the patients on each committee in #1 that we’ve voted in have veto power over their committee – or a transparent mechanism and resolution process if they feel there is an issue? For eg there should be no investigators on the trial that believe that ME and CFS are psychological problems.

  10. Hello,
    I would like to see:
    1) answers from NIH B Wallit and why he was appointed
    2) answers that reflect why all the housebound/bedbound/severe ME cohort was not included in the study after publicaly stating the devistation of the disease
    3) why there are only 40 people being studied in a patient population of over 1,000,000 americans. An explanation
    4) input from Top ME/CFS Clinicians having them consult with the committee and tell the patient community about it. For example webinars.
    5) Q and As by all top ME/CFS experts to the NIH group that is abled to be viewed online by patient community
    6) Q and As submitted by the patient community answered via webinars and chosen by groups such as MEAction as a facilitator of the questions.
    7) Why when Francis Collins said that we are very disabled and this illness affects a lot of people have they not released funding to OMF and or set a larger budget for the illness?
    8) Should an exterior consulting company be used to facilitate our stance on the neglect of the disease?
    I think their are a lot of questions that need to be answered by the NIH First and foremost with Francis Collins being interviewed again, with Dr Nath, and wallit present. For the Patient community.
    Then we facilitate how patients are involved overall in the working group.
    Thanks,
    Justin

  11. The emotional abuse needs to stop. When I get spinal meningitis now, I don’t go to the hospital anymore. I’ve had to call an ambulance twice; I got the same lady. The 1st time she told my husband my seizures were fake, the 2nd time, I was having a hard time breathing, I finally called for help, she made..MADE me walk to the gurney? Told me there was no such thing as chronic meningitis! She said she’d been an EMT for 19yrs. That scares me. Especially for people that doesn’t have a support system. I was only 23yrs old, my body just stopped one day. I’m now 41, I’m a wife, a mother of 3 and getting ready to be a grandma for the first time.
    30% if patients with Myalgia Encephalomyelitis, Chronic Fatigue Syndrome, THIRTY PERCENT, commit suicide. That’s from the physical pain alone. What are we supposed to do when we’re kicked out of hospitals for something we have no clue what to do, you’re told to always ask for help, not only do you not get help..you’re made to feel like you’re an idiot, there’s nothing wrong with you, you want drugs (didn’t realize your body chemistry is allergic to about 1/2 everything, but don’t find out for a decade). Better communication and rights with doctors. Just because they have a degree, doesn’t mean they should have the right if I live or die! Or my other sick family members (some here, some passed).
    You should never have to feel scared to go to a Dr. I’m not on any medications. The people I’ve met, just these past few months. I want them to be ok, to feel comfortable getting help. There may not be a cure yet, but ME doesn’t have to be made to make you feel bad on the inside. I woke up one day. My whole body kept shutting down. It’s not our fault. We shouldn’t have to feel like we did something wrong, trying so hard just live.

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