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#MEAction met with NIH Director – here’s what happened

woman at protest holds sign that reads, "Dear NIH we may be missing but we do exist!!!"

#MEAction activists for myalgic encephalomyelitis (ME) met with the director of the National Institutes of Health (NIH), Dr. Francis Collins, on December 7 to discuss accelerating research in order to more rapidly provide diagnostics and treatments to people with ME.

In addition to NIH director, Francis Collins, M.D., Ph.D., other attendees from NIH included the Director of the National Institute of Neurological Disorders and Stroke (NINDS), Walter Koroshetz, M.D., NINDS Clinical Director, Avindra Nath, M.D., NINDS Program Director and Chair of the Trans-NIH ME/CFS Working Group,Vicky Whittemore, Ph.D., NINDS Health Program Specialist, Andrew Breeden, Ph.D., and Immunoregulation Section Chief at the National Institute of Allergy and Infectious Diseases (NIAID), Joseph Breen, Ph.D., also a member of the Trans-NIH ME/CFS Working Group.

#MEAction representatives included #MEAction Campaigns Director and person with ME, Ben HsuBorger, activist and person with ME, Terri L. Wilder, MSW, advocate and carer, who is retired from a career in pharma, Mary Dimmock, biochemist and person with ME, Becky Taurog, PhD, and immunologist and person with ME, Rochelle Joslyn, PhD. (#MEAction Executive Director, Jennifer Brea, was unable to attend the meeting due to her recent surgery.)

#MEAction made three key requests for the NIH to immediately undertake:

  • Bold leadership for ME
  • Disease-specific, multi-year Request for Application (RFAs) and investigator-initiated funding opportunities
  • A strategic plan: comprehensive, fully-funded, cross-Institute and outcome-driven

The #MEAction representatives discussed how progress for ME is being throttled by low levels of funding, few researchers, and the NIH’s step-by-step approach focused heavily on basic research and waiting for the underfunded Collaborative Research Centers (CRCs) to deliver their findings in five years. This approach will take many years to deliver relief to people with ME.

“This wait-and-see approach of taking one step and then waiting to take the next step lacks a focus on delivering patient-centered outcomes as quickly as possible,” explained Becky Taurog, PhD, a former biochemistry professor who has ME. “It also fails to leverage opportunities to accelerate progress by pursuing parallel streams of research.”

Issue Funding Opportunities

To more rapidly overcome researcher disinterest and discouragement, grow the field, and deliver urgently needed biomarkers and treatments, #MEAction called on the NIH to issue a portfolio of ME-specific, multi-year funding opportunities, including investigator-initiated opportunities and RFAs. This is needed to capitalize on what is already known about biomarkers, disease pathophysiology, treatments and instrumentation and methods. (See the powerpoint presentation for the range of research opportunities the MEAction representatives outlined.)

“NIH does not have a single funding opportunity specific to ME. This lack of explicit NIH commitment to further invest in ME disincentivizes researchers who might be interested in entering the field,” explained ME advocate and caregiver, Mary Dimmock.“ We need a concrete plan to rapidly and steadily increase the number of researchers, the range of research and the amount of funding in the field.”

Of course, ramping up research in this way will require a much greater, cross-NIH financial commitment to ME than seen in the Collaborative Research Centers. NIH funding for ME in 2018 was approximately $11.6 million, dramatically less than that of diseases with comparable disease burden. Based on the disease burden, funding should be at approximately $190 to $250 million, according to this study.

Walter Koroshetz, M.D, director of NINDS, has previously acknowledged underfunding in this field, stating, “The budget [for ME] is going to have to be 10 to 20 times what it is now.”

“It is the NIH’s responsibility to generate research interest in this domain” said immunologist Rochelle Joslyn, PhD, who has ME. “Researchers in diverse fields with fresh insights will show up to this problem when you incentivize them, not when our community emails them.”

Provide Bold Leadership for ME

#MEAction representatives called on Dr. Collins to provide bold, proactive leadership in the field, and to address the misperceptions and numerous barriers that have stymied progress.

“Your leadership got the intramural study and the Collaborative Research Centers going,” Joslyn said. “Your leadership is still necessary to substantially ramp up the funding commitments for ME from across NIH and boost growth in the field.”

#MEAction outlined key barriers that have undermined progress in the field that need to be resolved. Examples include the need to build consensus on the case definition and methods for patient selection in research, the challenges that researchers continue to express with the grant submission and review process, and the crisis resulting from the lack of clinicians.

As Dimmock pointed out, the crisis with the lack of expert clinicians, many of whom are nearing retirement, is not only impeding quality clinical care but also choking the ability to ramp up research. NIH, more than any other organization, could significantly alleviate this crisis by using its position to proactively engage the leadership of key medical associations.

#MEAction also called on the director to use his megaphone to generate interest amongst researchers for ME, and to educate the medical community about the disease’s biomedical realities.

“You are in a position to do more to evangelize ME to both researchers and clinicians to establish its legitimacy, stimulate scientific and clinical interest, and debunk the psychosomatic narrative that still holds us back and causes harm,” Joslyn said. “We need not just young investigators but also established researchers and clinicians to rapidly make progress. These people listen to you.”

Implement a Strategic Plan

Finally, #MEAction called on Dr. Collins to develop and implement a comprehensive, strategic plan that begins with the goal of delivering the first biomarkers and FDA-approved treatments within five years, and then identifies the streams of work and resources needed to achieve those outcomes.

The current focus on building foundational knowledge is important, but without clearly defined patient-centered goals, milestones of delivery, and a strategic funding commitment (including from the Director’s Discretionary Fund), it lacks a sharp focus on rapidly delivering what matters most to patients.

“It is past time for a moonshot approach to ME, with the full weight of the director’s office to make this happen urgently. We have the skills, motivation, intellect, and basic knowledge of this disease to implement a concrete strategic research plan with resources to end the ME epidemic, said Terri L. Wilder, MSW, who has ME.

Take-away:

#MEAction appreciates that Dr. Collins, Dr. Koroshetz, Dr. Nath, and NIH program staff took the time to meet with us. We felt that there were some good discussions on opportunities to incrementally advance the field that will be important to pursue. However, it was evident that NIH leadership is not yet ready to significantly accelerate NIH’s approach and commitment to ME because they feel the science is not ready, and that the field lacks the needed researchers and high-quality grant applications. NIH reaffirmed its approach of focusing on foundational research and using the Collaborative Research Centers to create what Dr. Koroshetz has previously referred to as “a seed” to grow the field over time.

We strongly disagree with this approach. We see significant opportunities in both basic research and treatment trials to rapidly transform ME research, drug development, and clinical care. Achieving this requires a much stronger and more strategic commitment from NIH, one that is focused on delivering outcomes for patients as quickly as possible.

We are immensely proud of our community for rallying on the streets last May, and for the 580-page letter our community sent to Collins that culminated in this meeting with the NIH leadership.

We will continue to fight on all fronts for the NIH to deliver outcomes to people with ME as quickly as possible, including through our Congressional work. As a community, we will hold the NIH accountable and demand that meaningful outcomes are delivered for people with ME within the next 5 years.

Take Action

Right now we need Dr. Collins to hear from you, the community, on how necessary it is for the NIH to take bold steps to urgently produce outcomes for people with ME. Dr. Collins needs to hear from every single person whose life has been affected by ME that we demand full throttle action now.

 

Tweet to Francis Collins

 

Additional Reference

  • Tweet-to-Dr. Francis Collins campaign page
  • December 7, 2018  presentation to Dr. Francis Collins
  • May 24, 2018 letter to Dr. Francis Collins (580 pages, includes #MillionsMissing photos and all 7,253 signatures)
  • May 24, 2018 letter to Dr. Francis Collins (3 page version, just letter)
Categories: All News, Featured news, NIH, United States

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2 comments on “#MEAction met with NIH Director – here’s what happened
  1. Jennifer Mars says:

    Heartfelt thanks for all the incredible work you do!

  2. Kay P. says:

    What a tremendous disappointment.
    But, unfortunately not a surprise.
    Thank you for being our voice and keeping the hope alive.

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