US Congress’s Long COVID Moonshot Legislative Proposal

In advance of tabling a legistative proposal to Congress, Sen. Bernie Sanders, Chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee has asked the Long COVID community (including Long COVID patients and their families, scientific researchers, and medical professionals) to submit their views on how proposals for research funding and infrastructure can be improved and strengthened to deal effectively with what Sen. Saunders descibes as a “public health emergency”.

What are the Proposals?

Read in light of the current debate in the UK over the terms of a Delivery Plan for ME/CFS and the identified weaknesses of the draft, the proposal is indeed a ‘moonshot legislative’ one and much can be learned. Not only does it mandate a ring-fenced, multi-year reseach funding requirement but also the creation of a coordinating entity and a direction to prioritise drug repurposing. In addition, there are tight timescales for grant assessments, mandatory feedback on applications, patient and patient organisation involvement, and educational requirements.

Sen. Sander’s factsheet to the Long COVID community narrates that 2 million adults in the United States have the illness, though this is likely an underestimate, and lays down a number of actions. The ‘ask’ of $1 billion in mandatory funding per year for 10 years is certainly bold.

However, ME/CFS is also relatively common, afflicting 1.3 percent of the American population and an estimated 67 million people globally, yet US federal funding levels to study this disease are also undefensibly low. The NIH, which currently has an annual budget of $48 billion, has only funded ME/CFS research to the level of between $5 to 17 million in each of the last ten years. Yet, even pre-COVID-19, ME/CFS’s economic cost in the USA was over $36 billion a year and this will undoubtedly be greater post-pandemic as the numbers diagnosed with ME/CFS rises.

The danger which has been identified is that if Sen. Sander’s proposal omits mention of ME/CFS research then the NIH may decide to meet its mandated research spend on Long COVID research to the exclusion the equally deserving, serious, and oft overlooked diseases – specifically ME/CFS.

Sen. Sanders has invited detailed proposals and comments to his committee before close of business on 23 April 2024 and it will be interesting to see if amendments are made to accommodate ME/CFS research.

Information :

The draft proposal would:

  • Provide $1 billion in mandatory funding per year for 10 years to the National Institutes of Health (NIH) to respond to the Long COVID crisis with the sense of urgency that it demands.
  • Create a centralized coordinating entity for the majority of Long COVID research activities at NIH, with a clear leadership structure that includes patients who have lived experience with Long COVID.
  • Require NIH to establish a new grant process for clinical trials related to Long COVID. These grants would be reviewed more quickly than traditional grants and prioritise funding for studies that test non-behavioral therapeutic and preventative interventions in patients with Long COVID, including but not limited to repurposing existing pharmaceutical interventions.
  • Establish an NIH research advisory board made up of scientists, health care providers, and patients who have lived experience with Long COVID and other COVID-induced chronic conditions. The goal of the research advisory board would be to provide advice on research funding.
  • Require NIH to establish a Long COVID database for the storage and dissemination of de-identified patient data to make Long COVID research more accessible.
  • Require federal entities to provide continued education and support to patients, providers, and the public about the ongoing risks of Long COVID, as well as how to identify and address it.

Even the addendum to the factsheet holds pointers to ensure the success of the proposal. These include action points to –

  • Require the NIH Director to establish a Long COVID Research Program to create a centralised, coordinating structure for the majority of Long COVID research and clinical activities at NIH.
    • The NIH Director to appoint a Director to oversee the Long COVID Research Program and establish a strategic research plan that would expand, intensify, expedite, and coordinate NIH’s Long COVID activities. This plan would be published within 6 months of the development of this research program and be updated annually.
    • The Director of the Long COVID Research Program to be someone who has experience directing a research program on Long COVID or other infection-associated chronic conditions. Preference must be given to individuals who have previously demonstrated commitment to Long COVID and other COVID-induced infection associated chronic conditions. As part of the hiring process, the NIH shall seek recommendations from Long COVID patient advocacy organisations.
  • The purpose of the program would be to:
    • Investigate the etiology, pathophysiology, risk factors, and pathology of Long COVID; explore best ways to prevent, detect, monitor, treat, and cure Long COVID and other COVID-induced conditions; and contribute knowledge to the understanding, prevention, mitigation, and treatment of Long COVID and other COVID-induced conditions;
    • Develop and facilitate both intramural and extramural programs on clinical and fundamental aspects of Long COVID and other COVID-induced conditions.
  • As part of the new Long COVID Research Program, the NIH to develop a new Scientific Research Group composed of individuals represented by leading Long COVID researchers and patient advocates for the purposes of evaluating Long COVID research grant applications.
  • The NIH Director to establish a fast track mechanism for seeking, evaluating through a peer-review process, and funding research grants relating to Long COVID. Grant requests will receive higher priority if they demonstrate the ability to begin interventions in a timely manner and if they have letters of support from patient organisations with a history of Long COVID advocacy.
  • Grant funding announcements must be made in a way that provides potential applicants at least four weeks to prepare and submit their application.
  • The NIH must ensure that authors receive a final decision on their grant applications within 120 days. For those proposals that are denied, the NIH must provide an explanation.
  • These grants shall prioritise funding for studies that test outcomes of pharmaceutical interventions in patients with Long COVID, with an emphasis on drugs and interventions that are currently being utilised by patients and providers off-label. These grants can also be used to aid in the development of new pharmaceutical interventions that have strong evidence to suggest effect in treating or curing Long COVID.
  • The NIH shall also provide guidance to recipients of these grants on how to contact patients for potential clinical trials.
  • The Long COVID Research Program will work with the CDC and Office of Long COVID Research and Practice to provide information and continuing education programs for health care providers and allied health professionals who will provide care for patients with Long COVID (primary care providers, specialists, community health centers, community health workers, Long COVID Clinics, etc).
  • NIH will also create professional education modules specifically for a community-based health workforce so that information about Long COVID is delivered in culturally and linguistically appropriate ways.
  • To support education of providers, the NIH will hold an annual conference of clinicians, researchers, patients, and government partners to share information on Long COVID. These conferences will include virtual options and plain language summaries that enable participation by those most
    affected by Long COVID.
  • The NIH will host a conference with Long COVID experts to build consensus on clinical terms, definitions, and clinical endpoints for Long COVID studies and to share the state of the science in this multidisciplinary field.
  • The Director of the Long COVID Research Program must provide an annual public report on expenditures in the previous year with respect to Long COVID. Must include for each program, project, or activity:
    • A specification of the amount obligated for each activity;
    • Summary description of each project, program, or activity; and
    • Summary of progress made by each program, project or activity with respect to increased knowledge of etiology, detection, treatment, and prevention of Long COVID.

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