Restless Legs Syndrome Foundation Blog

Dear Honorable Chairs and Ranking Members:

On behalf of the 63 member organizations of the National Heart, Lung, and Blood Institute (NHLBI) Constituency Group, we support your efforts to finalize a Fiscal Year (FY) 2023 omnibus funding bill and include a robust investment in the National Institutes of Health, including at least $3.946 billion for the NHLBI. A timely FY 2023 appropriation is vital to allow the NHLBI to continue addressing COVID-19 while maintaining progress on mission critical research addressing cardiovascular, respiratory, blood, and sleep related research priorities.

As you know, delays in regular annual appropriations funding make it challenging to launch major initiatives and pursue critical scientific opportunities to prevent and develop new treatments for heart, lung, blood, and sleep diseases and conditions. This tends to impede our rapidly evolving understanding of cardiovascular disease, including heart failure and congenital heart disease, novel therapies under development for lung diseases such as chronic obstructive pulmonary disease (COPD), asthma, and improved treatment of blood disorders such as sickle cell disease and hemophilia.

The best approach to sustaining incremental progress in research and discoveries is effective planning made possible by recurring, timely, and continuous appropriations. This certainty is critical to scientific advancement. Without regular annual appropriations funding, vital basic, clinical, and translational research opportunities to address critical needs related to the long-term impact of COVID-19 across heart, lung, blood, and sleep, including protection of our most vulnerable populations, are compromised, delayed, or potentially curtailed.

Without sustained annual appropriations, NHLBI will not be able to maintain the momentum associated with its spotlight on the disparate effect that COVID-19 and post-acute COVID-19 has had on vulnerable communities, to continue with research efforts aimed at identifying the causes of and contributors to health disparities, and develop more effective approaches to effectively address, reduce, and ultimately eliminate them. The pandemic also has underscored the need for significant investments in understanding, diagnosing, and treating lung disease as well as preserving lung health.

Given that cardiovascular disease is the leading cause of pregnancy-related deaths, NHLBI has also taken a lead role in working with others at NIH to support research to reduce the nation’s alarming rates of maternal mortality and morbidity, especially among women of color. Without sustained and timely annual funding, NHLBI’s programs focused on improving women’s health throughout the lifespan, including initiatives concentrated on maternal health disparities, will not keep pace with this epidemic.

New sleep research that focuses on risk prevention strategies associated with sleep loss such as hypertension, diabetes, cardiovascular disease, and obesity is needed, especially in populations with relevant health disparities. The alarming growth of these comorbid factors since the onset of COVID-19 impact health related quality of life leading to further impacts on mental health, specifically depression, and suicidal ideation.

An FY 2023 appropriation of $3.946 billion for the NHLBI would allow the Institute to enhance current programs and pursue promising basic, translational, clinical, and prevention research to better diagnose, treat, and prevent these diseases.

Please contact Valerie Adelson with the American Thoracic Society at vadelson@thoracic.org or John Laughner with the American Heart Association at John.Laughner@heart.org if you have questions or need additional information. Thank you for your consideration.

Sincerely,

Valerie Adelson
Co-chair
NHLBI Constituency Group

John Laughner
Co-chair
NHLBI Constituency Group

The 2022 CDC Opioid Prescribing Guidelines released on November 3, 2022, replace earlier guidelines that had led to confusion, misinterpretation, and faulty application by medical providers. Like the 2016 guidelines, the new guidelines focus on acute, subacute, and chronic pain.

Unfortunately, the new Guidelines fail to recognize that restless legs syndrome (RLS), a serious disease affecting millions of Americans, can only be relieved by daily small doses of opioids in many cases. This omission is surprising in light of the fact that the guidelines call out three medical conditions (sickle cell disease, cancer, or end-of-life care) that may require sustained doses of opioids. RLS, like these three conditions, should have an exemption from this Guideline.

RLS Foundation Board Member and Chair-Elect, Dr. Shalini Paruthi says, “RLS symptoms can occur anywhere along the spectrum from an urge to move the limbs to a painful sensation. RLS can be a chronic disorder for many people. Furthermore, patients with RLS face significant impacts on physical health, mental health, access to care and barriers to treatment. These health disparities disproportionately affect individuals with refractory RLS who require daily medical treatment. The RLS ODYSSEY II study found a four-fold risk for depression and suicidal ideation in patients with RLS, signifying the heavy burden of disease in this population.”

We are disappointed to learn that RLS was not included in the exemption of medical conditions, given the scientific validation of population prevalenceⁱ, strong genetic basisⁱⁱ and impacts on health-related quality of lifeⁱⁱⁱ.

RLS Foundation Scientific and Medical Advisory Board Chair, Dr. Christopher J. Earley says, “These guidelines have the potential to affect the 1 in 33 Americans with severe RLS who require daily medical treatment. Patients with moderate to severe RLS live every day with awareness of the burden of this disease; forever conscious of the limitations and barriers to appropriate and effective treatment.” Many RLS patients have experienced the negative consequences of the prior CDC Opioid Prescribing Guidelines as they find physicians and pharmacists unwilling to prescribe or supply the only medications that bring them relief. Without explicit mention of RLS in the new guidelines, they fear that federal and state agencies will use the revised guidelines to continue to deny them treatment.

The new guidelines are an improvement from those they replace, recognizing that no “one-size fits all approach” is appropriate and that provider clinical judgment is fundamental to making decisions on the use of opioids to manage pain.

The RLS Foundation and its Science and Medical Advisory Board will sharpen and clarify the recommendations to minimize their impact on long-term prescriptions of opioids to treat refractory RLS. In the interim, we urge members to report any problems they face in maintaining a relationship with their healthcare provider and/or obtaining prescription access to opioid therapy to manage refractory RLS. We ask that you provide your contact information and permission to use your experience to explain to policymakers the barriers facing the RLS community.

The RLS Foundation thanks the nearly 500 individuals that responded to the call to action during the public comment period on the proposed draft of the 2022 CDC Opioid Prescribing Guidelines. We are disappointed by the CDC’s lack of an exemption for RLS and plan to accelerate our advocacy efforts on Capitol Hill to ensure patients with refractory RLS have appropriate treatment access to opioid therapy. The RLS Foundation will continue to provide updates on our outreach activities and opportunities for you to voice your concerns with public officials in Washington, DC and at the CDC.

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