March 5, 2018

Giving You A Voice in Washington

By Kris Schanilec

On February 22 and 23, members of the RLS Foundation staff and leadership team traveled to Washington, DC, to advocate on behalf of the RLS community.

The delegation met with staff at the National Institutes of Health (NIH), US Food and Drug Administration (FDA), and Congress. Their goals were two-fold: to educate policy makers about RLS and the need to ensure that RLS patients continue to have access to opioid therapies; and to promote funding for RLS research that will advance better treatments and a cure.

"We are focused on making our collective voice heard in Washington to help ensure continued access to opioids as a treatment for individuals with severe cases of RLS," Executive Director Karla Dzienkowski, RN, BSN, said. "We hope to enhance and expand our advocacy efforts so that no one in our community is denied access to this critical treatment option."

For the millions of people in the US who have chronic, unrelenting, nightly RLS symptoms, opioids may offer the only hope for long-term relief, when all other treatment options have failed. If these patients lose access to opioids, they will lose the ability to manage their symptoms so that they can function in their work and social lives.

During the visit to Washington, the Foundation’s partner, the Health and Medicine Counsel of Washington (HMCW) -- a government relations organization that works with nonprofit organizations and companies in the healthcare industry -- organized opportunities for the RLS Foundation to dialogue with lawmakers, policy makers and others who influence regulations related to opioids and biomedical research.

Day 1: Meetings with NIH and FDA

On February 22, the RLS Foundation hit the ground running. Led by Dzienkowski, the RLS Foundation team included Ronald Barrett, treasurer of the Board of Directors; Dr. Christopher Earley, chair of the Foundation's Scientific and Medical Advisory Board (SMAB); Dr. Michael Silber, SMAB member and head of the Opiate Committee; Kris Schanilec, RLS Foundation communications consultant; Peter Herzog, HMCW legislative associate; and Dale Dirks, HMCW president.

"Our role here is to advocate for an open-minded view on the value of opiates in treating RLS," Dr. Earley said. "It is an important treatment option that needs to be continued and maintained, such that patients with severe RLS, if they need to use these vital medications, are not restricted in any way."

Day one included meetings with leaders of the National Heart, Lung, and Blood Institute (NHLBI), the National Institute of Neurological Disorders and Stroke (NINDS), and the program staff at the FDA.

During meetings with the NHLBI and NINDS (both are institutions within the NIH), the RLSF team discussed ways to increase funding for RLS research and explored possible areas for collaboration. The NIH staff were supportive of the Foundation’s goals and offered many suggestions to explore in follow-up. “The fact that you've taken the time to network with us is a powerful statement," said Dr. Nina Schor, who is deputy director of the NINDS. “RLSF has provided vital input to NINDS in our efforts to support research that will decrease the burden of neurological illness.”

The Foundation shared the challenges of RLS patients who face limited treatment options, and the specific areas where research is needed to discover and test new therapies. The team also stressed the need for both clinical trials of opioid medications and long-term studies on their safety and effectiveness for treating severe RLS.

These meetings were important to building new relationships with individuals at the NIH who can champion the RLS cause and influence decisions about RLS research funding at the NHLBI, NINDS and other institutes within the NIH.

At the FDA, the RLS Foundation met with the office of Public Affairs and Stakeholder Engagement (PASE) at the Center for Drug Evaluation and Research (CDER) to discuss the importance of low total daily dose opioids as an RLS treatment option. The Foundation shared stories of individuals in the RLS patient community who have been taking opioid medications for decades and are encountering barriers to accessing their prescriptions. After highlighting information on new opioid treatment guidelines for patients with RLS, the team stressed the importance of safeguarding access to these medications for RLS patients who genuinely need them.

"The FDA members that we met with recognized the possibility of unintended consequences of heavy-handed restrictions on legitimate opioid use and the potential impact on RLS sufferers,” Barrett said. “Hopefully there will be positive outcomes from our meeting."

Day 2: Championing RLS on the Hill

On February 23, the RLS Foundation team met with Congressional representatives on both sides of the political aisle in 16 Senate and House offices. Meetings included staff members from the offices of Senator Joni Ernst (R-IA), Senator John Cornyn (R-TX), Senator Tina Smith (D-MN), Senator Ted Cruz (R-TX), Representative Rod Blum (R-IA), Representative Tim Walz (D-MN), Representative Roger Williams (R-TX), Representative Mike McCaul (R-TX), Senator Dianne Feinstein (D-CA), Senator Kamala Harris (D-CA), Senator Chris Van Hollen (D-MD), Senator Ben Cardin (D-MD), Representative Judy Chu (D-CA), Representative John Sarbanes (D-MD), and Representative Anna Eshoo (D-CA).

In these meetings, the RLS Foundation delegation explained the specifics of RLS and its devastating effects on the daily lives of millions of Americans. The team delivered nearly 100 letters written by RLS Foundation members, and shared stories that they hear from the RLS community about everyday struggles and increasing issues with access to opioid medications. They stressed the limitations of current treatment options, and that there is no cure for this debilitating disease.

In turn, the RLS Foundation asked that the Congressional representatives support the full $36 billion for NIH funding in fiscal year 2018 so that funds will be available for RLS research and related areas. The Foundation also encouraged the inclusion of “sleep research” as a condition eligible for research grants from the Department of Defense, so that RLS researchers will continue to be eligible for funding through this channel.

Finally, the Foundation pointed to the need for a safe harbor for RLS in any upcoming opioid-related legislation, regulations and policies, so that people with severe RLS who genuinely need opioids to manage their symptoms can continue to access these medications.

These talks were a first step in building relationships with each of the Congressional representatives, and an especially strong connection was sparked with one staffer who has a family member with RLS. The Foundation team will continue to contact these representatives in the coming months to educate them about RLS and the needs of the community.

"It was a very productive visit, and it's just the beginning of our advocacy outreach," Dzienkowski said.

This advocacy trip was an enormous stride for the RLS community and an important milestone in the Foundation’s advocacy initiative. And the fight is far from over. With the help of HMCW, the Foundation will continue to increase awareness among policy makers about the serious nature of RLS, the need for individuals with severe RLS to have access to opioids when they are the best treatment option, and the need for more funding for research that will help identify better treatments and a find cure for RLS.

Your US senators and representatives want to hear from you – their constituent. They are there to represent you. Meeting them is not difficult – it is straightforward and simply a matter of telling your story, sharing your experience and asking them to take your needs into consideration. Want to get involved? Visit the advocacy page of the RLS Foundation website to find out how you can take action now!