We are writing to enlist you in the fight to find a cure for ALS (amyotrophic lateral sclerosis). Also known as Lou Gehrig’s Disease, ALS is a progressive neurodegenerative disease that attacks nerve cells in the brain and the spinal cord. People with ALS lose the ability to initiate and control muscle movement, which often leads to total paralysis and death within five years of diagnosis.  

Studies funded by the DOD, VA and NIH have found that people who served in the military are up to twice as likely to develop and die from ALS as those with no history of military service regardless of which branch they served in, where they served, or whether they served during peace or war. Researchers do not know why there is a greater risk of developing ALS for people that serve in the military, but the fact remains: no effective treatment is available to save or extend the lives of people living with ALS.

The prognosis of people diagnosed with ALS is the same as it was nearly 80 years ago when baseball legend Lou Gehrig lost his fight with the disease. However, with your support, we can provide hope that a cause will be identified, and treatments will be found.

Please join us in the fight against ALS by supporting our request for $40 million in funding for the DOD ALS Research Program (ALSRP) and $10 million in funding for the CDC National ALS Registry for fiscal year 2021. These programmatic requests support groundbreaking early-stage ALS research and the collection of critical data that is helping scientists learn the causes of ALS and how it can be treated, cured, or even prevented.

DOD ALS Research Program

Congress has recognized the critical role the ALSRP plays in advancing the search for a treatment by providing funding for the program since FY2007. In FY2019, Congress provided $10 million for the ALSRP, but it was estimated that between $12-13 million in additional funding was needed to fully fund the program’s most scientifically meritorious research applications. In FY2020, Congress increased funding to $20 million, but increased funding for FY2021 is needed.

We are writing today to request your help to find a treatment for this horrific disease by supporting $40 million in FY2021 funding for the ALSRP. The program is explicitly designed to create novel treatments for ALS by promoting translational research, the “bench-to-bedside” process that harnesses knowledge from basic scientific studies to support clinical research. The ALSRP’s support for translational research fills a gap in the therapy development pipeline which prevents emerging treatments from reaching patients. A $40 million appropriation will enable the ALSRP to fully fund its existing preclinical portfolio while providing the resources necessary to fund early phase clinical trials that translate preclinical findings into treatments.  

Building on a solid foundation of promising preclinical research, the ALSRP is positioned to make investments in early phase clinical trials. Funding early phase clinical trials will bridge the so-called “valley of death” between promising preclinical research and human studies to make private investment into ALS therapies more viable. With promising, ALSRP-funded preclinical projects approaching early phase clinical trials, now is the time to increase investment in this critical stage of the ALS research continuum.

CDC National ALS Registry

The National ALS Registry at the CDC, established in 2009 following enactment of the ALS Registry Act (P.L. 110-373), collects data on ALS patients in the United States to better describe the incidence and prevalence of ALS, and to examine risk factors and the demographics of those living with ALS. Congress has maintained funding for the Registry ever since its creation. We hope you will join us in supporting level funding in FY2021 to provide $10 million for the National ALS Registry.

Thanks to previous congressional support, the Registry is fully operational, collecting critical information about potential causes of ALS, connecting patients to clinical trials and other studies, and strengthening ALS research. FY2021 funding is needed to continue the groundbreaking work carried out through the Registry, coordinate federal efforts, and conduct outreach activities to identify cases across the country. Funding is also needed to advance the Registry’s biorepository to collect blood and tissue samples for epidemiologic studies, research into biomarkers and risk factors, and clinical studies necessary to identify new treatment targets.

Conclusion

Please join us in signing the attached letters to the Appropriations Subcommittee on Defense and the Subcommittee on Labor, Health and Human Services. Together, we can continue working towards finding a treatment and cure for ALS. If you would like to sign the letter please fill out this google form. If you have further questions, please contact Justin.Meuse@mail.house.gov in Rep. Crow’s office or Maggie.Woodin@mail.house.gov in Rep. Gallagher’s office by COB February 28th.

Sincerely,

 
Reps. Jason Crow (D-CO), Mike Gallagher (R-WI), Joe Courtney (D-CT), George Holding (R-NC), Seth Moulton (D-MA), Peter King (R-NY), Eliot Engel (D-NY), Brian Fitzpatrick (R-PA)
 
 
_______________________________________________________________________________________________________

The Honorable Pete Visclosky
Chairman
Subcommittee of Defense
Committee on Appropriations
Washington, D.C. 20515

The Honorable Rosa DeLauro
Chairwoman
Labor-HHS-Education Subcommittee
Committee on Appropriations
Washington, D.C. 20515
 
The Honorable Ken Calvert
Ranking Member
Subcommittee on Defense
Committee on Appropriations
Washington, D.C. 20515

The Honorable Tom Cole
Ranking Member
Labor-HHS-Education Subcommittee
Committee on Appropriations
Washington, D.C. 20515
 
RE: FY2021 DOD and CDC ALS Research Requests

Dear Chairs Visclosky and DeLauro and Ranking Members Calvert and Cole:

Thank you for your continued strong support of the ALS Research Program (ALSRP) within the Congressionally Directed Medical Research Programs (CDMRP) at the DOD and the National ALS Registry at the CDC. Your support of these critical programs is helping to advance the search for a treatment for ALS, also known as Lou Gehrig’s disease.

As you know, ALS is a fatal neurodegenerative disease that destroys a person’s ability to control muscle movement. As the disease progresses, people become trapped inside a body they can no longer control. The average life expectancy for a person living with ALS is just two to five years after diagnosis. There is no effective treatment for the disease, no known cause, and no cure.

DOD ALS Research Program

We believe it continues to be important for the DOD to identify and research all diseases that may be related to service in the U.S. military, including ALS. According to numerous studies by the DOD, VA and NIH, people who served in the military are up to twice as likely to develop and die from ALS as those with no history of military service regardless of which branch they served in, where they served, or whether they served during peace or war.

The ALSRP is explicitly designed to promote new ideas in the earlier stages of development with the potential to yield high-impact knowledge and new avenues of research. This innovative program fills a gap in the therapy development pipeline where limited resources often stymie promising treatments. As you know, the ALSRP also supports the best science through a peer-reviewed, competitive grant process. To date, the ALSRP has supported several promising ALS drug candidates that have moved into advanced drug development and into early phase clinical trials.

Building on a solid foundation of promising preclinical research, the ALSRP is uniquely positioned to make investments in early phase clinical trials. These investments will help bridge the so-called “valley of death” between promising preclinical research and human studies in ALS drug development. With several promising ALSRP-funded preclinical projects nearing early phase clinical trials, now is the time to increase investment in the program.

We request $40 million for the ALSRP in fiscal year 2021. Additionally, we request report language to encourage the ALSRP to fund early phase clinical trials to accelerate the development of treatments to improve life for all patients impacted by this disease. A $40 million appropriation will enable the ALSRP to fully fund its existing preclinical portfolio while providing the resources to fund early phase clinical trials that translate preclinical findings into treatments. The specific report language proposal follows:

“CDMRP
ALS Research – The Committee is aware of promising research underway through the Amyotrophic Lateral Sclerosis Research Program (ALSRP). Given that people who served in the military are up to twice as likely to develop and die from ALS as those with no history of military service, it is especially important this progress be continued into early phase clinical trials. The Committee encourages the Department of Defense to take a broad approach to the type of research projects it may support through a peer-reviewed approach to help advance potential treatments to people living with ALS.”

CDC National ALS Registry

The National ALS Registry at the CDC, established in 2009, collects data on ALS patients in the United States to better describe the incidence and prevalence of ALS, and to examine risk factors and the demographics of those living with ALS. It includes information voluntarily provided by people living with ALS and it collects and compiles data from federal agencies (such as CMS, NIH, and the VA). The Registry:

• Makes collected data available to researchers who are looking to identify disease patterns and risk factors;
• Connects patients directly with clinical trials, epidemiological studies, and patient-focused surveys;
• Funds ALS research on disease etiology and determining risk factors for ALS;
• Conducts public health surveillance of the incidence and prevalence of ALS in the United States; and
• Collects risk factor data through seventeen longitudinal surveys of patient enrollees.

We request $10 million for the National ALS Registry in FY2021. This funding will enable the Registry to continue its critically important work through the CDC’s Agency for Toxic Substances and Disease Registry.

We thank the Subcommittees for their support of funding for critical ALS research and the ongoing operation of the National ALS Registry. We appreciate your consideration of our FY2021 appropriations requests including $40 million for the ALSRP within the Department of Defense Appropriations Act and level funding of $10 million for the National ALS Registry in the Departments of Labor, Health and Human Services Appropriations Act, and Education, and Related Agencies Appropriations Act. With these strategic investments, we will be able to build momentum to confront this devastating disease.

Sincerely,