The U.S. Department of Health and Human Services and a National Plan to Cure Parkinson’s Disease

By STEVEN ZERCOLA

The U.S. Department of Health and Human Services (“HHS”) plays a crucial role in a wide range of activities related to medical and public health. With a staggering 60,000 employees and an annual budget of $1.7 trillion, including approximately $140 billion for discretionary spending, HHS is well-positioned to make a significant impact in the field of healthcare.

For the past 13 years, HHS has been at the forefront of a National Plan for addressing Alzheimer’s disease and has achieved notable successes in this area. Given its extensive resources, expertise, and mandate, it is imperative for HHS to now launch a National Plan to cure Parkinson’s disease that mirrors its approach to Alzheimer’s disease.

Legislation, or Not

The U.S. House of Representatives has passed H.R.2365, the National Plan to Cure Parkinson’s Disease. This bill aims to establish HHS as the central point for strategic direction and coordination of PD research. It would also require the formation of a broad-based Advisory Panel to provide strategic advice and course corrections as needed. Notably, there is no incremental funding required to implement this National Plan, and no Congressional approval is necessary. HHS can put the structure of H.R. 2365 into effect immediately without waiting for Senate action or inaction, marking a crucial step towards finding a cure for Parkinson’s disease.

A Cross-Section of Policy and PD Research

For many, the application of regulatory policies to Parkinson’s disease research has not yielded a productive narrative. Despite significant research efforts, the gold standard of treatment, Levodopa, remains the same for the past fifty years. Research dollars have primarily been targeted toward drugs that delay the need for Levodopa or control its side effects. The regulatory landscape around PD research has also faced challenges such as limitations on stem cell research due to opposition from certain quarters, hindering potentially fruitful paths for progress. Despite the House passing bills for a National Plan to Cure Parkinson’s in its recent sessions, the Senate has failed to act.

Building Upon Lessons from the Past

Reflecting on the National Plan to Address Alzheimer’s disease, established in 2011, there are many lessons that can be applied to a National Plan for PD. The original plan had set forth specific objectives, including preventing and effectively treating AD/ADRD by 2025. Despite increased funding and the identification of potential treatments, the process to get an effective treatment identified and approved has been slow. HHS should limit the FDA’s involvement in PD research to approval of Phase 3 trials, allowing for faster development and innovation while maintaining adequate safety controls. Recognizing the need for a multivariate solution to treat PD, HHS should encourage and expand data collection efforts such as the Parkinson’s Progression Markers Initiative to identify and evaluate various explanatory variables that could impact PD.