By STEVEN ZECOLA
Congress will need to amend its faltering Parkinson’s disease legislation if it hopes to achieve meaningful results.
Why Change Is Necessary
For more than 50 years, the National Institutes of Health (NIH) has pursued Parkinson’s disease (PD) research with limited success. Nearly $5 billion has been spent, yet no approved treatment exists that slows, stops, or cures the disease.
This is not a new concern. By the mid‑1990s, Parkinson’s advocacy groups had grown frustrated by the absence of major therapeutic advances since L‑dopa’s approval 25 years earlier. That frustration led to three national plans launched in 2000, 2006, and 2014. None produced meaningful breakthroughs.
Congress to the Rescue?
Congress attempted to address this stagnation by passing the National Plan to End Parkinson’s Act (Public Law 118‑66), signed July 2, 2024. The Act:
- Calls for an integrated national strategy to prevent, diagnose, treat, and cure Parkinson’s
- Establishes an Advisory Council on Parkinson’s Research to deliver annual recommendations to the HHS Secretary, with the first report due within 18 months
- Requires the HHS Secretary to issue a progress assessment within 24 months
What Happened Instead
The HHS Secretary delegated implementation of the Act to NIH. As a result, the Advisory Council and HHS missed their first statutory deadlines and produced no measurable progress. NIH convened the Council’s first meeting on June 29, 2026—two years after enactment.
The meeting materials omitted information essential for forming a credible strategy, including:
- The time and cost of the current drug‑approval process
- Lessons learned from the three previous national PD plans
- The role of artificial intelligence and other emerging technologies
- Regulatory barriers
- A comparison of federal vs. non‑federal PD research funding and coordination
- Funding allocations across projects
- An assessment of where industry stands on potential cures and the remaining scientific steps
- A plan for engaging external subject‑matter experts
- Any economic analysis
Even basic administration proved difficult. NIH collected comments from 162 individuals but posted them a month late—and did not include my submission. Despite recommendations, NIH still does not use regulations.gov, which would eliminate many of these administrative failures.
More importantly, NIH shows no recognition that the regulatory system itself is broken and imposes massive societal costs. Parkinson’s disease alone generates over $80 billion annually in direct and indirect costs.
What the Advisory Council Is Likely to Recommend
Based on the 162 public comments, the Council’s top recommendation will likely be a substantial increase in PD research funding.
More funding would be logical—but only if used efficiently. Efficiency requires acknowledging that the technology, regulation, and process must change. NIH, as currently structured, cannot deliver on that acknowledgement or those changes.
A Better Approach
Congress should not wait for the fourth national plan to fail. Instead, it should establish a private investment vehicle, funded with federal research dollars and majority‑owned by the federal government. Executive leadership should be recruited from the healthcare industry and granted a 20% carried interest, aligning incentives and ensuring accountability for research outcomes.
Congress should also require the FDA to adopt a zero‑based regulatory framework for AI‑driven applications, including collapsing the multi‑trial model and incorporating real‑time data into the review process.
Conclusion
Human brain cells are complex and fragile, and central nervous system drugs have among the highest attrition rates in medicine—approved at less than half the rate of drugs in other therapeutic areas.
Layer on the length, cost, and complexity of today’s regulatory process, and the Advisory Council’s recommendations risk becoming the fourth demonstration of how not to solve the problem. Congress should anticipate this outcome and implement a system capable of delivering real progress for Parkinson’s patients.
Hope for PD patients exists—but only if Congress acts decisively and soon.
Steven Zecola is a former technology executive and government official. He retired 24 years ago with a diagnosis of Parkinson’s disease. He currently is an ardent patient advocate.
