Patient advocates merit a voice in FDA drug reviews | READER COMMENTARY

I am writing in response to the recent commentary criticizing patient advocacy groups for their involvement in the U.S. Food and Drug Administration’s approval of Relyvrio, a drug for ALS (“Patient advocacy groups should stay out of drug approvals,” May 10). While the commentary raises valid concerns about the FDA’s approval process and the drug’s efficacy, it unfairly blames advocacy groups for advocating on behalf of patients.

These groups, such as the ALS Association and I AM ALS, represent patients often marginalized in the drug development process. As an FDA-appointed Alzheimer’s disease patient advocate, I have personally provided patient feedback to the advisory committee. The FDA actively recruits patient advocates to ensure patient perspectives are considered, highlighting the importance of these voices.

It is unfair to expect advocacy groups to remain passive when patients need effective treatments. These groups are composed of individuals directly affected by ALS and are deeply invested in improving patients’ lives. Their advocacy efforts aim to accelerate the approval of promising treatments.

Suggesting that advocacy groups should stay silent undermines patient autonomy and empowerment. Patients have a right to participate in decisions affecting their health. Dismissing patient advocates risks perpetuating a system that prioritizes profit over patient outcomes.

Instead of blaming advocacy groups, we should reform the FDA’s approval process to ensure rigorous scientific evidence is prioritized. The FDA must uphold high standards for drug approval with robust clinical trials and implement transparency and accountability mechanisms to prevent conflicts of interest.

In conclusion, patient advocacy groups should be commended for their efforts to improve access to effective treatments for patients. We should work collaboratively to address systemic issues within the FDA’s approval process and ensure patients receive the care they deserve.

— Jim Taylor, Sherman, Connecticut

The writer is president and CEO of Voices of Alzheimer’s.

Add your voice: Respond to this piece or other Sun content by submitting your own letter.