Type in the phrase “the power of the patient voice” in any online search engine and you’ll generate thousands of articles and posts about the importance of listening to what patients have to say. The articles are on websites run by a diverse group from patients and researchers, to advocacy organizations and pharmaceutical companies. Everyone it seems recognizes the importance of listening to what the patient says. Even the Food and Drug Administration (FDA) has gotten in on the act. But what isn’t as clear is does all that talking and listening lead to any action?

In the last few years the FDA launched its ‘Patient-Focused Drug Development Initiative’, a series of public meetings where FDA officials invited patients and patient advocates to a public meeting to offer their perspectives on their condition and the available therapies. Each meeting focused on a different disease or condition, 20 in all, ranging from Parkinson’s and breast cancer to Huntington’s and sickle cell disease.

The meetings followed a standard format. Patients and patient advocates were invited to talk about the disease in question and its impact on their life, and then to comment on the available treatments and what they would like to see happen that could make their life better.

The FDA then gathered all those observations and comments, including some submitted online, and put them together in a report. Here’s where you can find all 20 FDA Voice of the Patient reports.  The reports all end with a similar concluding paragraph. Here’s what the conclusion for the Parkinson’s patient report said:

“The insight provided during this meeting will aid in FDA’s understanding of what patients truly value in a treatment and inform the agency’s evaluation of the benefits and risk of future treatments for Parkinson’s disease patients.”

And now what? That’s the question many patients and patient advocates are asking. I spoke with several people who were involved in these meetings and all came away feeling that the FDA commissioners who held the hearings were sincere and caring. But none believe it has made any difference, that it has led to any changes in policy.

For obvious reasons none of those I spoke to wanted to be identified. They don’t want to do anything that could in any way jeopardize a potential treatment for their condition. But many felt the hearings were just window dressing, that the FDA held them because it was required by Congress to do so. The Ageny, however, is not required to act on the conclusions or make any changes based on the hearings. And that certainly seems to be what’s happened.

Producing a report is fine. But if that report then gets put on a shelf and ignored what is the value of it? Patients and patient advocates want their voices to be heard. But more importantly they want what they say to lead to some action, to have some positive outcome. Right now they are wondering if they were invited to speak, but no one was really listening.