The Voices Heard Round The World – The November 5th FDA Meeting
The November 5, 2015 joint meeting of the FDA Antimicrobial Drugs Advisory Committee and FDA Drug Safety and Risk Management Advisory Committee regarding the use of Fluoroquinolones (FQs) for certain medical conditions, is now recent history. However, the impact that was made during the meeting by those present will be heard for some time to come.
There were many who made this moment possible, but the true heroes were those who gave their testimonies. They came from all over; an articulate woman from Massachusetts, an impassioned man from North Carolina, a brave young woman from Washington State, and others from all parts in between. Not only did they muster the strength to share their personal stories, but they did so in such a way that eloquently, articulately, and powerfully rose above everything else and captured the hearts and minds of those present and many more worldwide. They easily overpowered the minority that was on-hand to present a rebuttal.
I, along with many others, were truly humbled and honored to have those individuals give a voice to the community.
I do not want to call the November 5th FDA hearing a culmination.
A high point to-date? Yes, definitely.
An outcome much better than expected? Yes, absolutely.
It presents a huge step in the progress we are making to gain complete recognition of the travesty that the fluoroquinolone class of pharmaceuticals has wrought upon society, to achieve justice for those that have been damaged by these drugs, and to prevent future unnecessary pain and suffering not only for this generation, but for generations to come.
The foundational work has been building over the last seven years. Despite overwhelming resistance from many sources, members of our community have been working together with researchers, organizing rallies, seeding media stories, putting pressure on political and governmental entities, and providing a continuous stream of data to various sources. There have been thousands of miles logged, numerous meetings, conference calls, and negotiations. Slowly it has been paying off.
The November 5th Hearing
Our FQ team met with the FDA several times during the past seven months. These meetings did not come about overnight. We had to establish our ability to deliver a clear, scientific, and public safety oriented message. This, along with the scrutiny created by the coordinated media stories, started getting the FDA’s serious attention.
As a result, we were notified by the FDA, ahead of the public announcement that they were going to be holding the November 5th, 2015 meeting of the Advisory Committee.
Once we were notified, like cogs on a wheel, other members from our community worked closely together to organize the influx of community members who wished to attend.
This set the stage for the true stars of our community to take to the podium and tell their personal stories in their own words.
Well, in the immortal words of John Paul Jones “I (we) have not yet begun to fight.” We are continuing our pressure. In the afterglow of the wonderful presentations of November 5th, we must not rest on our laurels. Because of the now established relationships with the FDA, researchers, media, and others, we are going to continue to stay on top of all things FQ related.
The future holds more meeting meetings to press for labeling changes and warnings.
“Fluoroquinolone Associated Disability” (FQAD) was coined by the FDA in the briefing for the November 5th, meeting (1). FQAD represents a monumental milestone in our fight for recognition. For the first time in FDA literature they have, in writing, acknowledged a syndrome of adverse events that stems from fluoroquinolone usage and have given it a name.
We face a foe that wields a tremendous amount of resources. It is truly a David and Goliath story. We must be prepared for strong opposition to our victory and not let any opposition deter us from our goal.
However, we have a group of dedicated community members with a proven track record of working together who, I believe, can overcome any challenges that we will face in the future. Teamwork using the strengths of each other is the key to the ultimate victory.
The November 5th, 2015 FDA hearing will go down as a milestone in our communities’ journey with many positive aspects. The pharmaceutical companies were unprepared for the testimonies of the courageous community members who faced many personal hardships to attend. These true heroes will help us ensure that, in the end, we have the ultimate triumph, because truth is on our side.