Wednesday, November 11, 2015

QVF Testifies at FDA Hearing on November 5, 2015

On October 23,2015 the Quinolone Vigilance Foundation announced that we were testifying at the FDA, where an unprecedented hearing was taking place to discuss fluoroquinolone antibiotics.

The joint meeting of the Antimicrobial Drugs Advisory Committee (ADMAC) and Drug Safety and Risk Management Advisory Committee convened on November 5 at which the panel discussed the risks/benefits of the systemic fluoroquinolone antibacterial drugs for the treatment of sinus infections, urinary tract infections (UTIs) and bronchitis. The panel reviewed evidence and listened to testimony from victims during the Open Public Hearing portion of the meeting.

QVF Ambassador Jonathan Furman and I joined thirty-three other people who came to the FDA to share our stories and to urge the FDA to make vital changes in how fluoroquinolones are prescribed.  

Jonathan Furman and I in front of the FDA

QVF Ambassador Jonathan Furman testifying at the FDA- speaker #13

The speaker testimonies from all 35 speakers are available here.
The written transcript can be found here. Open Speaker testimony starts on page 211. Jonathan's testimony starts on page 256. Mine starts on page 282.

Me testifying at the FDA
I was speaker #21

This was mine:

Good afternoon. My name is Rachel Brummert and I am the Executive Director of the Quinolone Vigilance Foundation. Neither the foundation, nor I, have any financial ties to this hearing.

Slide one:

Fluoroquinolone antibiotics are incredibly powerful with the capability to save lives when used as a treatment of last resort for life-threatening bacterial infections like anthrax. These antibiotics have equal power to destroy lives when they are prescribed for routine infections like sinus infections and UTIs that don’t need their strength. Just as it is irresponsible to squelch a kitchen fire with the defenses we would mount against a wildfire, likewise, it is reckless to use a fluoroquinolone antibiotic to squelch a routine infection. There are safer, effective antibiotics for the treatment of routine infections in the event that an antibiotic is even necessary.

Slide two

I am living proof that the risks in using a fluoroquinolone to treat a routine infection far outweighs the benefits. In 2006, I was prescribed Levaquin for a sinus infection. Within weeks, my achilles tendon ruptured in a parking lot, the first of ten tendon ruptures I’ve suffered over nine years.

Slide three

A first-line of defense antibiotic like Amoxicillin, would have resolved my sinus infection, and I would not have been exposed to the relatively disproportionate risks of known fluoroquinolone-associated injury, which includes a progressive neurodegenerative disorder, from which I will never recover.

With just one prescription, a once-healthy wage-earner, parent, or grandparent – just like you, just like me – can no longer enjoy a reasonable quality of life and now lives with lifelong risks for the development of an illness that is life-threatening.

Slide four

What can the FDA do to protect patients from profound, preventable harm? A preventable problem is a fixable problem. The FDA is responsible for protecting and promoting public health through the regulation and supervision of a wide variety of consumer products including prescription medications. Fluoroquinolone antibiotics are causing widespread disability and their overuse is also a contributing factor in the antibiotic resistance epidemic. Antibiotic resistance is such an important issue that there is a White House objective to do something about it. If fluoroquinolones are being prescribed for routine infections which don’t need their strength and they are disabling otherwise healthy patients, and their overuse is leading to an international epidemic, the answer is clear: The FDA must apply its highest level of scrutiny, regulation and surveillance of fluoroquinolones to achieve this shared goal.

Thank you for your time and consideration and for holding this very important meeting.

Thirty-five people were compelled to speak at the FDA. Victims, who through enormous pain and disability, traveled so they could look the panel in the eye and tell their emotional, gut-wrenching stories of what fluoroquinolone antibiotics did to them. Not only did speakers speak for themselves, they also spoke for the untold number of victims who could not attend. There were doctors and other experts who conveyed the seriousness of the damage.  Still others traveled far and wide to attend the hearing in the audience to support the speakers and to show that there is a strength in numbers and the panel needed to be put on notice that these antibiotics--approved by the FDA without proper testing--are causing injury, disability, and death, and that is not okay. The panel needed to know that unless restrictions are put on these powerful drugs, more people will suffer, more people will lose everything, and more people will die.

Thirty-five people that day, through their pain and suffering, made a difference. Thousands of people who worked tirelessly through the years made a difference.  We all made a difference because we came together and were there to save lives so that what happened to us, doesn't happen to anyone else.

The advisory panel heard us. The 21 member panel voted 21-0 for a label revision on sinusitis, 20-1 for UTIs, and 18-2 with one abstention for bronchitis.  

The panel did not recommend specific warning language because only the FDA has the power to do so, and the FDA is not required to follow advisory panel recommendations. But the good news is that the FDA often does follow advisory panel recommendations, and that is reason to hope.

Thank you to everyone who attended the hearing, who testified, who supported the speakers, who spoke to the media...everyone. Thank you for all you did at the hearing and in your own communities to raise awareness. It all makes a huge difference.

Rachel Brummert
Executive Director
Quinolone Vigilance Foundation

No comments:

Post a Comment