On November 5, 2015 the FDA’s Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory Committee) and Drug Safety and Risk Management Advisory Committee held a special hearing on the safety of Fluoroquinolones, especially when used as a first line of defense. This hearing lasted all day and included a team of Dr’s, Scientists and Execs from Bayer, J&J and Pfizer who were on hand to give hours of testimony that their drugs are safe.
The intent of the committee was to revisit the issue to determine if the benefits really do outweigh the risks when prescribing for sinus issues, bronchitis, UTI’s, colds/sniffles/coughs.
I heard about this hearing about 3 weeks in advance, giving me time to rest and save energy to attempt to make the trek to the FDA HQ in Silver Spring MD. I should have been having surgery to amputate at least one toe from the damage Levaquin has caused. A few days before I was set to leave I cancelled on going to the FDA. My baseline was far too low and getting lower, I was weak and getting weaker. My foot was in so much pain, as was the rest of my body. On top of my condition, logistically I didn’t think we could do it. The world still happens too fast and while my intellect is in tact, my mind gets slower as my energy drains. There would be no way I could do this without significant, constant help. I needed a seeing eye human to help care for me and keep me safe and it started to look like there was no way for me to be safe, no way for me to be able to stop the world once I “hit the wall”. But this was far too important to miss, no matter the cost. My mother accompanied me and pushed the wheelchair, made sure I ate, made sure I knew where I was supposed to be and what was happening.
I was already becoming weak from the trek to the FDA and beginning to have tremors, my energy was draining so fast – and I’m sure the stress of knowing the people who did this to me were in that room had a huge impact. Stress and anger immediately make my symptoms worse in a way that I would only describe as a violent reaction in my body. I tried to keep myself as calm and grounded as I could, but there’s no doubt that had a huge effect. This is a known issue for severe mitochondrial patients as the body uses so much energy when in a stressful state, and for those like me it is more energy than we have available and an “energy crisis” is triggered.
Between the help from my mother and the help of all of my fellow warriors, I was able to make the trek.
My testimony was a compilation of many “scraps of paper” and recordings. It was an enormous struggle to get words out and arrange them so they made sense. But that day, the universe guided me and allowed them to flow. The complete transcript is found below.
Good afternoon. My name is Michael Christian Kaferly. I have no affiliation.
In Sept 2008 I was prescribed Levaquin to clear a chest cold before a minor surgery. There was no testing done to determine if I had a bacterial issue. It was given to me JUST IN CASE. Soon a nuclear bomb detonated inside my body. I quickly went from an intelligent and healthy man who worked out almost daily to being bedridden, unable to understand the world around me and in horrific pain not of this earth. For much of the first 18 months my entire body would become too weak and too heavy to move – not even to use the washroom. At its worst I was so weak I could not hold my head up, chew food or even produce a voice to tell my little boy I loved him.
Our search for help took us coast to coast. Among my list of diagnosis are Autonomic Neuropathy and mitochondrial damage. Testing shows my body has suppressed cell replication, which is the explicit mechanism of action of the drugs that we’re here to discuss today. My full list of diagnosis and symptoms spans across multiple systems and is far too long to list here.
I have fought this monster for 2,585 tortuous days and nights, but I am hardly improved. While I have good and bad days, I am never well and I rarely leave the house. I am like a defective battery that discharges far too quickly and doesn’t recharge correctly. I have a minimal and unpredictable energy supply to fuel my muscles, systems and organs. That means as I tire, my entire body gets progressively weaker and heavier. My vision worsens and I can become confused, frail and weak many symptoms become unimaginably severe including layers of unspeakable pain. Even though I’ve rested for weeks to be here today, this trip is dangerous for me and I will suffer devestating consequences for the energy spent.
Abandoned by the very medical system that did this to me, I have been forced to give myself over 475 IV’s to help manage some of the horrific symptoms Levaquin has caused.
I made videos of my IV process to help other victims – one of which has over 15,000 views. There are many more like me.
Modern medicine offers no cure for my mitochondrial disorder that began as a result of taking Levaquin. It is imperative to manage symptoms to prevent this disorder from progressing, but the only known therapies are not covered by insurance. I can no longer afford the extensive supplementation and IV’s that helped me to fight back. I have been forced to go without and my condition has deteriorated significantly as a result. Until a few weeks ago my family was homeless again. When I get home to my little boy, I face immediate amputation from the damage Levaquin has caused.
In 2008 there was no warning about Autonomic Neuropathy or mitochondrial damage. Just tendon issues. If the FDA protected me and allowed me to make an INFORMED decision, I absolutely would have chosen to keep the cough. The salesmen are here today to tell you their drugs are safe, but you already know this class of drugs CAN cause mitochondrial damage, I came all this way to look each one of you straight in the eyes and tell you that in fact, it DOES.
My little boy was 15 months old when my life was hijacked. Now 8, he has never gotten to know his father as a healthy man. He has been forced to see things no child should ever witness. My life and his childhood have been stolen in the pursuit of profit. I am here today for the hundreds of thousands like me, labeled as crazy who still don’t know what is happening to them. I am here for my son and for his entire generation, to implore the FDA to rethink how these powerful biological weapons that we call “cures” are labeled and monitored. Levaquin has unquestionably cut my life short by decades. There is no sane measure that makes this level of metabolic damage an “acceptable risk” except to those whose sole directive is to sell more pills.
Media outlets were on hand to cover this historic event. Just before I was set to testify, I met with a wonderful reporter named Jacqueline who aired this in Charlotte NC and another version on 10 more stations in 9 states. Below are two of the many stories, there were far too many for me to keep track of. I will try to add the rest and update the media section as energy allows.
I began to hit the wall hard after my testimony and many of my symptoms were becoming violently worse. Luckily my seeing eye human noticed – as I would have been unable to articulate my immediate need – and wheeled me out of the room immediately following my testimony. I desperately wanted to stay to support my fellow warriors, but I had no choice but to eliminate all energy expenditures in attempt to stop the progression of symptoms/issues.
No matter the physical cost, it was clearly worth it.
After a full day of testimony by the Pharmaceutical industry, the results were a landslide victory for all of humanity. The FDA voted unanimously, deciding that in fact the benefits do not outweigh the risks.
I couldn’t be there for the end, my body forced me to leave immediately after I spoke. The FDA panel read their justification for their votes, below are just a few quotes from the FDA panels. Including the need to officially acknowledge “Fluoroquinolone Associated Disability” as a diagnosis to cover the constellation of strange symptoms that millions suffer.
“Education is important for the physicians”
“Uncertainty about the safety”
“Does not provide sufficient guidance for practitioners”
“Business as usual is not acceptable”
“Misuse has to be addressed immediately”
” FQAD-legitimate warning for this”
“Relying on the labeling alone is too passive”
“We have to act now”
“Need to extend who is at risk”
“Remarkable testimony today”
“No first line of defense use”
“Black box should be expanded-highlighted-raise alarm”
“Serious safety concerns-a flawed tool-need red flags-BIG red flags”
“The black box does not look serious to me.”
“Thank you to the Press and patients”
“Learned a lot today”
Again, the intent of the committee was to revisit the issue to determine if the benefits really do outweigh the risks when prescribing for sinus issues, bronchitis, UTI’s, colds/sniffles/coughs. They answered NO unanimously. To me, this means that I have lived long enough to fulfill a mission that I’ve had ever since these drugs caused me to be bedridden and unable to communicate. NO ONE will ever be poisoned by these drugs the way I was – for a cough. These drugs will no longer be allowed to be the first line of defense for minor issues. Which was far and away the bulk of the prescriptions . The drug companies lost hundreds of millions of dollars on Thursday, and I am proud to announce to my son and the world that we did it buddy. We did it.
I returned home safely, but I am in rough shape. This trip took far more from my body than I had available. I am far weaker than I was before I left, layers of pain are exponentially worse and my baseline is far lower. The infection has spread further, but so far it doesn’t look like it’s gone past my toe – so I got that going for me. But the pain in my foot is so much worse as well, on top of all of the other symptom and pain increases across my body and across systems. I don’t know if I will ever recover to my previous baseline, or if so how long that might take. But this was a victory for every man, woman and child. I haven’t yet had the opportunity to process all thats happened, I’ve been slow the last few days. Right now I am still overwhelmed with gratitude that I was able to use my words for those 3 minutes. I couldn’t make that same speech today, nor on most days. But when it counted, I had words. And nothing can ever take this moment away from me or my son…
Thank you to all of my fellow warriors who testified and for all those who made this moment possible for me, and for all of the innocent and unaware who just dodged a bullet because of our sacrifices. Make no mistake, my hand has already been dealt. I have no dog in this fight; Johnson and Johnson decided my fate for me on Oct 6 2008. Nothing good can come of this for me personally, in fact, nothing but suffering will come for me after this. But I can look my little boy in the eyes and say that day buddy, we made a difference. And I taught my son that sometimes, you just have to take a stand for what’s right – no matter the consequence.
I love you all.
Your Brother in Fight,