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.

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FQ Warriors and Heroes Standing Outside the FDA

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.

Background

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

Nov 5 Purple Beads Small

Terry Aston holding up beads representing over 6,000 victims of FQ toxicity.

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.

What’s Next?

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.

In Conclusion

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.

Admin

...damaged by fluoroquinolones in 2007 at age 46. Prior to, a healthy law enforcement official. Now an amateur FQ researcher, author, and blogger.

9 Responses

  1. maureen says:

    Thanks for all you do! And for keeping us informed!

  2. Thank you so much for your never ending dedication and efforts in spreading the truth about these toxic, poisonous drugs. You are an invaluable asset and resource to our community. I was one of many who testified, and without the effort of community members like you, I may never have had that opportunity. Thank you, thank you thank you. Now onward and forward to our next battle.

    Your Brother in Fight.

    • Admin says:

      Michael, No, thank you! Your testimony was truly awe inspiring and humbling. I admire your spirit and am honored to be your brother in this fight.

  3. Tyler Brosseau says:

    Excellent summary of the meeting; it needed to be articulated that it was a high point and in no way an end point or culmination. Thanks for your continual work David.

  4. Greg says:

    Thanks for all your work! It was a great victory, but as you say, we cannot rest on our laurels. I’m reminded of another quote by Churchill: “This is not the end, nor even the beginning of the end… but it is the end of the beginning!”

  5. August Iaboni night mare
    on September 23, 2015Please read what happens to me (In 2003 (August Iaboni )I took Levaquin with out warning of unreversable side effects.look at what I was getting in to 500 mg
    intervenes daily for a period 3 week 24 hours 15 days and fallow up with 30 day perception until till finish
    I was given the same treatment in 2004,2005 2006 2007 2008 I believed the doctors They Sed my pain is coming from cellulites, othritis pain and the fact I am getting old at 53 years old I should have aspected thing to go wrong I was in great health all my life i work out 3 to 4 x days weekly able to jump over park benches no problems with my body at allcould bench press 200lb. and so I just can’t believe what came next suffering the
    debilitating effects of this drug.(levaquin) Tendinopathy throughout my body, peripheral neuropathy, damage to my central and autonomous nervous systems, vision problems, GI problems, heart and lung problems. I have spent tens of thousands of dollars Since I am not able to work since I can not walk stuck in my house, in my bed and suffer immense pain daily. Given the debilitating, costly, long-term (even permanent) effects of these drugs, there is no question that they are more dangerous than other antibiotics. If anyone disagrees, please name the antibiotic that causes more long-term and permanent multi-system effect I know it was levaquin in 2003 for cellulites skin infection pain was crippling hade to go on disability 2008 in order to support my existence in a one room apartment on my bed I found out about levaquin in 2013 on tv at 3:15 am Here we go… Time to start calculating what Alex Gorsky has cost Johnson & Johnson:
    Keep in mind, Johnson & Johnson only has ONE source of income, the wallets of consumers who are their customers and shareholders – ultimately, the fines, restitution and long-term health consequences for their victims comes from inflating the price of their products: drugs, consumer goods, medical devices.
    Johnson & Johnson failed to Warn and hid the facts of the potential danger of levaquin. MANUFACTURER: Johnson & Johnson’s Ortho-McNeil-Janssen Pharmaceuticals, Inc.
    OVERVIEW: Levaquin (levofloxacin) is an antibiotic that is part of a group of drugs known as fluoroquinolones. It is one of the most widely used antibiotics, and has been used by millions of Americans.might assume that a pharmaceutical representative might have been forewarned about taking a drug so dangerous that it can cause a lifetime of irreversible agony, but the bitter irony is that not even the representatives have been made fully aware of the flaws and dangers in many of the drugs they are selling, due to what alleges are deceptive marketing practices.

    Prior to the introduction of generic competitors, Levaquan generated over $1.3 billion in annual sales for the drug makers.plus 1.50 billion in their sister company Bayer

    Although the antibiotic has been on the market for nearly 20 years, it appears that potential Levaquin side effects have not been thoroughly researched and that inadequate warnings have been provided for users and the medical community about the risk of peripheral neuropathy, ligament rubture which can has cause:

    Pain in the Arms, Legs, Hands or Feet
    Burning, Tingling or Numbness
    Weakness, Tiredness or Heaviness
    Sensitivity to Light Touches, Temperator and Motion

    between fluoroquinolone antibiotics and peripheral neuropathy and ligament rupture tendentes for decades, for the rest of my life because Johnson & Johnson failed to Warn and hid the facts of the potential danger of levaquin so Levaquan alleges are deceptive marketing practices.
    generated over $1.3 billion in annual sales for the drug makers.n Profit over lives
    now I a being represented by barn & bud pharmaceutical class action lawyers to get after them and help me get justice and live a better life pray for me one day at a time
    Risperdal: Courtesy of JNJ CEO Alex Gorsky – this corrupt mess was his project while in control at Janssen. Hard to believe this asshole is CEO. Was Billy-Boy Weldon in his right mind when I hope my lawyers and my government will correct this injustice relive some of my pain that I Indore for the last 12 years stop it now so there is no more victims that have to go threw this agony can’t the doctor read and educate them self. Or are the looking the other way for there own profit let stop this madness I would like to see the C.E.O president of Johnson& Johnson take and give to his family levaquin intervenes for 15 days 24 hours a day and 30 day percrption of any one of the 3 drug and prove we are all wrong please join me on this fight we the people are stronger together and not afraid of them like the news channels r scared that the multimillion of advertisements of J&j would threatening to pull there adds and profits now I just reliese that I have to say one last thing now. That I am forced to give the drug companies more $$$ For the drugs I have to take for the pain
    Thay created waow can u believe that please contact me with any news that is out there. thank youPosted by
    74 314 Google +1 Reddit0 2 9
    Levaquin Lawsuit

    November 1, 2014
    Written by: AboutLawsuits
    378 Comments

    CONTACT A LAWYER

    Have A Potential Case Reviewed By An Attorney
    FULL NAME

    PRIMARY PHONE

    ALTERNATE PHONE

    EMAIL ADDRESS

    DETAILS ABOUT CASE

    Side effects of Levaquin have been linked to permanent and debilitating nerve damage, known as peripheral neuropathy, which can last for months or years after last use of the antibiotic.

    STATUS OF LEVAQUIN NEUROPATHY LAWSUITS: A growing number of Levaquin lawsuits are being pursued by individuals throughout the United States who have discovered that nerve problems may have been caused by use of the medication. Product liability lawyers are reviewing potential claims for individuals diagnosed with peripheral neuropathy, or who have suffered symptoms of nerve damage.

    >>REVIEW A LAWSUIT WITH A LEVAQUIN LAWYER<<

    MANUFACTURER: Johnson & Johnson’s Ortho-McNeil-Janssen Pharmaceuticals, Inc.

    OVERVIEW: Levaquin (levofloxacin) is an antibiotic that is part of a group of drugs known as fluoroquinolones. It is one of the most widely used antibiotics, and has been used by millions of Americans.

    Prior to the introduction of generic competitors, Levaquin generated over $1.3 billion in annual sales for the drug makers.

    Although the antibiotic has been on the market for nearly 20 years, it appears that potential Levaquin side effects have not been thoroughly researched and that inadequate warnings have been provided for users and the medical community about the risk of peripheral neuropathy, which can cause:

    Pain in the Arms, Legs, Hands or Feet
    Burning, Tingling or Numbness
    Weakness, Tiredness or Heaviness
    Sensitivity to Light Touches, Temperator and Motion
    LEVAQUIN NERVE DAMAGE SIDE EFFECTS: Scientific evidence has established a link between fluoroquinolone antibiotics and peripheral neuropathy for decades, with the first published case reports coming as early as 1992.

    Concerns about the development of peripheral neuropathy after using fluoroquinolones was raised by doctors from Infectious Disease Clinic and Microbiology Laboratory at Institut Jules Bordet of Belgium in 1992, in a letter to the editor of The Lancet, which outlined a case involving a 37 year old patient.

    In 2001, a published study in the U.S. examined dozens of reports involving long-term peripheral neuropathy nervous system damage following use of fluoroquinolone antibiotics, finding that over half of patients continued to experience symptoms more than a year after last use of the medication. Approximately 80% characterized the peripheral neuropathy problems as severe.

    Although peripheral neuropathy warnings were added to many of the medications in September 2004, it appears that this information was false and misleading. The warnings suggested that the peripheral neuropathy problems from Levaquin were “rare” and failed to disclose that users may be left with permanent nerve damage.

    Many users may have been able to avoid permanent and debilitating nerve injury if adequate information had been provided about the potential link between Levaquin and peripheral neuropathy, informing users and the medical community about the importance of switching to a different antibiotic upon the onset of symptoms.

    In August 2013, the FDA announced that new and stronger warnings would be added to Levaquin, Cipro, Avelox and other fluoroquinolone antibiotics. The new warnings remove prior claims that the nerve damage cases were rare, and indicate that the problems may affect users for years after they stop taking the drug. In many cases the peripheral neuropathy causes permanent disability and limitations for the remainder of the users life.

    – See more at: http://www.aboutlawsuits.com/levaquin-1119/#sthash.pRDOrFrL.dpuf

    Janssen Pharmaceuticals, Inc.
    OVERVIEW: Levaquin (levofloxacin) is an antibiotic that is part of a group of drugs known as fluoroquinolones. It is one of the most widely used antibiotics, and has been used by millions of Americans.might assume that a pharmaceutical representative might have been forewarned about taking a drug so dangerous that it can cause a lifetime of irreversible agony, but the bitter irony is that not even the representatives have been made fully aware of the flaws and dangers in many of the drugs they are selling, due to what alleges are deceptive marketing practices.

    Prior to the introduction of generic competitors, Levaquan generated over $1.3 billion in annual sales for the drug makers.plus 1.50 billion in their sister company Bayer

    Although the antibiotic has been on the market for nearly 20 years, it appears that potential Levaquin side effects have not been thoroughly researched and that inadequate warnings have been provided for users and the medical community about the risk of peripheral neuropathy, ligament rubture which can has cause:

    Pain in the Arms, Legs, Hands or Feet
    Burning, Tingling or Numbness
    Weakness, Tiredness or Heaviness
    Sensitivity to Light Touches, Temperator and Motion
    LEVAQUIN NERVE DAMAGE SIDE EFFECTS: Scientific evidence has established a link between fluoroquinolone antibiotics and peripheral neuropathy and ligament rupture tendentes for decades, for the rest of my life because Johnson & Johnson failed to Warn and hid the facts of the potential danger of levaquin so Levaquan alleges are deceptive marketing practices.
    generated over $1.3 billion in annual sales for the drug makers.n Profit over lives
    now I a being represented by barn & bud pharmaceutical class action lawyers to get after them and help me get justice and live a better life pray for me one day at a time
    Risperdal: Courtesy of JNJ CEO Alex Gorsky – this corrupt mess was his project while in control at Janssen. Hard to believe this asshole is CEO. Was Billy-Boy Weldon in his right mind when he chose Alex as CEO?
    Federal: $2,200,000,000 ($2.2 BILLION)
    Arkansas: $1,200,000,000 ($1.2 BILLION)
    South Carolina: $327,000,000 ($327 million)
    Texas: $158,000,000 ($158 million)
    Louisiana: $258,000,000 ($258 million)
    36 states, class action: $181,000,000 ($181 million)
    Kentucky: $ Currently in litigation I hope my lawyers and my government will correct this injustice relive some of my pain that I I dored fore the last 12 years stop it now so there is no more victims that have to go threw this agony can't the doctor read and educate them self. Or are the looking the other way for there own profit let stop this madness I would like to see the C.E.O president of Johnson& Johnson take and give to his family levaquin intervenes for 15 days 24 hours a day and 30 day percrption of any one of the 3 drug and prove we are all wrong please join me on this fight we the people are stronger together and not afraid of them like the news channels r scared that the multimillion of advertisements of J&j would threatening to pull there adds and profits now I just reliese that I have to say one last thing now. That I am forced to give the drug companies more $$$ For the drugs I have to take for the pain
    Thay created waow can u believe that please contact me with any news that is out there. thank you

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