Saturday, December 19, 2015

QVF Year in Review 2015

QVF had a busy and productive year in 2015.
In January, Executive Director Rachel Brummert and Assistant Director Donna Schutz were interviewed by Health Cosmos. http://www.healthcosmos.com/community/fluoroquinolone_toxicity_41. QVF will be interviewed for a second interview in the coming weeks. 
 
In February, investigative reporter Jim Strickland and ABC2 in Atlanta, Georgia airs a story about the dangers of Levaquin. Featured are QVF Duluth, Georgia Ambassador Kathy Dannelly whose husband Chris died after taking Levaquin, as well as Quinolone Vigilance Foundation Assistant Director Donna Schutz and her fiancee Jeff Stephens, who is disabled after taking Levaquin: http://www.wsbtv.com/videos/news/channel-2-investigates-complaints-about-popular/vDDZZS/. The station told us that the original story is the biggest story in the last two years for the station, and that it was viewed on social media over 5 million times. To date, it is the most shared news story about Fluoroquinolone Toxicity. 
 

The following week, QVF Assistant Director Donna Schutz is featured in a radio show about Fluoroquinolone Toxicity http://www.progressivemedicalcenter.com/antibiotics-concerns/. Progressive Medical Center is the only medical center in the country that specifically treats Fluoroquinolone Toxicity and we appreciate all they do.
 
On March 3 the Quinolone Vigilance Foundation honored WSB-TV Atlanta reporter Jim Strickland and his team from WSB-TV. Pictured are Producer Kellie Burkett, Jim Strickland and Photographer/Editor Leah Dunn who worked very hard on the Atlanta news stories which featured QVF Ambassador Kathy Dannelly, QVF Assistant Director Donna Schutz, and floxie Jeff Stephens. Kathy Dannelly began working with WSB-TV on the story June 2013. Reporter Jim Strickland began working with us in October 2014. The original news segment was filmed in December 2014. Kellie, Jim, and Leah did an excellent job and it was a pleasure working with them.
 

 


Also in March, QVF's Vice President Chris Butler set up and was interviewed for a news story: http://www.kctv5.com/story/28170151/fda-evaluates-popular-antibiotic-that-patients-say-makes-them-sicker 
 
On March 13th, the Quinolone Vigilance Foundation held a fundraiser at the Grog and Tankard Sports Bar & Grill in Stafford, Virginia. Executive Director Rachel Brummert and QVF Ambassador Jonathan Furman were on hand to talk about our work and educate the patrons and we raised a lot of awareness. https://www.youtube.com/watch?v=8E01kFyqXDA . We thank Dark Anubis Promotions, Chris Welborn, and the bands Helafyde, Echoes of Solitude, goddess Crow, Service of Shadows, and ZFL for playing the event. http://quinolonevigilancefoundation.blogspot.com/2015/03/qvf-fundraiser-31315.html . 
 

March 27, QVF Executive Director Rachel Brummert testified at an FDA Hearing in Silver Spring, Maryland. Joining her were Lisa Bloomquist and QVF Ambassador Jonathan Furman. Rachel and Lisa testified in front of the FDA panel at the Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products Hearing. The FDA proposed a rule that would hold generic drug makers accountable for the damage their products cause and make them update their safety information. Due to the Pliva v Mensing Supreme Court decision, patients who are injured by generic medications cannot sue the drug maker, and generic drug makers are also not required to update safety information. The FDA was to make a decision in September 2015, and it was postponed to February 2016 and then to July 2016. (More on that later)

 
 


 
You can hear their testimony:
 
 
 
Rounding out March, QVF's Italy Ambassador Andrea Favero was featured in a newspaper article in Italy about fluoroquinolones.  



 
The same day as the QVF fundraiser in March, Executive Director Rachel Brummert and QVF Ambassador Jonathan Furman were interviewed in Fredricksburg, Virginia by WRIC-TV reporter Kerri O'Brien. It aired on April 23. The first video is the short version and the second video is the full version: http://wric.com/2015/04/21/8news-investigates-could-this-antibiotic-permanently-damage-your-health/





At the end of April, Rachel Brummert was interviewed by Dr. Joe Hudak and Dr. Chris Burfield for their podcast Journey to Wellness. http://hwcdn.libsyn.com/p/d/a/2/da255c17bcd3794a/013__Edison_NJ_Chiropractor.mp3?c_id=8894298&expiration=1450560766&hwt=1b4c3253c536b1fdf06baed7910a652a

June 13, 2015- QVF Executive Director Rachel Brummert and Treasurer Christina Manthos-Sorrell met up for a lovely visit and to discuss future QVF projects 
 
 


Around mid-June, Rachel Brummert was approached by actor, author, and international speaker Rivedal and asked her to participate in the i'mPossible Project. Rachel is one of 50 authors who share their stories. The book will be released January 13.  http://www.bizjournals.com/prnewswire/press_releases/2015/09/16/MN02683.  Per Rachel's request with the publisher, 100% of the proceeds from her portion of the book will be donated to QVF. Her story in the book has already raised awareness; people who have reviewed the proof copy of the book and some of the other authors have contacted her about her story and how they have been affected too.
 




 
On June 16, Rachel Brummert met Bob Grozier's family- his sister and mother. They had a wonderful visit. For those who don't know, Bob Grozier passed away in June 2014, 12 years after he suffered adverse reactions to Cipro. With the Grozier's blessing, QVF produced a video about his life and death. Bob was a staunch advocate and he helped untold numbers of victims despite his own suffering. We miss him very much.

 


QVF also produced a video called the Real Cost of Fluoroquinolone Antibiotics.




YouTube: https://www.youtube.com/watch?v=4UkAwJFyKNA

In July, QVF relocated to beautiful North Carolina from New Jersey. It was a lot of hard work and a lot of paperwork, but we have settled in nicely. Thank you for your patience while we were in transition.
 
In August, Wall Street Journal journalist interviewed Rachel Brummert and the article was published on August 3rd. Idelle did a fantastic job on the article and we thank her for her for her hard work. https://www.washingtonpost.com/national/health-science/it-pays-to-read-the-warnings-when-you-open-up-a-prescription/2015/08/03/a29e11b4-d70e-11e4-b3f2-607bd612aeac_story.html?tid=hpModule_9d3add6c-8a79-11e2-98d9-3012c1cd8d1e

Tulsa World http://www.tulsaworld.com/opinion/idelle-davidson-the-risky-business-of-taking-antibiotics/article_bcce562a-bd78-5d92-b156-6926115be61c.html?TNNoMobile
and http://www.courant.com/consumer/hc-ls-antibiotics-drug-reaction-20150821-story.html picked up the story.





At the end of August, QVF produced a video called Shattered Lives: Destroyed by Fluoroquinolone Toxicity. It was widely shared and we raised a lot of awareness. Thank you to all who shared it and participated in it. 

Facebook: https://www.facebook.com/video.php?v=956683854350489&set=vb.207825862569629&type=3&theater

YouTube: https://www.youtube.com/watch?v=DOEDyfvYo-o


We also got an update about the fluoroquinolone lawsuits that were filed by Baron & Budd law firm on behalf of clients who suffer with peripheral neuropathy. The cases were consolidated in Minnesota, which is good news. 
 
In September, Chris Butler joined our team and was elected to the Board of Directors in September 2015 and serves as Vice President. He works in Federal Employment Law, utilizing his skills in effective workplace communication, and problem resolution. Mr. Butler holds a B.S. in Human Resource Management from Friends University and an Associates Degree in Applied Science in Business. He retired from the United States Army in 2001 and has held many positions in his career including Instructor, Field Artillery Cannon Crew Chief, Survey Party Chief, leadership development training programs and Human Resources. He also currently serves as Ambassador for the Kansas City area. 
 
 Also in September, Steven Brill wrote a scathing 15 part series about Johnson & Johnson, “America's Most Admired Lawbreaker”. We are eternally grateful for his comprehensive coverage. http://highline.huffingtonpost.com/miracleindustry/americas-most-admired-lawbreaker/

Unfortunately, we did get some disappointing news. QVF had been trying to work with a mayor and a governor to bring awareness about fluoroquinolone toxicity and to have it recognized on a local and state level. After submitting the necessary applications, paperwork, and documentation, and waiting several months for a response, we received responses and unfortunately they have both rejected our applications.
 
We did our best and we will continue to approach other officials. The mayor declined on the grounds of this being too "controversial". The governor did not specify a reason.We obviously hoped for a different outcome, but this will not deter us from trying again elsewhere. As we like to say here at QVF "If someone tells you no, you are asking the wrong person". This illustrates an important point of what we are up against. It is difficult to get doctors to listen and it is difficult to get the attention on fluoroquinolone toxicity that it deserves. We vow to keep trying and we will keep you updated on our progress.
 
In October, we spoke to Dr. Noble from the University of Rochester for an update on his research. Dr. Noble ran into a bit of an issue in regards to the preclinical phase of the research study. However, he has assured us that this issue is of little importance. The more important thing we can share is that he has identified a team that has a mouse model predisposed to certain factors in their health in order to better represent the spectrum of problems that have been caused by FQ exposure that will help him push forward in the study. This avenue looks very promising and we look forward to seeing where this goes. As always we appreciate his hard work.
 
On November 4, Executive director Rachel Brummert and author Josh Rivedal were interviewed about their upcoming book The i'Mpossible Project: Reengaging with Life, Creating a New You, due out January 13, 2016. Ms. Brummert was also interviewed about the FDA hearing at which she was testifying the following day. http://wric.com/2015/11/04/fda-to-hear-patient-complaints-about-commonly-prescribed-antibiotics/
 

 


Ms. Brummert and QVF Ambassador Jonathan Furman presented a plaque to reporter Kerri O'Brien for all of her coverage on fluoroquinolones since April. Ms. O'Brien has run several stories on fluoroquinolones and she also covered the FDA hearing which was happening the next day. Thank you to two very generous QVF staff who paid for Ms. O'Brien's plaque out of their own pockets.  



Rachel Brummert and Jonathan Furman joined 33 others, many of whom are victims of fluoroquinolones, and testified at the FDA at the Antimicrobial Drugs Advisory Committee (ADMAC) and Drug Safety and Risk Management Advisory Committee. 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. 
 
Thank you to everyone who traveled to Maryland to speak and those who came to support the speakers. Seeing everyone come together to call on the FDA to take action on fluoroquinolones was a wonderful experience.
 
To hear everyone's testimony, click here: https://collaboration.fda.gov/p7q9g54ygww/?launcher=false&fcsContent=true&pbMode=normal


Ms Brummert wrote a guest blog about testifying at the FDA. https://baronandbudd.com/protecting-whats-right/2015/11/fda-takes-notice-of-fluoroquinolone-associated-disability/?utm_source=facebook&utm_medium=social&utm_content=Oktopost-facebook-profile&utm_campaign=Oktopost-FLQ




The twenty-one member FDA panel voted 21-0 for a label revision on sinusitis, 20-1 for UTIs, and 18-2 with one abstention for bronchitis. http://news.sys-con.com/node/3553775.

We await a decision from the FDA about when/if they will implement the panel's recommendations.
Also in November, QVF produces a video called “But You Don't Look Sick”, putting in the spotlight that fluoroquinolone toxicity is an invisible illness. https://www.youtube.com/watch?v=bof4-Uyt7ME

Consumer Reports mentions fluoroquinolones in their Consumer Reports Health Letter. QVF has been talking with them and we look forward to more projects.
 



Journalist Yee-Liu Williams wrote an article about the November FDA hearing and quoted executive director Rachel Brummert in her article. https://medium.com/the-intrepid-fascinator/fluoroquinolones-an-advisory-fda-panel-urge-drug-companies-for-clearer-and-prominent-label-1c6a2980fe5f#.euxpmg3mq

In December, we had the sad duty to inform everyone that Dr. David Flockhart from the University of Indiana passed away. Dr. Flockhart had treated patients with FQ Toxicity for years and was a leading doctor in this field. He will be missed and our thoughts and prayers are with his family during this difficult time.http://www.legacy.com/obituaries/indystar/obituary.aspx?n=david-a-flockhart&pid=176686429
 
QVF also added attorney Scott Harford to our website on the Fluoroquinolone Lawsuits page. http://www.saferpills.org/resources/fluoroquinolone-lawsuits/
 
Mr. Harford has been representing individuals suffering from Avelox-induced structural eye injuries since 2013. http://harford-law.com/aveloxocular-injuries/  
 
His law firm is accepting cases from all 50 states. If you have structural eye injuries as a result of Avelox, please contact Mr. Harford for a free case review.
212-390-8983
299 Broadway, Suite 1310
New York, New York 10007
scott.harford@harford-law.com
 
As always, the Quinolone Vigilance Foundation receives no compensation of any kind from the law firms listed on our website. There are several other attorneys who are taking cases who are not listed on our site. To be listed on our site, we must be able to interview them extensively, review their CVs, and be able to verify with the American Bar Association that they are attorneys in good standing. All three criteria are required to be listed on the QVF website. Whether listed on our site or not, it is important that you are comfortable with any attorney you choose and we encourage victims to use who they are comfortable with. 
 
Also in December, QVF received the disappointing news that the FDA decision regarding the generic loophole was delayed a second time (we started talking about this earlier). The hearing was on March 27, 2015 and a decision was supposed to be reached in September 2015. The decision was then delayed until February 2016. In the FDA's agenda, released in November, the decision was again delayed and now it is scheduled for July 2016. QVF issued a press release urging the FDA to stop with the delays and put patient safety first, echoing outrage by Public Citizen. http://finance.yahoo.com/news/fda-delay-safety-rule-leaves-140200312.html 
 
QVF also weighed in on the 21st Century Cures Act, a bill that was passed in the House of Representatives, and now the Senate is working on a similar one. Unfortunately, the 21st Century Cures Act has several provisions that are especially worrisome and would weaken consumer safety, leaving patients exposed to potentially unsafe medications. QVF contacted North Carolina Senators Richard Burr and Thom Tillis urging them to amend the bill before it becomes law. If the law passes “As Is” consumer protection will take an even deeper hit than it already is. We urge everyone to join us in urging the Senate to make necessary changes to the bill before it is too late. https://www.facebook.com/notes/quinolone-vigilance-foundation/call-to-action-21st-century-cures-act/1056122027740004
 
Many news stories ran this year. It's been continuous coverage since November of last year and we are very proud of everyone who reached out to the media and told their stories. Fluoroquinolone toxicity reached a new level of advocacy this year and we could not be more pleased of everyone's advocacy efforts. Keep up the good work! https://www.facebook.com/notes/quinolone-vigilance-foundation/qvf-fqs-in-the-media/866857179999824 
 
On December 16, we were asked by the National Center for Health Research to join the Patient, Consumer, and Public Health Coalition. We are truly honored and we thank NCHR for recognizing our work.
 
Sadly, we had to postpone our annual auction twice in November due to staff medical emergencies and deaths in our families. We don't yet know when it will be rescheduled but we are doing our best. In the meantime, please support QVF through our online store www.cafepress.com/quinvigil, KonectIDY http://konectidy.com/charity/quinol..., via PayPal using donations@saferpills.org or a check to Quinolone Vigilance Foundation, 9817 Stephen Thompson Lane, Charlotte, NC 28213. Your donation will help us continue our work in advocacy, educating doctors, and funding upcoming research. QVF is a 501(c)(3) organization and donations are tax deductible. QVF staff are all volunteers and we receive no compensation of any kind. We do not have sponsors and we rely on private donations. Thank you to everyone who donated to us in 2015. We take our responsibility to the fluoroquinolone community very seriously and we got a lot done thanks to your support.
 
QVF has accomplished quite a bit in 2015, and we are looking forward to another productive year with your support.
 
Without all of you, our Board of Directors, volunteer staff, and Ambassadors, we would not be able to do what we do. 
 
Rachel Brummert, Executive Director
Chris Butler, Vice President
Donna Schutz, Assistant Director
Leslie Day, Assistant Director and Secretary
Christina Manthos-Sorrell, Treasurer
Victoria Chiovare, Fundraising Director
Jenny Frank, Public Relations Director
 
 





 

Quinolone Vigilance Foundation: Who We Are, What We Do video






Our latest video about who we are and what we do.


Monday, December 7, 2015

Call to Action: 21st Century Cures Act




Recently, The House Energy and Commerce Committee of the U.S House of Representatives unanimously passed the 21st Century Cures Act in a 51-0 vote, essentially putting pharmaceutical companies before patient safety. The U.S Senate is working on similar legislation.
Unfortunately, the 21st Century Cures Act has several provisions that are especially worrisome and would weaken consumer safety, leaving patients exposed to potentially unsafe medications.
The bill weakens an already flawed system and would lower the standards by which the FDA approves antibiotics, putting patients at risk and giving companies big shortcuts when it comes to clinical testing of high-risk antibiotics like fluoroquinolones.
If enacted into law, the 21st Century Cures Act would allow for more fast-tracking of medications, and eliminate Phase III clinical trials as a requirement for drug approval. Phase III is when the drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. Eliminating this important phase would mean that the FDA would be able to approve drugs based on smaller phase II studies alone. Many medications, especially fluoroquinolone antibiotics, come with adverse reactions that are not known until long after the drug is approved. Bypassing critical safety protocols by fast-tracking medications means that more patients will not find out how dangerous they are until years later. Post-market surveillance relies on human subjects to provide the data to prove safety and effectiveness of a medication after it has been approved by the FDA. Alarmingly, there are no provisions in the 21st Century Cures Act to fund the FDA's examination of post market data.
The current version of the 21st Century Cures Act would allow consideration of drug approvals based on case studies and medical journals alone, rather than making considerations on evidence-based science and data. The legislation seems backward rather than forward-looking, contrary to what its name suggests. In an era of big data and high tech breakthroughs in medicine, institutional acceptance of non-scientific approaches sends the wrong message about the FDA's role in protecting the public. It risks losing the respect and support of the scientific community and the public. In effect, the FDA would give no more assurance than a patient's favorite health magazine which, however reputable, is not based on controlled experimental evidence, but is a collection of opinions from conflicting sources with potentially varying agendas. Patients would surely wonder whether their tax dollars are being spent wisely.
Additionally, the 21st Century Cures Act will encourage the production of new antibiotics, regardless of their safety profile or mechanism of action. The legislation includes incentives to prescribe newly developed antibiotics. Hospitals would receive a bonus for using new antibiotics, that would lead to more over-use and antibiotic resistance, which undermines one of the issues the legislation is supposed to address. Antibiotic resistance is a rapidly growing epidemic. The answer to antibiotic resistance is not the development of new antibiotics. It is the over-prescribing and over-use of existing antibiotics that caused it in the first place. Instead of using fluoroquinolone antibiotics as a last resort for life-threatening infections such as anthrax, doctors are prescribing them for routine, simple infections for which there are safer alternatives. Encouraging the production of new, more powerful antibiotics will only compound the problem, and disable and kill people more than fluoroquinolones already are. But if the 21st Century Cures Act passes, removing regulatory and procedural requirements from the drug approval process is exactly what will be allowed to happen. Instead of protecting patients from already dangerous antibiotics, this will only encourage even more dangerous antibiotics to enter the market and put more patients at risk.
A preventable problem is a fixable problem and we can fix the flaws so patients are protected with improved treatments that are safe and effective without compromising patient safety.
The bill has already passed in the House of Representatives, but it has not in the Senate. It is up to us to voice our concerns about this legislation and let our elected officials know that patient safety should be of paramount importance and that the loopholes in this legislation must be closed. There is still time to amend legislation before more lives are destroyed.
Contact the primary authors of the bill- Congressman Fred Upton and Congresswoman Diana DeGette- and let them know how you feel about this legislation and how it will lead to more preventable harm. Also contact your Senators. The Quinolone Vigilance Foundation has already sent letters, which you may use as an example, or write your own. Please join us and demand that the Senate puts patients first. It is not too late to get this bill amended by the Senate before it becomes law.
Letter from the Quinolone Vigilance Foundation to North Carolina United States Senators Richard Burr and Thom Tillis:

Dear Senators Burr and Tillis,
I am writing to express my concern over a bill recently passed by the U.S. House of Representatives that would lower the Food and Drug Administration's standards for approving drugs and medical devices. As you consider legislation intended to promote medical innovation, I strongly urge you to reject provisions that would undermine the FDA's ability to make sure treatments are safe and effective.
In 2006, I became disabled after suffering severe adverse reactions to the fluoroquinolone antibiotic Levaquin. To date, I have ruptured ten (10) tendons, and endured over a dozen other adverse reactions including a neurodegenerative disorder, from which I will never recover. 
If enacted into law, the 21st Century Cures Act would allow for more fast-tracking of medications, and eliminate Phase III clinical trials as a requirement for drug approval. Many medications, especially fluoroquinolone antibiotics, come with adverse reactions that are not known until long after the drug is approved. Bypassing critical safety protocols by fast-tracking medications means that more patients will not find out how dangerous they are until years later. Post-market surveillance relies on human subjects to provide the data to prove safety and effectiveness of a medication after it has been approved by the FDA. Alarmingly, there are no provisions in the 21st Century Cures Act to fund the FDA's examination of post market data.
The current version of the 21st Century Cures Act would allow consideration of drug approvals based on case studies and medical journals alone, rather than making considerations on evidence-based science and data. This seems backward rather than forward-looking, contrary to what its name suggests. In an era of big data and high tech breakthroughs in medicine, institutional acceptance of non-scientific approaches sends the wrong message about the FDA's role in protecting the public. In effect, this would give no more assurance than a patient's favorite health magazine which, however reputable, is not based on controlled experimental evidence, but is a collection of opinions from conflicting sources with potentially varying agendas. Patients would surely wonder whether their tax dollars are being spent wisely.
Additionally, the 21st Century Cures Act will encourage the production of new antibiotics, regardless of their safety profile or mechanism of action and includes incentives to prescribe newly developed antibiotics. That would lead to more over-use and antibiotic resistance, which undermines one of the issues the legislation is supposed to address. Antibiotic resistance is a rapidly growing epidemic. The answer to antibiotic resistance is not the development of new antibiotics. It is the over-prescribing and over-use of existing antibiotics that caused it in the first place. Encouraging the production of new, more powerful antibiotics will only injure, disable, and kill more patients instead of protecting them from already dangerous antibiotics.
But if the 21st Century Cures Act passes, removing regulatory and procedural requirements from the drug approval process is exactly what will be allowed to happen.
A preventable problem is a fixable problem and we can fix the flaws so patients are protected with improved treatments that are safe and effective without compromising patient safety.
The bill has already passed in the House of Representatives, but it has not in the Senate. Going forward, the Senate must amend the serious mistakes made by the House. I strongly urge you to put consumers first in the medical marketplace, and keep treatments safe, effective and affordable.
Please take measures to balance the 21st Century Cures Act to ensure that patient safety and consumer protection are not overlooked and adverse reactions to medications and medical devices are taken into consideration.
Thank you for your time and consideration.

Rachel Brummert
Executive Director
Quinolone Vigilance Foundation
Charlotte, NC

 
Response from Senator Thom Tillis on December 15, 2015

Response from Senator Richard Burr:


Press Release: FDA Delay in Safety Rule Leaves Patients at Risk








FDA Delay in Safety Rule Leaves Patients at Risk

Completion Date for Generic Labeling delayed until July 2016

CHARLOTTE, N.C., Dec. 7, 2015 /PRNewswire-iReach/ -- The Food and Drug Administration (FDA) has postponed for a second time a decision on whether to close an important drug safety loophole, leaving millions of patients who rely on generic medications at serious risk.

Currently, patients who are harmed by a generic drug cannot sue the manufacturer. Even more distressing, manufacturers of generic drugs are not required to update the patient warning labels like manufacturers of brand name drugs are.

The FDA has not yet finalized a proposed labeling rule and has several times delayed its expected completion date. Originally scheduled for September, it was delayed until February 2016. However, in its regulatory agenda, released in November, the FDA has now pushed back the date even further to July 2016.

The FDA's proposed rule is in response to a Citizen Petition filed by consumer safety advocacy group Public Citizen. On March 27, 2015 the FDA held a Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products hearing in White Oak, Maryland.
Rachel Brummert, executive director of the Quinolone Vigilance Foundation, testified on behalf of herself and other patients who took a generic fluoroquinolone antibiotic such as levofloxacin, ciprofloxacin, moxifloxacin and others, and were disabled by them. She urged the FDA to take action and close the generic drug loophole.

"Patients who are hurt by generic drugs should have the same rights as those who are injured by brand name versions of the same medications. Lives could be saved and injuries prevented if all prescription medications carried up-to-date and adequate warning labels. Finalizing the proposed rule by the FDA will promote safety by holding generic drug manufacturers accountable and would speed the dissemination of safety information to doctors and patients. A delay in finalizing the proposed rule will only lead to more patients being hurt", says Ms. Brummert.

Unfortunately, the delay has happened a second time, leaving Brummert gravely concerned. "More patients have been hurt, and will continue to be hurt, by generic medications due to this delay".
The generic drug loophole has gained the attention of United States Senator Al Franken, who asked FDA Commissioner nominee Dr. Robert Califf during a recent Senate hearing about the current plan to finalize the labeling rule.

Rachel Brummert, and other victims who were harmed by generic medications, are grateful that others are taking notice of this important proposed rule. "Generic drugs account for more than 80 percent of prescriptions in the United States, and under current guidelines, patients are at serious risk. The Quinolone Vigilance Foundation urges the FDA to close the generic loophole promptly and to end the delays to ensure that patients have access to updated safety information in a timely manner", affirms Brummert.

About The Quinolone Vigilance Foundation

The Quinolone Vigilance Foundation (QVF)--www.SaferPills.org- is a non-profit, charitable foundation that helps raise awareness about fluoroquinolone antibiotics and their dangers among patients and medical professionals, and funds research on fluoroquinolone toxicity.
Media Contact: Rachel Brummert, Quinolone Vigilance Foundation, 609-575-9839, rachel@saferpills.org

 

Sunday, November 15, 2015

Press release: New FDA Panel is a Big Win for Victims of Fluoroquinolone Antibiotics








New FDA Panel is a Big Win for Victims of Fluoroquinolone Antibiotics

Quinolone Vigilance Foundation Applauds the FDA Panel's Recommendation to Limit Fluoroquinolone Use

PR Newswire
CHARLOTTE, N.C., Nov. 12, 2015 /PRNewswire-iReach/ -- The Quinolone Vigilance Foundation testified before an FDA advisory panel last week to help save lives from the dangerous antibiotics known as fluoroquinolones. The FDA panel on fluoroquinolones is a big step in helping to keep patients who need antibiotics safe.

Photo - http://photos.prnewswire.com/prnh/20151112/286639

In a recent review, the FDA refers to the constellation of adverse reactions in previously healthy individuals as "fluoroquinolone-associated disability."

The FDA advisory panel voted 21-0 for a label revision on sinusitis, 20-1 for UTIs and 18-2 with one abstention for bronchitis. At this time, the panel cannot recommend language for stronger warnings because that is up to the FDA to decide. However, the fact that the panel recognized that the risks outweigh the benefits in fluoroquinolones is a big win for victims of fluoroquinolones.

The panel heard powerful testimony from 35 people, including the Quinolone Vigilance Foundation's executive director Rachel Brummert and Virginia ambassador Jonathan Furman.

In her testimony, Rachel Brummert stated, "These antibiotics have the 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."

Brummert's testimony comes after she was prescribed the fluoroquinolone Levaquin for a routine sinus infection in 2006. Weeks later, her achilles tendon ruptured in a parking lot, the first of ten tendon ruptures she was to endure during the next nine years, as well as other severe adverse reactions, some life-threatening.

According to Rachel Brummert, "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."

The complications associated with Levaquin and other fluoroquinolone antibiotics like Cipro and Avelox are severe and may be permanent and life-threatening.

The FDA's advisory panel hearing, and telling votes, is a necessary step in the right direction to keep patients safe from unnecessary and preventable harm and combating antibiotic resistance.
The Quinolone Vigilance Foundation urges the FDA to continue this necessary work by further regulating fluoroquinolones, strengthening warnings in clear language, and applying its highest level of scrutiny and surveillance of fluoroquinolones.

About The Quinolone Vigilance Foundation
The Quinolone Vigilance Foundation (QVF)--www.SaferPills.org-  is a non-profit, charitable foundation that helps raise awareness about fluoroquinolone antibiotics and their dangers among patients and medical professionals, and funds research on fluoroquinolone toxicity.

Media Contact: Rachel Brummert, Quinolone Vigilance Foundation, rachel@saferpills.org
News distributed by PR Newswire iReach: https://ireach.prnewswire.com

SOURCE Quinolone Vigilance Foundation

Guest blog: FDA Takes Notice of “Fluoroquinolone-Associated Disability”






*Guest blog written for Baron & Budd Law Firm. The original post can be found here:



Sinusitis, bronchitis and urinary tract infections are common infections that typically send patients to the doctor looking for relief.


Millions of prescriptions are written every year for fluoroquinolone antibiotics such as Avelox (moxifloxacin), Cipro (ciprofloxacin), and Levaquin (levofloxacin) in pill form, IV, and eye and ear drops. As the number of prescriptions have increased, so have the number of adverse reactions reported to the FDA. These adverse reactions encompass several body systems including the peripheral, autonomic, and central nervous systems, psychiatric, cardiovascular, musculoskeletal systems, and more.

The FDA is taking notice of this, and in a recent review, the FDA refers to this constellation of symptoms in previously healthy individuals as “fluoroquinolone-associated disability”.

Fluoroquinolones are incredibly powerful antibiotics with the capability to save lives when used appropriately as a treatment of last resort for life-threatening bacterial infections like anthrax. But these antibiotics also have the power to destroy lives when they are inappropriately prescribed for routine infections like sinus infections, uncomplicated UTIs, and bronchitis which don’t need their strength.

That is exactly what happened to me. I went to my doctor for treatment of a routine sinus infection and instead I was inappropriately prescribed an antibiotic that has disabled me.

On November 5, 2015, I was honored to testify at the FDA Joint Meeting of the Antimicrobial Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. (You can watch the video from the meeting here.) The panel discussed the risk/benefit ratio of fluoroquinolone antibacterial drugs for the treatment of routine infections. I shared my story of how I was an otherwise healthy individual who was prescribed Levaquin for a sinus infection in 2006 and became disabled with ten tendon ruptures, peripheral neuropathy, cardiac problems, and a progressive neurodegenerative disorder from which I will never recover.  My sinus infection would have resolved had I been prescribed a safer alternative and I would not have been exposed to the relatively disproportionate risks of known fluoroquinolone-associated injury.
And I was not alone. Thirty-four other people testified to their horrific injuries and disabilities, and some shared their emotional stories of having lost a loved one due to these dangerous antibiotics. We came together with the common goal of fighting for vital changes in how fluoroquinolones are prescribed to help save others from our fate.

We were heard and we made a difference. The panel agreed that the risks outweigh the benefits when fluoroquinolone antibiotics are inappropriately prescribed for routine infections. This is the first time that a government agency acknowledged how widespread the damage is. And that is huge.
The twenty-one member FDA 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 a decision on that matter would need to be made by the FDA. However, the FDA often implements panel recommendations and that is a reason for hope.

What happened to me, to everyone else who testified, and to everyone worldwide who could not be there in person was preventable. It is too late for us but not too late to save others. The FDA has a duty and a responsibility to protect the public and promote public health and therefore the FDA must apply its highest level of scrutiny, regulation and surveillance of fluoroquinolones to achieve that goal. We urge the FDA to implement the panel recommendations, strengthen warnings in clear language, and regulate fluoroquinolones so that they are only used in life threatening infections.
Anything less and more people will get hurt and that is not acceptable.

For more information about fluoroquinolones and our work at the Quinolone Vigilance Foundation, please visit our website www.SaferPills.org.


Rachel Brummert

About the Author:

Rachel Brummert is the Executive Director of the Quinolone Vigilance Foundation- www.saferpills.org. In her position, she guides strategic planning for the foundation and acts as its spokesperson. As someone who has been personally impacted by quinolone toxicity, she oversees the implementation and evaluation of the organization’s programs, and promotes collaboration with researchers, donors, politicians, community groups, and others to further the organization’s mission.
The views expressed herein reflect the opinions of the author and do not necessarily reflect the views of Baron & Budd, P.C., its affiliates or its employees.

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
www.SaferPills.org