November 2016 Patient Network Digest
Visit our website to see what we've added! 

 Please email Miara at  mj@center4research.org if you have any comments or suggestions.
|| NEWS ||NEWS
Introductory Patient Training Workshop

Our third Introductory Patient Training workshop was a success! Thirty patient advocates representing over 20 states came together to learn about research issues important for determining the safety and effectiveness of treatments. The workshop featured the following guest speakers:
  • Dr. Susan Wood (former FDA associate commissioner for women's health and current Professor at GWU), who told patients how to get their voices heard at the FDA
  • FDA's Salina Prasad and Andrea Furia-Helms, who answered questions on behalf of the FDA Patient Representative Program
  • Kim Witczak (Founder of Woody Matters), who shared her journey to patient advocacy)
Patient advocates learned the different types of clinical trials, how the FDA approval process works, and why subgroup analysis matters. Participants also learned how to examine and question information advertised on TV drug commercials. One of the highlights of the workshop was the Mock FDA Advisory Committee meeting, where NCHR staff and participants played committee members, public comment speakers, an industry representatives and a FDA reviewer to discuss the risks and benefits of the sleeping pill, Belsomra.   

Great news! Although participants knew a lot before the workshop, they learned even more! Workshop participants really enjoyed every part of the Workshop. On a 5-point scale, every presentation was rated an average of 4.7 or higher! 

All of the slides from the Workshop are available in the tools section of our website at www.USAPatientNetwork.org 
You can see the Twitter conversation by following #PatientNetwork
Upcoming Opportunities
Unapproved Uses of Approved Medical Products 
Advisory Committee Meeting
November 9-10, 2016
(Several Patient Network members will be speaking!)
 
Substitutability of Generic Drugs:
Perceptions and Reality Workshop
November 18, 2016

For more information  please click here.
In the News

Liberal groups urge Congress to delay 21st Century Cures until after lame duck session. [ Read more]

NCHR President, Diana Zuckerman  tells FDA that biosimilars don't always  make drugs  more affordable, like they are  supposed to.   [Read more]

For more news, check out the News section of our website .
|| SPOTLIGHT ON NETWORK MEMBERS ||Spotlight
Rachel Brummert and Jonathan Furman 
Quinolone Vigilance Foundation 

Rachel Brummert is the President and Executive Director of the Quinolone Vigilance Foundation and Jonathan Furman is the Virginia ambassador for the foundation, a nonprofit established to answer the call of countless victims affected by the adverse reactions of fluoroquinolones (a type of antibiotic drug).  They are building an international  awareness movement to educate the public about the dangers of fluoroquinolones .

Why did you become an advocate?
Like many people who become active in advocacy, we both had something terrible happen to us as a result of medical harm. We both suffered severe and permanent adverse reactions from a class of antibiotics called fluoroquinolones. Rachel became disabled in 2006, after taking Levaquin for a suspected sinus infection. Jonathan's life was altered in 1999 after taking Cipro and Levaquin. We were never warned of the adverse reactions and we were both told that they were safe. 

After doing some research and connecting with others, we learned this happens to people worldwide at an alarming rate. Fluoroquinolones such as Levaquin, Cipro, and Avelox are meant for the treatment of life-threatening infections. However, they are commonly, and inappropriately, prescribed as a first line of defense for routine infections. The more we learned about fluoroquinolone antibiotics and their associated risks, the more compelled we felt to do something about it. We felt we had two choices: accept that this is the way things are and find a way to live with it, or make changes to pave the way for others and make patient safety a priority. We chose the latter.  

What is your advice to others that are just starting their advocacy?
Your voice is important and you can be a voice for the voiceless. You deserve a seat at the table so that patients have a role in making changes. Keep sharing your story. Not only have you been harmed, so many others have been harmed also and it is important to network. Be persistent and be confident in your skills as an advocate.

What is your greatest accomplishment as an advocate?
There have been many, such as working with Congressional leaders, testifying at the FDA several times, collaborating with agencies such as the Centers for Disease Control and Prevention on awareness and communication campaigns, and working closely with the media to raise awareness. If we had to pick just one, it would be that our work has helped save the health and lives of patients internationally. It is very rewarding and it fuels us to do even more to help others. 

What challenges did you face becoming an advocate? 
One of the many challenges is that doctors do not tend to believe that antibiotics can do more harm than good, so many patients are dismissed by the medical community. Another is that we learned that it's the entire healthcare system, the FDA, and the pharmaceutical industry that needs changing, not just changing the labels on antibiotics. Further, there is a lot of sabotage and opposition to overcome when you're an advocate. We've also learned that self-care is very important because sometimes we are so invested and passionate about what we're doing in the fight to protect others that we forget to take care of ourselves.

How should we move forward dealing with this issue?
Transparency is very important when addressing harm caused by medications and devices. Moving forward, we should put more focus on disclosure and communications of fluoroquinolone issues to patients and prescribers. It is also hard to make changes when more work needs to be done to put together the big picture. It would be helpful to better assess the depth of the damage done to patients. It is more widespread than we even realize. In addition, we need to work on policies across the board if we are going to be effective in protecting more patients from harmful medications.
 
What can be done to prevent this from happening to others?
Education is important so that patients and prescribing 
physicians are aware that the risks can outweigh the benefits with fluoroquinolone antibiotics in certain medical conditions, and should be used as a last resort and for life threatening infections. The adverse reactions associated with this class of antibiotics can be permanent, and sometimes the cure for a condition can be worse than the condition itself. Know when an antibiotic is appropriate and when it isn't, and educate yourself about risks.

What are your goals for the USA Patient Network?
Our goals are to collaborate with other patient advocates in the network, learn more about how to navigate a complicated healthcare system, and help agencies and researchers determine outcome measures so that what happened to us doesn't happen to others. We believe that we as a network can make vital and life-saving changes to a broken system together. 
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USA Patient Network | mj @center4research.org | Washington DC