June 2018 Patient Network Digest
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On May 4th three members of USA Patient Network met with the new director of the FDA Patient Affairs Office.  Jonathan Furman, Katherine Leon and Janet Holt, along with Diana Zuckerman met with the Director Andrea Furia-Helms. 

Andrea's office is located within the Office of the Commissioner. This new department was established in December of 2017. Its goal is to work with patients and family members seeking to address the FDA.

Andrea expressed a deep concern with the needs of patients and family members to have their voices heard by the appropriate FDA offices. The Patient Affairs Office will direct us to the right departments within the FDA to address our concerns.

Janet Holt and Jon Furman (pictured above right) and Katherine DeLeon attended the  National Center for Health Research's annual Awards  Luncheon  May 4th  at the Mayflower Hotel in Washington, D.C. It featured Maureen Bunyan a champion of DC news for 40 years, Dr. Rita Colwell who spent her life developing clean water around the world, Lynn Povich an award winning journalist advancing women's causes in all areas, and  two health policy heroes from Parkland, Florida: student  Kai Koerber  and teacher Susan Rioux, both of whom have  lobbied Congress for  safer  gun laws since the   February  shooting. This gathering turned into a chance to share our stories and recognize the fact that one advocate can overcome adversity to make a difference.

Members of USA Patient Network attended the premier of The Bleeding Edge documentary at the Tribeca Film festival. A story on the documentary film, which features several USAPN members, such as Angie Fermalino and Kim Hudak, may be found here.

Pictured: Linda Radach, Lisa McGiffert, and Kim Wit czak
Salute to a Champion of Patient Safety upon Her Retirement

Valiant, fearless, compassionate, a leader and nurturer, Lisa McGiffert of Consumer Reports has retired.  H aving been named as one of the nation's top 100 leaders in patient safety, Lisa's work is well-known.  Many of us know her personally, and are quick to say that her encouragement and support have helped us transition from angry, hurt people into advocates whose stories of pain and loss are being used to motivate others and impact changes in our healthcare system.  Lisa, you will be missed on the front lines, but we know you will always be engaged in patient safety and the efforts to bring an end to medical harm. Congratulations on your retirement!

Right to Try Legislation - A Shell Game for Patients
By: Linda Radach

The Right to Try Legislation (RTT), sponsored by Senator Ron Johnson (R-Wis.), chairman of the Senate Homeland Security and Governmental Affairs Committee, went through modifications in both the Senate and the House, and was eventually passed and sent to President Trump to be signed into law.

Supporters of the bill called the legislation compassionate and necessary in order to speed access to experimental drugs for terminally ill patients who have no remaining available approved options. The bill aims to remove the FDA from the process by which patients have access to experimental treatments, citing delays in access through the FDA's Expanded Access Program. Unfortunately, the belief that the FDA is a roadblock is unfounded; a fact which opponents pressed hard to expose.

Opposition came from patient advocacy groups, including the USA Patient Network, physicians, and drug companies. The FDA has provided access to new treatments in 99% of all cases while also providing the protection of requiring that drugs for which access is being requested have been clinically tested enough to provide at least a minimum of assurance of safety and efficacy. Other valid concerns include no cap on costs for treatments, and promises for which there is no evidence. There is nothing in RTT which requires the drug companies to provide access, and it is unlikely that many will grant use of a drug when the risks to future marketing are so high. Finally, adverse event reporting is not required. The Right to Try law promises hope to terminally ill patients and their families, but delivers a shell game.

Raylene S. Hollrah 

In the Spring of 2013 I was getting ready to turn 40, to some this is a milestone, to me it was blessing.  I was 6-years breast cancer free, living life every day as a blessing.  What I didn't know was around the corner; I was going to receive my second cancer diagnosis by the age of 40. 

I was diagnosed with Breast Implant Associated Ana-Plastic Large Cell Lymphoma (BIA-ALCL) in June of 2013.  I didn't even know I was at risk for this cancer.  I chose to do reconstruction after my breast cancer led me to a bi-lateral mastectomy.  I went to 3 plastic surgeons, and it took me 1 ½ years after my first cancer diagnosis to make the decision for reconstruction.  I felt like I educated myself about the risks, and I was ready to move forward with a safe decision to reconstruct my chest. 

After I was diagnosed, I became a patient at MD Anderson in Houston, TX because they were the most knowledgeable about my rare cancer.  During my doctor visits I had the pleasure of meeting Dr. Mark Clemens, Plastic Surgeon and one of the leading doctors regarding BIA-ALCL.  At the end of my first visit after we reviewed everything he asked if I had any questions. I asked, "How did I have an implant that was known to cause cancer with a tractable serial number and the FDA put out a warning, and I was never notified?"  He told me there was a lot of work to do on that front, and after he got me well we would work on it. 

After 5 months of being in Houston I came back to Missouri, ready to start advocating.  It wasn't easy at first. I felt very lonely advocating about the dangers of breast implants, a message many didn't want to hear, and I was told on countless times that I chose implants therefore I chose cancer.  In May of 2016 my advocacy efforts were ignited by meeting a fellow breast implant advocate, Jamee Cook, which led to a large group of wonderful women and advocates. Together our voices are greater. 

We have come a long way in the past 2 years, 2 testimonies in front of the FDA, the cover of the New York Times in May of last year and countless television interviews.  Even more so, we have pushed for better information educating women about the increase risk of BIA-ALCL, pushed for better education of Plastic Surgeons and for testing patients with symptoms. We have helped push for the acknowledgement by the World Health Organization to recognize this cancer, and that acknowledgment happened with the lead push by Dr. Mark Clemens. 

Our fight is not over and our numbers continue to increase by women that have been harmed by breast implants and cancer diagnosis.  Our strong social media outlets continue to grow and relationship with Dr. Diana Zuckermann has opened many doors for our advocacy efforts.  Dr. Zuckermann has helped lead the way with the FDA hearings and congressional meetings. I often say that I have lost my chest but I have not lost my voice. We have a lot more work to do and we will continue advocating about the dangers of breast implants.

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For more information about research results regarding numerous new drugs and devices, see www.center4research.org and www.stopcancerfund.org .
USA Patient Network | info@center4research.org  | Washington DC