April 2017 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.
Last chance to apply for our upcoming
Introductory Patient Advocacy Workshop
June 2-3, 2017
Washington, DC

Please share with anyone you know that might be a good addition to our Patient Network! 
For more information please visit our website:
You're Invited!
Every year we honor Foremothers who have broken barriers for women while improving the lives of men, women, and children. This year's foremothers are news anchor Maureen Bunyan and former ambassador Melanne Veveer. We are also honoring Health Policy Heroes, Sarah Jane Tribble  and  Sydney Lupkin of Kaiser Health news for their ongoing investigative series raising awareness about the unintended consequences of federal policies on orphan drugs. We welcome you to join us on  May 15  in honoring these wonderful women. See sponsorship and ticket information here.
 FDA Finally Agrees Breast Implants Linked to Rare Cancer  

The FDA finally announced that they agree with the World Health Organization (WHO) that breast implants can cause cancer of the immune system. The agency says it has received 359 reports of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Since reports are voluntary, it is assumed that this is just the tip of the iceberg. 

The FDA says BIA-ALCL is typically diagnosed about a decade after getting breast implants and is more common for women with textured implants. Although the FDA and plastic surgeons say that BIA-ALCL is rare, there is conflicting information about just how rare it is. According to Australia's health agency, BIA-ALCL affects 1 in 1,000 women with breast implants, which is more common than U.S. estimates. However, there's no reason to think the disease would differ among women with breast implants in different countries. To find out just how worried women should be about this rare cancer,  c lick   here .

The media didn't "discover"   that breast implants can cause cancer until FDA's announcement a few weeks ago, but the truth is that experts have known that breast implants cause ALCL since at least 2013, and some of the foremost plastic surgeons in the country were discussing it behind closed doors since at least 2010. You can read Dr. Zuckerman's blog for the full history in

This is a shout out to Patient Network member Jamee Cook, who first pointed out to us that FDA had not updated its website to indicate the link between ALCL and cancer. Building on Jamee's research, we contacted FDA officials with specific suggestions, and they agreed to update
their website. Great work Jamee, as well as the other Patient Network members at work on this issue, including Raylene Hollrah (ALCL survivor), 
Chandra DeAlessandro, and Nicole Weber!
...More in the News

Brand name drug makers can change product labels after learning of potentially harmful side effects, but generic companies cannot do the same unless the corresponding brand name drug has already made the change. Generics account for 90% of prescriptions written in the US. This puts patients at risk if the FDA fails to implement this rule to generic drug companies.  [ Read more]

This excellent article in Milbank Quarterly summarizes the history of FDA's important role in protecting Americans from unsafe and ineffective drugs and devices. Nevertheless, the agency often gets attacked for keeping unteste d products away from patients, with too little attention to harm that is done by dangerous products that were approved without sufficient safety studies.
Read more ]

For more news, check out the News section of our website .
Congratulations to our new Board of Directors!

 Rachel Brummert, Jamee Cook, Veverly Edwards, Janet Holt, John James, Meghan Mimnaugh, Beverly Pennington, Linda Radach, Dru West and Kim Witczak have been elected to serve as the USA Patient Network Board of Directors.
Congratulations and thank you for your commitment and service to the USA Patient Network!
NCHR staff Jack Mitchell attended a Consumers United for Evidence (CUE) meeting on March 19 in New York City. The all-day program focused on the politics of consumer advocacy and progress in patient/consumer engagement in healthcare decision-making and research. Dr. Vinay Prasad, Assistant Professor of Medicine at the Oregon Health and Sciences University, gave
an  excellent keynote   on how some advocates harm their credibility by accepting excessive amounts of pharmaceutical and medical device industry contributions.
Janet Holt - Floresville, TX 

Janet Holt participated in our October 2016 Workshop.  She
became a patient advocate after being  injured by a transvaginal mesh implant and undergoing 14 mesh-related reconstruction surgeries. Since then she has been dedicated to educating and supporting other women harmed by this device.   

Why did you become an advocate?
I believe most people become advocates after they themselves or someone they love has been harmed by a medical device or a drug. It is a way to look for answers when none can be found. A way to feel empowered after a personal disaster has taken over your life through no fault of your own. It was a way of learning so I could understand "why" it happened to me.  
What is your advice to other advocates?
Technology has made it so much easier than it used to be. So much has changed in the 10 years since I was first injured. I think it is important to first find others who are facing the same challenge as you. At the beginning of the injury, you may feel that you are the only one in the world facing this type of injury. Trust me, you are not. Reach out to others and try and start a Facebook group. Use Twitter to find others. Come together if possible or via a conference call. There is strength in numbers moving forward. Become involved with the National Center for Health Research (NCHR). They can give you so much advice in ways to move forward. Join other patient advocacy groups to learn what areas they have had the most success. It really doesn't matter if their medical device or drug is different from yours. Patient safety is the umbrella that brings us all together.
What challenges did you face becoming an advocate?
My own limitations. I was so injured when first trying to speak out.  It was difficult to make all the long travel journeys to Dallas and DC. It was hard for me to understand in the beginning why sick and injured patients were the ones who had to speak out on dangerous devices. Why weren't the doctors the ones speaking out on behalf of their patients who had been harmed? After 10 years it has become easier to travel to speak out. It has been a very long journey.

What is your greatest accomplishment as an advocate? 
I don't know if I can find just one. When the phone rings and at the other end is a woman crying. It may take her a while to finally speak but she does. I just listen. They are in pain and looking for answers. There are none to be found in the medical community. I take satisfaction in being able to let each woman know that they are not alone, and their pain is real. To be able to share my personal story with each one about how I weaved in and out of so many doctor's offices until I finally found someone who could help me. It gives them so much hope that answers are out there. 
The other accomplishment may be when the medical device called " mesh" was reclassified to one of the most dangerous medical device categories. It took so many women speaking out on the device that had harmed over 100,000 women. 
What can be done to prevent this from happening to others?
I know of no answer.  There is not one. At least not yet. It will take organizations like NCHR, Consumers Union, USA Patient Network and individual patient involvement.  It will take legislative change to make all medical devices safer. It will take a complete overhaul of the out-dated 510 (k) process. Clinical trials that are broader in scope, longer-term data collection, a better reporting system, and tracking of devices implanted inside the body to just name a few.
How should we move forward dealing with this issue?
Legislation. It is a huge uphill battle for change but we must stay in the fight. Patient safety is one of the most important issues in healthcare right now. It will take pure determination on our part as injured patients to keep showing up at every event where anyone given the opportunity can speak. On the patients' part, it is a huge undertaking financially to show up but we must keep showing up.
"There is so much strength in numbers."

What are your goals for the USA Patient Network?
I am so excited about the new network. We will have one "umbrella" network that will allow us to share information and data with each other. This is going to be just awesome for anyone starting out as an advocate as well as us "older" advocates. The information flowing within such a broad network is going to be amazing. As advocates, having a network to keep us up to date on hearings, meetings, legislative activity and new information will allow us to grow and have the tools needed to do so. We will be so much stronger in our ability to influence Congress on changes for patient safety that are desperately needed. There is so much strength in numbers. That is my goal for the USA Patient Network. To be a network of information.  

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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 | mj @center4research.org | Washington DC