Summer 2019 Patient Network Digest
Visit our website to see what we've added!

Welcome to new board members Angie Firmalino and Amanda Dykeman, who both came onto the board with years of advocacy experience on the issue of Essure and now other unsafe devices.

We sadly said goodbye and many thanks to exiting board members Janet Holt and Meghan Mimnaugh for their work on the board and their contribution in helping get our board up and running. We look forward to their continued work in the USA Patient Network.


Jamee Bramlett Cook, USA Patient Network board member, appeared as an invited speaker at the March FDA hearing on breast Implants. Read about her testimony here and here..

USA Patient Network's Linda Radach and Diana Zuckerman explain to ABC News in Atlanta that too many implants aren't studied on humans before being sold and too often patients aren't informed when implants are recalled. See the video here

We need your help on two important petitions to support two bills.

Links to sign both Petitions and tell your representative you want them to support these bills are given below.

The Medical Device Safety Act 2019 H.R. 2669

The bill would amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting all Class III devices. Including, but not limited to Essure, nerve stimulators, hip implants, defibrillators, pacemakers, infusion pumps, surgical mesh, cochlear implants, and breast implants. This bill is identical to The Medical Device Safety Act of 2009 that Senator Ted Kennedy introduced after the 2008 Riegel vs. Medtronic ruling, which had 23 cosponsors. Kennedy immediately recognized that the Supreme Court's interpretation of the Medical Device Amendment was inappropriate. However, when Kennedy passed away, the bill never went to vote.

Read more about H.R. 2669 and sign the Petition here.

The Medical Device Guardians Act of 2019 H.R. 2915

We are asking for your support of The Medical Device Guardians Act H.R. 2915. This bill will REQUIRE physicians to file an adverse event report with the FDA when they see a patient that has or had an adverse event from a medical device.

Currently, this is NOT a requirement!  Requiring this action will help to ensure that the FDA quickly flags devices that are causing injury or death.

Read more about H.R. 2915 and sign the Petition here.

The USA Patient Network responded to a Request for Comments
 on the Federal Register:  Modernizing the Food and Drug 
Administration's 510k Program.  You can read our response 
here. (The page is slow to load.)
USAPN Regulatory Watchdog Group Report to Network Membership
June 26, 2019
National Drug Pricing Discussion

The mission of the USA Patient Network revolves around safe, effective, and affordable medical treatments. Affordability is an access issue. The USA Patient Network Board of Directors has established a regulatory work group to act as a watchdog for the network as well as to bring proposed actions to the board and the network’s members.  The work group held a conference call to discuss the flurry of activity in Washington, DC over the past two weeks.  

In summary of the discussion, we first recognize that the psychology of hope, health, fear, and drug pricing is a major player that is not being acknowledged in the grand debate. In a market driven economy, products are priced at a level that the market will bear. Decisions made about drug pricing and demand for those drugs is not always rational.  Drug treatments represent hope for many who are plagued with particular health issues.  

It is not possible to put a price on hope, and yet it is well known that drug prices in the USA are higher than anywhere else in the world.  The solution is going to be found in a complex web of players.  
Manufacturers claim high costs for research and development demand high prices.  We know, however, that many times the research and development has actually been paid for with tax payer dollars through the work of the National Institute for Health. Internationally, other countries will point to our lack of a single payer health care system and the costs of direct to consumer marketing as two big reasons for the higher prices in the USA.  Much of this recent discussion was focused upon the need for cheaper generics as part of the solution, but that brings up another complex web of real dangers for patients.  Supply chain, quality, production costs, generic laws, marketing, insurance companies, our health care structure, for profit goals driving pharmaceutical companies, and intense lobbying efforts, are all significant pieces to this challenge.  
This work group will continue to seek to understand these dynamics, and we are looking for ways to impact a discussion at the national level, which up to this time, is just a hot political football.

Background Quick Links:  
  • Families USA's short analysis of Rep Lloyd Doggett's (D-TX) bill on lowering drug prices is here. Read the entire bill here: Representative Doggett's Medicare Negotiation Proposal to Meaningfully Lower Drug Prices.  
  • During the House of Representatives Energy and Commerce Committee hearing on drug price transparency, Frederick Isasi, Families USA Executive Director, testified.  He broke down the problem with high drug prices and potential solutions under consideration by the committee. Read his testimony here
  • The Senate Health, Education, Labor, and Pensions Committee held a hearing on a bill with sections to lower prescription drug costs  The link to Watch the Video and download testimony given is here.
  • Senate Judiciary Committee Meeting Video Link is here.
  • Updates from Prescription Justice Weekly Drug Prices Advocacy are here.
  • From Lobby Efforts Stall Drug Cost Reduction Efforts. Read here.
FDA Transparency News - Release of hidden adverse event/device malfunction report
As promised in late 2018, the FDA has released nearly six million adverse event reports from two previously hidden databases (DEN & ASR). Because the information is not user friendly, access is problematic.  In addition the reports only come with device problem codes, and are lacking explanatory narrative as well as patient outcomes.  The FDA - CDRH has been asked about the feasibility of including this data. Although some of the information dates back to the 1980's, it could be potentially valuable in potentially demonstrating that there were problems with certain devices (such as breast implants) years ago of which providers and patients were unaware.  If so, this would constitute a case of failure to warn.

While ending the ASR program, the FDA created, piloted, and began a new summary reporting system beginning in 2017 – the Voluntary Malfunction Summary Reporting (VMSR) program.  No deaths or serious injuries may be reported in this system. Breast Implant problems are not allowed in summary reports.  

Supposedly the data from VMSR is/will be accessible in the FDA MAUDE database, but the data is also redacted of valuable patient outcome information.
Link to the full FDA Press Release on Friday, June 21 is
Link to Released MDR Data Files is here

Linda Radach

As is true for all of us, I came to advocacy through the back door of medical harm due to metal on metal hip resurfacing devices. The doctor told me they were newly approved by the FDA and would last 20 years, perhaps my lifetime. Less than 2 years later, it became apparent that something was desperately wrong with one of the hip implants. Thirteen years later, I have had 6 total hip replacements, three on each side, and am presently looking toward surgery #7.

During the 6 years in which I had 5 hips replacement surgeries, I began investigating the original devices used in my hips. What I learned was appalling! The FDA did approve the devices, but not until three years after the first implant was placed in my body!

Many years ago growing up, my father would listen to me express my frustration or hurt regarding any circumstances having to do with injustice. He always ended the conversation the same way.

Dad: How do you spell your last name?
Me: L-E-S-L-I-E
Dad: That's right! Now what are you going to do about the situation?

I hated this little interchange, but looking back, I can see that my Dad gave me a sense of justice and the belief that I could take responsibility for that injustice. Thus my advocacy is focused on all medical devices, lifting up people who have been beat down by unfit devices, and advocating for legislative and regulatory changes that will make our medical treatments safe and effective.

I have served on Yale CORE TEP panels, received training at NCHR by Diana Zuckerman, am a member of the Patient & Family Engagement Network, as well as an admin for Medical Device Problems, a member of Patient Safety Action Network and the coordinator for PSAN Medical Device Roundtable meetings, and a founding board member with the USA Patient Network.




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