Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Twitter: @JjrkCh

Monday, December 3, 2012

Righteous Indignation!

Righteous indignation is typically a reactive emotion of anger over perceived mistreatment, insult, or malice. It is akin to what is called the sense of injustice. In some Christian doctrines, righteous indignation is considered the only form of anger that is not sinful.

ReginaHolliday, the Walking Gallery, just completed this amazing jacket for my brother, Steven Baker.  "Don't Tell Me To Zip It!" 

 What you see in our eyes is not disappointment, but righteous indignation!

The righteous indignation stems from research (my blog is an aggregate of that research) that easily uncovers a continuing systemic abuse of our government by elements of the entitled implanted medical device industry.  The indicators are patient harm (mutilation, torture) and futile class action lawsuits that do not stop the perpetrators from exploiting others. 

This morning the Senate Medical Technology Caucus was briefed  (with the FDA/CDRH) about the new “Medical Device Innovation Consortium” an unnecessary and redundant platform for the industry to influence regulators and legislators.

Patients are the primary stakeholders.  Patient engagement is a term that is not being honored.  I am witness as a patient advocate who has dedicated much of my life the last 5 years to following protocol to determine why my brother’s elbow implant failed and to get him the care that he needs.   It is clear to me that our government (FDA) is unable to assure that implants are safe and effective and subsequently unable to provide justice/assistance to correct the system so this does not happen to others. 

The cost of this failure to U.S. healthcare consumers is staggering, but the profit of the device industry is driving exploitive legislation and status quo medical practice.  Public education and public indignation is coming.  Ethical CEO’s must get out in front and lead the US medical device industry to embrace patient adverse event reports as an essential, timely mechanism to improve product. 

Dear MDIC founders,
 "Maura Donovan, PhD" <>  
Dale Wahlstrom <>
Please accept this as my application for MDIC membership.  Please waive the $5000 annual fee.  I represent patients harmed by failed implants with the goal of making implants safer and more effective.  FDA/OSHI has interviewed me, I attended a FDA Patient Representative workshop and testified at 2 CDRH Town Hall meetings and the first MDUFA meeting 1/2011.  I understand that MDIC is interested in inclusion of all stakeholders in this new 501(c)3 nonprofit partnership.  I look forward to working with you.
By Associated Press, Updated: Monday, December 3, 10:11 AM
WASHINGTON — The Food and Drug Administration says it will collaborate with medical device manufacturers on a public-private partnership designed to speed up the development of new medical technology.
The agency says it hopes to offer guidance to the Medical Device Innovation Consortium, a new industry-backed group that aims to simplify the design and testing of medical devices.
Medical device makers have criticized the FDA for an overly burdensome review process, which they claim slows down development of important new therapies. Congressional Republicans have held several hearings to scrutinize the agency’s system.
Faced with criticism from industry and Capitol Hill, the FDA has been highlighting efforts to slash red tape and accelerate review times.
The new consortium was created by LifeScience Alley, a Minnesota-based industry group that includes leading manufacturer Medtronic Inc.

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