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.
Please share what you have learned!
Twitter: @JjrkCh

Monday, February 27, 2012

PCORI - Patient Centered Outcomes Research - My Testimony today

Hello.  I am Joleen Chambers - a volunteer and uncompensated patient advocate, blogger and tweeter for safer implanted medical devices.    I am grateful that PCORI and this badly needed forum for patient care discussion and research now exists.
Failed implanted medical devices place patients in medical and legal purgatory.
Patient centered outcomes research is essential to provide vulnerable patients with real time information about the #1 expenditure of Medicare:  joint replacements. 
PCORI research could
provide real-time post market data that would help patients & their chosen clinicians select life-enhancing medical device implants
PCORI research could
Facilitate a transparent and accessible registry that would be responsive to patient/consumer input about the quality of life risk/benefits of joint replacement
PCORI research could
Allow scientific information to determine which implanted devices are safe and effective and should remain on the US market.  Devices that underperform will be exposed and will be either recalled or retooled so they would not compete with  successful innovations.
PCORI research could
Clarify when implanted medical devices fail to deliver benefit to patients.  If the device harms patients, the path to patient compensation and care will not be in conflict with device industry, surgeon or regulatory defensiveness.
My personal story is that my brother in 2008 received a rare elbow implant paid by private insurance at one of the most highly respected medical facilities in the US. It failed after just 4 months and was unsuccessfully surgically “revised”.  He lives in constant pain.  Powerful prescribed painkillers have caused his teeth to disentegrate and fall out while he sleeps. He is in medical and legal purgatory.
He is just one of tens of thousands.  Federal public policy must change to alter the entitlement of the medical device industry.  Now the FDA clears these implants through 510(k) with no clinical testing and there is no post-market data that would expose the patient harm and prevent others from selecting the same failed treatment.  FDA patient representatives are not full voting stakeholders and patient advocates are restricted to speaking only at FDA Town Hall meetings for 5 minutes.  Patient-centered it is not.  
In fact, in yesterdays’ Star Tribune Eric Campbell a director of research at Harvard said “ the first thing people have to realize is that (the medical device industry) makes a product to sell a product.”  Patients/citizens wrongfully assume that regulation and science are driving these decisions.  PCORI research will help us all to make better decisions and the medical device industry will benefit from elevation of it’s reputation and products globally.

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