Good morning. I am Joleen Chambers - a volunteer patient advocate from Dallas, Texas. This is my fourth in-person opportunity for access with FDA/CDRH.
Failed implanted medical devices place patients in medical and legal purgatory.
A canary in the coal mine: (hold up image)
September 25, 2010 at the FDA workshop for Patient Representatives in Washington,DC, I told FDA that my brother had a failed implanted elbow that required revision surgery (removing two components) after just 4 months. That second surgery did not restore function or relieve pain. Constant high dose painkillers cause his teeth to disintegrate while he sleeps. His insurance provider and the surgeon/designer deny him continued care. FDA knows Steven Baker as MedWatch adverse event #5009052.
A jolting alarm clock: (hold up image)
January 13, 2011. Invited (but treated as an unwelcome participant) I attended the MDUFA consumer group meeting in Washington,DC. I stated that patients are not treated as full stakeholders in FDA decisions clearing implanted joint replacements for the U.S. market.
A red flag: (hold up image)
March 10, 2011 at the FDA/CDRH Texas Town Hall meeting my speech referenced that Medicare is in financial peril and the #1 expenditure of Medicare is joint replacements.
The IOM report: (hold up image)
July 29, 2011 The Institute of Medicine was charged to review the 510(k) method that is used to clear medical devices for the U.S. market. The report concludes that that method is substantially flawed and does not protect patients or assure that implanted medical devices are safe and/or effective.
The British Registry: (hold up newspaper)
On September 15, 2011 (last week) the New York Times reported that according to the British registry, Johnson & Johnson DePuy ASR metal-on-metal hips were failing early 29% of the time. More than 90,000 of these devices were sold worldwide. This means that the U.S. is exporting failed devices on a large scale and relying on a foreign registry for post-market evaluation.
This petition: (hold up petition)
Today I present this petition to Congress and President Obama asking that the charter of the FDA be changed to substantially increase implanted medical device patient protection and increase industry accountability to comply with the IOM report on the current flawed 510(k) system.
The canary, the alarm clock, the red flag the IOM report, the British Registry and the petition are all warning signs.
Ignore the warning signs and risk depleting Medicare funds wastefully,
losing the public’s trust in the integrity of the FDA/CDRH, devaluing U.S. export credibility internationally and endangering valuable domestic medical device industry jobs.
Recommendations:
Change the FDA charter to grant full stakeholder voting rights to the position of Patient Representative & Consumer Representative on all FDA implanted medical device advisory panels.
Establish an accessible, independent, national comprehensive registry of implanted medical devices to track all post-market data. Provide real time quality information that patients and their doctors can use to make life-enhancing decisions such as the information Consumer Reports provides on automobiles and appliances.
Require the implanted medical device industry to identify what the life-expectancy is for a joint replacement product and warrant a percentage of that period. This will provide patients speedy & reliable compensation for “innovations” that fail and a real-time safety/effectiveness feedback loop for the industry. Reducing the percentage of failures will encourage quicker innovation since unsafe and ineffective devices will be identified and corrected or be denied continued market access.
Revoke the entitlements to the medical device industry that violate patients’ basic citizen rights & access to justice in state courts.
Focus less on perceived shortcomings of the patient messenger or the patient’s medium of delivery and more on the message that patients are offering to the agency. The bureaucracy and exacting requirements of FDA/OSHI are intimidating barriers. Recognize that patients generally do not have-nor should be expected to have-extensive medical training, graduate degrees in statistical analysis, the physical ability to travel, a substantial travel budget, public speaking skills, computer access, and deep knowledge of FDA regulations. Investigate reports of life-altering adverse events by elderly, medically and/or financially challenged patients with due respect. Accommodate patients’ special needs to promote their full stakeholder participation as they partner with FDA regulators and the medical device industry to the mutual benefit of all.
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