Thursday, September 22, 2011

A town hall meeting with the FDA: democracy at work.

Dr. Jeff Shuren, Director,
Today, I had the exceptional opportunity to speak before Dr. Jeff Shuren director of the FDA’s Center for Devices and Radiological Health (CDRH). The CDRH is the center within the FDA that is responsible for pre- and post-market regulation of medical devices. Pacemakers and ICDs are under the center’s purview.

The town hall meeting was organized with the objective of having the FDA engage in discussions about issues of importance to the public. It was the third and last meeting being held this year.

It was a unique experience that filled my heart with patriotism, and an inspiring feeling of health activism and civic participation. I felt like a true patient advocate.

This is the message I delivered:

Good morning.

Thank you for the opportunity to be here.
 My name is Hugo Campos and I am a heart patient 
living with an implantable cardiac defibrillator.

Each year, hundreds of thousands of Americans are implanted with pacemakers, loop recorders and cardiac defibrillators like mine. However, not a single one of these patients has access to the wealth of personalized data that is continuously collected by their implantable devices.
 It is time for us to change this.
Pacemakers and ICDs are small, battery-powered, electrical impulse generators that are implanted in patients with slow heart beats or who are at risk of 
sudden cardiac arrest.
In addition to providing life-saving therapy, these medical devices collect and store advanced diagnostic information pertaining to their normal function and a patient’s clinical status. This information is transmitted to a secure and private network owned by the manufacturer of the device.
Some of the data collected is made available to clinicians through a secure Web site, enabling them the convenience of monitoring patients without the need for in-office visits.
However, this data is not made available to the patient who originates it.
Studies have shown that remotely monitored patients experience a significant reduction in time from 
clinical event to clinical decision and also benefit from shorter hospital stays and reduced costs per hospitalization.
This clearly makes the point that access to information saves lives and money.
Yet, even in light of such evidence, patients continue to be denied the right to access such useful and incredibly rich data about their bodies.
The main obstacle, in my view, has been the Cardiac Rhythm Management industry itself, which claims that a pacemaker or defibrillator is put into a patient’s body for the therapy it delivers, not for the information it gathers, and that making this data available to patients does not fit their business model.
The types of information collected by a modern ICD, for example, vary from trivial to potentially critical. Among other things, the device monitors its own battery voltage, the amount of time it takes to deliver a life-saving shock, collects and stores intracardiac electrograms, and monitors a patient’s heart rhythm, daily activity, arrhythmia episodes, and even the build-up of fluid in the lungs — which is critical to patients dealing with congestive heart failure.
In addition, patients who are at risk for atrial fibrillation and atrial flutter, have a higher propensity for stroke and heart failure. Atrial arrhythmias can also cause the ICD to deliver inappropriate shocks. So, rapid patient awareness of atrial fibrillation is crucial for those at risk.
Access to our data can do more than just help patients take control of our disease. It may also help with timely identification of device-related malfunctions, and ultimately, contribute to better patient engagement and improved health outcomes.
Knowledge is power. And a patient privy to his data is an empowered partner in his own health and healthcare. Access to my device’s data can help me track, understand and manage my condition better, become more active in my care, and work more effectively with my providers.
I rely on the FDA to protect me. And I need the FDA to stand with me in this quest for openness, access and transparency.
In the spirit of the new rules proposed last week by Health and Human Services Secretary, Kathleen Sebelius, that strengthen patients’ rights to access their own laboratory test results directly from labs, I would like to ask the FDA to follow suit and publicly declare that patients also have the right to the raw data collected and stored by the manufacturers of their implantable devices.
I have the right and the responsibility to care for myself, but cannot do so without information. It is time to fix this and put patients and our families at the center of our own care. And I call on the FDA to help us get there.
Thank you.

The highlight of the morning came at the end of the meeting when the audience was given the opportunity to ask questions. I asked Dr. Shuren who owns the data collected via remote monitoring by the manufacturer of my implantable device. He replied: “As a patient myself, I view the data on me...  it’s my data.


Attendees at the FDA CDRH town hall meeting of 9/22
in South San Francisco, during a break.

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