Putting the Patient at the Center of the Device Recall

In a recent blog post, Dr. Kevin Campbell makes the point that when faced with recalls, physicians should remain focused on the patient, not on the press. I agree. What I don’t agree is with Dr. Campbell’s classification of the New York Times coverage of the recall (here, here and here) as “rhetoric”. Patients are usually the last ones to be warned of a recalled device, so we rely on the media for timely information. 

Here’s my response to Dr. Campbell’s blog post:

Dr. Campbell,

I appreciate your intent, but I do not agree with your point of view. “Rhetoric put forth in the New York Times”? Seriously?

In a world in which physicians’ views are sometimes marred by speaking fees and consulting arrangements with medical device companies, patients must rely on the media for information about recalls.

This case is not at all about the sensationalization of a medical device recall. This is about the unprecedented request by St. Jude for the retraction of Dr. Hauser's paper and failed attempt to discredit his work by dragging a competitor down with them.

This is about the Class 1 recall of a lead that's been implanted in 79,000 U.S. patients. These are people who, like me, were told the device would be there to save their lives in case they ever needed it, and who are now learning that this might not be the case.

This is about how poorly the "the guys in the suits" have handled this crisis so far: defensively and arrogantly. And how it reflects on their company's image and reputation.

Doctors and medical device companies should realize that a new world has emerged. It is a world in which patients are more empowered, equipped with information and engaged in their care. We are connected through social media like never before and we are talking. We're talking about doctors, therapies, brands of devices and even recalls.

You can no longer control the message. Patients have the right to know. After all, we are the ones living with heart disease. That's how WE put ourselves at the center of a device recall.

Hugo Campos

Deaths caused by the failure of St. Jude Riata Implantable Cardioverter-Defibrillator (ICD) leads

I figured it would be useful to post this here since there are currently 79,000 patients in the U.S. with these recalled leads. If you have a Riata or Riata ST, I’d encourage you to stay informed and ask your doctor if he has a plan for the management of your leads.

This manuscript became available yesterday. It’s an assessment of the deaths of patients with Riata and Riata ST leads that have been reported to the FDA in an attempt to determine if these deaths were due to lead malfunction.

The analysis was done by Dr. Robert Hauser of the Minneapolis Heart Institute Foundation. The report claims 22 deaths caused by the St. Jude Riata lead failure. Dr. Hauser concludes that no deaths were caused by externalized wires, the problem most commonly associated with the Riata. Rather, the deaths were caused by short-circuits between high voltage components. This could prove ominous for the Durata lead as well. The Durata lead is currently being implanted worldwide and is not a subject of any recalls or confirmed externalizations. But it’s similar in design to the Riata, apart from its Optim insulation. Watch a St. Jude Medical video about the benefits of Optim insulation.

Adverse events (deaths and injury) are voluntarily reported by hospitals and doctors into a public FDA database called MAUDE. Manufacturers are required to report deaths and injuries, however, there are an unknown number of delays in adverse event reporting by the manufacturer. So, adverse events reported into MAUDE is incomplete. By some accounts, only 5% of all adverse events are ever reported (watch Dr. Rita Redberg, UCSF, in this video at 16:57).

Dr. Hauser believes the information in MAUDE is accurate but incomplete. His study classifies 50 deaths as indeterminate because important information was not reported (see page 22). He says that the number of deaths is likely being underestimated.

We need the reporting of adverse events to be mandatory and for a public registry to be created in the U.S. with data flowing in from all remote monitoring platforms. It’s the only way for us to know for sure what's going on when there's a recall. Patients should have the right to access this information in a way that is timely and easy to understand.

Dr. Hauser’s manuscript:
Deaths Caused By the Failure of Riata and Riata ST Cardioverter-Defibrillator Leads.

On ICDs and access to data

Last week my video profile went live on Stanford's Medicne X Web site. Medicine X is "an academic conference designed for everyone", including patients. It's organized by Dr. Larry Chu and the Stanford Anesthesia Informatics and Media Lab. It is scheduled to convene on the campus of Stanford University Sept 28-30, 2012.

When it comes to data, patients aren't always trusted to care for ourselves. An antiquated view. After all, we're entrusted with managing all aspects of our lives: our finances, our careers, our investments... so why is it any different when it comes to health care? Think about it.

Thank you to Dr. Larry Chu and his talented team for this beautifully shot and edited short film.

Top Five Excuses ICD Manufacturers Use to Justify Not Releasing Data to Patients

I’ve been asked a few times to list the reasons why manufacturers of ICDs won’t release raw data to patients. (This data is collected via remote monitoring and shared with clinicians, but not with the patient who originates it.)

Here are their top five excuses:

Excuse #1: HIPAA.

“HIPAA prevents us from releasing data to patients.”
This is the most ridiculous of all excuses. HIPAA is the Health Insurance Portability and Accountability Act passed by the U.S. Congress in 1996. HIPAA is the single most significant legislation affecting the health care industry since the creation of Medicare and Medicaid back in 1965. One of the reasons HIPAA was created, was to give patients control over the use of their health information. NOT to prevent us from having it.

Excuse #2: Too complex.

“This information is too complex, patients wouldn’t understand it.”
You heard the ridiculous, now you heard the top patronizing excuse. To that I say: try us!

Excuse #3: Let us help you first.

“Sure, we’ll give patients their data. But first, let us figure out a way to put it into meaningful context for patients so they can understand it.”
Paternalism at its best. How about putting it into meaningful context WITH patients? Having manufacturers put our data in context means that they get to spin it for us. That is not what we want. Just give us our damn data and let us partner with whomever we want: doctors, family, statisticians, researchers, other patients, app developers or our electrical engineer friends to make it meaningful. Plus, different patients have different needs and different levels of understanding. We’re all in different phases of the same journey. It’s our job to make our health information meaningful, not theirs.

Excuse #4: It will overwhelm doctors with calls.

“If we give patients their data, doctors will be flooded with phone calls for no important reasons.”
Another patronizing excuse. I actually think that the exact opposite would happen. Instead of calling for every little thing, patients who are empowered with information and equipped with knowledge would only call their doctors for reasons that are important enough. Wouldn’t you?

Excuse #5: Doesn’t fit our business model.

“A pacemaker or defibrillator is put into a patient’s body for the therapy it delivers, not for the information it gathers. Making data available to patients does not fit our business model.” (Watch this on YouTube, here.)
In other words, “who’s going to pay for this?” or “why should we commit dollars to creating an infrastructure that provides data to patients when they don’t influence device purchase?” The doctor is the customer, in case you’re wondering. Not the patient.

The issue of giving patients access to our data will only be settled when doctors start talking about this and demanding that their patients be empowered with information.

Thankfully, this has already started to happen. Yay!

Read these related posts by Dr. David Lee Scher:

• Five Reasons Why Patients with Implantable Defibrillators Deserve Their Data, 
• Data from Implantable Defibrillators and Pacemaker: The World’s Best Kept Secret

I will get back to you.

I’ve been on a journey to unlock data from my implantable defibrillator for over two years now. While I’ve had quite a few successes, nothing compares with the overwhelmingly positive response received after a video of my talk at TEDxCambridge went live last week.

It was followed by an interview with Brooke Gladstone of NPR’s “On the Media” in which she asked: “Who owns the data from inside your body”?

These two developments caused my inbox to overflow with offers from hackers (listen to the interview) and emails from NPR listeners from the UK, Canada, and the entire U.S.

I was unprepared for such an overwhelming response. So, if you’re one of the people who wrote to me, please know what I will get back to you in time.

This has been a wild and unexpected ride, but I wouldn’t have it any other way.

Fighting for the right to access my heart’s data

Karen Sandler: a cyborg lawyer running on proprietary software

Should patients have the right to inspect and scrutinize the software that runs the implantable devices that keep them alive? Karen Sandler thinks so. Karen is a lawyer, executive director of the GNOME foundation, and Hypertrophic Cardiomyopathy patient who’s received an implantable defibrillator for primary prevention of sudden cardiac arrest.

In this talk, Karen explains how the FDA never reviews the source code that runs our ICDs and pacemakers and makes a case for free and open platforms for life-critical software.

“I don’t want to rely on one company for any part of my life. I don’t want to rely on Medtronic for my heart, and I don’t want to rely on any other company for any other thing. I want everybody to be able to see the source code. And I specially want to see the source code. We’re at a crossroads and it’s time to change.”

Watch:

Also, an interview with Karen Sandler:

VIDEO: A town hall meeting with the FDA

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

Dr. Jeff Shuren, Director,
FDA CDRH

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.”

Hoorah!

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

It isn’t nice, I want my data!

Each year, hundreds of thousands of pacemakers, ICDs and loop recorders are implanted in people all over the world. However, these patients have no access to the vast amount of critical data that is collected by their devices. I am one of those patients.

This song is inspired by the classic protest song “It isn’t nice” by Malvina Reynolds.

Follow along:

It isn’t nice to grab my data
from my implantable device.
Then to hog it, keep it from me.
That’s not right, I’ve told you twice.
It isn't nice, it isn't nice,
How can it be so hard to see
that I am the patient, it’s my data,
my heart, my ICD.

You ask me why I want these numbers
that you collect through my phone line
Then I give you all these reasons,
You still say no, that is not fine.
It isn't nice, it isn't nice.
It is my heart, my ICD
All I want is access, why on Earth...
won’t you give it to me?

Your excuse is: I'm unable
to make sense of the reports.
Will you please not patronize me.
Do I have to take this to the courts?
It isn't nice, it isn't nice.
How can it be so hard to see?
After all I am the patient
And the one with the ICD.

I think I know what your concerns are.
You want to keep me in the dark
I may learn who has the pacer
with longer life and bigger spark.
It isn't nice, it isn't nice,
How can it be so hard to see?
It’s time for you to unlock this,
I’m the one with the ICD.

I know it’s not nice to hack my pacer,
or intercept my Carelink call,
There are nicer ways to do it,
but you always seem to stall.
it isn’t nice, it isn’t nice,
but if my data is kept from me,
I just have no choice, I gotta have it

Why won’t you hear my plea?
One day you’ll go into retirement.
I hope still to be around,
with full access to my data.
Before they put me in the ground
It would be nice, it would be nice
If you are finally made to see
That the data is mine, just hear me out!
We have to set it free!