Tuesday, April 17, 2012

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 (herehere 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

1 comment:

Fran Lesicko said...

Thanks for your comments, Hugo. I also have thoughts on this. I am a 20 year survivor of SCA and am on my 4th ICD. During the first 11 years after my SCA, ICDs saved my life 9 times. Four of these episodes occurred when I was sleeping. If my ICD had not worked, I would have died in my sleep with no chance for intervention. I need my ICD to work.

When I look at Guidant's management of their ICD failure, which led to the death of a young man, I don't think the companies can be trusted on this. Guidant's position was that patients would want new devices and the risk of complications from replacement was higher than the risk of failure. For some patients that might be true. But for many who have experienced SCA and also have needed shocks to save them, to have it fail means death. Pretty big risk. Especially for people who are already expecting to need replacements over the long term. As I said, I am on #4 and expect to receive #5 down the road.

I only ask for accurate information and my doctor and I will look at the odds and make the decision as to what is best for my health. The device companies should not be making those decisions for us.

I am a psychologist and after 20 years, am well aware of the psychological factors surrounding SCA and ICDs, not only from Dr. Sears' work, but also from my own experience and that of others I know. For me (and many others), I have a greater feeling of control and less anxiety when I have accurate information and am involved in decision-making around my health. I am an active participant in the process. Hiding information from patients ("what they don't know won't hurt them") is deceptive and inappropriate. And it COULD hurt the patients. We used to have this attitude toward terminal patients and now we know better.