This Special Bonus Interview is from the November 5, 2007, issue of "The Gray Sheet"
Leslie Saxon says the next big thing in medicine is "body computing."
As the chief of cardiovascular medicine at the University of Southern California's medical school describes it, body computing relies on devices with sensors that transmit information to the Web to be accessed and acted upon not only by doctors but by patients as well.
Medical devices with remote monitoring capabilities (see 1previous story), already available from firms including Medtronic, St. Jude Medical, Boston Scientific and MedApps in the cardiac rhythm management and diabetes spaces, will be central, though not sufficient to achieve this model, she says.
To help make it happen, Saxon, an electrophysiologist, invited device and drug executives, along with FDA officials and other industry reps, to the first annual Body Computing Conference in Los Angeles Oct. 26.
Boston Scientific CEO Jim Tobin, Medtronic Senior VP Chris O'Connell, and CDRH Director Dan Schultz showed up, along with reps from Johnson & Johnson, GE Healthcare and Texas Instruments. Athletic apparel maker Nike also was there, with the firm giving an update on its Nike+ system, which includes shoes that communicate pace and other information to an iPod, and allow downloading of the information to a community Web site, Saxon explained.
She spoke to "The Gray Sheet" about body computing and the recent meeting.
"The Gray Sheet": What is body computing? Is it synonymous with remote monitoring?
Leslie Saxon: Remote monitoring allows us to think about the broader concept of body computing. When I think about body computing, I think about a world where you turn on your computer, and along with surfing the Web and watching YouTube, you check on you and your family's health status. There is the implanted network device that may be the hub and part of the overall management of the patients.
TGS: Why is this important? What motivated you to organize a conference on the topic?
LS: I view it as a solution to some of the gaps in health care. In the United States, we have the best specialists, a great investor community, a good FDA, but our outcomes lag behind. Doctors are the sole holders of the silo of information. Even though I run a division of cardiology and do all of this other stuff, 70% of the time I am in cases. To have to depend on someone like me to provide you with the complexity of information that you need with your chronic disease, say it is heart failure, is a frustrating thing. It is for any chronic disease patient who is treated by multiple subspecialists.
My idea for this conference was to bring together thought leaders from a large swath of expertise and see how we can leverage our strength and technology to liberate this information, empower these patients and develop models for early detection and treatment. It is a personal topic for me because I follow over 500 patients with implanted devices.
TGS: So, your vision of body computing seems to involve a more active patient component?
LS: Yes. The patient could maybe actually treat themselves. It is kind of like the Internet in 1994 when you could send e-mail but you did not have the Web. Now, we have some devices that are radio frequency-enabled, but we have not turned on the World Wide Web. If we do that, the possibilities are endless. We can pony on weight and blood pressure information to a defibrillator. We are soon going to be able to monitor heart pressure, but you can do so many other things.
TGS: How do you bring the patient in the loop with body computing in the case of heart failure?
LS: For instance, there is a new device that St. Jude is developing in pivotal trials, it measures left atrial pressure with a defibrillator (2"The Gray Sheet" Feb. 20, 2006, p. 8) and then it feeds that information back through a Palm to a patient who then gets a prescription as to how much more medicine to take, that instant.
TGS: So that would be completely automated?
LS: Yes. The patient interrogates their device to get the pressure and then it tells them: 'take this much Lasix [the diuretic furosemide] or take this much whatever.' Often, the pressure is a first indicator of a worsening condition. If you can intervene early and keep patients with chronic disease out of the hospital, you have cut enormous amounts out of care cost.
TGS: What were some takeaway messages from the recent meeting you hosted?
LS: What I heard people saying from Jim Tobin down was that it needed to be scaled. We need to just start on a project before they retool their entire businesses. Two, there probably needs to be ... a patient-pay component.
And three, it is yet unclear what the FDA's approach is going to be for this in terms of proof of concept - safety and effectiveness. Is the bar going to be that you show that you can keep patients out of a hospital if you have them monitor their left atrial pressure? It sounds like Dr. Schultz was saying that - that "this is all great, but let's do some clinical trials."
TGS: How often do you use remote monitored, networked devices? What role did they play for you in the recent Medtronic recall of its Sprint Fidelis leads (3"The Gray Sheet" Oct. 22, 2007, p. 3)?
LS: I do not put in a device unless it is networked now. That is how strongly I feel about it. It is just so much easier to follow people. There is no way you can justify not putting a network device in.
On the recent Medtronic advisory, I am following patients [remotely] every week until I get a sense of each individual patient. That allows me to take a very high-level advisory impacting two point something percent of leads and say to any individual patient: "You know, I have looked at your lead every week for three months; you are very stable, now I am going to take it out to two months."
TGS: Are you ahead of the game in terms of using these technologies to such an extent? Are your colleagues on board?
LS: I think I am ahead of the game. I passionately believe that this is the way it is going to go. I feel a sense of urgency behind getting some of this stuff going quickly to justify the upfront costs of these technology innovations, so that we do not ruin what is really good about American medicine and we continue to innovate.
This is the next big thing. I am sure of it. I am convinced that this is the next thing that is going to glue the system together with communication links, therapeutic links, where we can spend less time talking about health care and more about what the next cures will be.
- David Filmore
