Dr. Michael Jaff discusses on-label versus off-label use

Physician inputs and clinical data are needed to determine best therapies for patients

Interviewed by Primacea At VIVA10, Dr. Michael Jaff is concerned about physicians losing their ability to select the best technologies for their patients.

Dr. Michael R. Jaff, Medical Director of the Vascular Center,
Massachusetts General Hospital, discusses the impact of on-label use and hospital purchasing policies on device selection by physicians with Primacea at VIVA10.


Dr. Jaff's interview (slightly edited for readability)

"I think a lot about this concept of on-label versus off-label use, and I saw the Primacea Data Solutions data. It's pretty striking to me how physicians have started to realize the importance of on-label use. Let me just give you my perspective on this. I actually covet the fact that, as a physician, I can choose what I think is right for my patient, and FDA law says I can. So if a device or a drug is available for use in the United States, and I think there is a reason to use it outside of the labeled indication, as a physician, I can make that choice with my patient, obviously explaining to my patient the reason I'm making that choice and the alternatives that I think are not as good. That's critical. If we lose that, it's going to be a real problem for patient care.

"On the other hand, there are realities of life—financial pressures, purchasers, hospital purchasing boards, who have to figure out how to control their inventory and the costs associated with what they are doing. This is the reality. We as doctors cannot kick and scream and drag with our nails in the wood trying to avoid this. So, on-label use is probably a good thing if a device is a commodity.

"If there really is no clinical benefit of one device that is off-label versus one device that is on-label, it's OK. The fact that 50% of the people who answered the Primacea question suggested that hospital purchasing decisions significantly impacted their practice is a fairly bone-chilling statistic. I'm all for controlling costs. I'm very interested in comparative effectiveness and doing the right thing for patients, but this is a very slippery slope. And particularly if those decisions are being made in the absence of physician input, experts and clinical data—losing the focus on what's best for the patient—the slope is almost straight down. I think that data forces us to reevaluate how decisions like that can ultimately be made.

"I just got off the main panel at VIVA 2010 where I watched two incredible live cases with technologies used in combination that clearly resulted in an impressive acute procedural outcome. I said to the audience, "Will we see this in the United States? Will our patients be able to get this type of therapy?" If the answer is "no," we've done something really wrong."