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SPEAKER: One of the criticisms of the US Food and Drug Administration is that it takes so long to get anything approved. Is this still a big problem?

EARL BAKKEN: Yes, it's a problem. It was interesting. When I built my first pacemaker in 1957, it was four weeks from the time Dr. Lillehei and I talked about the need for a battery-operated pacemaker till we were using it on children. Now, of course, you couldn't do it in four years.

SPEAKER: Why has it changed so dramatically?

EARL BAKKEN: In 1976, the devices came under the auspices of the FDA-- Food and Drug Administration. And so that changed the way that we had to get approval of these devices before applying them. And over the years, that has become a longer and longer period of time to get that approval.

Of course, the FDA has its problems. They're in a tough position of being under the pressure of Congress and the pressure of the businesses on the other side that want quick approval. And being in career positions, they don't want to make mistakes.

So they have a problem to themselves. I don't deny that. But it's important that we get faster and faster approval of devices. Now, it can take six to seven years from the time a concept comes up till the time you've gone through all of the procedures.

As a result, Medtronic has now moved-- just about all of our venture research is over in Europe. We have a large research center in Southern Holland and we will be building other research centers in Europe. We have one in Japan because they have a much shorter approval and they still have great trust in physician's abilities to make the right decisions for their patients.

SPEAKER: That has some serious economic consequences for the US and for Minnesota, doesn't it?

EARL BAKKEN: Well, it certainly does. It means that many jobs have to be moved to Europe, particularly when we reach the point on any device where we want to enter clinical testing.

And it's interesting that some of the major devices that we eventually get approved here in the US were helping patients four and five years earlier in Europe or in other countries in the world.

SPEAKER: The FDA would argue, of course, that they're protecting American consumers from devices and medicines that haven't been fully tested and fully proven. Do you think that's unnecessary? Is it going too far?

EARL BAKKEN: Well, I think that's necessary to go through some of that. Unfortunately, not every company is totally as responsible as they should be. Most of them are because you don't make a bad device, you don't stay in business.

Your greatest responsibility is to the physician, the customer, and the patient. And they want reliability. They don't want to be called in the middle of the night or whatever with some failure problem and their reputation. And so your demand for making quality devices for the market is far greater than the imposition implied by the FDA.

But the delay of getting good devices to patients means that patients in this country, and most of our patients are elderly, although we do make devices at all ages, they do not get the best or most modern technology that is restoring people to better, fuller lives in Europe on a timely basis.

SPEAKER: Are you--

EARL BAKKEN: So it actually ends up with people dying that could have been helped by devices that were available.

SPEAKER: Are US companies falling behind foreign counterparts because of this, or are you able to keep up because you can have research facilities overseas?

EARL BAKKEN: We as a company, being as large as we are and with facilities all over the world, are able to keep up because we have the ability to carry out clinical research many places in the world and to lean a lot on foreign technology. So it does mean that companies here that can't do that, smaller companies and so forth, have a very hard time.

SPEAKER: Look into your crystal ball for us, will you, Mr. Bakken, and tell us what you see in the future. You hear things now about the possibility of interfacing with nerve endings to restore control of paralyzed arms and legs. I mean, it's almost science fiction-like stuff.

EARL BAKKEN: As industry moves more in artificial sight, hearing, and some of these, we need really great development in that interface, the electrodes and the biology that is on the other side of the electrode. And to couple those is something that's been studied for centuries, and we've made some progress, but we have a lot of progress yet to be made.

SPEAKER: Artificial sight, artificial hearing, are those possibilities?

EARL BAKKEN: Oh, yes. Oh, yes. Of course, the implantable hearing aids, now 3M has one that has multiple electrodes that at least begins to give formerly deaf people some sensitivity to sound.

And there's a company in Australia that's making a fairly effective implantable hearing aid that has nerve electrodes. And eventually that will be possible in sight and other sensors as we can make smaller and smaller electrodes.

SPEAKER: What is high-touch medicine?

EARL BAKKEN: Most of our Western scientific medicine today is high-technology, and it has tremendous things to offer, as we do with the Medtronic products. It's extremely important, has made a lot of progress.

But it has forgotten in many ways that humans are not just bodies, but they are minds and spirit. And that while you can cure the body, if you don't take cognizance of the mind and emotions and the spiritual side of human beings, you can't really heal.

And what I am talking about, combining high-tech and high-touch, is to put the two really back together. The high-touch medicine has been there for centuries, a lot of it.

Massage and no-touch, touch healing, and imagery, and all of the tai chis and oriental medicines and so forth are more human-oriented, recognizing that the greatest healer that exists is the healer within.

SPEAKER: I'm sure you talk to first rate physicians in this country about this kind of thing. What's their reaction to it? Do they think you're kind of off on some tangent, or do they accept it?

EARL BAKKEN: There are still a few that do, but most of them recognize that as-- and many of them apply it. Many of our best, highest quality cardiologists and surgeons are very holistic in their approach. But the way medicine is moving today in HMOs and managed care, they don't have the time or the facilities to carry out the high-touch part.

The bedside manner, as it used to be called years ago, is so important. There are a lot of those physicians, more and more, most every major health center now is looking at what is our role in complementary medicine going to be because it's what people want.

1/3 of the population of the US partake in some form of complementary or sometimes wrongly called alternative medicine. They pay for it out of their pockets because they want it. They want that human touch.

SPEAKER: The big push in medicine now, of course, is cost containment. What do you think the impact of that is going to be on all of this?

EARL BAKKEN: Well, the more we work on cost containment by controlling supply with managed care, HMOs, and so forth-- if you're trying to cost contain, you have to do it by rationing because the demand is increasing for health care, and it's increasing for both allopathic and complementary care.

And there's no way you're ever going to solve the cost problem by controlling supply. What you've got to do is control demand. You've got to get people involved and empowered to make their own decisions about health care, and to be financially rewarded for staying well.

So the system has got to change down the road to a system that now has the name of medical savings accounts, where the money that's going to be applied to patients care, rather than going to an insurance company, goes into an account that the person has, like an IRA, but money that can be expended only for health care.

But with that, you've got to teach people to be more knowledgeable about health care and how not to accept everything that a doctor tells them they need to do, but to use doctors as consultants.