Volunteer Focus
Louis J. Dunka, PhD--Principal Scientist, LifeScan; Founder, CLSI Area Committee on POCT

Louis J. Dunka, PhD, is Principal Scientist at LifeScan, a Johnson & Johnson company which has arguably revolutionized blood glucose monitoring by developing technologies to make the process more painless and convenient for the diabetic user.  Spending the earlier part of his career as Quality Assurance Manager at both Lifescan and Fisher Diagnostics, Dunka also developed a unique line of Latex Immunoassays for Therapeutic Drug Monitoring during his years as Senior Research and Development Manager at Instrumentation Laboratory in Lexington, MA.  Both "an employee and a customer" of LifeScan, Dunka's work in improving the quality of life for diabetic patients brings him around the globe, with about 50% of his time dedicated to travel for summits and conferences at which he maintains an active voice on the hot topics in the glucose monitoring field.  Founder of the Area Committee on Point-of-Care Testing (POCT), Dunka's involvement with CLSI has been characterized by a drive towards finding innovative ways to accommodate industry needs through creating new niches and opportunities for standards development.

I’d like to begin by asking you about CLSI's very new point-of-care testing committee.  How did it develop?

In, I believe it was 1999, a bunch of laboratorians got together, and essentially said, hey, each and every company that’s developing a POCT system is developing their own way of connectivity; their own docking station, their own data management station, their own proprietary communication station.  

Individually.

Yes, and so they had four or five different instruments.   And they had four or five different connectivity solutions.  And none of these were compatible, so you could never put the data together in one place.  And so they went to Emery Stephens, who’s very active in CLSI and the industry division of AACC, and he put together this network called the Connectivity Industry Consortium (CIC).  The idea was to develop a standard way of communicating a standard that all the companies could use so that their products could intercommunicate with each other—to come up with these technical standards and then to hand them over to some standards development organization to maintain and enhance.

Why CLSI?  If you’re talking about POCT connectivity and there was no POCT area committee yet...

CLSI was chosen because of its connection to the laboratory.  At that point, it was done under the Area Committee on Automation, which then became the Area Committee on Automation and Informatics.

Which is what you were initially involved in.

Exactly.  And Jeff DuBois and I were chair and co-chair of the subcommittee that developed POCT1—and did it in record time:  seven months.  It was the first CLSI document ever to be published on a CD, which cut down the publication costs, and the time to get it out to market.

And why did things go so quickly and smoothly?

Because we held weekly conference calls; we had people working in between the conference calls.  If you were a big company like Abbott or Roche, you were expected to contribute $10,000 and a person for six months. 

How did the POCT area committee form from there?

Well, this was a really dedicated effort by a lot of really good, smart people, going through the consensus process to form these specifications into a standard, and to get them out to the users as quickly as possible.  The experience brought together people in the POCT community in such a way that they responded by asking, what else can we do?  And it turned out that there were probably about a half a dozen projects that people wanted to do—so Jeff DuBois and I put in a project proposal to form an area committee on POCT.  And we used as some of the ammunition that POCT is growing 12 to 15% a year.  The POCT division in AACC is the single largest division, with almost 20% of the membership of AACC.

That’s so interesting—so here’s this largest of the divisions of the AACC, and yet it doesn’t exist yet at CLSI.  Is that because it had always been melded together with the automation group?

It's because a lot of the related projects actually were in the area of Clinical Chemistry/Toxicology—those had to do with glucose testing.  There were some that would have gone under Healthcare, some under Automation… POCT had not, to that point, been looked at as a separate discipline.

So there was overlap.

Yes, and so Jeff and I went back and we said, 'Okay, we won’t take any existing projects unless you want to give them to us—we’ll take on new projects.'  At that point, everybody agreed.  And we did something else—we went out and raised the funds to take the committee through the first several projects.

Now this self-funding—you and Dr. DuBois just came together and decided, 'these things have to happen, so let’s get this money together even though there really hasn’t been a precedent for this in the past?'

Why not?  We weren’t talking about a huge amount of money.  And our marketing department had spent many multiples of that in the past, so if this was going to help us move this thing along, then why not do it?  And before us, it had happened with the automation committee, with fundraising to the tune of about $750,000 funding CLSI’s first five automation standards.  What it comes down to is, if there is a driving need, and the companies see that need, they’ll be willing to put the money forward.

With what exactly in it for them?

Well, we don’t have to go out and develop our own proprietary connectivity, and our systems—we’re in the business of selling glucose strips, not doing—you know—connectivity.  So this gives us a way of doing it in the end—to sell more products, and to sell to more people who wouldn’t have bought otherwise.  You know, we’re in this to make money for our stockholders.

Of course—your primary responsibility.  And so this kind of just tied into that.

Yeah—and so it came to fruition.  There was a meeting at AACC last year of the area committee—that was the first one—and that was attended by about 57 people:  a large, large attendance—a lot of interest in this area committee.  Two projects proposals were put forward; those were information guides:  one for healthcare providers of hospitals, and the other for manufacturers.  So in other words, it’s how do you take this very complex, 280-page standard, which is full of software-specific terms, and make it interpretable to “mere humans.”

And so those two committees are up now, they’re going, they’ve had their first conference calls, they’ll have their first face-to-face meetings at AACC this year.  We also have two other project proposals that were put forward at the leadership conference in March.

So it’s kind of a repertoire of action that’s being developed in the way you’re going ahead with these new documents—that you’re also kind of adding into the equation the possibility that you may have to do a bit more of this fundraising, and that this is an investment.

Absolutely.  One of the things we currently believe is that we can sort of bring the practices of this into this process, and there are funded things and self-funded things—and I don’t want to take money away from worthy projects in other parts of the organization.  And we have to work together with the other chairholders.  We have to support one another’s projects.

Now, POCT—obviously a very contentious issue.  Is self testing the wave of the future?  Where do you see things going?

It’s really a growing problem for the country—particularly for people who take insulin, testing is required.  There’s another group of patients for whom self-testing benefits, and that’s people who are on Coumadin, which is blood-thinner, and if they self-test, then that avoids them having to go to the clinic—beyond that, I’m not sure there’s going to be a proliferation of self-testing.  There are three things you have to have to have a successful test in the home:  you have to have a lot of people who have the condition; they have to test on a fairly frequent basis to make it a business proposition for you; and then they have to be able to do something with the results once they get it.

To give a perfect example, there were a number of companies that put out self-test systems for cholesterol, but you get the results, and maybe test a month later—and you really can’t do much about it.  It’s always the tests like the pregnancy tests that will be successful, the glucose tests, Coumadin… but I’m not sure you’re going to see a whole lot more in the near future. 

Tell me about the big issues right now in your field.  What are people talking about?

One of the things that is a real humming area in the whole area of glucose monitoring is what’s called “continuous monitoring.”  So right now the standard of care is—stick a patient’s finger and they can do it in their home—and even if they’re really conscientious they’ll do it six to eight times a day.  Most patients will do it a lot fewer than that.  And in the hospital, let’s say you’re using intensive insulin therapy; they’ll stick the person a number of times a day, as often as once an hour.  Intensive insulin therapy is a new protocol that is really catching fire to hospitals, that says, if you receive people in intensive care units, or normal care units with a range of glucose, in a range of 80 to 110, you dramatically improve their survival rates, and you dramatically reduce the number of complications.

Why is that?

We have hypotheses, but we really don’t know.

Can you share the hypotheses, or is it too early?

There’s a hypothesis that, if you go up higher, you stimulate the release of insulin, and that insulin has an inflammatory effect.  So if you keep it low, you’re producing less insulin.  If you produce less insulin, you don’t cause that inflammatory issue. 

I know that you’ve brought groups of scientists together in the face of a number of contentious issues—to the point where this is something you’ve become known for.  What’s the most important thing to remember when dealing with conflict in the CLSI consensus process?

There are at least a couple.  One of them is culturally understanding the other people you’re dealing with.  People from laboratories have a totally different outlook on life than people from government who regulate.  And they’re different from the people in industry.  And then you add into the equation, people who come from different world cultures—understanding how people act and react is extremely important.  That’s number one. 

Number two is, trying to gain an understanding of why people are taking a certain point of view.  Put yourself in their shoes.  Try to understand why their point of view is what it is—even if it doesn’t agree with yours or even make sense to you.  And the third thing is to be willing to give up what you consider minor stuff in order to gain your major objectives.

Do you feel that working within the CLSI process, coming from an industry perspective, there are any kinds of conflicts or issues that you tend to face by virtue of the sector that you are from, or that industry people tend to face?

Yes, and that very simply is that—it comes with the territory, but we can’t be viewed as credible when we’re advocating something… in other words, people don’t think we can separate ourselves from the best interest of our company.  A simple example—I  was on this ISO/TC 212 glucose committee—and they really wanted to know somebody who was knowledgeable technically, and a diabetic—you know, what would they think of some of the things the committee was doing?  So I held up my hand, and they said—no, not you, you work for industry.

So you yourself are a diabetic.

Yes—I’m healthy, under good control, but I do have type 2 diabetes.  But it’s difficult because, when I walk in, I believe a laboratorian is just there to support the profession—and I believe the same thing about regulators.  And I think for the people who have worked with me for five or ten years, that they start to think that I’m from the profession too—but walking in the door, industry is not viewed as—credible.

What would you like to see happen now—with CLSI, either in the POCT area or the organization in general?

I think a number of developments are going on right now that are going to revive the organization.  I think… well, one of the things about me is, I have a grey beard, I’m 64 years old… too many people in CLSI look like me!  They’re my age!  We should be bringing in a lot of younger people with newer thoughts and not just the people who have done this for a long time.

On Tuesday, 26 July 2005, at the IFCC/AACC 2005 Annual Meeting Clinical Lab Expo, Dr. Louis J. Dunka will be present at CLSI Booth #1663, at the Orange County Convention Center in Orlando, Florida, USA, as part of CLSI's "Experts in the Booth" program.  He will be available from 12-3 p.m. to answer questions, discuss documents, and provide input for all booth visitors.

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