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U.S. Department of Health and Human Services

Animal & Veterinary

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Welcome and Introductions by Patrick McDermott, M.S., Ph.D., Director, The National Antimicrobial Resistance Monitoring System, FDA

MORNING SESSION (8:00 a.m.)

DR. McDERMOTT: Good morning everyone. Welcome to 2010 NARMS Scientific Meeting. I appreciate everybody coming today. We’ve got a very full program, probably a little too full. One of the goals of this meeting was to sort of showcase to our stakeholders some of the activities that we’re engaged in. And so I hope you will find it beneficial from that point of view.

A few issues to go over here. First of all for those who have presentations from the meeting today and tomorrow there are clearance forms or I’ve forgotten the technical terms, there are forms over here that Joanne has on the side that you’ll need to sign, because one of the goals is to publish the presentations on the web after the meeting.

What I would like to do this morning though is begin to get us started, is to begin with just a brief overview of the program. Sort of what our current trajectory is. And then hopefully set the stage for the rest of the discussion to show us, you know, how well we’re doing in trying to meet the goals that we’ve set for ourselves. Now, some of these goals are still evolving, issues have been changing quite a bit lately, but my intention this morning is to just give you the high fly-over of NARMS. And then we’ll get more and more into detail and into the research. And then at the end of the meeting we’ll hear from some of our stakeholders.

(Slide)

So, many of you know the goals of the program. It’s to monitor trends in antimicrobial resistance in foodborne bacteria. Get the information out so that it’s useful and timely and interventions can be implemented, to conduct better research because surveillance alone really isn’t enough information, we need the research that goes with it to help understand the surveillance data. And ultimately to use this information and make scientifically sound decisions about antimicrobial use.

(Slide)

Looking back on the program it’s quite a busy program. NARMS, we started in 1996 and since then we’ve looked at somewhere around 27,000 retail meat samples, about 40,000 clinical strains of foodborne bacteria, 100,000 food animal strains. We’ve published annual reports including Executive Reports since 2003, which combines the data in the single format. We’ve worked continuously to improve our testing schemes and our sampling schemes. We’ve published in the peer review literature, in this time over 110 peer review research manuscripts.

We conducted several pilot studies, looking at different pathogens in food types. We’ve recognized the global importance of the issue and have reached out to international partners both through the WHO and some of their programs. But also through research collaborations and direct interactions with some of our trading partners.

An important event that’s happened since our last public meeting is that we had the NARMS program reviewed by an Advisory Board to the FDA. The FDA Science Board Advisory Committee, made a subcommittee look at NARMS in 2007.

Some of the positive things that it had to say about the program is it’s become mission critical for FDA. It’s made great progress. It’s a high priority program. And then they made suggestions for looking towards the future and making the process more real time.

(Slide)

And they looked at, the four main areas are our sampling, our research studies, our international activities and our data harmonization and reporting. And from these recommendations we’ve started to put together a draft strategic plan for the next five years.

(Slide)

And so based on these recommendations we have a goal to implement a shared database, which will have reported data acquisition and reporting tools, and ultimately analytical tools. And we have started this process with funding from FDA and from CDC mainly to help us get more real time in our reporting.

(Slide)

The second strategic goal is to get more representative sampling, all monitoring problems have issues with sampling. And we’ve acknowledged some of those. Some of the bias sampling we have, the lack of some geographic representation, retail meat testing and so on. And so we made sampling of priority.

(Slide)

To strengthen collaborative research projects as I said this is an important component to surveillance because it helps add some of that missing information and so we’ve outlined some objectives for pursuing that strategic goal.

(Slide)

And then to reach out internationally. And that really, this last point is really what sort of what’s driven the theme of this public meeting. There are quite a few surveillance systems which might be described as mature, at least longstanding, that faced similar challenges through the years in trying to make their programs more and more robust. And we saw one of the main goals of the meeting today and tomorrow is to talk with our international partners and try to learn from each other and see what sorts of challenges they have faced and overcome and try to identify best practices, because there’s always room for improvement.

(Slide)

And so following on this international theme there’s a big push now for harmonization, not just in what we do but in all aspects and all enterprises from business standards and so on. And we need the same sort of harmonization as much as we can achieve in the monitoring that we do, if we’re going to make really valid, strong comparisons between countries.

(Slide)

And so to the agenda, as I mentioned, we have at least today especially on the big emphasis on the international aspects which we’ll hear from this afternoon, after we go over the NARMS program. And then a roundtable discussion this afternoon to carry on that conversation.
Tomorrow will be in the morning mostly about the research part of NARMS, the NARMS programs. And then hear from our partners on NARMS and how it’s valuable and recommendations on how it can be made better.

(Slide)

So, that’s a little bit of background on what drove the themes for our meeting today and tomorrow.

(Slide)

A couple of things worth mentioning, we have a really over packed agenda. I suppose if you look at it it’s a very tight schedule. I encourage everyone to try to stay on it. If there are questions one can always meet with the speakers later if they have some things that need to be clarified.

We’ll have refreshments every morning and at the breaks. And the meeting is being recorded and transcribed. And a meeting transcript will be posted on the web hopefully within about 30 days, 30 business days of the meeting.

As I mentioned for the speakers who would like to agree to have their presentations published the release forms are available over here with Joanne.

(Slide)

A couple of acknowledgments. I would first like to, for those of you who don’t know, announce that Heather Green is now serving as NARMS coordinator. Heather is sitting to my left, who replaced Beth Karp, who will be speaking in a little bit. Beth has gone on to CDC to work on NARMS and other issues down there. So, welcome to Heather.

Also, I would like to thank the FDA Office of International Programs, which provided the funding for us to meet this week. And also Joanne Kla from CVM who’s done a lot of great work on trying to get all the logistics worked out. And Syreeta Tate-Jones who is out front, who working with Joanne has done a lot of the meeting organizing.

So, and I’m sure I left people off this list, but a lot of people helped to try to bring this together.

So, those are my introductory remarks. And what we’ll do now is wade through the NARMS program and hear from each of the three agencies that participated in the program in the United States. That will bring us then right into the first session. And our first speaker today is David White.

And what I’ve asked the first three speakers to do today, Doctor White, Doctor Tauxe and Doctor Torrence, is talk about how NARMS fits into their agency goals, or where it fits in the activities of their agencies to sort of give that big picture view. And then from there we’ll get more specifics.

So, I think probably everyone in this room knows Dave White. Dave is currently the Director of the Office of Research, at FDA Center for Veterinary Medicine and a past Director of NARMS. And a very experienced and well published scientist in the area of Antibiotic Resistance in Foodborne Pathogens. And Dave is going to talk about activities at the FDA and antibiotic resistance. David.