Panelist Comments: Question Six
DR. YOUNGMAN: Thank you very much.
We are at our last question, and then I would like to open it up for general comments, if I could. So if we could finish off with the last question, which is, NARMS is funded by FDA through inter-agency agreements with CDC and USDA. For the next several budget cycles, it is unlikely that funding for NARMS will be increased. In fact, it is likely it is going to be decreased. How do you suggest that we enhance and sustain funding for NARMS? And if I can start with you, Lyle.
DR. VOGEL: Sure. From the viewpoint of an organization that has gone by itself -- that organization being AVMA -- by itself to Congress to obtain and support funding for the FDA total budget, as well as specifically for NARMS budget. And also, as a member of the Animal Agriculture Coalition.
I think one of the ways that we can enhance and sustain funding for NARMS is to ensure that we maintain and improve stakeholder buy-in into NARMS. Stakeholders that we deal with are supportive, but with some concerns. So we need to improve that buy-in from the stakeholders.
Some of the concerns that have been expressed in the past are the fact that one arm of NARMS saw decreased funding over a period of time, while other NARMS were having increased funding. And that caused concern with the stakeholders.
One of the ways I think that we can improve buy-in of stakeholders is the oversight committee that was mentioned in the CDC panel review, that there be an oversight group of experts to meet periodically to --- the list, to evaluate the whole total NARMS program, and to provide advice.
You know, receive information about what is going on with NARMS, with the budget, with other aspects, and then to provide scientific advice to NARMS. I think if that such an oversight group was created, and the stakeholders had an opportunity either to sit on that group, or to provide nominees for that group, I think that would improve the stakeholder comfort with the programs.
DR. YOUNGMAN: Thank you very much. Awa.
DR. AIDARA-KANE: Yes, I have also noted the stakeholder’s participation should be improved maybe by sharing some success stories, or using data from the three arms of NARMS for advocacy.
And also, another point is maybe NARMS should consider having a steering committee with representatives from the three agencies, but also from all stakeholders. And one of the terms of reference of this steering committee may be, for example, fund-raising.
DR. YOUNGMAN: Thank you very much. Scott.
DR. MCEWEN: Yes, I found this kind of the toughest question. And I would just like to thank Dr. Sundlof for making it harder by saying we should also suggest how it could be even better. But I think that was a very wise request because funding does go in cycles. And while there needs to be some short-term belt tightening, hopefully, things will be better down the road. So we need to keep that in mind.
I guess general suggestions would be -- and it has been said many times, we need to revisit and tighten the objectives and use those as a basis for prioritizing activities and sort of -- hopefully, there won’t be things, actually, that fall off the table. That, hopefully, there will be some things that maybe can be cut back, but kept alive I guess until anticipating that there will be more opportunities for support down the road. So there is a maintenance of at least a presence in some of these other areas in the meantime.
It seems to me a core activity is monitoring of susceptibility and representative isolates of key foodborne pathogens, Salmonella and campylobacter in humans, food animals, and food. And I think we have to maintain that as a core.
I think it is important to retain some flexibility in the budget for various types of pilot studies and sort of investigations into other areas. I think those types of things tend to be trimmed in periods of physical crises, but I think that is -- and lots of examples provided in the last couple of days where those pilot studies have yielded useful information. So, try to retain some of that flexibility.
And, where possible, to try to deal with the question in front of us to continue to partner with other organizations. Again, to leverage opportunities where they exist. And, again, it made good use of that. There may be some others that can be taken advantage of.
Where possible, broaden the collaboration outside of government, to academia and elsewhere, to help fulfill some of the objectives of NARMS. I think, again, to expand on the example provided with CDC’s collaboration.
And I know that the other branches do this as well, but where the opportunities arise, to provide NARMS data and isolates to willing researchers and graduate students who may be funded from other sources. That is an opportunity to meet objectives, again, but have it paid for by other sources sometimes.
I guess, you know, if push came to shove, if I had to identify some things, I guess I -- again, I mention what I see is the core. Obviously, there is questions about cutting back on some of the commensal testing if necessary.
Maybe be more strategic, at least, with some of the characterization studies. I guess I wonder whether the return on investment of the Vet diagnostic isolates is there. And the usefulness of some of the isolates from compliance testing.
In answer to Dr. Sundlof’s request for some thoughts about how NARMS could be made even better, given an opportunity -- I think it has been mentioned already -- but I think try to make it more comprehensive in its representation of the farm-to-fork continuum.
So much more presence on the farm, and at other levels of the continuum. And, obviously, then try to integrate that information. A big, big challenge, but it needs to be met.
I think the system could do a lot to be more robust and statistically valid. And that is going to require a stepping up of sampling. I think another thing to consider is to broaden the range of antimicrobial resistance issues beyond purely animal, and its impact on humans to animal health issues. And, eventually, perhaps, embrace other, more purely human health issues and resistance.
I think design a system to better address issues of attribution. The contribution made by antimicrobial use in various animal species on impacts in human health, I think we need to get a much better handle on that.
Get a better handle on the issue I have already mentioned, the impact of resistance and sort of non-target, or non-pathogen species, commensal species, and their role as reservoirs of resistance.
A system that is better able to measure the impact of co-selection. And I think that is an important issue that is under estimated. And a better capacity to link NARMS with other important databases, such as human health databases, animal health databases. And, again, in the spirit of helping us to better address the main objectives of NARMS and measure impacts on human health.
I think there could be capacity for broader input of scientists from outside of the agencies. And if we had a blank check, to have capacity for research grants and fellowships that would encourage members of academia to make more use of NARMS data and help fulfill NARMS objectives would be beneficial.
And a point I will mention later is I think we need to include antimicrobial use in different ways. The farm level, aggregate, measures of use, and that sort of thing, to address NARMS objectives.
DR. YOUNGMAN: Thank you very much. Marissa.
DR. MILLER: I have just a couple of thoughts. First of all, I think there is a remarkable amount of productivity for the $5 million investment. At least what was the dollars that were presented to us. So bravo, good job.
And I know that it was mentioned, the leveraging off of other resources; which, obviously, will need to continue and be expanded as appropriate. Especially, in lean budget years. I think what you are not really taking into consideration are many hidden costs.
And, I wonder if it might be worthwhile to look at those. In other words, the true costs of running these programs so you would build in personnel costs, travel, training, the provision of isolates. Other things that happen that aren’t a line item in the budget.
And the reason I bring this up is it might help you justify continued funding it at your current level -- or, hopefully, slightly higher -- if you show the resources that go into it that aren’t being asked for. Just a thought.
I also will bring up once again an idea. It may not be viable but, perhaps, it can be explored. Because NARMS is really providing a post-marketing monitoring strategy for the center and, in essence, covering quite a few industry sponsors and industry groups, I think that, perhaps, there could be a justification for asking industry to pay into the system if it comes down to it.
I don’t know how this could work out, but I just throw that out; particularly, because of CDER’s requirements. Similar requirements for post-marketing surveillance that are burdened by the sponsors themselves.
I agree with Dr. Vogel about rallying your constituency groups and your stakeholders. And I would suggest that it might be a good time to bring those groups in into a forum similar to this where you ask for feedback, get buy-in, allow some ownership, and then raise the funding issue with them as well. And that could help, again, building up steam for justifying more money, or the current funding levels. I guess that was all I had.
DR. YOUNGMAN: Thank you. Sue.
DR. KOTARSKI: Yes. I would like to echo the sentiments of Dr. Vogel and Dr. Miller about the possibilities for engaging the ag groups. It seems like there has been points in the discussions over the past day and a half that we are lacking that information about resistance associated with food animals. We only have the NARMS every five years for aparticular commodity. And it would be useful to have that.
We do have available the CAHFSE Program, which is an example by which we can get integrated data, but that program needs to grow so it takes into account more commodities. So you have elements in the NARMS Program, and in the CAHFSE Program, where you have systematic sampling, national monitoring, and good examples of obtaining that data.
And, with the engagement of the ag industries, capitalize on that. Identify if you can take a portion of your NARMS money and invest that with those groups to enhance your ability to understand the resistance that you are seeing, or that is out there with respect to animals. Engage them, actively involve them, and developing and enhancing that program.
You have good example right now of that occurring. So it seems like there has been opportunity to have that happen by working with them. And I would encourage that.
And, perhaps, you could think about doing that at the expense of the diagnostic isolates. Ask yourself, what information are we getting from the diagnostic isolates, how are you using that information, are we using that information, could that be put towards the healthy animals instead rather than diagnostic animals. That is a process that I think the agency might want to consider.
DR. YOUNGMAN: Thank you very much. Sean.
DR. ALTEKRUSE: First, I think it would be helpful if each of the arms of the surveillance system defined what their core objectives were. We have heard that a lot. And then, if the three arms could develop sort of an integrated summary of what the overall objectives were, and work with their stakeholders -- and that has the potential to form a pretty unusual coalition, potentially, of the agricultural coalition, the American Public Health Association, drug companies.
So, as Marissa was pointing out, maybe they would support -- perhaps, they could provide funds, but they might also advocate on our behalf for post-marketing surveillance activities. Consumer groups, the American Society for Microbiology. There are a lot of constituents that have specific interests related to this.
And as Awa and Marissa mentioned, those people could be brought together in a sort of forum like this to talk about what commonalities they share and support us, I think it would go a long way towards getting the funding to continue this.
The other aspect is it may be that we could find some places that we could, at this point -- you know, nine years into the project -- where we could identify some aspects for belt tightening and some refinements. And if that could be incorporated in the sort of integrated objectives. I think each arm mentions some aspects that they might be willing to take a look at.
Listeria and vibrio isolates, diagnostic isolates, commensal isolates, and some slaughter isolates that belong to less than compelling serotypes, as examples. But, I believe that if this is packaged correctly, and a broad coalition is brought together, it is very possible to get funding for this project to continue.
DR. YOUNGMAN: Thank you very much.
Well, that finishes our six questions that we posed originally to be considered during this conference. Again, I want to thank everyone who presented, everyone who attended, and all of the panelists for your thoughtful comments. Thank you very much, we appreciate them.
I would now like to open it, I know we have very limited time. We were aiming to end by 12:00, which is about 10 minutes away. But if there are some additional over-arching comments that have nothing to do with the six original questions posed, I would like to open it up for general comments now. Scott.