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U.S. Department of Health and Human Services

Advisory Committees

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Committee Deliberations - Question #2 (Moderator, Dr. Michael Doyle)

 Question #2, Discussion

DR. DOYLE:  All right.  So that brings us up to the next question:  “Based on the information and data presented today, are there any additional modifications, additions or deletions to the ProHeart 6 RiskMAP and/or labeling that you would suggest?”  General comments?  Yes, Dr. McKean?

DR. McKEAN:  I think we have given a laundry list already.

DR. DOYLE:  Okay. 

DR. McKEAN:  You have heard -- I have really no additional modifications other than the ones that we raised over the last hour.

DR. DOYLE:  Okay.  Any other thoughts?  Dr. Senior, you were getting ready to say something?

DR. SENIOR:  Well, I was going to say the same thing.  We brought up surveillance and we talked about surveillance if you were going to give vaccinations at the same time, and we also brought up the matter of “practitioner, beware.”

DR. DOYLE:  Okay --

DR. SENIOR:  You are giving a drug; you need to know more about the animal.

DR. DOYLE:  Dr. Apley, do you have any thoughts?

DR. APLEY:  Like you were expecting them or something.


DR. APLEY:  Well, what is running through my mind is I would like us to tell the people that came and testified who had lost animals that it hasn’t fallen on deaf ears from the Committee.  I think it puts a face -- to me, it has put a face on the fact that adverse reactions aren’t just a number, and I appreciate that and respect you for coming.

At the same time, I think what we are struggling with as a Committee is a well-designed surveillance program, and I compliment you on that. I think it was well-designed to go out and look for stuff that we are struggling to use, as if we had some prospective, randomized clinical trial, maybe, to really guide us, and everyone realizes the limitations of design and we are dealing with low-incidence things.

I think, if we go back to the data deal, what I want to be on the label is any way you can help a veterinarian to work with their clients to balance risk versus benefit.  I think if we were to have left here today with a clear decision on putting something on the label where they can say, “Here is the risk versus here is the definitive benefit.”  And I am  not one to tell you where we go to generate that data to say a clear risk versus benefit. 

I think if there is anything you might use as a theme as you look forward to more modification of the label, it is anything we can do to continue to characterize the risk more clearly and in an easily understood manner that would be told to the client so that the client can make a decision along with the veterinarian.  And again, we are dealing with incredibly low-incidence things that, when they happen, they are someone’s animals, and so the -- that is the whole thing. 

And I don’t know how to tell you to design a study to do that with such low-incidence rates.

But I like the RiskMAP concept, I like where you are going with that.  I think surveillance needs to continue to happen, probably at an increased level with this drug for a while versus just the standard, what you are dealing with the RiskMAP, and power to you for doing that.

DR. DOYLE:  Dr. Griffin, do you have any comment?

DR. GRIFFIN:  It is a struggle, and I -- and my concern really has to do with labeling. 

I would like -- if you look at the missing information, it would be really nice on every label if we asked for prescription drugs to record some use data of that drug that would be available without having to -- and we do that pretty -- we do that routinely with all of our population stuff.  It just doesn’t seem to happen with companion animals much.  And it frustrates me that somewhere in the middle of it we lay ourself open to doing things that don’t make a difference.  And I think the blood work question is one of those that you have really got to ask yourself:  Why am I doing this, and how does that fix the problem? 

I think about the benefit of -- okay, here is an opportunity to see a dog one time, or a cat, and the owner.  We may not have another opportunity to see that animal again, so here is a product that will give us six months of coverage, especially if it is in a high-risk area.  Well, that is awesome.

But we don’t necessarily seem to have communicated that risk to the owners who are very willing to have a relationship with their veterinarian:  “I am going to bring my dog back in 30 days.” 

We do -- I don’t know.  It seems like we are wanting to put a handle around one wording that satisfies too much.  It is the same reason I am not -- still not in favor of diluting the possibility for an adverse reaction associated with some other products that are known to cause allergic responses such as vaccines.  If that is there and you protect that one dog, which could be my dog, and my wife would rather see me not come home than the dog.


DR. GRIFFIN:  And I don’t make that as a joke.  That is a fact.


DR. GRIFFIN:  In fact, maybe it is my wife I want you to protect and say, “Don’t do anything to jeopardize the relationship she has.”  And if that means don’t dare tread on that water that might lead to an adverse reaction, then stay away from it until you know more.  And thus far, the data that we have says it is -- it was associated with the event and then data since then has not been collected, so it is just up in the air. 

But collecting additional money for blood work is -- you know, we need to engage the population of people who care for pets and make them part of a family of communication and sharing information with the FDA, engaging their clients to be part of this --  since it is we provide the information, the FDA needs to make these decisions.  And I don’t think we have that today.

DR. DOYLE:  Okay, thank you.  Thank you, Dr. Griffin.  Dr. Mathew?

DR. MATHEW:  Well, I think the labeling obviously is important and we are working towards getting some clarity there, but with ProHeart 6 you also have the advantage of the veterinary training modules and registering for use of the product, so I think that is a very good avenue to maybe infuse some more emphases into insuring that animal is low-risk for adverse effect through whatever means the veterinarian deems necessary.

For those individuals who have spoken and who had the tragic loss of the animal, I certainly have my regrets as well. 

The unfortunate part about research and extending the database further is that it is almost impossible to prove the negative, and we are trying to prove that a product did not cause a reaction.  And I don’t think we are ever going to satisfy the customers in coming to that conclusion, although I am not suggesting that we not carry on more surveillance.  I am just -- you know, I am just looking at the challenges ahead to address any concerns that some others have expressed here today.

DR. DOYLE:  Thank you.  Thank you, Dr. Mathew.  Any other thoughts from Dr. McKean?

DR. McKEAN:  No.

DR. DOYLE:  All right, thank you for that.  Dr. Poppenga?

DR. POPPENGA:  Just very briefly, I don’t think I could say anything better than Dr. Apley said it.  I -- having lived through the pet food recall two years ago and fielded a number of phone calls from pet owners, I certainly understand the attachment people have to their pets, and I am sure all of us up here at the table feel the same way about our pets.

So the only comment, I think, is this sort of emphasizes to me the importance of educating practicing veterinarians with regard to reporting ADEs in how to handle those kind of cases because I think a lot of our graduating veterinarians are not really equipped to do that.  So maybe this is a good model, using this RiskMAP approach to educate the veterinarians about the importance of these kinds of reporting activities.

DR. DOYLE:  “How to be a doctor” as part of a college curriculum course, then?

DR. POPPENGA:  Well, it should be a part of every pharmacology course I think that is taught. 

DR. DOYLE:  Thank you.  Dr. Senior?

DR. SENIOR:  No, nothing new to add.

DR. DOYLE:  Okay.  I do have a comment from Dr. Wolf which I shall read:  “Insures CIS explains what to look for (signs/symptoms) to be vigilant for ADEs.”  And that is it.

So, anybody else have a thought?  Dr. Murtaugh stepped out.  Oh, Dr. Altier.  So, I am sorry.  I want you to have an opportunity as well.

DR. ALTIER:  Yes, I am fine.  I have appointed Dr. Apley as my personal spokesman.


DR. DOYLE:  All right.  Well, it looks like we are out of ideas.  Last call.

(No response)

All right.  Bernadette, I guess we will turn this back to you unless someone from the panel has other comments.

(No response)

DR. DUNHAM:  Back to the panel, anybody have any comments from the panel?

(No response)

DR. DUNHAM:  Well, if not, then I sincerely want to extend a real heartfelt appreciation to everybody that made this today.  We sincerely appreciate your compassion, your intellect, your advice, your criticism.  Everything you have shared with us today means so much as we all try to advance what we do.

It is challenging.  We really always seek to have drugs come to us for review that we can approve, that are safe and effective for human medicine, animal medicine.  And whenever we have an adverse drug reaction, we really do value that information so that we can insure minimization of anything that has an adverse impact. 

This is a preventive drug that has the potential, as you have realized, to address the very serious issue of heartworm disease in animals, and at the same time, you have said it all.  Communication is so critical as we try get our hands around what is happening and how we can interact and intervene and improve, be it a modification to the product or labeling or information.

This is the first time we have had an opportunity in veterinary medicine to embrace the RiskMAP, and as you have highlighted, we are learning.  I think there is tremendous potential, and there could be other ways and reasons when you would want to use a RiskMAP. 

But I think the bottom line has been:  How do we further hear from everybody when we are having problems and to build that database of our surveillance?  And that is going to take, as you have said, communication from veterinarians, from the owners.  We really do want to protect the pets that we all care for, that is for sure.  And I think the communication is critical, to have it as soon as possible.

The education that comes from the RiskMAP to the veterinarians on certain aspects, as you have alluded to, I think is very important, and those are then things we can build on.

What we will be doing now is taking, as we want, your recommendations to us to take a look at those questions and to make the revisions.  And I will be able to communicate this back to everybody.  And I really do sincerely, again, appreciate everybody coming to share that with us and advise us.  That is why we have the RiskMAPs.  Yes?

DR. DOYLE:  Just one last thing.  Dr. Murtaugh has come back, so we would like for --

DR. DUNHAM:  Oh, yes.

DR. DOYLE:  -- the record for him to comment on that last question, if he would care to.

DR. MURTAUGH:  I agree with the comments of the other panelists.

DR. DOYLE:  All right.  For the record, he agrees.


DR. DUNHAM:  Very good. 

Well, thank you so much, and what I really do want to also, as I said -- I would like to just, if I may, in addition to what I just said for thanking you, I would like to thank a few of the folks that were very specific in helping us with the VMAC today: 

As you saw, Aleta Sindelar, who is our VMAC Executive Secretary, was fantastic in helping the organization. 

*Joanne Clough was helping with our PowerPoint presentations. 

Kevin Boyd, who was doing audio timing and helping with the presentations. 

Lisa Burns, has been our transcript recorder. 

Zoe Gill, who has been the project manager and helping with a lot of materials.

But I really want to send a very, very warm and sincere thank you to those folks who specifically came here to Washington, D.C. today to participate in the public open comment period and share with us their comments, their views.

As always, we really want to continue to protect the animals under our care with any of the products that we review.  And by far, I really do appreciate the VMAC and, again, your participation and your advice. 

What we have heard today will be followed through because this is still going forward, so we should be able to come back and gather the information, and hopefully the ADE reporting system, which is so important for human medicine and veterinary medicine, is something that we can grow together.

So without any further ado, I want to thank you all so very, very much, and I hope you have safe travels back home.  Thank you.

(Whereupon, the meeting adjourned at 3:35 p.m.)