VMAC Statements/Speeches, January 31, 2005

By Connie Dominy

My name is Connie and I have been through sleet, ice, snow and hail to get here.

First let me say I am here on my own. I do not represent any group or individual. I do not stand to have any monetary gain. I do not own stock in any pharmaceutical companies, although maybe I should. I have absorbed all costs of this trip.

By profession I am a psychotherapist currently in private practice. I have been in the healthcare industry for over 20 years in various positions. I am very familiar with product development, marketing tactics and post approval safety data collection.

My goal today is to challenge the FDA and the Advisory Committee to simply do their job. You are consumer advocates. Your consumers are the animals that can't speak for themselves. You are charged to do this to the best of your ability and to not let politics, power, greed and intimidation influence your decision. You are to hold the manufacturers of animal products accountable for safety. I encourage you to look deep within your soul and make the right decision regarding the use of ProHeart6.

I have heard Banfield mentioned a lot today. Let me tell you what happened when I went in to the Banfield in my area. This was 6 weeks AFTER the product had been recalled. They still had all of the promotional information up. Is this representative of a responsible company whose data we need to believe? I think not.

I am here because my family member received the ProHeart 6 injection. I remain firm in my belief that the symptoms he exhibited over a 6-7 month period after the injection were related to PH6.

Fort Dodge remains firm in their belief that their product is safe and "science will prevail". I hold firm in my belief that this product is NOT safe and "science will prevail".

I have read the FDA report. I am appalled to think that a Fort Dodge would refer to the reports sent in by veterinarians as being over reactive and bias. I believe veterinarians UNDER reported Adverse Reactions. I also believe that veterinarians were grossly mislead by FD and the sales reps.

You keep mentioning "necropsy" reports and the lack of them. By the time some of our family died and cost absorbed by the owners, necropsy was the last thing on their mind.

When looking at all of this from a scientific perspective, I question the validity of the initial studies presented to the FDA for product approval. To have a valid study the sample group should receive the treatment for the time the drug is purported to work. Data less than 180 plus days, does not represent a study of validity and reliability. The sample size was inadequate based upon the projected population size and number of dosages FD projected to sell. Nor was it representative of a cross section of the subjects that would receive this medication.

Another concern is the glaring absence of longitudinal studies of significant sample size. It is interesting to note that all of the laboratory trial subjects were destroyed. This is

otherwise known as destroying the evidence. In some areas, this is considered a criminal act.

It is my opinion that Fort Dodge has been negligent in their job to provide a safe product. They have also failed in their job of appropriately addressing the issues the data collected post approval indicated. They have categorically denied that the symptoms seen are not related to PH6. The denial of FD is similar to that exhibited by the parent company when they denied that PhenFen was the cause of problems reported by consumers. We know how that ended up. Don't we?

Does this exhibit's a potential trend with this company? It certainly brings me and I hope the FDA and the Advisory Committee to question Fort Dodge's integrity and their ability to provide unbiased information to the FDA and consumers. Afterall, the bottom line is profit, not safety or concern for our family members. This creates the biggest bias reported here today.

As late as October 2004, Fort Dodge was still denying that my dog's symptoms were a result of the shot. When he received the shot on Sept. 27, 2003 he received no other shots or medications. The Fort Dodge vet also told me that they had contacted my vet and had been told that he suffered no more symptoms after the initial symptoms and they closed the case. That was not true. They did not contact my vet again.

His ongoing symptoms required frequent trips to the vet and were so severe that tests for vonwillabrand and an upper GI were done. All testing was done at my expense and in an effort to rule out anything. FD told me that vomiting and diarrhea were not side effects. Fort Dodge insulted my intelligence, my knowledge of my dog and what my vet had presented to them. All because the severe reaction occurred on day 11 after the injection. His medical records have been submitted to the FDA for review. I have a copy with me if you would like to see the documentation.

I encourage you to insist that more comprehensive studies be done on existing data and surviving subjects. There are no valid and reliable long range studies. Reddy is a survivor but who knows what the long range effects are. BTW He is a Champion in more ways than one. Let him be one of your teachers.

We as humans were put here to be the stewards of all that is around us including the animals.

One parting thought.

"Until One has loved an animal, a part of One's soul remains unawakened."
-- Anatole France