My name is Laurie Rentas and I am here today because on February 5, 2004, ProHeart6 destroyed a member of our family, our precious little Yorkie, Murphy, after a nine month agonizing and ultimately…. losing battle. My initial intention was to focus my time here on her loss, until other tragic stories came to my attention and showed me that the impact of ProHeart6 was much bigger than just Murphy’s case. We didn’t want her sacrificed so that other dogs could be saved. We didn’t want our lives changed forever and we most certainly didn’t want to end up a statistic of an unsafe drug and an apathetic pharmaceutical company, but we are. And because we are, I want this panel to know even MORE of the horror stories regarding ProHeart6.

I want to say right now that at no time have I ever, or will I ever, claim to be a scientist, a statistician or an expert regarding the knowledge I have of ProHeart6. The totally voluntary and unsolicited data I’m about to share with you came from a website called CAPS. The president of CAPS created, and made available, a ProHeart6 complaint form because she knew of people who suffered at the hands of ProHeart6 and wanted to see who else was out there and going thru the same thing. Complaints rolled in on almost a daily basis.
Keep in mind that at no time did ANYone go out looking for complaints…. these victims found CAPS because they were looking for answers. But they found, as we did, that there’s no going back once you introduce this poison into your dog’s body.
There are far more deaths than anyone was lead to believe, all which came as a result of a product that was suppose to offer “safety” against heartworm. And the veterinarians led us guardians literally to slaughter by misleading us as to the safety of ProHeart6, “the new convenient alternative to the monthly tablets”. But, it was really an UNSAFE heartworm prevention promoted over the perfectly effective products that have been on the market for years! We went to these veterinarians because we trusted them to know more than we did regarding heartworm prevention and we accepted their recommendations.
There’s a “denial” factor in these vets. Out of all of these reports, there are only 10 positive comments made by the guardians that their vet tried to help them, or was at least empathetic and open to the possibility that ProHeart6 could be causing the problems. Most vets wouldn’t even engage in conversation regarding the possibility. Guardians basically hit brick walls in trying to “fix” what was happening to their pets…and the brick walls were Fort Dodge and the VETS that they trusted in the FIRST place! I won’t even address the thousands of dollars we have thrown away as a direct result to ProHeart6. There was a test for every symptom and all it took was the guardians’ credit card to carry it out. Yet, definitive answers as to the problems were never forthcoming. Were the vets lied to? Who lied to them and convinced them of the effectiveness and safety of this product?
All of us in this room were informed that the purpose of this hearing is to determine the safety of ProHeart6. ProHeart6 is not safe…the comparisons against ALL of the monthly tablets PROVE that! The numbers show unequivocally that there are not the same degree of adverse reactions in the monthly prevention drugs.

Unfortunately, there are still people who are in the midst of fighting what ProHeart6 is doing to their dog. It’s only been off the market for five months so we KNOW there are still dogs out there with this poison in their system.
There was never the degree of effort spent STOPPING the use of ProHeart6…that there was in coaxing everyone into using it. In fact, there are reports of dogs receiving the shot AFTER the recall.
Over 60 adverse reactions were volunteered by guardians in 35 states.
There’s no rhyme or reason to the drug’s affect on size, sex or age.
There are practically equal numbers of both female and male.
There are dogs from age 15…as ridiculous as it was that ProHeart6 was even PROMOTED for a 15 yr old dog, down to a puppy that was barely 6 months old.
7 years old is the most common age of death reported…..with 4 years old the being next common age of death.
We have complaints from Chihuahuas and Yorkies to St. Bernards and Great Danes!
70 of the 174 guardians (which translates to over 40 %!) responded that on the day their dog received ProHeart6, no other drug was introduced into their system.

But the most disturbing fact to come out of all of these statistics is this. Out of the 174 reports, 80 of these dogs have died. SO FAR.
Think about this statement. That’s a revolting 46%.
If Fort Dodge truly feels that their product is so safe, then I question why a company of this magnitude would offer thousands and thousands of ‘hush money’ to the victims if they have nothing at all to hide.
Safe? You tell me.
Oh, one last thing. The one…and only one…common denominator in all of these dogs???
Right.
ProHeart6.

Laurie Rentas

(Paraphrased) Because of ProHeart 6, I am here in memory of my deceased dogs, Tasha and Niki, and on behalf of my survivor dog, Casey. They each had one shot of ProHeart 6 during the “peak period” of 2002. Casey is still on medication and on the low end of “normal” after two and a half years. I will not be speaking about my dogs today because it is still too painful for me to talk about them.

Some of the individuals speaking this hour are not a group of fanatics on the Internet, as we've sometimes been called. We are here because we have been victims of ProHeart 6; our dogs took ill. Many of them, like my dogs, died.

Some may say, “These are ‘JUST’ dogs, they can be easily replaced." But not for us. These dogs were and are our family members. For some of us, our dogs are the children we never had and never will have.

I'm sure each of you in this room has bonded with a child. Perhaps it’s one of your own. Your love for this child is so great, you cannot imagine your life without him.

Imagine a drug you agreed to be given to this child to keep him in good health. Imagine this child adversely reacting to this drug and there is no known antidote to counteract its adverse effects. Imagine this child having to suffer through the adverse effects for many months until the drug passes from his body, if his body can "live that long."

Imagine the horror of watching day after day your child seizing on the floor, or walking into walls, or not being able to eat or drink, or urinating or defecating on himself, or blood coming out of every orifice of his body, his crying out in pain. And there you sit powerless, not able to do a thing to help him.

All you can do is turn over your child to the doctors, the so-called “experts,” and hope the doctors can figure out how to treat him, because they sure as heck don't know what's wrong with him. And it sure as heck cannot be the drug that THEY administered to your child. Your doctor won’t admit it if he thinks it is the drug because he doesn’t want to be slapped with a lawsuit. And the manufacturer won’t admit it because they don’t want to be slapped with lawsuits.

Meanwhile, you sit in desperation and pray that God fixes it all, brings you the miracle you are so desperately praying for. But the miracle never comes. You are faced with quality-of-life issues for your child. He’s never going to eat or drink on his own, walk, talk, play again. So what do you do? Do you let him suffer, or do you play God and pull the plug? Either way, your child dies, and all you can do is blame yourself because it was YOU who trusted your doctor when he said this product was "safe," but YOU played a part in killing your own child. How do you live with yourself the rest of your life?

Welcome to our world. This is OUR private living hell, the world of thousands of us guardians who have had our dogs, our family members, adversely affected and even killed by ProHeart 6.

If this happened to your child, would you sit idly by? We think not. This product is NOT safe. You know it, and we know it. The manufacturer will say that less than 1 percent of dogs are affected, that it benefits more dogs than it hurts. But when all of the dogs in your household are affected by their product, that’s 100 percent. It was 100 percent in my household.

Fort Dodge, we want you to stop the experimenting on our children. Stop the killing. Stop this “poison for profit.” Members of the Committee, tell them to leave our families alone. Look into your hearts, and do the right thing by us and by our innocent, loving animal companions. Please . . . do the right thing.

Thank you.

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 turned out, 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

Connie Dominy