VMAC Statements/Speeches, January 31, 2005

By Ingrid Zorge

My name is Ingrid Zorge and I am a legally blind Canadian citizen. I would like to offer my apologies for not being able to personally present my statement, but my priority had to be to care for my dying dog.. I would like to state that all information in this statement are my personal opinions only and conversations are recalled to the best of my knowledge.

On May 27, 2004, I made a decision that would forever change my life. I agreed to allow my vet to give a ProHeart 6 injection to all three of my dogs. One of those dogs was my lifeline - my seeing-eye dog named Tigger, a 10 year old Golden Retriever.

I had raised Tigger from a sickly 6 week old puppy into a happy, healthy and extremely intelligent friend, who later was privately trained to become my sight. During the course of his duties as a service dog, Tigger literally saved my life twice while walking in traffic. I cannot begin to explain the bond that we shared, or the depth of my feelings for this extraordinary animal who was my best friend, living by my side 24 hours a day.

Within a few hours of receiving the ProHeart 6 injection, Tigger developed diarrhea and vomited several times. He became lethargic, depressed, weak, lost his appetite, and at times would collapse on the floor too weak to stand. These symptoms continued and after 3 weeks of supportive vet care, an ultrasound revealed tumors on his spleen. His spleen was removed and during the surgery it was discovered that he had many other tumors on his liver and his abdominal cavity was full of blood. Tigger did not improve after the surgery and about a week later he died a painful, horrible death, vomiting blood and suffering paralysis to his back legs. The diagnosis was Haemangiosarcoma - a canine cancer.

Tigger's cancer did not develop, nor did it end, by normal standards. He was very happy, healthy and energetic prior to the ProHeart 6 shot. Haemangiosarcoma is usually diagnosed by ultrasound only after the dog has shown signs of weakness, lethargy, and collapse. Several studies suggest the average time from the onset of this cancer until the diagnosis is about 8 weeks. Usually after the spleen is removed, the dog makes a positive recovery and the average life expectancy is then 3 months, longer if treated with chemotherapy. Tigger made no recovery and he died on July 6, 2004, only 5 weeks after receiving the ProHeart 6 shot.

My second dog to receive the ProHeart 6 shot on May 27 was Mack, my 7 year old Rottweiler. Mack also vomited several hours after receiving this shot but he appeared to return to normal in a day or so.
In July and August 2004, about 6 to 8 weeks after the shot, Mack again began vomiting, he was lethargic and had an intermittent fever. His symptoms increased and in November 2004 he had an ultrasound which showed tumors on his spleen and liver.
The diagnosis: Haemangiosarcoma - canine cancer, the same as Tigger.
Again - Mack was happy, healthy and very energetic prior to receiving the ProHeart 6 shot.

Yesterday, January 30th, Mack collapsed again and began vomiting, I was forced to make the painful decision to have him euthanized by our vet. This beautiful, courageous animal fought for his life to the very last minutes, struggling to rise even though he was heavily sedated. I will carry this disturbing image for a long time to come.

Three days ago, January 28, 2005, my third dog to receive the ProHeart 6 shot on May 27, 2004, collapsed, vomited many pools of blood and had bloody diarrhea. Rayn is a one year old Border Collie X and has had intermittent vomiting and diarrhea for the past 6 months. We are waiting for test results to determine Rayn's outcome.

There are many times that I feel overwhelmed by the guilt for making the decision to give my dogs the ProHeart 6 shot. There is not a doubt in my mind that ProHeart 6 is responsible for the deaths of Tigger and Mack, and Rayn's illness may prove to be the third. I am very afraid that this nightmare will never end.

There are approximately 1,000 diseases that can affect dogs. The mathematical probability of all 3 dogs developing the same cancer within this time period would be 1 in 160 Million.
Think about it - 3 different breeds of dogs, three different ages, 3 different diets. Only one common denominator and that is ProHeart 6.

Do I believe that ProHeart 6 is safe for my dogs? Absolutely not!!

(Safety)

This meeting is to evaluate the SAFETY of ProHeart 6. And I believe that the safety of this drug or any other drug, is directly affected by the business practices and ethics of the drug manufacturers.

Drugs companies are very powerful entities, I'm sure we would all agree to that.
But with Power, comes responsibility and accountability.

Fort Dodge Animal Health, a division of Wyeth, manufacturers ProHeart 6 here in the United States. These vials of ProHeart 6 are then shipped to Canada and distributed to Canadian vets by Wyeth Animal Health.

In the United States, there have been 3 recalls for ProHeart 6 due to varying factors, one of which was for contaminated vials. I believe this recall was to be international, however, there was no actual recall for ProHeart 6 done in Canada.

In the United States, there have been 3 labels revisions, a new package insert, and several Dear Doctor letters issued to US vets due to reported adverse drug reactions to ProHeart 6. Adverse reactions reported that included deaths.

Why was this information withheld from Canadian vets and consumers? Why did Fort Dodge Animal Health, the sole manufacturer of ProHeart 6, only make the 3 label revisions for vials of ProHeart 6 sold in the US?
Why did Fort Dodge Animal Health not send the Dear Doctor letters warning of Adverse reactions to ProHeart 6 to all Canadian vets as they sent to US vets?
Why would representatives of Wyeth Animal Health here in Canada not feel a responsibility to inform Canadian vets and consumers of the reported adverse reactions including deaths?
And why would sales reps of Wyeth Animal Health continue to misrepresent the safety of ProHeart 6 here in Canada, even after the total recall of ProHeart 6 in the US in September 2004?

My vet or myself would never have allowed my seeing eye dog, nor my companion dogs, to receive a ProHeart 6 injection had we been informed of the possible dangers.

Two different veterinarian executives of Wyeth Animal Health here in Canada, have told me that they are not required to distribute this important information to Canadian vets or consumers.
Why on earth not? Are we, as Canadian consumers, not entitled to make informed decisions for the health of our service dogs and companion animals?
Does Fort Dodge or Wyeth Animal Health not feel they have an ethical or moral responsibility to warn consumers of potential dangers to their drug products?
Obviously not.

In Canada, our veterinary drugs are approved and regulated by the VDD, which stands for the Veterinary Drug Directorate. The VDD is a division of our Health Canada System.
Wyeth Animal Health is using the regulations of the VDD to avoid disclosing the adverse reactions to ProHeart 6 to Canadian vets and consumers.
Can this be considered a responsible or ethical business practice?

I have questioned the VDD several times since the death of my seeing-eye dog. The VDD has confirmed to me that they were aware of the adverse reactions to ProHeart 6 reported in the US. The VDD has also confimed to me that they were aware of all the label revisions and Dear Doctor letters sent to US veterinarians.
However, the VDD advises me that they do not feel there is a cause for concern and will not order these changes to be made in Canada.