VMAC Statements/Speeches, January 31, 2005

By Laurryn Simpson

My name is Laurryn Simpson and I'd like to thank everyone for allowing me to speak today. I receive no financial gain by speaking today.

Let me clarify I am not a scientist, a vet or in any medical field and never have been.

But as a Cybrarian, I started collecting information regarding this drug, and posted on the website DogsAdverseReactions.

My pug did have a reaction to PH6, very minor compared to the majority of reactions you will hear or read about. She was only given this injection because the vet was conveniently "out of her regular preventative." Later I found - it was suggested that vets carry only one preventative so as to not confuse the consumer with choices.

I stand before you today, not just as an individual, but for thousands of caregivers that feel their companion is part of their family and not "just a dog."

When they were told this product was 'safe' - there are no reactions - better then monthly's - they thought they are doing the right thing for their pets.

Then to watch them suffer, and possibly die, spending hundreds and thousands of dollars trying to save them.
All the time being told that it could NOT possibly be from PH6 because that is SAFE!
Or to be told, it's to soon or to late to be related to PH6.
Or this type of reaction has never been reported before.

The guilt we feel because we not only okayed - but paid for this injection and blaming ourselves for not researching it.

I've recommended Rainbow Bridge more times then I could ever think possible.

Now I've been told -- that we have our own bridge, a Proheart 6 bridge.

But we are here to discuss the safety of PH6 with our pets. Safety appears to have been sidelined for our pets - either for the all mighty dollar or something bigger.

There are two parts of PH6 to consider, Moxidectin and also the delivery system of time released microspheres.

Microspheres are new in the veterinary world. Although they are also testing them in humans for females with Uterine Fibroids.

They have been described as little golf balls that emit moxidectin. They are supposedly fragile .... "shake to mix" but only 'roll' once stored. I can't help but wonder what happens to these microspheres after an injection if the dog is rough housing, or playing and that injection site gets hit. Remember we are talking every day dogs, not dogs that are kept in a cage the majority of their lives.

Moxidectin is used in horses, cattle, sheep and other animals. It has been tested on fish, tortoises and humans. It is administrated by gels, pour-ons, orally, injections and the time released injections for dogs.

In 2000 Proheart 12 aka SR 12 was approved in Australia as a one year preventative, just nine months before approved as 6 month injection in the US. Australia may not have the adverse reaction reporting system as we do and it may not be that well known to the public, but they DO have reports that have been already been evaluated as 'probable' and 'possibly' related to moxidectin. Italy recently started a reporting system and they have reports also.

The manufacturer has stated repeatedly in the last 3-4 years that "PH6 is NOT effective against adult worms." That it is "not effective for microfilariae clearance, but that circulating microfilariae may decrease."

Yet in 2000 the World Health Organization stated that "a single treatment produces 'slow' death of adult worms in dogs." That was a year before the manufacturer told the FDA/CVM that it does NOT?

"Not effective for microfilariae clearance" - - but on page 30 of their document before you they state "microfilariae counts were reduced to almost 0 three weeks after treatment."

I've no doubt that the manufacturer presented testing for what was required by the FDA/CVM at that time, for a new drug. Yet I wonder if they took into consideration, that being innovative, MORE testing should have been done?

Alabama did testing for heartworm positive dogs.
Twenty dogs were in the test, ten were control.
TEN dogs received Proheart 6... but ONLY at 3 times the regular dose.
Then they were ALL sacrificed at TWENTY EIGHT days!Texas did testing for 'repeated doses' The test lasted 3 years according to the FOI Summary. But look deeper, apparently only FOUR dogs received regular doses of PH6, every 6 months for 3 years. FOUR dogs, is this extensive testing?

In Field Trials, the FOI summary AND the document before you states 280 dogs received regular doses of PH6 for a year and that three died. In a press release to Chicago and Boston CBS in February of '03 they stated that 330 started the trial receiveing proheart 6, but only 280 finished it. That is a difference of 50 dogs receiving Proheart 6!

In the document they presented to you on page 27 it states that in an 18 month study 12 dogs died or were euthanized and apparently after the manufacturers review, these deaths could not be attributed to Proheart 6. I wonder what did they attribute it to? Old age? heart failure? Liver failure? Kidney problems? Maybe an immune disorder? Or maybe while crossing a street they had a seizure and were hit by a car?

We all know what the labels state so I won't repeat it here.

"Give to healthy dogs", in field trials they still administered to one that was underweight and had a history of congenital problems and he didn't survive. "Use with caution in sick dogs" how much caution can you use with a 6 month time released formula with no antitode except not to use it? Evidently the manufacturers and researchers ideas of 'healthy' is different then the veterinarians who administer it.

According to the charts I found, suggested ages to start 'geriatric screening' can be as early as 4 years of age for a larger breed. Were there warnings for this?

It is stated on the label that "PH6 was safely used in conjunction with a variety of veterinary products including vaccines".
How many dogs that have always had vaccines and boosters by the old protocols, suddenly has PH6 thrown in with them and has a reaction?
But THAT can't be attributed to PH6.

A lot of veterinarians have admitted they have never read the label OR the dear doctor letters, because they were told in seminars while earning education credits that this drug is SAFE! This is also when they were told PH6 would make them more money.

It has been documented by several tests and summarized in an article in the May 01 Journal of the American Animal Hospital Associate that there are breeds that are predisposed to vaccine reactions. Akitas, cocker spaniels, german shepherds, golden retrievers, irish setters, great danes.. And the list goes on. Yet PH6 is supposedly safe with all medications and ALL dogs?