Proheart 6 - Heartworm Injection

[Cavandra]

Just thought i would add this to the thread............showing the corruption involved! If you want to look at the links you will need to cut & paste them to your browser.

_http://blogs.usatoday.com/oped/2008/06/our-view-on-dru.HTML#more_

Our view on drug safety: FDA vet tracks dog deaths, gets smeared in the

Process

Tale of ProHeart 6 raises questions about who calls the shots at agency.

_ProHeart 6_ (http://www.proheart6.com/) — a controversial heartworm drug

For dogs — came back on the market last week, almost _four years after it

was

Pulled_ (http://www.senate.gov/~finance/press/Gpress/2008/prg060508.PDF)

When hundreds of dogs died and thousands more suffered adverse reactions.

Ordinarily, this might be of interest mainly to pet owners and

veterinarians. But

This is much more than a dog story.

(Photo - Hampshire: Questioned heartworm shot / Leslie E. Kossoff, AP)

During the process that took ProHeart 6 off the market, the drug's maker

_investigated and denounced a Food and Drug Administration scientist_

(http://www.usatoday

com/money/industries/health/drugs/2005-12-05-FDA-wyeth-probe_x.htm)

Who gathered the damning data. And instead of protecting its scientist, the

FDA booted her off the case and tried to have her criminally prosecuted.

It's a disturbing tale for anyone who relies on pharmaceutical companies and

The FDA to ensure that medicines for animals and humans are safe, one that

Raises questions about the conduct of a major corporation and its federal

Regulator.

The story begins in 2001, when ProHeart 6 came on the U.S. Market. It was

Regarded as a breakthrough. Veterinarians could inject it once every six

months,

Replacing the once-a-month pill people gave — or often forgot to give —

Their dogs to ward off potentially deadly heartworms. Though many dogs did

fine

On ProHeart 6, others had dangerous complications. Eventually, the FDA says

500 to 600 dogs died and there were "adverse" reactions, including seizures

And uncontrolled bleeding, in 5,500 to 6,000.

In 2004, the FDA pushed ProHeart 6 manufacturer Fort Dodge Animal Health, a

Subsidiary of pharmaceutical giant Wyeth, to _remove the drug from the

Market_ (http://www.FDA.gov/BBS/topics/answers/2004/ans01312.HTML) . Wyeth

argued

That the drug was safe but agreed to remove it. Then it fought back.

The company _targeted Victoria Hampshire_

(http://www.whistleblower.org/content/press_detail.cfm?press_id=1302) , a

veterinarian and FDA safety officer

Who collected and analyzed the adverse drug reports on ProHeart 6. Wyeth

hired

Investigators who dug up information on Hampshire's home, her tax records

and

A veterinary website where a handful of her friends and veterinary clients

Could buy drugs and pet supplies. (It's not uncommon for FDA's vets to

Practice medicine part-time in their off hours.) Wyeth executives then

alleged that

Hampshire had a conflict of interest.

Without telling Hampshire what was going on, the FDA took her off the

ProHeart 6 case and began an internal investigation that culminated when FDA

Investigators asked the U.S. Attorney in Maryland to criminally prosecute

her. It

Took one day for the U.S. Attorney to sort through the flimsy referral and

Refuse to press charges. The FDA _eventually exonerated Hampshire_

(http://www.msnbc.MSN.com/id/18137930/) , and she now works at the agency in

a different

Job.

ProHeart 6, meanwhile, is back on the market. The manufacturer and the FDA

Say the drug is safe, free of the solvent residue thought to have caused the

Earlier problems. But the drug is being administered under a strict "_risk

Minimization_ (http://www.FDA.gov/cvm/Documents/Proheart6RiskMAP.PDF) " plan

that

Applies to only a small number of FDA-approved drugs for animals and humans

We know much of this story not because Wyeth or the FDA disclosed it

Voluntarily, but because a persistent _investigation by Sen. Chuck

Grassley_

(http://finance.senate.gov/press/Gpress/2008/prg020608.PDF) , R-Iowa,

dragged it out

Of them. The probe revealed that Wyeth officials had easy, undocumented

Access to the FDA to lobby for ProHeart 6 and attack Hampshire. FDA

managers

Seemed more interested in placating Wyeth than in dealing fairly with one

of its

Scientists.

The most troubling aspect of this is the effect it will inevitably have on

Other FDA safety officers. After seeing what can happen when someone gathers

Evidence that a drug is unsafe, what safety officers wouldn't think twice

about

Risking their careers by antagonizing powerful companies?

That's a terribly dangerous way to run a drug safety process that can

ultimately mean life or death to animals and humans alike.

Posted at 12:22 AM/ET, June 17, 2008 in _Animals - Editorial_

(http://blogs.usatoday.com/oped/animals_editorial/index.html) , _Drug abuse

- Editorial_

(http://blogs.usatoday.com/oped/drug_abuse_editorial/index.html) , _USA

TODAY

editorial_ (http://blogs.usatoday.com/oped/usa_today_editorial/index.html)

[Guest Tess32]

Terrible. And the amount of vets will giving it at vaccination time also....is just revolting.

[Jey]

I got my dog the annual heartworm injection because it was such a drama feeding him the heartworm tablets. Is there only one type of heartworm injection?

At least I now know to ask more questions of the vet.

If the dog was ok initially, is there a chance of risk throughout the year?

If the dog was ok the first time, will he be ok the second time?

[Guest Tess32]

The effect can be cumulative, so yes it's still dangerous to give it again.

[stormie]

Interesting that there's nothing on the SR-12 labels, nor have the reps etc mentioned anything about not giving it within 1 month of vaccination.

It's possible that Fort Dodge have added this to proheart 6, so that people cannot claim a vaccine reaction is a proheart 6 reaction.

Edited June 20, 2008 by stormie

[sausy.dog]

Both vet practices in our country town say they have never heard anything about proheart side effects. I asked the vet at a consult where I usually take my dogs and she said she would do some reading but had never heard of it causing any problems. When I took Elly to puppy preschool - run by the other clinic - the vet nurse was telling us we should get it done and when I queried it she also said that their clinic gives it routinely without any adverse reactions. I am not sure, I haven't done enough reading on it, but I am not happy to give it to my dogs on what I have read.

[Cavandra]

Both vet practices in our country town say they have never heard anything about proheart side effects. I asked the vet at a consult where I usually take my dogs and she said she would do some reading but had never heard of it causing any problems. When I took Elly to puppy preschool - run by the other clinic - the vet nurse was telling us we should get it done and when I queried it she also said that their clinic gives it routinely without any adverse reactions. I am not sure, I haven't done enough reading on it, but I am not happy to give it to my dogs on what I have read.

They say this because they are talking about a dog suddenly becoming ill or dying suddenly after having it done.....that is rarely the case..........What it does is causes things like seizures months later.........Ask your Vet how many dogs they have on their books that have "epilepsy"....then ask how many have the heart worm shot!

Wonder how many clients they have lost because the customers dog did die, or did have a reaction at the time & they blamed that Vet rather than the drug itself & so changed Vets & never told them why they changed Vets....get my drift............Australians in general believe everything the Vet tells them, Many Americans dont, and that is why all our reactions (whether Vaccine, heartworm, anaesthetic, drug related ) never get reported here !!!

Many dogs never show any signs of distress, death, seizures etc. ....what about the ones that do though, and just because a dog has had it 5 years in a row doesnt mean it wont die from it the next year..........the death will be presumed to be from something else of course........

[sausy.dog]

Both vet practices in our country town say they have never heard anything about proheart side effects. I asked the vet at a consult where I usually take my dogs and she said she would do some reading but had never heard of it causing any problems. When I took Elly to puppy preschool - run by the other clinic - the vet nurse was telling us we should get it done and when I queried it she also said that their clinic gives it routinely without any adverse reactions. I am not sure, I haven't done enough reading on it, but I am not happy to give it to my dogs on what I have read.

They say this because they are talking about a dog suddenly becoming ill or dying suddenly after having it done.....that is rarely the case..........What it does is causes things like seizures months later.........Ask your Vet how many dogs they have on their books that have "epilepsy"....then ask how many have the heart worm shot!

Wonder how many clients they have lost because the customers dog did die, or did have a reaction at the time & they blamed that Vet rather than the drug itself & so changed Vets & never told them why they changed Vets....get my drift............Australians in general believe everything the Vet tells them, Many Americans dont, and that is why all our reactions (whether Vaccine, heartworm, anaesthetic, drug related ) never get reported here !!!

Many dogs never show any signs of distress, death, seizures etc. ....what about the ones that do though, and just because a dog has had it 5 years in a row doesnt mean it wont die from it the next year..........the death will be presumed to be from something else of course........

I understand everything you are saying and I agree. I think a lot of vets are just not informed about this drug - either because they don't actively seek info or they aren't given it - and its a real worry.

I suspect that in our area there would have been little or no alarm bells ringing by linking seizures etc with proheart because few people actually treat for heartworm here - it is not in our area at the moment. I know it is only a matter of time but until large numbers of people start treating for it with proheart then there will be very little to link adverse reactions to proheart that the vets will pick up on which is possibly why they are still ignorant about it.

[stormie]

The problem is, there is no scientific evidence to say the drug causes problems. No one can say that the dogs who developed seizures and other issues, wouldn't have had these problems anyway.

[Miss B]

I got my dog the annual heartworm injection because it was such a drama feeding him the heartworm tablets. Is there only one type of heartworm injection?

If the daily tablets are a bit of a drama, and you don't want the heartworm injection - you could try something like the monthly 'Heartgard' chews - they are pretty palatable and most dogs will happily eat them. My dogs love them

Interesting that there's nothing on the SR-12 labels, nor have the reps etc mentioned anything about not giving it within 1 month of vaccination.

It's possible that Fort Dodge have added this to proheart 6, so that people cannot claim a vaccine reaction is a proheart 6 reaction.

I was thinking the same thing. The Fort Dodge promotional posters actually use wording such as "Simple yearly injection, can be given at the same time as your dog's annual health check and vaccination" or something to that effect.

As with anything though, there are good vets and there are bad vets and I do not believe they should all be tarred with the same brush. I would never support a vet who promoted the breeding of designer dogs Obviously they are all about the money, and squeezing as much as possible out of their clients. Thankfully not all vets are like this. I'm lucky enough to work for a wonderful clinic owned by vets who genuinely care about their patients and clients and are not 'all about the money' :D

[Jey]

If the daily tablets are a bit of a drama, and you don't want the heartworm injection - you could try something like the monthly 'Heartgard' chews - they are pretty palatable and most dogs will happily eat them. My dogs love them :D

I made a mistake; it was those monthly chews that were a drama. The vet nurse would have to force them down his throat. Next year I might give crushing up the tablets in his food a go.

Is there only one type of annual vaccine?

[rose of tralee]

It's very good that this is being discussed, vets who can balance the bottom line with animal welfare have nothing to fear.

[stormie]

It's very good that this is being discussed, vets who can balance the bottom line with animal welfare have nothing to fear.

Even if SR-12 eventually is proved to be harmful, its not going to be the vets who get done, it will be the company. Vets rely on information they receive, which usually includes scientific studies and evidence to show products to be effective and safe. Just because there are websites out their stating these products to be harmful, until a properly done study shows that moxidectin is causing all these problems, it's still going to be used.

Rather than having a go at vets, why not target the companies that make them.

[dogbesotted]

From my perspective given the fact that as the company itself acknowledges that a small % of dogs have adverse reactions to the proheart.. why on earth would anyone run the risk that their dog may be one of the few and that the drug ( it is NOT A VACCINE) remains active for at least 12 months.

cheers

H

[morgan]

My vet stopped using it after several cases of autoimmune haemolytic anaemia occurred after the shot. He said that it is supposed to be a 1 in 10,000 occurrence, but he only vaccinated a few hundred dogs.

This link has been posted in almost every Proheart thread, but here it is again for those who have not seen it.

http://www.wyethah.ca/pdfs/Canine/EngLetterMarch16.pdf

The boxed warning on the caution section of the label is as follows -

BECAUSE OF ITS POTENTIAL FOR SERIOUS ADVERSE DRUG REACTIONS AND THE

ABSENCE OF IDENTIFIABLE RISK FACTORS ASSOCIATED WITH THOSE REACTIONS,

PROHEART 6 IS ONLY INDICATED FOR THOSE DOGS IN WHICH ALTERNATIVE

PREVENTATIVES CANNOT BE EFFECTIVELY ADMINISTERED.*

As far as I'm concerned, vets should be showing this label to their clients and giving them the ability to make an informed choice.

[stormie]

The boxed warning on the caution section of the label is as follows -

BECAUSE OF ITS POTENTIAL FOR SERIOUS ADVERSE DRUG REACTIONS AND THE

ABSENCE OF IDENTIFIABLE RISK FACTORS ASSOCIATED WITH THOSE REACTIONS,

PROHEART 6 IS ONLY INDICATED FOR THOSE DOGS IN WHICH ALTERNATIVE

PREVENTATIVES CANNOT BE EFFECTIVELY ADMINISTERED.*

As far as I'm concerned, vets should be showing this label to their clients and giving them the ability to make an informed choice.

I still can't work out why this is on the label of proheart6, but not on the label of proheart SR-12

[morgan]

I still can't work out why this is on the label of proheart6, but not on the label of proheart SR-12

Go figure - Proheart 12 has 3 times the active ingredient of Proheart 6. Obviously different labels for different countries :rolleyes:

[stormie]

I still can't work out why this is on the label of proheart6, but not on the label of proheart SR-12

Go figure - Proheart 12 has 3 times the active ingredient of Proheart 6. Obviously different labels for different countries :rolleyes:

Surely the suspension the moxidectin is in must be different, otherwise the SR-12 would all be absorbed in 6 months. There must be something different about it to make it be absorbed slower. It wouldn't just be because there is more of it being injected, because otherwise the size of the dog would determine how long it lasted, if that makes sense. Which could potentially be why the proheart6 has had more problems, because the chemical is being absorbed much faster.

Definitely something I'm going to question the FD reps on when they next come by...

Edited June 22, 2008 by stormie

[Cavandra]

Surely the suspension the moxidectin is in must be different, otherwise the SR-12 would all be absorbed in 6 months. There must be something different about it to make it be absorbed slower. It wouldn't just be because there is more of it being injected, because otherwise the size of the dog would determine how long it lasted, if that makes sense. Which could potentially be why the proheart6 has had more problems, because the chemical is being absorbed much faster.

Definitely something I'm going to question the FD reps on when they next come by...

Trouble is that if it were this simple the yanks would have adopted Proheart 12, and they never have.........why not I ask ????? My theory is that due to drug companies having zero ethics, so long as they are "getting away with it" they will continue, Australia is a far easier target as we dont sue over everything like Americans do, and we are more gullible.... JMO