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Fired Scientist Alleges Heartgard Plus Cover-Up

Heartgard PlusThe maker of Heartgard Plus, a heartworm drug used by millions of dog owners, “extortionately fired” its head of “global pharmacovigilance” after she refused to destroy documents questioning the drug’s effectiveness, the Ph.D. claims in federal court.

In her suit against Merial LLC, the animal drug division of Sanofi Aventis, Dr. Kari Blaho-Owens says that she was hired in 2006 after the Food and Drug Administration (FDA) expressed concern about reports of Heartgard Plus being ineffective in preventing heartworm in dogs.

Blaho-Owens said that after reviewing the situation, she became aware that Merial had known of the problem since at least 2002 but had done nothing to update its labeling to specify that Heartgard Plus was not 100 percent effective in preventing heartworm.

Blaho-Owens said that in one discussion, Dr. Felipe Dolz, then Director of Regulatory Affairs, U.S., said that a labeling change would put Merial at a marketing disadvantage compared to competitors’ products and that the company would prefer that FDA make the labeling change “product wide,” meaning that it would also apply to competitors’ drugs.

The suit alleges that internal studies conducted by the company were unscientific and used “cherry-picked” data to support the company’s contention that the product was safe if used as indicated.

The suit also says that in 2005 the FDA instructed Merial to change its labeling and to stop claiming 100 percent effectiveness and the company agreed to do so–but didn’t. In August 2006, the FDA warned Merial that it was in non-compliance.

In June 2007, seven months after Blaho-Owens began working at Merial, the FDA again issued a warning letter stating that the company had misbranded Heartgard Plus – this time because of its claim that the drug would prevent the spread of animal diseases to humans, even though Blaho-Owens said the company had no information to support that claim.

Blaho-Owens also said that the company supposedly had evidence that heartworms had developed resistance to the active ingredients in Heartgard Plus and the company was actively working to reformulate it.

The suit contends that when Blaho-Owens questioned the company’s practices, she was fired.

Story By Elaine Furst For Dog Files

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Tasha
Tasha
10 years ago

Will there be a recall or at least the option of a refund? We as consumers put our trust into a company that knew that this drug was not functioning at 100% for our dogs.

Russellgelfuso
Russellgelfuso
10 years ago
Reply to  Tasha

Who CARES about a REFUND? Is this stuff SAFE and EFFECTIVE or NOT?

Mtrgp
Mtrgp
10 years ago
Reply to  Tasha

I lose Two Dogs while on this crap, due to the treatments that have to be administered after a positive  result. My working dog cost 12.000. This company has lost public trust.  

Willow7233
Willow7233
10 years ago

Here we think our beloved pats are protected, but they really aren’t.  Why is the holy dollar above that of a part of a family?  This could be a huge lawsuit!!!

paintman
paintman
10 years ago

big pharmaceutical doesn’t care about people… what makes you think they’ll worry about a dog?

Julie Brant Moultrie
10 years ago

My dog was on Heartguard and came up heartworm positive.

Mbaserena
Mbaserena
10 years ago

If this is true they will pay for treatment.

Gjbarnes
Gjbarnes
10 years ago
Reply to  Mbaserena

They will pay for the treatment under some circumstances. However, the treatment is far from without risk!

Sunshyne293
Sunshyne293
9 years ago
Reply to  Gjbarnes

It is true, treatment is not without risk and is also expensive.   that’s why prevention is better medicine. You go for yearly checkups to catch disease in its early stage; you go because prevention is infinitely is better than finding a disease in Stage III or Stage IV.  Same thing in animals.

Christopher Lambert
10 years ago

Unfortunately there have evolved strains of heartworms that have become resilient to traditional heartworm pills….Have no doubt they will use this fact to bail themselves out of a lot of lawsuits. I suggest dog owners talk to their vets,and make sure your pets are getting the most up to date medications…

Larry
Larry
10 years ago

Can anyone trust any drug maker?

Chesapeakelady
Chesapeakelady
10 years ago
Reply to  Larry

No, unfortunately you can’t.  Doesn’t matter if it’s animal or human drugs.  Sad, but true.

Chesapeakelady
Chesapeakelady
10 years ago
Reply to  Larry

No, unfortunately you can’t.  Doesn’t matter if it’s animal or human drugs.  Sad, but true.

Scott Watkins
Scott Watkins
10 years ago
Reply to  Chesapeakelady

I couldn’t agree more.  All these companies care about is making money and could care less.  Find yourself a top notch supplement company and take care of yourself and your animals, don’t rely on anyone else.  Also do your research on supplements, lots of supplement companies out there making false claims also. 

Gary Mintz
Gary Mintz
10 years ago
Reply to  Scott Watkins

I agree it’s all about the money. An no you can’t trust drug makers, just listen to the possible side effects of the drugs they try and sell in TV commercials. One of them has a side effect of Glaucoma but it will resolve your allergy problems you could be blind but your allergies are gone,.

Gary Mintz
Gary Mintz
10 years ago
Reply to  Scott Watkins

I agree it’s all about the money. An no you can’t trust drug makers, just listen to the possible side effects of the drugs they try and sell in TV commercials. One of them has a side effect of Glaucoma but it will resolve your allergy problems you could be blind but your allergies are gone,.

Sunshyne293
Sunshyne293
9 years ago
Reply to  Scott Watkins

Supplements are not reglated by the FDA; therefore no oversight on making claims.

Francine
Francine
10 years ago
Reply to  Larry

NO…nothing can be trusted on this earth any more….:(

Pat G.
Pat G.
10 years ago

This should have been anticipated, since veterinarians and all medically knowledgeable personnel have known for decades that any parasite, including viruses and bacteria, develop a resistance to any medication given in too large a dose on a regular basis.  Horsemen/women are also having a problem with the same ingredient, ivermectin, because drug manufacturers convinced vets that horses should be wormed on a MONTHLY basis, and worms are now resistant to it!

Jedijoe501
Jedijoe501
10 years ago

my vet told me no heartworm preventative was 100% , that’s why we all bring our pets back to see their vet once a year

Sunshyne293
Sunshyne293
9 years ago
Reply to  Jedijoe501

Other than death and taxes, what else in life is 100% certain?

Frances
Frances
10 years ago

I’ll bet they blamed you…saying you probably missed a dose or was late with a dose.

Chillzin
Chillzin
10 years ago

Not 100% sure, on all diseases, but pretty sure humans and animals, cannot cross the species line, and share a disease, as this would indicate.  Getting ready to Google it.  AND nothing in life is  a 100%  sure thing.  We should know this going in!

Rhalferty
Rhalferty
10 years ago

if you have a large dog, be sure and break the heartgard into pieces. lots of larger dogs swallow them whole and they pass through them intact. my large boxer is a woofer…..goes in whole , comes out that way

Starbird55
Starbird55
10 years ago

We had our German Shepherd on this.  No one, Vet, said anything about the fact that it might not be effective.  She died last August un an unknown cause (instantly) but thought to be a heart attack. Our little dog that we have now tested heartworm negative when we got her from the shelter.  I had heard about Heartguard not being safe, so we put our new little dog on alternating months of Iverhart Max and Interceptor at our Vet’s advice.  Anyone care to comment on these preventatives for Heartworm disease?

Sunshyne293
Sunshyne293
9 years ago
Reply to  Starbird55

As long as you’re watching to make sure they’re not spitting out the tablets.  When I was getting the house ready for my son’s graduation party, I found spit-out tablets in the corner  and behind the sofa.  My lesson:  Just because they take the tablet from me doesn’t mean they’re not spitting it out somewhere else.

Stirrup3
Stirrup3
10 years ago

What’s is coincidental is that Merial also makes IMMITICIDE the only “quick kill ” of heartworms for dogs. Now it is supposedly in “short supply”………….you read between the lines

Andi Lyon
Andi Lyon
10 years ago

Sadly, no medication is 100% effective, dogs get heartworms while on prevention, not just Heartgard but the others too, women get pregnant while on birth control.  it happens, what I want to know is just What Is The Manufacturing Problem With Immiticide, just telling me there is a problem does not answer my questions?

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