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

Comments

  1. Tasha says

    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.

    • Mtrgp says

      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.  

  2. Willow7233 says

    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!!!

  3. paintman says

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

      • Gjbarnes says

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

        • Sunshyne293 says

          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.

    • says

      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…

    • Chesapeakelady says

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

    • Chesapeakelady says

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

      • Scott Watkins says

        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 says

          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 says

          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,.

  4. Pat G. says

    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!

  5. Jedijoe501 says

    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

  6. Chillzin says

    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!

  7. Rhalferty says

    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

  8. Starbird55 says

    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 says

      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.

  9. Stirrup3 says

    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

  10. Andi Lyon says

    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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