Heartgard Plus Coverup, Whistleblower Fired

by Mary Haight on June 25, 2011

Heartgard Plus

Heartgard Plus, a popular product used to prevent heartworm (and hookworm and roundworms) in dogs, may not be all it claims to be. A lawsuit filed against Merial, the British drug-maker, says research showed among other things  that the claims made to the public and the FDA by the company regarding Heartgard Plus effective performance in keeping dogs safe from heartworm were not true. A former Merial regulatory employee, Kari Blaho-Owens, PhD, filed these and other charges when she was fired.

As head of global pharmacovigilance, and who says irony is dead, Blaho-Owens was fired when she refused to get rid of a document proving that Heartgard Plus was losing effectiveness in preventing heartworm. This document would be a damning piece of evidence in a pending class action suit.

In 2002 the FDA ask Merial to revise the wording on the Heartgard Plus label, which claimed 100% prevention of heartworm in dogs. Nothing was done. In late 2004 the FDA sent a letter to Merial warning that the data sent to the FDA before pre-approval to market the drug did not square with data of adverse events reported after the drug was released, despite owners’ using the drug as directed.

Heartgard Plus Underperforms

In 2005 the company conducted an internal study of findings according to the FDA complaint. Blaho-Owens’ team was asked to study the problem with Heartgard Plus in 2006.  That study showed Heartgard Plus was ineffective in 2 out of 10 cases according to the lawsuit, contrary to the company study of 2005, which blamed the increase in negative reports on consumer misuse and other factors. The cases taken into the Blaho-Owens study were the cream of the crop – conditions for administration of  the medication to the dogs were such that there could be no question it was anything other than drug failure.

Blaho-Owens reported these findings to multiple executives heading various sectors of the company, and shared her concern regarding the less than transparent reports being sent to the FDA.  She was ordered to stop generating documents focused on the efficacy of Heartgard Plus. So much for pharmacovigilance.

Blaho-Owens charges that Merial executives knew claims of 100% efficacy of Heartgard Plus were not true but Merial refused to change the label because it would give competitors an advantage. Is your head spinning yet? No? Well, read the lawsuit linked above and I think it will – talk about weaving a tangled web…

You can read more at Courthouse News Service by Dan McCue where I first saw this story.

 

8 comments
Kimmie
Kimmie

Thanks for the article. I've been reading on this all day. With working in this field, I'm concerned about recommending Heartgard. It's our main heartworm prevention and Frontline our main flea prevention at work. Frontline is so ineffective that Meriel recommends applying twice as often. So inefficacy doesn't surprise me. However, another article warned that the inefficacy comes from our overuse of ivermectin. It noted that horses have been needing to be wormed (with ivermectin) more often. Just another piece to the puzzle I suppose...

Jasmine
Jasmine

Oh, yes, I do believe there are SOME companies who are still honest and try to do what's in the interest in their consumer. My guess is they are few and far in between. I did have some exposure to food industry back in my country - I wouldn't touch those products if my life depended on it! And those were human food products! As for the benefit of doing a good job, I'd like to quote Chris Rock: "The money isn't in the cure, the money is in the medicine." Food for thought, thought not related to flea protection per se.

Jasmine
Jasmine

It shows as Jasmine because that's my handle on my Wordpress blog :-) Yes, these things are quite disturbing ... and frankly I trust FDA only as far as I can throw it too. Well, the Interceptor seemed to have worked well so far (either that or the guys didn't get bitten by an infected mosquito), plus we do regular blood tests anyway, particularly in light of the talks of resistant strains. Unfortunately my point of view is that if somebody (a company) stands to gain from "cheating" - they will.

Jasmine
Jasmine

And to think I was considering switching from Interceptor ...

Mike Carlo
Mike Carlo

No shock to me. Merck lied about Vioxx & it killed 10's of thousands of humans...what is a few dogs. I never will buy a Merck/Merial product ever!

MaryHaight
MaryHaight

Oh, thanks for clearing that up! I know it seems like *all* companies must be cheaters...but I know there are companies out there who are not. We just don't hear about them. Or maybe they haven't been pushed to the brink, yet - but that's beyond the scope of this post;) The FDA - well, they have no power. Their hands are tied. They can't even force a company to recall a bad product. When the overseers have no teeth, the overseen can run amok without fear of getting bitten. Yet it's to every company's benefit to do a good job, put out a good product, to sell more widgets - in business, politics and even in our personal lives, it's always the cover-up that gets you in trouble...

MaryHaight
MaryHaight

I'm concerned about loss of efficacy, as well as the issue that the data was submitted falsely to FDA. I thought I read somewhere that the company is adding another drug in the mix besides ivermectin and pyrantel - *that* would be interesting! But this is just hearsay. The company is going to fight this naturally. But given the FDA records...it will be one to watch. Thanks for stopping in, Jasmine (and Jana)!

MaryHaight
MaryHaight

Whoops - missed your comment here and just wanted to thank you, Mike, for reminding us about Vioxx. Thanks for stopping by.

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