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.