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Monday, June 13, 2011

Cover-up alleged over Heartgard Plus

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In 2006, the Sanofi unit of Merial LLC hired Dr. Kari Blaho-Owens to be its global head of pharmacovigilance. She was charged with making sure that Sanofi followed standard practices for procedures and compliance.

There was a good reason she was hired. The FDA had started hearing complaints that HeartGard Plus was not proving as effective as advertised in preventing heartworm. Once she got to work, Dr. Blaho-Owens learned that not only were the allegations true, but that the company had known it since at least 2002 and hadn’t done anything to change the problem. They also hadn’t updated any of their public marketing materials or documentation to alert veterinarians (or end users, for that matter) that the medication wasn’t doing its job, as stipulated by FDA. From Consumer Affairs,

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

The FDA repeatedly demanded changes in product labeling. When a class-action lawsuit was initiated in 2009, the company’s U.S. director of regulatory affairs allegedly directed Dr. Blaho-Owens to destroy key documentation. She refused. From Courthouse News:

She says she did not destroy the document, but reported the exchange to Merial’s legal counsel. She says that led Merial to retaliate by putting her on a “performance improvement plan, which cited a ‘lack of understanding of differences in levels of priorities’ between Dr. Blaho-Owens and management.”
She says she was fired after she filed a claim of retaliation with the Labor Department’s OSHA division.

Dr. Blaho-Owens is suing in federal court, asserting Merial “extortionately fired” her, and in so doing violated the whistleblower protection sections of the Sarbanes-Oxley Act and is seeking damages. Thanks to Cathy B for the links.

Good dog! Bear is a huge (180 pounds) German Shepherd. He’s a service dog in Parker, County, Texas. His owner suffered a seizure and hit her head, which prompted Bear to go door to door (literally) to get help. From the Star-Telegram,

After being unable to awaken his owner, Bear went to a neighbor’s house and scratched on the door to try to get help, but no one was there, said Karen Kessler, Parker County animal control supervisor, who saw Bear going door-to-door.

Bear went to another neighbor’s house, but that home owner had replaced their fence and the new fence was too high for the dog to jump over, Zeisler said.

Kessler found the dog wandering around in the 100 block of East Cattail Lane in Millsap on Saturday while answering an unrelated call with a co-worker, Kessler said. Or perhaps Bear actually found Kessler.

“Bear just crawled up in my lap while I was sitting in the truck,” Kessler said. “One of his tags said ‘I am a service dog’ and another said ‘I am a seizure dog.’ When we found him we knew there was a problem because service dogs normally don’t leave their people.”

Bear had been adopted from a local shelter a year ago.

The rescue in Bastrop: Dr. Becker, Gina and McKenzie are in Austin, Tex. today on the next-to-last stop of the Big Bus Tour. That makes it a good time to give you the story about a huge rescue from nearby Bastrop County, courtesy of the Austin Humane Society. It’s a cautionary tale about hoarding. I’d caution you that the attached video is tissue-worthy. Thanks to Rori.

Bedbugs are no match for The Nose: There is such a thing as a “bedbug location canine,” and Susan Fox sent me the link to an SFGate article about thirty of them competing for certification in Philadelphia.

How do you lose that many? Los Angeles shelters are having a problem that I would think would be a matter of simple inventory tracking: they keep losing animals. In the course of one year, one shelter (in Lincoln Heights) has allegedly misplaced forty dogs, cats and other animals. Across the system, 64 animals went missing during the year. Brenda Barnette is the general manager of the Los Angeles animal services department, and she was willing to go on the record with the Los Angeles Times.

Although some animals could have been incorrectly listed as missing because of clerical errors, at least some have “wrongly disappeared,” Barnette said. Many of the missing animals were considered “highly adoptable” and officials are trying to determine if any were stolen and sold for a profit.

“They were the young ones, the cute ones,” Barnette said. “They were ones that would have been likely to have been sold or be a nice gift for someone.”

Except in this case, if they were, the authorities couldn’t tell you one way or another. Shelter fail. Thanks again to Susan for the tip.

RIP Edward Gardner: A very sad story from examiner.com:

Edward Gardner loved animals, said his best friend Jim Gollwitzer. He loved them so much that on Memorial Day he pulled his car over on an Illinois interstate and got out to protect a family of ducklings trying to cross. For that act of compassion, after a limousine ran into him, Gardner paid the ultimate price—his life.

Our condolences to Mr. Gardner’s family and loved ones.

Plump kittehs on sale. If you’re near Columbus, Ohio and you want to adopt  a cat, heavier ones are on sale. No really, I read it in boston.com.

And finally,
funny pictures - CUE "MISSION IMPOSSIBLE" THEME
see more Lolcats and funny pictures, and check out our Socially Awkward Penguin lolz!

I always like to hear from readers, especially if you have tips, and links for interesting stories. Give me a shout in the comments, or better yet, send me an e-mail.

Photo credit: Heartgard image from ConsumerAffairs.com.


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