Proheart 6 – USA Today Editorial

[Kris_Christine]

http://blogs.usatoday.com/oped/2008/06/our-view-on-dru.html#more
USA Today Editorial Board June 17, 2008

Our view on drug safety: FDA vet tracks dog deaths, gets smeared in the process – Tale of ProHeart 6 raises questions about who calls the shots at agency.

"The most troubling aspect of this is the effect it will inevitably have on other FDA safety officers. After seeing what can happen when someone gathers evidence that a drug is unsafe, what safety officers wouldn't think twice about risking their careers by antagonizing powerful companies?

That's a terribly dangerous way to run a drug safety process that can ultimately mean life or death to animals and humans alike."

[renaultf1]

Bad…really bad. Thanks for posting that.

[Kris_Christine]

You're welcome. It's scary to think of how many FDA Safety Officers were successfully silenced for raising safety concerns – all at the cost of our precious ones.

[wizard]

Interesting report – too bad it didn't make national news. While I'm sure the "rank and file" government workers (like the USDA inspector in the story) are good people, I never trust government top level managers, especially political appointees (no matter which political party). They all suck.

[Kris_Christine]

For more information on Proheart 6,

Letter from Wyeth to veterinarians about Proheart 6 adverse reactions http://www.wyethah.ca/pdfs/Canine/EngLetterMarch16.pdf .

American Veterinary Medical Article about Proheart 6 http://www.avma.org/onlnews/javma/oct04/041015a.asp "Over the course of the past three years, however, the FDA has received 5,913 adverse events reports about the drug from veterinarians and dog owners. According to the FDA, many of these reports involved life-threatening events, such as anaphylaxis, convulsions, hematopoetic disorders, and hepatopathies—about 616 reports involved deaths. The FDA has also evaluated a number of reports involving neurologic problems and cardiac signs."