A war of words has broken out over the past week between Eli Lilly's ($LLY) Elanco animal health division and the company's hometown newspaper, the Indianapolis Star. At issue is an overriding question that weighs on the minds of pet owners worldwide: Are medications for dogs and cats really safe?
Unfortunately for Elanco, the Star is using the company's chewable flea-and-tick medication, Trifexis, as a poster child for what it alleges are unsafe research and marketing practices across the animal health industry that may be putting our pets at risk.
The debate started on Dec. 14, with an investigative story in the Star that opened with the heartbreaking tale of Sesame, an 8-year-old golden doodle whose premature and sudden death is one of many with a suspected tie to Trifexis. The story goes on to explain that one of the active ingredients in the drug originated as a crop pesticide, and that dog owners have reported more than 700 deaths to the FDA since the product hit the market in 2011.
Elanco said in a statement to the Star that it reviewed all adverse event reports on the chewable flea-and-tick fighter and found "no established link between Trifexis use and death."
Still, Trifexis was the touching-off point for a bruising series of investigative stories in the Star that question the rigor of the regulatory process that veterinary medicines go through, as well as the financial relationships between pet med makers and the veterinarians who prescribe their drugs. The first story, for example, points out that the average drug approved for pets is tested in 200 to 300 animals, whereas the average drug for people must be tested on 5,000 patients before the FDA clears it for marketing.
In the second story, which ran on Thursday, the Star alleged that drug companies have "loose purse strings" when it comes to courting veterinarians. The paper included several examples of animal health companies wooing veterinarians with prize giveaways at conventions and payments for speaking engagements. For example, the paper cites one veterinarian who sang the praises of Merck's ($MRK) flea preventer Activyl during a speech at a conference, without disclosing that the company had paid him $56,705 to conduct research on the drug.
The Star asked Lilly to disclose the total amount that Elanco paid to veterinarians in 2012 but the company declined to do so, according to the second story in the series.
Elanco has long been a bright light at Lilly, and in the first 9 months of this year its sales rose 9%, even as the company's overall revenues fell 16%. Earlier this year, Lilly picked up Novartis' ($NVS) animal health unit for $5.4 billion.
|Elanco President Jeff Simmons|
Elanco President Jeff Simmons weighed in on the controversy with an editorial in the Star that also ran on Thursday.
"Sensational media reports and social media chatter could lead some people to believe that the companies developing and selling pet medications do not follow required laws and regulations and that the treatments are unsafe. That's simply not true," Simmons wrote. "We take every adverse event report seriously, whether it's related to our medicine or not. We thoroughly analyze each adverse event report to determine if there are any trends or concerns and submit the reports to the FDA."
One major theme that runs through the Star's investigative pieces is the notion that makers of pet pharmaceuticals do not have to disclose paid consulting relationships they have with veterinarians or the monetary value of gifts the companies give to them--a potential conflict of interest, the paper contends. As the Star points out, the lack of transparency stands in stark contrast to recent trends on the human health side of the business, where pharmaceutical companies have been cutting back on the lavish gifts they used to bestow on doctors, especially now that they have to disclose the value of consulting relationships they maintain with healthcare providers under federal law.
When the Wall Street Journal blog Pharmalot reached out to Lilly and Novartis Animal Health for responses to the conflict-of-interest contentions, a spokeswoman for Lilly pointed to guidelines from the trade group Animal Health Institute, which say the value of incentives offered to veterinarians should be "reasonable and proportional to the situation." A Novartis spokeswoman said the company "would fully comply" if guidelines requiring payment disclosures were to change and encompass the animal health industry.
Certainly we haven't heard the last of this debate. The American Veterinary Medical Association (AVMA) issued a statement on Thursday saying it was preparing a response to the Star's series, but that overall the organization believes the articles "impugn veterinarians' character and call into question their motives and their integrity."
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