COLLARGATE: How leading animal health company Elanco was ambushed when environmental “investigative” reporters got leading newspaper chain Gannett to publish their dubious Seresto story

       On the morning of Tuesday, March 2, editors at America’s largest newspaper chain, Gannett, hit send on an “investigative” report that alleged that the popular Seresto flea and tick collars were killing hundreds of dogs and cats.

The story spread across the Internet and went viral within hours. The allegation — that Seresto collars, a product that’s been on the market since 2012 and has been purchased more than 25 million times in the United States, had fatally poisoned hundreds of cats and dogs — immediately forced the stock of Seresto’s manufacturer, Elanco (ELAN – NYSE), down nearly eight percent, even though the collar is only one of more than 200 products sold by the multi-billion dollar company and, in fact, is only one brand in a division of the company (Pet Health Disease Prevention) that is not its highest-dollar unit, according to a recent SEC filing.

It was high-impact journalism, for sure. But the quality of the report appears not to have been worthy of that impact.

TCR has established that the article — which was co-produced by USA Today (owned by Gannett) and a little-known “investigative” journalism entity called The Midwest Center for Investigative Reporting, was flawed, incomplete, and misleading. The reporters seem to have been so eager to get the “goods” on a large corporation that they ignored — or never tried to understand — fundamental facts about veterinary toxicology that undercut the core of the story.

 

American Board of Veterinary Toxicology President-Elect: “We feel very comfortable with the safety profile of these [Seresto] collars”

Dr. Ahna Brutlag is the Director of Veterinary Services at the Pet Poison Helpline in Minneapolis, MN, and has been with the organization since 2004. She is also the President-Elect of the American Board of Veterinary Toxicology, the internationally recognized certifying body for veterinary toxicologists “demonstrating broad knowledge and expertise.”

TCR pressed Dr. Brutlag about her awareness of any serious adverse events thought to be connected to Seresto collars, and whether, through her practice or her work on the hotline, she was aware of examples of a serious event connected to a collar. Her answer: She said she was not aware of any such adverse events. “Our data has really shown that the collars are not associated with severe adverse events,” she explained.

Dr. Brutlag added that the two active ingredients in Seresto collars, imidacloprid and flumethrin, are both widely used. “We feel very comfortable with the safety profile of imidacloprid and, also, flumethrin,” she said. “So, in our experience, we feel like there’s a pretty wide and favorable safety profile for the collars.”

It’s worth noting that Dr. Brutlag, who does not have any financial conflicts of interest and is probably the individual in the highest position of authority to make such a statement, was not evasive. TCR was able to speak with her within hours of our request and a cursory search of her name turns up multiple articles in which she is also quoted. Thus, she is clearly accessible to reporters—and likely would have been glad to speak with Mr. Hettinger (who, she says, did not try to contact her, though she also told TCR she was surprised not to find any veterinarian sourced in the story).

The question is whether Hettinger would have welcomed what she had to say.

TCR asked Mr. Hettinger if he spoke with a veterinarian for the story or attempted to. He declined all of our requests for comment.

AMBUSH: COLLAR-GATE GOES VIRAL

Although the president of the body that certifies veterinarians who wish to specialize in toxicology says, definitively, that USA Today’s story does not ring true, the story went viral online soon after it was published.

By 10 o’clock that morning, a cursory search for the Seresto hashtag on Twitter yielded hundreds of users posting about “#seresto” including panicked pet owners and members of the news media.

“Scary. Common Flea Collar Linked to Almost 1700 Pet Deaths,” @JenDelgadoFOX wrote from her Twitter account.

“Let retailers like @chewy, their parent company @petsmart, @petco, and @1800petmeds know that consumers WILL BOYCOTT THEM if they don’t pull these evil #fleacollars #seresto #recall #animalrescu #fleas,” another Twitter user wrote.

Over at VIN, a closed online network for veterinarians, dozens of practitioners flocked to a discussion of the story on the network’s message boards, according to a source. Most of the posts, the source said, were incredulous about the reporting, some expressing confusion and frustration about now having to field calls and emails from concerned clients who use the collars. “I know of no data to support and have not seen problems in my patients (other than lack of efficacy in the last couple of years),” one person wrote.  “No one in the VIN community (so far) has reported any major issues,” another source in the profession told TCR.

On New York City’s Upper West Side, the news was also spreading. Dr. Andrew Kaplan, the owner of City Veterinary Care on West 72nd street, issued clients this email:

“As you may have read about in the news, there’s a report implicating Seresto flea and tick preventative collar with the deaths of 1700 dogs. I think this is going to end up being unfounded hyperbole. I have not had a single reaction (even skin) in all the years I’ve been prescribing them. Veterinary Information Network (VIN), the premier veterinary information resource has over 45,000 veterinary members, and thus far there is no support for these allegations because, as for City Vet, veterinarians across the country are not experiencing what’s being reported in the news.

They do discuss some rare idiosyncratic, non-fatal reactions, such as can occur with any drug, but the consensus on VIN believes it more likely that the reported fatalities are a result of counterfeit Seresto being sold online. This makes sense because veterinarians purchase Seresto directly from the manufacturer and so it stands to reason that if counterfeit Seresto is responsible, our experience would be different. Whether this turns out to be true or not, if you’re purchasing prescription products online, make sure you do your due diligence to purchase through a reputable source, and to learn what to look for when assessing a product for its authenticity.

Asked to discuss his email further with TCR, Dr. Kaplan wrote, “This story, and the email flood I have received from my clients, have already taken way too much of my time and I can’t devote any more to it.”

Over on Facebook, things were also heating up over the USA Today story. Groups with thousands of members quickly formed such as the Facebook Group that calls itself “BAYER ELANCO SERESTO COLLARS OF DEATH.” (The reference to Bayer had to do with the fact that Bayer had recently sold its Animal Health division, which includes Seresto, to Elanco.) In the group’s “about” information, the founder wrote:

“I AM STARTING THIS GROUP TO INFORM PEOPLE OF HOW DANGEROUS THESE SERESTO FLEA & TICK COLLARS CAN BE TO YOUR PETS…IT’S MORE HUMANE TO PLAY RUSSIAN ROULETTE WITH THEM THAN TO SEE HOW HORRIBLY MY 2 DOGS DANNY & DOMINIC DIED FROM THESE COLLARS OF DEATH.”

“Heartworm preventives are also poison!” another member wrote.

“Does anyone know how long it takes for the toxins to be removed from pets once the Seresto collar is removed?” another user asked.

“Mine had a seizure like a day after it was put on,” another wrote, referring to the collar. “I didn’t realize it was connected to wearing the collar. I wish I would have known and removed the collar, she added.”

 Missing in Action:  Veterinarians, Medical Context, Causality, Denominators

Dr. Brutlag explained that whenever there is any concern about product safety, a critical piece of information is the denominator, by which she meant the total number of uses or cases into which the adverse case number is factored. More than 25 million Seresto collars have been purchased in the United States, for example, which makes 25 million the denominator.

Referring to the USA Today’s report that the Environmental Protection Agency, which regulates pesticides, had logged thousands of purported adverse events associated with Seresto, she explained that, “Seresto collars are very popular in the U.S. and probably globally….The fact that there are however many hundred reports of adverse events, none in which causality is established or even indicated — the EPA  numbers are purely the number of reports — is not sufficient for the claims the story makes.”

“What you really want to know is, how many of these deaths or products or problems are caused by the collars,” Dr. Brutlag explained, “and what’s the medical context there, because that’s really the nuts and bolts of the [story].” Asked if she thought the reporter established any meaningful causality between incident reports from an EPA database and animal deaths, Dr. Brutlag said “No” adding that the reporting was “lacking.”

“The 2020 incident report rate for all adverse events related to Seresto is a fraction of 1% of users,” McGrath said, adding that, “the significant majority of these incidents relate to non-serious effects such as application site disorders – reddening o the skin or hair loss below the collar.”

“It is critically important for people to understand that a report is not an indication of cause,” Keri McGrath wrote addressing the same issue Dr. Brutlag was focused on. McGrath continued: “What those numbers represent is the number of reports received, and do not reflect causality. So, if a dog were to be wearing a collar and experience any sort of adverse event, the collar would be mentioned in the report. Drawing a causal link from individual incident reports is misleading,” she added.

When asked about Elanco’s exchanges with the USA Today reporter – USA Today’s managing editor of regional investigations, Emily LeCoz, Midwest editor Pamela Dempsey and reporter John Hettinger declined repeated requests for comment, including questions about whether they asked Elanco to comment on medical records, necropsies, or anything else that could have established causality.

McGrath added this note about the seriousness of any adverse effects:

“A note on how the reporting works individual report is evaluated using an industry-standard and regulatorily required ABON coding system for causality. A = Probable  B= Possible  N= Unlikely  O=Unclassifiable/Unassessable. So the answer, of course is ‘yes’ we do have reports of adverse effects from collars in which causality has been ‘probable’ . For example, when we see redness or hair loss under the collar, we can presume that it is related. But, again, there is no established link between death and exposure to the active ingredients contained in Seresto.”

Top Vet Toxicologist: ‘Even When Ingested, Seresto Collars Don’t Kill’

Dr. Brutlag offered another reason she and her colleagues were confident in the safety of the products. “When we have had ingestions of those collars, what we have seen as, really, the worst-case scenario is some upset stomach, maybe vomiting, or diarrhea. And I think that’s actually quite telling,” she asserted, adding that the outcome is not always as benign “when animals ingest [other] products that are just made to be on the surface of the skin.” She explained that in those situations, “more severe adverse events” are not uncommon, yet the Seresto collars, when ingested, do not have any major adverse effects that she is aware of, she says. “That, to me, speaks pretty highly of the safety profile of Seresto collars,” she concluded.

TCR pressed Dr. Brutlag on whether she was aware of any conflicting positions or perspectives among the small group of accredited individuals or research to the contrary. “I don’t think this is a considerable debate amongst veterinary toxicologists. I think that many of us are very comfortable with the safety profile. I do not think that the products pose a high risk.”

How Hettinger was supervised and had his work vetted by the capable editors at Gannett is unclear (because none of the participants would speak with TCR for this story and declined to answer TCR’s questions). Yet, Hettinger has written numerous stories that criticize companies that use chemicals, all taking the same point of view, and that would seem to have been a reason the Gannett editors would have been especially careful in reviewing his work. At a minimum, it now seems clear that they should have asked about how he had checked what he was preparing to conclude from the EPA data with qualified veterinarians who were willing to be quoted on the record.

Instead, Hettinger, apart from the accounts from pet owners, relied on three sources  – and two of his supposedly dispassionate expert sources share bylines with each other; and they are published with Hettinger at Environmental Health News, a non-profit online news service funded by various foundations that describes itself as a “nonpartisan organization dedicated to driving science into public discussion and policy on environmental health issues…”

USA Today editor Emily LeCoz and Midwest editor Pamela Dempsey both declined to answer TCR’s questions about details of the reporting process, including any steps taken to talk to veterinarians. However, each offered statements that highlight the raw data obtained through FOIA requests. The editors would not walk TCR through the efforts Hettinger made to understand the information in the documents.

The ‘Pink Slime’ Effect

In the news business, stories that villainize big companies with huge brands – brands like Seresto – can sometimes make reporters more eager, more breathless – – and less careful. In 2017, ABC News paid $177 million to settle a defamation case in which the evidence was clear that the network had presented a distorted, one-sided report that a South Dakota beef company’s product was actually an adulterated product that ABC’s on-air reporters called “Pink Slime.” Sales plummeted and the company was forced to lay off more than 700 workers.

Ongoing, endemic issue of counterfeit products sold through Amazon

When TCR first contacted Elanco on March 2, the day the story was published, spokeswomen Keri McGrath and Colleen Dekker responded within minutes, adamantly disputing the substance of Hettinger’s reporting. They’ve since been responsive to all of our questions — except for those related to whether their counsel had engaged Amazon at any point about counterfeit goods – an issue TCR has encountered in covering other pet products. At an earlier point, however, McGrath wrote:

“We work closely with retailers who are just as committed as we are to ensuring customers are protected from counterfeits. We have a constellation of controls in place to protect consumers from counterfeits and to identify and remove counterfeit listings from online marketplaces….Still, there is always a chance that once a confirmed counterfeit product listing is taken down, it may pop up again on another website or marketplace. Counterfeiting operations are very smart, but consumers can protect themselves by only buying products (and this goes for any product) from a trusted source, regardless if it’s a 3rd party seller in a marketplace platform or a URL.”

According to McGrath, at no point during any of the company’s written or verbal exchanges with Hettinger or his editors, was Elanco asked about counterfeit products on e-commerce platforms like Amazon, where problems with third-party sellers and counterfeit products have proliferated.

“The information presented to us [ by the reporter] was from the EPA – spreadsheets with numbers and a memo. We didn’t discuss counterfeits – it didn’t come up,” McGrath said.

In a September 2020 quarterly report that the company filed with the Securities and Exchange Commission, one portion stands out:

“The illegal distribution and sale by third parties of counterfeit or illegally compounded versions of our products or of stolen, diverted or relabeled products could have a negative impact on our reputation and business….Our reputation and business could suffer harm as a result of counterfeit or illegally compounded products which are alleged to be equivalent and/or which are sold under our brand name….With the acquisition of the Bayer Animal Health business, we have now expanded our business more into direct to retailer and e-commerce channels in order to meet the pet owners where they want to purchase, which may increase the risk of counterfeiting of our products. Public loss of confidence in the integrity of vaccines and/or pharmaceutical products as a result of counterfeiting, illegal compounding or theft could have a material adverse effect on our business, financial condition and results of operations.”

Yet, at no point was Elanco ever asked about counterfeit products for the USA Today story, McGrath told TCR.

Hit Job News: What Makes Elanco and Seresto Attractive Targets

Elanco is a big name with big money, and Seresto is arguably an even bigger name. And big names mean clicks for people in today’s news business.

“Products from the legacy Bayer Animal Health business contributed $396.3 million, including $100 million from the Advantage family of products and $64 million from Seresto,” a February 2021 company press release noted.

“The story that we published by the Midwest Center for Investigative Reporting focused on many complaints submitted to the EPA by consumers of Seresto,” USA Today editor Emily LeCoz said in an email.  “Those complaints, which were obtained by a public records request, detail skin rashes, seizures and deaths linked to the collars. The Midwest Center made that report available to the public, and we have linked to it from the story. The accounts were corroborated by some of the EPA’s own documentation, as well as through interviews with a former EPA official, scientists and pet owners. We think the story speaks for itself.”

TCR thinks so too, starting with the fact that TCR has now confirmed that at no point during any of the written and verbal exchanges between Elanco and reporter Hettinger did the word “veterinarian” or “necropsy” or, for that matter, “counterfeit” come up.

Is that because Hettinger decided, before he began, what direction his story would take just because he had seen the raw EPA data? What else could explain a reporter who elects to conduct “investigative” journalism about animal health without speaking to a veterinarian?

Again, Hettinger would not comment when asked about the efforts to speak with any veterinarians. And although neither Hettinger nor his editors would answer any of our questions about their reporting process, Elanco provided TCR with the full written exchanges between the company and Hettinger.

Hettinger built his story, instead, solely on pet owners’ anecdotes paired alongside the EPA raw data.  TCR, for example, always cross-checks owner accounts with veterinarians; not because we assume owners are lying, but because what the owner believes or understands and what the veterinarian offers are often different, and those discrepancies are important.

Apart from the owner accounts, there is also the “former EPA” source that LeCoz, the USA Today editor, mentioned earlier. She is Karen McCormack, who is identified to readers as “a retired EPA employee who worked as both a scientist and communications officer.” As for the “scientists” quoted on record, one is identified as Nathan Donley, a “senior scientist” and “expert on U.S. pesticide regulation” at the Center for Biological Diversity. The Center is no doubt a legitimate organization, but it’s also one whose mission is not likely to look favorably at chemical companies. It’s a nonprofit whose mission is “to obtain sweeping, legally binding new protections for animals, plants, and their habitat,” according to its website. Donley, who is not a veterinarian or a physician, is also an opinion writer for the Environmental Health News website, where Hettinger also writes — although that part of his work is not mentioned in the USA Today story.

Hettinger also omitted that McCormack is also an avid opinion writer for Environmental Health News, including a piece she penned with the “expert” “scientist” Donley. Its title: “The reckless embrace of banned pesticides in the US: A broken EPA pesticide office stands at a crossroads.”

Thus, two of his three expert, on-record sources were, unbeknownst to readers, are colleagues of Hettinger’s at Environmental Health News.

Including ‘All Sides Relevant to a Story’

“We will strive to include all sides relevant to a story,” USA Todays’ code of “ethical conduct” pledges on its website. Under a sub-section about fairness it adds, “When news develops and we can’t include important perspectives immediately, we will share updates, including additional sources, when possible.”

It is often a good sign when a news organization publishes its ethical code of conduct and policies for its newsgathering operations on its website. That’s because publishing the rules you say your newsroom follows makes your newsroom more accountable and, therefore, more deserving of readers’ trust. The downside of publishing newsroom policies is that if/when an organization elects not to follow any or most of its published policies, it’s not a great look.

Will the editors update the story with Dr. Brutlag’s comments?

Or, perhaps, they might consider those of Ann Hohenhaus, a staff doctor with board certifications in Internal Medicine and Oncology at New York City’s Animal Medical Center, the world’s largest nonprofit animal teaching hospital?

“I dispense the Seresto collar for my canine patients who spend time outside of NYC during tick season,” she says, adding: “I have not seen serious adverse effects on patients wearing the collar.” In addition to reporting any adverse events with pet products to veterinarians, Dr. Hohenhaus encourages pet owners to “be proactive and alert not only those companies whose products may have caused an adverse reaction – but contact key government agencies.”

Mr. Hettinger might also consider updating his story with Dr. Adrienne Bautista’s comments. In an email to TCR, Dr. Bautista, who is a board-certified veterinary toxicologist like Dr. Brutlag, said that she and “many” of her colleagues had read the USA Today story:

“We feel that Seresto has a very wide margin of safety.  One of the active ingredients in the product, imidacloprid, has been used for decades as a topical with very low risk.  Imidacloprid is also FDA approved for oral use in flea products for dogs.  The other active ingredient, Flumethrin has been around for decades as well.  Both ingredients are released by a slow-release mechanism and are low in concentration,” she explained. “While I understand the concern, there are many gaps that need to be filled.  A lot of times we jump to causality without looking at the entire picture.  As one of my colleagues pointed out, the USA today piece does not include any knowledgeable medical opinions nor does it speak to the volume of sales of this product (massive).  I recommend reaching out to a veterinary toxicologist at the ASPCA Animal Poison Control or Pet Poison Helpline as they handle calls on a daily basis on products such as the Seresto collar.” 

If and when TCR receives any update from Mr. Hettinger or his editors, or if they elect to update their story, TCR will update this story.

“We will explain to audiences our journalistic processes to promote transparency and engagement,” the USA Today ethics code continues…