TOTALLY GEEKED!

This article appeared in our local paper yesterday.

Harry, Sesame, Ramsey, Kolbe, Rocky and Peaches have something in common — all of these beloved pets were prescribed a new chewable flea and heartworm medicine. And now they're all dead.

Their owners wonder if the drug, known as Trifexis, was the cause.

Several things about the drug make them suspicious. Trifexis, like many new pet drugs, was not developed specifically as an internal medicine for dogs. One of its two active ingredients started out as a crop pesticide.

Trifexis, which was developed by Eli Lilly and Co.'s animal drug division, Elanco, based in Greenfield, has many reported side effects. An Indianapolis Star investigation found that one of its two active ingredients, spinosad, ranks third among all pet drug ingredients for reports of convulsions, fourth for blindness, sixth for aggression and paralysis, and seventh for reports of unconsciousness, according to the latest data available from the U.S. Food and Drug Administration.

The other active ingredient, milbemycin oxime, ranks fifth for convulsions and ninth for deaths.

Dog owners across the country have reported more than 700 deaths to the FDA since the drug hit the market in 2011. And the FDA estimates that for every side effect that's reported nine times as many go unreported.

Trifexis is far from the only pet drug with hundreds of side effects and deaths reported. The database includes more than 19,000 dog and cat deaths reported in connection with a wide variety of pet medicines.

But did Trifexis kill Peaches? Ramsey? Rocky? What is the risk of it — or of other pet medicines — killing your dog or cat?

To such questions, pet owners simply can't get an independent answer. Not from veterinarians. Not from the FDA, whose job it is to ensure drug safety.

The companies insist their drugs are safe.

In a prepared statement, Elanco told The Indianapolis Star: "It's critically important to understand that reports are not an indication of cause. For any given (Adverse Drug Event) report, there is no certainty that the reported drug caused the adverse event."

The company said it completed a "thorough review and analysis" earlier this year of all reports it received from pet owners and found "no established link between Trifexis use and death."

It said such complaints are so infrequent that it has received less than one reported death for every 10,000 doses it sold, which is considered "very rare," according to standards published by the Council of International Organizations of Medical Sciences.

Yet, in the first examination by a major news organization of one of the fastest-growing segments of the pharmaceutical industry, The Star found an industry far different from the human drug market, one with higher risk of unforeseen side effects, a legal arena that offers little protection to pet owners and marketing tactics that have been eliminated from the human drug market.

The Star examined public records, studies and drug reaction data, and conducted interviews with company officials, pet owners, scientists, lawyers, epidemiologists, regulators and veterinarians. They told the story of an industry that is looking for ways to shore up declining revenues from human drugs, repurposing molecules that had an array of original uses for people and crops, and pushing government officials to speed up the approval process.

Dog owners across the country have reported more than 700 deaths to the FDA since Trifexis hit the market in 2011. Dozens submitted photos to The Star of dogs they claim died after taking the medicine. Elanco, the medicine's manufacturer, says the drug is safe and there is no established link between the drug and the deaths.
(Photo: IndyStar photo illustration)

Drug and medical-device companies are pouring millions of dollars a year into research and development of pet medicines, hoping they can help make up the difference for a slowdown in human drug approvals. There are specialized animal drugs for everything from arthritis and heart disease to obesity and kidney disease.

Retail sales of pet medicines in 2013 were $7.6 billion, up more than 60 percent from 2006, according to the Federal Trade Commission and Packaged Facts, a national market researcher. And the growth shows no sign of stalling, with sales projected to reach $10.2 billion by 2018.

Last year, the third-biggest initial public offering on Wall Street was a pet medicine company, Zoetis, a spinoff from drug giant Pfizer. This year, Lilly said it would pay $5 billion to acquire Novartis' animal medicine, which would make Lilly the animal health industry's second-largest player.

Yet the pace of change is raising safety concerns among thousands of pet owners, consumer groups and some veterinarians across the country.

The drug-development process for pet medicines is far shorter than for human drugs, which cuts costs but increases the health risks to the animals, several epidemiologists and statisticians told The Star.Once these drugs are released on the market, there are few checks on company claims of product safety.

Some drugs aren't even approved for animal use but are commonly prescribed to animals. Their safety record isn't even tracked by the government, meaning it's impossible for consumers to make informed decisions.

And when animals die, the companies don't have to shell out big legal settlements. Pet owners usually can recover only the replacement cost of the animal — often no more than $100.

While drug companies have paid billions of dollars to settle complaints about human drugs, they sometimes resolve consumer complaints about pet medicines with polite letters and payments not even large enough to cover the cost of veterinary treatment.

Dozens of human drugs have been removed from the market because of safety concerns, but The Star was unable to find a single pet drug that was permanently pulled for similar reasons. The message is clear: A dog is just a dog, and a cat is just a cat.

In 35 states, including Indiana, courts have rejected damages based on the emotional relationship between an owner and a pet.