FDA report on jerky treats: Analyst says it’s full o’ holes

The FDA released a progress report, of sorts, on the jerky treat issue today. The report updates the total number of pets affected to date, noting a sharp decline in adverse event reports after jerky pet treat products were removed from the market in January 2013 after a New York State lab reported finding evidence of up to six drugs in certain jerky pet treats made in China.

Although the agency would not go as far as admitting there is a definitive link between the drug residues found in those treats and sulfonamide hypersensitivity syndrome, nonetheless, FDA is taking a closer look at the NYSDAM findings:

“FDA is performing an evaluation to determine the possibility for low levels of the antibiotics to cause illness in dogs when fed over a length of time. This process involves review of the scientific literature, as well as any adverse event reports and consumer complaints sent to the FDA in connection with dogs and sulfonamide drugs, and may take many months to complete”.

The agency said that when measurable levels of antibiotic drugs were found in the treats, they say they were consistently at very low levels, “less than 1 part per million”.

Uncharted territory

Scientific data on trace drug residues in food and allergic reaction in pets is scarce and FDA scientists are experiencing an unprecedented event in veterinary medicine. Never before in history have animals been exposed to the vast number of known and unknown, legal and illegal drugs and chemicals that contaminate many of the products and ingredients used in pet food today. Many of which come from countries where food safety is a concept that is largely ignored.

Most studies involve much larger amounts of contaminates, making it difficult to establish new tolerance levels for a subset of the canine population that has a hypersensitivity to antibiotics, in particular sulfonamides. Most of those studies involve human patients that were administered the drugs for therapeutic purposes, therefore in much larger amounts than the trace residues found in the jerky pet treats.

Pets as sentinels

The agency addressed the question on every pet parents mind: Why is investigation still ongoing or more accurately, WTF is taking so long?

The FDA admits this investigation continues to be a challenging one for the agency. Complicating the investigation are some fundamental differences between investigations into illnesses in people versus those in pets.

In human illness, outbreaks caused by foodborne bacteria or contaminates, FDA works in concert with the Centers for Disease Control and Prevention (CDC) and state boards of health, which collect and track cases of foodborne illness. Unfortunately, there is no equivalent for pets, which means that it is difficult, if not impossible, to accurately evaluate the scope of an outbreak.

Additionally, some of the sources that are used in human medicine to define background or expected rates of illness, such as insurance databases, are unavailable in veterinary medicine.

The agency points to a tragic example of the difficulty facing the lack of data regarding to Fanconi Syndrome:

FDA is unaware of any statistics on the rate of occurrence of Fanconi Syndrome in non-Basenji breed dogs. Without such a baseline, it is hard to appreciate how unusual the findings of Fanconi syndrome might be….Very little is known about the possible causes for non-genetically related (acquired) Fanconi Syndrome cases in dogs, but certain toxins, medications, and infections have been linked to its development in dogs and people.

Another gruesome complicating factor in the investigation is the lack of post-mortem information. Typically when a human kicks the bucket unexpectedly, it is not unusual for a medical examiner to perform an autopsy to try to determine the cause of death, but when a pet dies, it is much less likely that veterinary pathologists will have reason or opportunity to perform a necropsy.

Therefore, by the time FDA receives reports of deaths in pets, the pet has usually already been cremated or buried, preventing scientists from gather more information about the pet’s illness.

The plea

The agency has made it clear that they, “need more information about the pets that are getting sick. In order to get that information, we need the help of pet owners and veterinarians”. In an effort to get that critical information they have issued a letter asking veterinary practitioners who treat animals they suspect may have been sickened by eating jerky treats to report these cases to CVM through the FDA Safety Reporting Portal right away, “so that we can suggest certain tests (and cover the cost of these tests in many cases) when appropriate”.

Specifically, the agency is asking veterinarians help in FDA’s ongoing investigation by providing samples and information on potential jerky pet treat-related illnesses to their Veterinary Laboratory Investigation and Response Network (Vet-LIRN), by posting and handing out to clients the newly created Fact Sheet on jerky pet treat products.

Still unaware

Despite extensive media coverage of the illnesses associated with these products, sadly there are still pet parents who are unaware of this issue. In response, the Fact Sheet for pet parents that will made available at veterinary hospitals, pet supply stores, other stores selling pet food, and anywhere pet owners visit. The Fact Sheet explains what symptoms to look for and how to contact your local FDA office.

Made in China

The agency emphasized that manufacturers do not need to list the country of origin for each ingredient used in their products, so packages that do not state on the label that they are made in another country may still contain ingredients sourced from China or other countries that export to the U.S.

They also warned consumers that although the majority of complaints involve chicken jerky (treats, tenders, and strips), others include duck, sweet potato, and treats where chicken, or duck jerky is wrapped around rawhide, dried fruits, sweet potatoes, or yams.

The fallout

With updates comes pissed-off pet food companies. The companies that still import treats from China complain to the agency that their business suffers whenever the agency posts ‘Warnings’ and ‘Precautions’ on the FDA website and attribute the rise in complaints and media attention to those notifications. Pity the poor pet treat peddler.

On a personal note

I would like to thank Dr. Dan McChesney, of the Office of Surveillance and Compliance at the FDA Center for Veterinary Medicine, for giving Susan and I advance notice of the update. Further, we both appreciated the opportunity to discuss with him our concerns and questions regarding the update.

While I felt a little relieved after our conversation, Susan was not so easily swayed. Dr. McChesney explained that although they feel the treats that were recalled in January were unlikely to be the cause of illness due to sulfonamide hypersensitivity because the residue amounts were below tolerance levels, he did say that sulfonamide hypersensitivity syndrome is their most promising lead thus far.

Dr. McChesney expressed hope that the CDC may be able to help with information regarding similar diseases in human medicine. He explained that sadly, pets are the sentinels for human health.

Ogres

I have to believe that not everyone at FDA are ogres and that they are capable of human emotion just like you and me and that quite possibly, many of them go home to their own pets and wonder if they are doing enough.

In a poignant account, Linda Tollefson, the Associate Commissioner for FDA’s Office of Foods and Veterinary Medicine recounts her struggle with her inability to help solve the jerky treat mystery and describes how “it hurts, both personally and professionally, when the cause of illness eludes us despite global efforts to track it down”.

Pets are the tragic victims of a dysfunctional and deadly global food system. Will we ever know what became of the millions of Chinese people who consumed chicken contaminated with multiple antibiotic drugs in fast-food restaurants in China? We may not ever know, but we do know that more pets will die until our government can find a way to protect consumers, and their pets, from all that is wrong with our deeply flawed and dangerous food system.