Sunday, November 7, 2021

Dog Owners Recount DCM Heartbreak in FDA Comment Docket

     September 21, 2021, the FDA CVM hosted a virtual Listening Session on the Oversight of Pet Food. In addition to the live, recorded session of oral presentations, a comment docket was opened for public submissions and closed 11:59PM EST on 10/25/2021.

In total, the docket has 137 published entries. Broken down by topic:

  • ~20 pertain to the use of 4D (dead, dying, diseased, down) meat in pet foods
  • ~12 are on the subject of transparency and access by the public to FDA (and/or AAFCO) meetings
  • ~12 are in regards to various other issues or general opinions of the FDA
  • Nearly 100 are about diet-associated (non-hereditary) dilated cardiomyopathy (DCM)

Of those, a handful are from concerned pet owners, advocates, and veterinary professionals. The vast majority, however, are the heart-wrenching personal stories of affected pet owners and their dogs, including those deceased, those continuing to battle, and those recovered. These pet owners represent only a minuscule fraction of the over 1100 complaints submitted to the FDA (as of 7/20/2020) and yet they are a poignant reminder that this issue is more than data, statistics, research papers, and debates between academia and industry. 

There are real dogs, real people, real families, and such real heartbreak underlying this investigation. Many of them have called on the FDA to take more action towards this issue.


    The data and research regarding diet-associated DCM and the FDA's investigation have been detailed extensively on this website both in timeline form as well as a Q&A. These resources include links to materials from specialists, researchers, the FDA, and primary scientific literature. In short, cardiologists began to notice a concerning trend in the years leading up to 2018, when the FDA finally announced the investigation to the public. The concern was diagnosis of dilated cardiomyopathy, a disease where the heart stretches and loses the ability to pump effectively, in breeds not typically diagnosed with the disease. Further raising concerns, many of the dogs were eating grain-free diets. In the years that have followed, research has continued to confirm evidence of association between diets that are grain-free or high in pulse legumes with atypical, oftentimes reversible, DCM. Reversible is one of the keys to this emerging disease. DCM is a progressive disease that does not improve, even with aggressive medical therapy, unless due to a secondary cause such as nutrition or chronic toxin exposure. In those latter cases, removal of the inciting cause can sometimes provide the heart enough respite to heal. That appears to be what we're seeing

The data can be belabored indefinitely, and is often met with push back from invested parties such as members of the pet food industry or pulse legume associations. There is more than just numbers at stake here, though. And because we're human, that cannot be forgotten. 

We have the numbers; these are their stories.
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    Oliver and Riley's story is told by Julie. Both loving Golden Retrievers diagnosed, and one could not be saved. She describes the trauma of Oliver's death secondary to an arrhythmia, "the moment he rolled onto the floor, the expression on his face, or the blank stare in his eyes. That moment made an indelible mark on my life and fundamentally changed me forever." Arrhythmias, or abnormal disturbances to the regular rhythm of the heart, are a complication that can occur at any time in a dog with DCM. These disturbances are undetectable without the use of technology, and can happen randomly, with the potential for sudden death. Oliver was 3.5 years old when diagnosed, and he passed less than a week after his fourth birthday. Julie shares that he was part of the Golden Retriever Lifetime Study, Hero #2803. His mission to help his breed was cut short, instead becoming a larger mission of awareness and advocacy for the disease that stole his life. Julie writes: "As I helplessly watched the life fade from my best friend, I made a promise to him and myself that his legacy would be one of education for those unaware and compassion for those affected by this cruel disease."

    Riley, Oliver's housemate and another Golden, would be diagnosed one month after his death. Today, her disease is considered 99% resolved. She is counted among the lucky dogs that, following diet change and medical management, can eventually experience resolution of disease. Reverse remodeling of the heart is something that does not happen with DCM of genetic origin, regardless of medications administered.

    Julie further details the path that led to these circumstances; counsel by a pet food store owner who insisted smaller, boutique diets were higher quality. When later pressed, he admitted he was not trained in nutrition, and was rather repeating what the pet food sales rep had told him. 

    Finally, she describes at length the immeasurable heartbreak, a "seemingly endless parade of affected dog owners," that flood the support group she helps to manage.

    "They arrive confused, terrified and often riddled with misplaced guilt, at the thought that somehow, their decisions could have contributed to the sickness or death of their best friend.  Diet-Associated DCM brings along an emotional and financial burden that no one deserves. ...The fact that these implicated brands remain  on the shelves is incredibly painful for all affected owners.  However, to see them advertised and promoted as if their brands have had no connection/correlation to this ongoing health risk  is unforgivable.

While Diet-Associated DCM is known to break the canine heart, enough emphasis has not been placed on the unspeakable toll it takes on the human heart.  I often struggle with what to say to our devastated and heartbroken owners... What can I say to someone whose heart has been shattered into a million pieces? Someone who has lost so much?  How can I find the ‘right’ words, when there is nothing ‘right’ about this situation?  After 3 years of saying I’m sorry... those words now seem hollow and meaningless.  Affected dog owners suffer emotionally, physically and financially.  They deserve more than I’m sorry.  They need answers and most of all they need action."

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    A beautiful mixed breed, Bob, is honored through Juliana. Bob and Juliana went everywhere together, and he loved to explore the wilderness. She fondly relays a story of Bob boldly playing with a pack of coyotes in the woods, much to her horror and his apparent amusement. She writes: "he had this  unmatched zest for life in everything he did. He was the best copilot I’ve ever had, springing out from  under the bed at 5:30 am ready for another day with us. Who knew that soulmates could transcend  species?"

    Bob was diagnosed at 4.5 years old. The cardiologist discussed the severity of disease and the suspected link to diet. "I heard his words and my heart knew what they meant, but I couldn’t comprehend the 6-8 month part. It was like I was under water. I couldn’t hear, I couldn’t breathe. I wanted to reverse the last 4.5 years and pick a different food for him. I wanted a do-over. I owed Bob more than choosing this $80-a-bag  death sentence for him." After starting on a regimen of medications, "Bob died 8 days after his initial diagnosis at his follow up appointment ... He  was walking into an exam room and collapsed from a fatal arrhythmia. He told us he was likely gone  before he hit the ground, a sentiment that is bittersweet. It was quick, but he wasn’t supposed to go so soon." She says that in reflection of his death, she connected with other affected pet owners, and found that they shared "many layers of guilt," regarding their dogs. 

"The work that we do supporting affected owners and advocating for more research and changes in the food industry is my way of carrying on Bob’s legacy. I won’t let his death be meaningless or senseless. If his story could prevent even just one dog from this horrible fate, he didn’t die in vain."

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 The story of a long road to recovery for two working Labrador retrievers is shared by Martha. Her dogs were diagnosed by chance, while one was undergoing treatment for a snake bite. This highlights the insidious nature of DCM; it can be a silent disease, one that manifests in ways undetectable through normal physical examination. Some dogs show no overt symptoms and abruptly die in a collapse episode. Others show vague and non-specific signs, like a generalized loss of energy and vigor.

"The emotional, mental, physical and financial toll that ensued can never be  fully described nor can it be understated. The heart medications used to  treat DCM are incredibly expensive, not to mention multiple regular trips to a cardiologist 3 ½ hours away for electrocardiograms every few months."

Martha laments that her active, energetic working dogs, one of them among the best retrievers her family ever knew, lost the prime of their life to management of a heart condition. Her comment discusses at length the impact that a strict medication schedule has on one's life, ensuring that the many needs of a dog in medical care are met, and all secondary to something as seemingly harmless as a commercial diet. Poignantly, she writes

 "These people should not have to become experts in pet food formulation in order to decide what food to buy, rather they deserve to be able to trust that the dog food they purchase should nourish their dogs instead of destroying their hearts. "
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Bentley, a Welsh Terrier, was not predisposed to DCM, and yet several years after diagnosis, he is still in incomplete recovery from the disease. The sad reality is that despite diagnosis and intervention, not all dogs will make an abrupt or complete recovery. Katie describes the moment of his diagnosis and the emotions over the following weeks, months, and years: 
 
"Bentley received a severe DCM diagnosis from the cardiologist, suspected (and now confirmed) of being of diet associated.  We were advised that we should cancel any travel plans that we may have because he did not have long. After the full exam, we were given the grim prognosis of 3 to 6 months “with a miracle.”  A part of me died inside. ... My husband and I have experienced so many emotions – Fear, Grief, Anger, Guilt, and Hopelessness being just a few.  How could we have known that the food we thought was the best possible thing for him was killing him? It still makes me tear up to think about and enrages me at the same time. "
    Bentley has had ups and downs, but in April of this year, he showed clinically significant improvements and is continuing his journey. His mom writes that his care has cost over $15,000 over the last several years, and acknowledges that for those that cannot make ends meet with such costs, a terrible decision may have to be considered. She closes, "Additionally, regulating the marketing and manufacturing process of the companies that are  selling/making the foods linked to DCM – holding them accountable – would be a very small comfort and source of closure to the families with dogs impacted with this believed-to-be-preventable disease."

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    Matilda, a service dog, developed DCM at just shy of three years. Her owner Lynne begins her comment in discussing disappointment with the FDA's handling of the issue, namely the failure to include pet owners in consideration as relevant stakeholders. 
 
 "I am a stakeholder. I expect the FDA to protect not just my interests but the health of my pet and in this case, my service dog. I expect the FDA to be transparent regarding the investigation that I am participating in. And I expect the FDA to do it’s due diligence in investigating the issue. Unencumbered by outside influences such as manufacturers. I expect FDA to ensure the food we as pet owners are feeding, is safe and will not cause harm to our pets."
She calls on the FDA to lift their silence on this issue and prioritize it within the CVM. She also requests that all information pertaining to the investigation be made public and accessible. 

Matilda has improved with a diet change.

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The owner of an unnamed Golden Retriever, Shannon lost her dog to severe DCM less than a year following his diagnosis at 5. She writes:
 
 "Oversight, communication, investigation and reparation to this industry is needed and must be done to prevent this from happening to other pets and families.  We are
still mourning the loss of our precious dog and feel that we have been let down by the system.   
 
Please hold pet food companies accountable to produce quality food that doesn’t result in the death of our animals."
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  Willyanne wrote in about three dogs, two deceased and one battling DCM. 

"As a affected pet owner to multiple dogs who were stricken by nutritional DCM caused by the food I was feeding, I am requesting openness and honesty from the FDA as well as the pet food companies. I trusted my beloved dogs with a certain company just to find out that the food I was feeding them was killing them.Once I found out what was happening, it was too late. Very tragically and brutally, I lost 2 of my dogs. It was not genetic related in the least. My 3rd dog is still after 3.5 years still on daily medications to reverse the damage caused by the food."
On an aside, it's important to understand that the medications used to treat DCM have never been shown, themselves, to reverse the disease. Rather, these medications provide additional stability to the heart and improve function, which allows affected dogs to survive longer and more comfortably. In dogs with secondary disease, this can effectively "buy time" while the heart heals from the insult. Otherwise, these dogs may succumb to their disease before having long enough to recover.   

Willyanne continues with a heart wrenching account of the emotional and financial toll of this disease, emphasis added: 

"The guilt for feeding and killing our dogs (even though we had no clue) is huge. The anger at the insensitive reactions from the pet food companies, the frustration and anger at the FDA for not being more proactive about this serious situation and their silence over the last year. The deep grief that affects every day life including while out in public and at work. The financial burden that we are suddenly thrown into because suddenly we have huge vet bills, cardiologist bills and countless medications. The mental state many of us are in, having to battle depression and anxiety because of the trauma this has all caused us. We do not know if we come home from work what we will find. It is with a quaking heart that I every day open the door and see if my dog will greet me or if I have to maybe go find a lifeless body somewhere. The sleepless nights, the nightmares. The list can go on about how life is no longer what is was before nutritional DCM struck"

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    Another Golden Retriever, Truckee, is discussed in Bryan's comment to the FDA. Many people are struck by the over-representation of  Golden Retrievers with this disease. While this had led some to speculate a genetic, breed-related component, the more likely explanation is that early advocacy and awareness within the Golden Retriever breed communities led to greater diagnosis. DCM is a disease that can be entirely silent unless an echocardiogram is performed, and as awareness of this disease spread, members of the community organized health clinics where dogs could be screened for cardiac disease. Additionally, Golden Retrievers are among the most popular breeds in the USA, increasing their numbers and easily inflating their representation.

Truckee was 7 years old when diagnosed. Bryan writes not just about the financial and emotional toll of the disease, but his disgruntlement with the FDA's inaction thus far:

"Over the past several years the FDA has not hesitated to act swiftly in matters related to human  health such as vaping targeted at youth and baby food concerns.  Unfortunately in the case of  providing oversight on pet foods, the FDA has made the conscious decision to move at a  glacial pace. 

My comment(s) can be summed up simply, I IMPLORE YOU TO PLEASE DO YOUR JOB AND FULFILL THE MANDATE OF THE FOOD AND DRUG ADMINISTRATION, by providing more actionable oversight of the pet food industry."

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  Stephanie writes about the difficulty of obtaining her dog's diagnosis after a cough developed. Her unnamed dog was eventually diagnosed with DCM by a cardiologist, and the comment states that he was taking close to 30 pills per day for management of the disease. 

"The cardiologist warned to keep the dog inactive and indoors in the air conditioning all summer to avoid overheating. I did the best I could. The dog developed an arrhythmia and more pills got added. Then on a hot July day in 2019 I let the dog out to potty. He was out less than 5 minutes. He came in the house and seemed the same as before he went out. I left the room for literally a few minutes and came back. My beautiful boy was laying dead on the floor!!!! I wasnt there with him. I couldn't do anything. I tried chest compressions, but nothing happened. My world fell apart. I am crying writing this. That dog meant the world to me. He is buried in a real pet cemetery. I still can not believe he's gone."

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     A mixed breed dog, Sabbath, has recovered significantly since her diagnosis, but is not completely normal. Her owner Nicole writes that despite submitting records to the FDA, there has been no response or follow-up. Sabbath's diagnosis started with suspicion of epilepsy. She collapsed on a walk, gasping for air with a hunched back, and frothing at the mouth. Nicole calls it one of the scariest moments of her life. At the ER, this was proposed to be seizure activity. Separately, this ER vet suggested changing Sabbath's diet due to an investigation underway at the FDA. At Sabbath's regular vet, the same tentative epilepsy diagnosis was made, but a heart murmur was also noted. X-rays confirmed the veterinarian's concern: an enlarged heart. Follow-up with cardiology revealed DCM. 

    With heart disease, "fainting" episodes known as syncope can occur due to transient loss of adequate blood flow to the brain. This is most often triggered by exercise, and to the untrained eye, can appear very much like a seizure.
"We are absolutely heartbroken. I want to share our story as a way to help raise the awareness of the risk of grain free diets and nutritional DCM. I am very concerned about the lack of progress made on diet related DCM with grain free foods. I am also very concerned about the lack of responsibility of the pet food companies involved."
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In the interest of not waiting too long to publish this, it has been published incomplete. Additional stories will continue to be added until they're all represented here.

Be sure to check back daily or weekly. In the interim, if you have questions or concerns about Dilated Cardiomyopathy in dogs, please check the resources below. You can also connect with other pet owners and read more stories from affected dogs in all stages in the Diet-Associated Dilated Cardiomyopathy in Dogs Facebook Group.

If your dog has been diagnosed with diet-associated non-hereditary DCM, you or your vet can report to the FDA using this link
 
Dr. Lisa Freeman, a veterinary nutritionist and one of the lead researchers investigating this disease process, has published a number of updates to the Tuft's Petfoodology blog, the most recent of which was published September 2021
 
 


 

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