TCR Challenges FDA Over DCM Redactions, Refusal to Update Website

Today, Yale Law School’s Media Freedom and Information Access Clinic filed an appeal letter on behalf of TCR and Emily Brill, which challenges several redactions in the FDA’s April 2023 FOIA response 2023-348. The appeal also challenges the agency’s non-compliance with FOIA in its repeated denials of our requests to update the Reading Room, per the Rule of 3/Frequently Requested Records statute of the FOIA.

No Major News Organizations Covering DCM Accurately

Remarkably, no major news organization has adequately or accurately reported on nutrition-associated dilated cardiomyopathy (DCM) in dogs, a condition identified by veterinary cardiologists and nutritionists who began comparing notes in 2014, when they began to observe atypical cases of the illness in dogs with one commonality: nontraditional diets, many of them “grain free.”

Many reputable news businesses, including the Associated Press, have failed to cover this story with the necessary level care a complex policy, business, and human interest story demand.

Even the American Veterinary Medical Association’s website newsletter, have botched coverage of this complex business and policy story which is,  at its core, a science story. How nutrition-DCM in dogs became a policy story – the underpinnings of those special interests – is what pushes this story

The press must engage and cover this story now that the information logjam may soon be cleared thanks to the lawyers. More than sixty million American households now consider the dog a family member. The economic, not to mention emotional, impact of the FDA’s persistent absence as far as refusal to provide updates cannot be overstated.

FDA DCM DATA BLACKOUT

In 2020, the FDA was pressured by farm state senators who were pressured by lobbyists to stop releasing information about a connection between certain types of dog foods and an often-fatal heart condition that comes with little or no warning and impacts even puppies. For nearly two years prior to the pro bono legal assistance from Yale MFIA, information about dogs and nutrition DCM in reports received to the FDA were unattainable. The FDA refused even to cite any FOIA exemption. And, even though their own data demonstrates urgency as case numbers more than double between 2018 and 2019, the last time the Agency released information before being muzzled by lobbyists was before TCR had launched.

The data we unearthed in late April revealed that some of the most popular dog food brands rank highest in the number of cases the brand has been associated with between 2019 and Nov. 2022. Acana (116), Taste of the Wild (114), Zignature (97), Blue Buffalo (69), Kirkland (49), Earthborn (34), Fromm (29), 4Health (26), Orijen (25), VDog (20), Natural Balance (19), Merrick (16), Diamond (15), Wellness (14), Wholehearted (13), Instinct (11).

“Silent Killer”

Veterinarians call it a “silent killer,” largely because the general public has never heard of diet DCM in dogs and even many veterinarians either don’t know about the FDA’s earlier warnings, or, unfortunately, read the irresponsibly written bulletins from the AVMA’s website or from an industry blog announcing DCM was effectively over.

But if a Facebook group’s activity in the past 48 hours is any indication, DCM is not over. TCR is concealing the surnames of the individuals we quoted because although the Facebook group has 130,000+ members, the veterinarians who moderate the group ask that members not post content outside the group. We are overriding this directive, as we’ve done in the past, because the group is public and because the group’s stated intention is to educate the public. To address privacy concerns, we removed surnames.

The tragedies we’re quoting are only from the past 24-48 hours in a Facebook Group with dozens of posts each day on average. One dog after the next. Diagnosis. Death. If it’s sounds awful, that’s because it is. One thing this isn’t is the end of DCM:

“We lost Tremor,” Jill X posted to the Diet Associated Dilated Cardiomyopathy (DCM) in Dogs group with more than 130,000 members on July 18, 2023, describing the dog as an “almost 8-year-old Irish Setter” diagnosed with diet associated diet DCM in June 2022.

“She had a sudden cardiac arrest a few minutes after we got home. She greeted us with a normal level of excitement and then curled up on her dog bed to wait for dinner. She gave a yelp of pain, jumped to her feet and tried to jump out the window. We ran to her, comforted her, and then she was gone.”

Alison Z. posted to the Facebook group on July 19, 2023, recalling her loss of Nyla to DCM in May. Nyla was eating Taste of the Wild when she was diagnosed, according to her owner.  “She was doing great for a long time, and then she collapsed..I held her to her last breath,” Ms. Z told the group.

Laurie Y. said Beau passed in June. “He survived this horrible, senseless disease for 28 months,” Ms. Y recalled.

“My beautiful girl just passed away,” Wendy S. wrote. “She was diagnosed with diet related dilated cardiomyopathy.”

“4 WEEKS”

“Overall, DCM-like changes observed with the wrinkled pea diet, but not lentil diet, after only 4 weeks in a breed not known to be susceptible, support a link between pea-based diets and canine nutritionally-mediated DCM,” renowned veterinary cardiologist Joshua D. Stern posted to the DCM group, quoting a recent study which had made a strong impression because its funding had come from the pulse industry, presumably hoping for a different outcome.

“4 weeks!!!!” Dr. Stern noted, referring to the short amount of time it took for dogs eating pea diets to present clinical signs (or measurable changes) to heart function.

In other words, science has established the nexus between diet and DCM. Pinpointing exactly what aspect of the diet is the question vets continue to try to answer. Without data, without the public sending more reports to the FDA, and without the media’s attention, researchers are fighting an uphill battle.

We’re hopeful that today’s appeal will flip the narrative and end the blackout.

Here is an excerpt from the appeal filed on our behalf today:
The Requester also challenges the FDA’s constructive denial of her request that CVM update its Electronic Reading Room to post DCM records and the agency’s failure to do so since April 30, 2019. The 2016 amendments to FOIA codified the “Rule of 3,” requiring automatic reading-room treatment for records requested three or more times. 5 U.S.C. § 552(a)(2)(D). Animal Legal Def. Fund v. United States Dep’t of Agric., 935 F.3d 858, 863 (9th Cir. 2019). The “Rule of 3” provides access to frequently requested records thereby “reduc[ing] the need for individual requests and the corresponding lag time.” Id. at 869 (citations and footnote omitted).
In correspondence between the FDA and the Requester in January of 2022, the Requester inquired as to why the FDA had not posted any DCM records in the CVM Electronic Reading Room since 2019. Ex.D. Ms. Anne Norris, Office of the Director of CVM, responded to the Requester on January 6th, 2022 stating that the “documents are being published in the CVM Electronic Reading Room on a rolling-basis.” Id. She also stated that although “it was going to be really tricky to estimate the wait time for the items in the reading room” that she would find out about the wait time and let the Requester know. Id. To date, those records have not been posted in the “reading room” and Ms. Norris has not provided the Requester with an estimated date as to when they will be posted. Moreover, the agency ignored the Requester’s April 2023 request that it confirm it would update the CVM reading room with the responsive records.
Aside from the FDA’s previous acknowledgement that DCM records are frequently requested, the agency’s FOIA logs also indicate as much: numerous other requesters have sought these same records in the last few months and years. This further makes clear the FDA’s obligation under FOIA to affirmatively post them. Its continued failure to do so violates FOIA.
I look forward to your response within 20 working days.
Sincerely,
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